PATENTS AND DRUGS
Item
- Title
- PATENTS AND DRUGS
- extracted text
-
RF_DR_39_PART_1_SUDHA.pdf
Page 1 of2
Naveen
From:
To:
Co:
Sent:
Attach:
Subject:
"msfh-india-medco-assist" <msfh-india-medco-assist@field.amsterdam.msf.org >
<mirashiva@yahoo.com >; <prasanna_aid@yahoo.com >; <naveen@sochara.org>;
<gopa.kumar@centad.org>; <drdabade@gmail.com>; <sahajbrc@icenet.co.in>;
<bodhi_fha@dataone.in >; "Anurag Bhargava" <madhurag_bhargava@rediffmail.com >; "sahajbrc"
<sahaj2006@dataone.in>; "Anant Phadke" <amol_p@vsnl.com>; <pc@lawyerscollective.org>;
"Kajal Bhardwaj" <k0b0@yahoo.com>; "aidslaw" <aidslaw@lawyerscollective.org>; "Y K SAPRU"
<yksapru@cpaaindia.org>; "Loone Gante" <loon_gangte@yahoo.com>; "chan park"
<chansoobak@yahoo.com>; "dr. sathyamala" <csathyamala@gmail.com>
<Ellen.T.HOEN@paris.msf.org>; "Fernando PASCUAL"
<Fernando.PASCUAL@geneva.msf.org >; <pascale.boulet@geneva.msf.org >; "MSFH-lndia-Hom"
<msfh-india-hom@field. amsterdam.msf.org >; "Ramya Sheshadri" <biotechramya@gmail.com >;
"prafulla saligram" <prapulli@gmail.com >; "Julie George" <george.julie@gmail.com>;
<rattan_mnp@yahoo.co.in >; <ncpplus2003@yahoo.com>; <kkabraham@inpplus.net >;
"Bappaditya Mukherjee" <bappaditya_mukherjee@yahoo.co.in >; "SAATHII"
<saathii@yahoo.com>; "vinod" <vinudirect@gmail.com>; <daisy@inpplus.net>; "msfh-indiamedco-assist" <msfh-india-medco-assist@field.amsterdam.msf.org >; <priya.pillai@centad org>
08 March 2007 12:04
attachments.zip
draft agenda stakeholders meeting, 12 & 13 march, mumbai
Dear mr. sapru, anant, chinu, mira, dr. sathya, prasanna, dr.dabade, abraham, loon and others,
many of you have requested a copy of the agenda, i am attaching the draft agenda. I hope that this meeting
brings together for the first time many from all those organisations (and individuals) in india who are deeply
connected by their work on access to treatment, the coming month is a crucial time with the novartis case,
moxifloxacin opposition coming up. the ministry of chemicals and fertilizers is drafting a new pharma policy,
proposing a unified regulatory authority and also finalising recommendations on data exclusivity.
ministry of health officials who understood the link between intellectual propoerty laws & prices and who were
proposing a meeting on price control have been transferred, minstry of commerce is quitely rewriting the
mashelkar report.
keeping in mind all this and many other developments that I may not be aware of i hope this meeting is the
first among others to discuss concerns and issues related to affordable prices of medicines.
hope to see you all at the meeting,
the venue of the meeting is West End Hotel located in new marine lines, opposite bombay hospital.
Warm Regards,
Leena Menghaney
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
C 106 Defence Colony
New Delhi 110 014
Tel: +91 9811365412, +91 1124332419
avast! Antivirus: Inbound message clean.
08/03/2007
Draft Agenda
Stakeholders workshop on Pre-grant Patent Oppositions and other
issues related to drug regulation and prices
12 & 13th March 2007, West End Hotel, Mumbai
Terrace Hall, West End Hotel
Objective of the meeting is to bring together stakeholders involved in
research, advocacy, legal, technical and communication work related to
access to treatment issues in India. Key stakeholders are health movement
experts, patient groups, legal and community based organisations. Some of
the issues of concern are related to law reform and implementation of the
product patent regime with respect to its impact on the production of
essential drugs by India for its people and patients in other developing
countries. Advocacy and communication strategies focusing on bringing
about mobilization and raising public debate around these issues are key to
the success of this workshop.
Time
Day 1 sessions
9: 00-9:30 a.m.
Tea & Registration of participants
9:30- 10:00 a.m.
Introductions
Welcome by Vivek Divan (Lawyers Collective HIV/AIDS
Unit)
Objectives of the meeting
Johannes van der Weerd (MSF - Holland in India)
Patents & Access
10:00- 1:00 p.m.
What are patents? How do you have the same
patent in different countries?
Lawyers Collective HIV/AIDS Unit
Patents, non-availability and high pricing of
medicines?
Cancer patient’s experience in India
Y.K Sapru (Cancer Patients Aid Association)
- MSF’s experience in other developing countries
Ellen ‘t Hoen and Fernando Pascual (MSF Access
Campaign)
The importance of patent oppositions in India?
Experience of opposing patent applications on
newer AIDS drugs
Loon Gangte (INP+/DNP+)
Can’t the original molecule be used if new form gets
patented? (E.g. can * imitinib’ be used instead of
imitinib mesylate in cancer treatment, can
6moxifloxacin’ be used instead of moxifloxacin
monohydrate in TB treatment?)
Chan Park (Lawyers Collective HIV/AIDS Unit)
Fernando Pascual (MSF Access Campaign)
1:00 - 2:00 p.m.
LUNCH
2: 00 - 4:30 p.m.
The process of identifying drugs on which patent
applications are pending in India
What are the inputs required of medical
practitioners and patient groups in identifying
drugs which are important /essential
Overview of ARV drug patent applications pending
in India
Lawyers Collective HIV/AIDS Unit
Overview of Cancer & TB drug applications pending
in India
Presentation of research by CENTAD
Discussion facilitated by MSF on how to identify
drugs which will be important for the future
4:30 - 5:30 p.m.
Explaining the legal process of filing patent
oppositions, hearings, appeals
Lawyers Collective HIV/AIDS Unit
Working groups (after the workshop)
6:00 - 7:30 p.m.
Working Group I
Patent oppositions on AIDS drugs with specific
focus on TDF, Lopi/rito (Kaletra)
(Concerned representatives PLHA networks, INP+,
Lawyers Collective, MSF)
6:00 - 7:30 p.m.
Working Group II
Moxifloxacin patent opposition
(Concerned representatives of AIDAN, Lawyers
Collective)
Day 2 sessions
9:30 - 11:00 a.m.
The TB drug patent opposition
When? - Lawyers Collective
Communication & advocacy strategy - discussion
(Facilitated by AIDAN)
11:30 - 1:00 p.m.
Novartis challenge to Indian Patent Law & Glivec
patent decision
Legal update - Lawyers Collective
Advocacy & Communication - future strategy
(Facilitated by Centad)
Advocacy in Parliamentary (Vinod Bhanu)
1:00 - 2:00 p.m.
LUNCH
2:00 - 3: 30 p.m.
Strategy regarding granted patents
Post grant oppositions (Lawyers Collective)
Post grant opposition - the experience in the
USA - are there options for collaboration?
Dan Ravisher - Patent Foundation US
- Advocacy with health & commerce ministry
(Centad)
3:30 - 4: 30 p.m.
Mashelkar Committee Report
Is a critique of the contents required in light
of the debate on the patentability of
“incremental innovations”
Strategy regarding the new report being
prepared by Ministry of Commerce
How to take this up in parliament?
(Discussion facilitated by Chan Park & Centad)
4:30 - 5: 30 p.m.
Campaign on access to affordable drugs in India
Focus areas
- Strategy
Concerns
Discussion facilitated by Loon Gangte (INP+/DNP+)
4:30- 5:30 p.m.
Reimbursements
---- Original Message----From: "msfh-india-medco-assist" <msfh-india-medco-assist@field.amsterdam.rnsf.org >
To: "Bappaditya Mukherjee" <bappaditya mukherjee@yahoo.co.in>; <csathyamala@gmail.com>: "Gopa Kumar"
<gopa.kumar@centad.org >; <ncpplus2003@yahQo.com>: <kkabraham@inpplus.net>; "MSFH-India-Hom" <msfh-indiahom@field.amsterdam.msf.org >; "Kausalya" <kousalya@pwnplus.org>; "Loone Gante" <loon gangte@yahoo.com>; "DNP+1
<dnpplus@yahoo.co.in>; <mirashiva@yahoo.com>; <upnpplus@yahoo.co.in>; "Naveen_CHC" <naveen@sochara.org>;
<priya.pillai@centad.org >; <rattan mnp@yahoo.co.in>; <reenageorge@vsnl.com>; "siddharth narrain"
<siddharth.narrain@gmail.com>; "Subhadip Roy" <subhadip roy 04@yahoo.com>; "vinod" <vinudirect@gmail.com>
Cc: "msfh-india-medco-assist" <msfh-india-medco-assist@field.amsterdam.msf.org>; "Mai DO" <Mai.DO@paris.msf.org>
Sent: Thursday, March 08, 2007 1:02 PM
Subject: Staekholders Workshop in Mumbai, Directions to the venue
H
Dear all,
> The venue for the 12 & 13th March Stakeholders Workshop on pre-grant patent
> oppositions is the West End Hotel, New Marine Lines, Mumbai. It is opposite
> to the Bombay Hospital and adjacent to the Liberty Cinema. Contact No. of
> the hotel is 022-22039121. For further details please see attached map. Taxi
> to the venue from the airport will cost approximately about Rs. 300.
Please feel free to contact us for any other assistance, 09871800723.
Saral Kumar
Project Assistant
Campaign for Access to Essential Medicines
Medecins Sans Frontieres - Holland (in India)
Tel:+91 11 24337225, + 91 1151552413
Fax: +91 11 24336834
E-mail: mslh-india-medco-assist@field.amsterdam.msf.org
West End Hotel
45, New Marine Lines, Mumbai - 400 020
Tel.:
2203 9121
Fax:91-22-2205 7506
E-mail: wesihoiel@haihway.com • Website: www,westendholelmunibai.com
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Draft Agenda
Stakeholders workshop on Pre-grant Patent Oppositions and other
issues related to drug regulation and prices
12 & 13th March 2007, West End Hotel, Mumbai
Terrace Hall, West End Hotel
Objective of the meeting is to bring together stakeholders involved in
research, advocacy, legal, technical and communication work related to
access to treatment issues in India. Key stakeholders are health movement
experts, patient groups, legal and community based organisations. Some of
the issues of concern are related to law reform and implementation of the
product patent regime with respect to its impact on the production of
essential drugs by India for its people and patients in other developing
countries. Advocacy and communication strategies focusing on bringing
about mobilization and raising public debate around these issues are key to
the success of this workshop.
Time
Day 1 sessions
9: 00 - 9:30 a.m.
Tea & Registration of participants
9:30- 10:00 a.m.
Introductions
Welcome by Vivek Divan (Lawyers Collective HIV/AIDS
Unit)
Objectives of the meeting
Johannes van der Weerd (MSF - Holland in India)
Patents & Access
10:00- 1:00 p.m.
What are patents? How do you have the same
patent in different countries?
Lawyers Collective HIV/AIDS Unit
Patents, non-availability and high pricing of
medicines?
Cancer patient’s experience in India
Y.K Sapru (Cancer Patients Aid Association)
- MSF’s experience in other developing countries
Ellen ‘t Hoen and Fernando Pascual (MSF Access
Campaign)
The importance of patent oppositions in India?
Experience of opposing patent applications on
newer AIDS drugs
Loon Gangte (IMP+/DNP+)
Can’t the original molecule be used if new form gets
patented? (E.g. can ‘ imitinib’ be used instead of
imitinib mesylate in cancer treatment, can
‘moxifloxacin’ be used instead of moxifloxacin
monohydrate in TB treatment?)
Chan Park (Lawyers Collective HIV/AIDS Unit)
Fernando Pascual (MSF Access Campaign)
1:00 - 2:00 p.m.
LUNCH
2: 00 - 4:30 p.m.
The process of identifying drugs on which patent
applications are pending in India
What are the inputs required of medical
practitioners and patient groups in identifying
drugs which are important /essential
Overview of ARV drug patent applications pending
in India
Lawyers Collective HIV/AIDS Unit
Overview of Cancer & TB drug applications pending
in India
Presentation of research by CENTAD
Discussion facilitated by MSF on how to identify
drugs which will be important for the future
4:30- 5:30 p.m.
Explaining the legal process of filing patent
oppositions, hearings, appeals
Lawyers Collective HIV/AIDS Unit
Working groups (after the workshop)
6:00 - 7:30 p.m.
Working Group I
Patent oppositions on AIDS drugs with specific
focus on TDF, Lopi/rito (Kaletra)
(Concerned representatives PLHA networks, INP+,
Lawyers Collective, MSP)
6:00 - 7:30 p.m.
Working Group II
Moxifloxacin patent opposition
(Concerned representatives of AIDAN, Lawyers
Collective)
Day 2 sessions
9:30 - 11:00 a.m.
The TB drug patent opposition
When? - Lawyers Collective
Communication & advocacy strategy - discussion
(Facilitated by AIDAN)
11:30 - 1:00 p.m.
Novartis challenge to Indian Patent Law & Glivec
patent decision
Legal update - Lawyers Collective
Advocacy & Communication - future strategy
(Facilitated by Centad)
Advocacy in Parliamentary (Vinod Bhanu)
1:00 - 2:00 p.m.
LUNCH
2:00 - 3: 30 p.m.
Strategy regarding granted patents
Post grant oppositions (Lawyers Collective)
Post grant opposition - the experience in the
USA - are there options for collaboration?
Dan Ravisher - Patent Foundation US
- Advocacy with health & commerce ministry
(Centad)
3:30 - 4: 30 p.m.
Mashelkar Committee Report
Is a critique of the contents required in light
of the debate on the patentability of
“incremental innovations”
Strategy regarding the new report being
prepared by Ministry of Commerce
How to take this up in parliament?
(Discussion facilitated by Chan Park & Centad)
4:30 - 5: 30 p.m.
Campaign on access to affordable drugs in India
Focus areas
- Strategy
Concerns
Discussion facilitated by Loon Gangte (INP+/DNP+)
4:30 - 5:30 p.m.
Reimbursements
Agenda
Stakeholders’ workshop on Pre-grant Patent Oppositions and other
issues related to drug regulation and prices
12 & 13th March 2007, Terrace Hall, West End Hotel, Mumbai
Objective of the meeting is to bring together stakeholders involved in
research, advocacy, legal, technical and communication work related to
access to treatment issues in India. Key stakeholders arc health movement
experts, patient groups, legal and community based organisations. Some of
the issues of concern are related to law reform and implementation of the
product patent regime with respect to its impact on the production of
essential drugs by India for its people and patients in other developing
countries.
Time
Day 1 sessions
9: 00 - 9:30 a.m.
Tea & Registration of participants
9:30 - 10:00 a.m.
Introductions
Welcome by Vivek Divan (Lawyers Collective HIV/AIDS
Unit)
Objectives of the meeting
Johannes van der Wecrd (MSF' Holland in India)
Patents & Access
10:00 - 1:00 p.m.
What are patents? How do you have the same
patent applications in different countries?
Lawyers Collective HIV/Al DS Unit
Patents, non-availability and high pricing of
medicines?
Cancer patient’s experience in India
Y.K Sapru (Cancer Patients Aid Association)
- MSF’s experience in other developing countries
Ellen ‘t Boon and Fernando Pascual (MSF Access
Campaign)
The importance of patent oppositions in India?
Experience of opposing patent applications on
newer AIDS drugs
Loon Gangtc (INP-t /DNP* )
Can’t the original molecule be used if new form gets
patented? (E.g. can ‘ imitinib’ be used instead of
imitinib mesylate in cancer treatment, can
‘moxifloxacin’ be used instead of moxifloxacin
monohydrate in TB treatment?)
Time
1:00
2:00 p.m.
2: 00 - 4:30 p.m.
________________ Day 1 sessions
Chan Park (Lawyers Collective HIV/AIDS Unit)
Fernando Pascual (MSF Access Campaign)
LUNCH
The process of identifying drugs on which patent
applications are pending in India
What are the inputs required of medical
practitioners and patient groups in identifying
drugs which are important /essential
Overview of ARV drug patent applications pending
in India
Lawyers Collective HIV/AIDS Unit
Overview of Cancer & TB drug applications pending
in India
Presentation of research by CENTAD
Discussion on how to identify drugs which will be
important for the future
4:30 - 5:30 p.m.
Explaining the legal process of filing patent
oppositions, hearings, appeals
Lawyers Collective HIV/AIDS Unit
Working groups (after the workshop)
6:00-7:30 p.m.
Working Group I
Patent oppositions on AIDS drugs with specific
focus on TDF, Lopi/rito (Kaletra)
(Concerned representatives PLHA networks, INP*-,
Lawyers Collective, MSP)
Time
Day 2 sessions
9:00 - 11:00 a.m.
Novartis challenge to Indian Patent Law & Glivec
patent decision
Legal update - Lawyers Collective
Advocacy & Communication - future strategy
(Facilitated by Ccntad)
Advocacy in Parliament (Vinod Bhanu)
11:30 - 1:00 p.m.
The TB drug patent opposition
When? - Lawyers Collective
Communication & advocacy strategy - discussion
(Facilitated by AIDAN)
1:00 - 2:00 p.m.
LUNCH
2:00-3: 30 p.m.
Strategy regarding granted patents
Post grant oppositions (Lawyers Collective)
Analysis of granted patents
Specific test cases undertaken to understand
legal process
- Advocacy with health & commerce ministry
(Ccntad)
3:30 - 4: 30 p.m.
Mashelkar Committee Report
Is a critique of the contents required in light
of the debate on the patentability of
“incremental innovations”
Strategy regarding the new report being
prepared by Ministry of Commerce
How to take this up in parliament?
(Discussion facilitated by Chan Park & Ccntad)
4:30 - 5: 30 p.m.
Patent oppositions in India
Focus areas
- Advocacy and communication strategy
Concerns
Discussion facilitated by Loon Gangte (INP+/DNP+)
— Original Message —
From: msfh-india-medco-assist
To: sahaibrc@yahoo.com ; sahaibrc@icenet.co.in ; Prasanna Saliqram ; Naveen CHC ;
Anurag Bhargava ; dr. sathyamala ; amol p@gmail.com
Sent: Tuesday, February 27, 2007 7:14 PM
Subject: Stakeholders Workshop on Pre-grant Oppositions, 12 & 13 March 07
dear AIDAN - dr. dabade, chinu, anurag, dr. sathya, anant, prasanna, naveen
In the last two years much work related to patent oppositions (technical, legal, advocacy,
communication) has been undertaken by public interest organisations in India, along the
way expertise and information has been built which needs to be shared, many pertinent
queries come up repeatedly which also require discussion and understanding.
While many of us work in close alliance with each other, developments on patent
oppositions (from identifying patent applications, filing, patent office hearings, the
novartis case) have increased the need to meet and plan technical/legal work, advocacy
and strategy on the same.
in this regard, the campaign for access to essential medicines seeks to hold
a Stakeholders Workshop on Pre-grant Oppositions, on 12 & 13 March 07 in Mumbai
(West End Hotel), we request you to block the dates, a background document is copied
below and the agenda will below.
On cofirmation, we will make the necessary travel arrangements for participants.
Accomodation is being arranged in the West End Hotel.
Please do get back to me,
Leena Menghaney
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
C 106 Defence Colony
New Delhi 110 014
Tel: +91 9811365412, +91 1124332419
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Background Note for Stakeholders Workshop on Pre-grant Oppositions, 12
& 13 March 07
Two years ago in March 2005, Indian Parliament approved the country's new Patent Act,
thereby allowing pharmaceutical products (medicines) to be patented in India. This new
law put some serious constraints on local production of drugs (generic competition) but
also had some potentially important features.
The Indian Patent Act, if rigorously interpreted, provides several grounds for rejecting a
patent, for instance if the pharmaceutical substance claimed is only a new form of a
known substance - a unique provision which attempts to prevent the common practice of
“ever greening” of patents and minor incremental changes to known substances. The
law also provides for formal proceedings for anyone to object to a patent before it is
granted.
Public interest groups realizing the potential of these provisions started to compile
information on essential drugs on which patent applications were pending. Organizations
like the Lawyers Collective, Alternative Law Forum and the Access Campaign (MSF)
also came forward with legal aid and technical support for the drafting and filing of the
patent oppositions on these essential drugs.
Consequently, the first opposition by a patient organization the Cancer Patient Aid
Association (CPAA) was filed in September 05 on the anti-cancer drug “imitinib
mesylate” (Gleevec). In January 06, as a result of the opposition filed by CPAA, the
Indian Patent Office in Chennai issued a decision rejecting Novartis’ patent application
for the anti-cancer drug Gleevec. The significance of the above decision and the right to
oppose patents before their grant cannot be understated. Firstly it enabled generic
producers to continue producing affordable versions of “Gleevec” at a fraction of the
price that Novartis sells it. It further set a legal precedent for the rejection of new forms,
new use, and new combinations of existing and known medicines.
In 2006, Indian Network for People Living with HIV/AIDS and other state level PLHA
networks legally opposed 13 key patent applications related to HIV/AIDS drugs and also
publicly advocated against the grant of these AIDS related patent applications. As a
result Glaxo withdrew one of the applications related to a lamivudine/zidovudine patent
application. Further, Mumbai patent office also shared information that Abbott Co. Ltd
had abandoned the ritonavir-lopinavir soft gel patent application. The other applications
are being examined and will soon be up for hearings before the patent controller of the
respective patent office.
Many other public interest groups are also getting involved in the patent opposition of
essential drugs. The all India Drug Action Network is taking up the legal patent
opposition of a key TB medicine. Others like the Torchbearers are keen to start the work
on identifying patent applications related to psychotropic drugs used in the treatment of
mental illness.
Besides the patent oppositions, other developments such as an ongoing legal challenge
brought by Swiss pharmaceutical company Novartis. Novartis has legally challenged in
the Chennai High Court the public health safeguard in India’s Patent Act - a provision
that stipulates that patents should only be granted on medicines that are truly new and
innovative. This provision lays down that companies should not be able to obtain
patents in India for medicines that are not actual inventions, such as drug combinations
or slightly improved formulations of existing medicines.
e.g. In 1985 zidovudine a drug invented in the 1960s, was patented for a new
use - ‘AIDS treatment’. This patent granted first in the U.S blocked access to
the crucial drug zidovudine for nearly a decade till Indian pharmaceutical
companies in the absence of a local patent in India started manufacturing and
exporting it at competitive prices to developing countries.
Therefore Indian Patent law (section 3d) was specifically targeted at preventing a
common practice used by drug companies of trying to get additional patents on
insignificant improvements of drugs. The provision was an effort to reward innovation,
which is the rationale of the patent system to begin with. It also aimed to ensure that
patents do not unnecessarily restrict access to medicines.
Public interest groups like Centre for Trade and Development (CENTAD), People s
Health Movement and many other organisations are supporting a people s campaign
asking Novartis to drop the case and to raise awareness in India regarding its potential
to severely affect access to affordable essential medicines for millions of people across
the developing world. The court hearings in Chennai are coming to an end and a
judgement is expected in March 07 itself. Novartis is likely to appeal the dismissal of the
challenge in the Supreme Court of India. Public interest groups are also likely to appeal
any decision that dilutes section 3(d).
The technical and legal process of identifying patent applications on essential drugs,
drafting and filing of the patent opposition, the hearings at the patent office have raised
many queries among organisations and individuals involved in the advocacy-legal work
around the patent oppositions on essential drugs.
With the aim of sharing information and. expertise on the patent oppositions, the
Campaign for Access to Essential Medicines would like to organise a workshop for
organisations and networks involved in this work for the past three years. The workshop
also provides an opportunity to meet and formulate joint advocacy, legal and
communication strategies around the patents oppositions and the Novartis case.
Agenda will follow.
Leena Menghaney
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
C 106 Defence Colony
New Delhi 110 014
Tel: +91 9811365412, +91 1124332419
Agenda
Stakeholders’ workshop on Pre-grant Patent Oppositions and other
issues related to drug regulation and prices
12 & 13th March 2007, Terrace Hall, West End Hotel, Mumbai
Objective of the meeting is to bring together stakeholders involved in
research, advocacy, legal, technical and communication work related to
access to treatment issues in India. Key stakeholders arc health movement
experts, patient groups, legal and community based organisations. Some of
the issues of concern arc related to law reform and implementation of the
product patent regime with respect to its impact on the production of
essential drugs by India for its people and patients in other developing
countries.
Time
Day 1 sessions
9: 00-9:30 a.m.
Tea & Registration of participants
9:30 - 10:00 a.m.
Introductions
Welcome by Vivek Divan (Lawyers Collective HIV/AIDS |
Unit)
Objectives of the meeting
Johannes van der Wecrd (MSF - Holland in India)
Patents & Access
10:00 - 1:00 p.m.
•0
What are patents? How do you have the same
patent applications in different countries?
Lawyers Collective HIV/AIDS Unit
Patents, non-availability and high pricing of
medicines?
Cancer patient’s experience in India
Y.K Sapru (Cancer Patients Aid Association)
- MSF’s experience in other developing countries
Ellen ‘t Boon and Fernando Pascual (MSF Access
Campaign)
The importance of patent oppositions in India?
Experience of opposing patent applications on
newer AIDS drugs
Loon Gangte (INP-* /DNP*)
Can’t the original molecule be used if new form gets
patented? (E.g. can ‘ imitinib’ be used instead of
imitinib mesylate in cancer treatment, can
‘moxifloxacin’ be used instead of moxifloxacin
monohydrate in TB treatment?)
Time
1:00
2:00 p.m.
2: 00 - 4:30 p.m.
Day 1 sessions
Chan Park (Lawyers Collective HIV/AIDS Unit)
Fernando Pascual (MSF Access Campaign)
LUNCH
The process of identifying drugs on which patent
applications are pending in India
What are the inputs required of medical
practitioners and patient groups in identifying
drugs which are important /essential
Overview of ARV drug patent applications pending
in India
Lawyers Collective HIV/AIDS Unit
Overview of Cancer & TB drug applications pending
in India
Presentation of research by CENTAD
Discussion on how to identify drugs which will be
important for the future
4:30 - 5:30 p.m.
Explaining the legal process of filing patent
oppositions, hearings, appeals
Lawyers Collective HIV/AIDS Unit
Working groups (after the workshop)
6:00 - 7:30 p.m.
Working Group I
Patent oppositions on AIDS drugs with specific
focus on TDK, Lopi/rito (Kaletra)
(Concerned representatives PLHA networks, INP+,
Lawyers Collective, MSP)
Time
Day 2 sessions
9:00 - 11:00 a.m.
Novartis challenge to Indian Patent Law & Glivec
patent decision
Legal update - Lawyers Collective
Advocacy & Communication - future strategy
(Facilitated by Ccntad)
Advocacy in Parliament (Vinod Bhanu)
11:30 - 1:00 p.m.
The TB drug patent opposition
When? - Lawyers Collective
Communication & advocacy strategy - discussion
(Facilitated by AIDAN)
1:00 - 2:00 p.m.
LUNCH
2:00 - 3: 30 p.m.
Strategy regarding granted patents
Post grant oppositions (Lawyers Collective)
Analysis of granted patents
Specific test cases undertaken to understand
legal process
- Advocacy with health & commerce ministry
(Ccntad)
3:30 - 4: 30 p.m.
Mashelkar Committee Report
Is a critique of the contents required in light
of the debate on the patentability of
“incremental innovations”
Strategy regarding the new report being
prepared by Ministry of Commerce
How to take this up in parliament?
(Discussion facilitated by Chan Park & Ccntad)
4:30 - 5: 30 p.m.
Patent oppositions in India
Focus areas
- Advocacy and communication strategy
Concerns
Discussion facilitated by Loon Gangte (INP+/DNP+)
J
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
AIDAN Statement
26 February 2007
The Report of the Technical Expert Group on Patent Law Issues
- A Retrograde Step
The group must not be allowed to re-submit the report. The matter must be referred to a
Parliamentary Standing Committee.
It is regrettable that a group such as the Technical Expert Group on Patent Law Issues, comprising of
such highly regarded persons in the country should submit a report with several sentences identical
to submissions made by an interest group. This could lead to questions about the interests and
motives about the group. The fact that certain sentences were quoted verbatim is a crucial issue, and
cannot be taken merely as an error of omission.
While welcoming the move to withdraw the Report of the Technical Expert Group on Patent Law
Issues, we would like to draw the attention back to the other contents of the report. The report of the
group headed by Dr. R.A. Mashelkar, which was submitted in December 2006 is high on rhetoric
and contains many unsubstantiated claims which can have serious implications on people’s access
to medicines. While the terms of reference of the group was to clarify the legal position with respect
to TRIPS, the report has gone beyond its mandate and has attempted to compromise public health
which will seriously hurt national interests in the long term.
The report rhetorically states, "'every effort should be made to prevent the grant offrivolous patents
and ‘ever-greening’”, but condemns the very provisions in the Indian Patents Act which were framed
to prevent ever-greening. The report also states "Article 7 and 8 as well as Doha Declaration on
TRIPS Agreement and public health cannot be used to derogate the mandate under Article 27\ but
fails to explain the reasons or basis for such an argument.
Grant of patent is based on applicant’s ability to satisfy patentability criteria and any other relevant
requirements. According to Article 27 patents are granted to an invention. Significantly TRIPS does
not offer any definition for invention and gives freedom to member states to determine the meaning
of invention and that too when they satisfy all three criteria i.e. novelty, inventive step and industrial
application. This gives an opportunity to the implementing country to determine the scope of
Page 1 of 2
Addresses for Correspondence:
Mira Shiva, A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@yahoo.com
Gopal Dabade, 57, Tejaswinagar, Dharwad 580002. Tel: 0836-2461722, 09448862270. Email: drdabade@gmail.com
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
patentability i.e. whether it should be limited to new chemical entities or whether it can also include
incremental innovations (not inventions).
The Article 27 of TRIPS quoted by the group prohibits discrimination of availability and enjoyment
of patent rights on the ground of place of invention, field of technology, place of manufacture. Here,
the prohibition is only against discrimination on the above grounds and not on differentiation. The
WTO Disputes Panel also recognized this reasoning in the EC-Canada Case (WT/DS 114).
Therefore limiting the scope of patentability to new chemical entities does not violate the
obligation of non-discrimination as to the field of technology under Article 27(1).
The Doha Declaration on TRIPS agreement states, “We agree that the TRIPS Agreement does not
and should not prevent members from taking measures to protect public health. Accordingly, while
reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should
be interpreted and implemented in a manner supportive of WTO members' right to protect public
health and, in particular, to promote access to medicines for alT\ Para 4). There is no doubt that
measurers like limiting the scope of patentability to new chemical entities will protect public health
by providing space to generic companies to legally produce drugs and promote access to medicines.
By ignoring these crucial commitments in the Doha Declaration on TRIPS Agreement, the group
tries to devalue the importance of the Doha declaration.
In an ambiguous section titled “national interest perspective”, to support its view on patent protection
for incremental modifications/ innovations, the group does not make a single reference to public
health concerns, leading one to question whether public health is not a factor while considering
national interest.
In light of the above points, we submit that the Report of the Technical Expert Group on Patent
Law Issues is a retrograde step in the discourse on patents in India, and call for a complete
rejection of the report in its present form. In addition, since the group report has been found to
contain several sentences identical to submissions made by an interest group, it would not be
fair to continue with the group, as it could lead to questions about the interests and motives
about the group. Hence the group should not be allowed to re-submit the report, and the
matter must be referred to a Parliamentary Standing Committee.
Page 2 of 2
Addresses for Correspondence:
Mira Shiva, A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@yahoo.com
Gopal Dabade, 57, Tejaswinagar, Dharwad 580002. Tel: 0836-2461722, 09448862270. Email: drdabade@gmail.com
2
WHAT IS SECTION 3 OF THE INDIAN PATENTS ACT?
Section 3 is included in chapter 2 of the Indian Patents Act, 1970. Chapter 2 deals with
inventions that are NOT patentable. Section 3 specifically lists the non-patentable
inventions. Among other things it includes, inventions which are frivolous, claims
anything obvious, contrary to well established natural laws, intended use of which would
be contrary to law or morality or injurious to public health, the mere discovery of a
scientific principle or the formulation of an abstract theory, a substance obtained by a
mere admixture resulting only in the aggregation of the properties of the components,
mere arrangement or re-arrangement or duplication of known devices, a method of
agriculture or horticulture, and so on.
Two specific clauses of interest to us are
Section 3 (d), which states that the mere discovery of any new property or new
use for a known substance, or of the mere use of a known process is not an
invention, untill such known process results in a new product or employs at least
one new reactant.
and
Section 3 (i), which states that any process for the medicinal, surgical, curative,
prophylactic or other treatment of human beings, or similar treatment of
animals or plants to render them free of disease or to increase their economic
value or that of their products is not an invention.
The other sections in Chapter-2 of the Indian Patents Act, 1970 are Section 4 and
Section-5. Section 4 deals with inventions relating to atomic energy, which are not
patentable, and section 5 - the lifeline of the Indian drug industry, ruled out giving patent
for substances (products) which could be used as food, medicine or drug. It also ruled out
product patent for inventions relating to substances produced by chemical processes
including alloys, optical glass, semi-conductors and inter-metallic compounds. Section-5
stated that patents would be allowed only the processes (or methods) of manufacture of
these substances.
The Patents (Amendment) Act, 2005 completed did away with section-5 of the
Indian Patents Act, 1970 thereby paving the way for patents on the substances
which could be used as food, medicine or drug (product patent).
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In section 3 (d), the Patents (Amendment) Act, 2005 made the following change:
Indian Patents Act, 1970
The Patents (Amendment) Act, 2005
The following are not inventions within the The following are not inventions within the
meaning of this Act:
meaning of this Act:
Section 3(d)
Section 3(d)
The mere discovery of any new property
or new use for a known substance or of
the mere use of a known process,
machine or apparatus unless such
known process results in a new product
or employs at least one new reactant.
The mere discovery of a new form of a
known substance which does not result
in the enhancement of the known
efficacy of that substance or the mere
discovery of any new property or new
use for a known substance or of the mere
use of a known process, machine or
apparatus unless such known process
results in a new product or employs at
least one new reactant.
The Patents (Amendment) Act, 2005 also gave the following eexplanation that—For the
purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle
size, isomers, mixtures of isomers, complexes, combinations and other derivatives of
known substance shall be considered to be the same substance, unless they differ
significantly in properties with regard to efficacy.
For the full text of the Indian Patent Act and its amendments, visit:
■ http://www.patentoffice.nic.in/
ARTICLE 27 of TRIPS
TRIPS or Agreement on Trade Related Aspects of Intellectual Property Rights was
negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and
Trade (GATT) treaty in 1994. Its inclusion was the culmination of a program of intense
lobbying by the United States, supported by the European Union, Japan and other
developed nations. Campaigns of unilateral economic encouragement under the
Generalized System of Preferences and coercion under Section 301 of the Trade Act
played an important role in defeating competing policy positions that were favoured by
developing countries, most notably Korea and Brazil, but also including Thailand, India
and Caribbean Basin states. In turn, the United States strategy of linking trade policy to
intellectual property standards can be traced back to the entrepreneurship of senior
management at Pfizer in the early 1980s, who mobilized corporations in the United States
and made maximizing intellectual property privileges the number one priority of trade
policy in the United States (Braithwaite and Drahos, 2000, Chapter 7).1
Article T1 relates to “Patentable Subject Matter”. Paragraph 1 of Article 27 basically
states that patents shall be available for any inventions, whether products or processes, in
all fields of technology, (1) provided that they are new, (2) involve an inventive (nonobvious) step and (3) are capable of industrial application (useful). It further states that
patents should be available without discrimination (1) as to the place of invention, (2) the
field of technology being used and (3) whether products are imported or locally
produced.
Paragraphs 2 and 3 of Article 27 deals with sections which can be excluded from
patentability inventions. Paragraphs 2 states that countries can prevent commercial
exploitation of things which are necessary to protect public order or morality, including
to protect human, animal or plant life or health or to avoid serious prejudice to the
environment. It lays down the condition that the above can be done “provided that such
exclusion is not made merely because the exploitation is prohibited by their law”.
Paragraphs 3 of Article 27 states that members can exclude from patentability
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological
processes for the production of plants or animals other than non-biological and
microbiological processes. It adds that , “Members shall provide for the protection of
plant varieties either by patents or by an effective sui generis system or by any
combination thereof’. The clause itself says that the provisions of this subparagraph shall
be reviewed four years after the date of entry into force of the WTO Agreement.
For the full TRIPS agreement, visit:
■ http://www.wto.org/
1 Agreement on Trade-Related Aspects of Intellectual Property Rights. (2007, February 18). In Wikipedia,
The Free Encyclopedia. Retrieved 11:30, February 26, 2007, from
http://en.wikipedia.org/w/index.php?title=Agreement on TradeRelated Aspects of Intellectual Property Rights&oldid= 109016838
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— Original Message —
From: Ramya Sheshadri
To: Naveen
Cc: aidanindia@yahooqroups.com ; Anant Phadke ; Gopa Kumar; Gopal Dabade ; Mira Shiva ; sathya
mala ; anuraq ; Bharqava Anuraq ; Prasanna Saliqram
Sent: Monday, February 26, 2007 7:08 PM
Subject: Re: Explanation of Section 3d and Article 27
Dear Naveen and all
The explanation looks good few more points to add
1. Sec 3(d) in simple means no patent will be granted on incremental improvements of an active
molecule which will not show any therapeutic efficacy (for ex Gleevac imatinib mesylate beta
crystalline form), having a new use of a already known substance (for example Moxifloxacin anti
bacterial drug which is now proven to be effective in treating Tuberculosis), it goes on to say
about the process how new use of a known process and new property of known process is not
patentable if there is no new product.
2. Sec 3(d) of current patent act (defined in the explanation by Naveen) is included to keep a
check on grant of frivolous patent leading to evergreening i.e. pharma companies by modifying
the existing active molecules to salts, polymorphs, isomers apply for patent for the same drugs
leading to extension of monopoly for the already patented drug. This will block the entry of
generic companies.
3. The uniqueness of this clause is although as mentioned in Naveen's explanation that Sec 3 talks
about inventions which are NOT PATENTABLE, 3(d) says that if the efficacy of the product and
if new product is formed out of a process it will be PATENTED.
4. As everybody is aware that this clause (3(d)) is under attack by the Novartis company telling it
is unconstitutional in Chennai high court which is a ongoing case. The main argumet being
INDIA is not incompliant with TRIPS agreement and 3(d) is the reason for it.
ARTICLE 27 of TRIPS:
The brief history is already explained in Naveen explanation. To add to it
1. The Article 27 under Section 5 of TRIPS talks about patentable products under which we have
3 paras
27(1) talks about availability of patent in all fields of technology and there will be no
descrimination in any field of technology on patenting.
27(2) this is about exclusion of inventions from patents mainly to protect public order or morality,
human, animals, plant life, health to avoid serious harm to environment. Member countries
cannot exclude certain inventions from patentability even though the exploitation of these is
prohibited under local law. In other words, they have to grant patents regardless of any
prohibition on the commercial exploitation of such a patent. For, example Indian patent laws did
not provide for patents in pharmaceutical products but under the TRIPS agreement they will be
forced to extend such protection from the year 2005.
The agreement does allow for the exclusion of certain patents if such action is necessary to
protect public order or morality or to protect human life and health. This provision provides some
flexibility for countries to promote public health policies by claiming their right to protect human
life and health, especially in the wake of deadly pandemics like AIDS, which are wreaking havoc
in 'developing' and 'least-developed' countries. However, most 'developed' countries do not read
this provision as a general exception in favour of public health, thus making it difficult for
developing and least developed countries to use it for the benefit of their citizens.
27(3) (a)and (b) is about products excluded from patentability.
27 (3)(b): Mainly animals, plants and biological processes excluded from the patent regime.
The interpretation of this last clause has been extremely contentious. The term sui generis
(Latin for 'of its own gender/genus') is not defined in the agreement, but it is generally believed
that it enables member countries to fashion their own protection scheme for plants. Possible
protection mechanisms include the Plant Breeder's Rights system offered by UPOV Convention,
plant patents or a licensing regime. More than one form of plant protection can be implemented in
a given member country.
Controversy surrounding Article 27.3
One of the controversies of Article 27.3 focuses on the meaning of'sui generic and exactly
what is considered an 'effective' form of plant variety monopoly right. In part because of the
difficulties with this provision, Article 27.3 was to be reviewed in 1999, four years after the entry
into force of the agreement. The review has never been completed, and this Article remains a hot
issue. To date, some 30 countries are calling for further discussion on Article 27.3, and some have
proposed:
1. rewriting the Article to exclude patents for any organisms or genetic material (although
ostensibly countries could achieve this by defining these subject matters as "discoveries"
and not "inventions");
2. defining in detail what an effective plant variety development right system is;
3. extending exclusionary rights of some sort to traditional or indigenous knowledge; and
4. making explicit linkages with obligations for the conservation and use of biodiversity,
including mandatory disclosure of the source of genetic materials used in a patented
invention, and creating obligations to record arrangements for access to genetic resources
as evidence of prior informed consent.
It remains to be seen whether any of these proposals will be adopted.
http://www.patentlens.net/daisy/patentlens/41 5.html (source)
Hope this helps.
Regards
Ramya
On 2/26/07, Naveen <navthom@gmail.com > wrote:
Dear friends,
Anurag has suggested that the Section 3d of Indian Patent's Act and Article 27 of TRIPS should be
simplified. I have attempted to do it. It can be simplified still further. I can work on it with your suggestions.
Hope this is useful.
Best wishes,
Naveen
PRE-GRANT REPRESENTATION BY WAY OF OPPOSITION
UNDER SECTION 25(1) OF THE PATENTS ACT
1970(39 OF 1970) AND RULE 55 (1) OF THE RULES
AS AMENDED BY THE PATENTS (AMENDMENT) ACT, 2005
The Patent Controller,
Delhi
Re: Patent Application No. 315/Del/2000 filed on 27 March 2000 titled “New Crystal
Modification of CDCH, And Pharmaceutical Formulations Comprising This
Modification”
STATEMENT OF FACTS/ EVIDENCE
1. AIDAN (All-India Drug Action Network) was founded in the early 1980s as a
network of like-minded individuals and groups in India to fight for a people oriented,
rational, drug policy. AIDAN the opponents hereby make a representation by way of
opposition under § 25(1) of the Patent Act 1970, as amended by the Patents
(Amendment) Act, 2005 (the “Act”) against the grant of patent application, titled: “New
Crystal Modification of CDCH, And Pharmaceutical Formulations Comprising This
Modification” made by Applicant Bayer Aktiengesellschaft (the “Applicant”), bearing
Indian patent application No315/Del/2000 filed on 27 March 2000 (the “Application”).
This representation is proper under § 25(1) of the Act as the application has been
published but a patent has not been granted. Specifically, this representation is brought
under the grounds as stated in § 25(1) (f), (h) of the act.
2. NEED TO INCLUDE THE REASON AS TO WHY AIDAN IS OPPOSING THE
APPLICATION. The Opponents are opposing the above-mentioned application for a
patent under section 25(1) of the Patents Act.
3. The patent application was filed at the Patent Office in Delhi, therefore, the Patent
Controller has the jurisdiction to hear this pre-grant opposition in Delhi. Opponents
hereby request a hearing as per provisions under Rule 55(1) of the Patent Rules, 2005.
4. The present Application relates to a treatment of infections caused by bacteria like
acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community
acquired pneumonia, bacterial conjunctivitis and uncomplicated skin/skin structure
infections. It is a broad spectrum antibiotic which is now being used to treat tuberculosis
caused by mycobacterium tuberculosis complex. Nine million new cases of tuberculosis
and nearly two million deaths are estimated to occur around the world every year, making
it the leading cause of death among curable infectious diseases. The World Health
Organization declared tuberculosis a global emergency in 1993. This application is of
particular interest for the treatment of tuberculosis in HIV-positive people because it has
no interactions with antiretrovirals and may be potent enough to shorten the duration of
TB treatment, which currently stands at a minimum of six months which can be reduced
to three months. (NEED TO INCORPORATE MORE INFORMATION ON ACCESS
TO TREATMENT - ALSO CITE COST ISSUES)
5. The most effective way to lower the cost of these essential medicines is to promote
competition, particularly within India’s vibrant pharmaceutical industry. However, in
order for there to be any effective generic competition, it is imperative that patents not be
granted in India for uninventive, incremental improvements to already-known drugs.
Although India was compelled by its WTO obligations to introduce product patent
protection for pharmaceutical products through the Patents (Amendment) Act of 2005,
India retains full sovereignty in determining the standards that must be met with respect
to patentability. As such, India is under no obligation to follow the perilous path that
many developed nations have taken in setting loose standards for novelty and inventive
step that result in patent protection for incremental innovations, all too often at the cost of
public health.
6. India’s Patents (Amendment) Act, 2005 was passed in order to bring India into
compliance with its TRIPS obligations under the WTO, and introduced for the first time a
20-year product patent regime in this country. India, however, is also a signatory to the
Doha Declaration on the TRIPS Agreement and Public Health (the “Doha Declaration”),
which states, in part, “we affirm that the [TRIPS] Agreement can and should be
interpreted and implemented in a manner supportive of WTO members’ right to protect
public health and, in particular, to promote access to medicines for allf (emphasis
added).
7. In part due to the recognition of its obligations under the Doha Declaration,
Parliament passed the Act with a few important provisions aimed at ensuring that a
product patent regime would not harm public health. One of the most important is § 3(d)
of the Act, a provision designed to discourage the pernicious but all-too-common practice
of “ever greening,” whereby pharmaceutical companies artificially extend the life of their
monopolies by patenting trivial improvements to already existing drugs. Declaring that
“a new form of a known substance which does not result in the enhancement of the
known efficacy of that substance,” and the discovery of a “new use for a known
substance” are not inventions under the meaning of the Act, Parliament expressed
through § 3(d) its unequivocal rejection of ever greening.
8. The present Application falls squarely in the category of “inventions” that Parliament
intended in rejecting when it enacted § 3(d). The original patents for the active
ingredients of this drug were granted prior to 1995, when India first incurred its
obligations under the WTO. The sole “improvement” at issue is the conversion of the
active ingredient into a particular crystalline form that does nothing to improve the drug’s
efficacy. Granting the current Application a patent will do nothing but further enrich the
Applicant at the expense of human lives.
9. The Opponent humbly submits that the obligation to “promote access to medicines
for all” has been incorporated into the Act by Parliament, and that the Act, whenever
possible, can and must be interpreted in a manner that is consistent with the Doha
Declaration’s binding promise, as it is this Office that ultimately makes the decision that
will determine whether millions of people will have access to essential medicines. The
Opponents respectfully request that the Patent Office keep the Doha Declaration in mind
as it examines the present Application and interprets the applicable law.
GROUNDS
10.
The Opponent has closely studied the specification and claims made by the
Applicant in the Application and strongly believe that the invention is not patentable
under the following grounds of § 25(1) of the Act:
i.
s25(l)(f) - that the subject of any claim of the complete
specification is not an invention within the meaning of this Act,
or is not patentable under this Act, in particular under section
3(d).
ii.
s25(l)(e) - that the invention so far claimed in any claim of the
complete specification is obvious and clearly does not involve
any inventive step under this Act, in particular under section
2(j)(a).
iii.
s25(l)(h) - that the applicant has failed to disclose to the
controller the information required under section 8 especially
form 3.
Accordingly, as permitted under s25(l) of the Act, which allows an opposition to
be filed by any person after publication but before the grant of a patent, and Rule
55(1) of the Rules, the Opponent submits its opposition to the Application on the
grounds set out below.
11. The Applicant has failed to meet its burden of showing that the alleged invention
described in the Application is entitled to a patent under the Act. The present application
merely relates converting a known pharmaceutical substance, referred to as CDCH, into a
monohydrate crystalline form - a process well known in the art - in order to make the
bulk manufacture of the drug substance more convenient. However, as will be explained
below, the conversion of a drug substance to its monohydrate crystalline form in order to
obtain certain benefits has been known in the pharmaceutical industry for years, and is
obvious to one skilled in the art. Further, because whatever benefits may be derived from
this conversion does nothing to make the final drug substance more effective, it is not
eligible for a patent under s3(d) of the Act.
12. Specifically, the Applicant’s claims can be summarised as follows:
a.
Claim 1 relates to monohydrate form of active molecule CDCH.
b. Claim 2 relates to the prismatic crystal form of the compound described in
Claim 1.
c. Claim 3 - 5 is dependent on Claim 1 and 2 and relate to the use of the
alleged invention as antibacterial compositions.
The Alleged Invention Is Not An Invention Under § 25(l)(f) and § 3(d) Of The Act
Because It Is The Mere “Discovery” OfA New Form OfA Known Substance.
13. The alleged invention is not patentable under the Act because it is, at most, the mere
“discovery” of a new form of a known substance. Under § 3(d) of the Act, the “mere
discovery of a new form of a known substance which does not result in the enhancement
of the known efficacy of that substance” is not an invention within the meaning of the
Act. The accompanying Explanation to § 3(d) states, “For the purposes of this clause,
salts, esters... combinations and other derivatives of known substance shall be considered
to be the same substance, unless they differ significantly in properties with regard to
efficacy,” (emphasis added).Because the alleged invention claims to be and is in fact
nothing more but only conversion of the active molecule in to monohydrate crystalline
form with no improvement on efficacy of the drug.
14. The conversion to monohydrate form is already known and there are ways in which
a hygroscopic active molecule can be manufactured with accurate dosage and not
necessary that it needs to be converted to monohydrate form. This clearly explains the
fact that this invention is just a new form of already known substance and has nothing to
do with efficacy or therapeutic effect of the drug.
15. The alleged invention is already disclosed attached here in as Exhibit D and E
respectively and the document says that the compounds can be used in various
pharmaceutical preparations which includes tablets, capsules pills etc. A person skilled in
art knows that for making tablets either one has to do wet or dry granulation, it’s very
well known in the art that granulation steps improve the flow properties of the active
molecule and can be obtained even with out converting it to monohydrate form. (NEED
TO GET PRIOR ART DOCUMENTS TO PROVE)
16. As the foregoing shows, all of the substances contained in the present Application
are known. Nevertheless, the Applicant Claims and purports to stake ownership over the
following: Monohydrate of CDCH in the prismatic crystal form used to treat bacterial
infections. It is very clear that the applicant fails to show any invention and it is only a
new form of a known substance with no enhancement on known efficacy under section
3(d) and therefore does not fulfill the criteria of patentability.
17. In order to meet its burden under § 3(d), the Applicant is required to present
evidence that the claimed invention (i.e., the monohydrate form of CDCH) represents an
enhancement in the known efficacy over the previously known substance, (i.e.,
anhydrous form of CDCH). The Applicant does not and cannot satisfy this requirement.
The Applicant admits that the only active ingredient in the claimed invention is CDCH
See, e.g., Application, p. 1, lines 4-10. Accepting the fact that the active molecule is
converted to monohydrate form to make it non-hygroscopic and free flowing and in no
way it has effected or enhanced the therapeutic activity of the active molecule.
18. This alleged “improvement” bears no relation to the ultimate therapeutic efficacy of
the active ingredients. It is, at most, a tool that may facilitate: (i) the mass production (ii)
of a particular dosage form of the active ingredients (i.e., the tablet form). However,
there is no sound reason why the relevant comparison should be between the therapeutic
efficacies of a active molecule converted to monohydrate form versus that of a active
molecule without conversion to monohydrate form. The Applicant has put forth no
evidence to show that the therapeutic efficacy of a active molecule converted to
monohydrate form is greater than that of, say, anhydrous CDCH which can be
manufactured through different means.
19. The applicant claims that to get non-hygroscopic, free flowing active compound the
active molecule is converted to monohydrate form which they claim is new. Attached
here in is Exhibit A, B and C US Patent No. 5,068,440, US Patent No. 3,655,656 and
US Patent No. 4,504,657 which clearly explains that hygroscopic materials are difficult
to handle and to get a non-hygroscopic form we need to convert the active molecule to
monohydrate form which is very much obvious and any person skilled in the art can
obtain the same.
20. The Applicant has disclosed the existence of the active molecule CDCH, attached
here in as Exhibit D and E EP-A-550903 and EP-A-591808 respectively, there by
accepting the fact that the active molecule was already known prior to the present
invention and therefore it’s not Novel. The current invention only claims the
monohydrate form of the active molecule which was used and prescribed for years prior
to the present Application and the Applicant nonetheless claims that the alleged invention
is patentable.
21. Thus the claims of the Application do not prove any efficacy of the drug and it is
only about the monohydrate form of the active molecule which is insufficient to render
the alleged invention patentable under the Act. This is because the mere conversion of the
active molecule to monohydrate form to improve its flow characteristics is not an
invention and also obvious under section 2(j)(a), the alleged invention is not patentable
under section 3(d) as it is a new form of a known substance which does not result in the
enhancement of the known efficacy, it is anticipated in the prior art and is not Novel.
Furthermore, the applicant has failed to disclose the controller the information required
under section 8 especially Form 3.
The Alleged Invention Is Not An Invention Under § 25(l)(e) and § 2(j)(a) Of The Act
Because It Is Obvious To A Person Skilled In The Art and does not Involve any
Inventive step.
22. For all of the reasons stated above, Claim 1 and its dependent Claims 2-5 of the
present Application also fail because they lack the inventive step required for
patentability. The claimed invention is obvious to a person skilled in the art i.e. obtaining
monohydrate forms to over come the hygroscopicity of active molecule and it is very
well known in the pharmaceutical industrial practices. Under § 2(j)(a) of the Act,
“inventive step” is defined as “a feature of an invention that involves technical advance
as compared to the existing knowledge that makes the invention not obvious to a person
skilled in the art.”
23. For the reasons already stated it would have been obvious to a person skilled in the
art, given the disclosures contained in the US Patent No. 5,068,440 which clearly
explains that hygroscopic materials are difficult to handle and to get a non-hygroscopic
form we need to convert the active molecule to monohydrate form which is very much
obvious and any person skilled in the art can obtain the same.
24. The sole “innovation” that the Applicant claims with respect to the conversion of
active molecule to monohydrate form which is already known and practiced from many
years does not involve any inventive step and it is very much a common practice i.e.
obvious (to a person skilled in art) is carried through out the Pharmaceutical industries to
obtain a non hygroscopic and free flowing active molecule.
The applicant has failed to disclose to the controller the information required Under
§25(l)(h) by section 8 especially form 3.
25. Section 8 of the Patents Act requires an applicant for patent to furnish the Patent
Office with detailed particulars of any patent applications for the same or similar
inventions made in any other country, and to undertake to update the Patent Controller of
detailed particulars of every other application made subsequent to filing within the
prescribed time. Under Rule 12(1 A), the statement and undertaking under section 8 must
be made within 3 months of filing. Rule 12(2) requires the Applicant to inform the
Patent Controller of additional particulars within 3 months of the additional filing. The
details required by section 8 are clear from Form 3, and include status of the application.
Under section 25(1 )(h), a failure to comply with section 8 is a ground for opposition and
is therefore sufficient to reject an application in its entirety.
CONCLUSION
26. Given all of the foregoing, Opponents hereby humbly request that the Patent Office
reject the Application on the following grounds:
•
The alleged invention is a “mere discovery of a new form of a known
substance” and thus not an invention under § 3(d) of the Act;
•
Claim 1 and its dependent Claims 2-5 of the present Application fail for
lack of novelty;
•
All of the Claims in the present Application fail for lack of inventive step.
•
The Application fails to meet the formal disclosure requirements under
section 8.
27. Opponents further request that the Office grant a hearing as per Rule 55(1) of the
Patent Rules.
Respectfully submitted,
On Behalf of the All India Drug Action Network,
THE atea HINDU
Date: 22/02/2007
URL: http://www.thehindu.com/2007/02/22/stories/2007022206751200.htm
National
Mashelkar committee on Patent Law withdraws report; seeks more time
Ravi Sharma and Sara Hiddleston
Cites technical inaccuracy and plagiarism as reasons
BANGALORE/CHENNAI: The Dr. R.A. Mashelkar-headed expert committee on Patent
Law has written to the Government of India asking that its 56-page report submitted last
December is withdrawn on the grounds of’’technical inaccuracy and plagiarism.”
In a letter dated February 19 and addressed to Ajay Dua, Secretary of the Department of
Industrial Policy and Promotion, Ministry of Commerce and Industry, the committee has
requested three months to re-examine and resubmit the report.
The 'Technical Expert Group on Patent Law Issues' was chaired by Dr. Mashelkar and
comprised four other renowned experts (Professors Goverdhan Mehta, Asis Datta, N R.
Madhava Menon, and Moolchand Sharma). It was set up in April 2005 to look into two
contentious issues that were referred to it by the Government of India following a debate
in Parliament after the Patents (Amendment) Bill, 2005 was introduced.
The issues were whether it would be compatible with the World Trade Organisation's
Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to: a) "limit the
grant of patents for pharmaceutical substances to new chemical entities or new medical
entities involving one or more inventive steps only," and b) "exclude micro organisms
from patenting." The committee took over a year and a half to reach its conclusions.
Dr. Mashelkar confirmed to The Hindu over the telephone that the group had
"unanimously" sought the report's withdrawal. He said that certain lines used in their
report's conclusion had been taken "verbatim" from a November 2005 paper (Limiting
the Patentability of Pharmaceutical Inventions and Micro-organisms: A TRIPs
Compatibility Review) that was authored by Shamnad Basheer, a doctoral student and an
Associate at the Oxford Intellectual Property Research Centre, University of Oxford.
A footnote in Mr. Basheer’s paper indicates that his work was commissioned by "the
Intellectual Property Institute, a United Kingdom-based independent charitable
organisation which carries out research on intellectual property matters.” It was
"financially supported by Interpat, a Swiss association of major European, Japanese and
U.S. research-based pharmaceutical companies committed to the improvement of
intellectual property laws around the world."
According to Dr. Mashelkar, it was only after the committee had submitted its report that
it came to their notice through newspaper articles that some plagiarism had occurred:
"We have identified eight to ten lines that have been extracted verbatim from Basheer's
paper. As a scientist I see this as not a good practice. In keeping with the highest and best
ethical practices we want to withdraw the report."
Dr. Mashelkar termed it "very unfortunate" and expressed the opinion that the "technical
inaccuracy" could have happened when the report was being "drafted by a sub group."
Asked whether the committee would now like to rewrite the report or just change the
"eight to ten lines" that have been plagiarised, Dr. Mashelkar said that "that depended on
the members of the committee."
Even while admitting that it had been ethically wrong to plagiarise, Dr. Mashelkar said
that Mr. Basheer in an e-mail had indicated that he was "not aggrieved" by the Mashelkar
report "using his conclusions." He also stressed that it was "mischievous" to insinuate
that multinational pharmaceutical companies had funded the committee's study. "We are
not aligned to any industry."
The recommendations of the technical expert group were significant for multinational
pharmaceutical companies, the Indian generic industry, and patient groups.
Novartis AG stated in a press release dated February 15: "A report from the Mashelkar
committee, commissioned by Indian Government and comprised of Indian experts,
supports many of the concerns about Indian patent law expressed by Novartis,
mentioning that the laws are not complying with international agreements like TRIPS."
Public health groups and patient associations were concerned that the recommendations
would encourage renewals of patents and block entry of cheap generic drugs into the
market. A paper by Professor Brook Baker, Northeastern University School of Law
Programme on Human Rights and the Global Economy, said that the "Mashelkar report
misstates India's right to define the scope of patentability and threatens access to
medicines."
© Copyright 2000 - 2006 The Hindu
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
Draft AIDAN Statement
on
The Report of the Technical Expert Group on
Patent Law Issues
23 February 2007
It is regrettable that a panel such as the Technical Expert Group on Patent Law Issues, comprising of
such highly regarded persons in the country should submit a report with several sentences identical
to submissions made by an interest group. This could lead to questions about the interests and
motives about the panel. While welcoming the move to withdraw the Report of the Technical Expert
Group on Patent Law Issues, we would like to draw the attention back to the other contents of the
report. The report of the panel headed by Dr. R.A. Mashelkar, which was submitted in December
2006 is high on rhetoric and contains many unsubstantiated claims which can have serious
implications on people’s access to medicines.
The report rhetorically states, “every effort should be made to prevent the grant of frivolous patents
and ‘ever-greening’”, but condemns the very provisions in the Indian Patents Act which were framed
to prevent ever-greening. The report also states “Article 7 and 8 as well as Doha Declaration on
TRIPS Agreement and public health cannot be used to derogate the mandate under Article 27”, but
fails to explain the reasons or basis for such an argument.
Grant of patent is based on applicant’s ability to satisfy patentability criteria and any other relevant
requirements. According to Article 27 patents are granted to an invention. Significantly TRIPS does
not offer any definition for invention and gives freedom to member states to determine the meaning
of invention and that too when they satisfy all three criteria i.e. novelty, inventive step and industrial
application. This gives an opportunity to the implementing country to determine the scope of
patentability i.e. whether it should be limited to new chemical entities or whether it can also include
incremental innovations (not inventions).
The Article 27 of TRIPS quoted by the panel prohibits discrimination of availability and enjoyment
of patent rights on the ground of place of invention, field of technology, place of manufacture. Here,
Page 1 of 2
Addresses for Correspondence:
Mira Shiva, A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@yahoo.com
Gopa! Dabade, 57, Tejaswinagar, Dharwad 580002. Tel: 0836-2461722, 09448862270. Email: drdabade@gmail.com
All India Drug Action Network (AIDAN)
Towards a people oriented, rational, drug policy!
the prohibition is only against discrimination on the above grounds and not on differentiation. The
WTO Disputes Panel also recognized this reasoning in the EC-Canada Case (WT/DS 114).
Therefore limiting the scope of patentability to new chemical entities does not violate the obligation
of non-discrimination as to the field of technology under Article 27(1).
The Doha Declaration on TRIPS agreement states, "'We agree that the TRIPS Agreement does not
and should not prevent members from taking measures to protect public health. Accordingly, while
reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should
be interpreted and implemented in a manner supportive of WTO members' right to protect public
health and, in particular, to promote access to medicines for alT\ Para 4). There is no doubt that
measurers like limiting the scope of patentability to new chemical entities will protect public health
by providing space to gerenric companies to legally produce drugs and promote access to medicines.
By ignoring these crucial commitments in the Doha Declaration on TRIPS Agreement the panel tries
to devalue the importance of the Doha declaration.
In an ambiguous section titled “national interest perspective”, to support its view on patent protection
for incremental modifications/ innovations the panel does not make a single reference to public
health concerns, leading one to question whether public health is not a factor while considering
national interest.
In light of the above points, we submit that the Report of the Technical Expert Group on Patent Law
Issues is a retrograde step in the discourse on patents in India, and call for a complete rejection of the
report in its present form. In addition, since the panel report has been found to contain several
sentences identical to submissions made by an interest group, it would not be fair to continue with
the panel, as it could lead to questions about the interests and motives about the panel. Hence the
panel should not be allowed to re-submit the report. If required, a new panel with representations
from public health experts and consumer groups must be asked to relook at the issue.
Page 2 of 2
A ddresses for Correspondence:
Mira Shiva, A-60, Hauz Khas, New Delhi. Tel: 011-26855010, 09810582028. Email: mirashiva@yahoo.com
Gopal Dabade, 57, Tejaswinagar, Dharwad 580002. Tel: 0836-2461722, 09448862270. Email: drdabade@gmail.com
2
WORLD NEWS
20
CHRONICLE PHHRMHBIZ
Nay 16, E0O6
Pfizer's smoking cessation medicine receives FDA approval
New York
-W-he
US
FDA
has
I approved Pfizer's antiI smoking pill, Chantix
■ (varenicline). Chantix,
the first new prescription
medication approved for
smoking cessation in nearly
a decade, received priority
review designation by the
FDA because of its potential
to be a significant therapeu
tic advance over existing
therapies.
According to the company
release, Chantix is specifi-
cally designed to partially
activate the nicotinic recep
tor and reduce the severity
of the smoker's craving and
the withdrawal symptoms
from nicotine. Moreover, if
a person smokes a cigarette
while receiving treatment,
Chantix has the potential to
diminish the sense of satis
faction associated
with
smoking. This may help to
prevent the cycle of nico
tine addiction.
"Pfizer's discovery and
development of Chantix
demonstrates groundbreak-
advertisers 7linden
The advertisers Index is provided as a reader service. /
ing science leading to the
first prescription treatment
aimed directly at smoking
cessation
in
nearly
a
decade," said Hank McKinnell, chairman and CEO of
Pfizer.
"Smoking harms
nearly every organ in the
body. It is responsible for
approximately one in five
deaths in the US and costs
the US health care system
about $167 billion annually.
This medical advance from
Pfizer will now help ma ty
smokers end their addic
tion," he .added. Chantix is
the fourth new Pfizer
medicine to receive FDA
approval in 2006.
Chantix's approval was
based on a comprehensive
clinical
trial
programme
including four pivotal trials
involving more than 2,000
cigarette smokers. Subjects on
average had smoked about 21
cigarettes per day for an aver
age of approximately 25 years.
Dr Cheryl Oncken, a Chan
tix clinical investigator and
associate
professor
of
Medicine at the University
of Connecticut Health Cen-
fpvartis's Glivec may
larm bones: Study
tre said, "It is never too late
to quit smoking. People who
quit smoking before the age
of 50 have one-half the risk
of dying of a smoking-relat
ed illness in the next 15
years compared to those
who continue smoking.
Patients who are unable to
quit on their own should
consider seeking medical
support and treatment".
In November 2005, Pfizer
submitted a European mar
keting authorisation applica
tion for varenicline for smok
ing cessation.
♦
Barr Labs' isotretinoin
receives approval
Although everyattempt has been made to
New York
make this index as complete as possible,
the accuracy of all listings cannot be guaranteed
PAGE NO
ACCORD ENVIRO
KAMAL(E)INDUSTRIES
19
21
26
7
21
23
26
19
11
23
25
11
23
25
22
25
19
1
2
24
19
19
19
19
26
19
23
25
21
19
V.RANGANATHAM PHARMA
25
KOMAL INDUSTRIES
24
VEEKAY BLOWER
23
KOTHARI PHARMA
23
25
21
24
17
24
24
21
VENERA BIO-TECH SYSTEMS
21
VESAT PLASTICS
19
VIKRAM THERMO
VL COLLEGE
WADEGATILABEQUIP
5
5
23
WINCOAT
WINTECH PHARMACHEM
YENPLAS
28
25
19
A.S. AUTOMATIONS
A.T.E. MARKETING
AGILENT TECHNOLOGIES
AIRBORNE
AIROKLEAN
AIRTECH SYSTEMS
AKSHAR PHARMA
ALKYL AMINES
AMI POLYMER
ANISH PHARMA EQUIP
ANMOLSEKRI
ARSEE ENGINEERING
ATLANTO ENTERPRISES
BANGALORE BIO
CABHAYKUMAR
CASTELINO ENGINEERING
COLORCONASIA
CPHI CHINA
CRYSTAL AUTOMATION
D.M. ENGINEERING CO
DRY AIR
ELECTROFINE ENTERPRISE
EUROPACK MACHINES
FLOCON INDUSTRIES
FOR-BRO ENGINEERS
GLOBAL ELECTRONICS
HMG (INDIA)
INDU ASSOCIATES
'■
LABGUARD
LIFE-CARE EQUIPMENTS
MAC-WELL PHARMA
MEASURHEST
MJ CORPORATION
MODERN LAB
NATURAL AIR SERVICES
J
PAGE NO
rraun»i«-
NEEL ENTERPRISES
19
NEWTRONIC
24
OASIS
21
PHARMA BOOK SYNDICATE
21
POWER GUN SYSTEMS
19
PRAGATI ENGINEERING
26
PRISM PHARMA MACHINERY
26
PROJECTS TODAY
RADIX
RAJ ANALYTICAL
6
24,25
25
RAJ INTERNATIONAL
1
RIDDHI PHARMA
19
ROUQUETTE STARLAC
4
S.K. INDUSTRIES
23
S.K. LAB FURNITURE
25
S.P. PRODUCTS
24
SAGAR PHARMA
26
SAP
27
SATELLITE ENGINEERS
23
: klovARTis AG's drug Glivec, which has : The US FDA approves Barr Laboratories'
: IN dramatically
improved
survival i I application to manufacture and market
i prospects for some cancer patients, can i Isotretinoin capsules USP, 30 mg. The compai interfere with bone development, accord- i ny will launch the product immediately
; ing to US researchers.
i under the trade name Claravis. The company
i Results of a small study published in the : will now market the full line of Isotretinoin
: New England Journal of Medicine found the i product strengths, including Claravis 10 mg,
: drug could inhibit bone formation and resorp- i 20 mg, 30 mg and 40 mg capsules.
: tion - a process known as bone remodelling.
Claravis capsules, 30 mg will compete with
i The side effect was detected by Dr Ellin : Ranbaxy's Sotret (Isotretinoin) capsules USP, 30
i Berman and colleagues at the Memorial ; mg that had total annual sales of approximately
: Sloan-Kettering Cancer Centre in New York ; $15 million for the most recent twelve months
: after some patients on the drug developed ; ending March 2006, based on IMS data.
; low levels of serum phosphate, a mineral
Barr filed a supplemental Abbreviated New
i important in bone formation, said report.
; Drug Application (sANDA) for the 30 mg
: The new finding, however, was based on ; strength of Isotretinoin capsules USP with the
; just 16 patients with low mineral levels and i FDA in June 2004 seeking approval to manu= the full significance of the discovery has yet : facture market this additional strength.
: to be ascertained.
: Claravis is indicated for the treatment of
: Glivec, or Gleevec as it is known in the Unit • severe recalcitrant nodular acne. Because
i ed States, was approved five years ago and has ; of the significant adverse effects associat
; grown to be Novartis’s second biggest selling i ed with its use, Claravis should be
; product, with sales last year of $2.2 billion.
i : reserved for patients with severe nodular
The drug has transformed life expectancy ; acne who are unresponsive to conventioni for people with chronic myeloid leukaemia ;i al therapy, including systemic antibiotics.
; (CML) and a type of stomach cancer called i: In addition, for female patients of childi GIST. Five years of use shows patients tak- i: bearing potential, Claravis is indicated
i ing Glivec have a 90 pei cent survival rate, i only for those females who are not pregj says the report.
♦ : nant and will not become pregnant.
SHANBHAG& ASSOCIATES
25
SHARP ANALYTICAL
26
SHET PET POLYMERS
24
SHETH FABRICATORS
25
i Arizona
SIGNET
3
STERITOOL
23
SUNJAY TECHNOLOGY
23
TECHNIC PHARMA
24
; The FDA has approved
i I Medicis's NDA for Soloi dyn (minocycline HC1,
: USP) extended release
; tablets. Solodyn is the only
i oral minocycline approved
i for once daily dosage in
i the treatment of inflammai tory lesions of non-nodu; lar moderate to severe acne
i vulgaris in patients 12
i years of age and older.
; Solodyn is also the only
approved minocycline in
extended release tablet
form. Solodyn is lipid solu
ble, and its mode of action
occurs in the skin and
sebum. Solodyn Is not
blooqulvalent tp any other
minocycline products, and
i is in no way interchange*
THERMOLAB
24
V.MICRON
26
; I—
New Jersey
Medicis gets FDA nod for oral minocycline
able with other forms of
minocycline.
The dosing and adminis
tration for Solodyn is
unique,
and
redefines
minocycline therapy for
acne. Based on extensive
multi-year clinical trials
conducted by Medicis in
which over 1,000 patients
participated, the recom
mended dosage for Solodyn
is 1 mg/kg daily
According to the release,
Solodyn is patented until 2018
by U.S. Patent No. 5,908,838,
which
covers
Solodyn's
unique dissolution rate. Other
patents covering solodyn's
dosing, pharmacokinetics, and
carrier composition are pend
ing. The company continues to
seek additional patent protec
tion for its products.
Jonah Shacknai, chairman
and CEO of Medicis com
mented, "Having the only
oral patented minocycline
extended release tablet for
acne with once daily
dosage is indicative of the
innovation of our product
pipeline. We believe Solo
dyn's unique, weight-based
dosing will transform the
way
doctors
prescribe
minocycline, and improve
the overall safety of oral
antibiotic use in acne. With
this highly specialized dos
ing method and safety pro
file, we. believe Solodyn
will be a leader in the oral
antibiotic market for acne,
where US dermatologlMts
prescribe
minocycline
more frequently than any
other molecule."
♦
ruolcU dl iviulliuai i auinu vnumivi vutiuiy vuiw, wiuh—•
Regn. No: MH/MH/South-WUUb-Ub vv.rr lic no: bouiii-wuuo-uo
■
,
IVV U LV
CHRONICLE PHflRMHBIZ
PHRRMRBIZ
Ru^jSt El, EOO6
t Cancer patients protest against Novartis move to challenge Gleevec patent rejection
f. .... ssssssss
Joe C Mathew, New Delhi
r-v, atient groups and health
! 1 activists like Cancer
Patients Aid Association
1
and Lawyers Collective
are planning a public protest in
Mumbai
on
Wednesday
against the decision of Novar
tis to challenge the Patent Controller's decision rejecting
patent application for Gleevec
The
(Imatinib Mesylate). The
J
J
protest assumes significance
as the
f Chennai High Court is
to hear the Novartis case on1
August 23 rd.
According to_ patient groups,"
Novartis's
“constant
I.
— litigation
threatens the lives of cancer
patients and renews fears of
future availability if the patent
j
case of Gleevec is reopened.
Further, it has raised concerns
-3 as
among other patient groups
the patent order set a good
g
tion of other crucial AIDS drugs.
It was in May 2006, Novartis
filed two cases in the Chennai
High Court challenging the
refusal of the application filed by
Novartis for a patent on 'Gleevec'
and the constitutionality of sec
tion 3(d) of the Indian Patents
Act which was specifically introduced by the Indian Parliament
to protect against obtaining
patents on old medicines i.e.
trivial patenting, new use
patents etc. While the 3 (d) case
is still to come up for hearing,
the challenge of the patent
order rejecting the Gleevec
patent is up for hearing on the
23rd of August.
The Novartis appeal came
after the Chennai Patent
Office rejected the patent
application in Jan 2006 on the
ground that the application
claimed 'only a new form of
qualify for patentability. Cancer
patients point out that the order
of the chennai patent office
"brought relief to cancer
patients as it not only prevented
a patent monopoly till 2018 but
also automatically withdrew
the EMR". The Gleevec patent
order rejecting a new form of -n
old drug also set an important
precedent for the examination
essential drugs including AIDS
medicines, they add.
According to the patient
groups, the situation of
unavailability of affordable
generic versions of the drug
continued till 2006. While the
generic versions of the drug
'Gleevec' in the Indian market
were priced at about Rs 10,000
per patient per month, Gleevec
Hydro
patient per
groups say that after Gleevec |
was granted EMR, Cancer |
Patients Aid Association and
other cancer groups who had
provided the more affordable
generic versions of 'Gleevec' to
Myeloid Leukemia patients for
their treatment had to with
draw such medical support to
cancer patients.
♦
D
1
we understand water best
- fifty
■
FMRAI complains against 17 pharma
cos to state govt for ineffective
enforcement of SPE Act
The Association said that the
pharmaceutical companies are
TT'ME Federation of Medical issuing appointments violat
PURIFIEO'!KPI
I and Sales Representa- ing the Section 5 of the Ac
SALIENT FEATURESl^W
., „
and
Rule
22
(1)
by
not
giving
S lives Association of India
• Hot water upto 85° C & chemically sanatizable system
letters
of
appointment
in
pre
(FMRAI) has asked Tamil
• Custom Design Module for optimization • Systems complies with 21 CFR Part 11 1
Nadu government to take scribed Form A, Section 7 o
• System is supported with complete validation documer tation (DQ, IQ, OQ)
stringent action against vio the Act and Rule 23 under the
• Intutive software with 5.7" Touch screen for operator friendliness
• CS 316L & PVDF sanitary interconnecting piping • SS 304 PLC & MCC panel
lation of Sales Promotion Act in respect of details o
___ z Act,, 1976, SPE engaged by the company
OTHER PRODUCTS:Employees (SPE)
and rules made there under as per prescribed Form B, Ser
• Ultra Filtration for Pre & Post treatment • Pressure Quartz Filter • Carbon Filter
. De-Mineralisation Plant • Softener Unit • UV Disinfection System
by the pharma companies vice book for every SPE as pe
• PW & WFI sanitary SS 316L Storage tank with internal finish of 240 grit
Form C, a register of servic
operating in the state.
(Tank can be provided with jacket & SS cladding)
In a memorandum, demand book in Form D, leav
^TWOYEAR?
ing the effective enforcement of account of each SPE in Form
SYSTEM
...........
'
SPE (Conditions of Services) E. Though the Act provide
WARRANTEE
Office
:
214,
Diamond
Estate,
Ketaki
Pada,
Act, the FMRAI asked the state punishments for contraven
Off. W. E. Highway, Dahisar (East), Mumbai 400 068
minister for labour to activate tion of the provisions unde
Tel • +91-22-2897 8725 / 2897 9097 • E-mail: sales@hydropure.in
the inspectors appointed under Section 9, none o( the compa
the Act for regular inspection of nies so far has been punishec
Wt Ul11 AMCwVpURtfICTWWai
the premises of the companies despite contravention, th
»;» * *
without further delay as work- memorandum points out. ♦
ers are being exploited
by the managements.
The Association stated
EXCIPIENTS
that the officials under
the Act, have not
inspected any of the
PARTIALLY PREGELATINIZED MAIZE STARCH
premises of the compa
nies for enforcement of
the provisions of the ^.ct
and rules made there
under though the Act
gives specific direction
to the inspectors for reg
ular inspection of regis
ters and documents.
FMRAI listed 17 Chen
nai-based pharmaceuti
cal
companies
for
allegedly violating the
Act in the memorandum.
The list includes compa
Colorcon Asia Pvt. Limited
nies like Tablets (India
Plot Nos. M 14-M 18,
Verna Industrial Estate
Ltd, Indo French Labs
Verna, Goa 403 722 India.
AN ISO 9001:2000 COMPANY
Ltd, SPIC Pharma, TTK
Tel. ♦91-832-2883434.
Fax: +91-832-2883440.
Health Care Ltd, Mano
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....... 2CHRONCLE PtlflRNnBIZ
V I IZrCT IK.
11 I I N I
J
fiugust 31, EOO6
jafvec case to defend international IP rights: Novartis
Vy—————_______
z Our Bureau, Mumbai
I 4. I ovartb India said for ttie
i \ past 4-year Novartis has
i IN given Glivec free for over
6000 mtients in India and the
case it filed in Madras High
Court is to demonstrate its commitment to defend international
intellectual property standards
and right to obtain patents for
innovative compounds under
the TRIPS agreement.
"Novartis demonstrated a sig
nificant commitment to patients
in India through its Glivec International Patient Assistance Pro-
gramme (GIPAP). As of Aug
2006, over 6000 diagnosed
patients in India received Glivec
completely
completely free
free ofof charge
charge
through
through GIPAP,
GIPAP, representing
representing
99% of ' patients
who are on
’ ’ To
> are
Glivec in fndia.
date on
Novartis
Glivec in India. To date Novartis
has given around Rs 1,100 cr of
Glivec free of charge under
GIPAP
GIPAP in
in IIndia. Globally,
GIPAP has helped more than
17,000 patients in 83 countries"
said Novartis in a statement.
It noted that Glivec is a worldclass drug for people suffering
from certain ----------forms of Chronic
f.«...
—----Myeloid Leukemia (CML) and
gastro
stromal
intestinal
tumours
tumours (GIST),
(GIST), the
theapproved
approved
indications
indications for
for Glivec
Glivec in
in India,
India,
and
and isis being
being studied
studied for
for other
other
rare
diseases.
Novartis
rare diseases. Novartis has
has
made
made this
this medicine
medicine accessible
accessible
to eligible cancer patients suf-
the TRIPS agreement.
As reported, patient groups
and health activists staged a
demonstration
Pro^in8
againstthedecisionofNovartis
tistotochallenge
challengt the Patent Controller's decision rejecting their
fering from these diseases
through its GIPAP programme,
It also said that the filing of the
writ petitions with the Madras
HC demonstrates Novartis'
strong commitnient to defend
ing international intellectual
property standards and its
right to obtain patents for its
innovative compounds under
patent application for Glivec
on Aug 23. The demonstration
__ _______
was
held on the pavement in
front of the office of Novartis at
Worli in Mumbai.
Sources with Lawyers Collecfive said the demonstrators were
denied police permission to conduct the demonstration and thus
had to stage a silent protest,
DSP, Sumitomo
| settle patent
j dispute with Pfizer
. ....
Your brand is
now ready to
take a leap
About 95 protesters from vari
ous organisations like Cancer
Patients Aid Association, Posi
tive Peoples foundation, Humsafar Trust, Uddan Trust, Com
mitted Childrens’ Development
Trust Network^ of Maharas
Positive People, Network by
People Living with H1V/AIDS
and Lawyers Collective HIV/
AIDS Unit. The protest was held
to coincide with the scheduled
hearing of Novartis application
for stay of the Patent Controller's
decision in the Madras HC. The
matter has now been adjourned
to Sept 13, 2006
♦
f
3
i Osaka City
Helping all people
live healthy lives
-4
';'X
BD Oralpak gives your liquid pediatric drug a value-add
Consider the currently used dosing de\|ce, the ineasuriiig cup, or even a
teaspoon. Because of volume variation and frequent spillage during administration, it
can compromise the accura^ of the therapy. >
BD brings to India the accurate solution tl^at pediatricians internationally prefer.
BD Oralpak, the new-age oral dispenser that pts your brand delker the therapy the
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Add value to your brand and set it apart.
^Kila Ltd 6th Floor,
wvv.bd.com/india
s»ak"
i
ainiiton Sumitomo Pharma
i L Company (DSP) and its par; ent company, Sumitomo Chem: ical Company, announced that
: they have come to an agreement
; with Pfizer (Pfizer LTd and Pfiz; er Corp, collectively) on a settlei ment in the lawsuits brought by
: Pfizer in Japan and England
i regarding the license for
j Amlodin, a company press
: release stated.
i DSP is engaged in the manufac; ture and sale of Amlodin (generic
; name: amlodipine besilate, a
i therapeutic drug for hyperteni sion and angina pectoris), for
j which Pfizer is the licensor. Pfiz; er l iled a lawsuit with the Tokyo
j District Court against the two
; Japanese companies on Nov 17,
i 2005, claiming that the license
; agreement had terminated due
; to the merger of the former
i Dainippon
Pharmaceutical
; Company and Sumitomo Phar; maceuticals Company to estabi lish DSP and seeking damages
; from patent infringement as well
\ as calling for the immediate ces; sation of the manufacture and
i sales of Amlodin by DSP.
i Pfizer concurrently filed a suit
i with the High Court of Justice in
\ England calling for cessation of
; the manufacture and sale of
i Amlodin by DSP and the return
i of all medical data and other
’ i information. DSP and SumitoI imo Chemical applied for an
I i order from the Court for lack of
I jurisdiction over the lawsuit,
| ; etc. On June 16, 2006, the High
i Court of Justice ruled that the
i Court would not exercise juris•• ; diction over the lawsuit and that
i the effect of the merger on the
? i license agreement should be
- ; analyzed under the Japanese
■Hgg | law relating to the statutory
merger procedure.
I This settlement will allow DSP
It0 continue the manufacture and
|: sale of Amlodin as before with
j no adverse impact to its earnings
’ ’ \ or the earnings of Sumitomo, the
: company release said.
♦
I
I
POLICY g Rl
CHRONICLE FHRRmBIZ
5€pt^rnj>€r 7, EOO6
Dr M.
Prohibitive prices of cancer drugs force takes
patients to turn away from treatment
chronic lymphocytic leukemia
P B Jayakumar, Mumbai
(CLL), costs about Rsl.2 lakh for
-------------------- x^.niiiwwiriwimniri........ *
a cycle of three weeks and the
hile the Central Gov
ernment is mulling patient has to undergo treatment
ways to rein in the for six such cycles for effective
prices of essential cure. Treatment with Roche's
drug
drugs including AIDS and can- another
Herceptin
cer drugs, cancer patient (Trastuzumab), to treat the
groups and NGOs lament that aggressive HER2-positive form
prohibitive costs of many criti- of breast cancer, is equally a costcal cancer care drugs in India ly affair in India. The patient has
are causing treatment beyond to spend over a lakh of rupees for
three-week medication and will
the reach of common man.
have
to undergo treatment for
Among the available 50 odd
about
nine such cycles.
important drugs for cancer care
Treatment
with Taxol (Paclitax
in India, most of the original
el),
the
ovarian
cancer drug from
molecules for effective targeted
Bristol-Myers
Squibb,
costs Rs
treatment are unaffordable to
more than 90% of the patients, 70,000 per a cycle of three weeks
says Y K Sapru, chairman and and six cycles are required for the
Novatis'
Shubh Maudgal, director of treatment. Gleevec, IJ
---- LJ
Cancer Patients Aid Associa myeloid leukemia drug treat
tion (CPAA), a Mumbai-based ment also costs Rs 1,20,000 per
NGO in the field of cancer care patient per month. Many of the
cancer drugs are used in a combo
for the last 35 years.
As examples, they cite that therapy involving surgeries,
treatment with Roche's Mab radiation and chemo therapy,
Thera (Rituximab), used in the and the patients will have to
treatment of several types of undergo lifelong medication.
CPAA alone spends about Rs 40
non-Hodgkin's lymphoma or
Our Bure
lakh in a year to help cancer
patients prolong their lives p|R.MVei
through medication, says Dr U India (v
Sapru. Novartis' offers free: General of j
Gleevec to about 5400 patients; He replc
out of the 25,000 odd cases detect- \ day, last
ed myeloid leukemia cases in the \ Dr M Ve
country. CPAA treats another 50 i ment as a
odd patients with the help of free; Western R
generics of Gleevec given by com-; Dr Venk;
panics like Natco Pharma.
: had his de
Countering the research: ceutical s<
based companies' argument: Pradesh, h
that billions of dollars involved i A renoA
development costs are what i Dr.Venkat
that forces them to price the: tions on In
products high, the NGOs point: national pi
out the lion's share of R&D; alsoamon
expenditure is with public i Revised S
funds. Most of the drugs are i devices an
born in the universities and the
companies' only fast track them
spi
to commercialization.
To support the argument,
sources with the Mumbai NGO Our Bun
Lawyers Collective cite the The Ur
cases of Taxol and Gleevec. I drugs
Taxol was invented by the US ■: count
National Institute of Health^ theminist
and was not patented.
^>e<f7are, Pana
UdayPrac
Accordu
drug seizu
eating spui
nous drug*
as the prices of 97.3% of non- i riousdrug
scheduled formulations moni
Paswe
tored by NPPA remained stable.
16-n
NPPA officials could not be con
tacted to ascertain the reason for
the seemingly abnormal price Usha Shi
fluctuation during August and The chei
September last year. However, I more ii
the common reasons given for \ drugpolii
rise in prices of medicines are j and 3 offL
increase in bulk drug prices, rise ; policy dn
in cost of production or import, \ Speakin
rise in cost of transport, freight i said that"
rates, rise in cost of utilities like : cals has aj
fuel, power, diesel etc, changes in \ emerged i
taxes and duties and (for import- = world and
ed drugs) rise in c.i.f. prices and i try is aboi
depreciation of rupee.
> ; motedevt
r
NPPA finds no major fluctuations in prices o
non-scheduled formulations in 3 years
I
Joe C Mathew, New Delhi
T*he National Pharmaceutical
I Pricing Authority (NPPA)
I has found that the prices of
87.7 % of non-scheduled formu
lation packs monitored by the
authority remained stable during
2005-06. The prices were even
more stable during the previous
two years, thereby allaying the
fears of huge price fluctuation.
The major fluctuation in prices
of non-scheduled packs hap
pened in the months of August
and September in 2005 when
there was a sharp price increase
of 27.25 % and 27.2% respectively.
I
r I
A substantial price decrease was
also noted during these two
months and was in the range of
21.59% and 23.63 % respectively.
The prices were moreover stable
during the rest of the year.
The observations have been
extracted from the monthly moni
toring of medicine prices carried out
by NPPA. The monitoring is based
on the monthly retail audit reports of
ORG-IMS Research Pvt. Ltd.
According to NPPA analysis,
the percentage of non-scheduled
formulations
prices
that
remained stable in 2003-04 was as
high as 97.4. The situation was
exactly the same in 2004-05 also
South ftsia's Mol F’harmahews Weakly
&
CHRONICLE
BUREAU CHIEFS
New Delhi
Joe C. Mathew
HEAD OFFICE: Saffron Media
Churchgate, Mumbai 400 02L
E-mail: ipharma@vsnl.com/sai'
-
MTS
CHROniCLE FHRRMRBIZ
September 21, 2006
/i
court
adras HC adjourns Gleevec case to Sept 26 |j Netherland
prevents Ranbaxy
Our Bureau, Chennai
Madras High Court
1 has adjourned
the
I hearing on the Gleevec
1 patent case to Septem
ber 26, 2006. The case has
been adjourned a day
before the hearing posted
by a single bench in the
Madras High Court on
September 13, allowing
time for the Indian Pharma
ceutical Alliance (IPA) to
file their version, according
to sources. The sources
informed that the single
bench has decided to postpone the case after receiving a notice from the IPA
impleading in the case as a
respondent, within the last
..
r ,
five days.
As reported earlier, IPA's
involvement in the issue is
expected to give a new dimen
sion to the Gleevec issue, the
first major pharmaceutical IP
case in the new product patent
era in India.
Meanwhile, some legal
sources commented »hat the
single bench might have
the case in
adjourned
now ready to
take a leap
forward.
advance if any of the partiiles the rejection of the patent
for
Gleevec.
request more time for prepa application
ration. While IPA declined to Novartis also challenged sec
confirm the implead move. tion 3(d) of the Patents
....................................
the patent attorney firm for (Amendment
Act),, 2005.
______ ts_____ t______ 1 _____ IQQfl
inn
Novartis refused to respond Novartis’ 1998 application;
to Pharmabiz on the devel for a patent on imatinib:\ New York
___________
myselate was opposed by
opment.
fixer Inc said today that the
It is to be noted that Novartis CPAA and later rejected by i
; U District Court of The
has filed seven cases on May the Chennai patent office on
; I Hague in the Netherlands
19, 2006 against the Govern- January 25, 2006.
Meanwhile, a protest march ; has ruled that the basic patent
ment of India, the Cancer
Patients Aid
Association against Novartis on the i covering atorvastatin - the
(CPAA), a 35-year-old cancer Gleevec issue was organised ; active ingredient in Lipitor group, and other last week in Mumbai at Azad i would be infringed by a compatients group.
generic companies in the High Maidan, by Cancer Patients i petitor product from generics
~
; manufacturer Ranbaxy. The
Court of Madras challenging Groups
and NGOs.
decision, which is subject to
; appeal, prevents Ranbaxy from
i launching its drug before Lipii tor’s basic patent (EP 247,633)
; expires in November 2011.
; "Today’sdedsior.isanotheraffir: mation of the strength of the intel|H|g : lectual property behind Lipitor,
: one of the most important medical
? ■ i i breakthroughs of our era,” said
; Pfizer General Counsel Allen Wax; man. 'The court's ruling reinforces
; the fundamental principle that
Helping all people
live healthy lives
; patent laws exist to support and
; encourage medical innovators, not
; undermine them."
: Ranbaxy also had challenged a
; second patent covering the calci: um salt of atorvastatin (EP
i 409,281). The court ruled that the
; patent, which expires in July
; 2010, is invalid. Pfizer said that,
; while it plans to appeal the rul; ing, it will have no practical effect
; on the patent life of Lipitor in the
; Netherlands because the basic
; patent will remain in effect
i beyond the expiration of the cal; cium salt patent.
♦
| for launching
atorvastatin before
; Nov 2011
GBD
) Impax wins in
! Alza's appeal to
| oxybutynin
Hayward, California___
Laboratories, Inc. has
I announced that the US Court
of Appeals for the Federal Cir
cuit upheld a lower court ruling
in favour of Impax in its
defense of a lawsuit brought by
Aka Corporation, a Johnson &
Johnson unit.
The suit alleged patent
infriitgement related to Impax's
filii>g of an ANDA for a generic
version of Ditropan XL (Oxybutvnin Chloride) tablets. 5,10 and
15 mg. Aka H\armaceuticals
markets Ditropan XL for the
treatment of urge urinan* incotv
i tinence. US sales of Ditropan XL
were approximately $350 million
in tire 12 months ended Mae 3L
20kx accorviing to Wolters Kluw
er I iealth.
“Wearv pleased that yet anoth
er court has seen through Aka's
attempt to delay the availability
to patients of a lower priced
alternative to the branded
drug," commented Larry Hsu.
prv<ddvntof Impax.
♦
impax
BD Oralpak Ogives your liquid pediatric drug a value-add
Consider the currently used dosing device, the measuring?cup, or even i
teaspoon. Because of volume variation and frequent spillage during^dministration, it
can compromise the accuracy of the therapy.
BD brings to India the accurate solution that pediatricians internationally prefer.
BD Oralpak, the new-age oral dispenser that let} your brand deliver the therapy the
doctor prescribes. It even customizes to your bragd identity.
Add value to your brand and set it apart.
I' '
I
L
Accurate and
i
PAItNIb
CHROHICLE FHfiRrifiBIZ
October 19, EOO6
SsfisssNGO, BD asks Novartis to withdraw Glivec appeal in India
interest groups, who alerted
- -1 ie Berne Declaration them
them on
on the
the Novartis
Novartis move.
move. "We
"We
| (BD), a Swiss
public- are
our
Swiss publicare writing
writing to
to you
you to
to express
express our
£ interest
organteatton concerns
concerns
regarding
legal
organisation
regarding
thethe
legal
propro
I with 19,000 members, ceedings that Novartis has startmembers, ceedings that Novartis has start....... - ed in May 2006.fc,.
in order to chalhas asked 4Novartis I.
Internachaitional to withdraw its appeal lenge the rejection of its patent
—
• HC against+ application for imatinib mesy
filed in Chennai
the rejection of patent applica late (Glivec/Gleevec) as well as
tion for Glived. The leading the compliance of the Indian
NGO wanted the Swiss multi Patents Act with the World Trade
national
to
stop r
attempting to restrict ;
using
ising the flexibility per- ij
mitted under the TRIPS \
agreement
igreement tn
to meet pub- •
lie health needs.
"We are shocked that :.
five years after the end of
the trial brought by ;
Novartis and other com- ;
panics against the South j
African
government, :
Novartis is trying again ;
to restrict the flexibility ;
given to a country to ;
adapt the TRIPS agree- i
ment to its public health
needs. The undersigned =
organizations demand •
that Novartis withdraws
the cases against the Indi
an Patents Act and the
decision of the Indian
Patent
Office
on
Glivec/Gleevec”, stated
Julien Reinhard, Cam
paign Director, BD.
The letter submitted to
Dr Daniel Vasella, Novar- ;
tis International AG has ;
been endorsed in her pri- j
vate capacity by Ruth ;
Dreifuss, chairperson of \
WHO's commission on ■
IPR, Innovation and Pub- j
lie Health. The organisa- \
tions that have supported \
BD demand include i
Aids-HilfeBem,Associa- ;
tion of European Cancer :
Leagues (ECL), Bethleem ;
Mission Immensee, - CO- ;
OPERAID, Groupe sida j
Geneve, Medecins Sans :
Frontieres,
medicuba, i
MIVA Schweiz, Pharma- ;
dens Sans Frontieres - i
Suisse, SID'Action (Lau- '■
sanne),
SoiidarMed ;
Suisse, Swiss Aids Care i
International, Swiss Can- j
cer League, Swiss Aids ;
Federation, terre des ;
hommes schweiz, etc.
Dr Claudia Kessler
Bodiang, member of
aidsfocus.ch,
Thomas
Schwarz, Co-Director de
Medicus Mundi Suisse
and Helena Zweifel,
Coordinator of aidsfo
cus.ch are among the
! members who have
endorsed the stand in
their individual capacity.
According to BD, the let
ter comes as an expression
of solidarity to the Indian
I patients with cancer,
lectual Property Rights (1RH S).
Wcarel0!n"^the““'°!'8^;
zahons in their demand that
Novartis
withdraws
these
are extremely concerned with
Novartis's challenge of Sec
tion 3(d) of the Indian Patents
Act, which Novartis claims i
‘g’
"Section 3(d), which prevents
the grant of patents for new
forms or new uses of known
substances, is one of the recog
nized flexibilities of the TRIPS
agreement that countries are
utterly free to adopt in their leg
islation. The importance of
these flexibilities has been
highlighted by the United
(
i Commission on
Intellectual Property Rights in
its 2002 report as well as by the
World I leallh Organization
Commission on Intellectual
Property Rights, Innovation
and Health in its 2006 report.
Such a challenge is in contradic
tion with the spirit and the let
ter of the Doha Declaration on
the TRIPS agreement and Pub
lic Health", they said.
“?..
..
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/ 7
CHRONICLE RMHRMHBIZ
October 5, EOO6
Gilead pact with 8 Indian cos for tenofovi^sHCrefers Gtoec
may turn against patients: NGOs
should not be considered a Z
new
,,
J Our Bureau, New Delhi
The major problem
agents
nentsisis'that
thatititallows
allowsaasingle
singleji The petition of Novartis AG challenging the refusal of Patent
keting Hcanse canonly weakenithe
chances of winning a pr g
^^“ZlZZutaetudnl'i tin.fa MraylSe) w™ beheard by a division bench of the Madras
nrnrketine of an essential '■ High Court in October. The single bench decided to refer the
UASoSKypZtly
feel that the recent decision of
According to them, the apparently
Gilead to sigr non-exclusive license harmless license agreement has sevagreements with eight generic eral in-built clauses toat prevenUhe
companies
from supporting
companies of India can prove generic
g
.
, ,
,
harmful to the long term interests of any move to oppose Gilead's 'patent
the patient groups in ensuring limits. "It prevents generic compa
nies from having rights on any
affordable medicines to the needy.
The groups question the ratio improvements, modifications or
nale behind running after Gilead derivative works that they might
when there is a strong case for work on Gilead's compound. Furrejection of its patent application in ther, the agreement-t ensures that
India. The public interest lawyers Gilead controls over the manufacproviding legal support to Indian hiring and marketing channels of
Network for People Livingo with TDF world over, as formulators are
HIV/AIDS (INP+)r and the Delhi required to source APIs only from
Network of Positive People, who '
'
jointly filed the pre-grant opposi
tion, argue that forming a salt agreement to P^de1^
------------------- to only those
(fumaric acid),out
of an existing
those~companies that have
compound (tenofovir disoproxil), license agreements with Gilead. The
the generic formulators are also to pay a
is a common jpractice
' within ""
pharmaceutical industry, and royalty to Gilead," they explained.
ZnZl-eonZtnvir'spatentianPatentsActwh^^
status before jumping into such; parliament to protect against obtaining patents on oiu
agreements, activists opined.
I medicines i.e. trivial patenting, new use patents etc
It is known that the license agree- i It was in May 2006, Novartis tiled two cases in the Madras HC
mentrequiresthegenericcompanies i challenging the refusal of the application f. eu by Novar is for
to assist Gilead on the issuing, main- \ a patent on Gleevec' and the constitutional validity of 3 (D) o
tenance and enforcement of the i Patent Act. The Novartis appeal came after the Chennai I atent
patents. In case of a patent infringe- i Office rejected the patent application in January 2006 on the
ment allegation, the generic compa- i ground that the application claimed only a new form of an old
ny
Gilead. in . \ drug', which does not qualify for patentability.
v may be asked to assist
turther
iv k-ud
further proceedings
proceedings and
and to
lend ilsi
its; In 1998, Novartis filed a patent application in India for Gleevec,
name to such actions or proceedings i the drug essential in prolonging the life of patients suffering from
if required by law in order to help i Myeloid Leukemia (Blood Cancer). Based on the patent appliea
if required by lai
Gilead.The
patientadvocacy
advocacygroups
groups := tion and a particularprovision ofthe Indian P^^^
Gilead.
The patient
say that such actions may lead to a \ 2003 obtained an exclusive marketing right (EMR) for a penod of
wrong precedence where trivial 1 five years. The EMI< operated like a patent monopoly preventing
patent applications get approved i Indian pharmaceutical companies from producing affordable
duetolalofoppositionfromgener- j genertevercionsof^
£ p aveS
Twould ultirLtely i L like Hetero, Ranbaxy, Cipla had to wiM
1C play
Diavers, inis WUUIUa
-------- J.in India
I
’
P~,the
resultin higherpricesand
monopoly :j anH
and ™rl<Ptin
marketing
the drue
drug in India and
and other
other developing
developing countnes.
countries
control over marketing of essential i Aftertherefusalofthepatentapplicahon^genenccomparaesare
medicines, they fear.
♦ i once again in the fray with their versions of Imatinib Mesylate.
Joe C Mathew, New PelhT~
Joe C Mathew, New Delhi
-r-HE patients groups and heaUh
| NGOs who have filed a pre-
hx^^appS
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r-Vr.
I
.. —.. - 4
CHROHICLE PHlTRMfiBIZ
December 7, EOO6
Its strengthens R&D pipeline with 138 projects in development
London
OVartis unveiled new
data on its promising
pipeline amid plans
• for multiple new
product approvals
and
launches over the next two
years. Many of these antici
are for
i pated
. ,. approvals
„
potentially
best-in-class
medicines
that
would
advance treatment stanbards tor patients with
hypertension, diabetes, cancer and other diseases.
Novartis highlighted progress
throughout its pipeline, particularly
the advance ofr-uixHULvuphamiaceu,
uLa fOmp°,UndS t0 PivOtaI triais
before regulatory submission as
well as the development portfo
lio in the newly created Vaccines
and Diagnostics division.
Its compounds FTY720 (fingol mod) for multiple sclero
sis, QAB149 (indacaterol) for
■
-
-
~
!
*
* A
GOVERNMENT OF INDIA
I
UH
I
*
and asthma,
AG0178
In total. Novartis n™,
______ _____________
In COPD
total, Novartis
now has
(agomelatine) for depression 138 projects in pharmaceutical and completed ahead of "wet" form of age-related mac
and ABF656 (Albuferon for clinical development. Of schedule in 2006 for two com ular degeneration (AMD),
hepatitis C as well as RAD001 these, 94 projects are in confir pounds: Tasigna (nilotinib) as after
both
compounds
(everolimus) for cancer and matory development (Phase a new treatment option for received positive recommen
with
resistance dations in November from the
SOM230 ’ (pasireotide) for lib, phase III or registration patients
and/or
intolerance
to treat Committee for Medicinal
Cushing s disease are moving with regulatory authorities).
ment
with
Gleevec/Glivec
for
into pivotal late-stage trials.
A total of 50 are new molecular certain forms of chronic Products for Human Use
I am pleased that our sus- entities (NMEs), while 88 are
(CHMP). The Commission
tained focus on innovation life-cycle management pro myeloid leukaemia (CML), generally follows the recom
and also for Aclasta/Reclast mendations of the CHMP and
and drive to address unmet
jects
involving
new
indica
(zoledronic
acid) as a once- delivers a final decision with
medical needs have enabled
tions
or
formulations.
More
yearly
bisphosphonate
infu
us to further strengthen our
than 20 projects have been sion for women with post in two to three months.
pipeline and file several new added to the j
A US regulatory decision is
pipeline during menopausal osteoporosis.
drugs for regulatory review
also
expected in the first half
2006. Key R&D
U areas are carUS regulatory decisions are of
over the past 12 months," said
2007
for
Galvus
Dr Daniel Vasella, chairman diovascular/metabolic condi also expected for Tekturna (vildagliptin) as a once-daily
tions, oncology and neuro (aliskiren), a renin inhibitor
and CEO of Novartis.
science as well as respiratory for hypertension, and Exforge oral treatment for patients
"Overme
thenext
nexttwo
twoyears
yearswe
with type 2 diabetes. The US
vver
and infectious diseases.
(valsartan and amlodipine), a FDA extended the review
wil1 launch several innovative
Novartis has completed
medicines and continue to many submissions in 2006 to single-tablet combination of period for Galvus by three
invest aggressively in discov regulatory authorities for new the two most prescribed months from November 2006
ery research and development compounds as well as new hypertension medicines in after recently available clini
their respective classes.
cal data were submitted to
activities and complement our indications
indications for
for medicines
Awaiting
European
Com
support
the proposed dosing
own skills and technologies already available to patients
mission approval are Exforge and indications as well as
through attractive collaboraThe US and EU regulatory and Lucentis, a new treatment
tions," Dr Vasella said.
submissions were accelerated option for patients with the complement earlier data on
VV1UI lHe therisk/benefitprofile.
■ ■MHM
O..
PhCTMCeufa,s
III
'
Y)
-1
“
RESEARCH PROPOSALS ARE INVITED FROM
ACADEMIC INSTITUTIOhlS/iyATIONAL LABORATORIES
___ *
IndoGlobal to develop
R&D tool for chemists
in pharma, biotech
Y V Phani Raj, Hyderabad
HE
Pune-based
IfnAud-
support in the near future,
she added.
The company with a
CHROniCLE FHHRNnBIZ
December Ed, 2006
;MSF urges Novartis to drop its Mirus Bio receives RNAi patent
case against Indian patent law
ment from importing cheaper with HIV/AIDS, a win by
Our Bureau, New Delhi
Novartis will mean a step back
AIDS medicines.
"It feels like we are back in in time to the days when we
■ nternational
medical
not
afford
our
I humanitarian organisation South Africa in 2001," said Dr could
I Medicines Sans Frontieres Tido von Schoen-Angerer, of medicines," said Loon Gangte
I (MSF) has launched an MSF's Campaign for Access to of the Delhi Network of Posi
international petition to put Essential Medicines. "Just like tive People. "Generic competi
pressure on the Swiss pharma five years ago, Novartis with its tion is what has made first-line
ceutical company Novartis to legal actions is trying to stand AIDS drugs affordable for
’ 1 right
’ J ‘ to
‘ ) people and for governments.
drop its legal challenge in the way of people's
medicines they Novartis needs to stop stand
L
against India's patent law access the
ing in the way of our right to
which could restrict access to need," he said.
India's law contains provi- access the medicines we need
affordable medicines in the
sions that help put people to stay alive," he said.
developing world.
Novartis filed patent applica
India has long been an before patents, but Novartis is
important source of affordable taking the Indian government tions for the cancer drug ima
a change
in the“ tinib
tinibin
inmost
mostcountries
countriesin
in1993.
1993.
essential medicines because to court"to force
'
’
Thecompany
companywas
wasnot
notable
ableto
todo
do
the country did not grant law. The company is challeng- The
inc
a
key
public
health
safeso
in
India,
as
the
country
was
so
in
India,
as
the
country
was
pharmaceutical patents until
guard
enshrined
within not
notgranting
grantingproduct
productpatents
patentsat
at
2005. Generic antiretroviral
that time.
time. In
In 1998,
1998, Novartis
Novartis
medicines produced in India India's Patents Act that aims to that
more specific
specific
are used to treat over 80 per restrict the granting of trivial applied for r aa more
the beta-crystalline
beta-crystalline
cent of the 80,000 people that patents. If Novartis gets its patent on the
receive treatment today in way, it could mean that essen- polymorph of a mesylate salt of
MSF’s AIDS projects in more tial drugs are more likely to be imatinib i.e. imatinib mesylate,
patented in India, thereby inorder to try to obtain a patent
than 30 countries.
"We rely on less-expensive, restricting generic production monopoly in India.
In January 2006, the patent on
good-quality medicines pro and keeping prices for newer
imatinib mesylate, which
duced in India to treat as many medicines high.
A constant flow of affordable Novartis produces under the
people with AIDS as xpossible,"
said Dr. Christophe Fournier, newer medicines is particularly brand name Gleevec, was
MSF International Council important for the treatment of rejected in India on the
inevitably grounds that it only representJ
President as the NGO officials AIDS, as people
held press conferences in this become resistant to their eci a new form of a known sub
regard in New Delhi and Gene medicines and need newer stance and therefore was not an
drug combinations. But cur innovation and not patentable
va simultaneously yesterday.
Novartis was one of the 39 rently, patent applications on under Indian law. In May 2006,
companies that took the crucial newer generation AIDS the company filed an appeal to
South African government to medicines await patenting the patent rejection, as well as a
<challenge
w against Section 3(d)
court over five jyears ago in an decisions in mdia.
effort to prevent the govern"For people like me, who live of India's Patents Act.
for delivery technology
Madison, USA
RNA into a vein or artery
ft AiRUS Bio Corporation acids being retained within the
IVI announced the grant of blood vessel until degraded
US Patent No.7,148,205 enti and filtered out of the body.
tled "intravascular delivery of However, researchers at Mirus
non-viral nucleic acid." The Bio together with collaborators
patent broadly covers admin- at the University of Wisconsinistration of RNAi-inducing Madison discovered that rapid
molecules via hydrodynamic injection of a large volume
intravascular injection.
nucleic acid-saline solution
A key bottleneck impeding combined with simultaneous
the progress of the ground- mechanical or biological alterbreaking field of RNA inter- ation of the permeability of the
ference (RNAi) has been the vessel wall enabled the
lack of effective delivery DNA/RNA to migrate into the
methods.
methods.This
Thisdelivery
delivery breakbreak surrounding tissue cells. This
through combined
combined with
with enables regional delivery
through
RNAi creates
creates aa powerful
powerful disdis- throughout an entire limb or
RNAi
cpvery
cpvery research
research tool
tool for
for other tissue rather than being
.studying gene function in am- localized to a single point ot
as happens
happens with
with a
mal models, and in the long injection as
needle and syringe.
term might be used for certain
RNA interference (RNAi) is
human therapeutic tissues,
a natural cellular process
"Mirus Bio is s«nr
increasingly
OacinC’
i being recognized for its world wherein short nucleic acids
class expertise in nucleic acid known as small interfering
chemistry and delivery," com RNA (siRNA) regulate gene
mented Russell Smestad, expression and protein pro
Mirus
Bio’s
President. duction. In normal cells,
"Hydrodynamic injection has DNA is copied to messenger
already been widely adopted RNA (mRNA) which directs
of protein. The
in the RNAi research field as the
' synthesis
. ”
the most effective method for RNAi gene silencing pr<
the introduction of
in vivo delivery to liver, where involves
'
RNA
it is a unique tool for target double-stranded
identification and validation molecules into a cell, after
studies. In the future we antic which a multistep cellular
creates
single
ipate that our proprietary process
•Pathway IV hydrodynamic stranded siRNA molecules
A-protocol for delivery of nucle- that interfere with the transJ
ic acids to limb skeletal muscle lation of mRN A into the pro
will similarly be recognized as tein it encodes. Blocking pro
an enabling platform for duction of disease causing
human therapeutics, both for proteins in this manner repRNAi as well as DNA based resents a fundamentally new
products. We are actively pur approach for innovative
suing strategic alliances and medicines. The significance
licensees to apply this tech of this biological pathway
nology as widely as possible." was highlighted in October
Hydrodynamic intravascu when the two researchers
lar injection is a method to credited with discovering
deliver nucleic acids through this powerful biological phethe bloodstream to surround nomenon were jointly award
ing cells and tissues. Normally, ed "The Nobel Prize in Physi
standard injection of DNA or ology or Medicine for 2006". ♦
Australian Federal Court rules against Ranbaxy ;
I
|
j
I
New York_________________
Australian Federal Court in Victoria has
/Aupheld the exclusivity of Pfizer's basic
patent covering atorvastatin, the active ingredient in Lipitor. The ruling, the culmination of a
lawsuit filed in 2005 by generic drug manufacturer Ranbaxy. It includes an injunction against
Ranbaxy's product and preserves Lipitor’s
patent coverage in Australia through May 2012.
Ranbaxy can appeal the decision.
The court found that a proposed Ranbaxy
generic product
infringe nci
Pfizer's
produ« ‘ would
~
— basic
...................
Lipitor patent (AU 601,981). A second patent
covering the calcium salt of atorvastatin (AU
628,198), which expires in September 2012,
was ruled invalid by the court. Pfizer will
appeal that ruling.
The Australian decision will not impact
ongoing Lipitor patent actions in other coun
tries. Pfizer said it will continue to vigorous
ly defend against challenges to its intellectu
al property, noting that patents provide the
necessary incentive to invest in new and life
saving medicines that benefit millions of
patients globally.
♦
degussa.
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Email: klran.kana8kar@degussa.com
1I
'r.
LINICAL 1 RIALS
/
1/
CHROniCLE FHflRNflBIZ
December Ed, EOO6
Novartis presents data on
new leukaemia drug
TRI at Narayana Hrudayalaya to
commence trials of vaccine for
heart attack prevention in 2008
chronic or accelerated phase
Ph+ CML with intolerance
< I ew clinical data has and/or resistance to Glivec.
|\| demonstrated
that
Tasigna was developed by
I 1 Tasigna (nilotinib) elimi Novartis as a next-generation Nandita Vijay, Bangalore
nated or significantly reduced targeted therapy based on the
< I ARAYANA Hrudaythe presence of blood cells con- success of Glivec. Although data
|pi I alaya, the leading
taining a defective chromo- from the landmark ’IRIS
D1C trial I
cardiac care major
some in approximately half the largest-ever conducted in
t
> in Karnataka and
of adult patients with a form CML patients - demonstrated
of life-threatening leukaemia that nearly 90 per cent of chron the Thrombosis Research
who developed resistance or ic-phase Ph+ CML patients tak Institute, London, UK
intolerance to treatment with ing Glivec were alive at five have teamed up to set up
Research
years, a small subset of patients Thrombosis
Glivec (imatinib).
The reductions has achieved in develop resistance or cannot tol- Institute, India. The facili
ty located at the Narayana
these patients resistant to erate this therapy.
Both Tasigna and Glivec are Hrudayalaya is undertak
Glivec, one of the first oncology
drugs developed based on an designed to inhibit production ing research on heart vac
heart
understanding of how some of cells containing the Philadel cine to prevent
cancer cells work, may be the phia chromosome by inhibiting attacks. The human trials
highest ever reported with a tar- the Bcr-Abl protein. Bcr-Abl is should commence by
geted therapy at a minimum of recognized1 as the key cause and 2008-2009 and an addi
driver of the proliferation of tional five years from
six months follow-up.
The phase II data, which forms white blood cells that character there for commercializa
tion of the vaccine. The
the basis for US and EU regula izes Ph+ CML.
While Tasigna and Glivec tar research is a DBT funded
tory submissions completed
earlier in 2006, showed that the get the same pathways, the strat- programme and a Tata
use of Tasigna in patients with egy behind the Tasigna research Trust initiative. The statePhiladelphia chromosome-posi- programme was to design a of-the-art research facility
five (Ph+) chronic myeloid preferentially Bcr-Abl targeted was inaugurated by Presi
leukaemia (CML) reduced or therapy that would be more dent of India APJ Kalam.
The affordable vaccine is
eliminated the presence of this potent against Glivec mutations
defective chromosome in 51 per but avoid the potential side expected to immunize vul
nerable adolescents against
cent of Glivec-resistant patients effects of less targeted agents,
diseases
"These exciting data demon cardiovascular
in chronic phase of this disease
and led to normalize white strate that Tasigna has the poten- including atherosclerosis,
blood cell counts in 74 per cent tial to offer a compelling new i which is a condition of
treatment option fcr patients: blood vessel thickenmg. The
of these patients.
The study also showed a sim with Ph+ CML. Designing ;................................................
ilar magnitude of elimination Tasigna to be ar even more taror reduction of these defective geted Bcr-Abl inhibitor than
cells in 55 per cent of intolerant Glivec appears to be providing
patients. Data from this trial impressive efficacy results with a
were presented at the Ameri manageable safety profile," said
can Society of Hematology David Epstein, CEO and presi
dent of Novartis Oncology. "We
annual meeting.
Joseph Alexander, New Delhi
Novartis has filed applica look forward to further explor
Fab's
R.Reddy's
Lab's
tions with both the US FDA and ing the potential benefits of
European Medicines Agency Tasigna through our broad phase I ■ global trials to test
f the benefits of a
(EMEA) for Tasigna as a III clinical trial programme in J
LimZ 'polypill', a combi
therapy for adult patients with earlier CML settings."
nation of four drugs to treat
heart diseases, will begin in
the next year involving 600
CHRONICLE
people in eight countries,
i including India.
■ : Prof Anthony Rodgers, of
| ; the University of AuckSPECIAL FEATURES IN [ANUARY 2007
i land's
clinical
trials
; research unit, who was an
advisor to the WHO, will
lead the team for the global
( . trials. New Zealand, India,
B & W Rs. 200/- per col cm ♦ Colour Rs. 350/- per col cm
i Australia , Brazil, China,
South Africa, the US and the
UK will be parties to the tri
Basel
vaccine would be an effec
tive way of arresting the
disease even before it
strikes, said Dr. Devi Prasad
Shetty, managing director
Narayana Hrudayalaya and
Thrombosis Research Insti
tute s trustee.
Dr Shetty, a renowned car
diac surgeon in the country
said that cardiovascular
disorders are a recognizable
complaint. For the research,
the medico-scientists have
assessed over 3,500 affected
patients below the age of 55
who have suffered a stroke
or a coronary disorder and
then traced it as heredity
linkage to establish the
effectiveness of the vaccine.
The study intends to inves
tigate 12,500 cases before
2008. The present analysis
already indicates that in
India cardio vascular dis
ease is not just a geriatric
condition but a disease
which has been affecting
even the young population.
Presently heart a Jments are
a dreadful epidemic grow
ing in magnitude. Around
10 per cent of India's one
billion
population are
affected with ischemic dis
eases. Every 140th person is
diagnosed with congenital
heart diseases and one in
1,000 are affected with
rheumatic heart condition.
Cardiac surgeons need to
perform 25 lakh heart surg
eries every year but the cur
rent estimates indicate only
70,000 surgeries. The short
fall is attributed primarily to
lack of awareness and
affordability for surgery.
The joint venture with
TRI London which is a
multidisciplinary organi
zation focusing on interre
lated problems of throm
bosis and atherosclerosis,
has given a platform for
TRI India to pursue genet
ic studies to assess the
increased susceptibility to
premature heart diseases
using a broad strategy for
genomic screening, fine
mapping of candidate
gene analysis and family
association.
This
will
allow faster drug discov
ery, in novel and afford
able therapies.
♦
Global trials for CVD polypill
from next year
1
PHARMABIZ
I
18 January
GOA
25 January
als involving people with
Arab Health, Dubai
B & WRs. 250/- per col cm ♦ Colour Rs. 400/-per col cm
Spcttal
riiniilablt to arli>t tti\i r\ nt
interiirtlioHal event special Jeatines
CHRONICLE
PHARMABIZ SPECIAL FEATURES
New Markets. New HojjzontLOne Publication.
I
To advertfce please conua Ms. Avisha Desai,
Tel.: 91-22-2283 6965 Fax: 91-22-2202 4261 Email: $ale$@saffronmedla.ln
j
Prof Rodgers said the people
for trials would be recruited
by second quarter of next
year. One group will take the
polypill and the second will
take a placebo.
"The first trial will confirm
whether the polypill lowers
blood pressure and choles
terol. If it goes ahead, the sec
ond trial will measure the
Prof finthony Rodgers,
of the University of
Auckland’s clinical
trials research unit,
mho mas an advisor
to the WHO, mill
lead the team
for the global trials
raised risk of having heart
Vv?
’
poly pill's success in reducing
attack or stroke.
"The four medicines - the occurrence of heart
aspirin, a statin to lower attacks and strokes," he said.
The
Health
Research
fho|p»terol and two blood
pressure drugs - combined Council of New Zealand is
into one will potentially be investing NZ $ 350,000 to
much more effective,'' feels support overall coordina
tion of the trial. Dr Reddy's
Prof Rodgers.
During his recent visit to will invest NZ$ 7.5 million.
India, as part of teaming up New Zealand researchers
with Dr Reddy's Labs as will also conduct separate
partner in the global trials, trials from early next year
with people at high risk of
heart attack and stroke.
Cardiovascular
diseases
(CVD)
are
reportedly
responsible for about 30 per
cent of all deaths worldwide.
The number of disease cases
is poised to go up from 380
lakhs of 2005 to 641 lakh cases
by 2015, it is estimated.
"The polypill is expected to
reduce the risk by 60 per cent.
Research shows that people
with chronic diseases like
heart diseases only take half
their medications. Polypill
will provide an easier and
more practical way to take
the
medications,"
Prof
Rodgers said.
The pill is likely to cost
only a few dollars a month
in developing countries. A
WHO report, prepared by
Prof Rodgers and team,
showed that it could be one
of the most cost-effective
interventions for CVD
globally.
WHO
data
showed that about 17 mil
lion people die premature
ly from heart diseases or
strokes every year and most
of the cases are in low and
middle-income countries.♦
bottom lines and sales dur
ing the first nine months of
2006 and they are likely to
achieve a growth rate of 23 to
25 per cent in the whole of
2006. The net profit of 15
companies in the nine
months ended September
2006 increased by 23 per cent
to $ 64,531 million from $
52,460' million in the corre-
earning per share for the year
full year 2006.
The
Pharmabiz
sample
of 15 global companies
namely Pfizer, GlaxoSmithK
line, Novartis, Sanofi-aventis,
AstraZeneca, Roche, Johnson
& Johnson, Merck & Co, Bayer
Group, Bristol-Myers Squibb,
Wyeth, Eli Lilly, Amgen,
Abbott and Baxter Interna-
243,435 million in the similar
period of last year. The phar
maceutical sales of 15 compa
nies in the US improved by
11.7 per cent to $ 135,266 mil
lion as compared to $ 121,099
million in the last period.
Pfizer remained on top with
net sales of $ 35,768 million
during the first nine months of
the year 2006, registering only
ecision on patentability criteria
and (jata protectioni soon
—
1
---------------------- —--------
PB Jayakumar, Mumbai
he expert committee set up by
the Central Government to
define the patentability crite
ria in the Patent Act has submitted
its report to the Government, and
the crucial expert committee on
data protection will submit its
report within a month.
Addressing the Indian Drug Manu
facturers Association (IDMA) annual
convention in Mumbai, last week,
Prithviraj Chavan, Minister of State,
PMO, Government of India, said the
Mashelkar Committee on patentabil
ity criteria submitted its report on
28th December 2006. The Committee
has recommended various options
and adequate safeguards to
protect the interests of the Indi
an pharma industry, while
defining patentability of NCEs.
The committee has also sug
gested restricting of patentabil
ity to manmade and biological
microorganisms and the Gov
ernment is likely to accept this
recommendation, considering
the concerns of domestic indus
try, said Chavan.
The Committee was set up by
the Department of Industrial
Policy and Pro.notion (DIPP)
and the Ministry of Commerce
to see whether it would be
tual Property Rights) compati
ble to limit the grant of patents
for pharmaceutical substance
to new chemical entity or to
new medical entity involving
one or more inventive steps.
Talking to Pharmabiz, he
said the Government was eval
uating the suggestions of the
Central druc
to streamliH’
c Vi IL -i v
Mashelkar
Committee and soon the
details will be announced. "There is Joseph Alexander, New Delhi
no need to amend the Patents Act or
RANDING of drug products wot
DC Act to incorporate these deci
brought under the purview c
sions, which can be done by a notifi
proposed Central regulator}
cation. The Government is studying : licensing system dismantling
the recommendations and will soon practice of licensing of products t
announce the criteria", he said.
state authorities. This major refo
He also said the Committee on data the drug licensing is with the obj.
protection, headed by the Joint Sec to check large scale 'misbrandii
retary, Dept, of Chemicals & Petro- : products taking place in the count
chemicals, will submit the recom
Necessary amendments in the
mendations either by the end of this ing rules have been mooted in th.
month or early next month. He said policy which is going to the Cc
the Government was exploring vari soon along with the note fron
ous models followed by other coun Chemicals & Fertilisers Ministry,
tries, especially like that of Brazil, this change in licensing system,
which did not heed to the pressure manufacturers will have to app
from the US interest groups.
♦ : only the Central licensing author.
r
TABCOAT
readymix film coat
» » a. •
*
>£.
TRIPs (Trade-Related Intellec
stilt compeli
ics in the key i
ingenvironrr
markets.
(GSK) climbc
among the 15
pharmaceutic
27z980 millioi
months peric
her 2006. Th.
tered a stron
a
.. .
/-
*
...
4
IO
1
QUALITY
MS
An 15
Pharmaee
CONSISTENCY
C-318, TTC MIDC IND
RELLAB! LITY
• Tel.:+91-22- 27685
• Fax: +91-22-2763
ACCEPTABILITY
*
PATENTS
-/^Novartis moves Chennai HC against invalidation of Glivec patent
I
As per3(d)
Section
3(d) of the that, the subject matter of this
------ „ . —-------rr----- sidered legally
As per Section
of the
siderednon-tenable.
legally non-tenable.
(patent) application (filed by
Joe C Mathew, New Delhi_ The HC has
& issued notices to Patents Act, any salt,
■ poly’
and has - morph
i *1 or
or derivative
derivative of
of known
known Novartis AG) is not patentable
all
respor
dents
■a | ovartis India has
hearing on substance
substance is
is not
not patentable
patentable under Section 3(d) of the
nt I approached Chennai called for a
’
*!1., polymorph Patents Act 1970 as amended
unless
such j
salt,
| \| High Court against August 23.
----------- shows by the Patents (Amendment)
The Glivec was the only or other ssubstance
■ » the orders of the
Act, 2005.
Patent Controller invalidat- drug that had received enhanced efficacy of the sub
It is against this ruling
marketing rights stance.
j ing the patent claim on exclusive
.... ...............
Giving its ruling in January Novartis has now approached
Novartis' blockbuster anti (EMR) during the mailbox
2006, Patent Office had stated the High Court.
canctrui
......— examination
------cancer drug njuvci
Glivec.
(Imatinib period. Further
Interestingly, the Chennai
i Mesvlate). The company has of the patent application that Glivec is only a new form
HC had, in an earlier ruling,
1 questioned
rt.tocririnoH the
fhp constitutionrnnstihition- showed that the patent sp<
spec- of a known substance. Furasked Novartis to give
al validity of Section 3(d) of ification of Novartis AG does ther, stating that Novartis AG Glivec free of cost to all
not bring out any improve- failed to prove enhanced effithe Patents Act 1970 itself
cacy of the beta-isomer over patients who are suffering
and has pleaded that any ment in the efficacy of the
the known substance, the from CML and are earning
beta-crystal
form
over
the
i decision considered under
patent office had concluded from less than Rs 3,36,000
I Section 3 (d) should be con- known substances.
Mologen gets
| EU patent for
] DNA-vaccine
Your brand is
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Jcrlin
w
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teaspoon, Because of volume variation andfr ?t|<jent spillage dicing admini^r^tionj n.
can compromise t|ie accuracy of the therapy
$
Y
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... •
_ _
I OLOGEN
AG
has
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V I pean Patent Office has
ranted patent for the DNAHelping all people
; vaccine against oncoviruses.
live healthy lives
; Corresponding
applications
i outside the European Union are
i pending before national patent
; offices, a company release said.
i The invention relates to a DNA: vaccin .* against oncoviruses, based
: on Mologen's proprietary DNAi vector MIDGE-TH1. Oncoviruses
i cause severe diseases including
: cancer, anaemia and immuno-sup: pression. Especially cats can be
; protected against infections with
• the oncov:rus FeLV (Feline
i Leukaemia Virus) by the vaccine.
i FeLV is a feline virus infecting
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i following infection are a major
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i the most important markets for
; veterinary pharmaceuticals for
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i Today, an effective therapy for
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i best case scenario, the disease can
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■ ; which in a minor number of cats
I j can cause severe side effects like
" i tumours at the injection site. The
i estimated average annual sales
i volume of FeLV-vaccines is fare
; above 50 million USD.
i Mologen uses its proprietary
DNA technologies to create and
develop treatments for hlglr
unmet*need Illnesses. Tlie main
focuses are the unique and patented
MIDGE and dSUM technologies.
Based on these platforms, Mologen
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____
per month. This was the• time
when
Novartis
was having
’
K
'
‘........
u
EMR on the drug. Natco was
the only generic company
that had obtained permis
sion to market the generic,
version of the drug at a frac
tion of Glivec’s cost in the
country. After the expiry of
the EMR period, Chennai HC
had allowed all generic man
ufacturers to enter the fray.
All generic manufacturers
who are into the manufac
ture and sale of the generic
versions of Glivec are party
to the new case.
Aaurate .nd convent wloto.
j
tOVn/ •
7
P ess Invite for Protest by Cancer patients groups and civil society grot ps in
ri
Er ngalore faxed for the following:
\7 \. Indian Express
22866617^
DD1
23337990 UdayaNews
2235:192 xZ
4. ETV
2238-483vZ
5. Deccan Herald
25880523
25586617^
6 Times of India
222E 366^
7. Samyuktha Karnataka
25543393 (X
8. NDTV
?. Hindu
10. Asian Age
22273561
11. U.T
22357292
■->
For Immediate Release
September 13, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
About 300 citizens of Bangalore gathered at Mahatma Gandhi statute on M.G.
Road on Tuesday (September 12, 2006) in solidarity with cancer patients and
protested against the threat of live-saving drugs being taken away from their
reach. Karnataka Cancer Society, Karnataka Prantiya Raitha Sangha, Karnataka
Prantiya Krishi Coolie Karmekara Sangha, Student Federation of India, BGVS,
Samraksha, Freedom Foundation, Milana, KNP+, Action Aid, AMTC, Abhaya, Pragathi,
CIEDS/ Karnataka Social Forum/ WSF, Sangama, Community Health Cell (CMC),
Janaarogya Andolana — Karnataka (JAA-K), Student representatives of different city
colleges, All India Drug Action Network (AIDAN) and many other civil society groups
participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but ’only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened. “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time, energy and resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2-
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec', made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
“India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard”, says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the ‘Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis.
Bangalore Forum for Access to Medicines - Karnataka Cancer Society, Karnataka Prantiya Raitha Sangha, Karnataka Prantiya
Krishi Collie Karmekara Sangha, Student Federation of India, BGVS, Samraksha, Freedom Foundation, Milana. KNP+, Action Aid,
AMTC, Abhaya, Pragathi, CIEDSZ Karnataka Social Forum/ WSF, Sangama, Community Health Cell (CHC), Janaarogya Andolana
- Karnataka (JAA-K), Garment Worker’s Association, Student representatives (SJC), Student’s representatives (ULC).
Contact person: Naveen, CHC, No. 359 (Old No. 367), Srinivasa Nilaya, Jakkasandra, 1st Main
1st Block, Koramangala, Bangalore - 560 034 Ph: 25525372, 25531518 Email: naveen@sochara.org
> Date: Wed, 30 Aug 2006 23:24:56 -0700 (PDT)
From: Sreepathi Prafulla <prapulli@yahoo.com>
> Subject: Gleevac - novartis petition
fo: aidbangalorci^yahoogroups.com,
drdabade@gmail.com, navthom@yahoo.co.uk ,
> chc@sochara.org
> Dear friends.
NOVARTIS CHALLENGES INDIA'S PATENT LAW!!!
SUPPORT INDIAN PATIENTS IN PROTESTING
AGAINST
> NOVARTIS LITIGATION!
> Earlier this year we informed you of the first
> victory
> of patients groups in India when the Chennai Patent
> Controller rejected Novartis' patent application for
> ‘Gleevec’ a crucial anti cancer drug. Novartis has
> now
•led three cases in India challenging this order
..nd
> against the Government of India and the Cancer
> Patients Aid Association a Mumbai based cancer
> patients group working in India for over 35 years.
■ Gleevec is (he test case of the Indian patent system
(hat so many persons living with Hl\ /AIDS and other
patients are relying on for the continuation of
’ generics manufacture. It is the first test of the
flexibilities of the TRIPS and Doha. Novartis’
litigation is a direct challenge to our lives and
health and we call on all activists and health
‘ groups
- to support Indian patients in this fight.
> WHAT IS GLEEVEC?
' Imatinib Myselate or Gleevec is a crucial cancer
> drug
; essential in prolonging the life of patients
• suffering
>m Chronic Myeloid Leukaemia (Blood Cancer). It is
> produced and marketed internationally by Novartis
■ and
various Indian pharmaceutical companies like Cipla,
Ranbaxy. Natco, and Hetero also manufacture.
> WHAT HAPPENED WITH GLEEVEC IN INDIA?
> Indian generics companies started manufacturing and
supplying affordable versions of Gleevec (much like
they did AIDS medicines). In 2003 Novartis got
“Exclusive Marketing Rights' (EMR) under a provision
of India s patent law for five years. The EMR acted
like a monopoly right and Novartis succeeded in
’ stopping generic manufacture of Gleevec.
To put the effect of all this in perspective;
generic
versions of Gleevec were available in (he Indian
market at about Rs. 8,000 ($1 75) per patient per
month. After Novartis prevented generic manufacture
> it
> marketed Gleevec at nearly ten times that price i.e.
> Rs. 1.20,000 ($ 2000) per patient per month. Gleevec
> was clear and damning proof of what happens when a
> drug company gets a patent.
> WHY WAS NOVARTIS' PATENT APPLICATION FOR
GLEEVEC
> REJECTED?
> After India's patent law changed in 2005 to become
I RIPS compliant (see attached note on Indian Patent
law) Novartis patent application came up for
> examination. 1 he Cancer Patients Aid Association.
which had to stop treatment for cancer patients
> after
> generic versions on Gleevec became unavailable,
> challenged this. Novartis patent application was
> rejected by the Chennai Patent office for being
> merely
> a ‘new form of an old drug', which under Section
> 3(d)
> of the Indian Patent Act is not patentable. This
> brought immense relief to cancer patients in India
> and
> indeed around the world whose lives could not wait
> for
> a 20-year drug monopoly to get over.
> WHAT IS NOV ARTIS DOING NOW?
' Now Novartis has challenged the rejection of its
patent application. Il has also challenged Section
> 3(d) of the Indian Patent Act in a separate case
> questioning the constitutional vailidity of 3(d) in
accordance of the TRIPS Agreement.
> URGENT ACTION
The Cancer Patients Aid Association and the Lawyers
> Collective are organizing actions in India to
> coincide
> with the hearing on 13th August 2006 in the Chennai
> High Court of Novartis challenge.
> We request you to participate in a planning meeting
> on
the 1st of September at 5 pm. to plan for a protest.
The venue: Lawyers Collective IIIV/AIDS Unit, First
Moor No 4 A M AH Road, Off park Road Tasker Town,
> Shivajinagar. Bangalore 560051
If you have any further clarification kindly contact
Prafulla/Raja Kumar at 41239130/3 I
> also pls find the attachments for your further
> reading
Lets all fight for access to medicine
' Prafulla
Gleevec Fact File
Cancer is a disease that is life threatening and a person affected requires monitoring and
treatment for life long. There are about 25,000 new cases of CML (Chronic Myeloid
leukemia). Leukemia accounts for nearly one third of pediatric malignancies. These numbers
represent women, men and children from all strata of society. About 18,000 people die due to
CML every year in India.
In 1993, research began on pyrimidine derivatives and processes for its preparation. The first
STI 1571 (crystalline form of Imatinib Mesylate, a pyrimidine derivative) studies began.
Imatinib Mesylate was found to be effective as a Signal Transduction Inhibitor (STI). STI
inhibits the action of the enzyme tyrosine kinase (BCR-ABL). The tyrosine kinase is the
protein produced by a DNA translocation (Philadelphia chromosome) that appears central to
the CML disease process.
Drugs which are available even by the generic companies, are out of their reach and
unaffordable for them. Treatment for cancer even though available at some government
hospitals is expensive. People affected by cancer die due to non-affordability of treatment.
The proposed patent application is for Gleevec which is p crystalline form of imatinib
mesylate, patent for Gleevac not only deserves to be rejected on the grounds that there is no
novelty, it is not an invention, it was obvious for person skilled in art, but also should be
rejected as the applicants have only used the purported invention for commercial exploitation,
by selling the drug in the Indian market at Rs. 1,20,000/- per month, which cannot be afforded
by patients affected by chronic myeloid leukemia.
By gianting a patent for the alleged invention, it would only allow for commercial
exploitation of the purported invention, thereby excluding all other generic companies,
causing serious prejudice to human health.
Such monopolizing of the drug at the above-mentioned exorbitant price is, thereby causing an
adverse affect on and serious harm to public health. It may be noted that this in itself is
contrary to public order and morality, and the patent should not be granted.
Novartis claims to have spent hundreds and millions of dollars in Research and Development,
manufacturing and clinically testing the drug that they have lead to set a world wide price of
Gleevec at USD 27,000 (INR 13, 50, 000 {Rupees thirteen lakhs and fifty thousand only}
approx.) per year per patient. The Petitioner has already earned about USD 1 billion from
Gleevec sales alone in the year 2003.
However, much of the research and development of Gleevec was carried out by one Dr. Brian
Drucker of Oregon Health and Science University. His laboratory worked in a partnership
with the Petitioner and identified the compound STI1571. The funding sources for developing
the drug was 50% from the National Cancer Institute (US government), 30% from the
Leukemia and Lymphoma Society (US NGO sector), 10% from the Petitioner, and 10% from
Oregon Health and Science Institute.
Page 2 of 2
We urgently need references to support our arguments. Please read the current sections with this in
mind and send your references to the current Penholder with copy to Rakhal.
We need to move quickly on the collection of personal data about research collaborators as well as
SRUs. There are new materials on the site which refer.
Progress is being made!
cheers all
d
On Yahoo!?
360°: Share your blog^hotos, interests and what matters most to you
9/1/2006
The sales of Gleevec in 2002 were about USD 762 million and till September 2003 the sales
in the international market was about USD 795 million. In India alone from May 2002 to
December 2002 Gleevec sales were Rs.96.773 million and between January and November
2003 it was about Rs. 112.354 million (Rupees eleven crores, twenty three lakhs and fifty four
thousand).
Novartis imports the said drug for commercial purposes in India at a rate of Rs.90,000/- to
Rs. 1,20,000/-. The generic versions of the drugs were much cheaper and cost about Rs.90 per
100 mg capsule, and if 4 capsules are taken in a day it would cost Rs.360/- per day, compared
to Gleevec's cost of Rs. 1,000/- per 100 mg capsule, and a cost of Rs.4,000/- per day.
S.NO
NAME
OF PER MONTH COST OF THE
COMPANY
1
2
AVAILABILITY
DRUG
M/s Novartis Between
Rs.90,000/-
AG
Rs. 1,20,000/-.
M/s Sun
Between
Rs.
to
Not
easily
available
the
in
market
8,500/-
to
Easily available in the market
Rs.9,000/-
to
Easily available in the market
Rs.8,500/-
to
Easily available in the market.
Rs.9,000/-
to
Easily available in the market.
Rs.8,500/-
to
Not
Rs. 10,200/3
M/s Natco
Between
Rs. 10,800/-.
4
M/s Cipla
Between
Rs. 10,500/-
5
M/s Ranbaxy
Between .
Rs. 10,500/-.
6
M/s Hetero
Between
Rs. 10,500/-.
7
M/s Shantha
Between
M/s Intas
Between
available
in
the
available
in
the
market.
Rs.8,500/-
to
Rs. 11,880/-
8
easily
Not
easily
market
Rs.8,500/-
to
Easily available in the market.
Rs.8,500/-
to
Easily available in the market
Rs.8,500/-
to
Not
Rs. 12,600/-.
9
M/s Camlin
Between
Rs. 10,200/-.
10
M/s Emcure
Between
Rs. 11,000/-
easily
market.
available
in
the
Briefing Note
August 06
NOVARTIS FILES CASE IN INDIA CHALLENGING PATENT CONTROLLER’S
ORDER AND PATENT LAW
CANCER PATIENTS DEMAND WITHRAWAL OF CASES
On 17th May 2006 Swiss pharma company Novartis Ltd. filed two cases against the Government
of India and the Cancer Patients Aid Association (CPAA) challenging the rejection of the
‘Gleevec’ patent application and the Indian Patent Law. CPAA is a Mumbai based cancer patients
group working in India for over 35 years.
Imatinib Myselate (Gleevec) - A Crucial Drug for Cancer Treatment
Imatinib Myselate (Gleevec) is a crucial cancer drug essential in prolonging the life of patients
suffering from Myeloid Leukemia (Blood Cancer). It is produced and marketed internationally by
the Swiss pharmaceutical company Novartis and various Indian pharmaceutical companies like
Cipla, Ranbaxy, Natco, and Hetero. Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient
per month. Generic versions of the drug 'Gleevec' in the Indian market are priced at about Rs.
8,000 ($175) per patient per month.
Novartis files patent application in India - temporary monopoly granted
In 1998 Novartis filed an application in the Chennai Patent Office for a patent on Imatinib
Myselate (Gleevec). Based on the patent application and a particular provision of the Indian
Patents Act, Novartis in November 2003 obtained exclusive marketing rights (EMR) for a period
of five years.
Cancer patient’s access to generic ‘Gleevec’ affected
The EMR operated like a patent monopoly preventing Indian pharmaceutical companies from
producing affordable generic versions of the drug Imatinib Myselate (Gleevec). Generic
companies had to withdraw the production and sale of the generic versions of the drug in India
and other developing countries.
With an over 10 fold increase in the price of the drug, Cancer Patients Aid Association and other
cancer groups who provided the more affordable generic versions of 'Gleevec' to Myeloid
Leukemia patients for their treatment had to withdraw their medical support to cancer patients.
Patients of other developing countries who were importing generic versions of the drug were also
seriously affected by the unavailability of the affordable versions of ‘Gleevec’.
Cancer Patient Group filed Patent Opposition
This situation of unavailability of affordable generic versions of the drug continued till 2006. In
2005 India changed its patent law to become TRIPS compliant and Novartis’ patent application
on Gleevec came up for examination. The Indian patent law allows for any person or group to
oppose a patent application and the Cancer Patients Aid Association (in addition to an already
pending Supreme Court challenge to the EMR) filed an opposition on behalf of cancer patients in
the Chennai patent office where the application of Novartis was pending.
Chennai Patent Office rejects ‘Gleevec’ patent application
In January 2006 the Chennai Patent office rejected Novartis’ patent application on the ground that
the application claimed 'only a new form of an old drug'. This order of the Chennai patent office
brought relief to thousands of cancer patients as it not only prevented a patent monopoly till 2018
but also automatically cancelled the EMR. The Gleevec patent order rejecting a 'new form of an
1
old drug’ also set an iimportant precedent for the examination of patent applications related to
essential drugs including AIDS medicines.
Novartis challenges Patent Order and Indian Patent Law
In May 2006 Novartis filed two sets of cases in the Chennai High Court. The cases have been
tiled against the Government of India and the Cancer Patients Aid Association.
The first case challenges the patent order of the Chennai Patent office rejecting the Gleevec
patent application filed by Novartis. This is scheduled for hearing on 23rd August 2006. Legal
representatives of the’Cancer Patients Aid Association will appear on their behalf before the
Chennai High Court. Novartis' constant litigation threatens the lives of cancer patients and renews
tears about the future availability of drugs if the patent case of ‘Gleevec’ is
reopened. Further it has raised concerns among other patient groups as the ‘Gleevec’ patent order
S^g°Od precedent for the examination of crucial drugs patent applications including those for
AIDS treatment.
The second case ffiled by Novartis challenges the constitutionality of section 3(d) of the Indian
Patents Act, whichh was specifically introduced by the Indian parliament as a safeguard against the
misuse of the product patent regime. Novartis in its petition is claiming that the section is not in
compliance with the TRIPS agreement and hence should be declared unconstitutional.
Section 3 (d) of the Indian Patent Law - an important public health safeguard
The section is aimed at preventing pharmaceutical companies from obtaining patents on old
medicines i.e. trivial patenting and new use patents etc. In the 1990s, pharmaceutical companies
obtained additional patents on cancer drugs like Zidovudine for a new use i.e. HIV/AIDS
treatment. The patent granted on Zidovudine prolonged the market monolpoly of Glaxo and
deprived millions in- the developing world from accessing AIDS treatment till Indian
manufacturers produced generic versions in the absence of product patents in India.
Therefore India while complying with the TRIPS agreement and introducing a product patent
regime for 'new drugs that were invented', also coupled its law with a safeguard of refusing
patents on discovery of new uses or forms of older drugs (i.e. to prevent evergreening)1 This law
is considered by experts to be in conformity with TRIPS as the agreement allows each country to
set its criteria of patentability and does not prevent countries from including safeguards against
the grant of patents on old drugs i.e. trivial patents. Each country can introduce a patent regime
that is more suited to its socio-economic context. This is also in keeping with the 2001 Doha
Declaration on the TRIPS Agreement and public health.
Cancer Patients demand withdrawal of cases
The Constitution of Indian guarantees the right to life and health and the reopening of the
’Gleevec patent order or a review of Section 3 (d) by the Chennai High Court, patient groups feel,
threatens future access to affordable medicines.
For more information contact:
Pratibha S., Lawyers Collective HIV/AIDS Unit, Phone:+91-22-22875482, Email:
aidslaw@lawyerscollective.org,
Leena Menghaney, Phone: +91-9811365412
1 See a critique of the Indian patent law at
http://www.msf.org/msfinternational/invoke.cfm?objectid=63C0Cl F1-E018-0C72093AB3D906C4C469&component=tooIkit.article&method=full html
2
NOVARTIS FILES CASE IN INDIA CHALLENGING PATENT CONTROLLER’S
ORDER AND PATENT LAW
CANCER PATIENTS DEMAND WITHDRAWAL OF CASES
Chennai/Mumbai/New Delhi 22 August 2006 - Clearly concerned about Swiss Pharma Company
Novartis action of filing a legal challenge to the rejection of a patent on a crucial cancer drug
‘Gleevec’, the Cancer Patients Aid Association (CPAA) is preparing for the legal battle ahead.
In May this year Novartis filed two cases against the government of India and the CPAA
challenging the rejection of its patent application and the Indian Patent Law. Novartis’ 1998
application for a patent on ‘Imatinib Myselate’ (Gleevec) was opposed by the CPAA and
subsequently rejected by the Chennai patent office on 25 January 06. The basis of the rejection
was that the application claimed not an invention but 'only a new form of an old drug'.
“Imatinib Myselate (Gleevec) is a life saving drug essential in prolonging the life of patients
suffering from Myeloid Leukemia (Blood Cancer). The order of the Chennai patent office brought
relief to thousands of cancer patients as it prevented a patent monopoly on ‘Gleevec’ till 2018”
said Y.K. Sapru from the Cancer Patient Aid Association.
The essential cancer drug is produced and marketed internationally by Novartis and Indian
pharmaceutical companies like Cipla, Ranbaxy, Natco, and Hetero. Novartis sells ‘Gleevec’ at
Rs. 1,20,000 ($ 2500) per patient per month while generic versions of 'Gleevec' in the India are
priced at about Rs. 8,000 ($ 175) per patient per month. CPAA and other cancer groups provide
the more affordable generic versions of ‘Gleevec’ to Indian cancer patients.
“India while complying with the TRIPS agreement and introducing a product patent regime for
new drugs that were invented, also coupled its law with a safeguard of refusing patents on
discovery of new uses or forms of older drug. The patent decision on Gleevec was an
implementation of this critical safeguard”, says Gopa Kumar, Centre for Trade and Development
The Novartis cases have raised concerns among public interest and health groups as the
‘Gleevec’ patent order set a good precedent for the examination of other essential drug patent
applications. “Patents have created 20 year monopolies over drugs and have directly resulted in
the denial of life saving treatment to millions around the world as particularly evidenced in the
case of AIDS drugs. The public health protections of the Indian Patent law have given hope to
many who depend on- generics manufacture and the Novartis litigation is a direct challenge to
those protections”, says Leena Menghaney, MSF India’s Access Campaign Manager.
Novartis' constant litigation threatens the lives of cancer patients and renews fears of future
availability if the patent case of Gleevec is reopened. “Novartis’ actions in challenging India’s
patent law are an ominous sign of things to come," said Anand Grover of the Lawyers Collective
HIV/AIDS Unit that is representing CPAA. “Patient groups will have to spend their invaluable time,
energy and resources in expensive legal battles designed by drug companies to discourage
oppositions to their patents and pricing policies. ”
Patient and public interest groups are protesting and demanding a withdrawal of the cases by
Novartis.
For more information contact:
Leena Menghaney: tel +91 98113.56412 or msfh-india-medco-assist@field.amsterdam.msf.org
Pratibha S.: tel 022-22875482 or aidslaw@lawyerscollective.org
Note : We have attached slogans if time permits translate it in Tamil and use it for the protest.
NO PATENT FOR NOVARTIS ON CANCER DRUG - "GLEEVEC"
TAKE BACK PATENT CASE
GLEEVEC IS A ESSENTIAL CANCER DRUG
NOVARTIS PRICE FOR CANCER DRUG = Rs. 14 LALHS A YEAR
WE WANT TO LIVE
NOVARTIS GO BACK
TAKE BACK CASE IN CHENNAI HIGH COURT
NOVARTIS WANTS TO KILL CANCER PATIENTS
PATENTS KILL PATIENTS .
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society, Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS, Samraksha, Freedom Foundation, Milana, KNP+, Action Aid,
AMTC, Abhaya, Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama, Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges, All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate'
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.’’ Patient groups have to spend their invaluable
time, energy and resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec', made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as '
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney.
Medecins Sans Frontieres (MSF) India s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis.
Bansalorc Eorum for Access to Medicines - Karnataka Cancer Society. Karnataka I'rantiya Raitha Sangha. Karnataka Prantiya
Krishi Collie Karmekara Sangha Student Federation of India. BGVS. Sainraksha. Freedom Foundation. Milana. KNP '
Action Aid.
\hha\a. Pragathi. (. II US Karnataka Social I oruin/ W'SI . Sangania. Coniinunii\ Health Cell (CIICl,
Indolantt
\XI It,
Karnataka t.l \ \-K I. (iannent \\ oikcr s Association. Student representatives (S.IC). Student s rcprcscnialivcs (I 'I.Cl
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
"India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections", says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis.
Ban«alorc Forum for Access to Medicines - Karnataka Cancer Society. Karnataka Prantiya Raitlia Sangha. Karnataka Prantiya
Krnhi Collie Karmekara Sangha. Student Federation of India. BGVS. Samraksha. I ieedoni Foundation. Milana. KNP‘ Action Aid.
Wl k
\bhu\a. I’ragathi. ( II DS Karnataka Social l orunv WSI . Sangaina. Conununils Health Cell (CIK 'I. ./(iiHitirof’vu Indoltnui
Karnataka (.1 \ A-K I (iannent \\ oikci > Association Student rcpiesentati\ cs (S.IC). Student s representatives 11 'I .Ci
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society, Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India, BGVS, Samraksha, Freedom Foundation, Milana, KNP+, Action Aid,
AMTC, Abhaya. Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama, Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate'
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened. “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come ” Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
If you want the cancer patients
to die then don't read this
Cancer Medicine can become costlier!!!! PATIENTS LIVES ARE THREATENED!!
Gleevec, a cancer drug will cost Rs. 1,20,000 per month instead of Rs. 8000 per
month!!!!
I
K
t
Cancer is a life threatening disease and a person affected requires life-long monitoring and treatment.
India has 25000 new Blood Cancer patients every year. 1/3 of them are children. 18000 die each
I
k
year without treatment as they cannot afford the prices of the medicine.
I-
-> Gleevec is the Anti-blood cancer drug made and sold worldwide by Novartis, a Multinational drug
company. Indian drug companies also make them
BUT ... Novartis’ Gleevec price is Rs. 1,20,000/patient/month. Indian drug companies’ price is Rs.
I
8,000 -10000/patient/ month.
Novartis claims to have spent hundreds and millions of dollars for research and development for so-calle
‘invention’ of Gleevec. Novartis has already earned about Rs. 4500 crores from worldwide Gleevec
sales alone in 2003.
The sales of Gleevec by Novartis in India in 2002 were Rs. 435crores and about Rs.504crores in 2003.
Novartis tried to prevent Indian companies from making and selling Gleevec through its patent applicatio
f
i
I
filed in Chennai in 1998. But this was rejected by the Patent Controller. This brought relief to thousands
cancer patients as Indian companies were free to make and sell a cheaper version of Gleevec.
However, Novartis has challenged this patent rejection by filing a case against the Cancer Patients’ Aid
Association..
Novartis’ greed to make profits at the cost of health through constant litigation threatens th
lives of cancer patients and renews the fears of future availability of the medicine.
I
I
I
Patient and public interest groups are protesting and demanding a withdrawal of the cases
by Novartis, which wants profits over cancer patients’ lives.
I
Join the battle to attain a person’s FUNDAMENTAL RIGHT TO HEALTH and
resist International drug companies FUNDAMENTAL NEED FOR GREED.
j
5
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J
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•
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!
If you want the cancer patients
to die then don't read this
*
Cancer Medicine can become costlier!!!! PATIENTS LIVES ARE THREATENED!!
Gleevec, a cancer drug will cost Rs. 1,20,000 per month instead of Rs. 8000 per
month!!!!
Cancer is a life threatening disease and a person affected requires life-long monitoring and treatment.
|
India has 25000 new Blood Cancer patients every year. 1/3 of them are children. 18000 die each
year without treatment as they cannot afford the prices of the medicine.
I -> Gleevec is the Anti-blood cancer drug made and sold worldwide by Novartis, a Multinational drug
I
company. Indian drug companies also make them
I => BUT ... Novartis’ Gleevec price is Rs. 1,20,000/patient/month. Indian drug companies’ price is Rs.
I
8,000 -10000/patient/ month.
I => Novartis claims to have spent hundreds and millions of dollars for research and development for so-calle
‘invention’ of Gleevec. Novartis has already earned about Rs. 4500 crores from worldwide Gleevec
sales alone in 2003.
=> The sales of Gleevec by Novartis in India in 2002 were Rs. 435crores and about Rs.504crores in 2003.
s
=> Novartis tried to prevent Indian companies from making and selling Gleevec through its patent applicatio
filed in Chennai in 1998. But this was rejected by the Patent Controller. This brought relief to thousands
cancer patients as Indian companies were free to make and sell a cheaper version of Gleevec.
However, Novartis has challenged this patent rejection by filing a case against the Cancer Patients’ Aid
Association..
Novartis’ greed to make profits at the cost of health through constant litigation threatens th
lives of cancer patients and renews the fears of future availability of the medicine.
Patient and public interest groups are protesting and demanding a withdrawal of the cases
by Novartis, which wants profits over cancer patients’ lives.
Join the battle to attain a person’s FUNDAMENTAL RIGHT TO HEALTH and
resist International drug companies FUNDAMENTAL NEED FOR GREED.
I
*
3
I
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n Q
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= zradcF
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=
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ds
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS. Samraksha, Freedom Foundation. Milana, KNP+, Action Aid.
AMTC, Abhaya. Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama. Community
Health Cell (CMC). Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges, All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis’ constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened. “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2v
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec' patent order set a good precedent for the examination of other essential
drug patent applications. "Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections", says Leena Menghaney.
Medecins Sans Frontieres (MSF) India's Access.Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis.
Bangalore Forum for Access to Medicines - Karnataka Cancer Society. Karnataka I'rantiya Raitha Sangha. Karnataka Prantiya
Krishi Collie Kannckara Sangha. Student Federation of India. BCiVS. Samraksha. Freedom Foundation. Milana. KNP - . Action Aid.
\M K . Abhavi. Pragathi. C It DS Karnataka Social Forum/ W'SF. Sangama. Communitx Health Cell (CMC). Juiuuuo^vn Aiidolanu
K.iniataku i.l \A-K |. Garment \\ oiker s Association. Student rcprescntatixcs (SJC). Student s representatives (I 'I .C)
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha. Student
Federation of India. BGVS, Samraksha, Freedom Foundation. Milana, KNP+, Action Aid,
AMTC, Abhaya, Pragathi. CIEDS/ Karnataka Social Forum/WSF, Sangama, Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time,
energy and
resources in expensive legal
battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2-
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec patent order set a good precedent for the examination of other essential
drug patent applications. Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney.
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Ban-.lor, Forum for Access t,, Medkines - Karnataka Cancer Society Karnataka Prantiya Rattha Sangha. Karnataka Prantiya
Kr.sln Colbe Kannekara Sangha. Student Federation of India. BOVS. Santraksha. I teedotn Foundation, Milana. KNP-. Action Aid.
\M FC. Ahhasa. Pragalh, Cll I >S Karnataka Soctal l orctt.i.- WSF. Sangama. Commumls I Icalth Cell (Cl IC).
K.miaiaka t.lAA-K I. Garment \\ orker s Association. Student representatives (S.IC). Student s representatives (Ul.( )
.l„dnl«lm
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach
Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha. Student
Federation of India. BGVS. Samraksha. Freedom Foundation. Milana. KNP+. Action Aid,
AMTC. Abhaya. Pragathi. CIEDS/ Karnataka Social Forum/WSF. Sangama. Community
Health Cell (CHC). Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
agarnst the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened "Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time,
energy and
resources in expensive legal battles designed
by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard', says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec patent order set a good precedent for the examination of other essential
drug patent applications.
Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections", says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Bangalore Forum for Access to Medicines - Karnataka Cancer Society. Karnataka Prantiya Raitha Sangha. Karnataka Prantiya
Krisht Collie Kannekara Sangha. Student Federation of India. BGVS. Samraksha. Freedom Foundation. Milana. KNP+. Action Aid.
\MIC. Abha\a. Pragaihi. ( II Ds Karnataka Social l orum/ WSF. Sangama. Commumtx Health Cell (Cl IC). .Iitiuuiio^yn Aiuiolaiia
Karnatakat.lAA-Ki. Garment \\ orker's Association. Student representathcs (S.IC). Student s representatives (UI.C)
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS, Samraksha, Freedom Foundation. Milana, KNP+, Action Aid,
AMTC. Abhaya. Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama, Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges, All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis’ constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come." Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of ’Gleevec', made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. ‘Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis.
Bangalore Forum for Access to Medicines - Karnataka Cancer Society. Karnataka Prantiya Raitlia Sangha. Karnataka Prantiya
Krishi Collie Kannekara Sangha Student Federation of India. BGVS. Samraksha. Freedom Foundation. Milana. KNP+. Action Aid.
XMIC Ahhaxa. Pragathi. CH DS Karnataka Social Forum/ WSF. SangaMia. Communnx Health Cell (CIIC). .kinaciro}>\u Andotcma
Karnataka (.I-\A-K l. Garment \\ orker s Association. Student representatives (SJC). Student s representatives (I .'I .C)
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS. Samraksha, Freedom Foundation. Milana. KNP+. Action Aid,
AMTC. Abhaya. Pragathi, CIEDS/ Karnataka Social Forum/ WSF. Sangama. Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis' actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed
by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of ’Gleevec’, made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
"India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The. patent decision on
Gleevec was an implementation of this critical safeguard ", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec' patent order set a good precedent for the examination of other essential
drug patent applications. Patents have created 20 year monopolies over drugs and
have directly resulted in the deniaj of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Bangalore Forum for Access to Medicines - Karnataka Cancer Society. Karnataka 1‘rantiya Railha Sangha. Karnataka Prantiya
Knshi Collie Karmekara Sangha Student l edcration ol India. IKiVS. Samraksha. licedoin l oundadon. Milana. KNP'. Action Aid.
Wilt, \bha\a. Pragathi. C II DS Karnataka Social loruin/ WSI\ Sangama. Coininunitx Health Cell (CIICi .laihKiro^v.i liidolunu
Karnataka 1.1A A-K |. Garment Workers Association Student representutnes (S.K'). Students rcprescntaliscs (I ’I.C)
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS. Samraksha, Freedom Foundation. Milana, KNP+, Action Aid,
AMTC, Abhaya, Pragathi, CIEDS/ Karnataka Social Forum/WSF. Sangama, Community
Health Cell (CHC). Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate'
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
"India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses orfojrns of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the deniaJ of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections", says Leena Menghaney,
Medecins Sans Frontieres (MSF) India s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Bangalore Forum for Access hi Medicines - Karnataka Cancer Society. Karnataka I’rantiya Kaillia Sangha. Karnataka Prantiva
Krishi Collie Karinekara Sangha. Student l ederation ol India. BGVS. Samraksha. Freedom Foundation. Milana. KNP+. Action Aid.
Wl It Abha\a. Prugalhi. Cll DS Karnataka Social l orunv WSF. Sangama. Coininnmix Health Cell (CIIC). .luiuuiro^vii Andolcuni
Karnataka < .I \ \-K i. Garment W orker s Association. Student representatives < S.IC). Student s representatives < I ’I.(.' I
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society. Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India, BGVS, Samraksha, Freedom Foundation, Milana, KNP+. Action Aid,
AMTC, Abhaya, Pragathi, CIEDS/ Karnataka Social Forum/WSF. Sangama, Community
Health Cell (CHC), Janaarogya Andolana — Karnataka (JAA-K), Student representatives
of different city colleges. All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate'
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India's patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
-2Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec'. made by Indian companies are priced at about /?s. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
“India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard’', says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the ‘Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Bangalore Forum for Access to Medicines - Karnataka Cancer Society. Karnataka Prantiya Raitha Sangha. Karnataka Prantiya
Krishi Collie Karmekara Sangha. Student Federation of India, BGVS. Samraksha. Freedom Foundation. Milana. KNP+. Action Aid.
AMIC. Abhaya. Pragalhi. CIEDS/ Karnataka Social Forum/ WSF. Sangama. Communit) Health Cell (CHC). Janaarogya Andolana
Karnataka (.IAA-K). Garment Worker s Association, Student representatives (S.IC), Student’s representatives (UI.C)
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec', made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent. Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
“India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this chtical safeguard”, says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the ‘Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of the
cases by Novartis.
Bangalore Forum for Access to Medicines - Karnataka Cancer Society, Karnataka Prantiya Raitha Sangha. Karnataka Prantiya
Krishi Collie Karmekara Sanghn Student Federation of India. BGVS, Samraksha. Freedom Foundation. Milana. KNP+. Action Aid.
AM IC. Abhaya, Pragathi. CIEDS/ Karnataka Social Forum/ WSF. Sangama. Community Health Cell (CHC), Junaarogya Andolana
- Karnataka (JAA-K). Garment Worker’s Association. Student representatives (S.IC), Student s representatives (ULC).
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in solidarity
with cancer patients and are protesting against the threat of live-saving drugs being
taken away from their reach. Karnataka Cancer Society, Karnataka Prantiya Raitha
Sangha, Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student Federation of
India, BGVS. Samraksha, Freedom Foundation, Milana, KNP+, Action Aid, AMTC,
Abhaya, Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama, Community Health
Cell (CHC), Janaarogya Andolana — Karnataka (JAA-K), Student representatives of
different city colleges, All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis’ constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India's patent law are an
ominous sign of things to come." Patient groups have to spend their invaluable
time, energy and
resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and are protesting against the threat of live-saving
drugs being taken away from their reach
Karnataka Cancer Society, Karnataka
Prantiya Raitha Sangha. Karnataka Prantiya Krishi Coolie Karmekara Sangha, Student
Federation of India. BGVS, Samraksha, Freedom Foundation, Milana, KNP+, Action Aid,
AMTC. Abhaya. Pragathi, CIEDS/ Karnataka Social Forum/WSF, Sangama, Community
Health Cell (CHC). Janaarogya Andolana - Karnataka (JAA-K), Student representatives
of different city colleges, All India Drug Action Network (AIDAN) and many other civil
society groups participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year. Novartis has filed cases challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.” Patient groups have to spend their invaluable
time,
energy and resources in expensive .legal battles designed
by drug
companies to discourage oppositions to their patents and pricing policies.
P.T.O.
I
-2-
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells Gleevec' at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of ’Gleevec'. made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard", says Gopa Kumar. Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the Gleevec' patent order set a good precedent for the examination of other essential
drug patent applications.
Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections”, says Leena Menghaney.
Medecins Sans Frontieres (MSF) India's Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of
the cases by Novartis
Bangalore Forum for Access to Medicines - Karnataka Cancer Socicts. Karnataka I'rantiya Rattha Sangha. Karnataka I’rantiya
Knshi Collie Karmekara Sangha Student l ederation of India. IKiVS. Samraksha. Freedom Foundation. Milana. KNP
Action Aid.
Ahhaxa. Pragathi. Cll DS Karnataka Social Forum WSI. Sangama. Cominumix I Icalth Cell (Cl IC).
IndokuM
Will
K.irmnakai.l \ \-Ki Garment W orker s Association. Student representatives (S.IC) Student s rcprcscnlaliws (('I.Cl
For Immediate Release
September 12, 2006
BANGALORE CITIZENS STAND IN SOLIDARITY WITH CANCER
PATIENTS
- DEMAND IMMEDIATE WITHDRAWAL OF CASES BY NOVARTIS
Citizens of Bangalore came to Mahatma Gandhi statute on M.G. Road today in
solidarity with cancer patients and protested against the threat of live-saving
drugs being taken away from their reach. Karnataka Cancer Society, Karnataka
Prantiya Raitha Sangha, Karnataka Prantiya Krishi Collie Karmekara Sangha, Student
Federation of India, BGVS, Samraksha, Freedom Foundation, Milana, KNP+, Action Aid,
AMTC, Abhya, Pragathi, CIEDS/ Karnataka Social Forum/ WSF, Sangama, Community
Health Cell (CHC), Janaarogya Andolana - Karnataka (JAA-K) and many other civil
society groups also participated in the solidarity meet.
Cancer patient groups and the civil society groups have been fighting a long battle
against the greed of companies to make a killing out of life-saving medicines. Novartis, a
Multi National Drug Company filed an application for a patent on ‘Imatinib Myselate’
(Gleevec) in 1998. This was opposed by the cancer groups and generic companies and
subsequently it was rejected by the Chennai patent office on 25 January 2006 on
the grounds that the application claimed not an invention but 'only a new form of
an old drug'.
In May this year, Novartis has again filed cases against the government of India and the
Cancer Patients Aid Association (CPAA) challenging the rejection of its patent
application and questioning the Indian Patent Law. Novartis' constant litigation threatens
the lives of cancer patients and renews fears of future availability if the patent case of
Gleevec is reopened. “Novartis’ actions in challenging India’s patent law are an
ominous sign of things to come.’’ Patient groups have to spend their invaluable
time, energy and resources in expensive legal battles designed by drug
companies to discourage oppositions to their patents and pricing policies.
P- T- O
Gleevec is a anti-blood cancer medicine. India has 25000 new Blood Cancer patients
every year in urgent need of medicines, with one-third of them being children. 18,000
people die each year without treatment as they cannot afford the prices of the
medicine.
Novartis sells ‘Gleevec’ at Rs. 1,20,000 ($ 2500) per patient per month while generic
versions of 'Gleevec', made by Indian companies are priced at about Rs. 8,000 ($ 175)
per patient per month. If Novartis is granted a patent, Indian companies will have to stop
manufacturing the medicine, which will greatly affect the prices and easy availability of
the medicine.
“India while complying with the TRIPS agreement and introducing a product patent
regime for new drugs that were invented, also coupled its law with a safeguard of
refusing patents on discovery of new uses or forms of older drug. The patent decision on
Gleevec was an implementation of this critical safeguard”, says Gopa Kumar, Centre for
Trade and Development (CENTAD). It is this crucial clause in the Indian Patent Act
which Novartis is challenging.
The Novartis cases have raised concerns among public interest and health groups as
the ‘Gleevec’ patent order set a good precedent for the examination of other essential
drug patent applications. “Patents have created 20 year monopolies over drugs and
have directly resulted in the denial of life saving treatment to millions around the world as
particularly evidenced in the case of AIDS drugs. The public health protections of the
Indian Patent law have given hope to many who depend on generics manufacture and
the Novartis litigation is a direct challenge to those protections’’, says Leena Menghaney,
Medecins Sans Frontieres (MSF) India’s Access Campaign Manager.
Patient and public interest groups are protesting and demanding a withdrawal of the
cases by Novartis.
Bangalore Forum for Access to Medicines - Karnataka Cancer Society, Karnataka Prantiya Raitha Sangha, Karnataka Prantiya
Krishi Collie Karmekara Sangha, Student Federation of India, BGVS, Samraksha, Freedom Foundation, Milana, KNP+, Action Aid,
AMTC, Abhya, Pragathi, CIEDS/ Karnataka Social Forum/ WSF, Sangama, Community Health Cell (CHC), Janaarogya Andolana Karnataka (JAA-K).
Q&A on Patents in India and the Novartis Court Case
Q: Why do millions of people rely on India for affordable medicines?
A: Drugs produced by companies in India are among the cheapest in the world. That is because
until recently, India did not grant patents on medicines. India is one of the few developing
countries with production capacity to manufacture quality essential medicines. By producing
cheaper generic versions of drugs that were patented in other countries, India became a key
source of affordable essential medicines, such as antiretroviral medicines to treat HIV/AIDS.
Drugs produced in India have been used for the country's domestic market and are also
imported by many developing countries that rely on India to provide the medicines needed e.g.
to run national AIDS treatment programmes. Over half the medicines currently used for AIDS
treatment in developing countries come from India and such medicines are used to treat over
80% of the 80,000 AIDS patients in Medecins Sans Frontieres projects today.
Q: What is the relationship between patents and affordable medicines?
A: Patents grant local monopolies to companies who hold them for a certain amount of time.
This means that a company that holds a patent on a drug in a particular country can prevent
other companies from producing or selling the drug in that country for the duration of the
patent's term, which, according to World Trade Organization (WTO) rules is a minimum of 20
years. This in turn allows companies to charge high prices in countries where they hold
patents, because there are no competitors in the market. Competition among producers is the
tried and tested way to bring prices down. Competition among generic manufacturers is what
helped bring the cost of AIDS treatment down from $10,000 per patient per year in 2000 to $130
per patient per year today. In the absence of patents, multiple producers compete for a share of
the market, driving the price down as low as possible. In addition, having multiple sources
helps increase the availability of drugs. Further, the absence of patents in India has helped the
development of e.g. three-in-one AIDS medicines and formulations for children.
Q: Why does India grant patents on drugs now?
As a WTO member, India has to comply with trade rules set by the WTO. One of these is the
Agreement on Trade-related Aspects of Intellectual Property, or TRIPS, which obliges WTO
countries to grant patents on technological products, including pharmaceuticals. To comply with
this international obligation, India changed its patent law in 2005 and started to grant patents
on medicines. As a result, if patents are granted in the country, Indian generic manufacturers
will not be able to produce cheaper generic versions of these medicines, which will have an
impact not only in India domestically, but also on other countries that import Indian generics.
Only a few new medicines have been patented in India today. Roche obtained the first
pharmaceutical patent in India in March 2006 for a hepatitis C treatment - but this is likely to
increase in the future. Currently, nearly 10,000 medicine patent applications await examination
in India. If India begins to grant patents the same way that wealthy countries do - where
medicines are routinely protected by several patents covering each small modification - it could
mean the end of affordable medicines in developing countries.
Q: Why is Novartis suing the Indian Government?
A: Novartis applied for a patent in India on the cancer drug imatinib mesylate, which the
company markets under the brand name Gleevec/Glivec in many countries. The patent was
rejected in India in January 2006 on the grounds that the drug was a new form of an old drug,
and therefore was not patentable under Indian law. In other countries where Novartis has
obtained a patent, Gleevec is sold at $2,600 per patient per month. In India, generic versions of
Gleevec are available for less than $200 per patient per month. Novartis is therefore trying to
have the patent decision overturned so that it can sell Gleevec at the same price in India as in
other countries. Novartis is also trying to challenge the Indian patent law so that patents are as
easily granted in India as they are in most other countries.
Q: How is it possible for India to reject a patent that is granted in other countries?
There is no such thing as an international or global patent. Patent applications are examined by
patent offices in individual countries, and each office deliberates whether a particular drug
should be patented or not on the basis of local patent regulations. Fortunately, India designed
its new patent law so that the number of patents granted would be kept to a strict minimum.
This was an effort to reward innovation, which is the rationale of the patent system to begin
with. The Indian law states that patents should only be granted on medicines that are truly new
and innovative. This means that companies should not be able to obtain patents for drugs that
are not really new, such as for combinations or for slightly improved formulations of existing
drugs. This part of the law was specifically targeted at preventing a common practice of drug
companies of trying to get patents on insignificant improvements of existing drugs, in order to
extend their monopolies on drugs as long as possible. Novartis is challenging this part of the
Indian law, which the company says violates WTO rules.
Q: Does India have the right to have this particular patent law?
In 2001, all WTO countries signed the Doha Declaration, which states "that the [TRIPS]
Agreement can and should be interpreted and implemented in a manner supportive of
WTO Members' right to protect public health and, in particular, to promote access to medicines
for all." The same declaration allows countries to take measures to protect public health. India's
patent law is based on this declaration. India chose to design a patent law that contains a key
public health safeguard, namely the provision that only truly new or innovative drugs should
be patented.
Q: Aren't patents needed to stimulate innovation for new drugs by pharmaceutical companies?
An increasing number of studies are showing that while patent protection has increased over
the last 15 years, the innovation rate has been falling, with an increase in the number of 'me-too
drugs' of little or no therapeutic gain. A survey published in April 2005 by La Revue Prescrire,
concluded that 68 percent of the 3,096 new products approved in France between 1981 and
2004, brought 'nothing new' over previously available preparations1. Similarly, the British
Medical Journal published a study rating barely five percent of all newly-patented drugs in
Canada as 'breakthrough.'2 And a breakdown of over one thousand new drugs approved by
the US Food and Drug Administration between 1989 and 2000 revealed that over three quarters
have no therapeutic benefit over existing products3.
Q: What will happen if Novartis wins the case?
If Novartis wins the case and succeeds in getting the provision of Indian law changed to
resemble patent laws in wealthy countries, patents may be granted in India as broadly as they
1 “A review of new drugs in 2004: Floundering innovation and increased risk-taking.”, Prescrire International, April
2005, vol. 14, n. 76 pp. 68-73.
2 “Breakthrough drugs and growth in expenditure on prescription drugs in Canada”, Morris L Barer, Patricia A
Caetano and Charlyn D Black, Steven G Morgan, Kenneth L Bassett, James M Wright, Robert G Evans, British
Medical Journal, 2nd September 2005, 331:815-6.
3 “Changing Patterns of Pharmaceutical Innovation”, The National Institute for Health Care Management Research
and Educational Foundation,. Washington, DC, NIHCM Foundation, May 2002,
http://www.nihcm.org/innovations.pdf
are in wealthy countries. This will mean that fewer and possibly no generic versions of newer
drugs will be able to be produced by Indian manufacturers during the patent terms of at least
20 years, and India will no longer be able to supply much of the developing world with cheap
essential medicines.
The example of HIV/AIDS medicines is a good illustration of the problem. Even though older
drugs to treat HIV/AIDS have become affordable thanks to generic competition, the availability
of newer and improved drugs is crucial, as people become resistant to the drug combinations
they take after a certain amount of time and inevitably need to be switched to newer "secondline" drug regimens. Data from MSF's project in Khayelitsha, South Africa, illustrates this
growing need: 17.4% of people on treatment there for five years have had to switch to a newer
drug combination. Yet today, newer drugs are largely still only available from originator
companies holding patents, which keeps prices high and availability low. This is because
Indian manufacturers have been reluctant to start producing these newer medicines, as they
fear production would have to stop if patents were granted on these drugs in India. This in
turn has led to the fact that prices for newer AIDS medicines can be up to 50 times more
expensive than older drugs.
TIMELINE - Some key dates on the Indian Patent Act and the Novartis Case
199^1995 - Creation of the World Trade Organization & entry into force of the TRIPS
Agreement, which obliges developing countries to grant patents on medicines no later than
2005.
2003- Novartis launches Gleevec in the US at $2,600 per patient per month. Generic versions of
Gleevec soon become available in India for under $200 per patient per month.
April 2005 - Amendment of India's Patents Act: medicines can now be patented in India.
However, the law stipulates that only true medical innovations will be protected by patents.
Section 3(d) specifies that new forms of known substances do not deserve patents.
Jan. 2006 - Novartis' patent application on Gleevec rejected by Indian patent office, on the
grounds that it is simply a new form of a known substance.
May 2006 - Novartis appeals patent office's decision in High Court in India. Novartis also
challenges Section 3(d) of the Indian Patents Acts.
September 2006 - First hearing of the appeal and challenge. No decision made, but broader
hearing set for later date.
29 Jan. 2007 - Next scheduled hearing in Chennai High Court in India
A Key Source of Affordable Medicines is at Risk of Drying Up
- The case of Novartis’s challenge against the Indian government and
what it could mean for millions of people across the globe -
Medecins Sans Frontieres Briefing Note - December 2006
Swiss pharmaceutical company Novartis was one of the 39 companies that took the South African
government to court five years ago, in an effort to overturn the country’s medicines act that was
designed to bring drug prices down. Now Novartis is up to it again and is targeting India. An ongoing legal
challenge brought by Novartis against the Indian government has the potential to severely affect access
to affordable essential medicines for millions of people across the developing world. Novartis is
challenging a public health safeguard enshrined within India’s Patents Act. If the company is successful,
the era of India being a producer of affordable generic medicines for much of the world could be coming
to an end with regard to newer and future medicines. This would have a devastating impact on people
the world over who rely on affordable medicines manufactured in India.
Patents in India threaten a key source of affordable medicines
India produces affordable medicines that are vital to many people living in developing countries. As an
example, over half the medicines currently used for AIDS treatment in developing countries come from
India, and such medicines are used to treat over 80% of the 80,000 AIDS patients in Medecins Sans
Frontieres (MSF) projects today.
That is because until recently, India did not grant patents on medicines, which allowed Indian generic
manufacturers to compete with patent holders and amongst each other to produce lower-priced generic
versions of drugs patented in other countries. This sort of generic competition among multiple producers
is what made the cost of AIDS medicines fall dramatically and helped facilitate global AIDS treatment
scale-up thus far.
However, India is drying up as a source of affordable versions of newer and future medicines. This is due
to changes made to India’s patent law in 2005, when the country was required to begin reviewing
pharmaceutical patents according to its international obligations under the World Trade Organization
(WTO) Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS).
Widespread medicines patenting in India could mean that cheaper versions of newer medicines will no
longer be able to be produced by Indian manufacturers. Precisely such newer drugs are crucial e.g. for
the treatment of HIV/AIDS.
Fortunately, when the Indian government designed its patent law, an effort was made to find a balance
between the intellectual property rights of pharmaceutical companies and the need to make drugs as
affordable as possible. However, with this legal challenge brought by Novartis, access to newer
affordable medicines produced in India could further worsen.
Generic competition needed to drive prices down: the example of AIDS medicines
Thanks to competition among generic manufacturers since 2000, which was strongly encouraged by civil
society pressure in countries such as India, Thailand and Brazil, the price of first-line antiretroviral drug
regimens has fallen by 99% from an average of US $10,000 to the current price of US $132 per patient per
year (see graph 1).1
1 Untangling the Web of Price Reductions: A pricing guide for ARVs in the developing world, 9th edition, 2006
2
Graph 1: Sample of ARV triple-combination: stavudine (d^T)
+ nevirapine (NVP), Lowest world prices per patient per year.
The Effects of Cneneric Competition
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However, a new problem is looming. Assuring the availability of newer and improved drugs is crucial, as
after a certain amount of time people become resistant to the drug combinations they take and
inevitably need to be switched to newer "second-line” drug regimens. Data from one of MSF’s longestrunning treatment programmes, in Khayelitsha, South Africa, shows that 17.4% of people who have been
on treatment for five years have had to switch to such second-line therapy. Additionally, improved firstline medicines also require newer drugs.
Today, however, newer AIDS medicines are largely still only available from originator companies.
Contrary to medicines used in first-line regimens, these newer drugs are under patent in other key
countries with generic production capacity, Brazil and Thailand, which keeps prices high and availability
low. These medicines are also awaiting patent review in India, which explains why competition on these
newer medicines is still limited among Indian manufacturers. If patents are granted on these medicines
in India, production of generic versions will not be possible. Even the production of medicines for which
patent applications are pending is a high-risk investment for generic manufacturers, as companies do not
know if they will be able to continue production and sell the drugs in the future. This lack of
competition on newer AIDS drugs today has had the result of prices for these medicines remaining much
higher than those for older drugs, despite price reductions offered by originator companies (see graph
2) .
2 Untangling the Web of Price Reductions: A pricing guide for ARVs in the developing world, 9th edition, 2006
3
Graph 2: Average weighted prices paid in 2005, reported to WHO CPRM for
second-line ARVs in low- and middle-income countries, compared with first-line
regimens
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Public health safeguards included in India’s Patents Act
WTO rules made it mandatory in 2005 for India to have a patent regime for medicines, and as a result,
the Indian parliament approved the country's new Patents Act, thereby allowing pharmaceutical products
to be patented in India. This new law puts severe constraints on generic competition. However, the new
law at least contains several crucially important features to prevent patents from being granted too
easily, such as provisions that specifically prohibit patenting of known compounds, and the possibility for
anyone to object to a patent before it is granted.
An effort to prevent "evergreening:” Section 3(d)
At the time of amending the Patents Act, the Indian parliament was aware of the concerns about
patenting of medicines that are not new. As a result, Indian lawmakers introduced a provision in
the Patents Act that stipulates that patents should only be granted on medicines that are truly
new and innovative. This means that companies should not be able to obtain patents in India for
medicines that are not actual inventions, such as drug combinations or slightly improved
formulations of existing medicines.
This part of the law [section 3(d)] was specifically targeted at preventing a common practice
used by drug companies of trying to get additional patents on insignificant improvements of drugs
already patented. The provision was an effort to reward innovation, which is the rationale of the
patent system to begin with. It also aimed to ensure that patents do not unnecessarily restrict
access to medicines. It is this part of the law that Novartis is challenging, claiming it is in
violation of WTO rules.
4
Further, manufacturers of patented medicines make minor variations to existing medicines in
order to extend companies’ monopolies for as long as possible. Also called "evergreening,” this
practice impacts the ability of patients to access affordable medicines by delaying or restricting
the introduction of competition among other pharmaceutical manufacturers that could lead to
lower prices.
An example of evergreening is the case of the ulcer medicine omeprazole, which Astra Zeneca
sells under the brand name Losec. Sale of generic omeprazole in Canada was successfully
blocked by the evergreening of patents by Astra Zeneca. As the basic patent on omeprazole was
about to expire, Astra Zeneca switched the product from a capsule to a tablet and acquired new
20-year patents on the tablet form.
Pre-grant oppositions: the right to oppose a patent before it may be granted
India’s Patents Act also allows room for any interested party to oppose a patent application that
is awaiting a patenting decision. This "pre-grant opposition” process was used for the first time
on an AIDS medicine in March 2006, when the Indian Network for People Living with HIV/AIDS
(INP+) filed the an opposition to the patent claim for a fixed-dose combination of zidovudine and
lamivudine filed by GlaxoSmithKline (GSK). INP+ based its opposition on Section 3(d) of the
patent law, as the patent claim in question was not for a new invention but simply for the
combination of two existing drugs. Similar oppositions on AIDS medicine patent applications have
followed as most of the patent claims are for known pharmaceutical substances such as
polymorphs, salts, and combinations. Soon after its patent was opposed in India, GSK announced
the withdrawal of all its patents and patent applications for the fixed-dose combination of
zidovudine and lamivudine.
In January 2006, the Indian patent office for the first time rejected a patent, on Novartis’ patent
application for the cancer drug imatinib mesylate, which the company sells under the brand
name Gleevec. The patent was rejected on grounds that the application claims a "new form of a
known substance.” The rejection was a major success for the Cancer Patient Aid Association of
India, which had submitted a pre-grant opposition to the patent office.
Novartis’s challenge against the Indian government could have global consequences
If Novartis succeeds in its challenge against Section 3(d) of India’s Patents Act, patents could end up
being granted in India just as broadly as they are in wealthier countries. This would mean that virtually
no generic versions of newer drugs could be produced by Indian manufacturers during patent terms
lasting at least 20 years. And that would mean that much of the developing world would no longer be
able to rely on Indian manufacturers for their supply of cheap essential medicines, in particular newer
medicines.
Patent applications have been filed in India by originator companies for all newer AIDS medicines needed
for second-line treatment regimens. These applications now await patent examination in Indian patent
offices. Under the terms of Section 3(d) of India’s Patents Act, many of these medicines may not be
granted a patent in India because the molecule is already known and therefore does not represent a real
innovation. If patents on these newer drugs are not granted, Indian generic manufacturers will be
allowed to produce generic versions, compete amongst each other and with originator companies and sell
these urgently-needed medicines at prices much more affordable for people in developing countries.
But if Novartis succeeds in getting the Indian Patents Act changed, India may apply the same standards of
intellectual property protection as wealthier countries, granting far more patents than required by the
WTO or envisioned by India’s lawmakers. This could lead to generic competition on newer drugs ending
entirely and prices for these in both India and developing countries increasing. This in turn would further
deteriorate access to essential medicines in the developing world.
5
Likely patent for newer AIDS medicine lopinavir/ritonavir if Novartis succeeds
Lopinavir and ritonavir are two key AIDS medicines that need to be taken in combination by
people who have developed resistance to their first set of medication. Although both medicines
were first discovered in the early 1990s, pharmaceutical company Abbott Laboratories has
applied for patents in India on new forms of these known medicines, in order to be granted a
monopoly in India. Both patent applications are still under review at the Indian patent office, and
have been opposed by civil society organisations.
Different countries need different patent regimes
Although the TRIPS Agreement obliges all WTO countries to grant patents on medicines, nothing obliges
developing countries to replicate patent systems of wealthy countries. The agreement allows each
country to set its criteria of patentability and does not prevent countries from including safeguards
against the grant of patents for known substances, i.e. trivial patents. The Doha Declaration on TRIPS
and Public Health, which was signed by all WTO countries, states that "the [TRIPS] Agreement can and
should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public
health and, in particular, to promote access to medicines for all.”3 Developing countries therefore have
the right to design their patent laws in a way that takes their public health needs into account. This is
precisely what India did when it amended its Patents Act in 2005. India fulfilled its obligation to grant
patent protection according to WTO rules. The consequences for access to newer medicines for
developing countries are severe; they should not be worsened further by making patenting too easy.
Novartis should not be standing in the way and challenging India’s rights.
-
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Sub:
PETITION OF Sh. N I THOMAS,
NO.359,(OLD NO.367) SRINIVASA
NILAYA,JAKKASANDRA 1 MAIN BLOCK,
KORAMANGLA-560034
2
A copy of letter dated 05-JUL-2006 received in
this office from Sh. N I THOMAS is forwarded herewith
for action as appropriate.
/
(0.D. SHARMA)
SECTION OFFICER
SECRETARY, D/0 CHEMICALS & PETROCHEMICALS, M/O CHEMICALS & FERTILIZERS
PMO ID®NO. 07/3/2006-PMP-4/726108
Dated
28-JUL-2006
Copy for information to
Sh. N I THOMAS
NO.359,(OLD NO.337) SRINIVASA
NILAYA,JAKKASANDRA 1 MAIN BLOCK,
KORAMAN GLA-56G034
(0.D. SHARMA)
SECTION OFFICER
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Prime Minister’s Office
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New Delhi - 110011
Sub:
PETITION OF Sh. NAVEEN THOMAS,
N0.359(OLD NO.367),SRINIVASA NILAYA
JAKKASANDRA,1ST MAIN,1ST BLOCK, BANGALORE-560034
A copy of letter dated 25-JDL-2006 received in
this office from Sh. NAVEEN THOMAS is forwarded herewith
for action as appropriate.
(0.D. SHARMA)
SECTION OFFICER
SECRETARY, D/0 CHEMICALS &. PETROCHEMICALS, M/O CHEMICALS & FERTILIZERS
PMO ID NO. 07/3/2006-PMP-4/726262
Dated
08-AUG-2006
Copy for information to
Sh. NAVEEN THOMAS
,\0.359(OLD NO. 367) .SRINIVASA NILAYA
JAkKASANDRA,1ST MAIN,1ST BLOCK,
BANGALORE-560Cj3.4
(0.D. SHARMA)
SECTION OFFICER
L0>
29th August 2006
Adv/thrmt/J/285/06
Re: Lawyers Collective HIV/AIDS Unit Monthly Thursday Meeting, 7th September, 2006
Dear Friends,
Participants at the last Monthly Thursday meeting held at our office on 3rd August 2006
discussed ’Tre-grani oppositions.” The minutes of the meeting are attached.
At the forthcoming Thursday meeting, we will be discussing ’’Novartis challenges the
denial of patent for Gleevec”. Gleevec, an anti-cancer drug is a life-saving drug for
patients suffering from Chronic Myeloid Leukemia (CML). There are about 25,000 new
cases of CML and about 18,000 people die every year in India. If patent is granted to
Novartis, a Swiss pharmaceutical company it would allow for commercial exploitation of
the purported invention, thereby excluding all other generic companies, causing serious
prejudice to human health. Such monopolizing of the drug at an exorbitant cost of Rs
1,20,000 per month will cause serious harm to public health and is unaffordable to
patients affected by CML. Prafulla Saligram of Lawyers Collective HIV/AIDS Unit
will discuss the implications of Novartis’s fight over the price of life and discuss
strategies to mobilize support to advance the treatment of cancer patients.
The meeting is scheduled for 7th of September 2006 between 3 pm — 5 pm at our office at 4A, I
Floor, M.A.H. Road, Tasker Town, Off Park Road, Shivajinagar, Bangalore 560051.
We look forward to the participation of representatives from groups of persons living with
HIV/AIDS, Cancer Patients Association, NGOs, as well as partner organizations working in
related areas. Please call us on 080- 41239130 / 31 to confirm your participation.
Hoping to see you there,
Warm Regards,
Lakshmi Murthy
Advocacy Officer
Lawyers Collective HIV/AIDS Unit
c\\
\\
PMU : Gr. Floor, Jalaram Kripa, 61. Janmabhoomi Marg, Fort. Mumbai 400 001. INDIA Tel: 91-22-2287 5482. 2287 5483, 2283 27/9 Fax • 91-22-2282 1 724
email : aidi>iaw@lawyerscuiiecitve.oiy
PO : 1st Floor, 63/2 Masjid Road, Jangpura. New Delhi 110 014. INDIA Tel : 91-11 2437 7101 / 2437 7102, 2437 2237 Telefax : 91-11-2437 2236
email: aidslawl @lawyerscollective.org
PO :1st Floor,No. 4A,M.A.H. Road. Off Park Road, TaskerTown,Shivajinagar, Bangalore560051. INDIA Tel:91-80-51239130/1,51125273Telefax:91-80-51239289
email: aidslaw2v9lawyerscollective.org
Regd. Office : 4th Floor, Jalaram Jyot, 63 Janmabhoomi Marg, Fort, Mumbai 400 001. INDIA Tel : 91-22-2283 0957, 2285 2543 Fax : 91-22-2282 3570
www.lawyerscollective.org
Minutes of the Monthly Thursday Drop In Meeting
03 August 2006, Lawyers Collective HIV/AIDS Unit, Bangalore Project Office
Participants:
S.No
Name
Organization
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
Jyothi Kiran
Neelamma
Amudha
Rachael Beiggs
Stephanie Godliman
Kirsten Harwood
Vishwanath K.S
Siju Mathew
Pradeep K.R
Jacob George
Lakshmi Omana Kuttan
Kamala Bhat
Devaraj
Benjamin
Dr.Latha
Shivu
Ranjitha
Radha.S
Jagadevi S.J
Suma C.T
Vidyalatha
Malathi
Kanya Kumari
Elizabeth
Sujatha
Gowramma
Basavarajappa. C
Laveena D’souza
Sunil George
Chan Park
Raj Kumar
Prafulla
Ramya Sheshadri
Varsha Iyengar
Manasi Kumar
Milana
Milana
Milana
DFTI
DFTI
INSA-INDIA
INSA-INDIA
INSA-INDIA
INSA-INDIA
Freedom Foundation
Samraksha
Samraksha
Samraksha
Samraksha
Samraksha
Samraksha
Samraksha
Samraksha
Samraksha
Arunodhaya Network
Arunodhaya Network
Asha Foundation
Asha Foundation
Asha Foundation
Samraksha
Samraksha
Snchadaan
Lawyers Collective HIV/AIDS Unit
Lawyers Collective HIV/AIDS Unit
Lawyers Collective HIV/AIDS Unit
Lawyers Collective HIV/AIDS Unit
Lawyers Collective HIV/AIDS Unit
Lawyers Collective HIV/AIDS Unit
AGENDA: PRE GRANT OPPOSITIONS
Raj Kumar introduced the topic on Pre Grant Oppositions and announced that the
resource persons will be Chan Park and Prafulla from Lawyers Collective HIV/AIDS
Unit. The participants introduced themselves.
Prafulla conducted a group exercise: 2 sheets of paper were given to every person. One
was a list ARVs of first line and second line regimen. The second list contains the places
ARVs are available. Every person was asked to tick on the names of the ARVs that they
know was being used by PLHAs and the places they recommended. It was also found
whether they were getting drugs free of costs or whether anybody paid for the drugs. The
following was the outcome:
A.
First form
1.
2.
3.
4.
5.
B.
Combivir- 22
Efavirenz- 5
DDL 2
Stavudine- 1
Nevirapine- 8
Second Form
1.
2.
3.
4.
5.
6.
7.
8.
ART centers- 10
Government- 11
Pharmacy- 3
Private Clinics- 6
Care home- 5
NGOs- 5
Rural- 2
Urban- 1
The discussion led to the revelation that Combivir is one of the most widely used ARV
drug. There were responses indicating people also bought from pharmacies and paid for
the treatment at private clinics. A question was put before the audience, ‘What would
happen if a rule comes into force wherein it stops multiple manufacturing and only one
company is allowed to produce?’ The reactions were high prices, supply shortages, no
competition among generic companies, chances of corruption, and delay in access to
drugs which would lead to more casualties. The discussion was led to understand patents
and what could do to access to medicine if Combivir is granted patent.
Chan’s Presentation:
What is WTO?
It is an international organization regulating free trade between countries.
Why does it exist?
❖ Fair trade
❖ Globalization
❖ Protect US interests
❖ Main reason is to promote free trade, is to allow more competition and thereby
reduction in prices.
One of the main agreements under WTO is the TRIPS- Agreement on Trade Related
Aspects of Intellectual Property.
What is Intellectual property?
It is a property of the mind. It includes patents, copyright, trademarks, design protection.
The government gives patents as an exclusive right. The government can choose to give
or deny a patent.
The granting of a patent indicates granting of an exclusive right on an invention that
could prevent others in using the invention. Therefore, no competition will arise as only
the inventor company can manufacture the product. This is in fact the opposite of the
objective of “free trade1' projected by the WTO.
How did Cipla manufacture drugs, before India became signatory of WTO?
India did not have product patents for medicines before 2005. Hence generic companies
such as Cipla began to manufacture medicines at much lower prices in late 2000 - 2001.
In 2001, when only MNCs produced ARVs it cost around Rs.5,00,000 per person per
year. Since India did not recognize product patents for medicines, companies like Cipla,
Aurobindo etc started producing the ARVs at much lower prices. The government started
giving free ARVs in 2004. It spends about Rs. 5-6000 per person per year. The
government buys the drugs at low prices from generic companies,
Affordability of medicines Post March 2005
March 2005, India had to introduce product patents to medicines, and some amendments
to patent laws, as it had to comply with its obligation under TRIPS.
If product patents are given on life saving drugs, it will be 20 years before the generic
companies can manufacture them. At present there are about 9000 patent applications
pending - Eg. Combivir, Atazanavir, Tenofovir, Abacavir, Valganciclovir etc.
Role of Pre-grant oppositions
In the 2005 amendments to the patent laws, the companies have to apply for patent, and
when it is under examination interested persons can oppose it before it is granted pregrant oppositions. There is also a post-grant opposition that is usually filed after the
patent is granted.
As a sign of opposing patents for life saving drugs, an opposition was filed against
Gleevec manufactured by Novartis. This was filed by the CPAA. Gleevec is a life saving
cancer drug, that cost Rs. 8,000 per month per person and this is the price of the generic
version. Novartis was granted Exclusive Marketing Right and the price shot up to Rs.
1,25,000 per person per month. The opposition was filed in September 2005 and in 2006,
the patent controller denied patent for Gleevec. Gleevec had patents in 35 other countries.
Taking this as an example, patent oppositions are being filed on ARV drugs by People
Living With HIV/AIDS networks like INP+, DNP+, MNP+, TNNP+, and KNP+ etc.
Currently the oppositions are filed for Atazanavir, Combivir, Tenofovir, Nevirapine,
Abacavir, and Valganciclovir.
In Thailand, there is likelihood of Combivir getting a patent. In connection with that the
Thai People Network Living with HIV/AIDS and the Thai NGO Coalition on AIDS will
organize a big demonstration in front of GSK office in Bangkok demanding them to drop
the patent application. As a mark of solidarity and support to the cause of affordability of
life saving drugs a protest is scheduled on 7/8/06 at 3 pm in front of the Glaxo Smith
Kline office on Cunningham road against the grant of the patent.
Questions asked by the participants:
Why can’t Indian companies get patents?
Nothing is preventing the Indian companies from getting patents. The situation is such
that life saving drugs has been patented by MNCs as they invent most of the drugs, which
sell them at high prices.
What about compulsory licensing as a measure to lower the prices?
Compulsory licensing (CL) can only be done in certain circumstances and it is the
prerogative ol the government. The Indian government is very hesitant to grant CL
because of pressure from USA and strong lobbying by pharmaceutical companies.
How does one ensure quality of drugs as PLHAs had their reservations in using the
generic versions?
WHO is monitoring the procedures and standards followed by generic companies and as
and when required withdraws the drugs from the marketing.
The letters explaining the impact of Combivir getting a patent and the protest being
held on Monday afternoon i.e. Aug 7,h was distributed to one and all and they were
requested for their active participation for the cause.
<1^9 uraft
chiqjAq
Prime Minister’s Office
. noon
New Delhi - 110011
Sub:
PETITION OF Sh. NAVEEN THOMAS,
N0.359,9OLD NO.367) SRINIVASA
NILAYA,JAKKASANDRA 1 MAIN,1 BLOCK,
BANGALORE-560034
A copy of letter dated 26-JUL-2006 received in
this office from Sh. NAVEEN THOMAS is forwarded herewith
for action as appropriate.
r
(O.D. SHARMA)
SECTION OFFICER
SECRETARY, D/O CHEMICALS &. PETROCHEMICALS, M/O CHEMICALS & FERTILIZERS
PMO ID NO. 07/3/2006-PMP-4/726259
Dated
08-AUG-2006
Copy for information to
Sh. NAVEEN THOMAS
N0.359,9OLD NO.367) SRINIVASA
NILAYA,JAKKASANDRA 1 MAIN,1 BLOCK,
BANGALORE-560034
(O.EK SHARMA)
SECTION OFFICER
QMlcImjx, H f\/ I
28th June 2006
Adv/thrmt/J/ 263 /06
Re: Lawyers Collective HIV/AIDS Unit Monthly Thursday Meeting, 1st June, 2006
Dear Friends,
Participants at the last Monthly Thursday meeting held at our office on 1st June 2006 discussed
“Pre -Marital Mandatory HIV testing.” The minutes of the meeting are attached.
At the forthcoming Thursday meeting, we will be discussing ’’Access to Medicines and
Data Exclusivity.” The Indian government is currently planning^to amend the Drugs
and Cosmetics Act in a way that could seriously impact the affordability of essential
medicines, including medicines critical in fighting the AIDS epidemic. We will discuss
the proposed "data exclusivity" provision, its potential impact on access to medicines,
and what we can do to make our voices heard. Chan Park and Arti Malik of Lawyers
Collective HIV/AIDS Unit will present the contours of this important issue.
The meeting is scheduled for 6th July, 2006 between 3 pm - 5 pm at our office at 4A, I Floor,
M.A.H. Road, Tasker Town, Off Park Road, Shivajinagar, Bangalore 560051.
We look forward to the participation of representatives from groups of persons living with
HIV/AIDS, NGOs, as well as partner organizations working in related areas. Please call us on
080- 41239130 / 31 to confirm your participation.
Hoping to see you there,
Warm Regards,
Lakshmi Murthy
Advocacy Officer
Lawyers Collective HIV/AIDS Unit
Bangalore
&b
PMU : 7/10, Botawalla Building, 2nd Floor, Horniman Circle. Mumbai 400 023. INDIA Tel. : 91-22-2267 6213, 2267 6219 Fax:91-22-2270 2563
email: aidslaw@vsnl.com / aidslaw@lawyerscollective.org
P.O. : First Floor. No. 4A. M.A.H. Road. Off Park Road. Tasker Town. Shivajinagar, Bangalore 560 051. INDIA Tel.: 91-80-5123 9130/1 Fax : 91-80-5123 9289
email: aidslaw2@lawyerscollective.org
P.O. : 1 sl Floor. 63/2 Masjid Road. Jangpura. New Delhi 110 014. INDIA Tel : 91-11 2432 1101 / 2432 1102, 2432 2237 Fax :91-11-2432 2236
email : aidslawl@ndb.vsnl.net.in / aidslaw1@lawyerscollective.org
Regd. Office : 4th Floor Jalaram Jyot. 63 Janmabhoomi Marg, Fort, Mumbai 400 001. INDIA Tel.. 91-22-2283 0957, 2285 2543 Fax : 91-22-2282 3570
www.lawyerscollective.org
______________ Minutes of the Monthly Thursday Drop In Meeting______
01 May 2006, Lawyers Collective HIV/AIDS Unit, Bangalore Project Office
Participants:
S.No
Name
Organization
1
2
3
4
5
6
Dawat
Jyothi Cardoza
Hamsa Krishna
Suchitra
Shobhna
Kamal a Bhat
Okoronkwo
Vishwanath
Chandrashekaran
Shantha
Sapthami
Sangeeta
Laveena
Vidyalatha
Regina
Manasi
Varsha
Benjamin
Pradeep
Edwina Pereira
Prabhavathy
Jagadevi
Lakshmi
Rajakumar
Samraksha
NIMHANS
NIMHANS
Freedom Foundation
Freedom Foundation
Freedom Foundation
Milana Foundation
KNP+
KNP+
KNP+
Samraksha
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
a
n.
Lawyers Collective HIV/AIDS Unit
Samraksha
INSA - India
INSA - India
KSAPS
Samraksha
Lawyers Collective HIV/AIDS Unit
a
Agenda: Mandatory Pre-Marital HIV Testing
After an introduction of participants, Rajakumar from Lawyers Collective introduced the
topic 'Mandatory Pre-marital testing’. On 18,h March, 2006 the Goa government had
announced that it would amend the public health Act by making HIV test mandatory for
couples before registration of marriage. It is based on the trend that more young women
in the age group of 15 to 29 are getting infected with HIV.
On 29th April 2006 a national meeting was organised by Lawyers Collective HIV/AIDS
Unit and Positive People, Goa to discuss and plan strategies to take the campaign
forward. The public opinion in Goa is divided on this issue. It is in this context that there
is a need to debate the pros and cons of pre-marital testing.
The objection was that there seemed to be little concern about the window period i.e. the
time between infection and testing positive, which would defeat the purpose of the pre
marital tests.
A pre-marital HIV test would not really prevent the spread of infection to the
unmarried sexual partners or the needle sharing partners of the person affected by
HIV.
It would also cause unnecessary distress for those with false positive results. The family
members will also face stigma and discrimination. There is scope for false certificates.
It should also be noted that people seeking marriage licenses are a very low-risk
population. HIV prior to marriage would only mean a false sense of security and a
false belief that the infection is being effectively prevented from spreading. Will
the government take responsibility if a person is tested HIV+ after marriage?
In United States of America, two states i.e. Illinois and Louisiana introduced mandatory
pre-marital testing, but ultimately repealed them when it was found to be an extremely
costly yet ineffective tool in the fight against HIV. It was a waste of important resources
in terms of counsellors, administrators, nurses, doctors and infrastructure costs. During
the six months of mandatory pre-marital testing there were fewer marriages than before.
People get married outside the state where such laws are absent.
Johor was the first state in Malaysia to carry out mandatory pre-marital HIV tests on Muslim
couples. Experts, however admit that the policy has been a failure and physicians from
Malaysia commented that singling out HIV/AIDS for pre marital testing has contributed to
stigma while having zero impact on the number of new infections.
Many viewed pre-marital mandatory testing as a very ineffective method to combat the
spread of HIV/AIDS. Some of the issues discussed in this regard were:
■ Studies have indicated that it is during the pregnancy of the wife that the husband
tends to stray away and contract HIV. The wife may later contract HIV from her
husband. Thus, pre-marital testing serves no purpose.
■ Experience tells us that law making is not a solution to all problems. Violating
laws is a common practice. A classic example being traffic laws that are violated
several times.
■
Enforcement of laws is a critical issue. The question raised was who will ensure
that a couple have undergone the test before tying the knot. This problem is
further amplified in India because of different personal laws for different people.
■ Counterfeit certificate markets will flourish with the requirement for pre-marital
mandatory test certificates.
With several loopholes, mandatory testing was viewed as an utter waste of the State’s
resources. It was opined that these resources should instead be utilised to generate
awareness among the people. People should be encouraged and educated to use condoms
in the hope of reducing their risk of HIV/STI infection.
Lack of awareness is an issue of tremendous concern. Some experiences in day-to-day
life were shared:
■ The girl’s parents are willing to marry off their daughter to a HIV+ person with
the ignorance that it’s a curable disease.
■ In Punjab ICSE teachers have said that it’s our karma that our husbands are
straying.
The positive aspects of pre-marital mandatory testing were also discussed:
■ In X v. Hospital Z, the Court upheld the right to life of the spouse as superior to
the right to confidentiality of the HIV+ person. Thus, mandatory testing cannot
be viewed as an infringement of the right of the HIV+ person.
■ Studies have indicated that the chances of a woman contracting HIV from her
sexual male partner are higher than vice versa. Thus, mandatory testing would
help many women know about their partners’ HIV status.
HIV / AIM
28,h July 2006
Adv/thrmt/J/273/06
Re: Lawyers Collective HIV/AIDS Unit Monthly Thursday Meeting, 3rd August 2006
Dear Friends,
Participants at the last Monthly Thursday meeting he’d at our office on 6th July 2006
discussed ’’ Access to Medicines and Data Exclusivity.” The minutes of the meeting are
attached.
At the forthcoming Thursday meeting, we will be discussing ’’Access to Medicines and
Pre-Grant Opposition.” Affordable and access to quality medicine is a major issue
because of the policy changes the government is bringing to accelerate industrial growth.
In this process there are some provisions which help to improve access to drugs and
treatment. Under the Indian Patent Act there is a provision to oppose inventions of new
pharmaceutical formulations before granting patents. At present there are many patent
applications for ARV drugs (second line regime) in the patent offices. If patent is granted
for these drugs it will impact the ARV rollout program of the government, which gives
free ARV drugs for the HIV+ persons. We will discuss the pre-grant opposition
provision and the role played by HIV+ people networks in the country to reduce the
impact on access to medicine. Chan Park of Lawyers Collective HIV/AIDS Unit will
explain the legal aspects and the process involved in the pre-grant opposition.
The meeting is scheduled for 3"1 of August 2006 between 3 pm - 5 pm at our office at 4A, I
Floor, M.A.H. Road, Tasker Town, Off Park Road, Shivajinagar, Bangalore 560051.
We look forward to the participation of representatives from groups of persons living with
HIV/AIDS, NGOs, as well as partner organizations working in related areas. Please call us on
080- 41239130 / 31 to confirm your participation.
Hoping to see you there.
Wann Regards,
I R^ja Kumar
Advocacy Officer
Lawyers Collective HIV/AIDS Unit
\0 TPMU : Gr. Floor. Jalaram Kripa. 61 Janmahhoomi Marg. Fort. Mumbai 400 001 INDIA l ei : 91 -22 228/ 6482 2287 5483. 2283 27/9 I ax
91 ^2-2282 1/24
email: aidslaw©lawyerscollectivo.org
PO : 1st Floor. 63/2 Masjid Road, Jangpura. New Delhi 110 014. INDIA Tel 91-11 2437 7101 / 2437 /102, 2437 223/ Telefax 9> 11-2437 2236
email: aidslawl @lawyerscollective.org
PO. 1st Floor,No. 4A, M.A.H. Road,Off Park Road, TaskerTown, Shivajinagar, Bangalore 560051. INDIATel:9l-80-51239130/1.5112 5273 Telefax. 91-80-51239289
email: aidslaw2@lawyerscollective.org
Regd. Office : 4th Floor. Jalaram Jyot. 63 Janmahhoomi Marg. Fort, Mumbai 400 001. INDIA Tel : 91-22-2283 0957, 2285 2543 Fax : 91-22-2282 3570
www.lawyerscollective.org
______________ Minutes of the Monthly Thursday Drop In Meeting
06 July 2006, Lawyers Collective HIV/AIDS Unit, Bangalore Project Office
Participants:
S.No
Name
Organization
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
Dheepak
Rebecca Desouza
Hamza.
Diwakara
Nataraj
Dr Manish
Meghna Girish
Radha
Vidyuth
Vidyalatha
Regina
Amit. M. Lobo
Charles Allwin
Christopher
Mary Bosco
Varsha
Lakshmi
Rajakumar
Chan Park
Ramya
Arti
Prasanna
Naveen
SPAD
Independent Researcher
Freedom Foundation, Bangalore
Freedom Foundation, Bangalore
Accept, Bangalore
Abhya, Action Aid , Bangalore
Action Aid, HIV Thematic Unit
Samraksha
Lawyers Collective
Samraksha
Samraksha
Prarana
Prarana
ICYE
KHPT
Lawyers Collective
Lawyers Collective
Lawyers Collective
Lawyers Collective
Lawyers Collective
Lawyers Collective
Public Health Movement
Community Helath Cell
Agenda: “Access to Medicines and Data Exclusivity”
Lakshmi introduced Arti, Prasanna and Naveen and said they will be resource persons for
the meeting. Also, she requested the participants to introduce themselves. Arti made the
first presentation, which was the introduction to “Data Exclusivity” and the second part,
was dealt by Prasanna and Naveen who shared further information about the campaign on
data exclusivity.
What is Data exclusivity?
The Government is preparing to amend the Drugs and Cosmetics Act 1940, which is
going to affect the people accessing affordable medicines in the country. According to
Drugs and Cosmetics Act (DCA), the drug controller has to approve any medicine that is
going to be marketed in India for its safety and effectiveness on human beings.
If any drug is a new drug and first of its kind to be marketed in India, the drug needs to be
tested on human beings though clinical trials. Based on the results of such trials the drug
controller can make a determination as to whether it is safe for human consumption. Only
then license will be issued for marketing.
If any company wants to produce a generic version of the branded medicine, instead of
repeating the clinical trial that have already been conducted, the company only needs to
show that its drug is bioeqivalent to the already approved. This is the present procedure
available for approval of drugs for marketing, and allows for quick introduction of
cheaper generic drugs into the market.
The amendment proposed, by the government will change all of this. Now, the Drug
Controller will be prohibited from even looking at the information already submitted by
the first company in approving a generic version until the expiration of the exclusivity
period - anywhere from 3-7 years. The MNC drug companies are claiming that they
need this protection because otherwise it would constitute “unfair commercial use” by the
generic companies of data that took years and miilions of dollars to generate. However,
under the current scheme, the generic drug companies do not actually “use” the data. It is
the Drug Controller that relies upon the data to approve a generic company’s drug
application. But then, the Drug Controller is not using this information for “commercial”
purposes - it is only relying on this data to perform its official duties, which is to ensure
that every drug marketed in India is safe and effective. Therefore, there is no “unfair
commercial use” going on anywhere under the current system.
ARVs manufactured by generic companies will get affected, as ;a data
’
• • ■
exclusivity
provision would give a monopoly over any new ARV drug introduced in India
throughout the duration of the exclusivity period. By bringing in this provision, access to
affordable medicines to the Indian public will be affected to a great extent. It is from this
point of view that civil society throughout India and internationally is opposing the
introduction of data exclusivity.
The need and update on Data Exclusivity Campaign:
Prasanna from Public Health Movement explained the need for a campaign on Data
Exclusivity as the ministerial meeting is going to take place on the 12,h July in Delhi to
take a decision on introducing data exclusivity in India.' It is in this context that public
health movement has launched a global week of action from 6th -11th July to lobby and
advocate against data exclusivity provision. The Health Ministry is against data
exclusivity, as it will affect access to treatment and health of the common people in India.
However, the Chemicals Ministry and the Commerce Ministry are supporting this new
proposed amendment. Hence more civil society organizations should express their view
to the government so that data exclusivity is not introduced into the DCA.
Even if the 12th inter-ministerial meeting takes a decision to introduce the data exclusivity
it has to be approved by parliament. In that sense the campaign has to continue even after
the 12th July.
1 The meeting was subsequently postponed to 26 July in light of the recent Bombay bombings.
Q. Why after patent act is amended they are brining one more provision giving monopoly
rights? What are they achieving?
Chan explained that Patent Act and its provision are separate from data exclusivity.
Patent Act gives monopoly to the invention at a very early stage. Data exclusivity is
introduced through Drugs and Cosmetics Act during the time of marketing approval by
the drug controller. Another monopoly status created preventing them from using the
data shared to the drug controller.
Prasanna explained health has become a commercial venture and investments are made to
make profit. Cosmetics and diseases likes diabetics, blood pressure, cancer that affect the
rich countries, attract research and development initiatives of the multinational
corporations. Research and development of drugs involves lot of financial involvement
and the companies do not want to part easily with drugs until they can make maximum
profit out of the drugs. That is why they lobby for more monopoly rights through Patent
Act and data exclusivity so that they can hold rights for selling beyond 20 years.
Q. What are Exclusive Marketing Rights? Gleevec continue to get the rights?
Exclusive Marketing Right is a temporary arrangement given for the interim period
between 1995 the year we become the member of WTO till we amended Patent Act in
2005. Gleevec applied for it, as they don’t want generics to produce the drug as they have
applied for patent. When the patent application for Gleevec was denied, the EMR was
automatically dissolved.
Q. If Data Exclusivity is introduced will it not allow Drug controller from using it?
Yes, under data exclusivity provision drug controller cannot refer to the clinical trial data
submitted by the branded drug companies under the official secrets act. Data exclusivity
is a TRIPS + requirement. According to section 39.3 of TRIPS, protection need to be
given for preventing unfair commercial use of the data provided by the branded
companies. According to the Drugs and Cosmetics Act a drug controller only refers to the
data of the branded drug company for approval of the generic company drugs are safe
and efficacy for human consumption. Drug Controller (DC) will not publish the
document, DC only refers the document and approves and there is no unfair commercial
use by another company involved in it. The proposed amendment goes beyond the
TRIPS requirement that is why it is TRIPS+.
Naveen shared about national level campaign is going on Data Exclusivity even global
week of Action is launched from 6th July to 10th July and following emerged as major
action points. Reading material on data exclusivity was circulated to the participants of
the meeting.
There is also a web site one can log on for further reading material http://dataexclusivity.blogspot.com
1. There is need for lobbying by writing letters to Prime Minister, Health Ministry,
Chemical &Fertilizers and Commerce Minster. Around 1000 NGO's belongings to
20 networks are lobbying against this law through PHM.
2. Templates for writing the letters to PM and other ministers are available which the
groups can use. The templates are available with Lawyers collective and PHM, which
can be used. It was decided that Lawyers collective would send to all the
organizations the templates by 07.06.06. An on-line petition can be signed at
www.shaii.org
3. The Health Ministry is convinced that this proposed amendment will have serious
effect on the health of the poor people and are opposing data exclusivity, whereas
Chemical and Commerce ministry are in favor. Hence it is decided to send as many
letters as possible from all the groups so that government will not bring this
amendment.
4. Apart from Individual letters by NGO’s it was also decided that a letter on behalf of
Bangalore NGO"s can be sent and the NGO’s who have attended this Thursday
meeting can be signatories to this letter.
5. By 07.07.07 Lawyers collective will send a summary of the decisions arrived at in the
meeting to all the NGO's.
6. Those NGO’s who are sending separate letters to the PM and other ministries and
send one copy to lawyers collective at aidslaw2@lawyerscollective.org. Lawyers
Collective will compile and hand it over to PHM. They intern can compile for the
entire country and give it to PM and other ministries which will be base to show that
civil society is not supporting this amendment.
7. PHM also announced that they have announced a global week of action from 6th -IO
-101th
July 2006. They announced that 12th July inter ministerial meeting is being organized
before that all the letters to be sent. However, even if the Inter Ministerial Meeting is
decides in favor of data exclusivity, Parliament has to approve this so we may have to
continue this battle it is not ending on 12th July itself.
8. Each Participant of the meeting said from their organisation what can be done by 10th
July. Most of them agreed to send a letter to the PMO; others asked for the minutes
of the meeting so that they discuss with in their organisation and take a decision.
9. Lawyer’s collective is having an informal press briefing on this issue on the 7th July
for Kannada journalists. It was suggested that CFAR could be of help in organizing a
more formal press conference.
10. It was decided that due to time constraints a protest rally could not be organized in
Bangalore. There was also information provided on lobbying activities from US
contact person guptahr@yahoo.com
A
nmol Maf-ln
A 'ICAVil
Honourable Minster of Commerce & Industry
Room No. 45, Udyog Bhavan
New Delhi
Tel: 23061008, Fax: 23012947
Shri Jairam Ramesh
Minister of State for Commerce
Udyog Bhavan, New Delhi
Tel: 23061194, Fax: 23062807
Dear Naveen it seems you did not recieve my longish earlier communication
you must mention that Data Protection against commercial misuse as mentioned in TRIPS is TOTALLY
DIFFERENT from DATA EXCLUSIVITY They are eing used synonamously to confuse Use y the
DRUG CONTROLLER to compare _PIOAVAILAILITY & PIOEQU AVALENCE DATA is
LEGITIMATE USE & TRIPS COM PT TANT. The letter after "A" has died in my computer & therefor I
amusing "P" instead.
Preventing comparative use cf data supmitted for getting MARKETING LICENSE from the drug
controller & that too for 5to 7 years is definately TRIPS PLUS MEASURE .Such measures are eing forced
on developing countries as part of FTA's &. PTLATERAL TRADE AGREEMENTS We are not aware of
what Dr Ramdoss has signed during his U.S .visit.
The pressure on PkTs office is mainly from PFIZER esides others . DR MASHELKAR IS STONGLY
SUPPORTING "DATA EXCLUSIVITY " THc IPR commission report docs not get legitimacy ccausc of
his presence there , infact earlier his STATEMENTS had een found very opjectionale at a meeting in
Geneva . Mr ILARDEEP PURI INDIA'S AM PASSODER wrote to GOI complaing that Dr
MASHELKAR"S poition as taken py him was not in national interest A cover up was done & it was
announced that he had made those statements in his personal capacity.
Ido not think a statement y ISA is enough , several letters from different organizations & individuals must
goI have taken up the issue with the WTO CELL OF THE HEALTH MIN1STERY At the PLANNING
COMMISSIONS STEERING COMMITTEE ON PRIMARY HEALTH CARE , TASK FORCE ON
SAFETY OF FOOD & MEDICINE,,
with the south Asian J oumnalists at a session on what their role could play in improving's women's
health. This issue was also dealt with grassroot groups working on children's issue I have promised to
write a simple note on this & drug related issues in HINDI
I tried to deal with the health persons in the P M"s OFFICE to ensure the pulic health aspects are protected
. hi the earlier schduled meeting only Commerce & Chemicals Minister}’ were invited
.It is definately not enough .
The pregnant silence of health NGO"s as policy threats of major magnitude arc taking place is indeed very’
tragic,
DATA EXCLUSIVITY IS JUST ONE OF THE ATTACKS ON PEOPLES HEALTH.MORE ARE IN
THE PIPELINE The wheat & vegetaple prices shooting up is just a reflection of the Market Havoc . The
DRUG POLICY is expected shortly.
More on that later.
Regards
Mira Shiva
Dear navccn and others.
faxing mashelkar is not a good idea its better that he does not know
where the opposition is coming from or who arc supporting hcaltli
ministry.
however i would like to clarify' what the govt is proposing - both the
proposal of health and ministry of chemicals & fert there seems to be
Resource Person
Database Form
.;1
A
People’s Health Movement
January 2004
Dear
Thank you for your participation in the International Health Forum as a resource person. People s Health
Movement is building a database of resource persons and volunteers for future reference. Kindly fill in the enclosed
form in BLOCK LETTERS, even if you have filled in the registration form earlier. Thank you for your co
operation.
Best wishes,
PHM Secretariat Team
NAME:
OFFICE ADDRESS:
NAME:
HOME ADDRESS:
Tel (with country/ area code) :
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some confusion, early working etc come in when DE is to introduced and
not in the case of Data protection also - the early working
rcqujrmcnt is part of the DE proposal by the ministry of chemicals &
fertilizers:
the ministry of health is supporting Protection against disclosure
only (no data exclusivity) i e Minor amendment in rules to the Drugs
and Cosmetic Act to ensure that the specified data submitted for the
purpose of marketing approval of pharmaceutical products should not be
disclosed to any third party for a period of three years. Ministry of
commerce is supporting them.
further data protection will be only available to ’new chemical
entities' never marketed anywhere in the world, since big pharma
rarely registers over here the}7 have very smartly even restricted data
protection to a few drugs
what is chemicals & fertilizers saying:
Ministry of chemicals is supporting data exclusivity i.e non
reliance by drug controller for a period of three years, availability
of drugs like kaletra. atanaz.avir may get affected
however their proposal is even more dangerous because market
exclusivity is available to 'new chemical entities" however they have
defined new chemical entity as a pharmaceutical product not marketed
in India before - that effectively will cover improvements,
derivatives of older drugs first marketed elsewhere and then they can
prevent generic production by claiming market exclusivity for 3 years.
safeguards they (ministry of chemicals & fertilizers) have suggested
(wh are good if DE is introduced):
The protection period in India should begin on the date of marketing
approval in the first country recognized by India (US, Canada, EU,
etc). Thus the data protection clock could be set running by a
registration in another country. Such a system would positively
encourage originators to expedite registration in that developing
country, so as to benefit from the longest possible period of
protection. For example if a medicine is first registered in Germany
and only registered in the India 2 years later then only one year of
data protection would be left in India.
Review of the second applicant's application is permitted to take
place during the period of exclusive rights. A generic product could
be approved during the latter period of exclusive rights and placed on
the market the first day after the expiry of the market exclusivity
period. If this were not permitted, their period of exclusivity would
include the specified term plus the amount of time that it would take
a generic firm to gain marketing approval based on their filing their
application on the first day after the expiry of that period, this
again we have to lobby for
0 If for a patented drug compulsory7 licence is granted then a
provision for accompanying compulsory licence for the necessary data
Resource Person
Database Form
People’s Health Movement
January 2004
Dear
Thank you for your participation in the International Health Forum as a resource person. People s Health
Movement is building a database of resource persons and volunteers for future reference. Kindly fill in the enclosed
forip in BLOCK LETTERS, even if you have filled in the registration form earlier. Thank you for your co
operation.
Best wishes,
PHM Secretariat Team
NAME:
OFFICE ADDRESS:
NAME:
HOME ADDRESS:
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Tel (with country/ area code) :
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is needed so that the licenced drug can be given marketing
authorisation To do otherwise would render empty the value of a
compulsory licence. India will need to ensure that die use of
compulsory licences are not restricted by Article 39,3
0
T|ic period of Data protection to be capped by the expiry of a
relevant patent
public health organisations are aiming for data protection but even if
it is DE (if they succeed) then the following safeguards in addition
to the above should be included:
Safeguards:
0
No protection to be provided for new indications. Restrict
Data protection or exclusivity rights to New Chemical Entities as
understood under patent law. Article 39.3 is after all aimed at
protecting data, which is the result of''considerable effort"
Subsequent data relating to new indications, routes of administration
and dosages - should not receive a separate period of data protection
Ministry of Chemicals & Fcrt refuses to agree to this, this is
something we must fight for in the event DE is intorduced,
A 'working' requirement should also be considered, where the
originator has to market the relevant product after obtaining
regulator}7 approval, failing which they forfeit their rights of data
protection/exclusivity (we may get this but we have to lobby for it)
0 Ensure that hcaltli and safety data would be immediately available
to the public. Also the DCGI in public interest should be authorized
to use and disclose any data turned over to it by an applicant for
registration
hope that clarifies.
Leena
Opqr Mcfirjapn
A * U4 V Wil ,
I just wrote a long letter & it has just disappeared DR MASHELKAR is strongly supporting DATA
EXCLUSIVITY' I le did not play a very good role earlier inGENEVA, Mr I lardeep Puri had to write to
GOT
There is a PIL filed agaist him .Chemicals ministrry is also supporting DATA EXCLUSIVITY .Health
minister}^ is OK
Ihavc taken it up with the WTO CELL of HEALTH MINISTERY , Planning commission - Hcaltli advisor
.& PM"S office-Health
We needto respond as JSA , AS INDIVIDUAL ORGANIZATIONS & get
individuals to respond.
I had written about many other urgent issues that needed to be responded to.
It takes me very very long to complete a letter with 2 fingure typing & when it all dissappears it is very
saddening.
WARM REGARDS
Resource Person
Database Form
People’s Health Movemeat
January 2004
Degr
Thank you for your participation in the International Health Forum as a resource person. People s Health
Movement is building a database of resource persons and volunteers for future reference. Kindly fill in the enc ose
form in BLOCK LETTERS, even if you have filled in the registration form earlier. Thank you for your co
operation.
Best wishes,
PHM Secretariat Team
NAME:
OFFICE ADDRESS:
NAME:
HOME ADDRESS:
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7/5/2006
Page 1 of 1
Main Identity
From;
'Priti Radhakrishnan* <priti.radhakrishnan@gmail.com >
<ravi@phmovernent.org>
To;
VAdnesday, July 05,2008 12:50 /M
Sent;
Subject: Update
DearDr.Ravi,
Hello! How are you? Hope all is well.
The current debate in India on data exclusivity? has severe
r 'lications for patients globally. Please find our paper modeling the
impact of the latest Government of India proposal, as well as brief
discussions on other potential alternatives!
ww.i-inak-oig.blogBpot.com
We hope you find it useful in your efiorts to advocate for access to
medicines and a more equitable intellectual property regime.
Warm regards,
Priti Radhakrishnan
Vishwas Devaiah
Tahir Amin
In. .Jive tor Medicines, Access & Knowledge (I-MAK)
www.i-mak.org (site is under construction)
“—----------------------------------------------------- —
PAT: jENT WATCH
pUTTiNq 11 IE "i" IN PATENTS
♦
Why Is KALETRA Important?
under India's new law the length of monopolies for brand-name
A newly approved form of the combination drug
manufacturers will be 20 years, ultimately jeopardizing global
Lopinavir/Ritonavir is now being marketed as KALETRA by
access to many essential medications such as KALETRA.
Abbott Laboratories. Earlier this year, the World Health Organi
zation recommended KALETRA as a critical 2nd-line medication
for the 40-million-f- people currently living with HIV.
Abbott has applied for several patents on KALETRA in Indja. If
granted, Abbott will have exclusive rights to manufacture the drug
without any competition, ultimately allowing the company to set
This tablet version of KALETRA is important because, unlike the
the price however it chooses.- At the current time, Abbott main
previous formulation, it can be stored at room temperature, has
tains that KALETRA cannot be produced for less than US$ SbQ
no dietary restrictions and significantly reduces the number of
pills a patient needs to take each day. These three features
per year, making it unaffordable for most people living with HIV
directly address the needs of many developing countries, since
in the world. With exclusive patent rights, no one will try to
this version needs no refrigeration and simpler regimens are
produce KALETRA for less and challenge Abbott's claim, which
easier for patients and clinics to buy, store and take.
means a key drug will be out of reach for millions of people.
,
. Patenting of KALETRA?
ne moment, however, the tablet form of KALETRA is not being
made available to the very people it appears to have been
Recently, the Delhi Network of Positive People (DNP+) an® the
created for. Why?
Indian Network for People Living with HIV/AIDS (INP+) have
■
formally opposed patent applications in India on key HIV drugs.
A^SC_„S™„O„(ALETRA
These patent oppositions are filed at one of India's four govern
Currently, Abbott is primarily focusing on marketing the drug
mental Patent Offices and argue against a pharmaceutical
in the United States and Western Europe, where profits are
company's often doubtful assertion that these key drugs dTe new
highest. Abbott has been reluctant to sell KALETRA affordably in
inventions. In the case of KALETRA, three patent oppositions
developing countries where the need for KALETRA is tremendous
and where the features of the tablet would be most useful. As a result, patients and advocates are challenging Abbott's position
have recently been filed on this basis to block the applications for
’
L°pinaVir' Qnd ,he S°f,-gel f°rmula,ion °f KALETRA'
on the pricing and patenting of KALETRA in order to make it
affordable and accessible to the millions who need it.
.. 4
.
i
!
.
'
.
''
-•
♦
We will continue to look for KALETRA patent applications and, •
WhAT Is hdiA's Role iw tIie KALETRA DtbATE?
where appropriate, file oppositions against these applications.
is at the center of the KALETRA debate for one crucial
For instance, the patent application for the form of KALETRA that
rea^n: as the world's leading producer of generic medications,
can be stored at room temperature will also be opposed because
India has in the past supplied affordable drugs for many
it is not a new invention.
Ind
diseases. Due to recent changes in its patent laws, however,
India's integral role as the "world's pharmacy" may-drastically
WhAT Can You Do To SuPPort This EFFort?
change, limiting the ability of companies to manufacture and sell
If you are concerned about ensuring affordable access to
key medications.
KALETRA and other key HIV drugs, you can advocate for this
This year, the Indian government will review patent applications
for several important HIV drugs. If patents are granted,
JlMAK iNiTtATivE fpR MEdiciNES
cause by asking Abbott and other key brand-name manufacturers
of AIDS treatment to withdraw their patent applications in*India!
You can also support l-MAK, which is leading the focused effort
against patents on HIV drugs in India, You can reach us afc
contact@i-mak.org.
access & kiNowledgE
sfpirmKfr 2006
---- Original Message-----From: sahajbrc
To: Anurag Bharqava ; Anant Phadke ; drdabade@qmail.com ; mirashiva@Yahoo com • sahajbrc
Cc: Naveen ; Prasanna Saliqram
’------ —
Sent: Sunday, October 01, 2006 6:37 PM
Subject: Re:
Dear Anurag and others,
We need to rebut 3 points in a press release:
1) The tokenism of the drug banks idea
2) Cap on generic and branded generic drugs touch only Rs 2000 cr
whereas the majority of the high priced top-selling 300 drugs of ORG list
(Rs25,000 cr) is untouched.
3) Setting up a commitee of industry wallahs
We shld also write to Paswan.
I have added points 9 and 10 in the piece drafted by Anurag. Will Naveen or Prasanna makeit
into a press release?
http://www.blonnet.com/2006/09/24/stories/2006092403880100.htm
Govt to set up drug banks in 600 districts
Our Bureau
Industry commits Rs 45 cr free medicines annually.
New Delhi, Sept. 23
The Government will set up district-level drug banks in the approximately 600 districts
across the country in public-private partnership (PPP).
On profit margins, the Minister said the industry had agreed to cap trade margins on
generic-generic and branded-generic drugs at a minimum of 15 per cent for wholesalers
and 35 per cent for retailers. As a result, prices of these drugs would come down between
2 and 70 per cent, he said.
HEALTH SYSTEMS
Green Pharmacy
Darshan Shankar
Indian people had an incredible knowledge of phyto-medicine driven apparently by a
tremendous passion for the study of medicinal plants. This is evident both in the living
folk traditions in the rural communities as well as the scholarly systems i.e. Ayurveda,
Siddha, Unani and Tibetan. Indians obviously care for medicinal plants because they
know so much about them and have done so much work has so extensive, detailed and
deep an understanding about the medicinal value of plants.
History of Medicin al Plans Use
The traditional definition of medicinal plants is given in Astaanga Hrdaya (600 AD) sutra
sthana Ch.9-verse 10 as:
‘Jagatyevam anoushadham
Na kinchit vidyate dravyam vashaannaarthayagayoh ’
'there is nothing in this universe, which is non-medicinal which cannot he made use of
for many purpose and by many modes ’
This definition rightly suggest that in principle medicinal value, although in practice a
plant is referred to as medicinal when it is so used by some system of medicine. There is
evidence since early Vedic period (Atharva veda) of plants being used for a wide range of
medicinal purposes. They have in fact been used in a continuous unbroken tradition for
over four millennia. Medicinal plant use, is still a living tradition. This is borne around a
million traditional, village-based carriers of herbal medicine traditions in the form of
traditional birth attendants, visha vaidyas, bonesetters, herbal healers and wandering
monks. Apart from these specialised carriers, there are millions of women and elders who
have traditional knowledge of herbal home-remedies and of food and nutrition. As per
recent statistics published by the Health Ministry. Government of India, there are
6,00,000 licensed and registered traditional physicians in India today.
At the folk level, in every ecosystem from the trans-Himalayas to the coast, local
communities have keenly studied the medicinal plants found in their locality. Every 100
km or so throughout the length and breadth of the country. One can observe variation in
ethnic names and use of local bio-diversity indicating the intimate and independent
appraisal that local communities have made of their local resources. Striking illustrations
of Eco-system knowledge can be seen in the case of medicinal plants known to the
Thakur tribals of coastal Maharashtra and the multiple regional uses of the same species
Seeds of Hope ~Lok.ayan
1 here is a verse in “Caraka1 that explains how local communities understood and
explored nature’s gift of medicinal plants to every eco-system:
“Yasmin deshe tuyo jaatah tasmin tajjoshadham hitam ’’
Natures is so (benevolently) organized that it has provided every mico-environment, the
natural resources (in the form of plants, animals and minerals) necessary for the health
needs of the people living in that environment”. It was perhaps this confidence in local
eco-system resources and nature’s benevolence that inspired local communities to
discover the medical uses of local plant resources.
The Indian system of medicine today uses across the various systems i.e. folk and
codified around 8,000 species of plants. The maximum numbers of medicinal plants are
utilized by the folk traditions, followed by Ayurveda, Siddha, Unani, Homeopathy.
In terms of life forms, medicinal plants are equally distributed across habitats viz. trees,
shrubs and herbs, Roughly. One third of the known medicinal plants are trees and an
equal proportion of shrubs and the remaining one-third herbs, epiphytes, grasses and
climbers, and a very small proportions of medicinal algae. The majority of medicinal
plants are higher flowering plants.
Preliminary analysis of the distribution pattern shows that medicinal plants are distributed
across diverse habitats and landscape elements. Around 70 percent of India’s medicinal
plants are found in the tropical zone, mostly in the forest of the Western and Eastern
Ghats, the Vindhyas, Chotta Nagpur plateau, Aravalis the Terai region in the foothills of
the Himalayas and the North East. Less than 30 percent of these medicinal plants are
confined to the temperate and colder zones, although species of great medicinal value
occur in some of these habitats. A quick analysis of the available data shows that the
proportion of medicinal plants recorded in the dry and moist deciduous tropical forest is
higher as compared to those recorded in the tropical evergreen forests.
The knowledge of the Indian people about plants and plant products is not based on the
application of western categories of knowledge and approaches to studying natural
products, like chemistry and pharmacology. It is based on sophisticated, indigenous
knowledge category called “Dravya Guna Shastra”
On the basis of such schemes of study, this approach has resulted in around 25,000
brilliantly designed plant drug formulations, in the codified tradition, in a variety of
dosage forms, although the traditional processing technology is pre-industrial, the range
of methods of processing plants and principles of drug design are sophisticated
In the folk system a guestimate suggest that over 50,000 herbal drug formulations have
been developed by the 4600 odd ethnic communities of India across her diverse
ecosystem for a very wide range of applications. The value of folk knowledge can be
dramatically illustrated from a single example of phyllanthus nirui, which is used by
400
Green Pharmacy
village communities in southern India for treatment of jaundice. The application of this
plant for treatment of viral hepatitis B has been validated and patented by an American
Noble Prize winner. During the last 200 years, there are several examples of local folk
knowledge contribution to global health care. It is well known for instance that quinine
extracted from the cinchona bark was used traditionally by natives of Peru for cure of
malaria fevers.
According to an all India Ethno-botanical survey conducted (1985-90) there are 6000
species of medicinal plants in India which can be used by traditional practitioners in tribal
areas and other village communities. In the local tradition, the internal fleshy
mucilaginous jelly of the aloe plant known locally as Korphad Kumari etc. is used
externally on burns
and wounds and orally for any gynecological disorder. In
Karnataka, a decoction of the bark of the bark of the astonia scholaris a flowering branch
is used in virtually every household at the onset of the monsoon to prevent malarial
fevers. The neck of the turtle is sometimes used for the treatment of a pro-lapsed rectum
or uterus, adathoda vassica or Adusi vasa, as it is locally known, is a common treatment
for coughs and to stop bleeding in the case of pies or dysentery
Boerhavia diffusa (punarva) is commonly used in the treatment of oedema as it has
diuretic properties it is also use to combat anaemia paticularly. The nomenclature of
medicinal plants is itself very rich. One can illustrate this with the example of “Guduchi”
i.e Tinospora cordifolis. It has 52 meaningful names. Such examples suggest the passion
with which the Indian people have indulged in the study of medicinal plants. The plant
name Guduchi which comes from the Sanskrit root gudu rakshane (that which protects)
has the following synonyms.
Amruthavalli, (a weak-stemmed plant which acts as an elixir), mandali (circular), kundali
(stem gets entangled with twiners) naagakumari (stem has a twining nature like that of a
young snake) tantrika (spreading nature of the plant, looks after the health of the body),
madhuparni (honey-like leaves) chadmika (thick foilage which forms a canopy)
catsaadani
(leaves eaten by calves), shyaama (smoky due), dhaara (young stems have slight
longitudal grooves) chakralakshana (wheel-like appearance of cross section) vishalya (no
thorns or other irritant appendage, removes disease chinna, chinnruha, chinnad bhaca,
chinnangi (these four names indicate the capacity of the cut bits of stem to withstand or
endure severe adverse conditions and to produce buds to develop new plants)
abdikaahvaya (reservoir of water) amtrutha (person using the plant would live long and
be healthy) soma (powerful action of the plant as an elixir), rasaayani, vayastha, jeevanti
(three names indicate rejuvenating nature of the plant) jvaranaasini, jvaraari (two names
indicate the specific use if the plant in fevers, bhishapriya, bhishakjita (favourite of the
physicians or that which has won the favour of physicians), vara best among medicines),
soumya (benevolent in action), chandrahassa (cresent moonlike smile) decanirmita
(created by God), amruthasambhava originated from nectat, surakritha (created by God)
401
Seeds of I lope Y^okayan
The depth of study of plants is clearly reflected in their manifold applications. It is not
uncommon to see several hundred applications of a particular plant used in various
formulations for different purposes. This can be illustrated by the example of a very
common plant called amla (Emblica officinalis).
There are nearly 180 formulations of amla. These formulations are used in wide range of
disorders e.g.: eye disorders like conjunctivitis, vision disorders, hyperacidity, rheumatic
disorders, abdominal disorders, jaundice, hiccough, breathing disorder, fever, cough, ear
disorders, good for hair growth and texture, skin disorders, intoxication due to alcohol
and gynecological disorders.
It is thus the ancient medical knowledges that has, though marginalized tremendously, the
holistic remedies that modern and allopathic system cannot cure.
402
Page 1 of 1
Main Identity
From:
To:
Sent:
Attach:
Subject:
"jvarghese" <jvarghese@cmai.org>
"pha" <pha-ncc@yahoogroups.com>; <reprohealth_india@yahoogroups.com >
Friday, September 22, 2006 10:53 AM
C jWe
621-c. pdf
[pha-ncc] Fw: BMJ: Favour needed
^<7
Please see the attached BMJ report on Hepatitis vaccination in India. Though late, the fact that Indian Medical
Association has now taken a position needs to be appreciated.
Joe
On 9/21/06, Puliyel <puliyel@gmail.com> wrote:
Dear Sujith
First thing in the morning tomorrow please see BMJ issue of next week that is released on Friday.
Send me the pdf of the hep b news item from India.
Any luck with the German papers?
Jacob
.T)
'E?V
H CTO
9/22/2006
Downloaded from bmj.com on 21 September 2006
■®
Indian association questions plan for hepatitis B
immunisation
-
Ganapati Mudur
BW2006;333;621doi:10.1136/bmj. 333.7569.621-c
Updated information and services can be found at:
http://bmj.com/cgi/content/full/333/7569/621-c
These include:
Data supplement
"Longer version"
http://bmj.com/cgi/content/full/333/7569/621-c/DC1
Rapid responses
You can respond to this article at:
http://bmj.com/cgi/eletter-submit/333/7569/621-c
Email alerting
service
Topic collections
Receive free email alerts when new articles cite this article - sign up in the box at
the top right corner of the article
Articles on similar topics can be found in the following collections
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Notes
To order reprints of this article go to:
http://www.bmjjournals.com/cgi/reprintform
To subscribe to BMJ go to:
http://bmj.bmjjournals.com/subscriptions/subscribe.shtml
News
Downloaded from bmj.com on 21 September z006
Indian association questions plan
for hepatitis B immunisation
scientific and medical research a
public resource.
The organisation is funded
by a $1.1 m (£590 000; €870 000)
grant from the Bill and Melinda
Gates Foundation as pan of a
new $68.2111 grant for research
into neglected tropical diseases
announced on I I September.
Peter Moszynski London
See www. pk xsni ds.org.
NHS Logistics stall
plan strike
The NHS was this week facing it.s
first national strike in 18 years, as
supplies staff diroughout Eng
land voted to take indusuial
action in protest al die privatisa
tion of the supply agency NHS
Logistics.
Ihe first 24 hour strike was
due to stall at 10 pm last Thurs
day, 21 September, with another
one day su ike planned next week
and further industrial action to
follow. Unison, rhe union repre
senting most of die organisation’s
1300 staff, is also calling for a judi
cial review into how the contract
was awarded.
llie action, which could lead
to cancelled operations, according
to Unison, follows die Depart
ment of Health’s decision earlier
this month to transfer the work of
NHS Logistics and its staff to the
Gennan company DI IL, which is
best known for its courier sciwice.
The new contract, worth
£22bn (€33bn; $41 bn) over die
next 10 years, comes into force on
I October and will, according to
health secretary Patricia Hewitt,
yield savings of about £ I bn.
She dismissed as “absolute
rubbish” suggestions that this
was part of a wider plan to priva
tise the NHS.
old state monopoly provider of
medical insurance.
The cabinet will publish draft
legislation early this autumn, after
a month long consultation period.
It blames the problem of corrup
tion on the low pay of medical
staff and the insurance structure
inherited from the bygone com
munist regime.
Dr Lajos Molnar, the health
minister, described the depen
dence of healthcare provision on
ubiquitous “gratuity’' payments
lor supposedly free services as “a
minefield of explosive conflict
ing interests.”
Patients make such payments
to medical staff to purchase priv
ileged treatment at the expense
of other patients, he says, will)
most people paying for fear of
losing out. He calculates that
such payments total as much as
lOObn forints (£250m; €370m;
$470m) a year.
Several recent studies have
examined corruption in the ser
vice. 'They describe various prac
tices. such as nurses ignoring the
discomfort of patients unless
they are given gratuities of about
11)00 forints and GPs being paid
two to tlirce times as much for
home visits to patients.
Thomas Land Budapesl
Dr Matthias Rath:
an apology
The Socialist-Liberal coalition
government in Hungary lias
promised to tackle what it
describes as widespread corrup
tion in the health service. It pro
poses to restructure healthcare
finance and discard the 50 year
In a news item published in the
22 July 2006 issue of the HMJ
(2006:333:166) and on the
bmj.com website, it was reported
that Dr Matthias Rath had gone
on trial in Hamburg "for fraud.”
In this context we suggested that
Dr Rath stood accused of the
serious crime of fraud in relation
to the death in 2004 of Dominik
Feld, a 9 year old boy witli bone
cancer; that he was culpably
responsible for Dominik Feld’s
death; and, in particular, that he
had
improperly
pressured
Dominik Feld's parents into
refusing to allow hospital doc
tors to amputate the boy’s infect
ed leg in an effort to save him.
We now accept that the alle
gations we published were with
out foundation, and in the
cit cumstances the HMj wishes to
set the record straight and to
apologise to Dr Rath for pub
lishing these allegations.
BMJ VOLUME 333 23 SEI’ IT.MBER
binj.com
Andrew Cole London
Hungary confronts
corruption in its
health service
(ianapali Mudur New Delhi
T he Indiaji Medical Association
has criticised a government pro
posal to expand universal immu
nisation against the hepatitis B
vims throughout India, saying
that it would be “wasteful spend
ing” on a low priority health
problem.
In a report sent to the health
ministry, the association said
that a systematic review of stud
ies indicates that the rate of
chronic c arriage of hepatitis B in
India is 1.6% and not 4% as pro
jected. ft has also cautioned that
the proposal to immunise
infants at 6, 10, and 14 weeks
would not significantly change
rates of chronic carriers because
most cases result from vertical
transmission (directly from
mother to baby during and after
pregnancy).
Fhe report, made public by
(lie association last week, has
evoked sharp reactions from
some doctors who have said that
die lower estimate of rates of
chronic carriers should not deter
universal immunisation. “When
an effective, inexpensive vaccine
is available, it would be unethical
io deny ii to the population,” said
Subrat Acharya, a gastroenterol
ogist at rhe All ffidia Institute of
Medical Sciences in New Delhi.
After a pilot project to immu
nise infants against hepatitis B in
15 cities and 32 districts, the
health ministry has proposed to
scale up the programme nation
wide at an estimated annual cost
of 5bn rupees (£58m; €86m;
$110ni).
The lower estimate of chron
ic carrier rate translates into only
16 million cases instead of 40
million, the association said in its
report, which follows a 10 month
long consultative process.
It has also cited national
cancer registry data dial show
that die number of deadis from
liver cancer from hepatitis B is
only 5000 instead of previous
estimates of more than 180 000.
“The decision to introduce
the hepatitis B vaccine into uni
versal immunisation appears to
have been taken without
thought to either the disease
burden or die efficacy of the
6, 10 and 14 week schedule,”
said Jacob Puliyel, a paedia
trician at the St Stephen’s Hos
pital in New Delhi and author
of the report released by the
association.
“Nowhere in the world is there
any study tiiat has demonstrated
die efficacy of die 6, 10, and 14
week schedule to reduce chronic
carrier rates,” Dr Puliyel said.
However, several doctors
have expressed surprise at the
association’s report and have
said diat its recommendations
spring from “mistaken notions
of the true disease burden from
hepatitis B.”
“Neidier the association nor
paediatricians are in any position
to appreciate the tine disease
burden caused by this vinis," said
Vivek Saraswat, a gastroenterolo
gist at the Sanjay Gandhi Post
graduate Institute of Medical
Sciences in Lucknow.
KI
*
n; The Indian Medical Association says vaccinating babies against
hepatitis B is wasteful as earner status is often transmitted vertically
621
Negative dose for Bangalore's HIV+
Priyanjana Dutta
CNN-IBN
Posted Friday , September 08, 2006 at 07:55
REELING UNDER SIDE-EFFECTS: A city-based NGO has written to NACO about the side
effects of HIV drugs.
Bangalore. Karnataka has the fifth largest number of HIV-positive cases in the country.
The
te|overnment has been distributing anti-retro viral drugs free to the HIV-positive patients
However, free doesn’t necessarily mean good as many patients found out.
After nearly one year of taking the medication, several patients started developing severe side
effects like nausea, dizziness, headache and high fever.
It was then that Milana, an NGO supported by the ActionAid network in Bangalore, decided to
take matters into their hands.
"We have more than 56 members from our network who take ART from Bangalore hospital
Initially when they started it was going smoothly the later 1/1 and half years there are lot of
reactions started developing," says Project Coordinator, Milana Jyothi Kiran.
Among those affected is 30-year-old Amrita who started her anti-retro viral treatment nearly one
year ago from Bangalore’s Bowring hospital.
"In the beginning when I took ART it was fine. I used to take from outside. It was fine for six
months. My CD-4 went from 14 to 136. It was Cipla company's Virulane-30. Now from the past
seven to eight months, the company changed to Amcure. After that I started getting reactions vomiting, giddiness, fever, stomach swelling," Amrita says.
After receiving complaints from Amrita and some others Milana wrote to the National AIDS
Control Organisation (NACO).
"We started wondering why these reactions so we wrote a letter to NACO. Then we went into the
details then saw why this reaction. The company brand had been changed from Cipla, Ranbaxy
to Amcure drug. After that we reafised these reactions were coming," says Jyothi Kiran.
However, NACO still hasn’t replied and the state health minister R Ashok says he's not aware of
the problem.
I don't know but in the world tender we take the lowest bids. Now we are receiving the oral
complains, so now we have to inform the Central Government,” says Ashok.
Despite the side effects, many people like Amrita have been regular with their medicines because
ART, once started, is a lifelong medication.
But there are others who just couldn’t continue due to the extreme side-effects.
For those who were given the thin hope of prolonging their immunity, it's the very medicine that is
turning out to be lethal.
t'-
Page 1 of 18
Naveen
From:
t M.
Cc;
Sent:
Subject*
•fe&na menghane/ d®eriamerighaney@gmaii.com>
DhalT ^a^an30^ahoo.com>; ’gopa kumar- <gopakurnar@uentad.org<: ‘B. K. KeayiaM
<i/\jgkeayia@dei63vsnLnetJn>; 3deihis <aidslaw1®^jyeracolleGtive.org>; ’Nsveen CMC’
<n aveen@sochara.org*
“Loongangte* Moon_gangte^ahoc.corn>
08 February 2007 12:37
Fwd: who will sign WHO letter and contact detail needed I
dear gopa, naveea, kajal, keaylaji, pawan.
thailand has issed compulsory licenses on AIDS drugs, the the new DG of WHO Cauticned Thailand a^,.
fesuing Compulsory License for Abbott’s Antiretroviral Kaida
Access this story and rd Med links co line:
httpiZ/www.kaiseinetwcaxoi^daily reports/rep indac.cfrn?DR ID=4270S
the deOii networic ofpositive people has prepared a sign on letter addressed to WHO regarding its
disturbing remarks of thailand s action of trying to save the lives of its people, please sign the letter on
behalf of your oiganisation by tomorrow, 9th feb so that the thai grs advocating for the CL can make use
of it.
warm regards.
L-eenn
letter is copied below.
To,
-V^HO-SEARO
-VvHO- india office
-UNAIDS-India.
Dear
We write to express our dismay at some comments that Dr. Margaret Chan, Hie new Director
General of the Worid Health Organization, was reported as having made during her recent visit
to Thailand s National Health Security' Office. In response to Thailand's recent decisions to
improve its citizens' access to essential medicines by issuing compulsory licenses on three
essential drugs, she allegedly stated, Td like to underline that we have to find a right balance for
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33/02/2007 i
Page 2 of 18
compulsoiy licensing. We can't be naive about this. There is no perfect solution for accessing
drugs in both quality and quantity."
These comments, if accurate, not onfy represent an attitude in contravention to WHO's mandate
to attain, for all peoples, the highest possible level of health, but also refelect a deeply flawed
understanding of foe compulsoiy licensing mechanism and its indispensability in promoting
access to essential medicines. As Dr. ( han's first public comments on this crucial topic we
harbour grave reservations about her ability to carry foiward Dr. Lee Jong-wook’s legacy of
promoting access to treatment forthose most in need.
Dr. Chan's observation that we have to find a "right balance” for compulsoiy licensing appears to
imply that the financial concerns ofthe patent holding pharmaceutical companies must be given
equal weight agahMt the urgent need to provide lifesaving treatment to those who are unable to
atiord the exorbitant prices that these patent monopolies create. Such an attitude is in
eontm-eiitioii to that of even the World Trade Organization, which stated through the Doha
Dec.ai’ation that tlie HUPS agreement" can and should be interpreted and implemented in a
manner supportive o/ the WTO Members' right to protect public health, and in particlular to
promote access to medicinesfor all:1
11118 statement admits of no requirement for determining the "right balance" between patent
Sates
ti,e
Declaraf'on P,aces to0 affirmative duty on member
states to use all TRIPS-flexibilities available to it, including the compulsory licensing
mechanism to promote access to medicines for all. As the Director General of the organisation
responsible for promoting global health, she should be applauding, rather than condemning
Piailands actions to drastically reduce the costs of essential medicines for its people
Tmifhennore we would like to question who, exactly, is being "naive" about compulsory
Licensing. \hen Dr. c han claims that "there is no perfect solution for accessing drags in both
« xsst
or Indutn manufacturers' generic versions would be a sscrifiee in quality? As these comments '
came without explanation or elaboration, we are left bewildered as to their meaning At foe vere
least, we feel that we are entitled to an explanation.
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World Health
Organization
Regional Office for South-East Asia
World Health House, indraprastha Estate, Mahatma Gandhi marg, New Delhi-1 10 002. India www.searo.who.int
Tel: 91-11 -2337 0804,2337 0809-11 Fax: 91-11 -2337 0197,2337 9395,2337 9507
In reply please
refer to:
G2/27/2
Your reference:
Mr Loon Gangte
Regional Coordinator
Delhi Network of Positive People
Indian Network of People Living with HIV/AIDS
Affordable Medicines and Treatment Campaign
<Commjjnity Health CeTR)
New DeW
16 February 2007
Dear Mr Loon Gangte,
Thank you for your letter dated 9 February 2007 and for sharing your concerns with us.
First and foremost, we would like to assure you that WHO remains totally committed to
promoting access to essential and life-saving treatment for all, and fully supports the use of the
flexibilities within the TRIPS Agreement, including compulsory licensing, to facilitate access to
affordable medicines. We consider Thailand’s recent decision to issue compulsory licenses
for three medicines to be in line with the TRIPS Agreement and the Doha Declaration.
We regret the confusion caused by the recent incident. We would like to inform you
that the WHO Director General has since clarified that her statement was made in the context
of ensuring a balance between the immediate and urgent need to provide affordable
medicines to those who need them, and the need to provide continuous incentives for
innovation. However, as requested, we will convey your concerns to our headquarters, while
reconfirming our position on these issues, as stated above.
Finally, we would like to assure you that WHO remains committed to dialogue with all
stakeholders, including people living with HIV/AIDS, civil society and NGOs, on policy issues
related to access and equity.
We hope this clarifies the matter.
Yours sincerely
Yours sincerely
Samlee Plianbangchang, M.D., Dr.P.H.
Regional Director
Dr S.J. Habayeb
WHO Representative to India
Page 1 of3
Naveen
From:
To:
Cc:
Sent:
Subject:
"Loongangte" <loon_gangte@yahoo.com >
<registry@searo.who.int>; <india@unaids.org>; <bround@unaids.org>; <india@unaids.org>
<naveen@sochara.org>; <k0b0@yahoo.com>; "'leena menghaney"'
<leenamenghaney@gmail.com >; "'chan park"' <chansoobak@yahoo.com >
10 February 2007 11:05
Open Letter to WHO/UNAIDS -India, on Margret Chan's remark on CL
Dr. Samlee Plianbangchang
World Health Organization
Regional Office for South-East Asia
World Health House
Indraprastha Estate
Mahatma Gandhi Marg
New Delhi 110 002, India
Fax:+91.11.23370197
Dr. S. J. Habayeb
World Health Organization
India Office
534, “A” Wing, Nirman Bhawan,
Maulana Azad Road,
New Delhi-110 011
Fax:+91.11.2301.2450
Dr. Denis Broun
UNAIDS
A2/35 Safdarjung Enclave
New Delhi 110029
Fax: +91.11.4135.4534
9 February 2007
Dear Drs. Plianbangchang, Habayeb and Broun:
We write to express our dismay at some comments that Dr. Margaret Chan, the new Director General of
the World Health Organization, was reported as having made during her recent visit to Thailand’s
National Health Security Office. In response to Thailand’s recent decisions to improve its citizens’
access to essential medicines by issuing compulsory licenses on three essential drugs, she allegedly
stated, ‘T’d like to underline that we have to find a right balance for compulsory licensing. We can’t be
naive about this. There is no perfect solution for accessing drugs in both quality and quantity.”
These comments, if accurate, not only represent an attitude which is not in conformity with WHO’s
mandate to attain, for all peoples, the highest possible level of health, but also reflect a deeply flawed
understanding of the compulsory licensing mechanism and its indispensability in promoting access to
essential medicines. As Dr. Chan’s first public comments on this crucial topic, we harbour grave
reservations about her ability to carry forward Dr. Lee Jong-wook’s legacy of promoting access to
treatment for those most in need.
Dr. Chan’s observation that we have to find a “right balance” for compulsory licensing appears to imply
20/02/2007
Page 2 of 3
that the financial concerns of the patent holding pharmaceutical companies must be given equal
weight against the urgent need to provide lifesaving treatment to those who are unable to afford the
exorbitant prices that these patent monopolies create. Such an attitude is not in conformity with that of
even the World Trade Organization, which stated through the Doha Declaration that the TRIPS
agreement "can and should be interpreted and implemented in a manner supportive of the WTO
Members ’ right to protect public health, and in particlular, to promote access to medicines for allT
The Doha Declaration admits of no requirement for determining the “right balance” between patent
rights and patients’ rights. Rather, the Doha Declaration places the affirmative duty on member states to
use all TRIPS-flexibilities available to it, including the compulsory licensing mechanism, to promote
access to medicines for all. As the Director General of the organisation responsible for promoting
global health, she should be applauding, rather than condemning, Thailand’s actions to drastically
reduce the costs of essential medicines for its people.
Furthermore, we would like to question who, exactly, is being “naive” about compulsory licensing.
When Dr. Chan claims that “there is no perfect solution for accessing drugs in both quality and
quantity,” does she mean to imply that Thailand’s decision to issue a compulsory license on
clopidogrel, which will have the effect of lowering the price of this critical treatment for heart
disease from 70 baht per day to 6 baht per day, was naive? Or that a 92% reduction in cost is
not something close to a perfect solution? Or, perhaps, that switching to the Thai GPO’s or Indian
manufacturers’ generic versions would be a sacrifice in quality in exchange for quantity? As these
comments came without explanation or elaboration, we are left bewildered as to their meaning. At the
very least, we feel that we are entitled to an explanation.
In September of 2003 WHO and UNAIDS declared the lack of access to ART for HIV/AIDS a “global
health emergency”. Countries like Thailand and India are responding to this and other emergencies in
access to affordable medication by using all means necessary to ensure that the right of every person to
the highest attainable standard of health - an international law and human rights obligation higher than
that of TRIPS - is not compromised by profiteering on life and death.
As the India office, we trust that you are aware of and understand the critical importance of measures
like compulsory licensing in ensuring access to treatment. We urge you to communicate to WHO HQ
the importance of prioritizing peoples’ health over the monopoly and profits of pharmaceutical
companies and the detrimental impact of Dr Chan’s statements on treatment access.
Developing countries asserting the right to life and health of their people must be fully and publicly
supported by the WHO and UNAIDS.
Sincerely,
Delhi Network of Positive People
Indian Network for People Living with HIV/AIDS
Affordable-Medicines and Treatment Campaign
Lunity Health Cell\
Reply Address:
Loon Gangte
Regional Coordinator
Collaborative Fund for HIV Treatment Prepapredness
South Asia
INP+
20/02/2007
The following edit will appear on February 28 issue of
MIMS but is being released early in public interest:
New Maximum Retail Price (MRP) System:
Over Rs. 2,000 Crore Burden on Patients;
Bonanza for Retail Chemists.
When Suresh went to a chemist shop to buy
Astymin-M manufactured by Tablets India, a shock was
in store for him: the new price of 20 tablets pack had
been printed as Rs. 172.38 while all along he had been
paying Rs. 124. On enquiry, the drug store owner
informed him that as per new rules, all medicines
manufactured after October 2, 2006 are obliged to
include all local taxes in the printed MRP. "But you
never charged me local taxes in the past" countered an
angry Suresh. "Due to competition, we were absorbing
local taxes from our own trade margins" explained the
shopkeeper and went on "we were earlier charging the
printed MRP and even now we are charging the printed
MRP." Little consolation for Suresh who was already
poorer by Rs. 50!
A survey done by MIMS covering a dozen retail
chemists in Delhi and Mumbai found that all of them,
without exception, were selling all old stock
medicines at the printed MRP without adding local
taxes.
Local taxes used to vary from state to state
ranging from 8% (Delhi) to 14.3% (West Bengal).
Except for one or two states, all others have replaced
local taxes (such as sales tax) with uniform Value
Added Tax (VAT) at the rate of 4%.
To make medicine prices uniform throughout the
country, the Ministry of Chemicals and Fertilizers
directed that henceforth MRP of medicines shall be
inclusive of local taxes and permitted drug companies
to increase the MRP accordingly on the basis of
national average. The total burden on account of local
taxes paid by private patients is just over Rs. 2,000
crores. This sum being earlier absorbed by retail
chemists from their trade margins has now been
effectively passed on to patients thus increasing
their burden.
Taking advantage of the confusion, many drug
manufacturers have hiked the retail prices of their
popular brands over and above the sum payable as local
taxes. Some examples:
• Dr. Reddy's Lab: the price of Nise (nimesulide) has
shot up from Rs. 27 to Rs. 32 - an increase of 18.5%.
However the price of less popular Relant (cetirizine +
ambroxol) has been increased by less than 9% - from
Rs. 35.73 to Rs. 38.85. Surely local taxes cannot be
less on one brand and more on another.
• Torrent: The price of Betacard (atenolol) has been
increased from Rs. 32 to Rs. 38 i.e. by 18%. On the
other hand, price of Alprax (alprazolam) has gone up
by just 7% - from Rs. 34.90 to Rs. 37.35. If the local
tax burden is 7%, why price of Betacard has been
increased by 18%?
• Novartis: the price of Voveran SR (diclofenac) lOOmg
has been hiked from Rs. 49.30 to Rs. 57.50 i.e. by
16%. However the price of Otrivin (xylometazoline) has
gone up by only 4% - from Rs. 37.50 to Rs. 39.
• Ranbaxy has increased the price of Storvas
(simvastatin) from Rs. 80 to Rs. 84.84 i.e. by 6% but
had no hesitation in hiking the price of Covance-50
(losartan) from Rs. 50 to Rs. 60.45 i.e. by more than
20%. Surely such hikes cannot be attributed to
inclusion of local taxes only.
These are merely illustrative cases. Under the garb
of including local taxes in the printed MRP, many
other drug makers have indulged in similar unethical
practices. "Ethics? There is nothing illegal about
it," observed an old industry insider "companies are
merely using the government-sanctioned opportunity to
increase their profits." Can any one beat this?
1
I DR N
SI ATE mL N T C
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CG^mi77'££
— Original Message —
From: Mira Shiva
To: Naveen ; Ramya Sheshadri
Cc: aidanindia@yahooqroups.com ; Anant Phadke ; Gopa Kumar; Gopal Dabade ; Mira Shiva ; sathya
mala ; anuraq ; Bharqava Anuraq ; Prasanna Saliqram
Sent: Tuesday, February 27, 2007 10:55 PM
Subject: Re: Mashelkar committee follow up
Dear Naveen,
1 naveen please do what you think best about the statement.
2 I have been busy with the Consumer Education Task Force on Safety of FOOD & MEDICINE
,related work with the zonal organizations who are now engaged in the process
meeting here in Delhi today & tomorrow .
The Food safety & Standards Act implementation has been transferred to Health ministry from
Food Processing Industry Ministry ,which is good news . .
3 Mashelkar Report
Tomorrow there is another meeting called by National Working Group on Patent Laws to discuss
the Indo US MOU on training of our Patent authorities by American patent Authorities &
Mashelkar Committee related Action plans . I will be going there .keayela ji is better & he will be
there . Since the issue is sensitive & tricky I guess before issuing the 2nd Statement there was a
need to have a consensus .
4 I met Asha Thomas briefed her about Mashelkar Issue , Drug Policy & Drugs & Cosmetics
Amendment.
Regards
mira Shiva
Naveen <navthom(fl)gmail.com> wrote:
Dear all,
Thanks Mira for that input. Shall we replace the JOINT PARLIAMENTARY COMMITTEE with
PARLIAMENTARY STANDING COMMITTEE (but which one) in our statement and send it
out to the contacts listed in my mail yesterday. Whom else should it sent to?
Naveen
— Original Message —
From: Mira Shiva
To: Ramya Sheshadri; Naveen
Cc: aidanindia@yahooqroups.com ; Anant Phadke ; Gopa Kumar; Gopal Dabade ; Mira Shiva ; sathya
mala ; anuraq ; Bharqava Anuraq ; Prasanna Saliqram
Sent: Monday, February 26, 2007 9:13 PM
Subject: Re: Explanation of Section 3d and Article 27
dear Ramya,
I saw the explanation of the sections .3 d & Article 27 they are claryfying & very important ,but
I think it would be better if these bits along with some other bits of info are sent to those who
are engaged in this issue , &avoid info overload for those who would want to give ust a
supportive statement .& not feel overawed with the complexity of the Excercize 7 disengage
Regarding the Mashelkar Committee report ,not landing back with Mashelkar Committee to be
DEVERBATIZED we have to ask for it to be sent to THE PARLIAMENTARY STANDING
COMMIITTEE NOT the JOINT PARLIAMENTARY Committee , since the latter will be
chaired by Congress which is backing the Mashelkar Committee Report. The standing
committee is chaired by opposition .i was told about claryfying Parliamentary Committee in our
demand this evening only .
I think it is important that the stands & demands on the issue are well coordinated
With .regards
mira Shiva
---- Original Message----From: <policy.global@novartis.com >
To: "Naveen Thomas" <navthom@yahoo,co.uk>
Sent: Friday, December 01,2006 4:02 PM
Subject: Response to your email to Dr Daniel Vasella at Novartis
Dear Naveen,
Thank you for contacting Dr Vasella. We share a common concern for the
well-being of patients and we value hearing from you.
Novartis' legal actions in India regarding our cancer treatment Glivec(c) /
Gleevec(c) have generated public interest and inquiry, as well as raised
concerns like yours about the reasons for the legal challenge and the
potential impact of the case on access to medicines in general. We are
happy to respond to these concerns.
> We too are deeply concerned about ensuring that patients throughout the
> world have access to the treatments they need. We strive through our many
> patient assistance (tiered-pricing or free of charge medicines to enable
> access) and other humanitarian and philanthropic programs to be a partner
> in finding and implementing solutions to help address the challenges of
> access to medicines throughout the world. Some of our programs with a wide
> reach in the developing world include providing treatments for malaria, TB
> and leprosy. For example, Novartis has partnered with the World Health
> Organization (WHO) to eradicate leprosy and has been donating the world's
> requirement for leprosy drugs absolutely free of any charge, and will
> continue to do so until leprosy is eradicated. India, with 70% of the
> world's leprosy patients, is the biggest beneficiary. Our comniitmont to
> improving healthcare in the developing world is also demonstrated through
> our continuing research into neglected tropical diseases, with a dedicated
> research centre in Singapore, one of the only of its kind in the world. We
> have committed to provide all medicines which are to be developed through
> this institution at no profit.
> More specifically, in India, Novartis provides Glivec totaliy tree of
> charge to over 6,500 patients (99% of all patients receiving the medicine)
> as part of our Glivec International Patient Assistance Program (GIPAP).
> Therefore only 1% of patients pay for their treatment. Worldwide, we
> provide Glivec free of charge to more than 17,000 patients in 83 countries.
> On the other hand, the generic versions of Glivec in India ire priced at
> approximately 4.5 times the average annual income, putting them out of
> reach for most patients needing Glivec in India. Clearly, generics do not,
> and will not sufficiently address the need for access to Glivec, or other
> life saving medicines in India.
Helping patients and access to the proper medicines begins with bringing
new and innovative medicines to market. Novartis' priority is to
contribute what our skills enable us to do best - that is to continue to
develop new and innovative treatments like Glivec. We will then do all we
can, working with governments and non-governmental organizations, to ensure
> that these medicines reach the patients who need them. The best way to
> encourage innovation is via respect for intellectual property. We do not
> believe that denying patent protection for innovative medicines and
> promoting unlawful generic production and use within developing countries
> will help patients or increase their access to medical treatment. Indeed,
> the Indian case about which you wrote to us demonstrates the opposite.
> Such actions would most likely adversely affect patients by denying them
> continuous access to innovative new drugs or even, eventually, generic
> medicines too, since these are priced beyond the means of many patients in
> need. For example, companies who currently offer generic versions of
> Glivec in India do not offer any patient assistance support.
> You might also know that Novartis is the worlds 2nd largest producer of
> generic medicines, and as a result, we are more aware of die complexity of
> this issue than most of our competitors. Indeed, the intricate issues
> associated with access to medicines in developing countries have been
> intensively discussed in international bodies such as the World Trade
> Organization (WTO), with the active involvement of many development NGOs.
> These discussions have moved towards finding ways to increase access to
> medicines through, for example, making compulsory licensing possible where
> countries choose to take that path, not through denying patent protection
> for innovative drugs, as is the issue in India today. The tension between
> intellectual property rights and access to medicine is addressed by the
> Doha declaration offering the instrument of compulsory licenses to tackle
> public health problems, and Novartis supports the flexibilities offered in
> this declaration.
‘ •
> Glivec is patented throughout the world, and we believe that our challenge
> to the denial of a patent for Glivec in India and to specific provisions in
> the Indian patent law are entirely legitimate and, indeed, in the public
> interest. India is a signatory to the WTO TRIPS (Trade-Related Aspects of
> Intellectual Property Rights) agreement and as an increasingly important
> industrial country and pharmaceutical power should be interested in
> promoting the development of innovative therapies. The Indian law creates
> new and unjustified hurdles in the way of pharmaceutical innovation. These
> shortcomings are likely not only to jeopardize further development of new
> medicines in many areas, but also to jeopardize continuous and reliable
> access to Glivec for patients in India today. That would be unacceptable
> to Novartis.
For more information about Novartis and on our various patient assistance
and other programs, we invite you to visit our website at
http://www.novartis.com
> Thank you once again for raising your concerns with us. These are taken
> seriously, we are sincerely interested in your views and welcome the
> dialogue.
Yours sincerely,
Head of Global Public Affairs, Novartis AG
I
Getting Heat-Stable Lopinavir/Ritonavir (LPV/r) to Patients in Developing Countries:
The Experience of Medecins Sans Frontieres (MSF)
How To Access the New Formulation
MSF Briefing Note
July 2006
An Essential Antiretroviral for Developing Countries
A new version of the fixed-dose combination lopinavir/ritonavir (LPV/r), marketed as Kaletra by Abbott
Laboratories, was approved for use in the US in October 2005. This new formulation has several critically
important.advantages over the old version: lower pill burden (four pills per day instead of six), no dietary
restrictions, and most important, storage without refrigeration. The WHO will recommend ritonavir boosted
protease inhibitor combinations such as LPV/r in its revised HIV treatment guidelines1 as part of a secondline therapy once first-line treatment failure has occurred. If made available and affordable, the new and
improved version of LPV/r will be the first boosted protease inhibitor - the cornerstone of second-line
therapy - that is practical to use in the hot climates of many developing countries, where refrigeration is not
readily available.
e So far, heat stable ritonavir is produced by Abbott only in combination with lopinavir and is thus not
available for combination with other protease inhibitors. Abbott Laboratories is the sole producer of new
LPV/r, as no generic versions are available. However, Abbott has railed to take steps to quickly make the
drug widely available in developing countries, despite the new version’s advantages for patients in these
countries. In April, the company finally announced a price for the new formulation of $500 per patient per
year for least-developed and African countries, which is still a very high price by developing country
standards. Further, Abbott has been dragging its feet in filing for registration in developing countries, and
although the company now has stated that it has begun filing in these, there is no further information
available at this point as to which countries these are or the status of the filings. Furthermore, by limiting
its $500 price to the poorest of developing countries, Abbott is adopting a policy that deliberately excludes
people living with HIV/AIDS in other developing countries.
In recognition of the critical role of heat-stable LPV/r in second-line treatment and the lack of access to it in
developing countries, leading HIV/AIDS researchers, physicians, policy-makers, and advocates around the
world have called on Abbott to make the new version available to developing countries without further
delay.
MSF’s Efforts to Procure the Best Formulation for Patients
Some MSF projects have an urgent demand for this drug for patients who needed to be switched to an
efficient, field-adapted second-line regimen. On 15 March 2006, MSF placed an order for the new
formulation directly with Abbott headquarters in the US to use in MSF projects in nine countries
(Cameroon, Guatemala, Kenya, Malawi, Nigeria, South Africa, Thailand, Uganda, Zimbabwe), requesting
that the drug be priced no higher than the differential price for the older version of the drug ($500 per
patient per year).
Initially, Abbott suggested to MSF that access to the old version of the drug should be sufficient until the
new version was available in developing countries even though, in many settings, the old formulation
cannot be refrigerated and, therefore, cannot be used Abbott no longer sells the old version of the drug in
the US.
After weeks of written exchanges, Abbott agreed to fill MSF orders in Africa. However, the company
refused to fulfil the orders for MSF’s projects in Thailand and Guatemala, where the old formulation sells
for between nearly $3000 and nearly $6000 per patient per year, respectively (see figure on p.2).
1 Summary of the guideline committee meeting results is available at
http7/www.who.int/3by5/ARVmeetingreport_June2005.pdf
Price ppy (USS) in MSF projects in 2005 for
old LPV/r marketed by Abbott
5,777 5,847
2,891
459
547
ED.
y1 #
Z'
572
I
I
723
n
■
1’058
El
z.
z
zZ
z
■/
o»
As the new version of the drug is not yet registered in any developing country, MSF sought and was granted
special import authorisation from national drug regulatory authorities. To complete the orders, MSF
provided Abbott with purchase orders for each project for which it needed new LPV/r, MSF’s General
Purchasing Conditions, and copies of the special authorizations to import and use new LPV/r received by
MSF from each country. Shipments are made once MSF approves the proforma invoices and terms and
conditions for each order. The first shipment of new LPV/r arrived in MSF’s Cameroon project at the end
of June 2006.
What Other Actors Can Do
MSF hopes that governments and generic manufacturers will take the necessary steps so that generic
production of heat-stable ritonavir in fixed dose combination with lopinavir and other protease inhibitors
like atazanavir can begin, in order to increase availability and decrease price of second-line regimens.
Where Abbott is not registering, not filling demand or reducing prices sufficiently, countries will need to
issue compulsory licenses to allow for generic production. But in the short-term, until there are more
producers of new LPV/r, care providers will depend on Abbott as currently the sole source of the only
existing field-adapted, corner-stone, second-line drug today. As a result, all actors should urge Abbott to
take immediate measures to make the drug available in developing countries and to announce an affordable
price for all developing countries.
Care Providers: Partners In Health has ordered heat-stable LPV/r for its clinic in Haiti and the National
Drug Supply Organization (NDSO) in Lesotho has ordered the new formulation to meet the needs of the
national program, including MSF-supported clinics, in Lesotho. (Both Partners In Health and NDSO
submitted their orders via a letter of request and a purchase order, and must provide proof of import
authorization to Abbott headquarters.) Other private and public care providers in need of LPV/r should
order the new formulation of LPV/r and ask for their stocks to be replaced with the heat-stable version, as
was done in the US.
National Drug Regulatory Agencies: National Drug Regulatory Agencies should invite Abbott
Laboratories to submit the dossier for registration and should fast-track the review of the new LPV/r
formulation, based on its approval by the US Food and Drug Administration, and on the dossier of the old
formulation already registered in more than 70 developing countries, to ensure the drug’s availability as
soon as possible.
Procurement Agencies: Procurement agencies should push Abbott to supply programs with the new
formulation and encourage regulatory agencies to accelerate the process of registration in developing
countries.
Donors: Funding agencies including the Global Fund and the President’s Emergency Plan for AIDS Relief
(PEPFAR) should encourage the purchase of new LPV/r as the only adapted, boosted protease inhibitor for
second-line existing today. Donors should also support the swift registration of the new formulation in
developing countries and encourage generic competition.
For further information, pteasc contact:
Carmen Perez, Head Pharmacist, MSF Campaign for Access to Essential Medicines
Carmen.Perez@paris.msf.org
Left warns against ‘hasty passage
of amended Patents Act
ernment must make full use of
the “flexibilities" available in
r... ....
o
the TRIPS agreement
and reNEW DELHI,rNOV. 25. The Left par
tes have cautioned the Govern- counted the experience of many
ment against “hasty passage” of countries since the agreement
amendments to the Indian Pat came into force in 1995. They
ents Act to make it Trade-Relat cited the instance of how an Ined Aspects of Intellectual dian pharmaceutical company
Property Rights (TRIPS) compli was offering drugs for HIV-AIDS
particularly in Africa at vastly
ant.
“We are strongly of the opin- reduced prices whereas global
ion that any hasty passage of companies were selling them at
the Bill (amendments 2003), 20-50 times their actual cost by
without any informed discus- seeking shelter under laws
sion, will not be in the larger in- mandated by the agreement.
terests of the country. We give
below a list of amendments ‘Reserve term’
that, we feel, need to be incor
On patentable subject mat
porated in die existing Indian ter, the parties said that the
Patents Act and the draft Bill term “invention” should be re
2003. These we believe are the served for a ‘new’ product or
minimum that need to be done process involving an inventive
to safeguard national interests,” step
t and capable of industrial
the parties said in a three-page application. All three criteria of
note submitted to the Govern- ‘novelty,’ 'inventive step’ and
ment on Wednesday.
the quality of being “capable of
The broad areas of concern of industrial application” must be
these parties include patentable insisted upon especially to limit
X4.— differentiating
j.cc--------------------------1------ofcapplications
-------------------subject —
matter;
the number
and1
inventions; compulsory licens- discourage frivolous claims,
ing; export by a licensee; transiThey said the Indian Patent
tional agreement and mailbox; Act allows patenting of “micro
royalty payment; and pre-grant organisms” and “non-biological
opposition.
and microbiological processes.”
The Left parties said the Gov- Patenting of these inventions
By Our Special Correspondent
5
that the Indian pharmaceutical
companies could export drugs
to developing countries at rela
lively lower prices to the mutual
benefit of both,
The agreement also provided
for receipt of patent applications through a mailbox be
tween January 1995 and
December 2004, which are to be
Compulsory licensing
examined after January 1. On
Compulsory
licensing,
.
„ they being granted, the patent would
.•—*an
--------* —:i. availremain effective for 20 years
said, -was
instrument
able in the TRIPS agreement to from the date of application,
safeguard the legitimate inter- The parties said that in cases
est of consumers by limiting the where production had been
possibilities of monopolies be- started by any enterprise during
ing created in different sectors,
sectors. the transition period, it should
“Unfortunately the Indian Act be allowed to continue produchas not made full use” of such tion on payment of a nominal
provisions unlike Brazil and royalty instead of being accused
China which have passed legis- of violating the patent. The
lations allowing compulsory li- quantum of royalty
payment
....
1—,Jlbe explicitly
—
censing ini cases where the rshould
stipulated if
patentee does not respond compulsory licensing was iswithin stipulated time the offer sued.
of reasonable
commercial
There was no justification in
terms and conditions to the pat- removing the existing pre-grant
—
opposition from the Act in the
ent
holder,
Similarly, the TRIPS agree- proposed amendment Bill.
ment allows export by manu- They said countries such as
facturers who produce through Australia, Japan, Canada and
a compulsory licence, and sug- the United Kingdom provide for
gested that the same be incor- pre-grant opposition in their
porated in the amendment so laws.
are under mandated review by
the World Trade Organisation
since 1999 and in the absence of
any decision, patenting of these
should not have been provided
for. All life forms and research
tolls for biotechnology should
be excluded from the scope of
patentability.
ii
hi
11| ||
■ I
The Prime Minister, Manmohan Singh, with the Bhutan King, Jigme Singye Wangchuk, at the former's residence
in New Delhi on Thursday. — PTI
Kalam’s plea to
Aga Khan
By Our Special Correspondent
J*
Goa DGP relieved of his duties
By Anil Sastry
gard. The State Cabinet on
November 12 had decided to
abolish the DGP post as the
head of the State police and
restore the post of InspectorGeneral of Police, while keep
ing the DGP’s post in abeyance
with immediate effect.
The State Government also
wrote to the Union Home Min
istry — the cadre controlling
authority — on the subject.
Mr. Kanth, who then was in
PANAJI, NOV. 25. The Goa Gov
ernment today relieved the Di
-NEW DELHI, NOV. 25. The Presi rector-General of Police (DGP),
dent, A.P.J. Abdul Kalam, today Amod Kanth, of his duties
suggested that the Aga Khan while asking him to report to
Foundation extend its projects the Union Home Ministry.
in social, education and health
Government sources said the
sectors beyond Maharashtra Home Ministry had not requi
and Gujarat.
sitioned the services of Mr.
The President made this sug Kanth, nor was there any com
gestion to Aga Khan, spiritual munication to him in this releader of Ismaili Khoja commu
nity, who called on him at
Rashtrapati Bhavan.
Official sources said Mr. Ka-lam suggested that the founda
tion also take up work in
Madhya Pradesh and Chhattis-garh, particularly in tribal areas.
He said the foundation
By Our Legal Correspondent
should take up more projects in
cused who would be the affect
the field of girls’ education.
ed party by ordering a CBI
The Aga Khan briefed the NEW DELHI, NOV. 25. The Supreme probe into the matter had come
President on the foundation’s Court today dismissed, at the to the court.
admission stage, a public inter
activities in India.
The decisions of the apex
The visiting King of Bhutan est litigation (PIL) petition filed court cited by the petitioner to
’
'his
' case would not
Jigme Singye Wankchuk and by a former BJP Rajya
L Sabhai iadvance
the crown prince Jigmi Khesar member, B.P. Singhal, seeking a support him as in all these matNamgyel Wanchuk also called CBI probe into the arrest of the ters the petitions were filed eiKanchi Sankaracharya, Sri ther by the accused or by the
on the President today.
They discussed the interna Jayendra Saraswathi, by the Ta- affected persons and orders
tional situation and bilateral mil Nadu police on November were passed in accordance with
11.
the facts and circumstances of
matters.
A Bench, comprising Chi' .those cases, the Bench said and
IiiQtirp R
T ahnti and Ti»
Hjcrnjccod the petition in
Delhi attending a DGPs’ con
ference, reported back to duty
on November 16 and was discharging his duties till today.
The incident comes when
two major international events
— the International Film Fes
tival of India (November 29 to
December 9) and the Exposi
tion of the sacred relics of St.
Francis Xavier (November 21 to
January 2).
Supreme Court rejects plea for
CBI probe into Acharya’s arrest
against the treatment meted
out to the seer. On the question
of locus standi, he cited many
earlier judgments to drive
home the point that the court
had entertained a PIL from
third parties and granted relief
by ordering a CBI probe.
Mr. Singhal, a retired Direc
tor General of Police, in his pet
ition alleged that the State
Government had deliberately
and with mala fide intentions
violated the human rights and
the fundamental rights of the
11/08 2006 15:04 FAI 028503197
GL.lXOSMII'HKLINE/HRCA
@002
:s
GlaxoSmithKline
GlaxoSmithKline (Thailand} Limited
Open letter from GSK regarding GSK patents and patent applications ,2th R-.
place.
directed to a specific formulation of Combid/Combivir
sswifdessRoad.
Lunipini. Paturnw^n.
Bangkok ’0330. Thailand
9 August 2006
Tel. (66 2) 659-3000, 655-456?
rax. (66 2)655-4563
GSK offices in Thailand and India have recently been subject to demonstrations against
GSK’s patents applications for Combid/Combivir in those countries. Prior to these
demonstrations GSK decided to withdraw its patents and patent applications directed to a
specific formulation of Combid/Combivir wherever they exist. This includes the patents
applications which were the subject of the demonstrations in India and Thailand.
In June 2006 GSK instructed its agents in Thailand and India to withdraw this patent
application. This means that GSK has no patent protection on Combid/Combivir in Thailand
or India, and is not seeking any.
The patent and patent applications relating to this specific formulation of Combivir have been
withdrawn, or are in the process of being withdrawn, in all countries where they have been
filed. Other patents and patent applications relevant to Combivir and other GSK
antiretrovirals are not affected.
GSK supports the World Trade Organisation’s Trade-Related Aspects of Intellectual Property
Rights (TRIPS) agreement, including the public health safeguards it contains. However, GSK
believes that focus on patents in addressing the challenge of HIV/AIDS is misguided and
counterproductive. New medicines and vaccines to address the challenge of HIV/AIDS are
desperately needed and the patent system fundamentally stimulates the necessary research
and development. The root cause of many countries’ inability to address HIV/AIDS does not
lie with the patent system but with the consequences of poverty, and lack of political will,
leading to a lack of healthcare infrastructure and resources.
GSK recognises the challenge that HIV/AIDS has put on health systems and seeks to work
in partnership with governments and NGOs to address this challenge. Dialogue with us on
this issue orior to the recent demonstrations in Thailand and India would have made them
unnecessary.
GSK’s commitment and contribution to the fight against HIV/AIDS embraces four key areas investment in research and development (R&D), preferential pricing of our antiretrovirals
(ARVs), community investment activities, and partnerships that foster effective approaches
against the disease and the challenges it presents. Details of our approach and progress can
be found at: http://www.gsk.com/responsibility/crjssues/dev_world_challenges.htm
-a
For any additional queries on this statement please contact:
Khun Areerat Tanglertpaibul
Corporate Affairs Manager
GlaxoSmithKline (Thailand)
Telephone (Direct) 0 2659 3093 Mobile 0 1812 5915
Fax 0 2659 3197 E-mail; areerat.tanglertpaibul@gsk.com
3. Such a framework must recognize the principles of national sovereignty over genetic resources, prior informed consent of
and benefit sharing with the countries in which the viruses originate.
4. The framework should ensure that the WHO collaborating centers and laboratories, as well as companies and other
institutions do not patent the viruses or the gene sequences or parts of the sequences nor research tools and medical
products that make use of the viruses or their parts or their sequences.
5. If there is intention that information contained in the virus, including gene sequences, are put in the public domain, the
framework should require that any party that want to make use of the data should not seek proprietary rights over the data
or parts of the data.
6. WHO must provide information on the viruses that have been provided to its Collaborating Centers and reference
laboratories, what research has been done on these, whether the viruses or vaccine strains produced from them have been
distributed to other organizations and if so to which ones, whether patent applications have been made and for what, the
commercial activities being undertaken, and whether the countries contributing the viruses have been informed, their
permission obtained and the benefit sharing arrangements, if any. There should be an inquiry and remedial action if
collaborating centers or reference laboratories have not acted in good faith, or have not followed the relevant WHO
guidelines, especially the WHO Guidance on sharing of influenza viruses (March 2005).
7.
WHO should encourage and promote local pharmaceutical R&D and production activities in developing countries,
including not-for-profit and public-owned organizations, and facilitate technology transfer and capacity building. WHO
should build the capacity in developing countries for vaccine development and production, including the scientific
research capacity to make this possible.
8. Prices of vaccines and other medical products should not be determined or influenced by monopolistic factors such as
patenting. The products should be priced at levels that are at cost or non-profit for developing countries so as to assure
their affordability.
9. The public health system should be strengthened to offer the best chances for prevention of avian flu pandemic, and to
ensure an effective delivery of health services in the event of pandemic.
10. Governments should increase public investment in research and development for vaccine production in developing
countries, and in building the capacity for local pharmaceutical production, particularly for production of affordable
vaccines and other medical products.
11. We hope that the WHA can reach agreement on these points so that a framework for the sharing of viruses and vaccines
and other medical products can be reached at this WHA.
Civil society groups endorsing this statement include:
People’s Health Movement (PHM) - International,
Third World Network (TWN) - International,
Medico International - Germany,
noshasthaya Kendra (GK) - Bangladesh,
Association for Health and Environmental Development (AHED) - Egypt,
Health Unlimited - UK,
Asian Community Health Action Network (ACHAN) - Asia,
All India Drug Action Network - India,
Initiative for Health - International,
Equity and Society - India,
Consumers’ Association of Penang - Malaysia,
Institute of Science in Society - UK,
Palestinian Medical Relief Society (PMRS) - Palestine,
National Front for People's Health - Ecuador,
Movimionto de Salud - Latin America,
Palestinian NGO Network (PNGONGT) - Palestine,
Arab Resource Collective (ARC) - Lebanon,
Global Health Watch - International,
Space Associative - Morocco,
International People’s Health University (IPHU) - International,
Community Health Cell (CHC) - India,
Doctors for Global Health (DGH) - USA,
Hesperian Foundation - USA
JOINT CIVIL SOCIETY STATEMENT
WHA must establish Fair Framework for Sharing of Virus Samples as well as Vaccines
We the civil society organizations listed below call on member states of the World Health Assembly (WHA) as well as the
WHO Secretariat to establish a fair and transparent mechanism and framework to govern the sharing of virus samples as well
as the equitable distribution of vaccines and medical products relating to the avian influenza.
Early this year Indonesia suspended sending samples of avian influenza viruses to the WHO Laboratories, calling for the
WHO set up a new framework for virus sharing that has better terms for developing countries.
Indonesia, a country severely affected by avian influenza thus far causing about 81 deaths, was offered by an vaccine
manufacturer vaccines at an unaffordable cost of USS 20 dollars per dose although the vaccine was produced using the
Indonesian virus strain, and without the knowledge of the Indonesian authorities. We believe that this is an unfair situation
which no country should be subjected to.
Developing countries simply cannot afford to pay high vaccine prices especially if entire or major parts of the populations
have to be vaccinated. This highlights the inequities in current global health system.
Availability of vaccines in a timely manner and in sufficient quantities is also a major problem. Developed countries having
financial and other resources are already booking in advance treatments including vaccines for pre pandemic and pandemic
use. As supply capacity is less than demand, especially in the event of a pandemic, acute shortages are forseen.
In the event of a global pandemic, and in the absence of a fair global framework, there is a fear that it will be “each country
for itself’, with those countries that have stockpiled vaccines being reluctant or unwilling to share their stockpile of vaccines
with other countries. Developing countries would likely face a situation of non-availability or acute shortage of badly-needed
vaccines, including countries that have contributed their viruses.
Although developing countries voluntarily donate their viruses to the WHO collaborating centers and reference laboratories at
present, these centers and laboratories have been passing on the virus or parts of it, or vaccine strains containing parts of the
viruses, to companies, without the knowledge or permission of the countries. This is in violation of the WHO 2005 Guidance
on sharing virus samples, which states that the viruses will not be distributed to parties outside the collaborating centers and
laboratories without prior permission of the contributing countries.
Moreover, patents are already being sought by several companies and research institutes on products and materials containing
parts of the viruses. The vaccine products are also to be patented. The resulting monopoly situation results in high profits for
the companies holding patents, while health needs are sacrificed.
The current framework also disregards internationally recognized rights of affected developing countries. The Convention on
Biological Diversity explicitly recognizes States’ sovereign rights over their own biological resources, the right to grant
access on agreed terms, the principle of prior informed consent and fair and equitable sharing of benefits arising from the
commercialization and other utilization of the viruses.
Instead, the current framework favors the industry that already benefits from grants and subsidies by the developed
governments for research and development of vaccines, and that will reap millions or billions of dollars from vaccine sales. It
also favors the developed countries that have the financial resources to build up stockpiles of pre-pandemic vaccines and to
purchase in advance pandemic vaccines.
The losers are the poorer countries that will not have vaccines and other necessary medical supplies in a timely manner in the
event of a pandemic although they may have contributed their viruses leading to vaccine development and have rights under
the CBD.
OUR ACTION PROPOSALS
1.
Noting the existing inequitable framework for sharing viruses, we call on the WHA to immediately establish a new global
framework on avian flu for the equitable sharing of both the viruses and the relevant medical products, including vaccines
and diagnostics.
2.
The highest priority and goal of the framework should be to meet public health needs, particularly in developing
countries. As such the over-riding goal is to ensure that people in developing countries have access to vaccines and other
medical products when they need these. The framework must establish systems by which scarce pandemic vaccines can
be produced, stocked and distributed according to the principles of public health needs (where and when they are needed)
and not according to financial and technological capacity and power (i.e. vaccines channeled to those who can pay for
them).
Briefing Note
May 2006
OPPOSITION TO TENOFOVIR PATENT APPLICATION IN INDIA
The Indian Network for People Living with HIV/AIDS (INP+), the Delhi Network of Positive People are opposing
a patent application filed by Gilead Sciences in India on tenofovir disoproxil fumarate (TDF), a key AIDS drug. The
organizations represent people living with HIV/AIDS in developing countries, and officially registered their pre
grant patent opposition at the Delhi patent office on May 9th 2006.
Alternative law Forum, Bangalore providing the legal support to INP+ argues that forming a salt (fumaric acid) out
of an existing compound (tenofovir disoproxil), is common practice within the pharmaceutical industry, and should
not be considered a new invention.
Medecins Sans Frontieres (MSF) supports Indian civil society groups in their legal battle of opposing the TDF
patent application, as it wants to be able to access and use the drug in its HIV/ AIDS treatment projects around the
world.
Tenofovir - A Crucial Drug for AIDS Treatment
TDF is clearly emerging as an important option for patients starting AIDS treatment for the first time, and those
who have been on antiretroviral treatment therapy (ART) for some time and require access to newer drugs due to
occurrence of toxic effects or as they develop resistance to first-line drug regimens. Because there are fewer known
side effects associated with the use of TDF in adults, it is commonly prescribed in the US and Europe, where the
drug is widely available at a priced of over USD 5,000 per patient per year.
In its HIV/AIDS treatment projects in South Africa, MSF has been trying to access TDF, as patients who experience
long-term side effects from other drugs need to be switched to a TDF-based regimen. MSF would like to be able to
provide TDF to its patients who urgently require the drug.
The updated World Health Organization (WHO) ART guidelines for HIV/AIDS treatment in developing countries
recognize the importance of TDF and recommend the drug for first and second-line regimens.1 It is ironic that at
the same time as the WHO is underlining the importance of and recommending TDF, there is a risk that it may
remain inaccessible to many patients in developing countries, if this patent were granted.
Very Limited Access to Gilead’s tenofovir in Developing Countries
MSF has experienced serious difficulties in trying to access TDF in countries where it operates, due to the fact that
the drug is not widely registered for use and marketed in developing countries. Gilead, the only producer of TDF
mtil 2005, had announced greater availability of TDF in 2002 with a preferential price for low-income countries. So
iar Gilead has made limited progress in making the drug widely available.
Another barrier to TDF’s use is its high cost in countries not eligible for the discounted price of $208 per patient per
year. Gilead has made no offer to provide TDF at a discounted price to middle-income countries like Brazil, India,
Thailand and China. In developed countries, Gilead’s price for TDF is $ 5718 per patient per year.
If tenofovir is Patented in India, Generic Production is at Risk
Indian pharmaceutical companies have been working on developing generic versions of TDF. A generic version of
TDF is already being marketed in India. Yet if Gilead were granted a patent on TDF, such generic production of the
drug in India would be likely to stop, making prospects of accessing generic versions of the drug worldwide slim, as
many developing countries rely on Indian generics. A TDF patent in India would lead to Indian drug manufacturers
having to withdraw their generic TDF from the market, and any other generic production of the drug would be
effectively blocked until 2018.
1 Summary is available for consultation at http://www.who.int/3by5/mediacentre/nevvs51/en/
In addition, a patent on TDF would further compromise ART in developing countries as it would act as a barrier for
developing fixed-dose combinations, or FDCs, which combine two or three drugs in a single pill, such as TDF/3TC
and EFV. Because FDCs significantly reduce pill burden and increase adherence to treatment, they have become the
backbone of scaling up AIDS treatment in developing countries. A patent on any of the drugs comprising the FDC
makes it impossible for a generic company to produce the FDC. Despite the fact that antiretrovirals like lamivudine
(3TC) and efavirenz (EFV) are not under patent in India, Gilead’s patent on TDF would prevent Indian generic
companies from developing this much-needed FDC.
AIDS treatment budgets are likely to be affected if TDF is patented. Developing countries scaling up AIDS
treatment programs under the WHO 3 by 5 Initiative will be seriously affected. Currently 1.3 million people living
with HIV/AIDS (PLHA) are accessing treatment under the 3 by 5 Initiative. In India, the National AIDS Control
Organisation (NACO) provides 20,000 PLHAs with antiretroviral therapy. Unavailability of ARV drugs included in
the WHO ART treatment guidelines for resource poor settings may impact the political will of developing countries
to provide HIV/AIDS treatment.
The international medical humanitarian agency MSF began providing HIV/AIDS treatment in 2000 and is currently
providing it to over 60,000 patients in nearly 30 countries including Thailand, South Africa and India. MSF hopes to
source TDF from India in the near future, as Indian manufacturers are the source of 84% of antiretrovirals MSF uses
in its AIDS treatment projects across the globe.
«•
BACKGROUND ON INDIAN PATENT ACT AND PRE-GRANT OPPOSITIONS
Indian patents: one year on
About this time last year, the Indian Parliament approved the country’s new Patent Act, thereby allowing
pharmaceutical products to be patented in India. This new law put some serious constraints on generic competition
but also included some potentially important features such as "automatic licensing" and the possibility for anyone to
object to a patent before it is granted.
Although the law was not passed until last year, from as early as 1995, companies could start filing patent
applications for pharmaceuticals in India with the patent offices. The Indian patent office started to examine these
thousands of patent applications last year after the revision of the Indian patent law. Many patent applications for
antiretroviral drugs (ARVs) such as tenofovir (tenofovir disoproxil fumarate - TDF) and Combivir
(zidovudine/lamivudine, or AZT/3TC) are waiting to be approved or rejected.
First patent granted in India in March 2006
On March 3rS 2006, Roche announced it was "becoming the first pharmaceutical company in India to receive a
product patent under the new patent regime". The patent was granted on peginterferon alfa-2a (Pegasys), a new
generation hepatitis C therapy.
Because no generic versions of this product are being manufactured yet, any generic competition will be impossible
until the new patent’s term runs out in 2017 - unless the Indian government grants a compulsory license to another
pharmaceutical company. Thus, this drug will only be available as a Roche product at about $5,000 per six-month
treatment course, a price that obviously rules out the use of this drug in developing country settings.
Not all patent applications lead to patents
Not all patent applications are valid. Many of the applications do not claim real ‘inventions’ and therefore should
not deserve a patent. Many patent applications are for a new use of old drugs, or simply for derivatives of old drugs
or combinations of old drugs. The Indian Patent Act, if rigorously interpreted, provides several grounds for rejecting
a patent, for instance if the pharmaceutical substance claimed is only a new form of a known substance.
-> Gleevac patent application was rejected
On January 25th 2006, the Indian patent office rejected Novartis' patent application for its anti-cancer drug
imatinib mesylate (Gleevac) on the grounds that the application claims a ‘new form of a known substance’
(Novartis’ patent application was related to a particular crystal form of the salt of imatinib mesylate). The
rejection was a major victory for the Cancer Patient Aid Association of India and some Indian generic
companies, which had both submitted a pre-grant opposition to the patent office. The rejection of the
Gleevac patent gives reason for optimism.
Essential drug patents in the "mailbox” waiting for examination
One of the next on the list for examination by the Indian Patent Office is Gilead’s patent for tenofovir disoproxil
fumarate (Viread), as the patent application was filed with the Delhi Patent office in 1998. The Lawyers Collective,
in collaboration with the Alternative Law Forum, is currently drawing up an extensive list of drugs based on
medical needs and for which patent applications are pending in India.
What is the pre-grant opposition system?
Due to the volume of patent applications, patent examiners often miss information related to the patent application
under consideration about it being just an improvement of an old drug and not a ‘new chemical entity’. If attention
is brought to information that shows that the patent application is for a ‘derivative’ or a ‘new use’ of a known drug,
the possibility of invalid patents being granted is reduced. Opposing patent applications in the case of ARV drugs is
feasible, as research has indicated that most of the patent claims for patent protection are for known pharmaceutical
substances like polymorphs, salts, and combinations.
Anyone can bring such information to the attention of the patent controller through the pre-grant opposition
process (as provided under Section 25 of the Indian Patents Act), and generic companies have already filed a
number of pre-grant oppositions. In addition to companies, patient groups (INP+ and other state networks)
and public interest organisations are also working to oppose patent applications for essential drugs.
On March 30th 2006, The Indian Network for People Living with HIV/AIDS (INP+), the Manipur Network of Positive
People (MNP+), represented by the Lawyers’ Collective HIV/AIDS Unit officially submitted their opposition to a
patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination
of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds. Clearly
concerned that the granting of such a patent will increase the burden on developing countries already struggling to treat
patients, INP+ objected to the Combivir patent application on the ground that it does not claim a new invention but
instead simply the combination of two existing drugs.
************************************************************************************************
^[\TC'i\ K
SR.NO.
PATENT APPLICATION
NO.
NO.OF THE
PATENT
GRANTED
PATENT HOLDER
1
83/MUM/2003
197696
DR. PATEL D1NESH SHANT1LAL,
DR. PATEL SACHIN DINESH,
KURAN1 SHASHIKANT PRABHUDAS.
2
488/M UM/2000
198178
LUPIN LABORATORIES L I D.
3
514/BOM/1998
197892
AJANTA PHARMA LIMITED.
4
738/BOM/1999
198002
5
IN/PCT/2002/01001/MUM
200076
6
IN/PCT/2002/01296/MUM
200062
7
IN/PCT/2000/00497/ML'M
200057
IN/PCT/2002/01000/M UM
200075
9
132/MUM/2003
200334
10
684/MUM/2003
200339
11
IN/PCT/2002/01005/M U M
200890
12
IN/PCT/2002/01890/MUM
200903
13
540/MUMNP/2003
200906
14
IN/PCT/2001 /00805/MUM
200884
IN/PCT/2002/00995/MUM
200889
WARNER-LAMBERT COMPANY
16
363/MUM/2003
201170
GLENMARK PHARMACEUTICALS
LIMITED.
17
228/MUM/2000
201137
PFIZER PRODUCTS INC
18
IN/PCT/2002/00671/MUM
201241
ASTRAZENICA AB
19
IN/PCT/2002/00745/MUM
201242
JANSEEN PHARMACEUTICAL N.V.
20
IN/PCT/2002/00922/MUM
201243
ASTRAZENICA AB
21
17/BOM/1995
202311
J.B. CHEMICALS & PHARMACEUTICALS
_____
LIMITED
22
IN/PCT/2001/01538/MUM
201237
JANSEEN PHARMACEUTICAL N.V.
23
IN/PCT/2002/00604/MUM
201240
A /(y /y^z/V^AV
TITLE OF THE PATENT GRANTED
^/'ftCc
DATE OF
GRANT
ANTI FUNGAL PHARMA CEUTICAL
COMPOSITIONS FOR THERAPEUTIC
12/12/05
_______________ USE._______________
ASYNERGISTIC AQUEOUS
Pl 1ARMACEUTICAL COMPOSITION FOR
9/1/06
PROPHYLACTIC TREATMENT OF
____________ MIGRAINE._____________
A PROCESS FOR ISOLATION AND
FORMULATIONS OF NUTRIENT - RICH 13/02/06
__________ CAROTENOIDS.___________
NOVEL INJECTABLE ANTIMALERIAL
1/3/06
COMPOSITIONS OF ARTEMISININ.
PATEL DINESH SHANTILAL AND KURANI
SHASHIKANT PRABHUDAS.
BOEHRINGER INGELH1EM
A NEEDLE-LESS INJECTOR FOR A LIQU1E 15/04/06
_______ INTERNATIONAL GMBH________
01. AMERICAN HOME PRODUCTS
CORPORATION 02. LIGAND
THIO-OXINDOLE DERIVATIVES.
15/04/06
PHARMACEUTICALS INC.
IMIDAZO PYRIDINE DERIVATIVES
ASTRAZENICA AB
WHICH INHIBIT GASTRIC ACID
17/04/2006
____________ SECRETION____________
A 2 - OXO - 1 - PYRROLIDINE
UCBS. A.
COMPOUND OR PHARMACEUTICAL
17/04/2006
________ salts thereof;________
CONTROLLED RELEASE
PHARMACEUTICAL COMPOSITION
GLENMARK PHARMACEUTICALS
CONTAINING ERYTHROMYCIN OR ITS
5/5/06
LIMITED.
DERIVATIVES AND A PROCESS FOR ITS
___________ PREPARATION.___________
GLENMARK PHARMACEUTICALS
TOPICAL PHARMACEUTICAL GEL
5/5/06
LIMITED.
COMPOSITION FOR VALDECOXIB.
A MICELLAR COMPOSITION FOR THE
NEW PHARMA RESEARCH SWEDEN AB TREATMENT OF PARASITIC DIASEASES
5/6/06
____________ IN ANIMALS____________
QU1NOLINYL AND BENZOTHIAZALYL
TULARIK INC & JAPAN TOBAGO, INC
5/6/06
PPAR-GAMMA MODULATORS
METHOD FOR INHABITING THE
EXPRESSION OF A TARGET EENE AND
RIBOPHARMA AG
5/6/06
MEDICAMENT FOR TREATING A
TUMOR DIEASE
AGOURON PHARMACEUTICALS.INC. &
TRICYCLIC INHIBITORS OF POLY [ADPCANCER RESEARCH CAMPAIGN
8/6/06
RIBOSEJPOLYMERASES.
TECHNOLOGY LIMITED.
DUAL INHABITORS OF CHOLESTEROL
ESTER AND WAX ESTER SYNTHESIS
FOR SUBACEOUS GLAND DISORDERS
8/6/06
NOVEL TRICYCLIC COMPOUND AS PDO23/06/2006
___________ 4 INHABITORS___________
A TOPICAL PHARMACEUTICAL
26/06/2006
___________ COMPOSITION___________
ADMANTANE DERIVATIVES
17/07/2006
A COMPOUND OF HOMOPIPERIDINYL
SUBSTITUTE BENZIMIDAZOLE
17/07/2006
____________DERIVATIVES___________
CRYTELLINE SALTS OF 7-[4-(4FLUOROPHENYL)-6-ISOPROPYL-2METHYL(METHYLSULFONLY) AMINO] 17/07/2006
PYAMIDIN-5YL) (3r,5y)-3, 5DIHYDROXYHEPT-6ENOIC ACID__
CONTROLLER RELEASE FORMULATION
5/8/06
___________ OF RANITIDINE___________
A COMPOUND BENZIMIDAZOLES AND
7/8/06
IMIDAZOPYNDINES
SOCIETE DE CONSEILS DE RECHCRCHES
OF D*APPLICATION SCIENTIF1QUES
NEW HETEROCYELIC COMPOUNDS
_____________ (S.C.R.A.S.)_____________
7/8/06
24
IN/PCT/2002/0I547/MUM
201254
JANSEEN PIIARMACEUTICAE N.V.
25
28/MUMNP/2003
201268
WARNER-LAMBERT COMPANY
26
508/MUMNP/2003
201282
PFIZER PRODUCTS INC
27
801/MUMNP/2003
201284
ASTRAZENICA AB
28
802/MUMNP/2003
201285
ASTRAZENICA AB
29
639/MUMNP/2003
200654
PFIZER PRODUCTS INC
30
14I/MUM/2000
472/MUM/2000
201976
201982
PITZER PRODUCTS INC
PFIZER PRODUCTS INC
IN/PCT/2002/00475/MUM
202295
PFIZER PRODUCTS INC
33
IN/PCT/2001 /00172/MUM
202299
ASTRAZENICA AB
34
IN/PCT/2001/00039/MUM
201231
TEIJIN LIMITED
31
A 2.3-DlHYDRO-|l,4| DIOXIDE-[2,3-B]
PYRIDINE COMPOUND OF FORMOULA
imb
(I) AND PROCESS OF PREPARATION
____________ THEREOF_____________
AN IODO PHENYLAMINO
7/8/06
BENZHYDROXAMIC COMPOUND
N-METHYL-D-ASPARTIC ACID
7/8/06
RECEPTOR ANTAGONIST
PHARMACEUTICAL COMPOSITIONS
A METALLOPROTEINASE INHABITOR
7/8/06
___________ COMPOUND___________
A METALLOPROTEINASE INHABITOR
7/8/06
___________ COMPOUND___________
PYRIDAINONE ALDOSE REDUCTASE
21/08/2006
___________ 1NHABITORS___________
A NOVEL BIARYL ETHER COMPOUND 31/08/2006
31/08/2006
ZIPRASIDONE SUSPENSION
PHARMACEUTICAL COMPOSITION
11/9/06
PROVIDING ENCHANCED DRUG
________ CONCENTRATIONS.________
AN ORAL IMMEDIATE RELEASE
11/9/06
FORMULATION IN SOLID FORM
THIOBENZIMDAZOLC DERIVATIVES 13/09/2006
PUBLICATION UNDER SECTION 43(2) IN RESPECT OF THE GRANT OF PATENT
Notice is hereby given, that any person interested in opposing the following patents under Section 25(2) may, at
any time within one year from the date of this issue, give notice to the Controller of Patents at the appropriate
office on the prescribed Form 7.
PATENT
S. NO PATENT
APPLICATION
NO
NO
TITLE
NAME OF THE
PATENTEE
1
188990 60/M AS/2000
A METHOD FOR OBTAINGING A
HYDROLYSATE FROM A
PROTEINACEOUS SUBSTRATE
CHENNAI
(I) NOVOZYMES A/S (II)
NOVOZYMES BIOTECH INC.
2
191551 936/MAS/1995
RANDOM DUMPED PACKING
ELEMENT
CHENNAI
KOCH-GLITSCH, LP, A
DELAWARE CORPORATION
3
191967 1014/MAS/1995
AN APPARATUS RESPONSIVE TO A
CONTROL SIGNAL FOR
DEVELOPING A PRESSURE
CHENNAI
FISHER CONTROLS
INTERNATIONAL LLC, A
DELAWARE CORPORATION
4
1922561393/MAS/1996
A PROCESS FOR MANUFACTURING TRAVANCORE CHEMICAL & CHENNAI
STRONTIUM CARBONATE OF ABOVE MANUFACTURING CO. LTD.,
AN INDIAN COMPANY
99% PURITY
5
192259 819/M AS/2000
CHENNAI
Dr. REDDY’S
AN IMPROVED PROCESS FOR
CONVERSION OF TRANS-N-METHYL- LABORATORIES LIMITED, AN
INDIAN COMPANY
4-(3,4-DICHLOROPHENYL)-1,2,3,4TETRAHYDRO-1NAPHTHALENEAMINE TO ITS CIS-NMETHYL-4-(3,4-DICHLOROPHENYL)1,2,3,4-TETRAHYDRO-1NAPHTHALENEAMINE (AN
INTERMEDIATE OF SERTRALINE
HYDROCHLORIDE)
6
192262 803/MAS/1995
A METHOD OF PRODUCING A
CATALYST FOR REFORMING OR
AROMATIZATION
CHENNAI
CHEVRON PHILIPS
CHEMICAL COMPANY LP, A
CORPORATION ORGANIZED
UNDER THE LAWS OF THE
STATE OF DELAWARE. USA
7
192264 33/MAS/1996
A DEPILATORY STRIP
RECKITT BENCKiSER
FRANCE, A FRENCH
COMPANY
CHENNAI
8
1926491249/MAS/1995
A CIRCULATING FLUIDIZED BED
REACTOR
FOSTER WHEELER
ENERGIA OY. A FINNISH
COMPANY
CHENNAI
9
192889 410/MAS/2001
SURENDRA KUMAR SOOD,
A PROCESS FOR THE
PREPARATION OF DEEP FAT FRIED AN INDIAN NATIONAL
POTATO CHIPS
I
The Patent Office Journal 19/05/2006
I
APPROP
RIATE
OFFICE
CHENNAI
9960
of
511
198649 481/M AS/2003
A PROCESS FOR THE
PREPARATION OF GABAPENTIN
FORM-II
512
198650 5/M AS/2001
SELFCONTAINED AIR CONDITIONED ASIR IYADURAI JEBARAJ, AN CHENNAI
INDIAN CITIZEN
ENCLOSURE
513
198651 944/M AS/2001
DEVICE FOR GAS DYNAMIC
DEPOSITION OF POWDER
MATERIALS
INTERNATIONAL ADVANCED CHENNAI
RESEARCH CENTRE FOR
POWDER METALLURGY AND
NEW MATERIALS (ARC!)
514
198652 1391/MAS/1998
FLAT CABLE CONNECTOR FOR A
BICYCLE
SHIMANO INC, A JAPANESE CHENNAI
COMPANY
515
198653 1881/MAS/1996
A PROCESS FOR PREPARING
POLYMERS FROM OLEFINS
DOW GLOBAL
TECHNOLOGIES INC., A US
COMPANY
516
1986541450/M AS/1996
A COMPUTER IMPLEMENTED
PROCESS AND A COMPUTER
SYSTEM FOR DETECTING
NETWORK FAILURE
INTERNATIONAL BUSINESS CHENNAI
MACHINES CORPORATION (
A COMPANY ORANGIZED
AND EXISTING UNDER THE
LAW OF THE STATE OF NEW
YORK, USA
517
198656 224/M AS/2001
A HANDHELD TYPE FOUR-CYCLE
ENGINE
HONDA GIKEN KOGYO
KABUSHIKI KAISHA, A
CORPORATION OF JAPAN
CHENNAI
518
198686 853/CHE/2003
A METHOD FOR TRANSPORT BLOCK NOKIA CORPORATION, A
FINNISH CORPORATION
SIZE (TBS) SIGNALLING
CHENNAI
519
198687 056/M AS/2002
INTERLEAVED ORTHOGONAL
FREQUENCY DIVISION
MULTIPLEXING (IOFDM) SYSTEM
INDIAN INSTITUTE OF
SCIENCE
520
198688 2295/MAS/1996
A HYDROFORMYLA-TION PROCESS
IN THE PRESENCE OF A METALORGANOPOLY PHOSPHINE LIGAND
COMPLEX CATALYST
1 TAKWAI LEUNG, 2 DAVID CHENNAI
ROBERT BRYANT BOTH ARE
US CITIZENS 3 BERNARD
LESLIE SHAW, A UK CITIZEN
521
198726 622/M AS/2002
AN IMPROVED PROCESS FOR THE
PREPARATION OF XANTHOPHYLL
CRYSTALS
CHENNAI
OMNIACTIVE HEALTH
TECHNOLOGIES PVT. LTD, A
COMPANY REGISTERED
UNDER THE INDIAN
COMPANIES ACT, 1956
522
198952 1032/M AS/1997
A PHYSIOLOGICALLY ACTIVE
BRANCHED PEG-IFNa CONJUGATE
F. HOFFMANN-LA ROCHE
AG, A SWISS COMPANY
CHENNAI
523
198953 43/CHE/2005
REMOVAL OF COLOUR IN TEXTILE
EFFLUENT USING CHEMICAL
REACTANTS
SUDHAKAR MUNISWAMI,
INDIAN NATIONAL
CHENNAI
u
MATRIX LABORATORIES
LTD, AN INDIAN COMPANY
The Patent Office Journal 19/05/2006
CHENNAI
CHENNAI
CHENNAI
10000
The Mashelkar Report - vs - the INTERPAT funded IP Institute Report
Mashelkar Report
S6
Granting patents only to NCEs or
NMEs and thereby excluding other
categories
of
pharmaceutical
inventions is likely to contravene the
mandate under Article 27 to grant
patents to all 'inventions'. Neither
Articles 7 and 8 of the TRIPS
Agreement nor the Doha Declaration
on TRIPS Agreement and Public
Health can be used to derogate from
this specific mandate under Article
27.
Interpat/ IP Institute Report
Section II, Part A
L Limiting the grant of patents only to NCEs or
NMEs and thereby excluding other categories of
pharmaceutical inventions (‘the proposed
exclusion ) is likely to contravene the mandate
under Article 27 to grant patents to all
'inventions'. Neither Articles 7 and 8 of the
TRIPS Agreement nor the Doha Declaration on
TRIPS Agreement and Public Health can be used
to derogate from this specific mandate under
Article 27.
Section II, Part A
L9
If the aim of limiting patents to new
chemical entities is to prevent a
phenomenon loosely referred to as
'ever-greening', this can be done by
a proper application of patentability
criteria as present in the current
patent regime.
3. If the aim of the proposed exclusion is to
prevent a phenomenon loosely referred to as
'ever-greening', this can be done by a proper
application of patentability criteria as present in
the current patent regime.
Section II, Part A
5.10
It is important to distinguish 'ever
greening' from what is commonly
referred
to
as
'incremental
innovation'. While 'ever-greening'
refers to an extension of a patent
monopoly, achieved by executing
trivial and insignificant changes to an
already existing patented product,
'incremental
innovations'
are
sequential developments that build
on the original patented product and
may be of tremendous value in a
country like India.
4. Lastly, it is important to distinguish the
phenomenon of 'ever-greening' from what is
commonly referred to as 'incremental innovation'.
While 'ever-greening' refers to an undue
extension of a patent monopoly, achieved by
executing trivial and insignificant changes to an
already existing patented product, 'incremental
innovations' are sequential developments
that build on the original patented product and
may be of tremendous value in a country like
India.
Drug Information Centre - A Profile and Activities
The Settings
The Drug Information Centre is a unit set up by the Karnataka State Pharmacy
Council,a statutory body constituted by the Government of Karnataka
under the
provisions of the Pharmacy Act of 1948. The mission of Drug Information Centre is to
improve patient care through dissemination of unbiased, well-referenced and critically
evaluated drug information.
Location & Facilities
Drug Information Centre is situated in the heart of Vijayanagar area, a prime locality in
the Bangalore City.
The premises encloses spacious seminar hall equipped with
modem amenities, Board Room to hold meetings and neatly designed office set up.
Drug Information Centre - Primary Objectives
•
To provide in-depth and unbiased source of crucial drug information in the Indian
context to meet the needs of the practicing pharmacists (chemists & druggists) and
other health care professionals.
•
To promote safe, effective, rational and economic use of drugs in patients by
provision of drug information.
•
To disseminate the latest advances in patient care through bulletins etc.
DRUG INFORMATION CENTER ACTIVITIES
Drug information center provides information for
•
•
•
•
•
•
•
•
•
Hospitals
)Ufla-ROT03
All the pharmacy colleges
•OlTAMHO^/i
Medical Colleges
3TAT2
Health and allied professionals
Governmental and regulatory agencies 0 1AY
Non governmental organisations
Mass media and other related bodies.
Community pharmacists
4
Members of the public
)S€-080
3
Our principle resources include
•
•
•
•
•
•
•
Drug database from Micromedex includes Tomes, Poisoindex, Drugdex etc.,
Drug database from Drug Facts and Comparison.
A current collection of texts and files on various drug related information.
Internet access for e-mail web searching and access to external databases.
Clinical pharmacology on-line service.
Online access to databases including medline, toxline , aidsline etc.,
Several online subscriptions.
Bulletin
We are about to release our bulletin, designed for local use within our pharmacy and
medical community. The council also has plans to prepare Bulletin in local language
(Kannada).
Training
The center also provides continuing education for community pharmacists on many
recent advancements in pharmacy field.
Drug Information Centre . its philosophy
Drug Information Center is a network of pharmacists producing comprehensive, up to
date health information for all. We strive to bring a doctor’s perspective to important
medical issues. Our goal is to be comprehensive, easy to use and responsive to the
patient's needs.
CONTACT
DEPUTY DIRECTOR-DRUG INFORMATION
DRUG INFORMATION CENTRE
KARNATAKA STATE PHARMACY COUNCIL
514/E, R.P.C. LAYOUT, I MAIN, II STAGE
VIJAYANAGAR CLUB ROAD
BANGALORE-560 040.
E-MAIL: info@kspcdic.org; kspcdic@blr.vsnl.net.in
TEL : 3404000; 3202345
FAX : 080-3202345
Visit us at http://www. kspcdic. org
i
Karnataka State Pharmacy Council - A Profile and Activities
Karnataka State Pharmacy Council is a Statutory body constituted by the
Government of Karnataka under the provisions of the Pharmacy Act of 1948. The
main function of the Karnataka State Pharmacy Council is to grant Registration to
the eligible pharmacists possessing requisite qualification as enunciated in the
Pharmacy Act and to enforce the provisions of the Pharmacy Act.
In addition to the main function of Registration, the Council has expanded it's
activities into the following areas:
1. PHARMACIST SOCIAL SECURITY SCHEME :
The members of Karnataka State Pharmacy Council have constituted Karnataka
registered Pharmacist Welfare Trust (KRKPWT) to provide financial security to
the survivors of the Registered Pharmacist in the State of Karnataka. This is the
first scheme of its kind in this country designed for the pharmacists by the
pharmacists themselves.
2. CONTINUING EDUCATION :
CONTINUING EDUCATION for the Registered Pharmacists has been started
by Karnataka State Pharmacy Council in 1998-99.
3. DRUG INFORMATION CENTRE :
Recognizing the growing need of up-to-date drug information by the healthcare
professionals, the council has started Drug Information Centre, which can
proudly say it is the first major venture in the country.
Drug Information Centre - Primary Objectives
• To provide in-depth and unbiased source of crucial drug information in the Indian
context to meet the needs of the practicing pharmacists (chemists & druggists) and
other health care professionals.
• To promote safe, effective, rational and economic use of drugs in patients by
provision of drug information.
• To disseminate the latest advances in patient care through bulletins etc.
4. APPOINTMENT OF PHARMACY INSPECTORS:
Karnataka State Pharmacy Council has appointed Pharmacy Inspectors under
section 26(A) of the Pharmacy Act, 1948. The Pharmacy Inspectors are
instructed to inspect premises where dispensing is carried out.
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Facts you should know about Colour
Adulteration
I
Simple Tests to Detect Colour
Adulteration
Why Colour Adulteration
#
Colour adulteration is the most frequent form
of adulteration.
#
No artificial food colouring is really safe
#
Colours are not foods and do not add to the
nutritive value of foods
#
Colour serves to mask defects in food making
inferior foods look superior
#
Consumers demand colour and variety in
foods
Colour/
Simple Test
Availability of a wide range of colours that
can produce the desired shade in foods
#
#
Food laws permit artificial colouring of
certain foods
Colouring are high risk for children and the
foetus in a pregnant mother
#■
#
The consuming desire of traders to make their
goods look superior and attractive and
thereby increase sales and profit
#
Consumer ignorance, carelessness,
indifference and lack of organised action to
check the menace
Colourings may react with the food and/of
change to poisons in the body, causing
mutations cancer or other toxic effects.
What is Food Adulteration
Use of any colour prohibited under the
Prevention of Food Adulteration Act, in or
upon and food or beverage
Use of marketed colours not stamped with the
ISI mark of quality
#
Use of colour on foods such as rice, pulses,
spices tea and coffee, where food laws
do not permit artificial colouring
#
Use of permitted colours exceeding the
maximum permissible limit of 0.2 gram of
dye per Kg of the final food or beverage
Inadequate enforcement of food laws and
absence of deterrent punishment for
offenders
Metanil yellow (in rice pulav, ladoo, jelebi,
halwa, gur, beverages, turmeric, mixed spices,
saffron etc.)
Shake portion of the food with cold water, the
water will turn yellow. Dilute the water till
almost colourless and add few drops of
concentrated hydrochloric acid. It will turn Red.
#
Rhodamine B or other red colour (on red
chilli whole)
Rub the outside of the red chilli with cotton
soaked in liquid paraffin. Cotton will become
red.
#
Coal Tar Dye (in butter)
Dissolve 2 ml. of melted butter in ether, shake
with 2 ml. of hydrochloric acid (1 part
concentrated acid plus 1 part water) Allow to
settle. Lower acid layer will turn pink or red in
the presence of coal tar dye
Consumers role in checking colour
Adulteration
3. Auramine Rhodamine B Blue
VRS Orange II:
Pathological lesions in vital organs like
kidney, spleen and/or live/, cance-r
# Create consumer awareness of the evil and its
consequences
4. Malachite green.
Tumours in liver, lung, breast ovary and
birth defects in offspring
# Help monitor the adulteration and check the
sale of adulterated stuff with the Government
help, wherever necessary
5. Amarnath:
Mutagenic
# Use natural coloured foods to brighten up
means and teach others to do the same.
If artificial colouring is a must, buy colours
with I SI stamp
Consume!”
Series - 8 •8I
I I
■
6. Ponceau 4R
Lowering of red cell counts and
haemoglobin in concentration
Information Source:
Super Bazar, New Delhi
COLOUR ADULTERATION
Suggested contribution : Rs.2/-
// Reject artificially coloured rice, pulses,
sweets, spices and beverages
# Get organised and fight the menace
Health effects of common food
colourings
1. Metanil Yellow:
Degeneration of reproductive organs,
sterility, stomach trouble, cancer
2. Lead Chromate:
Anaemia, paralysis, brain damage, specially
in children
The Consumer Rights, Education and Awareness
Trust (GREAT) is a non-profit, voluntary, non
political organisation working to promote
consumer awareness. GREAT was established in
Dec. 1993 and is registered as a public charitable
Trust.
GREAT represents consumers in Petroleum
consumer advisory committee. Chamber of
Commerce (Consumer Affairs Committee). The
activities of GREAT include publications,
training, advocacy, redressal of grievances,
consumer counselling, etc...
Associate membership fee Rs. 100/- per year.
GREAT
Consumer Rights, Education and Awareness Trust
239, Sth C Main, Remco Layout, Vijayanagar
BANGALORE: 560 040
Phone: 3403170
Position: 19 (40 views)