8230.pdf
Media
- extracted text
-
WHY BIOTECH PATENTS
ARE PATENTLY ABSURD:
A Scientific Briefing on
TRIPS and Related Issues
Mae-Wan Ho
TWN
Third World Network
WHY BIOTECH PATENTS
ARE PATENTLY ABSURD:
A Scientific Briefing on
TRIPS and Related Issues
Mae-Wan Ho
TWN
Third World Network
Penang, Malaysia
Wliij Biotech Patents Are Patently Absurd:
A Scientific Briefing on TRIPS and Related Issues
is published by
Third World Network
228 Macalister Road
10400 Penang, Malaysia
copyright © Third World Network 2001
This is part of a series of papers on biodiversity, knowledge and rights
published by the Third World Network, aimed at deepening public
understanding on the inter-relationships between biodiversity,
knowledge on the conservation and sustainable use of biological
resources, and the rights relating to such resources and knowledge.
Printed by Jutaprint
2 Solok Sungei Pinang 3, Sg. Pinang
11600 Penang
ISBN: 983-9747-55-X
G- no
88230 P°'
Contents
Chapter 1. Introduction
Glossary of Terms
1
2
Chapter 2.
2.1
2.2
2.3
2.4
5
2.5
2.6
Range of 'Patents on Life'
Patents Based on Plagiarism and Biopiracy
Patents Based on Discoveries
Patents on Transgenic Processes and Organisims
Patents on Nuclear-Transplant Cloning and
Other in vitro Reproductive Techniques and
Organisms Resulting From Those Techniques
Patents on Cell Stem Isolation and Culture
Techniques and the Stem Cells and Cell Lines
Patents on GM Constructs and Vectors
Chapter 3. Analysis of Articles Related to Patents in
TRIPS and EU Directive 98/44/EC
3.1
Article 27.3(b) of TRIPS
3.2
Articles 4 and 5 of the ELI Directive
Analysis
3.3
18
Chapter 4. General Critique on the Patentability of Genes
or Nucleic Acid (DNA or RNA) Sequence
22
Chapter 5. Conclusions
24
Endnotes
25
General References and Reports
27
Chapter 1
Introduction
TRIPS, or Trade-Related Aspects of Intellectual Property Rights, is
an agreement between member states of the World Trade
Organisation (WTO) that seeks to enforce US-style patent laws
around the world. The patent provisions of this agreement cover
all fields of technology, including everything from phar-maceuticals
to information technology software and human gene sequences,
and is emerging as a major issue dividing North and South.
The TRIPS agreement is controversial in at least two areas. First, it
threatens the right of poor countries to manufacture, or to import,
cheap generic versions of patented drugs. The AIDs epidemic and
other diseases are killing millions every year because people in poor
countries cannot afford the exorbitant prices the pharmaceutical
giants are charging for patented drugs.
The existing TRIPS agreement also forces all countries to accept a
medley of new biotech patents covering genes, cell lines, organisms
and living processes that turn life into commodities. Governments
all over the world were persuaded into accepting these 'patents on
life' before anyone understood the scientific and ethical implica
tions.
This paper examines Article 27.3(b) of TRIPS, currently under re
view at the World Trade Organisation (WTO), and its counterparts
in the European Union (EU) Patents Directive 98/44/EC (Legal
Protection of Biotechnological Inventions).
We show that the Articles, in both the TRIPS Agreement and the
EU Directive, are couched in undefined terms, designed to allow
the broadest categories of patents from genetic engineering and
other new biotechnologies. We also argue why all classes of new
biotech patents should be rejected from inclusion in TRIPS.
1
Glossary of Terms
A 'glossary' is supplied at the start to help negotiators understand
some of the dubious 'logic' behind the Articles.
Antibiotic resistance marker genes are genes coding for antibiotic
resistance used in genetic modification. They allow the cells that
have taken up the foreign GM construct (artificial or modified
genetic material) to be selected with antibiotics, and frequently
remain in the genetically modified organism and transgenic line
created.
A cell line is a supposedly genetically uniform population of cells
derived from one individual, or it could be a clone (theoretically
genetically identical descendants) of one original cell. The genetic
identity of all the cells is a fiction, as the genetic material is subject
to many 'fluid.genome' processes that constantly make cells
genetically different from one another, and especially in culture.
Both plant and animal cells are subject to large variations known
collectively as somaclonal variations.
A clone is an identical copy of a cell or an organism.
A DNA sequence refers to the sequence of bases in a section of
DNA. DNA is a linear molecule consisting of units strung together.
There are four different units, each identified by the specific base
contained, and four different bases, which are simply represented
by the alphabets, A, T, C and G. An example of a DNA sequence is
as follows: ATTTCCGCTACGCGTTA. A RNA sequence is similar,
except that the alphabet T is replaced by U.
An "essentially biological process" is scientifically suspect. Does
it mean a process that occurs naturally or which is carried out by
organisms?
Similarly, a "non-biological process" is difficult to define, as ail
processes in biotechnology, by definition, are biological. A weak
case may be made on the ground that it is one that does not occur
2
naturally, or which is not normally carried out by organisms.
A gene is a stretch of genetic material (DNA or RNA) with a defined
function in the organism or cell. It usually codes for a protein. There
are many genes within a genome. For example, the human genome
is now found to contain about 30,000 genes, while the rice genome
has about 50,000.
Gene expression refers to the synthesis of the gene-product or
protein encoded by the gene.
A genetically modified organism (GMO) is one which has foreign
DNA inserted into its genome by means of genetic modification in
the laboratory.
Genetic modification or transgenesis is the process whereby a
genetically modified organism is made in the laboratory. This in
volves making artificial or modified genetic material (GM con
structs) which are inserted into the genomes of cells or embryos.
The cell or embryo is regenerated to an organism, out of which a
GM line or transgenic line is derived.
A genome is the totality of all the genetic material (deoxyribonucleic
acid or DNA) in an organism, which is organised in a precise,
though by no means fixed or constant way. In the case of viruses,
most of them will have ribonucleic acid or RNA as the genetic
material.
Horizontal gene transfer is the direct transfer of genetic material
to unrelated species, as for example, from plants to bacteria.
A micro-organism is an organism that can be seen only under a
microscope, usually, an ordinary light microscope. It includes
bacteria, mycoplasm, yeasts, single-celled algae and protozoa. Mul
ticellular organisms are normally not included, nor fungi apart from
yeasts. Viruses are also not automatically included; many scientists
do not classify them as organisms. However, all organisms
including human beings begin life as microscopic germ cells and
3
fertilised eggs, so in practice, all reproductive processes can be
interpreted as microscopic, and hence patentable.
A "micro-biological process" is presumably one that is carried out
by micro-organisms. But as a micro-organism is ill defined, so too,
is a micro-biological process.
Nuclear transplant cloning is a process whereby the nucleus
containing the genome of an adult cell is transferred into an egg
from which the nucleus was previously removed. The egg with
the transplant nucleus is then stimulated to divide and develop
into an organism. The organism is supposed to be identical in
genetic makeup to the individual from which the cell was taken.
A promoter is a piece of genetic material that acts as a gene switch,
so that a gene can become expressed in the cell.
Stem cells are cells that have the potential to become many differ
ent cell types.
A vector is a carrier or transmitter, of genes or of disease. Artificial
vectors are made in genetic engineering for multiplying and trans
ferring genes into genomes.
A virus is a parasite consisting of genetic material wrapped in a
protein coat. It depends on infecting and entering a cell to multiply
copies of itself.
4
Chapter 2
Range of 'Patents on Life'
There are numerous patents and proprietary databases on lifeforms
and living processes under TRIPS Article 27.3(b), and the range is
growing all the time. All of them should be revoked and banned,
for one or more of the following reasons:
•
involve acts of plagiarism and biopiracy
•
technology unreliable and hazardous
•
all depend on biological proesses, therefore little or no
invention
•
discovery, not invention
®
knowledge, not invention
0
unethical in threatening livelihood
•
violation of basic human rights and dignity
0
contrary to public order or morality
•
lack of scientific basis
•
obstructs diagnosis and treatment
•
stifles scientific/medical research and innovation
Nearly 400 scientists from all over the world are calling for a ban
on all such patents, as well as a moratorium on releases of GMOs
on grounds of safety [1].
There are many ways to classify patents and proprietary databases
on life forms and living processes. We have done so on the basis of
5
how they fail to satisfy the accepted criteria for patent awards. Some
of the categories will overlap.
1.
Patents based on plagiarism and biopiracy.
2. Patents based on discoveries or knowledge, which also violate
basic human rights and dignity: These include patents on cell lines,
genomes and genes of natural organisms, natural microorganisms,
and proprietary information and databases owned by companies.
3. Patents on transgenic processes that cannot be said to be
inventions because they are unreliable, uncontrollable and
unpredictable as well as being inherently hazardous. These
properties also extend to the transgenic organisms and lines
produced.
4. Patents on nuclear transplant cloning and other reproductive
technologies, and on the cloned animals and lines produced, which
also do not qualify as inventions and violate public order and
morality, or are contrary to animal welfare.
5. Patents on stem cell isolation and culture techniques and the
stem cells and cell lines produced, which are parts of natural
organisms and should not be patentable. Many also violate public
order or morality.
6. Patents on artificial vectors and other GM constructs and
methods for producing them which depend on recombining natural
genetic material but the functions of which depend on living
organisms. GM constructs and artificial vectors are inherently
hazardous.
2.1 Patents Based on Plagiarism and Biopiracy
These include patents on extracts, formulas, and genes of plants
that have been developed and used for millennia by indigenous
communities for medicinal and other purposes. Examples are
patents on extracts of the neem plant from India (at least one of
6
which has been challenged and revoked), patents on extracts of
the bibiru and cunani from the Wapixana Indians in North Brazil,
and patents taken out by the Japanese cosmetic company Shiseido
on several traditional formulas of Indonesian herbs and spices
including the anti-ageing agents made from Sambiloto
(Aiidrographispanicurata) and Kenukus (Piper cubeba), and hair tonic
from Javanese chili.
Biotech companies are aggressively scouring the globe
'bioprospecting' and accessing the biodiversity of the entire world.
Diversa Corporation, one of the biggest players, is expanding its
microbial genomic libraries to develop products for the
pharmaceutical, agricultural, chemical and industrial markets. It
already has access to Alaska, Costa Rica, Bermuda, Indonesia,
Yellowstone National Park, and Russia, and the latest, South Africa
[2], one of the world's most biologically diverse environments, and
includes the famous Cape Floristic Region with 9,000 plant species,
70% of which are endemic.
The African agreement gives Diversa the right to discover genes
and commercialise products provided by the Council for Scientific
and Industrial Research (CS1R), which is currently undertaking
nearly 10% of all research and development activities on the African
Continent. In exchange, Diversa will support the ongoing
bioprospecting activities of CSIR and pay royalties on any revenues
that come from developed products.
Diversa's strategic partners include The Dow Chemical Company,
Novartis Seeds AG, Novartis Agribusiness Biotechnology Research,
Inc., Aventis Animal Nutrition S.A., Celanese Ltd., Invitrogen
Corporation, and Danisco Coltur.
This class of patents has the potential to destroy biodiversity and
livelihoods of indigenous communities. It could also undermine
the entire healthcare system of a country. The Association of South
East Asian Nations (ASEAN) has just drafted a position paper
supporting traditional knowledge and medicine [3]. It intends to
promote traditional medicine for healthcare and at the same time,
7
protect the environment and avoid over-exploitation. In the review
of Article 27.3(b) of TRIPS, it will maintain that plants and animals
are not patentable and emphasise the prevention of biopiracy.
2.2 Patents Based on Discoveries
This comprises the broadest categories of patents already granted.
Human cells and cell lines
Many are derived from blood collected from indigenous peoples
under the Human Genome Diversity Project, without informed
consent, and with coercion in some cases. A US company, Coriell
Cell Repositories, lists Amazonian Indian blood cells in a DNA kit
which is openly advertised on the internet.
A patent on umbilical cord cells was granted to the company
Biocyte, despite the fact that those cells have been used freely for
transplant purposes previously. Tire EU Patent Office have revoked
this patent in June, 1999, after a successful challenge by The
European Campaign on Biotechnology Patents, a coalition of
European NGOs.
Any cell line derived from a patient can be patented without
informed consent, as in the famous case of John Moore in the United
States, whose spleen cells were patented by his doctors.
Human population DNA databases
Since the DNA database of the entire Icelandic population was sold
by their Government to DeCode Genetics, a California-based
company, other populations have been targetted. The Tongan
population database has recently been sold to a private company,
and the Swedish Government is negotiating with another company
for the 'ethical' takeover of its population database. The UK
government is planning to establish one of its own, and geneticists
from Harvard University are cheating rural Chinese of their DNA
[4].
8
These collections are purportedly used to discover genes involved
in susceptibility to diseases. Apart from being entirely misplaced,
such collections have the potential for gross violation of human
dignity and rights to privacy [5]. It could compromise an
individual's employment and health insurance as well as civil
rights.
Human gene sequences, genefragments and single nucleotide variants of
genes (SNPs)
The pace of human gene patenting has accelerated to a frenzy as
the human gene map nears to completion. Applications for patents
in the US went from an annual 150,000 in the late 1980s to 275,000
in February 2001 when the 'complete' human genome map was
announced. In October 2000, there were patent applications on
126,672 human gene sequences.
By February 2001, there were 175,624, a 38% jump [6]. The US has
granted patents for millions of SNPs (single nucleotide
polymorphisms, variants of genes involving a single base change)
and gene fragments for which functions are unknown before it
tightened the patent laws in December 1999 [7].
Since then, both the gene function and industrial application have
to be specified. In practice, however, the 'function' is little more
than a surmise based on similarity in sequence to other genes, and
the industrial application simply a diagnostic test for predisposition
to condition x, where x could be anything from cancer to criminality.
The human genome is already covered with dozens of times more
patents than there are genes, because multiple patents are being
granted over the same stretch of DNA. Such patents are seriously
distorting healthcare and stifling scientific research and innovation.
Proprietary databases in 'bioinformatics'and 'genomics’
These databases have grown out of the application of information
9
technology to sequencing of the human and other genomes. Private
companies have been 'mining' the public databases (free access to
all) for information to include in their own proprietary databases,
which are made available, at exorbitant fees to corporate subscribers
hoping to identify targets for lucrative new' drugs. This has now
created an unprecedented knowledge monopoly.
The problem came to a head in February 2001, when Celera, the
private company w'hich raced the international consortium of the
human genome sequencers to the finishing line, published their
complete human genome map in the Journal Science. In a complete
break with accepted tradition, Celera was allowed to retain control
of access to the sequence described in the published paper, instead
of having to deposit it in the public database GenBank/EMBL/
DNA in Japan.
Celera stipulated it w'ould only publish on condition that the data
are retained exclusively on its own website. Users are limited to
downloading no more than one mega byte of data despite a
previous announcement that it would "make the entire sequence
available free of charge".
Those seeking larger downloads have to submit a letter from their
institution, promising not to redistribute the information. Scientists
are outraged, for it will seriously obstruct efforts to make sense of
the sequence data [8], and stifle any innovative research that can
come out of it.
Patents on genes of plants
The entire rice genome sequence was announced in January 2001,
by the European agribusiness giant Syngenta and US company
Myriad Genetics, which patented two breast cancer genes [9]. The
announcement triggered alarm from Action Aid, the hunger charity.
There are already 229 patents on rice; the diet of the world's poorest
will become the preserve of big business. Rice is grown in 100
countries but nine-tenths of the world's crop is produced in Asia,
10
providing four-fifths of South-East Asia's calories. Rice has been
domesticated by human beings for 5000 years.
Syngenta intends to sell data on the rice genome to seed businesses
and other commercial groups, and to make available the
information to scientists "through research contracts". It would also
provide information "without royalties or technology fees" to
scientists helping subsistence farmers. The two companies said they
would not patent the rice genome but they would patent particular
uses of the genes as they were identified.
However, if human gene patenting is anything to go by, it would
take no time at all to cover the rice genome dozens of times over
with patents that will not only stifle independent research and
innovation, but also seriously undermine farmers' rights to create
new varieties or to preserve existing ones.
Hundreds of patents have already been granted on DN A sequences
from plants taken from developing countries including such wellknown plants as nutmeg, cinnamon, rubber, jojobe and cocoa, and
the list is bound to grow as DNA sequencing is now routine.
These patents will have adverse impacts on technology transfer
and food security as they intensify corporate monopoly on food.
They will also jeopardize the entire healthcare systems of Third
World countries that are strongly dependent on indigenous
medicine.
Patents on genomes of pathogenic bacteria and viruses
These patents can, and are, obstructing the prompt diagnosis and
treatment of dangerous diseases such as meningitis and
tuberculosis. Delay in diagnosis and treatment will result in
unnecessary deaths. Dozens of bacterial and viral genomes have
already been sequenced and patented, one of the most recent being
the genome of E. coli 0157:H7 [10], responsible annually for
hundreds of thousands of cases of food poisoning in US, UK and
other countries around the world.
11
Patents on naturally existing micro-organisms
In TRIPS, micro-organisms are construed to be patentable. As
microorganisms are the most abundant and essential part of natural
biodiversity, this is potentially very serious. As mentioned earlier,
companies like Diversa have been given licence to bioprospect in
all parts of the world, and one of their main quests will be
microorganisms.
This class of patents could even infringe on natural processes that
people all over the world have been using for thousands of years,
as in baking, brewing, fermenting, and so on.
2.3 Patents on Transgenic Processes and Organisms
Transgenic processes are notoriously imprecise. Transgenesis is not
a technology at all. It is extremely hit or miss, with low rates of
success and many abnormalities and other unintended, unexpected
effects in both plants and animals, including toxins and allergens.
Each transgenic line originates ultimately from a single cell that
has taken up the GM construct. Its characteristics will depend on
the form in which the GM construct is inserted and the precise
location of the insert in the genome.
The GM construct is often repeated, rearranged, and may have parts
deleted or extra sequences originating from the vector used in
transferring the GM construct. There may also be more than one
site of insertion. The insertion invariably leads to genetic
disturbances spreading far from the site. So, even if the transgenic
lines are made with the same GM constructs, vectors and plant/
anima] cells, they will all end up being different from one another
as well as from the non-genetically modified organism.
An important class of transgenic process patents are on the 'Traitor
Technology' or 'Genetic Use Restriction Technologies' (GURT)
which are based on the original 'Terminator Technologies' that
engineer harvested seeds not to germinate, thus offering de facto
protection of transgenic seeds [11]. A newer version makes seeds
12
dependent on the application of a chemical for germination, or for
expressing the desired transgenic trait. These patents are unethical
as they serve no other purpose than to intensify corporate monopoly
on seeds and on food production, and have been universally
rejected by civil society around the world.
Large failure rates are typical in making transgenic animals and
abnormalities are frequent even among the successes. The GURT
technologies are even worse. They depend on 'site-specific' splicing
of genes that is supposed to be precise, but is far from the case in
practice.
Transgenesis in its current state-of-the-art certainly cannot be said
to be an invention in the usual sense of the word. Most importantly,
there is a raging debate on the inherent dangers of the process of
creating transgenic organisms, which is why there is still a de facto
moratorium in Europe, and many other countries are imposing
moratoriums or bans.
Transgenic DNA has the potential to generate new viruses and
bacteria that cause diseases, and may also cause cancer by
integrating into mammalian cells. Another major worry is the
spread of antibiotic resistance marker genes to pathogens, making
bacterial infections untreatable. The British Medical Association
issued a report in 1999 calling for an indefinite moratorium on
transgenic crops, and further research on the possible health risks
of GM foods, including new allergies, the spread of antibiotic
resistance and the effects of transgenic DNA in animals and human
beings.
The Terminator or GURT technologies involve even greater risks,
as they make use of genes that are inherently dangerous, one of the
genes kills all cells in which it is expressed, and the other, can
scramble genomes by breaking and joining the genetic material in
inappropriate places. These genes can escape both by ordinary
cross-pollination between related species as well as by horizontal
gene transfer to unrelated species. The Institute of Science in Society
has recently discovered that terminator crops have been field tested
13
in Europe and the United States since the early 1990s, and several
of them have been approved for commercial release in the US [12].
Both the US and EU are now granting patents on transgenic
processes as well as the resulting transgenic organisms or GMOs.
GMOs for which patents are granted include not only crops, but
also livestock and fish. Livestock such as cows and sheep are
genetically modified to serve as 'bioreactors' to produce
pharmaceuticals and industrial chemicals in their milk, blood, urine
and semen.
Fish are genetically modified to grow faster and bigger. Millions of
mice have been genetically modified to serve as models for human
diseases, the first transgenic mice to be patented was the notorious
'oncomouse', genetically modified for increased susceptibility to
cancer. Pigs 'humanized' to provide spare organs and tissues for
transplant into human subjects have also been patented [13].
Recently, a transgenic rhesus monkey was created, raising fears
that transgenic human beings might be next in line [14].
Broad patents for transgenic processes have been awarded which
include applications to all other species. This has led to disputes
among different patent holders: those holding patents on the
individual transgenic organisms, and others holding the patent on
the transgenic process. Hundreds of millions of dollars are spent,
unproductively, on litigation.
More seriously, the patents on GM seeds are preventing farmers
from saving seeds for replanting unless they pay royalities to the
companies. GM seeds intensify corporate monopoly which is
already threatening the livelihood of small farmers all over the
world. Patents on transgenic animals are encouraging transgenic
practices that are contrary to animal welfare.
14
2.4 Patents on Nuclear-Transplant Cloning and Other
in vitro Reproductive Techniques, and Organisms
Resulting From Those Techniques.
The procedure that produced Dolly, the first cloned sheep, involved
transferring the nucleus containing the genome of a cell from an
adult organism to an egg with its original nucleus removed. This
patent actually covered all species, including human beings. It
brought PPL, the company owning the original process patent, into
dispute with a Japanese company that used a similar procedure
later to produce clones of mice.
The same cloning procedure is involved in so-called 'therapeutic'
human cloning, the creation of human embryos in order to provide
spare cells and tissues for transplant (see 2.5 below).
The cloning process is hardly a technology, as it also generates large
numbers of failures and abnormalities even among the 'successes'
[15]. There are high proportions of fetal and neonatal deaths,
abnormalities in the placenta, the umbilical cord and severe
immunological deficiencies in cloned monkeys. In sheep and cows,
clones develop serious abnormalities in the heart, lungs and other
organs. Many die before birth, others succumb suddenly weeks or
months after birth. In some cases, the surrogate mothers carrying
the cloned fetuses are also affected. Three cows died while pregnant
with clones, and autopsy revealed livers that were filled with fat,
suggesting metabolic abnormalities induced by the clones. How
can we regard this as a patentable technology? It is both scientifically
flawed and ethically unacceptable to create so much suffering.
2.5 Patents on Stem Cell Isolation and Culture Techniques and
Stem Cells and Cell Lines
These patents are the most recent to come on the scene. Stem cells
can be isolated from both embryos, fetuses, newborns and adults.
Thus, the opportunity arises for patenting isolation procedures,
culture techniques and the cells and cell lines established [16].
15
Biotech companies already own dozens of patents on these
technologies and cells lines.
One of the most controversial aspects of stem cell research is
'therapeutic' human cloning. This involves using the nuclear
transplant cloning to create a human embryo in order to provide
embryonic stem cells for cell and tissue transplant, the embryo being
'sacrificed' in the process. In January 2001, the UK became the only
country in Europe to approve of such procedure, which has been
overwhelmingly rejected by all the other EU countries. In so doing,
the UK has committed a grave moral and scientific error, as the
scientific findings tumbling out of laboratories are indicating that
there is absolutely no need for such human cloning. The Institute
of Science in Society is calling on the UK to reject therapeutic human
cloning and to support research and development of adult stem
cells, especially those that minimise intervention and costs.
'Human' clones have already been created by transferring the
genetic material of a human cell into the empty eggs of cow and
pig. An application for such human-pig hybrid patent has been
rejected in Europe on grounds of being contrary to public order
and morality [17].
This entire class of patents should be vigorously rejected, as they
will seriously distort healthcare as well as social ethics.
2.6 Patents on GM Constructs and Vectors
In addition to separate stretches of genes and control sequences
such as promoters being patented, particular combinations have
also been patented. These include GM constructs and artificial
vectors of all kinds.
A case could be made to support the patenting of these constructs,
as indeed, many of them had never existed in the billions of years
of evolution. However, these could hardly qualify as inventions,
as they all imitate naturally existing combinations. The methods
for producing them and their functions are entirely dependent on
16
the cells and organisms themselves. Furthermore, they are
structurally unstable, and are inherently hazardous.
Many GM constructs are made from genetic material of bacteria,
viruses and other genetic parasites that cause diseases and spread
drug and antibiotic resistance genes. They are designed to cross
species barriers and to invade genomes. Therefore, they have
increased potential for horizontal gene transfer and recombination,
the processes responsible for generating new bacteria and viruses
that cause diseases, and spread antibiotic resistant genes.
17
Chapter 3
Analysis of Articles Related to Patents in
TRIPS and EU Directives
3.1 Article 27.3(b) of TRIPS states:
Members may also exclude from patentability:
(b) plants and animals other than microorganisms, and essentially
biological processes for the production of plan ts and animals other
than non-biological and microbiological processes. However, 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 non-exclusion of "non-biological and microbiological pro
cesses" needs to be challenged as all biotech processes are biologi
cal and there is no sound reason to regard microbiological as any
thing but biological.
3.2 Articles 4 and 5 of the EU Directive
Article 4:
1.
The following shall not be patentable:
(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or
animals.
2.
Inventions which concern plants or animals shall be patentable if
the technicalfeasibility of the invention is not confined to a particular
plant or animal variety.
3.
Paragraph 1(b) shall be without prejudice to the patentability of
inventions which concern a microbiological or other technical process
or a product obtained by means of such a process.
18
Article 5:
1.
The human body, at the various stages of its formation and
development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot
constitute patentable inventions.
2.
An element isolated from the human body or otherwise produced by
means of a technical process, including the sequence or partial
sequence of a gene, may constitute a patentable invention, even if
the structure of that element is identical to that of a natural element.
3.
The industrial application of a sequenced or a partial sequence of a
gene must be disclosed in the patent application.
"Essentially biological processes" could include transformation and
transfection, processes used in creating transgenic organisms.
The "technical feasibility of the invention is not confined to a par
ticular plant or animal" could be challenged, as without perform
ing the actual experiment, it cannot be assumed that what works
for one specie works for another. In fact, this is very often not the
case. Besides, as argued previously, neither transgenesis nor clon
ing qualifies as an invention, as each fails to work less than 99 times
out of 100.
The description, "a microbiological or other technical process"
needs to be challenged, as a microbiological process is not a technical
process, and should not be patentable.
3.3 Analysis
Both the TRIPS and EU Directive articles are designed to allow all
categories of patents listed in Chapter 2. One positive aspect of the
EU Directive is Article 6, which excludes from patenting,
commercial exploitation contrary to ‘ordre public or morality', such
as human cloning, use of human embryos for industrial or
commercial purposes, and modifications of animals causing
19
substantial suffering without substantial medical benefit. This has
led to the pig-human hybrid patent being rejected, for example,
though many transgenic animal patents are still being approved.
The EU Directive Article 4.1 appears to strongly exclude plant and
animal varieties, but Article 4.3 makes clear that transgenic plants
and animals are patentable, as they are produced by
"microbiological or other technical process". But this point should
be challenged, as transformation and transfection used in making
transgenic plants and animals, are biological processes. It is
important to recognize that the patentability refers, not to the
process, but to the product of the process. That is because in many
cases, the process is standard, such as base sequencing, or is covered
by another patent, such as cloning.
Similarly, the EU Directive Article 5.1 appears to exclude the human
body, cells and genes from patents. But this is nullified by Article
5.2, where the copying or amplification process enables the copy
of the gene, or the partial sequence of the gene, or the cell of the
organism to be patented. This should be strongly challenged as the
distinction between the putative original gene and cell in the body
and the copy is a legal fiction. The very identification of the gene
or cell involves processes of copying or amplification, so that it is
actually the copies that are identified.
The EU Directive also explicitly extends the patentability of a
process, say cloning, or technology, such as the transgenic
technology, to all plant or animal varieties. So, in the case of nuclear
transplant, the patent is protected for all other animals (though EU
Directive Article 6 may exclude human beings).
In the case of the technology using bt-toxin to protect plants, that is
also extended to all plant varieties. This should be strongly
challenged for reasons given above, what works in one specie may
not work in another.
The EU Directive is being challenged as illegal by a number of Eu
ropean countries, the latest being Germany [18].
20
Chapter 4
General Critique on the Patentability of
Genes or Nucleic Acid (DNA or RNA)
Sequence
The patentability of genes and other nucleic acid sequences is
justified on the ground that they have been subject to a
microbiological or nonbiological process, i.e., gene sequencing,
which is itself a standard process patentable and patented under
existing patent laws for invention. So, the actual patented entity is
the nucleic acid sequence itself and its putative function.
However, the DNA or RNA sequence is subject to change by muta
tion, deletion, insertion and rearrangement. Does it mean that, for
example, if the sequence patented is ATCCAGGAACCTA, then
variously mutated sequences such as the following are no longer
covered?
AACCAGGAACCTA
(single base substitution),
ATAGGAACCTA
(deletion of two bases),
ATCC ATCGG A ACCTA
AGACCTGAACCTA
(insertion of two bases),
(inversion of five bases)
The confusion is multiplied when single nucleotide polymorphisms
(SNPs) are ruled to be independently patentable by the US Patent
Office. Thus, the patent for the gene and the patent for the gene
variant will legally clash.
The same arguments of mutability of entire genomes raise the ques
tion as to which genome is being patented. If the patent is on one
DNA base sequence, does it cover genomes differing in DNAJ^isg
sequence?
For a DN A sequence of 1000 bases, the possible number of variants
is 41000.
The "industrial application" stated in the EU Directive Article 3.1
involves the functional side of the gene sequence, and presumably
qualifies it as an invention.
It is important to realise, however, that the nucleic acid molecule
by itself can do nothing. It can only have a function in a living cell
or an organism. However, its function depends on which kind of
cell it is in, where in the genome it is inserted (this is not under the
control of the human genetic engineer), in what kind of genome
and in which environment.
In other words, its function is uncertain and unpredictable. For ex
ample, the acetyl-CoA carboxylase gene, which confers herbicide
resistance in monocots, is claimed primarily for regulating oil
content in a patent. Under some circumstances, again beyond the
control of the genetic engineer, the gene is silenced, so it has no
function whatsoever. Thus, the patentability based on function is
equally unscientific.
The patenting of genomes raises the question of the function of the
genomes. Again, the isolated genome can do nothing by itself, while
its "function" in the organism cannot be considered separately from
the totality of the organism.
22
Chapter 5
Conclusion
All biotech patents should be rejected from inclusion in TRIPS on
the following grounds:
•
All involve biological processes not under the direct control
of the scientist. They cannot be regarded as inventions, but expro
priations from life.
•
The hit or miss technologies associated with many of the 'in
ventions' are inherently hazardous to health and biodiversity.
•
There is no scientific basis to support the patenting of genes,
genomes, cells and microorganisms, which are discoveries at best.
•
Many patents are unethical; they destroy livelihoods, contra
vene basic human rights, create unnecessary suffering in animals
or are otherwise contrary to public order and morality.
•
Many patents involve acts of plagiarism of indigenous
knowledge and biopiracy of plants (and animals) bred and used
by local communities for millennia.
23
Endnotes
1.
"World Scientists Open Letter to All Governments on GMOs",
Institute of Science in Society, (www.i-sis.org).
2. "Diversa signs first agreement granting legal access to
biodiversity in Africa", GENET News, 7 December 2000, (http:/
www.diversa.com / presrele).
3.
"ASEAN Position in the Context of Traditional Medicine/
Knowledge", Biotani Report, Jakarta, 15 February 2001,
(biotani@rad. net.id).
4. Biopatents Section, ISIS News (7/8), February 2001, (www.isis.org>).
5. Ho, M. W. "The human genome sellout", Third World
Resurgence (123/124, 4-9), 2000.
6.
Bunting, Madeleine. "The profits that kill", The Guardian, 12
February 2001.
7.
Kowalski, Thomas J. "Analysing the USPTO's revised utility
guidelines", Nature Biotechnology (18:349), 2000.
8.
"Slippery Slope?", Editorial, Nature Biotechnology (1:191), 2001.
9. Radford, Tim. "Scientists unravel genetic code of rice", The
Guardian, 27 January 2001.
10. Perna, N.T. "Genome sequence of enterohaemorrhagic
Escherichia coli O 157: H7", (et al), Nature (409:529-33), 2001.
11. Ho, M.W.; Cummins, J.C.; and Barlett, J. "Killing fields near
you, terminator crops at large", ISIS News (No.7/8), (www.i-sis.org).
12.
24
Ibid.
13. Ho, M.W. & Cummins, J.C. "Xenotransplantation - how bad
science and big business put the world at risk from viral
pandemics", ISIS Sustainable Science Report (No.2), August 2000.
14. Ho, M.W. "Green monkey not a glowing success", ISIS News
(No.7/8), February 2000, (www.i-sis.org)
15. Weiss, Rick. "Clone defects point to need for two genetic
parents", Washington Post, 10 May 1999.
16. Ho, M. W. & Cummins J.C. "The unnecessary evil of huiman
"therapeutic" cloning", ISIS News (No.7/8), (www.i-sis.org).
17. "Cloning teams cross pig and human DNA", Reuters, 6 October
2000, The Times, 8 October 2000.
18. Schweiger, Thomas (Greenpeace GE campaigner). Greenpeace
Press Release, GENET News, December 2000.
25
General References and Reports
1.
Ho, M.W. "Genetic Engineering — Dream or Nightmare? The
Brave New World of Bad Science and Big Business", (Chapter 8),
Gateway Books, UK, & Third World Network, Penang, 1998.
2.
"The Gene Giants, Masters of the Universe?", RAFI
Communique, March/April, 1999.
3.
"Traitor Technology - The Terminator's Wider Implications",
RAFJ Communique, January/February, 1999.
4.
"Genetic engineering and patenting - A disaster in the making
for developing world", Actionaid, February, 1999.
5.
"Selling suicides, farming, false promises and genetic
engineering in developing countries", Christian Aid, London, 1999.
6.
"The Impact of Genetic Modifications on Agriculture, Food
and Health - an Interim Statement", British Medical Association,
May, 1999.
7.
Thomas, S.M.; Brady, M. and Burket, J.F. "Plant DNA patents
in the hands of a few", Nature, p. 399, 405-6, 1999.
8.
Walker, Matt. "Vive la difference — A unique alliance is racing
to map genetic variability", New Scientist, p.1‘2., 17 April, 1999.
9.
"Hot property - It pays to understand the real currency of our
times", Editorial, New Scientist, p.3,17 April, 1999.
10. ISIS News No.3 to 7/8 contain regular summaries of all
biopatents, thanks largely to the efforts of Angela Ryan, (www.isis.org).
26
ABOUT THE AUTHOR
Mae-Wan Ho, a Senior Research Fellow at UK's Open
University, specializes in human biochemical genetics. She
is also co-founder and director of the Institute of Science
in Society, a non-profit organization which promotes criti
cal public understanding of issues in science and tech
nology, especially with regard to social accountability,
ethical implications and sustainability. Since 1994 she has
been scientific advisor to the Third World Network. Dr
Ho is well-known in the debate on genetic engineering,
biotechnology and biosafety, and has raised the issue at
tire UN, the World Bank and in the European Parliament;
in her prolific writings (over 250 works); in her lectures
and contributions to radio, TV, and in the written media
around the world.
BIODIVERSITY, KNOWLEDGE & RIGHTS SERIES
is a series of papers published by the Third World Network,
aimed at deepening public understanding on the inter-re
lationship between biodiversity, knowledge on the conser
vation and sustainable use of biological resources, and the
rights relating to such resources and knowledge.
ISBN: 983-9747-55-X
Position: 756 (6 views)