Why We Should Reject Biotech Patents from TRIPS
Scientific Briefing on TRIPS Article 27.3(b)
Dr. Mae-Wan Ho and Dr. Terje Traavik
Institute of Science in Society, UK and Institute of Gene Ecology, Norway
1. Introduction
This Report examines the TRIPS
Article 27.3(b), currently under review at the WTO, and its counterparts
in the EU Patents Directive. We show that the Articles 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
on one or more of the following grounds:
- - All involve biological
processes not under the direct control of the scientist. They cannot be
regarded as inventions, but expropriations from life.
- - The hit or miss
technologies associated with many of the ‘inventions’ are
inherently hazardous to health and biodiversity.
- - There is no scientific
basis to support the patenting of genes and genomes, which are
discoveries at best.
- - A range of patents are
unethical; they destroy livelihoods, contravene basic human rights and
dignity, compromise healthcare, impede medical and scientific research,
create excessive 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.
We shall begin with a ‘glossary’
in order to help negotiators understand the dubious ‘logic’
behind the Articles.
2. ‘Glossary’ of
terms
A micro-organism is an
organism that can be seen only under a microscope, usually, an ordinary
light microscope. They are usually of the order of microns (millionths of
a metre) or tens of microns in linear dimensions, and include bacteria,
mycoplasm, yeasts, single-celled algae and protozoa. Multicellular
organisms are normally not included, nor fungi apart from yeasts. Viruses
are also not automatically included; many scientists do not classify them
as organisms as they depend on cells to multiply.
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 which constantly make cells genetically different
from one another.
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.
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 estimated to contain 100 000
genes.
A DNA sequence refers to
the sequence of bases in a stretch of DNA. DNA is a linear molecule
consisting of units strung together. There are 4 different units, each
identified by the specific base contained. There are 4 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 all processes in biotechnology, by definition, are biological.
A weak case may be made on the ground that it is one that does not occur
naturally, or which is not normally carried out by organisms.
A "micro-biological
process" is presumably one that is carried out by
micro-organisms.
3. Patents on life-forms and
living processes
There are four categories of
patents on life-forms and living processes covered by TRIPS:
1. Processes producing extracts
of plants for medical or industrial/agricultural purposes,
2. Naturally occurring
microorganisms, cell lines, genomes and genes isolated from natural
organisms
3. Transgenic techniques and
constructs, and the resultant transgenic organisms,
4. Nuclear transplant cloning
and other in vitro reproductive technologies.
All these patents, in our
opinion, ought to be revoked and banned for one or more of the following
reasons:
- - depends on biological
processes, therefore little or no invention
- - claimed ‘technology’
unreliable, uncontrollable and unpredictable
- - ‘technology’ and
products inherently hazardous
- - qualifies as a discovery,
not invention
- - involves act of plagiarism
and biopiracy
- - threatens livelihoods
- - violates basic human rights
- - is contrary to public order
or morality
- - is contrary to public
interests
- - lacks scientific basis
We deal with the four classes of
patents below.
3.1 Patents on processes for
which fraudulent claims are made for novelty and invention. These include
the entire class of patents on extracts of plants which have been
developed and used for millennia by indigenous communities for the
purposes claimed in the patents. In many cases, the plants or seeds have
also been stolen from the same indigenous communities. Examples are
patents on extracts of the neem plant taken from India, and extracts of
the bibiru and cunani from the Wapixana Indians in North Brazil. Some of
the plants may come from ex situ seed banks held in botanic gardens in
developed countries.
3.2 Patents on discoveries, such
microorganisms, cell lines, genomes and genes which are derived from
naturally occurring organisms. These are by far the biggest category of
patents and include the following,
a. Microorganisms. These patents
would have included all microorganisms isolated from Yellowstone Park in
the US, for example, subject to an agreement that the US Government made
with a biotech company which was subsequently successfully challenged by
the Edmonds Institute and The Center for Technology Assessment in the US
on behalf of civil society.
b. Cell lines belonging to
indigenous peoples collected under the Human Genome Diversity Project,
without proper informed consent, and in violation of basic human rights. A
US company, Coriell Cell Repositories, lists Amazonian Indian blood cells
in a DNA kit priced at $500, which is openly advertised on the internet.
Another is the Biocyte patent granted on human umbilical cord cells which
have been used freely for transplant purposes previously. The EU Patent
Office revoked this patent on 8 June, 1999, after a successful challenge
by The European Campaign on Biotechnology Patents, a coalition of European
ngos.
c. Patents on human genomes and
sequences, all of which violate basic human rights and dignity
- An effective monopoly on genomes of Icelandic population by DeCode Genetics, Iceland
- About 150 US patents have been granted on human genes associated with genetic
diseases, cancer genes, etc., and 2500 similar patents are pending
- Expressed sequence tags (ESTs)(partical sequences of unknown function), 44 US patents have
been granted and 1 200 000 are pending, all to Incyte, a US company based
in California
- Single nucleotide polymorphisms (SNPs) (single base variants of genes) are ruled patentable
by US Patent Office, supporting dubious ‘personalised medicine’
but may be relevant to genetic ethno-terrorism. A public/private
partnership involving The Wellcome Trust and 10 companies are mapping SNPs
in order to put the data immediately in the public domain, so they cannot
be patented.
Many commentators have pointed
out that patents on human gene sequences will compromise medical
treatments and medical research. In a highly significant move in September
1999, British Prime Minister Tony Blair initiated an Anglo-American
agreement with President Bill Clinton to protect the 100,000 genes of the
human genome. The agreement aims to prevent entrepreneurs profiting
from gene patents and to ensure that the benefits of research are freely
available world wide to combat or even eliminate diseases. It will
ensure that the world’s largest medical charity, the British-based
charity, Wellcome Trust, and the US government’s National Institute
of Health, will publicise gene-sequences within 24 hours of their
discovery so that the benefits accrue entirely to the public. It is
thought that research institutions, universities or laboratories would be
obliged to waive their rights to patent their work in the public interest.
But private corporations are opposing this initiative.
d. Patents on genomes and genes
of plants which will have adverse impacts on technology transfer and food
security as they intensify corporate monopoly on food. These include
- whole plant genomes as they
become available
- more than 600 patents on genes from 78 plant species of economic or scientific interest already
granted, include DNA sequences from plants taken from developing countries:
nutmeg, cinnamon, rubber, jojobe and cocao.
According to a spokesperson from
the biotech industry, patents held on genes of plants also entitle patent
holders to own the plants themselves, although this is not claimed in
practice. These patents are further instances of biopiracy, contravening
CBD's stipulation of equitable benefit-sharing. Even when benefit sharing
is negotiated, the developing countries tend to receive a minute fraction
of the benefit they justly deserve.
e. Patents on genomes of
pathogenic bacteria and viruses, which are obstructing the prompt
diagnosis and treatment of dangerous diseases such as meningitis and
tuberculosis. Delays in diagnosis and treatment will result in unnecessary
deaths.
3.3 Patents on transgenic
techniques and constructs, and transgenic plants, animals and
microorganisms resulting from the techniques, which are being construed as
inventions and patentable in US, and recently also in the EU. 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 and constructs. Hundreds of millions of dollars are
spent, unproductively, on litigations.
More seriously, the patents on
transgenic seeds are preventing farmers from saving seeds for replanting
unless they pay royalities to the companies. Seed monopoly will intensity
and threaten livelihood of family farmers all over the world. Patents on
transgenic animals are sanctioning techniques and practices that are
contrary to animal welfare.
An important class of patents
are the ‘Traitor Tech’ or ‘Genetic Use Restriction
Technologies’ (GURT) based on the original ‘terminator
technologies’ that engineer harvested seeds not to germinate, thus
offering de facto patent protection of transgenic seeds. A newer
version makes seeds dependent on the application of a chemical for
germination, or for expressing the desired transgenic trait. These patents
serve no other purpose than to intensity corporate monopoly on seeds and
on food production. Monsanto has recently announced that they will not
commercially exploit the terminator technology, but it is not clear
whether they will continue research and development.
Transgenesis is not a precise
technology. We argue that it is not a technology at all. It is extremely
hit or miss, and generates a whole range of unexpected effects in plants,
including toxins and allergens. The GURT technologies are even worse. They
depend on ‘site-specific’ splicing of genes that is supposed to
be precise, but far from the case in practice. These process-patents apply
also to animals.
Large failure rates are typical
in making transgenic animals and abnormalities are frequent even among the
successes. It cannot be said to be an invention in the usual sense of the
word. Transgenic animals are being created to supply pharmaceuticals or
industrial chemicals in their milk or to supply spare organs for
transplant into human beings. These involve unacceptable exploitation of
animals which cause excessive suffering. We should encourage alternative
approaches which are more ethically acceptable.
Most importantly, there is a
running debate on the inherent dangers of the process of creating
transgenic organisms, which is why UK and many countries in Europe are
banning transgenic crops or imposing a moratorium.
Transgenic DNA has the potential
to generate new viruses and bacteria that cause diseases, and may also
cause cancer by integrating into mammalian cells. The British Medical
Association has issued a report 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 transgenic DNA from
terminator or GURT technologies involve even greater risks, as they
contain dangerous genes that prevent germination, which can nonetheless
escape into other species. Furthermore, the technologies depend on
gene-splicings that have to be engineered and regulated very precisely,
but those requirements are beyond the capability of the genetic engineer.
The hazards of the transgenic DNA resulting from GURT technologies are
much greater, because the imprecisions of inserting multiple
gene-constructs are multiplied, and because of the gene-splicing sequences
and genes deliberately introduced. Gene-splicing has the potential to
create new combinations of genes and to scramble genes and genomes when it
is imprecise.
3.4 Patents on
nuclear-transplant cloning and other in vitro reproductive
techniques, and organisms resulting from those techniques. An example is
the nuclear transplant technique that produced Dolly. This patent actually
covers all species, including human beings. A human clone has already been
created in June, 1999, by transferring the human genetic material into a
cow’s egg. It was destroyed on day 14, which is the current legal
limit in the USA. Such interspecific nuclear transfer clonings are known
to result in gross abnormalities. We deplore the deliberate cloning of
human embryos for experimentation or for producing spare tissues and
organs. There are already more ethically acceptable alternatives, such as
regenerating tissues and organs from cells of the patients themselves.
The cloning process, again, is
hardly a technology, as it also generates a large number of failures and
abnormalities even among the ‘successes’. A recent article ("Clone
Defects Point to Need for 2 Genetic Parents" Rick Weiss, Washington
Post, May 10, 1999) reports large numbers 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 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 invention when it is so hit
or miss and unreliable? It is both scientifically flawed and ethically
unacceptable to create so much suffering.
4. Articles related to
patents in TRIPS and EU Directives
4.1 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 plants 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.
As all biotech processes
are biological, they should be excluded from patenting, and this applies
also to microbiological processes. There is no sound reason to regard
microbiological as anything but biological. Also, microorganisms are
organisms, so there is no reason to treat them as patentable when plants
and animals are excluded.
4.2 Articles 4 and 5 of the EU
Directive state,
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 technical feasibility 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.
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 particular plant or animal"
must be demonstrated, as without performing the actual experiment, it
cannot be assumed that what works for one species works for another. In
fact, this is very often not the case. Besides, as argued in Section 3,
neither transgenesis nor cloning qualifies as an invention, as both fail
to work less than 99 times out of 100. The description, "a
microbiological or other technical process" is questionable, as a
microbiological process is not a technical process, and neither the
process nor the product resulting from it should be patentable.
4.3 Both the TRIPS and EU
Directive articles are designed to allow for the patentability of all
categories of life-forms and living processes listed in Section 3. 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, cloning human beings, and modifications of animals
causing substantial suffering without substantial medical benefit.
4.4 The EU Directive article
4.1b appears to strongly exclude plant and animal varieties, but 4.3 makes
clear that transgenic plants and animals are patentable, as they are
produced by "microbiological or other technical process". But
the transformation and transfection used in making transgenic plants and
animals are biological processes, and so transgenic plants and
animals should not be patentable. It is important to recognise that the
patentability often 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 it is covered by another patent, such as cloning.
4.5 Similarly, the EU Directive
Article 5.1 appears to exclude the human body, cells and genes from
patenting. But this is nullified by 5.2, where the copying process or the
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 is
highly questionable, 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.
4.6 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 excludes human
beings). In the case of the technique 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 species may not work
in another.
5. Critique on the
patentability of genes or nucleic acid (DNA or RNA) sequence
5.1 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, ie, 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.
5.2 However, the DNA or RNA
sequence is subject to change by mutation, deletion, insertion and
rearrangement. Does it mean that, for example, if the sequence patented
is, ATCCAGGAACCTA, then variously mutated sequences such as AACCAGGAACCTA
(single base substitution), ATAGGAACCTA (deletion of two bases), ATCCATCGGAACCTA
(insertion of two bases), AGACCTGAACCTA (inversion of 5 bases) are
no longer covered? 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 question as to which genome is being patented.
If the patent is on one DNA base sequence, does it cover genomes differing
in DNA base sequence?
For a DNA sequence of 1000
bases, the possible number of variants is 41000.
5.3 The "industrial
application" stated in the EU Directive Article 5.1 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 (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 example,
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.
6. Conclusion
All patents on life-forms and
living processes detailed in this paper 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 expropriations from
life.
- The hit
or miss technologies associated with many of the ‘inventions’
are inherently hazardous to health and biodiversity.
- There
is no scientific basis to support the patenting of genes and genomes,
which are discoveries at best.
- A range
of patents are unethical; they destroy livelihoods, contravene basic human
rights and dignity, compromise healthcare, impede medical and scientific
research, create excessive 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.
7. References and Reports
consulted
1. Genetic Engineering Dream
or Nightmare? The Brave New World of Bad Science and Big Business,
Mae-Wan Ho, Gateway Books, UK, and Third World Network, Penang, 1998, 2nd
ed. 1999.
2. The Gene Giants, Masters of
the Universe? RAFI Communique, March/April, 1999.
3. Traitor Tech. The
Terminator's Wider Implications. RAFI Communique,
Janurary/February, 1999.
4. Genetic engineering and
patenting. A Disaster in the making for the developing world. Actionaid,
February, 1999.
5. Selling suicide, farming,
false proises 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. Plant DNA patents in the
hands of a few. Thomas, S.M., Brady, M. and Burket, J.F., Nature,
399, 405-6, 1999.
8. Vive la difference. A unique
alliance is racing to map genetic variability. Matt Walker, New
Scientist, 17 April, p.12, 1999.
9. Hot property. It pays to
understand the real currency of our times. Editorial, New Scientist,
17 April, p. 3, 1999.
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