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Why We Should Reject Biotech Patents from TRIPS
Scientific Briefing on TRIPS Article 27.3(b)

by Dr Mae-Wan Ho and Dr Terje Traavik


1. Introduction

The TRIPS Article 27.3(b) under review, and its counterparts in the EU Directive are couched in undefined terms, designed to allow the broadest categories of patents from genetic engineering and other new biotechnologies. The proponents themselves must be asked to define and defend the scientific basis of those terms, which are matters of dispute among scientists. We have supplied a ‘glossary’ in order to help negotiators understand some of 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. It includes 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, as many scientists do not classify them as organisms.

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 10 000 to 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 under dispute

There are five kinds of patents involved in the TRIPS negotiations, all of which, in our opinion, ought to be banned for one or more of the following reasons:

 technology unreliable and hazardous
 all depend on biological processes, therefore little or no invention
 discovery, not invention
 involve acts of plagiarism and biopiracy
 unethical in threatening livelihood
 violation of basic human rights
 contrary to ordre public or morality
 lack of scientific basis

More than 80 scientists from all over the world have called for a global moratorium on transgenic agriculture, a ban on biotech patents, and an independent public enquiry on the future of agriculture and food security for all.

We deal with the five classes of patents below.

3.1 Patents on a process which can be considered to be an invention. The way this is abused is in the entire class of patents on extracts of plants which have been developed and used for millenia by 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. This class of patents can be excluded by appropriate protection of indigenous knowledge, restriction on exports of plants (and animals) and agreements on ex situ collections.

3.2 Patents on discoveries, such as cell lines, genomes and genes which are derived from natural organisms. These include,

a. Cell lines belonging to indigenous peoples collected under the Human Genome Diversity Project, and without proper informed consent, 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 have revoked this patent on 8 June, 1999, after a successful challenge by The European Campaign on Biotechnology Patents, a coalition of European ngos.

b. Patents on human genomes and sequences, all of which violate basic human rights and dignity - Monopoly on genomes of Icelandic population by DeCode Genetics, Iceland
- About 150 US patents granted on human genes associated with genetic disease, cancer genes, etc., 2500 similar patents are pending
- Espressed sequence tags (ESTs)(partical sequences of unknown function), 44 US patents granted, 1 200 000 pending, all to Incyte, a US company based in California
- Single nucleotide polymorphisms (SNPs) (single base variants of genes), US Patent Office ruled these are patentable, supporting dubious ‘personalized 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.

c. 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, includes DNA sequences from plants taken from developing countries: nutmeg, cinnamon, rubber, jojobe and cocoa, which amount to biopiracy, contravening CBD's stipulation of equitable benefit-sharing.

d. Patents on genomes of pathogenic bacteria and viruses, which are obstructing the prompt diagnosis and treatment of dangerous diseases such as meningitis and tuberculosis. These are unethical, as delay in diagnosis and treatment will cause unnecessary deaths.

3.3 Patents on transgenic plants, animals and microorganisms, which are being construed as inventions and patentable in US. In the EU, patents are being granted for the process, and therefore, only given if the process can be used in general in other organisms. 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 litigations.

More seriously, the patents on seeds are preventing farmers from saving seeds for replanting unless they pay royalities to the companies. Seed monopoly will intensity and threaten livelihood of small farmers all over the world. Patents on transgenic animals are encouraging transgenic and cloning practices that are contrary to animal welfare.

An important class of patents are the ‘Traitor Tech’ 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. A newer version makes seeds 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 intensity corporate monopoly on seeds and on food production.

Transgenesis is not a precise technology. It is extremely hit or miss, and generates a lot 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. 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. Most importantly, there is a raging current 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 BMA 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 terminator or GURT technologies involve even greater risks, as they make use of dangerous genes that prevent germination, which can escape. Furthermore, they 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 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 all microorganisms isolated or identified. These patents would have included any microorganism isolated from Yellowstone Park in the US, for example, subject to an agreement which was subsequently successfully challenged by the Edmonds Institute and The Center for Technology Assessment on behalf of civil society.

3.5 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.

The cloning process 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 technology? 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.

NB The non-exclusion of “non-biological and microbiological processes” needs to be challenged as all biotech processes are biological and there is no sound reason to regard microbiological as anything but biological.

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 conern 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 partical 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.

NB “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” should be challenged, 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 it 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 pententable.

4.3 Both the TRIPS and EU Directive articles are designed to allow for the patentability of all categories of patents 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 modifiaitons 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 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.

4.5 Similarly, the EU Directive Article 5.1 appears to exclude the human body, cells and genes from patentability. But this is nullified by 5.2, where the copying process or the amplification process that enables the copy of the gene, or the partical 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.

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 technology of using bt-toxin to protect plants, that is also extended to all plant varieties. This point 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 examle, 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 realize, 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 cirucumstances, 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.

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 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.
" Many patents are unethical; they destroy livelihoods, contravene 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 millenia.

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, Chapter 8.
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.

Dr. Mae-Wan Ho and Dr. Terje Traavik Institute of Science in Society, UK and Institute of Gene Ecology, Norway

Contact: Dr Mae-Wan Ho Biology Department, Open University Walton Hall, Milton Keynes, MK7 6AA tel:44-01908 653113 fax:44-1908-654167 e-mail: m.w.ho@open.ac.uk

 


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