3.1. The gene - that obscure object of desire

REGINE KOLLEK

What are genes?

Genetic engineering enables us to isolate and analyse the hereditary material from any living thing. Genes can be cut and pasted into the genetic material in the cells of any other organism which then expresses the new characteristics of the artificially transplanted genes. For instance, a gene from a flounder fish conferring resistance to cold has been transplanted into a tomato to make it frost-resistant. Cells, plants or animals modified in this way are termed transgenic.

This new-found ability to manipulate genetic material has great potential for commercial exploitation, since genes play a critical role in providing a blueprint for particular products or characteristics. The ability to patent individual genes is regarded as being vital to the exploitation of their commercial potential. But that is not as easy as it sounds, since the gene seems to be becoming an increasingly elusive and slippery entity to define.

What are genes

Johannsen introduced the concept of the gene as the carrier of hereditary material, in 1909. In the early 1940s, Beadle and Tatum postulated that each gene codes for one characteristic. Not long after, deoxyribonucleic acid (DNA) was identified as the complex molecule that acts as the vehicle for transmitting hereditary characteristics from one generation to the next. Genes were thought to consist of linear and continuous DNA segments coding for particular gene products. Genes were understood in two ways: in structural terms as DNA segments, and in functional terms in relation to the gene product, a protein, that they coded for.

This clear and simple model did not survive for long; over the last forty years the picture has become more complicated. It is now known that in addition to the structural genes identified initially, there are also regulatory genes which do not code for specific products but regulate and modify the action of structural genes. In addition, some genes, known as pseudogenes, are never actively translated into gene products, but are simply passed on passively to posterity. In the 1960s, repetitive sequences were recognized. The function of these short identical DNA sequences which recur frequently within the genome still remains a mystery. And in the 1970s it became apparent that even structural genes are not translated directly into products. Instead the active parts of the gene are separated by inactive chunks (introns) which are excised prior to translation.

Moreover, wandering DNA sequences known as transposons or 'jumping genes' have been found to have the ability to replicate themselves independently of the genome. If a transposon then 'jumps' to a different location in the genome, it can produce a different effect, such as changing the colour of maize.

The icing on the cake was the discovery that matching strands of the double helix making up the DNA molecule can code for different products. For example, one strand of a particular DNA molecule in the rat codes for a hormone produced in the brain, while the other strand codes for a chemical found in the heart. It had previously been believed that the sole function of the second strand of DNA was to ensure that the gene is correctly duplicated during cell division.

Thus the gene is now very hard to define. It cannot be conceived as a separate structural entity, since sequence overlaps can occur both on the same DNA strand and on the opposite one. It is not a continuous sequence and does not necessarily have a constant location in the chromosome. Nor does it have a unique and discrete function, since it may depend on the activity of one or more regulatory genes. Moreover, genes with the same function do not necessarily share the same structure, and genes with an identical structure do not always have the same function.

The gene, therefore, is not an easily identifiable and tangible object. It is more a mental construct which has been shaped by history and a great deal of intellectual effort. It is virtually impossible to develop a clear, empirical definition of a gene. This is why the gene concept is burdened at every turn with the ballast of myriad unresolved problems, which are often lost in the attempt to establish a universal definition, or are swept under the carpet by superficial textbook formulations.

From genotype to phenotype

The genotype refers to the structure of an organism's genetic information. The phenotype is the outward manifestation of the genotype (such as eye colour or tail length).

Scientists generally regard a gene as a known quantity when its DNA sequence has been decoded and the function of the gene product has been described. It is generally assumed that when such a gene is transplanted into a different organism it will perform the same function as in its parent organism or will not be active at all. But there is growing evidence that the relationship is not as simple as that, as the following example illustrates.

Since many life forms share early parts of their evolutionary history, similar or identical DNA sequences are often found among a wide variety of organisms. Many of these perform identical or similar functions in a range of different cells and organisms. However, this is not always the case. For example, the gene for a particular protein, called isomerase, occurs in bacteria, yeasts, insects and mammals. In spite of their broadly similar structural and biochemical properties, the proteins perform completely different functions in the various species. In the fruit fly isomerase is involved in vision, while in mammals it regulates the maturation of immune cells.

This example demonstrates that it is not just a gene's sequence which determines its properties, but that its location in its chromosomal, cellular, physiological and evolutionary context also plays a significant role. Position effects of this kind can influence the concentration of a gene product in the cell, or a gene's activation timeframe. It is know that structurally identical genes located on different chromosomes are capable of being triggered at different stages of embryo growths A particular gene's activity can also be determined by whether it is inherited through the mother or the fathers

According to Barbara McClintock, who first discovered jumping genes in maize, gene functioning is totally dependent on the environment in which they find themselves'. The functioning of a gene is determined not only by the structure, hut by the interplay of a large number of factors which need to maintain a specific relationship with each other. So it is only possible to make precise descriptions of the purpose of a specific DNA segment in a specific organism in relation to a specific constellation of biological and genetic factors.

Different concepts of the gene - different maxims for action

There is a trend in basic research and theoretical debate towards a partial dissolution of the traditional concept of the gene. However, this more fluid approach is not reflected by those concerned with the practical application of experimental findings. Here there are several different schools of thought which place varying emphases on different aspects of the relationship between genes and their environment. These varying perceptions can produce diverging responses to genetic engineering and the patenting of genes or transgenic organisms. The dominant viewpoints are:

(A) Genetic determinism

DNA is seen as carrying all the essential information that an organism needs to live fully. Less radical variants admit that the environment can play a part as well. But the fundamental starting point is that these environmental factors - like genes - can be considered in isolation and can have unambiguous and measurable effects. Because each contributing factor can be isolated and defined, manipulation of genes and organisms is seen as both logical and justifiable. From this standpoint, the organism is seen as a machine, and its physiology as little different from a series of industrial processes. Thus it follows that the patentability of genes and other genetic material is also both rational and acceptable.

One variation of this argument also accepts that hereditary material is the central component and control agency of the organism. However, a different value is attached to this fact than in the previous case. Since genes are the essence of life, it is seen as injurious to the integrity and dignity of the individual concerned to manipulate or patent its life source. While this and the previous view come to antagonistic conclusions about the legitimacy of genetic engineering and patenting, they both exaggerate the role of DNA in life processes, and sanctify it.

(B) The systems view

Genes are seen as an essential, but not the only, determining factor in the control of development processes. According to the developmental biologist H. F. Nihout, 'In a system in which every component and past history have come together at the right time and in the right proportions, it is difficult to assign control to any one variable, even though one may have a disproportionate effect.'

Nihout sees the control of development as being spread diffusely between gene products and structural elements of the surrounding tissues. Genes are passive material sources which a cell can call on when it has a need; they are not the control centre for the cell or organism. Nihout thus proposes a switch from a 'gene-centred' approach to an 'interacting components' model. Proponents of the systems approach see the development and maintenance of physiological functions as controlled by the whole organism, in an interconnected rather than hierarchical way.

From the viewpoint of the systems approach, the deliberate and targeted manipulation of complex traits is extemely difficult, given that it is almost impossible to predict the synergistic effects which could be triggered between different components. Nevertheless, this position does not exclude the possibility that functions could be corrected by trial and error in certain straightforward cases.

Arguments against the use of genes in isolation (which is the basis of their commercial exploitation) or against gene patenting do not arise from this perspective. From the systems perspective, such arguments arise less from ethical posturing than from the pragmatics of such undertakings.

(C) Scientific constructivism

The constructivist view starts from the assumption that scientific activity (the development of hypotheses and theories coupled with experimentation) is fundamentally an act of construction. The intellectual and material products of science are the direct result of the assumptions and/or methods used to produce them. Any role which is assigned to hereditary material is seen as an artificial construct determined not only by the inherent properties of the object of investigation, but also by the premisses and conditions required to undertake such investigation.

This means that the manipulation of genetic material has nothing to do with the 'essence' of an organism, and is consequently not subject to any moral qualification. 'Genes' are seen as creations of the human mind and represent scientific 'inventions' against whose patenting there can be no objection, at least not within the logic of this line of argument.

Positions along these lines are added to the scientific debate by Donna Haraway, amongst others. Her 'Manifesto for Cyborgs' only half-jokingly calls on women, in particular, to contribute to the cultural and material construction of their own bodies and not to leave the process entirely to male scientists.

Implications for the debate on gene patenting

All three attempts to explain the role of the gene are subject to ethical-moral and political pitfalls. Over-emphasizing the role of the gene creates the danger of genetic determinism, and some expressions of the radical rejection of genetic engineering are guilty of this. The systems approach inevitably raises the question of why genes should be treated differently from any other cell components. It suggests that genes should be given no more significance than any other substances isolated from plant or animal cells, and should therefore be freely available for patenting and manipulation. Adopting the constructivist approach makes the debate on whether genes have been 'found' or 'invented' unsustainable, since all phenomena emanating from scientific experimentation are perceived to he ultimately 'manufactured'.

What wisdom can we draw from this debate? Does the fact that the gene is so hard to pin down as a scientific object have any relevance for the patent debate? Is it not much more important to concentrate on the economic and social consequences that will flow from the extension of patent protection to genetic material and living organisms? While the last question is crucial to any political and ethical evaluation of regulatory regimes being drawn up for patents, the problem of defining the gene does raise some urgent and relevant questions. These relate primarily to the definition of the object or process which a patent is intended to protect.

The first step in the manufacture of transgenic cells or organisms is to select and isolate the DNA sequence whose coding information one intends to exploit and patent. The standard practice is not to use the structure as it exists in the organism, but to excise the introns and use only the area that codes for a particular protein. It is also general practice to use the gene of a single individual. However, not every gene is present in an identical form in different individuals. Gene sequences can vary somewhat without changing the characteristics of the derived gene product. These alternative forms of the same gene are known as alleles and occur at varying frequencies in different populations.

The so-called CTFR gene, whose mutation can lead to cystic fibrosis, for example, has more than 400 variants. Only very few are involved in causing the serious form of the illness. Alongside the variants that are found in those obviously suffering from the disease are others which do not have pathogenic effects. These are found in Northern, Central and Western Europe, and in varying frequencies in the USA.

As a rule, only a single variant is used to create a transgenic cell in order to synthesize larger quantities of the gene or gene product; this is registered as a prototype under the patenting procedure. Consequently, patent protection can apply only to this specific variant and not to any 'gene', however it is defined.

Different alleles can vary not only in terms of their structure, but also their effect on the organism. Some CTFR alleles may be able transmit improved resistance to cholera. Does a patent holder also inherit an automatic right to exploit such multiple properties of a gene or its alleles, even though the original patent application made no mention of them? Does the same scenario apply to other - as yet undiscovered - functions of the DNA sequence concerned, which might never come to light unless the sequence is implanted into a new host organism?

If every allele and every synthetic construction differs both structurally and functionally, then each patentable invention can only relate to a particular set of conditions within which a DNA sequence is made exploitable, and not to the DNA sequence itself. With this insight, the current trend towards awarding extremely broad patent protection for genes and their exploitation (see p. 89) is both dubious and absurd.

Until now, the debate within the scientific community over the patentability of genetically engineered products has paid scant attention to certain fundamental problems of definition. An explanation for this fact lies in the highly pragmatic nature of patent law procedures, which do not follow the logic of scientific argumentation but focus on the needs of the market and the commercial interests of inventors. Nevertheless, defining the object of the patent remains a problem which patent law will have great difficulty circumventing in the long term.

A framework of rules to resolve this issue will need to respect the interests not only of commercial users but also of scientists who fear that the patenting of genes will hinder their work. However, disputes over special interests must not take precedence over the principle that, however expressed, the new regime must not injure human dignity and must not denigrate other creatures as merely the servants of humankind's inventions.

References

1. Adelman, J.P., Bond, C.T. et al. (1987). 'Two mammalian genes transcribed from opposite strands of the same DNA locus', in: Science 235, 1514-1517.

2. Fischer, G., Wittman-Liebold et al. (1989). 'Cyclophilin and peptidylprolyl cis-trans isomerase are probably identical proteins', in: Nature 337, 476 478. Shieh, B.H., Stannes, M. et al. (1989) The ninA gene required for visual transduction in drosophila encodes a homologue of cyclosporin A-binding protein', in: Nature 338, 67-70. Takahashi, N., Hayano, T., Suzuki? M. (1989) 'Peptidyl-prolyl cis-trans isomerase is the cyclosporin A-binding protein cyclophilin', in: Nature 337, 473-475.

3. Bonnerot, C., Grimber, G. et al. ( 1990) 'Patterns of expression of position-dependent integrated transgenes in mouse embryos', in: Proceedings of the National Academy of Sciences 87, 6331-6335.

4. Howlett, R. (1994) 'Taking stock in Stockholm', in: Nature 370, 178-179.

5. Quoted in Evelyn Fox Keller (1986). Love, power and learning (Liebe, Macht und Erkenntis), Hanser: Munich, p 179.

6. Nihout, H.F. (1990). 'Metaphors and the role of genes in development', in: BioEssays 12 (9), 441-446.

7. See, for example, Strohman, R. (1994). 'Epigenesis: the missing beat in biotechnology', in Bio/Technology 12, 156-164.

8. Haraway, D. (1985). 'A manifesto for Cyborgs: science, technology and socialist feminism in the 1980s'. In: Socialist Review 15 (2): 65-108.

9. D T., Schlr, et al. (1991). 'Gene mutation analysis in German cystic fibrosis patients' (Mutationsamalyse bei deutschen CF-patienten) in: Medizinische Genetik Vol 3, 24-26.

10. Rodman, D.M., Yamudio, S. (1990). 'The cystic fibrosis heterozygoteadvantage in surviving cholera?' in: Medical Hypotheses 36, 253-258. Gabriel, S.E., Brigman, K.N. et al. (1994) 'Cystic fibrosis heterozygote resistance to cholera toxin in the cystic fibrosis mouse model', in: Science 266, 107-109.

3.2. Patenting life - trends in the US and Europe

CHRISTINE NOIVILLE

It is very unusual for patent law to hit the news headlines. But that is exactly what has happened since intellectual property rights have been extended to the products of biotechnology and the patenting of life became a reality in Europe and the USA. Before discussing the implications of these developments, it is important to outline briefly what biotechnologies are, what patent law is and how these two subjects relate to biodiversity (Box 3.1).

A patent is a legal mechanism for offering a temporary monopoly of rights to any person presenting an invention that satisfies certain conditions. To qualify for protection, the invention must be:

· novel- original and not already known. In most countries (except the USA) the patent is awarded to the first person to apply, whether or not this person was the first to invent.

· non-obvious- not obvious to a person skilled in the technology, and requiring some degree of innovation to distinguish it from mere discovery.

· useful- it must have industrial application. Ideas and theories are not enough to warrant a patent.

The purpose of patents is to encourage technical innovation and progress by rewarding the inventor. A patent can be awarded for products per se, a specific use for a product, processes (rather than the product made by the process) and products made by a specific process.

From these principles, the connections between patents, biotechnology and biological diversity unfold. The building blocks of biological diversity are genes, which also represent the raw materials for biotechnology. When genes or cells are isolated from the natural environment or transformed by biotechnology, they can be considered as inventions and protected by patents.

Patents on life

Legal protection of biotechnological inventions has evolved in a climate of protest. Most of the objections to the patenting of life have questioned the 'utility' criterion required for a patent to be issued and the impact this could have on biological diversity. Many fear that ecosystems will come to be regarded merely as reservoirs of genetic resources protected by patents. Others have concerns about ethics, seeing the patenting of life-forms as appropriating the work of nature, envisioning abuse of the power to transform life as we know it, or simply as a desecration of life.

Other objections are guided by ecological considerations. Patenting life could risk damaging biological diversity, not only because of the exploitation of the elements of this diversity, but also because it results in the creation of totally new organisms. Their release into the environment could provoke serious ecological disruptions, further endangering biodiversity. Finally, patenting leads to privatization of the elements of diversity, which could conflict with their sustainable use.

Patent law is seen by patent specialists as being neutral because it has no direct impact on biological diversity. Applying for a patent for a genetically modified plant does not guarantee exploitation of the plant by, for instance, cultivating it in a field or selling it on the market. It simply guarantees a monopoly of rights. It is up to the legislator to determine whether the exploitation of a plant is dangerous or unacceptable, and to prohibit or limit its use accordingly. Intellectual property rights experts have always considered patent law to be a technical law protecting and stimulating industrial development, and that it is not their responsibility to consider ethical or environmental questions. This is seen as the remit of other branches of law.

This is the context in which most of the patents affecting biological diversity have been issued. So long as the claims have been shown to fulfil the technical requirements for protection, they have been granted. To do this, it has often been necessary to modify the traditional criteria for patentability because they are poorly adapted to deal with living things.

Many of the patents on life granted so far are not inventive in the sense traditionally required by patent law, and could be considered to be discoveries. In both Europe and the US, this obstacle was overcome by considering the gene or micro-organism in question not to be an exact replica of that which exists in nature, but merely a reflection of it. It was deemed that the human intervention to isolate, purify and reveal its function takes the claim beyond mere discovery. It is this particular bias in interpretation that has opened up the patenting arena to living organisms.

The US vs Europe

Initially, legal traditions in the US and Europe challenged the patenting of living organisms, because of concern over the question of discovery or invention. Patents were created for inventions of inert products like sewing machines, and living systems did not easily fit the model. For a long time, the contribution of nature was considered more important than the human intervention leading to the discovery, identification, isolation and transformation of its components.

However, at the end of the 1970s a US judge granted a patent on a genetically modified micro-organism, reversing this position. In doing so, he abolished once and for all the boundary between the inert and the living, regarding the micro-organism more as a factory for chemicals than as a living being. Patenting micro-organisms leads fairly logically to patenting human cells, genes, whole animals and even higher beings. It is now possible to envisage a scenario in which everything that is useful to humanity could become the subject of a patent.

In Europe, the administration charged with issuing patents, the European Patent Office (EPO), lagged a few years behind the US in issuing patents on life. In this it has taken a new tack, quite distinct from the US approach. This move constitutes a fundamental change in the nature of patent law and the manner in which it could impact on the protection of biological diversity.

If adopted, the proposed EC Directive on the Legal Protection of Biotechnological Inventions will require all EC Member States to adopt the principle of patenting living organisms. These would be considered patentable so long as they satisfy the traditional technical criteria for protection. This process is independent of any reflection on their utility or their ecological effects, from which patent law considers itself to be completely dissociated.

In the US, several years after granting patents on micro-organisms, patents were summarily extended to animals. The first claim was for a genetically engineered mouse used as a model for the study of cancer, the oncomouse. The patent was granted by extending the same principle of neutrality that had justified the patent on micro-organisms. The EPO, however, took a different stance. As this was the first claim for a patent on an animal, the EPO's ruling held implications for all future claims. The patent was granted, but protection was subject to certain new conditions. It is not enough for the animal to be novel, innovative and useful. It must also demonstrate some benefit to humanity, which must outweigh the harm inflicted on the animal and the environmental risks entailed.

In the case of the oncomouse, the animal obviously suffered, but the environmental risks were judged to be low because it was destined to live in a laboratory. The mouse's therapeutic potential was seen to outweigh other considerations. The ruling would probably have been different for an animal modified for some other purpose, such as a genetically engineered fish developed for more abstract scientific purposes. In this case, the fish might not suffer, but the benefits to society could be less than the ecological risks of releasing the fish into the environment.

This 'softening' of patent law by the EPO is significant. The new assessment technique, which emphasizes the utility of animals rather than just their physical attributes, seems to have been prompted by pressure from public opinion. Through this ruling, the EPO changed the traditional vision of patent law. Patent law must now judge technical progress more critically, since it reserves the right to veto a technology that presents risks to the environment. This is a major step forward because it forces the two branches of law concerned with biotechnology - patent law and environmental law - to work together. In this way, socio-political considerations can be drawn into a system that is largely economics-driven.

Limits of jurisprudence of the EPO

(A) Limiting the new conditions to claims on animals

Since one of the aims of the restrictions is to consider the risk that biotechnologies present to the environment, the conditions should be extended to plants and micro-organisms, since some of these present far greater risks to the environment than do animals.

(B) Assessing environmental risks

Environmental risk is extremely difficult to assess because of the wide range of potential impacts and possible knock-on effects (see Chapter 2.2). For example, if a salmon is given a rabbit gene, an evolutionary step is effected in the salmon species that cannot be achieved through sexual reproduction. Assessing the environmental risk of this release requires looking beyond the direct effect on the salmon species, to the complex interactions with the ecosystem into which it is released and the organisms with which it cohabits.

There is a further risk which has received little attention to date. If, as we hope, genetic manipulation leads to more rapid and effective gene selection, the existing difficulties in conserving biodiversity are likely to be exacerbated. The problems arising from the replacement of diverse races and varieties with more uniform ones is already painfully familiar, and this question should be addressed fully before taking the patenting of biotechnological innovations any further. However, this kind of risk assessment is too difficult and complex to be conducted by patent offices.

The impact of patents on the circulation and exchange of genetic resources

The most fundamental impact of extending the patent system to living organisms is that it transforms the modalities for exchange and circulation of genetic material In choosing to patent genetic material, we set out on a path of privatization, moving away from the common ownership of genetic resources. This could have huge implications for research in the formal and informal sectors, for global food security and for biodiversity conservation.

Table 3.1. Comparisons of main provisions of PBR under UPOV 1978 and 1991, and patent law

Source: The Crucible Group: People, Plants and Patents, IRDC, Ottawa, 1994.

Once genetic material becomes the property of states, its collection is subject to the signing of trilateral deals between countries or between a country and a corporation. While this is certainly more equitable for the countries of origin of the resources than are the existing arrangements' it by no means guarantees access to those who need it. Conditions of access to both natural materials and protected innovations become strictly controlled.

The patent system does allow some sort of 'research exemption' which enables other innovators to use protected genetic resources for research purposes. However, unlike with Plant Breeders Rights (Table 3 1), the researcher cannot freely commercialize any invention he or she creates For example, in order to commercialize a tomato variety created by crossing a high-yielding patented variety with a local disease-resistant variety, authorization must be gained from the holder of the patent for the high-yielding variety. There is no obligation on the patent holder to consent to this. Thus, access to genetic material is no longer absolutely guaranteed. This situation is already leading to problems and disfunctioning in research strategies.

Conclusion

I have described two opposing movements in the field of patents. On the one hand, in Europe there has been a positive effort to widen the patent brief and incorporate the considerations of environmental risk (including loss of biodiversity) into the appraisal process. On the other hand, the more general movement towards promoting biotechnologies via the patent mechanism tends to pull the process in the opposite direction.

References

1. Dullforce, W. (1990). 'EC Suggests Draft Text of Law on Intellectual Property. Financial Times, March 7.

2. UNDP ( 1994) Conserving Indiginous Knowledge: Integrating Two Systems of innovation. UNDP, New York.

3.3. The changing face of patents

Most of the patents that have been granted on life forms have, at the very least, stretched the criteria required for protection, and in some cases there seem to have been outright violations of the basic criteria for awarding patents:

(a) Patents challenging novelty There are numerous examples of patents that have been issued to companies for products which have been used for centuries by communities in the South. The claim on the neem tree (see Box 3.3) is one clear example. Similarly, a patent granted to Lucky Biotech and the University of California for thaumatin, a natural sweetener from the berries, leaves and stalks of the Katemfe shrub, has caused dismay in West Africa, as this could lead to prohibiting some uses of the plants in the countries where they are endemic and in the communities in which they have been nurtured.

(b) Patents challenging the inventive step. The neem and thaumatin claims are a clear challenge to the inventive step. The coloured cotton claim is another. Plant Breeders' Rights have been granted to a US breeder for strains of traditional Andean coloured cotton, which she modified through conventional plant breeding to lengthen the staple for commercial weaving. Critics maintain that the genius was not in lengthening the staple but in establishing the colour. The breeder has publicly acknowledged that Andean peoples bred the original cotton and the clothes made from it are even marketed as coming from 'the ancient peoples of the Andes'. Yet these 'ancient people', who are very much alive and living in the Andes today, will not be compensated for their contribution.

(c) Patents challenging utility Current excitement over gene sequencing successes and competition for potential markets has led to a spate of patent claims on genes and DNA fragments whose functions (if any) have not yet been identified. By mid-1993 the US National Institutes of Health (NIH) had laid claim to several thousand human genes or DNA fragments related to the human brain. The claim challenged conventional interpretations of both the inventive step and utility concepts. For this reason the US Patents and Trademarks Office twice rejected the claim, but the case has caused great concern. The NIH argued that since these fragments relate to the human brain, they must be useful in some way. By extrapolation, a claimant could contend that anything found in an ecosystem (plant, animal, microbe, gene) must have utility and therefore be a valid subject for protection.

Under pressure from the scientific community, the new NIH administration announced that it would drop its attempt to claim intellectual property rights over the brain. Nevertheless, lawyers who have studied the claim believe that it would be upheld. In April 1994, the US company Incyte revealed that it had taken the NIH lead and applied for a patent on 40 000 human genes and DNA fragments, and declared that it would pursue its claims aggressively.

If claims such as these are accepted in court, the implications for agricultural research will be wide-reaching, as this path could lead to monopoly control of the most important genes used in the breeding of food crops. This 'driftnet patenting' could also impact directly on bioprospecting since companies might he able to gather up large quantities of flora and fauna and lay claims on them simply because no one else has documented the existence of the species.

(d) Driftnet patenting 'Driftnet patenting' is a catch-all, safety-net approach to ensure that no opportunities for commercialization are missed. Driftnet patent claims, like the NIH claim, are becoming more and more common. Making patent claims as broad as possible leaves options open for companies and offers more chances for economic exploitation. There are two reasons for this - firstly that over the course of time new applications may come to light; and secondly that patent conditions may change.

Linda Bullard, who co-ordinates the Greens' position on genetic engineering in the European Parliament, points out that 'the patent system has been quietly trundling along for the last 100 years, gradually removing exclusion after exclusion without people taking too much notice. Now it has reached the very last exclusion: that of patents on life itself, which would make the system complete, applicable to everything under the sun.'

(e) Patenting human life At present, human cells and genes removed from the body are patentable, but those attached to a living person are not. As Linda Bullard states, this is the last exclusion to remain limiting the scope of patent power. Proponents of patents argue that the existing legislation allowing the patenting of human cell lines and human genes is a totally separate issue from patenting human beings themselves, and that there is no question of this latter exclusion being removed. Opponents suggest that the dividing line between the two categories is woolly at best, and that patenting a cell line is the same as patenting an individual, because each cell contains the whole human genome. Even if there were no question of the exclusion being removed, for many people (particularly those with strong spiritual and religious beliefs or a different value system to the Western capitalist model), patenting of human genes in any form is unethical.

The issue of patenting life has become a major issue in the European Parliament. After a tortuous eight-year passage through the Parliament, the Directive on the Legal Protection of Biotechnological Inventions was voted down on 1 March 1995. The 'exclusion debate' was one of the thorniest issues to deal with, and this was probably the point that finally killed the directive. Had it been approved, the directive would have resulted in the harmonization of legislation on patenting of biotechnological inventions (including life forms) across the European Union. The directive has no direct influence on the European Patent Office, which can carry on giving patents on microorganisms, plants, animals and human parts, just as before. But the decision may well affect the decisions made, since it reflects a shift in the climate of public opinion (see p. 185).

(f) Patents on species In 1992 a patent was issued in the US for genetically engineered cotton. It was awarded to Agracetus, a wholly-owned subsidiary of one of the world's largest chemical companies, W.R. Grace. The sweeping claim, unless successfully challenged, gives the patent holder a monopoly over all forms of genetically engineered cotton, regardless of germplasm or technique. Agracetus could use the claim to prevent any other country from exporting genetically manipulated cotton (and maybe even finished cotton and clothing) to the US. The patent is also pending approval in Central America, China, Europe and other places.

In January 1994, a law firm in the US - representing an anonymous client - filed a request that the patent be re-examined. In June, the US Department of Agriculture, which itself conducts research on cotton, filed a similar request. Both argued that the critical inventive steps to transform cotton had already been published by other researchers before Agracetus made its patent application. In December 1994, the US Patent and Trademark Office notified Agracetus that it intended to revoke both patents that the company had been awarded - a very rare step according to patent experts. Agracetus was required to respond directly to the patent office, and if it was not convinced by the rebuttal, the company has recourse to appeal. Although such appeals rarely succeed, the outcome is not known at the time of writing.

The granting of this patent could profoundly influence the future of a $20 billion crop critical to the economies of many countries in the South. Some 69 developing countries produce cotton, and 250 million people are dependent on incomes from cotton production or processing. One major producer, India, took the unusual step in early 1994 of rescinding the Indian patent claim because it was seen to act against the interests of its people.

In March 1994 Agracetus received a similar species patent from the European Patent Office, this time on genetically engineered soybeans. This patent has been challenged by Rural Advancement Fund International, with the support of other NGOs around the world, on the grounds that it is neither novel or non-obvious, and because it represents a threat to world food security: monopolization of soybean technology will increase the price of seeds and hamper research into this important food crop, which is valued at $27 000 million annually, according to RAFI.

References

1. UNDP (1994). Conserving Indigenous Knowledge: Integrating Two Systems of Innovation. UNDP, New York.

2. (1993) Ag Biotech News, February, 4.

3. Fox, J. (1994). NIH Nixes Human DNA Patents: What Next? Bio/ Technology, 12 (April), p348.

4. Mestel, R. (1994). Cotton Patent Left Hanging by Thread. New Scientist, December 17, p.4.