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.