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.