|Biotechnology and the Future of World Agriculture (GRAIN, 1991)|
|Controlling the profit|
Imitation is precisely one of the main problems for the emerging biotechnology industries. The raw material of biotechnology - genetic resources - tends to imitate itself continuously, and without human intervention. During the heated discussions on intellectual property protection towards the end of the last century, the question of how to apply such protection to living matter was hardly considered. The reproductive forces of life were considered too unpredictable even to start trying to make money on them. But that began to change as the big-sciences developed to a stage where, through systematic research, life forms could be changed and brought to the market place. After the work of Gregor Mendel and the rediscovery of his laws of inheritance at the beginning of this century, systematic plant-breeding started to take off. With plant-breeding maturing into an industrial activity, pressure to protect the ownership of the resulting products grew. But 'life' never fitted comfortably into the rigid industrial patent schemes. Seeds change, mutate and reproduce - all too difficult for patent systems, which were designed for inanimate products of manufacture.
The political problems are, however, even greater than the technical ones. As late as the 1960s, when preparing the European Patent Convention, the Europeans were still involved in a heated debate on whether food, chemicals, plants and animals should be included in the patent regime. The debate was not so much on technicalities, but much more on the question as to whether society should grant monopoly rights in these fundamental sectors. They decided that plants and animals should stay outside the industrial patent system and adopted a special protection regime for plants: the Plant Breeders' Rights system (PBR). In 1961 the Union for the Protection of New Varieties of Plants (UPOV) was formed, and the UPOV Convention was signed by a number of - mainly European - industrialized states.
In the 1970s the USA and several other industrialized countries joined the UPOV Convention, but the growth of UPOV came to a halt by the end of the 1970s when several industrial states did not ratify the Convention and efforts to persuade the developing countries to join the club backfired. A major reason for this setback was increased recognition of the negative impact of PBR for plant breeding. Evidence began to appear that because of PBR, multinational companies started to take control of the breeding sector. It was also argued that the PBR system, because of its requirements of uniformity, promotes a further impoverishment of genetic diversity and that it hardly contributes to the development of new qualitatively distinct varieties. Developing countries recognized that PBR would not favour the build-up of strong national agricultural systems, but on the contrary would jeopardize efforts to establish an independent national breeding sector. (26) The UPOV Convention has attracted only 19 member states up to now, and with the industrial patent system moving in its future looks bleak.
A major difference between the Plant Breeders' Rights and industrial patent systems lies in the scope of protection granted. PBR gives the breeder, for a certain period of time, exclusive monopoly control on the reproduction of a plant variety for commercial purposes, its marketing and sale. Under the current UPOV Convention, the protected plant variety can be freely used by others for further breeding and by farmers for repeated planting. PBR does not provide ownership over the germplasm in the seed, it gives only a monopoly right for the selling and marketing of a specific variety.
The monopoly rights of industrial patents go much further. With the PBR system, the protection is always limited to a specific plant variety. A patent, however, can be claimed on virtually anything: from a specific DNA sequence to a whole set of plants and animals, and everything in between. The only conditions are that what you claim must be new, it must involve an 'inventive' (non-obvious) step, and it must be useful for something. It is up to the patent office to decide whether these rules of the patent game have been met.
The extension of the industrial patent system to living matter carried an incredible number of problems. Some of these lie in the characteristics of the patent system itself. One of the requirements for a valid patent is that the item to be protected must be a new invention, not a discovery, and it must be non-obvious. But where is the borderline in biology? 'Who will have the guts to declare a gene novel and non-obvious? Would anyone know enough of genetics and nature to claim such arrogance?' cried a desperate plant-breeder at a recent conference on life patents." His frustration is quite understandable. Plant-breeders have, through cross-breeding, moved genetic material around for many years. Farmers have done it for thousands of years. Nature has done it from the very beginning! Now biotechnologists are claiming intellectual property on isolated and cloned genes, cells and entire living beings. Who, then, decides what is new, what is nonobvious?
Another problem is linked to the 'exhaustion principle' of current patent laws. It holds that the monopoly ends once the product is brought to the market. No patent law prevents me from buying a television set and then using it as a fish tank; or from selling it to someone else. But the exhaustion principle makes life difficult for those who want to patent engineered living matter, as this tends to reproduce itself, making unlimited free copies of the patented material. They do not want to see their patent exhausted at the moment the farmer puts seed in the soil.
The patent system, then, would have to be reconstructed to cope with life forms. In practice, however, patent lawyers are doing just the opposite: redefining biology to fit patent law. This is when the most eloquent arguments start. Several centuries ago, Linneaus came up with classifications to create some order in the human mind with respect to the natural 'chaos' out there. Patent examiners today need different classifications to decide on what is patentable. The results are often outrageous as a recent EEC biotechnology patent proposal shows. This text defines a cell as a microorganism,28 which prompted members of the European Parliament to joke about elephants consisting of an immense heap of microbes. For the European patent lawyers the logic is simple: micro-organisms are patentable, and if individual cells are included in the same group, they become patentable as well. On the other hand, the European Patent Office points out that the new definition of a plant variety proposed by UPOV, (29) would include items such as individual cells, protoplasts, DNA itself and even 'all greenplants'. (30) According to the European Commission, a cell is a microorganism; according to UPOV, a cell is a plant variety. Are we to conclude then that a plant variety is a micro-organism?!
Debate in the international community on the patenting of plants, animals, genes and processes has only just begun. The push for strong patents comes, of course, from the major corporations that are now investing heavily in biotechnology. The problem for the proponents is that existing legal conventions would have to be changed to make all their wishes come true. This is especially the case in Europe. The European Patent Convention (EPC), signed by 13 European countries and adopted as late as 1973, specifically excludes 'plant or animal varieties or essentially biological processes for the production of plants and animals' from patentability. (31) As was made abundantly clear in the documents of the Council of Europe when member states were laying the groundwork for this Convention in the 1960s, these exclusions were meant to apply to animals and plants in general, and were incorporated because 'they derive largely from considerations of public interest'. (32) For the same reasons, pharmaceuticals and food products were put forward for exclusion but these exceptions were scrapped during the negotiations despite strong opposition, especially from Austria. (33)
Policy makers are known to be short of historical memory. For the officials at the European Commission, 'the public interest' must be something that mutates rapidly and depends largely on the interests of the industry. In 1988, only 15 years after the adoption of the EPC, the European Commission published a draft law proposal ('directive') on the patenting of biotechnological inventions. (34) At this time of writing, the directive is under heated negotiation at different levels. If adopted, it would make everything from a gene to entire classes of living beings patentable in the European Community. To avoid open clashes with the European Patent and the UPOV Conventions, the directive excludes plant and animal varieties and essentially biological processes from patentability, but redefines those terms in such a way that virtually the entire plant and animal kingdoms are up for intellectual property protection. In the EEC proposal, everything is patentable, as long as you do not call it a 'variety'. Even human beings are not specifically excluded. Rather than going through the long and tedious process of renegotiating international conventions such as the EPC, the Commission is proposing simply to redefine their basic assumptions. The European Patent Office itself is not very happy with such manoeuvres. It has publicly stated to the European Commission that if the aim is to make plants and animals patentable, then 'tine right approach would be to revise the EPC itself'. (35)
The legal situation in the United States is more open to plant and animal patenting due to the historical particularity of this country. After two important legal decisions, one by the US Supreme Court in the Chakrabarty case (1980) and one by the US Board of Patent Appeals in the Hibberd
case ( 1985), industrial patent protection can now be granted to plants. It is expected that a major shift will now take place in the US from PBR to industrial patents. (36) Once seeds were eligible for industrial patents in the US, it was not long before the first animal patent was granted. On 12 April 1988, this dubious honour fell to a little mouse into which a human cancer gene was grafted. The applicant was Harvard University, but the monopoly went to Du Pont, the multinational company who paid for the research.