Brevetabilité du vivant : du biobrevet au bio-big-bang

Inventions, like processes or products, have long been protected in many ways: secrecy, monopoly, trademarks, international conventions, regulations by public authorities. Nowadays, intellectual property rights (IPR) are regulated under the "Trips" system (Trade-Related Intellectual Property Rights) within the World Trade Organisation (WTO). WTO members have to protect innovative products or processes either by awarding a utility patent or through sui generis systems. For decades, plant breeders have developed "plant variety protection certificates" which are awarded under an international UPOV convention implemented in 1968, revised in 1990. Since the 1980 decision of the US Supreme Court, living organisms or part thereof (including genes) became patentable subject matter. Thereafter, large numbers of patents have been delivered to life forms, some of which resulting in conflicting situations in terms of novelty, applicability, or infringment of biopatents. To illustrate some of the situations involved, four specific cases are analysed in this article, in order to evaluate the limits of biopatentability: i) Sequencing the human genome. The improvement of DNA sequencing techniques paved the way for characterizing the entire human genome. In the early stages of the project, results were published. In 1988, however, patents were requested for "Est", i.e. expressed sequence tags whose location or function were unknown. After a period of refusal, such patents were granted in the USA and later on in Europe, notwithstanding the opposition of a fraction of scientists who disputed their status of "novelty", considering it was like unduely patenting knowledge. After a period of unrest, President Clinton and Prime Minister Blair called for the publication of the whole genome sequence to the benefit of mankind. This was done, thus precluding further patentability of the human genome; ii) The saga of Monsanto suing the farmer Schmeiser. Percy Schmeiser successfully cropped canola in Saskatchewan (Western Canada) during half a century. Tests conducted in the 1998 crop revealed a high resistance to the glyphosate-based weed killer Roundup, due to the prevalence of genes patented by Monsanto and Monsanto Canada Inc. As Schmeiser never purchased Roundup-resistant canola seeds, nor obtained a licence to use them, Monsanto brought an action for patent infringement. Schmeiser denied any intentional introduction of patented genes on his land, and accused Monsanto of inadequate confinement of its patented material. The trial judge found the patent to be valid and allowed the action, granting $CAN 19,832 compensation to Monsanto, together with $CAN 153,000 of judiciary costs. The Federal Court of Appeal affirmed the decision and Schmeiser brought the appeal to the Supreme Court. The Court split five to four on the matter. The five majority Justices confirmed that the farmer was guilty of infringement for "using" patented canola without due authorization. Compensations were denied to Monsanto, however, because the company had elected accounting of profits as remedy. Considering that the appellant earned no profit from the invention, the Court ruled that the respondents were entitled to nothing on their claim of account. In view of this mixed result, it resolved that each party bear its own costs throughout. The four minority Justices expressed views opposed to the majority ruling. They considered that plants, or their offspring, were unpatentable by law, so that a person skilled in the art could not be expected to realize that patent protection of genes extends to standing crops. They therefore estimated that the lower Courts erred in considering gene patent infringement as applicable to plants and harvested grains. Furthermore, the complexity and nuances of "innocent bystander" protection, in the context of agricultural biotechnology, should be expressly considered by Parliament, because it can only be inadequately accommodated by the law in use; iii) Revocation of the US patent granted to the yellow bean variety Enola. In 1999, the US Patent and Trademark Office (USPTO) patented a variety of common bean with yellow-coated seeds, under the name Enola. Originally, Enola parents had been bought on a market place in Mexico. After selection in Colorado State, Enola was patented. As yellow-seed beans are much appreciated by latinos, both in Mexico and in the United States, patenting Enola was challenged by Mexican bean growers, who argued the lack of novelty compared to yellow bean varieties previously cropped in their country. After a legal battle and further scientific evidence based on DNA comparison, it appeared that Enola could not be distinguished from hybrid yellow beans which preexisted in Mexico. In 2005, Enola patent was revocated for imprecision of the original request for patenting, and undue heterogeneity of parent and progeny seeds; iv) Revocation of the European patent granted to a process for the preparation of a fungicide from neem extracts. In 1994, the European Patent Office (EPO) patented a fungicide fraction extracted from neem, a tree originating from the Indian peninsula. Neem seed extracts had been used for many centuries in India, mainly as medicine, cosmetics, and control agents against fungi or insects. The patent, which had been granted jointly to Grace C° (New York) and to the US Department of Agriculture (USDA), was challenged by a consortium of three ladies: a Belgian representative to the European parliament, together with an Indian NGO activist and an American NGO activist. In 2000, EPO revocated the patent for lack of inventivity, but the US government, together with Grace C°, called for appeal. Five years later, on march 8, 2005, the patent was made irrevocably void. The appeal body of EPO stated that patenting was denied to items previously known, including through local tradition. It should be noted that, during ten years, the neem marked had been in trouble as the result of the patent, thus inflicting indirect damage to the traditional users of neem extracts. It is concluded that patentability of living items should be clarified by including protection of intellectual property rights within the concept of "bionomy", which covers the highly complex components interacting in biosphere governance. The mere application of regular patent rules to biological items in a climate of "commoditization", resulted in undue patent delivery, which had either to be revocated (yellow-seed bean variety, fungicidal neem extracts), or to be retracted under political and ethical pressure (sequencing the human genome). Patent infrigment in open-field agriculture revealed very complex interactions, with split evaluation by judges in Court. Judiciarisation of this sector should receive due attention, in order to improve the coherence, both operational and legal, in protecting the mixed property rights involved. Time has come to solve the equation expressing relationships between these property rights, when applied to genes, organisms, or crops within the complexity of open-field agricultural processes.

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