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Patentability of living organisms: From biopatent to bio-big-bang

机译:生命有机体的可专利性:从生物专利到生物大爆炸

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摘要

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, t
机译:像过程或产品一样,发明长期以来在许多方面受到保护:保密,垄断,商标,国际公约,公共当局的法规。如今,知识产权(IPR)受世界贸易组织(WTO)内的“ Trips”系统(与贸易有关的知识产权)的监管。 WTO成员必须通过授予实用新型专利或通过特殊制度来保护创新产品或过程。几十年来,植物育种者已经开发了“植物品种保护证书”,该证书是根据1968年实施的国际UPOV公约(于1990年修订)颁发的。自1980年美国最高法院判决以来,活生物体或其一部分(包括基因)已申请专利。主题。此后,许多专利已交付给生命形式,其中一些导致在新颖性,适用性或生物专利侵权方面存在冲突。为了说明所涉及的某些情况,本文分析了四个具体案例,以评估生物专利性的局限性:i)测序人类基因组。 DNA测序技术的改进为表征整个人类基因组铺平了道路。在项目的早期阶段,发布了结果。但是,在1988年,“ Est”(即位置或功能未知的表达序列标签)申请专利。经过一段时间的拒绝后,尽管有一部分科学家对自己的“新颖性”状态提出异议,但他们却在美国授予了专利权,后来又在欧洲获得了这种专利权,因为认为这就像不当的专利知识一样。经过一段时间的动荡,克林顿总统和布莱尔总理呼吁公布全基因组序列,以造福人类。这样做是为了排除人类基因组的进一步专利性。 ii)孟山都的传奇人物起诉农民Schmeiser。 Percy Schmeiser在半个世纪的时间里成功地在萨斯喀彻温省(加拿大西部)种植了双低油菜籽。 1998年作物的测试表明,由于孟山都和孟山都加拿大公司拥有专利的基因的普遍性,草甘膦除草剂Roundup具有很高的抗性。由于Schmeiser从未购买抗Roundup的油菜籽,也未获得使用许可,孟山都公司提起专利侵权诉讼。 Schmeiser否认有意在自己的土地上引入专利基因,并指控孟山都对其专利材料的限制不足。初审法官认为该专利是有效的,并允许诉讼,向孟山都公司赔偿19,832加元的赔偿金,并向司法部门支付153,000加元的司法费用。联邦上诉法院维持了这一决定,施梅瑟将上诉移交给了最高法院。法院对此事一分为五。五位多数法官确认,该农民因未经适当授权“使用”专利油菜籽而被判侵权。但是,由于公司选择了利润会计作为补救措施,因此拒绝向孟山都公司赔偿。考虑到上诉人没有从发明中获得任何利润,法院裁定,被诉人无权就其帐户主张获得任何权利。鉴于这种混合结果,它决定由各方自行承担全部费用。四名少数法官表示反对多数裁决。他们认为植物或其后代在法律上没有专利权,因此无法期望本领域技术人员认识到基因的专利保护已扩展到常规作物。因此,他们估计,下级法院认为将基因专利侵权适用于植物和收获的谷物是错误的。此外,t

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