从Myriad案谈基因专利的正当性及美国对基因专利授权实质性要件分析

按照专利制度构建的本质,基因专利的作用在于激励产业创新,促进基因研究的发展。但基因专利从产生以来就一直存在着争议。2011年美国Myriad案对分离DNA序列的可专利性具有不同的观点,从Myriad I案认为分离的DNA是不可专利的客体,到Myriad II上诉案中联邦巡回上诉法院推翻地方法院的观点,认为分离的DNA具有不同的化学结构,满足专利客体的适格性,但同时也反射出了对DNA序列可专利性的怀疑。Myriad案引起了美国、欧洲和澳大利亚司法审判中就基因专利适格性问题的较大争议。本文结合美国Myriad案来分析DNA序列作为专利客体的适格性以及目前美国对基因专利授权的实质性条件。

Analysis of the Justification for Gene Patent and Its Substantial Requirements in Patent Examination of America with the Myriad Case as Exemple

In regard to the nature of the patent law, the aim of gene patent is to promote the gene research and its related technological innovation as well. However, the issue of gene patent has been controversial since its advent. Especially,The Myriad patents have prompted strong reaction in the jurisdiction of America, Europe as well as Australia. It is not uncommon that the 2011 Myriad case in America then brought about different points of view concerning the isolated DNA sequence. The district court held that Myriad’s composition claims to "isolated" DNA molecules cover patent-ineligible products of nature under §101 since the molecules as claimed do not exist in nature. However United States Court of Appeals Federal Circuit reversed the district court’s decision and held that isolated DNA molecules qualified as patentable subject matter because the claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or compositon of matter——a product of human ingenuity "having a distinctive name, character and use". But it still reflects a state of uncertainty on patentability of isolated DNA. This paper then justifies gene patent and analyzes substantial requirements of gene patent in patent examination of America.