美国2011年专利法第一案Myriad案评——人类基因可专利性的再思考

Myriad公司从人体DNA中分离的两种基因片断(BRCA1,BRCA2)获得了专利。美国分子病理协会等提起诉讼,宣称人类基因不是可专利性客体,该专利无效。上诉法院判定该基因片断是合法的专利客体,但该判决与最高法院的先例并不完全吻合。在成文法及司法先例对基因类专利都没有明确规定的情况下,公共政策的分析是更适当的切入角度。从政策性角度分析,否认人类基因的可专利性是对社会最有利的政策。专利制度是工具,不是目的。加拿大的有益实践启示我国也应坚持否认人类基因类专利的政策。

A Review of the Top1 U.S.Patent Case in 2011:Rethinking the Patentability of Human Gene

Myriad obtained a patent on isolated Human Genes BRCA1 and BRCA2. Association for Molecular Pathology etc. sued USPTO and alleged that the patent is not valid because human genes are not patentable subject matter. U.S. Court of Appeals for the Federal Circuit ruled that genes are patentable subject matter, but its ruling is not following the precedents by U.S. Supreme Court. When the law is not settled, a public policy analysis is a better approach to this issue. The policy analysis suggests that a policy invalidating the human gene patent is the best for the interest of the society. Patent system is a means, not a goal by itself. Canada’s experience also suggests that China should adhere to the policy that human genes are not patentable.