专利的公共政策--以印度首个专利强制许可案为例

Public Policy in Patent Regime: Citing the First Compulsory Licensing Case on Patented Drug in India

2013年德国拜耳公司诉印度拿特科公司一案中,印度知识产权上诉委员会维持了授权拿特科公司的药品强制许可。这是印度首个专利强制许可案,对发展中国家有导向性作用,也将对欧美大型药剂企业的知识产权战略产生巨大影响。本世纪初建立在《多哈健康宣言》《总理事会决议》以及《修订TRIPS协议议定书》基础上的药品强制许可机制,让发展中国家和最不发达国家的民众能够负担起必要的基础药品,一定程度上缓解了这些国家某些公共健康危机。不过,机制建立至今,实际案例还是屈指可数。中国专利法上虽有这一制度,但却从未利用这一公共政策工具颁发过一例强制许可。在财产性权利和生命健康权利发生根本性冲突时,作为一种公共政策工具,专利强制许可可以在医药市场上加以运用。

The pharmaceutical case Natco v .Bayer in early 2013 , has ended with a first-time compulsory license of a patented drug being granted by the Indian Intellectual Property Appellate Board .As the very first compulsory license ever to be granted , this particular decision will exert its guiding effects on other developing nations, whilst substantially influencing the IP strategies of Euro-American pharmaceutical giants .The com-pulsory licensing mechanism of patented drugs based on the Doha Declaration , the Decision by the WTO Gen-eral Council on the Implementation of Paragraph 6 of The Doha Declaration in 2003 and Amendment of the TRIPS Agreement , has enabled developing nations and least developed nations to afford essential drugs , which in turn has alleviated certain public health crisis in these areas .However , actual cases of compulsory licenses have been rare since the establishment of the said mechanism .Such dilemma also troubles Chinese patent re-gime as the public policy doctrine has not been practically maneuvered despite its existence .Compulsory li-cense as a tool for the enforcement of public policy , ought to be applied in the pharmaceutical field when sub-stantive conflicts arise between property rights and rights to health and life .