美国药品专利反向支付问题的反垄断法规制研究  

A Study on the Antitrust Regulation of Drug Patent Reverse Payment Problem in US

作　　者：相靖[1] Xiang Jing

机构地区：[1]对外经济贸易大学国际经济研究院

出　　处：《知识产权》2019年第11期87-96,共10页Intellectual Property

摘　　要：分析了美国最高法院Actavis案之后各级法院在该案指导下,对药品专利和解协议中涉及反向支付的一些新问题,如反向支付的多种表现方式、“数额巨大且没有合理解释”标准的理解与适用,以及反向支付反垄断案件私人诉讼主体资格的确定等问题的分歧、探讨和法律推理,为我国在药政改革背景下构建基于专利链接制度的药品专利创新与保护制度过程中正确看待反向支付问题提供了有益的借鉴。The paper analyzes some new problems in relation to reverse payment practices included in drug patent settlement agreement,which are arisen after the US Supreme Court Actavis case,and are disputed,explored and reasoned by various American courts based on the legal reasoning of Actavis case.These problems include the analysis on multitude methods of non-cash reverse payment,the reasonable understanding and application of“large and unexplained payment”standard as being vaguely established by the Actavis case,and the difficulty in establishing the plaintiff pleading standard in the antitrust litigation brought about by private entity,etc.By the analysis,the paper hopes to contribute some useful experiences for Chinese departments concerned which are structuring the drug patent protection and innovation system based on the patent linkage system,aiming to accelerate the current Chinese drug policy reform.The paper provides some legislative suggestions to prevent from anticompetitive harm which may be brought about by reverse payment problems.

关 键 词：反向支付 药品专利和解协议 合理原则 数额巨大且不合理 专利链接制度 反垄断 

分 类 号：D92[政治法律—法学]