仿制药专利挑战行为拟制侵权的合理性证成及制度建构  

Rationalization and Institutional Construction of Artificial Infringement of Generic Drug Patent Challenge

作　　者：冯振龙 周莹[1] Feng Zhenlong;Zhou Ying(Institute of Intellectual Property,School of Law,Central China Normal University,Wuhan 430070,China)

机构地区：[1]华中师范大学法学院知识产权研究所,湖北武汉430070

出　　处：《中国科技论坛》2023年第4期142-150,157,共10页Forum on Science and Technology in China

基　　金：国家社会科学基金后期资助项目“数字经济下的创新政策组合理论与实证研究”(18FGL001)。

摘　　要：仿制药专利挑战是药品专利链接制度的核心内容,也是药品注册审批阶段引发专利权属争议的主要制度动因。当前,关于专利挑战行为法律属性的界定存在争议,拟制侵权与确认不侵权两种观点各执一端。前者以法律拟制和知识产权侵权促成事由为理论基础,并具有平衡内外部利益的功能,在逻辑结构标准与同一法益标准的审视下,拟制侵权与Bolar豁免构成一般法与特别法的关系。通过分析与借鉴美韩专利挑战相关立法,建议中国引入拟制侵权,在立法层面确认仿制药专利挑战为拟制侵权的同时将其作为Bolar豁免的特别规定。针对拟制侵权的权利扩张风险,采取限缩路径明确其司法管辖的专利声明类型、客体范围及法律后果,赋予CFDA批准等待期审查权,完善等待期规制措施。Generic drug patent challenge is the core content of the drug patent linkage system and the main institutional motivation triggering disputes over patent ownership during the drug registration and approval stage.Currently,there is a controversy over the definition of the legal attributes of patent challenge,with the two views of artificial infringement and confirmed non-infringement spilt on each end.The former is based on the theory of legal fiction and contributory cause of intellectual property infringement,and has the function of balancing internal and external interests.Under the examination of the logical structure standard and the same legal interests standard,the artificial infringement and the Bolar exemption have formed a relationship of general law with special law.By analyzing and learning from the relevant legislation of patent challenge in the US and Korean,it is recommended that China introduce artificial infringement,confirm the generic drug patent challenge as artificial infringement in legislation and add it as the special provision of the Bolar exemption.In response to the risk of rights expansion of artificial infringement,a restrictive path should be adopted to clarify the types of patent declarations,the scope of objects and legal consequences under its jurisdiction.At the same time,the CFDA should be endowed with the authority to verify the waiting period and perfect the regulatory measures for the above.

关 键 词：仿制药 拟制侵权 专利挑战 专利链接 

分 类 号：DF913[政治法律—国际法学]