药品专利挑战的机制和策略  

Mechanism and strategy of drug patent challenge

作　　者：管荣齐[1] 刘少华[1] GUAN Rong-qi;LIU Shao-hua(Intellectual Property Law Research Base,Tianjin University,Tianjin 300072,China)

机构地区：[1]天津大学知识产权法研究基地,天津300072

出　　处：《沈阳工业大学学报（社会科学版）》2022年第2期97-103,共7页Journal of Shenyang University of Technology(Social Sciences)

基　　金：国家社会科学基金项目(19BFX145)。

摘　　要：众所周知,仿制药专利挑战机制是药品专利链接制度的核心。中国作为仿制药大国,近年来开始关注美国首仿药,致力于推进医药国际化进程。2020年10月17日,全国人大常委会通过修改《中华人民共和国专利法》的决定,新增的药品专利链接制度有关内容被视为调整药品专利相关制度的重大突破,给医药知识产权从业者带来新的机遇和挑战。通过追溯药品专利挑战机制的建立,结合有关规定及案例,归纳药品专利挑战机制的运行模式,对药品专利挑战策略提出完善建议。As it is known to all,the generic drug patent challenge mechanism is the core of the drug patent linkage system.As a large country of generic drugs,China has begun to pay attention to the first generic drugs in the United States in recent years and is committed to promoting the internationalization of medicine.On October 17,2020,the Standing Committee of the National People’s Congress adopted the decision to amend the Patent Law of the People’s Republic of China.The content of the newly added drug patent linkage system in the amendment to the Patent Law is regarded as a major breakthrough in the adjustment of the drug patent-related system,which brings new opportunities and challenges to medical intellectual property practitioners.Through the retrospective research of its establishment,the operation mode is summarized about the drug patent challenge mechanism,combined with relevant regulations and cases.Perfecting suggestions are proposed for the drug patent challenge strategy.

关 键 词：药品专利 仿制药 专利挑战 Hatch-Waxman法案 首仿 

分 类 号：DF523.2[政治法律—民商法学]