美国首仿药制度及专利挑战策略研究

Research on the first generic drug system and the patent challenge strategy of USA

介绍了美国《药品价格竞争与专利期恢复法案》、药品专利链接制度及首仿药制度,对药品专利期延长、市场独占期、橙皮书、简化新药申请(ANDA)制度以及专利挑战制度等做了简要说明。从立项、策略和声明确定等3个方面,概括介绍美国首仿药开发的专利策略。美国首仿药制度对中国药企有启示作用。

This paper introduces the first generic drug system of the United States from the perspectives of Drug Price Competition and Patent Term Restoration Act and the pharmaceutical patent linkage system,and briefly explains the patent term extension,marketing exclusivity,Orange Book,ANDA system,and patent challenging system. On this basis,this paper briefly introduces the patent strategy for development of first generic drugs from three aspects： project initiation,strategy,and paragraph statement confirmation. At last,this paper points out the enlightenment of the first generic drug system of USA for Chinese pharmaceutical enterprises which attempt to seize the first generic drug market of the United States.