浅析药品专利链接制度带来的机遇和挑战

Opportunity and Challenge from Pharmaceutical Patent Linkage System

本文以中国第一个专利挑战成功的仿制药——帕罗西汀案例为线索,通过比较美国药品专利链接制度、中国现行药品注册中涉及专利的相关规定以及修改方案,分析专利链接制度,特别是专利挑战过程中,原研药和仿制药分别面对的机遇和挑战,并对中国药品专利链接制度的设立进行思考。

Basing on the comparing of pharmaceutical patent linkage system in USA, prescripts about patent in drug registration and the modification in China, the opportunity and challenge to original and generic drug was expatiated, the establishment of pharmaceutical patent linkage system in China was father elucidated.