我国药品专利链接制度下确权程序研究

Research on Rights Confirmation Procedure Under Drug Patent Linkage System

药品专利链接制度又称为药品专利纠纷早期解决机制,将仿制药与专利药之间的药品专利纠纷前置于上市审批环节解决,旨在衔接仿制药审批与专利药专利二者间的问题。其内容包括专利声明制度、专利公示制度、仿制药简化申请制度等子制度。司法实践中,药品专利链接制度并非独立运行,链接案件中往往夹杂无效宣告案件的审理,二者间的程序衔接影响着药品专利确权程序的运行。本文通过案例分析和比较研究总结出专利确权程序在药品专利链接制度建立后,在药品专利领域出现了无效程序滥用、四类声明趋于同化这两个现实问题,并在此基础上探析问题出现的根本原因,提出相应解决对策,积极探索二元制体系中司法和行政机关新的可能性。

The drug patent linkage system,also known as the early resolution mechanism for drug patent disputes,prioritizes the resolution of drug patent disputes between generic drugs and patented drugs in the market approval process,aiming to bridge the gap between generic drug approval and patented drug patents.It includes sub systems such as patent declaration system,patent disclosure system,and simplified application system for generic drugs.In judicial practice,the drug patent linkage system does not operate independently,and the trial of invalidation cases is often mixed in the linkage cases.The procedural connection between the two affects the operation of the drug patent confirmation process.With case analysis and comparative reasearch,this article summarizes two practial problems in the field of drug patent after the establishment of the drug patent linkage system:abuse of invalid procedures and assimilation of four types of declarations.On this basis,the article also explores the root causes of the problems,proposes corresponding solutions,and actively explores new possibilities for judicial and administrative organs in the binary system.