南京医科大学学报（社会科学版）2025，Vol.25Issue(5)：479-484,6.DOI:10.7655/NYDXBSSS250270
利益平衡视域下药品专利链接制度的优化
Optimization of the drug patent linkage system from the perspective of interest balancing
摘要
Abstract
From the perspective of interest balancing,this study analyzes key challenges in the theoretical and practical implementation of core components within the drug patent linkage system,including the registration system,declaration system,approval waiting period system,and market exclusivity period system.These challenges include the lack of regulatory mechanisms for patent registration review,unclear account ability,the prevalence of erroneous patent declarations with ambiguity in supporting regulations,the absence of effective control against the abuse or disregard of the approval waiting period,and dysfunction of the market exclusivity period.By drawing upon and analyzing international and practical experiences,specific optimization measures are proposed to address these issues.The aim is to continuously facilitate the effective implementation of the drug patent linkage system and reach a tripartite equilibrium among original drug companies,generic drug manufacturers,and public health by clarifying legal norms,enhancing procedural coordination,and optimizing the review mechanisms.关键词
药品专利链接制度/利益平衡原则/专利登记/专利声明/批准等待期/首仿独占期Key words
drug patent linkage/principle of interest balancing/patent registration/patent declaration/approval waiting period/market exclusivity period for the first generic drug分类
社会科学引用本文复制引用
梁思逸,冯艳艳..利益平衡视域下药品专利链接制度的优化[J].南京医科大学学报（社会科学版）,2025,25(5):479-484,6.基金项目
山东省社会科学规划研究项目"文化数字化战略背景下中华优秀传统文化'两创'法律保障机制研究"(23CLCJ16) （23CLCJ16）
