药品专利纠纷早期解决机制中“登记”和“声明”的司法审查  

Judicial Review of"Registration"and"Declaration"in the Early Resolution Mechanism for Pharmaceutical Patent Disputes

作　　者：崔宁 Cui Ning

机构地区：[1]中国社会科学院大学

出　　处：《电子知识产权》2025年第2期62-76,共15页Electronics Intellectual Property

摘　　要：药品专利纠纷早期解决机制(药品专利链接制度)是我国近年来在药品专利保护领域的重要制度创新,旨在通过提前解决仿制药上市过程中可能引发的专利纠纷,平衡原研药企业和仿制药企业的利益,兼顾激励创新和保障药品可及性。有必要围绕该机制中的“登记”和“声明”两个关键环节探讨司法审查的标准问题。包括分析“登记”和“声明”在药品专利链接制度中的作用,对比美国、加拿大和韩国在药品专利链接制度中的“登记”和“声明”审查机制。在此基础上,结合最高人民法院受理药品专利链接诉讼以来的典型案例,详细讨论“登记”和“声明”的具体审查规则,包括可登记专利类型的界定、原研药技术方案与专利权保护范围的关系、声明时机与声明错误的救济等问题,并提出药品专利链接制度目前存在的问题和进一步完善的建议。The early resolution mechanism for pharmaceutical patent disputes(also known as the pharmaceutical patent linkage system)is a significant institutional innovation in China’s pharmaceutical patent protection field in recent years.It aims to balance the interests of originator and generic drug companies and ensure public access to medicinesby resolving potential patent disputes before generic drugs enter the market.This article focuses on the two key components of this mechanism—"registration"and"declaration"—and explores the specific standards for judicial review.The article first analyzes the roles of"registration"and"declaration"in the pharmaceutical patent linkage system and compares the review mechanisms for"registration"and"declaration"in the United States,Canada,and South Korea,then discusses in detail the specific review rules for"registration"and"declaration"based on typical cases handled by the Supreme People’s Court since the implementation of the pharmaceutical patent linkage litigation system.Key issues addressed include the types of patents eligible for registration,the relationship between the originator drug’s technical solution and the scope of patent protection,the timing of declarations and remedies for declaration errors and so on Finally,the article identifies current issues unsolved in the pharmaceutical patent linkage system and proposes suggestions for further improvement.

关 键 词：药品专利链接制度 专利信息登记 仿制药声明 司法审查 利益平衡 

分 类 号：D923.42[政治法律—民商法学]