欧盟药品补充保护证书制度的裁判趋势及启示  

Judicial Trend and Implications of the EU Supplementary Protection Certificate System for Drugs

作　　者：孙潭霖 许光凯 吴琪 Sun Tanlin;Xu Guangkai;Wu Qi(National Medical Products Administration Institute of Executive Development,Beijing 100073,China;NMPA Research Base of Regulatory Science for Medical Devices,South China University of Technology,Guangzhou 510000,China)

机构地区：[1]国家药品监督管理局高级研修学院,北京100073 [2]华南理工大学国家药监局医疗器械监管科学研究基地,广州510000

出　　处：《中国药事》2025年第3期355-362,共8页Chinese Pharmaceutical Affairs

基　　金：国家药品监督管理局高级研修学院研究项目资助(编号NMPAIED102024003)。

摘　　要：目的:为我国药品专利期限补偿制度持续完善提供建议和参考。方法:系统梳理2010年以来欧盟法院(CJEU)对欧盟“药品专利期限补偿制度”——补充保护证书(Supplementary Protection Certificate,SPC)初步裁决裁判案例,并进行比较研究,总结裁判思路和趋势。结果与讨论:裁判思路和趋势包括注重公平性、放宽专利与产品对应关系的直接限制,加强专利与产品研发过程相关性的审核,并注重规则的确定性和可操作性;同时重视在法规和裁判中明确或阐述立法目的,也限制专利长青和产品跳转。这为我国优化药品专利期补偿制度包括探索“中国新”产品的补偿资格等问题提供了启示。Objective:To provide suggestions and references for continuous improving the drug patent term extension system in China.Methods:The preliminary rulings of the European Court of Justice(CJEU)on the supplementary protection certificate(SPC)system were systematically reviewed and analyzed since 2010.And a comparative study was conducted to summarize the judgment ideas and trends.Results and Conclusion:The judgment ideas and trends include emphasizing fairness,relaxing direct restrictions on the correspondence between patents and products,strengthening the review of the correlation between patents and product development processes,and emphasizing the certainty and operability of rules;at the same time,it is important to clarify or elaborate on the legislative purpose in regulations and judgments,while also limiting patent longevity and product redirection.This provides inspiration for optimizing the drug patent term extension system in China,including exploring the eligibility for compensation for“new Chinese”products.

关 键 词：药品专利期限补偿 补充保护证书 知识产权 

分 类 号：R95[医药卫生—药学]