我国与欧洲药品专利补充数据比较研究  

Comparative study on supplementary data of pharmaceutical patent between China and Europe

作　　者：李亚林 来小鹏[1] LI Ya-lin;LAI Xiao-peng(School of Civil,Commercial and Economic Law,China University of Political Science and Law,Beijing 100088,China)

机构地区：[1]中国政法大学民商经济法学院,北京100088

出　　处：《中国新药杂志》2020年第17期1921-1926,共6页Chinese Journal of New Drugs

摘　　要：药品专利补充数据的目的在于证明药品的技术效果,由于药品的技术效果存在不可预期性,且药品的技术效果通常是药品发明的核心,故我国对于药品补充数据的审查较为严格。补充数据能否被接受、能够证明怎样的技术效果已成为全球制药行业关注的重要议题。本文针对药品专利补充数据的问题进行研究,分析我国现行专利制度下补充数据的规则,探讨补充数据规则的法律根源,比较欧洲与我国关于补充数据规则的异同并分析其原因,对改进我国补充数据的审查规则提出可行的建议。The purpose of supplementary data of drug patents is to prove the technical effects of the drugs. Since their technical effects are unpredictable but usually the core of drug inventions, review of supplementary data for drugs is quite strict in China. Whether the supplementary data can be accepted and what kind of technical effects can be proved have become important issues of concern to the global pharmaceutical industry. This article studies the problems existing in supplementary data for pharmaceutical patents, analyzes the rules of supplementary data under the current patent system in China, discusses the legal roots of such rules, compares and analyzes the similarities and differences of the rules between China and Europe, in order to provide feasible suggestions on improving the review rules for supplementary data in China.

关 键 词：药品专利 补充数据 技术效果的合理性 技术效果的确信 

分 类 号：R95[医药卫生—药学]