补交实验数据在药品专利保护中的两面性研究  

Supplementing experimental data,a double-edged sword in pharmaceutical patent protection

作　　者：许磊 尹昕 杨悦[1,4] XU Lei;YIN Xin;YANG Yuel(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Reexamination and Invalidation Department of the Patent Office,China National Intellectual Property Administration,Beijing 100086,China;Capital Normal University,Beijing 100037;School of Pharmaceutical Science,Tsinghua University,Key Laboratory of Innovative Drug Research and Evaluation,National Medical Products Administration,Beijing 100084,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]国家知识产权局专利复审和无效审理部,北京100086 [3]首都师范大学,北京100037 [4]清华大学药学院/国家药品监督管理局创新药物研究与评价重点实验室,北京100084

出　　处：《中国新药杂志》2023年第24期2517-2525,共9页Chinese Journal of New Drugs

摘　　要：本文结合国家知识产权局(CNIPA)在药品专利保护中对实验数据的要求、国家知识产权局近期的行政决定、“重磅炸弹”药物研发中实验数据的反复性以及美国联邦巡回法院的相关案例,对补充实验数据在药品专利保护中的两面性进行了探讨。Based on the requirement on the experimental data in the pharmaceutical patent examination of China National Intellectual Property Office(CNIPA),some recent administrative decisions of CNIPA,the repetition of experimental data in the development of some"blockbuster"drugs,and the relevant cases of the US Federal Circuit,this paper discusses the two sides of supplementary experimental data in pharmaceutical patent protection.

关 键 词：药品 专利 补充实验数据 两面性 实用性 公开充分 创造性 

分 类 号：R95[医药卫生—药学]