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.
作者
许磊
尹昕
杨悦
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)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第24期2517-2525,共9页
Chinese Journal of New Drugs
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
medicines
patent
supplementary experimental data
bilaterality
utility
full disclosure
inventivestep
