原研药创新悖论的影响因素分析  

Analysis of influencing factors for innovation paradox of original drugs

作　　者：吴鹤松 黄璐 WU He-song;HUANG Lu(Jiangsu CTFH Pharmaceutical Co.,Ltd.,Nanjing 210046,China;Guangzhou Wellhealth Bio-pharma Co.,Ltd.,Guangzhou 510200,China;School of Pharmaceutical Sciences,Wuhan University,Wuhan 430072,China)

机构地区：[1]江苏正大丰海制药有限公司,南京210046 [2]广州丹康医药生物有限公司,广州510200 [3]武汉大学药学院,武汉430072

出　　处：《中国新药杂志》2019年第10期1160-1163,共4页Chinese Journal of New Drugs

基　　金：江苏省企业知识产权战略推进计划一般项目(ZTYB1646)

摘　　要：现有实践表明,原研药专利包括化合物专利在中国极易因创造性等被视为无效,由此形成了原研药创新悖论。本文从不同时期对同一问题的专利审查标准尺度的变化,原研药专利中具体实验数据缺失,无效过程中权利要求无法适当修改,无效请求人提起原研药专利无效的策略,以及商业上的成功对于原研药创造性的影响这5个因素,对原研药创新悖论的影响进行了深入分析,认为原研药创新悖论并不存在。Existing practice shows that the patents of original drugs,including compound patents,are easily invalid because of inventiveness in China,thus forming the innovation paradox of original drugs.This paper analyzed the innovation paradox of original drugs and its five influencing factors,including the changes in the standard of patent examination on the same issue in different periods,the lack of specific experimental data for the patents of original drugs,the inability to modify the claims during invalidation process,patent invalidation strategies of applicants,and the influence of commercial success on original drugs’inventiveness.The authors considered there does not exist innovation paradox of original drugs.

关 键 词：原研药 创新 悖论 专利复审 专利无效 商业成功 

分 类 号：R95[医药卫生—药学]