摘要
药品专利由于研发时间长,在申请日后会产生大量的补充实验数据。我国的立法及实践已明确,应当对补充实验数据进行审查。但审查不等于被接受,典型案例反映出,对补充实验数据的接受标准依然存在较大争议。域外美国、欧洲、日本的立法模式和司法实践也各不相同。解决当前药品专利补充实验数据接收标准所存在的问题,应当从以下几个方面进行着手:分别规定“技术方案”和“预测效果”不同的接受标准;厘清补充实验数据与证明目的之间的关系;放宽对预测效果的严格标准;广泛理解本领域公知常识及现有技术。
Due to the long research and development time of drug patents,a large amount of supplementary experimental data will be generated after the application.China’s legislation and practice have made it clear that the supplementary experimental data should be reviewed.However,review does not mean acceptance,and the typical cases reflect that the acceptance criteria for supplementary experimental data are still highly controversial.The legislative models and judicial practices of the United States,Europe and Japan are also different from each other.To solve the problems existing in the acceptance standards of drug patent supplementary experimental data,it should be improved from the following aspects:Clarify the different acceptance standards of“technical scheme”and“predicted effect”;clarify the relationship between supplementary experimental data and the purpose of proof;relax the acceptance criteria for predicted effect;extend the understanding of common knowledge and prior art in the field.
作者
刘媛
黄运鸿
LIU Yuan;HUANG Yunhong(Law School,Chongqing University,Chongqing 400044)
出处
《中国发明与专利》
2024年第6期66-77,共12页
China Invention & Patent
基金
重庆大学教改项目“知识产权案例教学中的类型化方法研究”(编号:2019Y17)阶段性成果。
关键词
补充实验数据
药品专利
接受标准
创造性
充分公开
supplementary experimental data
drug patent
acceptance criteria
creativity
full disclosure
