补充实验数据规则适用与医药创新成果保护研究  

Research on the Application of the Rules for Supplementary Experimental Data and Protection of Pharmaceutical Innovation

作　　者：耿胜燕[1] 姚云[1] 苏莹 GENG Shengyan;YAO Yun;SU Ying(Patent Examination Cooperation(Beijing)Center of the Patent Office,CNIPA,Beijing 100160;National Science Library,Chinese Academy of Sciences,Beijing 100090)

机构地区：[1]国家知识产权局专利局专利审查协作北京中心,北京100160 [2]中国科学院文献情报中心,北京100090

出　　处：《中国发明与专利》2025年第4期77-86,共10页China Invention & Patent

摘　　要：[目的/意义]补充实验数据对医药创新成果保护至关重要。近年来,越来越多的医药创新主体倾向于通过补充实验数据来支持其发明的可专利性,提升创新主体对补充实验数据规则的运用能力,对于强化技术成果的保护、提升核心竞争能力具有重大意义。[方法/过程]通过对比欧洲、美国和我国补充实验数据相关规则,分析总结国内司法实践中相关案件的分布特点,在此基础上选取近期具有代表性的典型司法判例,探究司法机关对补充实验数据的裁判标准和考量因素。[结果/结论]从专利申请文件和补充实验数据两个维度为医药创新主体提供具有实践性和前瞻性的建议,为实现高质量、高水平的医药创新成果保护提供助力。[Purpose/Significance]Supplementary experimental data is crucial for protecting pharmaceutical innovation achievements.In recent years,more and more pharmaceutical innovation entities have tended to support the patentability of their inventions by supplementary experimental data,enhancing their ability to apply rules for supplementary experimental data,which is of great significance for strengthening the protection of technological achievements and enhancing core competitiveness.[Method/Process]The relevant rules of supplementary experimental data from Europe,the United States and China are compared.The distribution patterns and characteristics of relevant cases in domestic judicial practice are analyzed.Recent representative cases are selected and analyzed to explore the judgment standards and considerations of judicial authorities on supplementary experimental data.[Result/Conclusion]Practical and forward-looking suggestions are proposed for pharmaceutical innovation entities from the perspectives of patent application documents and supplementary experimental data,so as to provide assistance for achieving high-quality and high-level protection of pharmaceutical innovation achievements.

关 键 词：药品专利 补充实验数据 司法实践 接受标准 采信标准 

分 类 号：D923[政治法律—民商法学] G353[政治法律—法学]