药品专利审查中的补充实验数据  

On Additional Experimental Data in the Drug Patent Examination Procedure

作　　者：李彦涛 Li Yantao

机构地区：[1]同济大学上海国际知识产权学院

出　　处：《知识产权》2019年第9期61-72,共12页Intellectual Property

基　　金：国家社科基金重大项目（16ZDA236）

摘　　要：实验数据是药品专利药品创造性判断中的重要考量因素,申请日后补充实验数据与先申请制存在潜在的冲突。中国长期坚持较为严格的标准。本文对欧洲、美国和日本相关问题进行了比较研究,并梳理了中国历来的专利审查指南的规定和重要的专利审查和审判的具体案例。经过具体分析之后,建议对相关标准进行调整,以适应中国制药行业的发展。The experimental data is an important factor for consideration in measuring the creativity of drug patents during the examination procedure.The additional data system may con flict to the first-to-file rule.The paper carries out comparative studies of the relevant systems and cases in Europe,US and Japan,and sorts out stipulations of Chinese patent examination guidelines as well as the cases in relation to patent examination and judicial trials.Based on careful analysis,the paper suggests modifying relevant standard to accommodate the development of Chinese drug industry.

关 键 词：药品专利 补充实验数据 先申请制 创造性 

分 类 号：G30[文化科学]