浅析新《中华人民共和国专利法实施细则》《专利审查指南》背景下药品专利期限补偿制度  

Analysis of the drug patent term extension provisions in the context of the new Detailed Rules for the Implementation of the Patent Law of the People s Republic of China and Patent Examination Guidelines

作　　者：孙明明[1] SUN Ming-ming(Patent Examination Cooperation(Tianjin)Center of the Patent Office,CNIPA,Tianjin 300304,China)

机构地区：[1]国家知识产权局专利局专利审查协作天津中心,天津300304

出　　处：《中国新药杂志》2025年第4期346-351,共6页Chinese Journal of New Drugs

摘　　要：新《中华人民共和国专利法》首次设立了我国药品专利权期限补偿制度条款,2023年修订的新《中华人民共和国专利法实施细则》《专利审查指南》对其进行了细化规定和解释。本文对新《中华人民共和国专利法实施细则》《专利审查指南》规定的适用对象、请求条件、补偿时长计算方法、请求的主体和流程进行了解析,并与美国、日本相关制度进行了对比。统计分析了当前正处于申请上市阶段药品情况以及近期已批准上市药品情况,并基于《中华人民共和国专利法实施细则》《专利审查指南》规定计算获得了近期已批准上市药品可获得专利权期限补偿的时长,为企业申请药品专利权期限补偿提出了意见建议。The new Patent Law of the People s Republic of China establishes for the first time the provisions of patent term extension for an invention patent relating to a drug.The new Detailed Rules for the Implementation of the Patent Law of the People s Republic of China and Patent Examination Guidelines revised in 2023 provided detailed provisions and explanations.This paper analyzed the applicable objects,request conditions,calculation method of patent term extension,subject and process of request stipulated in the new Detailed Rules and Guidelines and compared them with the relevant provisions in the United States and Japan.The current situation of drugs in the application stage and the situation of recently approved drugs was also analyzed.Based on the provisions of the new Detailed Rules and Guidelines,the length of time for which the recently approved drugs can be extended for the patent term was calculated,and suggestions for enterprises to request for extension for the patent term of drugs were put forward.

关 键 词：《中华人民共和国专利法实施细则》 《专利审查指南》 专利权期限补偿 新药 

分 类 号：R95[医药卫生—药学]