摘要
药品专利信息登记体系是药品专利链接制度的重要组成部分,完善的药品专利信息登记体系能够提高药品专利链接制度的运行效率。通过从实体性和程序性两方面对比美国的《经治疗等同性评价批准的药品》(简称《橘皮书》)和拟构建的中国药品专利信息登记平台,发现中国药品专利信息登记平台在专利提交主体身份、专利提交时间、专利信息登记前审查、专利登记后内容和状态变化处理等方面存在问题。中国药品专利信息登记平台应该规定提交专利的主体是药品申请人,药品监督管理部门应对药品专利与所申请上市药品之间相关性进行形式审查,并要求药品申请人对登记专利内容和状态变化附有强制性备案义务。
The drug patent information listing system is an important part of the pharmaceutical patent linkage system.A complete drug patent information registration system can improve the efficiency of the pharmaceutical patent linkage system.By comparing the“Orange Book”of the United States and the planned Chinese drug patent information listing platform from both substantive and procedural aspects,it is found there are several problems in the Chinese drug patent information listing platform,including the patent submission subject identity,patent submission time,patent information pre-listing review,the content and status change handling after patent registration.The China Drug Patent Information Listing Platform should stipulate that the subject of patent submission is the drug applicant.The drug regulatory authority shall conduct formal examination of the relevance between the drug patent and the drug applied for on the market,and require the drug applicant undertake mandatory filing obligation.to attach the contents and status changes of the registered patent.
作者
刘立春
漆苏
Liu Lichun;Qi Su
出处
《电子知识产权》
2021年第7期85-93,共9页
Electronics Intellectual Property
基金
教育部人文社科项目“健康中国背景下驱动原始创新的药品专利特权制度优化研究”(19YJCZH104)
国家社科基金一般项目“巨型自由贸易协定视角下国际知识产权规则的演变趋势和中国对策研究”(20BFX132)。
关键词
药品
专利
信息登记
Drug
Patent
Information Listing
