药品专利申请补充实验数据的审查——细胞基因公司专利驳回复审行政纠纷案

On the Examination of Supplementary Experimental Data of Drug Patent Application

允许药品专利申请补充实验数据是我国专利审查指南2017年修改的主要内容之一,也是世界各国药品专利申请审查中的普遍做法,但基本上都采取审慎的态度,以免违背专利先申请原则和公开换保护原则。我国司法实践亦是如此。而中美第一阶段经贸协议第1.10条明确要求放宽对药品专利申请补充实验数据的审查标准,最高人民法院也已就此发布相关司法解释面向社会公开征求意见,但该司法解释的具体条款内容仍有待于进一步商榷。

Allowing drug patent applications to supplement experimental data is one of the main contents of the 2017 revision of the guidelines for patent examination of China,which is also a common practice in drug patent application examination around the world,but it is basically prudent in order to avoid violating the patent first-application principle and the disclosure for protection principle.The same is true of judicial practice in China.However,Article 1.10 of the Economic and Trade Agreement between the Government of the People's Republic of China and the Government of the United States of America clearly requires the relaxation of the examination standard for the supplementary experimental data of drug patent application.The Supreme People's court has also issued a relevant judicial interpretation for public comments,but the specific content of the relevant article in the judicial interpretation remains to be further discussed.