浅析《协议》对我国药品专利补充数据审查标准的影响

A Brief Analysis of the Impact of The Agreement on the Standards for Examination of Supplementary Data for Pharmaceutical Patents

2020年1月15日,中美双方签署的《中华人民共和国政府和美利坚合众国政府经济贸易协议》第一章第三节提到药品专利补充数据问题,并对具体审查标准进行规定。本文以协议规定的补充数据条文为切入点,详细梳理“美国与我国的补充数据审查规则、趋同美国审查标准对我国专利制度影响及我国医药产业现状”,并对我国补充数据审查标准进行了剖析。笔者认为,我国必将进一步放宽对补充数据的审查标准,加大药品专利的保护力度,建议国内相关企业尽早做好准备,以迎接未来的机遇和挑战。

On Jan. 15, 2020, China and the United States signed the Economic and Trade Agreement Between the Government of the People’s Republic of China and the Government of the United States of America(hereinafter refers to The Agreement) which refers to the supplementary data on drug patent(Chapter Ⅰ Section Ⅲ) and provides regulations on standards of review. This paper, which starts by introducing the clauses on supplementary data specified in The Agreement, provides a detailed review and analysis on the paper "the different reviewing regulations between China and the United States on supplementary data, the influence on China’s patent system applying the standards of review similar to the United States and the current situation of medical industry in China" as well as the standards of review on supplementary data in China. The author believes that China will further lower the standards of review on supplementary data and strengthen the protection on drug patents. It is suggested that the domestic enterprises concerned shall get prepared as early as possible in face of the future opportunities and challenges.