中美药品专利补充实验数据审查标准的比较研究  

Comparative study on the review standards for supplementary experimental data of pharmaceutical patent between China and the United States

作　　者：贺文奕 HE Wen-yi(School of Civil,Commercial and Economic Law,China University of Political Science and Law,Beijing100088,China)

机构地区：[1]中国政法大学民商经济法学院,北京100088

出　　处：《中国新药杂志》2022年第20期1984-1990,共7页Chinese Journal of New Drugs

摘　　要：药品专利补充实验数据是历次中美经贸摩擦中的焦点问题,尽管双方均认可对补充实验数据进行审查,但争议的关键点在于实践中的采信标准。因此,首先有必要厘清中美在专利审查实践中对补充实验数据的采信标准并加以比较,进而结合我国专利立法、医药产业发展现状等进行针对性调整。对补充实验数据采取适度宽松的采信标准,在我国此次《专利审查指南》修订中已有体现,这有利于我国制药企业的长远发展以及有序竞争格局的形成。同时,从对外开放与国际经贸合作的角度看,也能缓和中美间的经贸摩擦。It is the focus issue to supplement experimental data to pharmaceutical patent in the past Sino US economic and trade frictions. Although both sides agree to review the supplementary experimental data, the key point of dispute is the admissibility standard in practice. Therefore, it is necessary to clarify and compare the acceptance standards of supplementary experimental data in the patent examination practices between China and the United States. Targeted adjustments should be made based on the patent legislation and the development status of the pharmaceutical industry in China. The adoption of a moderately loose admissibility standard for supplementary experimental data has been reflected in the revision of the patent examination guide, which is conducive to the long-term development of Chinese pharmaceutical enterprises and the pattern formation of the competition order. Meanwhile, from the perspective of deepening of reform and opening-up and international economic and trade cooperation, it can also alleviate the economic and trade friction between China and the United States.

关 键 词：药品专利 补充实验数据 说明书充分公开 创造性 

分 类 号：R95[医药卫生—药学]