摘要
关于药品试验数据的保护,《TRIPS协议》第39条第3款做出了明确规定,即不得因商业目的而擅自披露药品试验数据。这一规定是为了保护药品创新,在专利保护之外单独设置的又一种知识产权保护路径。由于各成员国发展水平存在差异,对该条款的理解不同,因此,在各成员国形成了药品试验数据保护的不同标准和不同模式。为了提出并论证我国药品试验数据的专有权保护模式和保护标准,需要以药品试验数据为研究对象,一方面分析药品试验数据的保护及特点,剖析我国药品试验数据保护的现状及存在的制度缺陷,另一方面,借鉴国外各种药品试验数据保护模式以及相关立法,在比较中选择我国的保护模式,以促进我国专利药和仿制药的共同发展。
As for the protection of drug trial data,the clause 3 in article 39 of the“TRIPS Agreement”has made a clear provision that drug trial data should not be disclosed without authorization for commercial purposes.This regulation is made to protect drug innovation,and it is another way of intellectual property protection in addition to the patent protection.Due to the difference in the level of development in each member country,and the different understanding of this clause,different standards and modes of drug trial data protection have been formed in each member country.In order to put forward and demonstrate the protection mode and standard for the exclusive right to drug trial data in China,it is necessary to do research on the drug trial data.On the one hand,we should analyze the protection and characteristics of drug trial data,and examine the status quo of drug trial data protection in China and the existing system flaw in it.On the other hand,we should use for reference the various protection modes of drug trial data in foreign countries and related legislation,and in comparison,select the protection mode in China so as to promote the common development of patented drugs and generic drugs in China.
作者
李文江
白娅楠
Li Wenjiang;Bai Yanan(Law School,Henan University of Technology,Zhengzhou City,Henan Province,450001)
出处
《黄河科技学院学报》
2021年第1期89-95,共7页
Journal of Huanghe S&T College
基金
国家社科基金项目(20FFXB060)
2020河南省社科规划决策咨询项目(2020JC30)。
