药品试验数据的保护与限制

发布时间：2018-02-28 08:14

本文关键词： 药品试验数据资料专属权与贸易有关的知识产权协定多哈宣言强制许可北美自由贸易协定美国—中美洲自由贸易协定　出处：《知识产权》2017年03期 　论文类型：期刊论文

【摘要】：药品试验数据保护是在专利权之外政府为鼓励药品创新而提供的另一种知识产权保护形式。药品试验数据专属权是指在一定期间内,赋予创新药试验数据所有人以其药品试验数据申请药品上市的权利。在药品试验数据保护期内,禁止提出该创新药的学名药上市申请,以保障创新药研发企业在此期间内收回研发药品的投资。通过分析《TRIPS协定》《北美自由贸易协定》《美国—中美洲自由贸易协定》中关于药品试验数据保护的规定,从公共健康的角度梳理了药品试验数据保护的例外限制及强制许可制度。在比较药品试验数据独占保护和非独占保护两种模式的基础上对我国药品试验数据保护制度的完善提出了建议。
[Abstract]:Drug test data protection is another form of intellectual property protection provided by the government to encourage drug innovation outside the patent right. The exclusive right to drug test data refers to the exclusive right to drug testing data for a certain period of time. The owner of the innovative drug test data shall be granted the right to apply for the listing of the drug on the basis of his drug test data. During the period of protection of the drug test data, it shall be prohibited to apply for the listing of the drug under the scientific name of the innovative drug, In order to ensure that innovative drug R & D enterprises recover their investment in R & D during this period. By analyzing the provisions of the North American Free Trade Agreement (NAFTA) on the protection of drug testing data in the United States-Central America Free Trade Agreement (NAFTA), From the perspective of public health, the exception limitation and compulsory licensing system of drug test data protection are combed. On the basis of comparing the two modes of exclusive protection and non-exclusive protection of drug test data, the data protection of drug test in China is given. Suggestions are put forward for the perfection of the system.
【作者单位】：中国人民大学法学院;
【分类号】：D997.1

【相似文献】