药品专利链接制度的移植与创制

发布时间：2018-01-26 04:44

本文关键词： 专利链接原研药学名药公共健康药品注册管理办法　出处：《政治与法律》2017年08期 　论文类型：期刊论文

【摘要】：药品专利链接制度属于美国力推的TRIPS-Plus规则,它强化了原研药的专利保护水平,直接影响学名药的上市。不同国家的药品专利链接制度产生了不同的经济后果。在比较法上,欧盟与印度等国反对专利链接制度,其本质是保护国内的学名药(或仿制药)产业。在不负有相应的国际义务、国内制药业以学名药生产为主的背景下,我国应该慎言移植美国式的药品专利链接制度;药品专利链接制度为知识产权保护的重大变化,不宜通过制定行政规章的方式进行制度移植。我国应废除《药品注册管理办法》的相关规定,且不宜在我国《专利法》上将申请药品上市的行为规定视为侵犯专利权的行为,而应在我国《药品管理法》中建立以信息公示为中心的专利链接制度。
[Abstract]:The drug patent link system belongs to the TRIPS-Plus rule pushed by the United States, which strengthens the patent protection level of the original drug. Different countries have different economic consequences of drug patent link system. In comparative law, the European Union and India and other countries oppose the patent link system. Its essence is to protect the domestic generic medicine (or generic medicine) industry, in the absence of corresponding international obligations, the domestic pharmaceutical industry to the production of generic medicine background. Our country should be careful to transplant the American-style drug patent link system; The drug patent link system is a major change in the protection of intellectual property rights, so it is not appropriate to transplant the system by making administrative rules and regulations. China should abolish the relevant provisions of the measures for the Administration of Drug Registration. Moreover, it is not appropriate to regard the regulation of the application for drug listing as an infringement of patent right in the Patent Law of China, but to establish a patent link system with information publicity as the center in the Drug Administration Law of our country.
【作者单位】：南京师范大学法学院;
【基金】：中国法学会2015年项目“药品创新激励机制研究”[项目编号:CLS(2015)D129]的中期研究成果
【分类号】：D922.16
【正文快照】： 一、问题的提出药品专利链接(patent linkage),是指依据有些国家的法律规定,药品行政主管部门将药品上市申请的批准条件与该药品受专利保护的地位相联系,如果涉嫌侵犯专利权,就不会批准药品的上市申请。(1)通常情况下,驳回申请的原因并不是该药品不符合安全性、有效性和质量

【相似文献】