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药品专利常青化策略及应对之探讨 被引量:10

Discussion on the Strategies and Solutions of Evergreening of Drug Patent
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摘要 药品专利常青化指的是品牌药制药商为了延长其核心药物的专利期或者市场独占期而采取的法律和商业措施,这些措施会阻碍相关仿制药进入市场,使得药品价格居高不下,进而对公共健康产生负面影响。本文采用了比较法研究、案例研究等方法,介绍了国外实践中制药企业常采取的专利常青化策略,以诺华案为例评述了印度法院对次级专利是否具有创新性的判断过程;分析了专利常青化的影响,并对各国对于常青专利的应对措施做了梳理;最后结合我国医药产业的发展现状,从事前和事后两方面,探讨了我国应对常青化专利的态度以及可采取的措施。 Evergreening of drug patent is any of legal and commercial measures by which branded drug producers extend patent period or market exclusivity of core drugs.These measures could have a negative impact on public health by preventing generic drugs from entering the market and keeping drug prices high.Using the methods of comparative legal research and case study,this paper introduces strategies of patent evergreening which are often adopted by pharmaceutical companies in foreign practice,and takes the case of Novartis AG v.Union of India as an example to review the judgment process of Indian court on whether the secondary patent is innovative or not.This paper analyzes the influences of patent evergreening and sorts out the countermeasures to evergreen patent in various countries.Finally,based on the development status of Chinese pharmaceutical industry,this paper discusses China1 s attitude and measures to be taken to evergreen patent from pre-and post-event aspects.
作者 李蓓 易继明 LI Bei;YI Ji-ming(School of Law,Peking University,Beijing 100000,China)
机构地区 北京大学法学院
出处 《科技与法律》 CSSCI 2019年第1期1-10,共10页 Science Technology and Law
关键词 专利常青 次级专利 审查标准 利益平衡 patent evergreening secondary patent review standard balance of interest
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