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中美药品专利链接制度研究
Study on the Pharmaceutical Patent Linkage System between China and the United States
【摘要】 医药产业与社会公众健康权息息相关,但由于对新药的专利保护与社会公众利益之间存在矛盾,故仿制药便成为解决这一矛盾的重要手段。药品专利链接制度就是在实现保障制药企业的专利权、激发企业的研发热情的同时,将更多的仿制药迅速推向市场,减少仿制药被诉侵权风险,降低药价,从而增强药品的可获得性,维护和保障社会公众的健康权。本文阐述了药品专利链接制度相关的基本理论以及该制度的产生和发展过程,对比了美国构建药品专利链接制度的经验教训,并扬长避短依照我国国情提出了完善该制度的合理建议。
【Abstract】 Pharmaceutical industry is closely related to public health right. However, there are contradictions between patent protection of new drugs and public interests. So generic drugs can be a significant way to resolve this contradiction. Pharmaceutical patent linkage system is a way of getting more generic drugs to market, reducing the risk of accused infringement for generic drugs, cutting drug prices on the basis of protecting drug patents of pharmaceutical companies and stimulating their enthusiasm for drug research and development, thereby enhancing availability of drugs and safeguard public health right. By means of illuminating basic theories related to pharmaceutical patent linkage system, combining with its emerging background and development process, and also,referring to experience and lessons of establishing pharmaceutical patent linkage system in the United States, this paper seeks to puts forward reasonable proposals on perfecting this system based on our national conditions.
【Key words】 pharmaceutical patent linkage system; drug registration and approval; balance of interests;
- 【文献出处】 科技与法律 ,Science Technology and Law , 编辑部邮箱 ,2018年01期
- 【分类号】D923.4;D971.2;DD913
- 【被引频次】44
- 【下载频次】1284