中美通用名药产业发展中的专利权挑战

发布时间：2018-02-15 00:29

本文关键词： 专利权挑战通用名药专利无效专利链接　出处：《中国药学杂志》2016年16期 　论文类型：期刊论文

【摘要】：目的以立普妥为例比较中美通用名药上市过程中的专利权保护与挑战,探讨原研公司的专利药保护、仿制药企业的专利权无效以及各国的药品专利链接制度。方法检索立普妥的原研药专利布局、中美首仿企业的专利布局,检索首仿过程中的专利无效及专利诉讼判决,在对原始文献进行分析和整理的基础上,开展通用名上市过程中的专利法律、市场与管理等分析。结果与结论随着我国通用名药产业升级、海外新药申请与专利权挑战、并购逐渐增多,国内制药企业需要积累仿制过程中的国内外专利策略,同时,药品管理部门在促进国内通用名药产业发展上,也应当进一步完善国内的法律环境,以帮助国内的制药企业参与全球市场的竞争。
[Abstract]:Objective to compare patent protection and challenges in the marketing process of Chinese and American generic drugs with Lipitor as an example, and to explore patent drug protection of the original research company. Methods the patent layout of the original research drug of Lipitor, the patent layout of the first imitation enterprise in China and the United States, the invalid patent in the first imitation process and the patent litigation judgment were searched. On the basis of the analysis and arrangement of the original documents, the patent law, market and management in the process of general name listing are analyzed. Results and conclusions with the upgrading of the generic drug industry in China, the overseas new drug application and patent challenge. Mergers and acquisitions are gradually increasing, domestic pharmaceutical enterprises need to accumulate patent strategies at home and abroad in the process of imitation. At the same time, in promoting the development of domestic generic pharmaceutical industry, the drug management department should further improve the domestic legal environment. To help domestic pharmaceutical companies participate in the global market competition.
【作者单位】：专利审查协作北京中心;北京国之专利预警咨询中心;
【分类号】：R95

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