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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。
Objective To compare the protection and challenge of patent rights in the process of the listing of generic drugs between China and the United States by using Lipitor as an example to discuss the patent protection of the original research company, invalid patent rights of generic drug companies and the system of drug patent linkage in various countries. Methods To search the layout of original research patent of Lipitor, the patent layout of the first imitation enterprise in China and the United States, the patent invalidation and the patent litigation judgment in the first imitation retrieval process. Based on the analysis and arrangement of the original documents, the common name listing process In the patent law, market and management analysis. Results and Conclusion With the upgrading of generic pharmaceutical industry in China, the challenge of overseas new drug application and patent right and the increase of mergers and acquisitions, domestic pharmaceutical companies need to accumulate domestic and foreign patent strategies in the imitation process. At the same time, In terms of development, the domestic legal environment should also be further improved to help domestic pharmaceutical companies participate in the competition in the global market.