仿制药的专利侵权风险防范问题研究

发布时间：2018-06-24 03:53

本文选题：药品专利 + 仿制药　；参考：《华中科技大学》2013年硕士论文

【摘要】：TRIPS协议将药品纳入了专利保护范围之后，仿制药工业的知识产权风险变得突出，同时专利药的价格上涨，，引起了发展中国家的用药紧张和公共健康危机。尽管之后的《TRIPS协议与公共健康多哈宣言》及《关于TRIPS协议和公共健康多哈宣言第六段的执行决议》提出了发展中成员要求防止滥用知识产权阻碍社会经济发展的愿望，但仍有许多具体适用上的限制性规定或障碍。在医疗开支居高不下的压力和大批医药专利即将到期的利好形势下，仿制药已受到包括发达国家和发展中国家的重视，近年来发展迅速。出于对本国大型制药公司的利益保护，发达国家对外仍推行高水平的知识产权保护水平，对于一些发展中国家利用TRIPS协议灵活性条款作出的医药专利强制许可等采取打压政策。本文就药品专利与公共健康之间的冲突原因和协调途径进行了分析和论证，并对我国相关的药品专利制度提出建议。作为人口大国，保障药品的可及性是我国面临的现实挑战。我国目前97%以上的国产药为仿制药。但是很多企业仍处于低水平重复仿制的状态，带有盲目性和风险性，不能充分掌握知识产权规则。通过对药品仿制过程中的专利风险进行分析与控制，我国相关制药企业能够有效防范专利侵权风险，取得经济效益和社会效益的最大化，为我国的公共健康事业作出贡献。
[Abstract]:After trips brought the drug into the scope of patent protection, the intellectual property risk of generic medicine industry became prominent, and the price of patent medicine increased, which caused the tension of drug use and public health crisis in developing countries. Although the subsequent Doha Declaration on trips and Public Health and the implementation resolution on trips and paragraph 6 of the Doha Declaration on Public Health set out the aspirations of developing members to prevent the abuse of intellectual property rights from impeding socio-economic development, However, there are still many restrictive provisions or obstacles to their specific application. Under the pressure of high medical expenditure and the favorable situation that a large number of medical patents are about to expire, generic drugs have been attached great importance to by both developed and developing countries, and have developed rapidly in recent years. In order to protect the interests of domestic large pharmaceutical companies, developed countries still implement a high level of intellectual property rights protection, and some developing countries take measures to suppress the compulsory licensing of pharmaceutical patents, which are made by some developing countries using the flexible terms of trips Agreement. This paper analyzes and proves the conflict between drug patent and public health and the ways of coordination, and puts forward some suggestions on the relevant drug patent system in China. As a large country with large population, it is a realistic challenge for our country to guarantee the accessibility of drugs. At present, more than 97% of domestic drugs in China are generic drugs. However, many enterprises are still in the state of low level repeated copying, with blindness and risk, unable to fully grasp the intellectual property rules. By analyzing and controlling the patent risk in the process of drug imitation, the related pharmaceutical enterprises in our country can effectively guard against the risk of patent infringement, maximize the economic and social benefits, and contribute to the public health in our country.
【学位授予单位】：华中科技大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：D923.42

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