药品注册管理与药品专利保护的关系研究

发布时间：2019-02-19 17:07

【摘要】：药品发明是高风险、长周期、大投资的,该领域的发明对知识产权的依赖性非常高。而药品作为一类特殊的商品,其质量可控性、安全性、有效性只有在药品监督管理部门进行全面的检查后,才可批准其上市销售。但是在进行上市许可审查的过程中,如果出现审批药品涉及其他人的专利,这时的行政注册行为肯定会影响药品专利的保护状态。因此，对于怎样协调药品注册管理与其专利保护之间的关系这对于给予药品专利权人的合法权益、保护新药研发单位的积极性和仿制药生产商的积极性都有很强的促进作用。本论文采用的主要的研究方法是,历史研究分析法,分析比较研究法、实例分析法等。本文一共分为下面5个部分：第一个部分从药品注册管理和专利保护的基本概念入手,主要梳理了我国药品注册管理制度的变迁回顾和药品专利保护的历史沿革。第二部分首先通过分析药品注册管理和专利保护的关系,阐述了两者的联系、区别及交叉影响,然后分析了协调处理两者的关系理念是利益平衡原则。第三部分主要概述了我国《药品注册管理法》中专利相关问题的规定,和现有制度与实际操作中的不足。第四部分详细论述了美国药品专利链接制度和专利期延长制度,通过中、美相关制度的比较研究,提出我国有必要借鉴国外的有益经验,构建妥善处理药品注册与专利保护关系的制度。第五部分就如何协调药品专利保护与药品注册审批之间的关系提出了一些合理的建议,主要包括完善药品注册管理制度,和对我国是否建立药品专利期延长制度进行了思考。
[Abstract]:Pharmaceutical invention is high risk, long-term, large investment, the field of invention is highly dependent on intellectual property rights. As a special kind of commodities, the quality control, safety and effectiveness of drugs can only be approved after the drug supervision and administration departments conduct a comprehensive inspection. However, in the process of listing license examination, if the approval of drugs involves other people's patents, then the administrative registration behavior will definitely affect the state of drug patent protection. Therefore, how to coordinate the relationship between drug registration management and patent protection has a strong role in promoting the legal rights and interests of drug patentees, protecting the enthusiasm of new drug research and development units and the enthusiasm of generic drug manufacturers. The main research methods used in this paper are the historical analysis method, the comparative analysis method, the case analysis method and so on. This paper is divided into the following five parts: the first part starts with the basic concepts of drug registration management and patent protection, mainly combing the changes of drug registration management system and the history of drug patent protection in China. The second part analyzes the relationship between drug registration management and patent protection, expounds the relationship, difference and cross-influence between the two, and then analyzes that the concept of coordinating the relationship between the two is the principle of balance of interests. The third part mainly summarizes the provisions of patent related issues in the Drug Registration and Administration Law of our country, and the deficiencies in the existing system and practice. The fourth part discusses the drug patent link system and patent extension system in the United States in detail. Through the comparative study between China and the United States, the author points out that it is necessary for our country to learn from the beneficial experience of foreign countries. To establish a system to properly handle the relationship between drug registration and patent protection. The fifth part puts forward some reasonable suggestions on how to coordinate the relationship between drug patent protection and drug registration examination and approval, mainly including perfecting the drug registration management system and thinking about whether to establish the drug patent extension system in our country.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R95

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