《跨太平洋伙伴关系协定》下药品知识产权保护规则研究

发布时间：2018-02-10 21:56

本文关键词： TPP 国际药品贸易知识产权专利数据独占权　出处：《武汉大学》2017年硕士论文　论文类型：学位论文

【摘要】：本文旨在研究跨太平洋伙伴关系协定(Trans-Pacific Partnership Agreement,TPP)下的药品知识产权保护规则。目前,国内外学者对TPP协定中药品知识产权保护专章的研究取得了一定成果,但从总体上对TPP协定中知识产权,特别是药品专利权和试验数据保护问题的研究还不够充分。TPP协定是签订协议的发达国家与发展中国家相互妥协的产物,认真研究TPP协定中知识产权制度对中国更好地应对药品全球化趋势、突围发达国家专利防火墙并构建中国特色国际贸易领域的药品知识产权保护制度有着重要意义;随着特朗普上台及美国做出退出TPP协定的决定,TPP的未来似乎并不光明,TPP条款影响力或有所减弱,但已签署TPP协定的国家仍在环太平洋地区药品贸易中占有重要份额,也并不排除未来中国加入TPP的可能性,TPP协定条款仍将对全球药品知识产权保护进程产生不可忽视的重要影响。本文共分为五章:第一章概述了国内外的研究现状,指出本文的研究方法与创新性,第二章概述了全球药品贸易现状与趋势,阐述了药品知识产权保护的定义和必要性,厘清本文的研究对象,确立本文的研究基础;第三章是对TPP协定中药品知识产权保护条款主要内容的翻译、分析及研究,辨析了 TPP协定与现行国际条约特别是TRIPs协议中药品知识产权保护的异同,凸显了 TPP协定药品知识产权保护条款的先进性,其对药品的知识产权保护程度突破了传统国际条约与国际协定的范畴,其严格性是史无前例的,是本文的核心内容与价值所在;第四章对TPP与药品相关规则的正负效应做出评价;第五章详述了 TPP协定药品知识产权保护条款与我国规定的差异,对中国国际贸易协定中药品知识产权保护条款的启示,及其对中国中医药和仿制药行业的影响,为中国应对TPP协定中药品知识产权保护高要求做铺垫,为中国构建和完善现行药品贸易知识产权保护制度提出可能的解决方案。本文在借鉴前人研究成果的基础上对药品专利保护的概念和意义进行辨析,从专利权、药品试验数据保护与强制许可规定等方面研究了 TPP协定中药品知识产权保护架构,探讨TPP有关条款与现行国际条约的异同,并指出TPP协定知识产权专章中药品专利保护条款的创新与不足之处,发掘TPP协定有关条款的对中国定立国际贸易协定中药品知识产权保护条款的借鉴意义,力图找出中国对TPP协定有关条款的应对措施并加以完善。
[Abstract]:The purpose of this paper is to study the rules of pharmaceutical intellectual property protection under Trans-Pacific Partnership Agreement. At present, some achievements have been made by domestic and foreign scholars on the special chapter on the protection of pharmaceutical intellectual property rights in the TPP Agreement. However, the overall study of intellectual property rights in the TPP Agreement, especially the protection of drug patents and experimental data, is not enough. The agreement is a product of compromise between the developed and developing countries that have signed the agreement. It is of great significance for China to deal with the trend of drug globalization, break through the patent firewall of developed countries and construct the protection system of pharmaceutical intellectual property rights in the field of international trade with Chinese characteristics. With Trump taking power and the United States taking the decision to withdraw from the TPP, the future of the TPP does not seem to be bright or weakened, but the countries that have signed the TPP still account for an important share of the drug trade in the Pacific Rim. Nor does it rule out the possibility that China's accession to the TPP agreement will still have a significant impact on the process of global drug intellectual property rights protection. This paper is divided into five chapters: chapter one summarizes the current research situation at home and abroad. The second chapter summarizes the current situation and trend of global drug trade, expounds the definition and necessity of drug intellectual property protection, clarifies the research object of this paper, and establishes the research foundation of this paper. The third chapter is the translation, analysis and research of the main contents of the drug intellectual property rights protection clause in the TPP Agreement, and differentiates the similarities and differences between the TPP Agreement and the existing international treaties, especially the TRIPs agreement, on the protection of pharmaceutical intellectual property rights. It highlights the advanced nature of the pharmaceutical intellectual property protection clause in the TPP Agreement, and its degree of intellectual property protection for drugs breaks through the scope of traditional international treaties and international agreements, and its strictness is unprecedented. Chapter 4th evaluates the positive and negative effects of TPP and drug-related rules. Chapter 5th details the differences between the provisions of the TPP Agreement on the protection of pharmaceutical intellectual property rights and the provisions of China. The enlightenment to the protection of pharmaceutical intellectual property rights in China's international trade agreement, and its impact on Chinese traditional medicine and generic medicine industry, will pave the way for China to respond to the high requirements for the protection of pharmaceutical intellectual property rights in the TPP Agreement. This paper analyzes the concept and significance of drug patent protection on the basis of the previous research results, and analyzes the concept and significance of drug patent protection from the perspective of patent right in the light of the previous research results, and puts forward a possible solution for the construction and improvement of the current intellectual property protection system of drug trade in China. From the aspects of data protection and compulsory licensing of drug testing, this paper studies the framework of drug intellectual property protection in the TPP Agreement, and probes into the similarities and differences between the relevant provisions of TPP and the existing international treaties. It also points out the innovation and deficiency of the pharmaceutical patent protection clause in the intellectual property rights special chapter of the TPP Agreement, and explores the reference significance of the relevant provisions of the TPP Agreement for the protection of pharmaceutical intellectual property rights in the international trade agreement established by China. Try to find out China's response to the provisions of the TPP Agreement and improve it.
【学位授予单位】：武汉大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D997.1

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