论生物制药知识产权保护与公共健康的冲突与协调
发布时间：2018-10-08 09:55
【摘要】：随着全球范围内知识经济的快速发展,经济和科技全球化贸易自由化进程加快,知识产权可谓是无处不在,知识产权的重要性也被各国重视起来。知识产权也渐渐成为衡量综合国力的一项重要指标,发达国家更是把知识产权作为处理国际政治和经济关系的重要手段。TRIPS协议成为WTO成员国都必须遵守的知识产权准则。在生物制药领域也不例外,生物制药的知识产权保护和TRIPS协议成为近年的热议问题,而其中争议最多的就是生物制药知识产权保护和公共健康的关系问题。 本文正文部分分为四章：第一章介绍生物制药知识产权保护和公共健康的现状,及国际上与公共健康相关的药品知识产权保护立法。公共健康危机一次次的爆发,专利药厂商和发达国家在危机中的表现不尽如人意,引起了全世界人民对药品知识产权过度保护的不满。第二章着重论述了生物制药的知识产权保护和公共健康的辩证关系,具体阐述了知识产权保护对公共健康的积极促进作用,而后本文从三方面论述了药品知识产权保护和公共健康的矛盾。世界主要知名制药企业都是来自美国和欧洲,第三章分别介绍了美国和欧盟平衡药品知识产权保护和公共健康矛盾的宝贵实践经验及其主要法律制度及完善过程。美国是全世界药品专利最多的国家,也是生物制药产业最发达的国家,这些繁荣的背后是与之相适应的专利保护制度在支撑着,本文主要介绍了影响美国生物制药行业的美国Hatch-Waxman法案、仿制药简化申请制度、Bolar例外和《仿制药实施法》。欧盟的仿制药发展对降低药品价格、保护公共健康利益和SPC制度对专利的保护和补偿也是值得我们去研究和借鉴的。我国知识产权保护起步比较晚,但是我国用20年的时间走过了发达国家历经100年的知识产权发展路程。第四章从我国《专利法》的三次修改对生物制药行业的影响引出我国药品知识产权保护和公共健康关系平衡的探讨,面对不断发展变化的国际国内形势,如何依法保护药品知识产权兼顾社会公共健康利益,促进药品研发技术创新和应用。作者提出针对性对策并最终得出结论。
[Abstract]:With the rapid development of the global knowledge economy and the acceleration of the trade liberalization process of economic and technological globalization, intellectual property rights are everywhere, and the importance of intellectual property rights has also been attached importance to by all countries. Intellectual property rights have gradually become an important indicator to measure the comprehensive national strength. Developed countries regard intellectual property rights as an important means to deal with international political and economic relations. Trips Agreement has become the intellectual property standards that all WTO member countries must abide by. In the field of biopharmaceuticals, the intellectual property protection and TRIPS agreement of biopharmaceuticals have become a hot issue in recent years, and the most controversial issue is the relationship between intellectual property protection and public health of biopharmaceuticals. The main body of this paper is divided into four chapters: the first chapter introduces the current situation of intellectual property protection and public health of biopharmaceuticals, as well as the international legislation on the protection of pharmaceutical intellectual property rights related to public health. The public health crisis broke out time and again, and the performance of patent drug manufacturers and developed countries in the crisis was unsatisfactory, which caused the people all over the world dissatisfied with the over-protection of intellectual property rights. The second chapter focuses on the dialectical relationship between intellectual property protection and public health of biopharmaceuticals, and expounds the positive role of intellectual property protection in promoting public health. Then this paper discusses the contradiction between intellectual property protection and public health in three aspects. The main famous pharmaceutical enterprises in the world are from the United States and Europe. Chapter three introduces the valuable practical experience of balancing the contradiction between intellectual property protection and public health in the United States and the European Union, as well as the main legal system and the process of perfection. The United States is the country with the largest number of drug patents in the world and the most developed country in the biopharmaceutical industry. Behind these prosperity are the corresponding patent protection systems. This paper mainly introduces the Hatch-Waxman Act of the United States, the simplified application system of generic drugs, the exception of Hatch-Waxman and the implementation of generic drugs Act, which affect the biopharmaceutical industry in the United States. The development of generic drugs in the European Union is also worthy of our study and reference to reduce the price of drugs, protect the public health benefits and the patent protection and compensation of the SPC system. China's intellectual property protection started late, but it took 20 years for China to go through 100 years of intellectual property development in developed countries. Chapter four discusses the balance between the protection of pharmaceutical intellectual property rights and public health from the impact of the three revisions of the Patent Law on the biopharmaceutical industry, and faces the ever-changing international and domestic situation. How to protect the intellectual property rights of drugs according to law and give consideration to the social public health interests and promote the innovation and application of drug research and development technology. The author puts forward targeted countermeasures and finally draws a conclusion.
【学位授予单位】：中国政法大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：D923.42;D996;R-051
[Abstract]:With the rapid development of the global knowledge economy and the acceleration of the trade liberalization process of economic and technological globalization, intellectual property rights are everywhere, and the importance of intellectual property rights has also been attached importance to by all countries. Intellectual property rights have gradually become an important indicator to measure the comprehensive national strength. Developed countries regard intellectual property rights as an important means to deal with international political and economic relations. Trips Agreement has become the intellectual property standards that all WTO member countries must abide by. In the field of biopharmaceuticals, the intellectual property protection and TRIPS agreement of biopharmaceuticals have become a hot issue in recent years, and the most controversial issue is the relationship between intellectual property protection and public health of biopharmaceuticals. The main body of this paper is divided into four chapters: the first chapter introduces the current situation of intellectual property protection and public health of biopharmaceuticals, as well as the international legislation on the protection of pharmaceutical intellectual property rights related to public health. The public health crisis broke out time and again, and the performance of patent drug manufacturers and developed countries in the crisis was unsatisfactory, which caused the people all over the world dissatisfied with the over-protection of intellectual property rights. The second chapter focuses on the dialectical relationship between intellectual property protection and public health of biopharmaceuticals, and expounds the positive role of intellectual property protection in promoting public health. Then this paper discusses the contradiction between intellectual property protection and public health in three aspects. The main famous pharmaceutical enterprises in the world are from the United States and Europe. Chapter three introduces the valuable practical experience of balancing the contradiction between intellectual property protection and public health in the United States and the European Union, as well as the main legal system and the process of perfection. The United States is the country with the largest number of drug patents in the world and the most developed country in the biopharmaceutical industry. Behind these prosperity are the corresponding patent protection systems. This paper mainly introduces the Hatch-Waxman Act of the United States, the simplified application system of generic drugs, the exception of Hatch-Waxman and the implementation of generic drugs Act, which affect the biopharmaceutical industry in the United States. The development of generic drugs in the European Union is also worthy of our study and reference to reduce the price of drugs, protect the public health benefits and the patent protection and compensation of the SPC system. China's intellectual property protection started late, but it took 20 years for China to go through 100 years of intellectual property development in developed countries. Chapter four discusses the balance between the protection of pharmaceutical intellectual property rights and public health from the impact of the three revisions of the Patent Law on the biopharmaceutical industry, and faces the ever-changing international and domestic situation. How to protect the intellectual property rights of drugs according to law and give consideration to the social public health interests and promote the innovation and application of drug research and development technology. The author puts forward targeted countermeasures and finally draws a conclusion.
【学位授予单位】：中国政法大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：D923.42;D996;R-051
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