论我国药品专利强制许可制度的实施

发布时间：2018-06-15 03:01

本文选题：药品专利 + 强制许可　；参考：《西南大学》2014年硕士论文

【摘要】：经济全球化在推动各国快速发展的同时,也导致因人口激增和频繁性跨国流动引起的传染性疾病跨区域爆发。这一现象在缺乏先进医药技术和资金投入的发展中国家和最不发达国家表现得尤为突出。我国作为其中的典型国家之一,面对近年来多次爆发的公共健康危机,如何让患者及时获取廉价有效的药品成为亟待解决的问题。然而,制药企业技术水平与资金的有限性,导致发生公共健康危机时,我国不能立刻为患者提供有效的药品,而其他国家疗效显著的专利药品因价格过高只能让患者望而却步。为提高国人的药品可及性,同时又不损害专利权人的合法利益,实施药品专利强制许可制度成为重要的解决途径。自世界贸易组织(WTO)签署的《与贸易有关的知识产权协定》及之后达成的一系列协议给予成员国实施药品专利强制许可的权利后,一些发达国家和发展中国家就已通过实施该制度达到了限制专利权滥用、保障公共健康的目的。如美国为对抗炭疽病毒感染而与德国拜耳公司进行了以实施强制许可相威胁的谈判,最终迫使拜耳公司主动降低药价；泰国针对心脏病的治疗药品签发了抗心脏病药品“波立维”的专利强制许可。两国在减轻国内医疗保险负担的同时,也满足了患者对药品的需求,降低了因缺乏药物导致的死亡率。然而,当别国通过实施药品专利强制许可而为保障公共健康作出努力时,我国仍然对该制度保持着仅限于纸面的态度。从制度层面分析,TRIPS协定对实施专利强制许可的条件、程序、种类等都作出了规定。作为TRIPS协定的成员国,我国在借鉴其规定的基础上已初步形成了《专利法》、《专利法实施细则》和《专利实施强制许可办法》为主的专利强制许可制度体系。从社会层面分析,近年来突发性公共健康危机的增加,患者对专利药品的需求增大,为实施药品专利强制许可制度提供了市场基础。那么导致我国至今尚未实施药品专利强制许可制度的原因到底是什么?通过哪些途径可以改善我国已有的现状?为应对将来发生的公共健康危机可能引起的药品供应不足,为促使我国医药企业能够更快的学习先进的医药技术,也为使我国已有的法律制度得以实施。本文试图通过比较分析国外与我国药品专利强制许可的实施状况,探讨我国未实施该制度的问题之所在,从而为完善我国药品专利强制许可制度的实施提出建议。具体研究如下：第一部分,分析药品专利强制许可制度实施的相关概念、国际国内背景及实施的必要性；第二部分,分析我国实施该制度的现实困境；第三部分,介绍部分发达国家与发展中国家的制度实施情况并总结经验；第四部分,通过借鉴国外制度与具体实施的经验,提出推进我国药品专利强制许可制度实施的途径。
[Abstract]:Economic globalization not only promotes the rapid development of countries, but also leads to cross-regional outbreaks of infectious diseases caused by population explosion and frequent transnational mobility. This phenomenon is especially evident in developing countries and least developed countries which lack advanced medical technology and capital investment. As one of the typical countries, in the face of the public health crisis which broke out many times in recent years, how to get cheap and effective drugs in time has become an urgent problem. However, due to the limited technical level and capital of pharmaceutical enterprises, when public health crisis occurs, our country can not provide effective drugs for patients immediately, and other countries can only put off the patients because of the high price of patented drugs with remarkable curative effect. In order to improve the availability of drugs without harming the legitimate interests of the patentee, the enforcement of the compulsory licensing system of drug patents has become an important solution. Since the Agreement on Trade-Related aspects of intellectual property Rights (trips Agreement) signed by the World Trade Organization (WTO) and a series of subsequent agreements giving member States the right to enforce compulsory licensing of pharmaceutical patents, Some developed and developing countries have implemented the system to limit patent abuse and protect public health. For example, in order to combat anthrax infection, the United States and Germany Bayer company to carry out the threat of mandatory licensing negotiations, eventually forced Bayer to take the initiative to reduce drug prices; Thailand has issued a patent enforcement license for the anti-heart drug Polyvir. While reducing the domestic health insurance burden, the two countries also meet patients' demand for drugs and reduce mortality caused by lack of drugs. However, when other countries make efforts to protect public health by enforcing compulsory licensing of drug patents, our country still maintains a paper attitude towards the system. This paper analyzes the conditions, procedures and types of compulsory patent licensing in trips. As a member of trips Agreement, China has formed a patent compulsory licensing system based on the provisions of the trips Agreement, including the Patent Law, the detailed rules for the implementation of the Patent Law and the measures for compulsory Patent Licensing. From the social level, in recent years, with the increase of sudden public health crisis, patients' demand for patented drugs increases, which provides a market basis for the implementation of the compulsory licensing system of drug patents. So what is the reason why China has not yet implemented the compulsory licensing system of drug patents? Through what ways can we improve the existing situation in China? In order to deal with the shortage of medicine supply caused by the public health crisis in the future, to promote the Chinese pharmaceutical enterprises to learn the advanced medicine technology more quickly, and to make the existing legal system of our country carry out. This paper attempts to compare and analyze the implementation of drug patent compulsory licensing in foreign countries and in China, and to discuss the problems that have not been implemented in our country, so as to put forward some suggestions for perfecting the enforcement of compulsory drug patent licensing system in China. The concrete research is as follows: the first part, analyzes the related concept, the international and domestic background and the implementation necessity of the drug patent compulsory license system; the second part, analyzes the realistic predicament of the implementation of this system in our country; the third part, the third part, This paper introduces the implementation of the system in some developed and developing countries and summarizes the experience. The fourth part puts forward the ways to promote the enforcement of compulsory licensing system of drug patents in our country by learning from the experience of foreign institutions and concrete implementation.
【学位授予单位】：西南大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D923.42

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