药品专利强制许可中的法律问题

发布时间：2019-03-15 20:27

【摘要】：20世纪后半期开始,伴随着世界人口大规模的自由流动,以及科技、环境、经济等诸多原因,传染性疾病也开始在全球蔓延开来。众所周知,多数发展中国家及不发达国家国内欠缺完善的公共保健措施,而高药价使其无法从外部获得所需的药品,所以基础药品的缺失在一定程度上引发了全球性的健康危机。“药品专利强制许可制度”就在于解决公共健康危机的核心——药品在世界范围内的普及问题。所以在当前环境下探讨“药品专利强制许可制度”中的法律问题具有很高的现实意义。本论文分别从理论以及案例层面阐述了“药品专利强制许可”的必要性问题、标准问题、程序问题等,并结合国际条约以及国内法给出相应对策,以期为“药品专利强制许可制度”的推广提供有益的思路。导论部分简要介绍了本文的研究背景,即国际及国内公共健康卫生共同面临的药价过高和通用药缺乏的困境,并以案例引出了药品专利强制许可在推广中的法律问题及其争执点。第一章首先提出了药品专利强制许可中的突出问题。简要介绍了药品专利强制许可的必要性、以及药品专利强制许可标准问题与程序问题中的问题点。第二章首先以法理探讨的方式说明了药品专利强制许可的必要性在于保障人的基本权利与保护社会公共利益,并且驳斥了药品专利强制许可阻碍反垄断法的观点。本文随后对药品专利强制许可的标准问题进行了详细的分析,并结合国际条约,明确了现行的弹性标准不利于启动颁布药品专利强制许可,并得出了应当将药品强制许可标准明朗化、国际化,方有利于使强制许可的价值发挥到最大化,同时防止专利权人利用一切可能性滥用权利。之后,本文又针对药品强制许可中相关程序的合法性问题进行了深入分析。第三章以《涉及公共健康问题的专利实施强制许可办法》文本出发,指出现阶段我国仅规定了不完整的药品专利强制许可标准,且缺乏必要的救济程序规定,只能援引参照我国《专利法》的相关规定。笔者建议我国今后的立法动向应该充分利用TRIPs协定赋予的自主权,保护我国的社会公共利益。第四章是结论部分。明确了药品专利强制许可制度是发展中国家和不发达国家应对全球性健康危机和在国际药品贸易寻求优势的关键。
[Abstract]:At the beginning of the second half of the 20th century, along with the large-scale free movement of the world's population, as well as many reasons such as science and technology, environment, economy and so on, infectious diseases began to spread all over the world. It is well known that most developing and least developed countries lack adequate public health-care measures and that high drug prices prevent them from obtaining the medicines they need externally, Therefore, the lack of basic drugs to a certain extent triggered a global health crisis. The compulsory licensing system of pharmaceutical patent lies in the core of solving the public health crisis-the popularization of drugs all over the world. Therefore, it is of great practical significance to probe into the legal problems in the compulsory licensing system of pharmaceutical patents in the current environment. This paper expounds the necessity, standard and procedure of compulsory licensing of pharmaceutical patents from the theoretical and case levels, and puts forward the corresponding countermeasures in combination with international treaties and domestic laws. In order to provide a useful idea for the promotion of the compulsory licensing system of pharmaceutical patents. The introduction briefly introduces the research background of this paper, that is, the international and domestic public health is confronted with the dilemma of high drug price and lack of common drugs. The legal problems of compulsory licensing of pharmaceutical patents in the promotion and the points of contention are also introduced in this paper. The first chapter puts forward the outstanding problems in the compulsory licensing of pharmaceutical patents. This paper briefly introduces the necessity of compulsory licensing of pharmaceutical patents, as well as the problems in the standard and procedure of compulsory licensing of pharmaceutical patents. The second chapter explains that the necessity of compulsory licensing of pharmaceutical patents lies in the protection of human rights and the protection of public interests, and refutes the view that compulsory licensing of pharmaceutical patents hinders the anti-monopoly law. In this paper, the issue of compulsory licensing standards for pharmaceutical patents is analyzed in detail, and combined with international treaties, it is clear that the current elastic standards are not conducive to the initiation of the promulgation of compulsory licensing of pharmaceutical patents. It is concluded that the compulsory licensing standards should be clarified and internationalized in order to maximize the value of compulsory licensing and prevent patentees from using all possibilities to abuse their rights. After that, this paper makes a deep analysis on the legality of the related procedures in the compulsory licensing of drugs. The third chapter begins with the text of "compulsory licensing measures for patent enforcement involving public health issues", pointing out that at the present stage, only incomplete compulsory licensing standards for pharmaceutical patents have been prescribed in our country, and the necessary relief procedures are lacking. Reference can only be made to the relevant provisions of the Patent Law of our country. The author suggests that the future legislative trend of our country should make full use of the autonomy conferred by the TRIPs Agreement to protect the social and public interests of our country. The fourth chapter is the conclusion. It is clear that the compulsory licensing system of pharmaceutical patents is the key for developing countries and underdeveloped countries to deal with the global health crisis and to seek advantages in international drug trade.
【学位授予单位】：天津师范大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：D997.1

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