我国药品专利强制许可实施问题研究

发布时间：2018-06-01 04:37

本文选题：专利法 + 强制许可　；参考：《中国社会科学院研究生院》2017年硕士论文

【摘要】：获得药物是保障疾病有效治疗的必要环节,如何提高药物的可及性是困扰发展中国家的一个重要问题。专利权具有独享性和垄断性,药品专利权是保护一个企业的长远发展和运行的重要手段。专利强制许可是专利授权的一种特殊情况,旨在防止专利人滥用专利权,并达到在专利人与公共利益之间的利益平衡。国际贸易组织在《多哈宣言》协议中明确指出国际贸易组织成员可使用药品专利强制许可的权利,从政治和法律等方面增强了发展中国家和不发达国家获得药物的能力。《多哈宣言》同时指出每个成员国当处于诸如艾滋病、疟疾、结核病和其他流行病等造成的公众健康危机时,即构成可以实施药品专利强制许可的“紧急状态”。我国目前艾滋病治疗现状严峻,一、二线抗病毒药物可及性存在严重问题,临床面临药物短缺问题和窘境。我国目前已积极开展抗艾滋病原研药物的开发、转化和上市。与此同时,使用药品专利强制许可是现阶段提高我国艾滋病药物可及性的备用手段,但我国在药品强制许可具体实施过程中存在诸多问题。本文将就药品专利权强制许可制度相关的国际条约、国内相关法律规定及实施现状展开研究和剖析,重点讨论我国在此领域可改进及完善法律规定和相关制度。首先,专利制度是国家通过法律授予的、为了保护由创造性工作而获得的权益,是市场经济制度的一部分。但当与社会公共利益发生冲突时,专利制度中的强制许可由此逐渐形成和发展。本文通过文献和法律典籍对专利强制许可制度的起源背景、发展历程、适用范围进行回顾和整理;以抗艾滋病药品可及性需求为例,分析我国实施药品专利强制许可的紧迫性和必要性。其次,基于我国艾滋病、结核病、病毒性肝炎及新发突发传染病等疫情的严峻形势,以我国相关立法情况和药品强制许可制度的现状为切入点,结合实际案例分析和讨论我国在规定和操作层面上存在的问题。再次,考虑到国际贸易摩擦等问题,各国对药品专利强制许可均采取审慎态度。本文将针对发达国家和发展中国家在涉及紧急状态或公共利益时采取的不同态度和强制许可实施经验进行对比、剖析和借鉴。最后,深入探讨我国作为发展中国家在立法和制度层面可针对药品专利强制许可进行改进,并对申请、操作、监督等具体实施环节进一步完善提出建议。再次以抗艾滋病药物专利强制许可为例,论证其对药物可及性提高的正面效应。本文旨在解析药品专利强制许可对现阶段我国提高药物可及性的意义,通过案例分析和经验借鉴,进而提出我国可在其立法及制度层面有待完善的建议,以避免将来发生严重公共卫生健康危机时所面临的法律问题。
[Abstract]:Obtaining drugs is a necessary link to ensure effective treatment of diseases. How to improve the accessibility of drugs is an important problem for developing countries. Patent right is exclusive and monopoly. Drug patent right is an important means to protect the long-term development and operation of an enterprise. Compulsory patent license is a special case of patent authorization, which aims at preventing patent holder from abusing patent right and achieving the balance of interests between patentee and public interest. In the Doha Declaration Agreement, the International Trade Organization explicitly stated the right of members of the International Trade Organization to use compulsory licensing of pharmaceutical patents, The political and legal capacity of developing and least developed countries to obtain medicines has been enhanced. The Doha Declaration also states that each member State should be placed in a situation such as AIDS, malaria, Public health crises caused by tuberculosis and other epidemics constitute a state of emergency for compulsory licensing of drug patents. The current situation of AIDS treatment in China is severe. First, the second line antiviral drugs have serious problems of accessibility, and the clinical drug shortage and dilemma. China has been actively engaged in the development of anti-AIDS drugs, transformation and marketing. At the same time, the compulsory licensing of drug patent is a standby means to improve the accessibility of AIDS drugs in China at present, but there are many problems in the implementation of compulsory drug licensing in China. This paper will study and analyze the international treaties related to the compulsory licensing system of drug patents, domestic relevant laws and regulations, and the status quo of their implementation, with a focus on the improvement and improvement of the legal provisions and related systems in this field in China. First of all, the patent system is granted by the state through the law, in order to protect the rights and interests obtained by creative work, it is a part of the market economy system. But when it conflicts with the public interest, the compulsory license in patent system is gradually formed and developed. This paper reviews and arranges the origin background, development course and applicable scope of compulsory patent licensing system through literature and legal records. Taking the demand for accessibility of anti-AIDS drugs as an example, This paper analyzes the urgency and necessity of compulsory licensing of drug patents in China. Secondly, based on the severe situation of AIDS, tuberculosis, viral hepatitis and new outbreaks of infectious diseases in China, the current situation of the relevant legislation and the compulsory licensing system of drugs in China are taken as the starting point. This paper analyzes and discusses the problems existing in the regulation and operation of our country based on the actual cases. Thirdly, considering the problems of international trade friction, countries take a prudent approach to compulsory licensing of drug patents. This paper compares the different attitudes and experiences of compulsory licensing between developed countries and developing countries when it comes to state of emergency or public interest. At last, it is discussed that our country, as a developing country, can improve the compulsory license of drug patent at the level of legislation and system, and put forward some suggestions on the application, operation, supervision and so on. Taking the compulsory license of anti-AIDS drug patent as an example, the positive effect of anti-AIDS drug patent license on drug accessibility is demonstrated. The purpose of this paper is to analyze the significance of compulsory licensing of drug patents to improve the availability of drugs in China at the present stage. Through case analysis and experience, this paper puts forward some suggestions that our country can make to perfect its legislation and system. In order to avoid future serious public health crisis in the face of legal problems.
【学位授予单位】：中国社会科学院研究生院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D923.42

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