我国药品专利强制许可制度的实现路径及其完善研究

发布时间：2018-06-30 06:20

本文选题：药品专利 + 强制许可　；参考：《兰州大学》2014年硕士论文

【摘要】：随着现代文明的发展,国际交往不断频繁,各种突发性的流行性疾病得以在短时间内肆虐全球。与此同时,癌症、艾滋病等恶性疾病困扰着世界各地的人们。在与病魔抗争的过程中,各类高技术含量的特效药物成为患者的必需品。在广大的发展中国家和欠发达国家,经济水平低、科技欠发达、居民消费水平有限,广大患者不能及时足额地获得廉价的专利药物。为此,相关国际组织通过的《与贸易有关的知识产权协定》等国际性法律文件设置了药品专利强制许可制度,旨在通过限制药品专利权人的专利权益,保障那些急需药物的国家和人民的生存权和健康权。在这样的背景下,为了落实国际条约的精神,包括我国在内的很多国家都通过制定和修改专利法,具体规定了本国的药品专利强制许可制度,一些发展中国家还率先进行了此类实践,取得了良好的效果。与他们相比,我国专利法的相关规定还存在着不少的问题,如法律体系不完备,法律规范之间不协调,规定的科学性和合理性欠缺等。在实践中,我国也没有一例成功的药品专利强制许可案例。这些理论与实践方面的问题让法律人遗憾,也让我国众多疾病患者无法享受到药品专利强制许可制度的好处。本文分为引言、正文、结语三大部分,其中正文由三章构成：首先,对药品专利强制许可制度的基本内涵和发展轨迹进行介绍,以此为起点,进而对我国药品专利强制许可制度的内容进行梳理。之后考察了我国药品专利强制许可的实践现状。在实践现状一节,主要惜用我国典型案例——白云山版达菲事件来阐述。通过解读我国专利法的规定与相关实践,初步探讨我国药品专利强制许可制度存在的问题；其次,介绍国外药品专利强制许可制度的规定和典型实例,在此,选取了具有代表性且同为发展中国家的泰国和印度这两个国家,来阐述其药品专利强制许可的制度规定及实践案例。之后对这两个国家药品强制许可的成功案例进行评析。通过这种考察其他发展中国家成功实践案例的方式,来吸取其宝贵经验,完善我们的药品专利强制许可制度；最后,在剖析我国药品专利强制许可制度的缺陷的基础上,对比研究国外药品专利强制许可成功案例,总结其给予我们的启示和经验,同时立足于我国基本国情和实际情况,对我国药品专利强制许可制度提出相关措施及完善建议,进而找寻出一条中国特色的药品专利强制许可路径,以期更好地促进我国专利法律体系的完善,及早地迈出药品专利强制许可实践的第一步,更好地保障我国国民的生存权与健康权。
[Abstract]:With the development of modern civilization and frequent international communication, various sudden epidemic diseases can wreak havoc on the whole world in a short time. At the same time, cancer, AIDS and other malignant diseases are afflicting people around the world. In the process of fighting the disease, all kinds of high-tech special-effect drugs become necessary for patients. In the developing and underdeveloped countries, the economic level is low, the science and technology are not developed, the consumption level of residents is limited, and the majority of patients can not get cheap patent drugs in full and on time. To this end, international legal documents, such as the Agreement on Trade-Related aspects of intellectual property Rights, adopted by relevant international organizations, have set up a system of compulsory licensing of drug patents, with the aim of restricting patent rights and interests of drug patentees. To guarantee the right to life and health of those countries and people in urgent need of medicine. Against this background, in order to implement the spirit of international treaties, many countries, including China, have specified their drug patent compulsory licensing system by formulating and amending patent laws. Some developing countries have also taken the lead in such practices and achieved good results. Compared with them, there are still many problems in the relevant regulations of patent law of our country, such as the imperfect legal system, the disharmony between legal norms, the lack of scientific and reasonable provisions and so on. In practice, there is not a successful case of drug patent compulsory licensing in China. These problems in theory and practice make the legal people regret, and make many patients in our country unable to enjoy the benefits of the compulsory licensing system of drug patents. This paper is divided into three parts: introduction, text, conclusion, in which the text is composed of three chapters: first, the basic connotation and development track of the compulsory licensing system of drug patents are introduced, which is the starting point. Then the content of compulsory licensing system of drug patent in China is combed out. After that, the author examines the practice of compulsory licensing of drug patents in China. In the section of practice, we mainly use the typical case of Baiyun Mountain Tamiflu incident to explain. By interpreting the regulations and relevant practices of patent law of our country, this paper preliminarily discusses the problems existing in the compulsory licensing system of drug patents in China. Secondly, it introduces the regulations and typical examples of the compulsory licensing system of drug patents abroad. Two countries, Thailand and India, which are representative and developing countries, are selected to explain the regulations and practical cases of compulsory licensing of drug patents. After that, the successful cases of drug compulsory licensing in these two countries are evaluated. Through this way of examining successful practice cases in other developing countries, we can draw on their valuable experience and improve our compulsory licensing system for drug patents. Finally, On the basis of analyzing the defects of the compulsory licensing system of drug patents in China, this paper compares and studies the successful cases of compulsory licensing of drug patents abroad, sums up the inspiration and experience it gives us, and at the same time, bases itself on the basic conditions and actual conditions of our country. This paper puts forward relevant measures and suggestions to the compulsory licensing system of drug patents in China, and then finds out a path of compulsory licensing of drug patents with Chinese characteristics, in order to better promote the perfection of the patent legal system of our country. The first step of the compulsory licensing of drug patents should be taken as early as possible to better protect the rights of survival and health of Chinese people.
【学位授予单位】：兰州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D923.4

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