【作者】 叶抗抗；

【导师】 龚宇；

【作者基本信息】 厦门大学 ， 国际法学， 2007， 硕士

【摘要】 严重流行性疾病引发的公共健康危机,再次掀起了如何平衡专利持有人利益与公众利益的讨论高潮。作为提高药品可获得性最为直接有效的方式,药品专利强制许可被推向了论战的风口浪尖。本文将公共健康问题与药品专利强制许可置于WTO框架下进行研究。本文主要由四章内容组成。文章第一章围绕专利强制许可制度,以时间为线索,介绍了该制度的形成及一般原理。包括强制许可的简要发展历史、强制许可的定义及特点、相关立法概况等。重点分析了公共健康危机与药品专利强制许可的关系。同时,针对传统的强制许可,指出了药品专利强制许可在国际层面实施的特殊性。文章第二章论述了WTO框架下药品专利强制许可机制之构成。该章以TRIPS协定第31条、《TRIPS协定与公共健康宣言》、《执行TRIPS协定与公共健康宣言第六段的决议》及TRIPS协定修正草案等重要法律文件为依托,以对上述法律文件的分析为核心内容,特别阐述了各项法律文件的联系及发展。从总体上呈现了药品专利强制许可机制的国际立法现状。文章第三章以实证的方法,论证了药品专利强制许可机制的执行问题。该章首先从理论角度分析了现有法律规定的缺陷:复杂的申请安排、强制许可授予义务的缺失、悬而未决的问题,这些构成了机制执行的内在障碍。接着从实践角度探讨了机制执行的外在障碍,包括发达国家的知识产权政策及后续立法的影响,以及制药公司的产业策略等。文章第四章针对如何完善WTO框架下的药品专利强制许可机制,提出了一些建议与设想。不仅涉及了机制之内尚待完善的规定,还介绍了解决公共健康问题可以考虑的其他方法。更多还原

【Abstract】 Public health crisis caused by severe epidemic diseases leads to a hot debate on how to balance the patent holder’s interests and public interests. Compulsory license of pharmaceutical patents, as the most effective method to promote access to medicines, becomes the focus of the debate.This thesis does research on public health problem and compulsory license system of pharmaceutical patents under WTO, which is divided into four chapters.Chapter One introduces formation and general principles of the compulsory license, including brief history of compulsory license, definition and characters of compulsory license as well as relevant legislation. It attaches importance to the relationship between public health crisis and compulsory license of pharmaceutical patents. Compared with traditional compulsory license, it points out particularity of international application of compulsory license of pharmaceutical patents.Chapter Two describes the structure of compulsory license system of pharmaceutical patents under WTO. Based on Article 31 of TRIPS Agreement, Declaration, Decision and Amendment to TRIPS Agreement, it analyzes the above legal documents as the core, and particularly dissects the relationship between these documents. The chapter presents international law on compulsory license of pharmaceutical patents on the whole.Chapter Three eleborates barriers to practice of compulsory license of pharmaceutical patents from the angle of theory. Firstly, it analyzes deficiencies of existing provisions. Complicated application arrangement, lack of obligation to authorization, pending problems are barriers within the System. Secondly, it discusses barriers beyond the System from the angle of practice, which includes the impact of developed countries’polices on intellectual property rights and subsequent legislation, as well as pharmaceutical enterprises’industry strategy.Chapter Four proposes assumptions on how to perfect compulsory license system of pharmaceutical patents under WTO. It involves deficient provisions within the System, but also introduces other applicable methods contributive to resolve public health problems.更多还原