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。
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.
引文
① 例如康安峰.TRIPS 框架内药品专利强制许可制度之研究(硕士学位论文)[D].吉林:吉林大学,2004. 张宁.TRIPS 协议下公共健康与药品专利强制许可研究(硕士学位论文)[D].武汉:武汉大学,2005. 方岩.论知识产权国际保护中的药品专利强制许可制度(硕士学位论文)[D].北京:中国政法大学, 2005. 宋珊珊.药品专利强制许可制度的进展(研究硕士学位论文)[D].北京:中央民族大学,2006. 其他相关论文见后文引注。
② 目前的专著仅有:冯洁菡.公共健康危机与 WTO 知识产权制度的改革-以 TRIPS 协议为中心[M].武汉:武汉大学出版社,2005. 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.
① 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.23.
② 同上,第 28 页。
③ 同上,第 26 页。
④ 冯洁菡.公共健康危机与 WTO 知识产权制度的改革-以 TRIPS 协议为中心[M].武汉:武汉大学出版社,2005.113.
⑤ 同本页注①,第 33 页。
① 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.38.
② 同本页注①,第 42 页。
③ 冯洁菡.公共健康危机与 WTO 知识产权制度的改革-以 TRIPS 协议为中心[M].武汉:武汉大学出版社],2005.113.
④ 郑成思.知识产权法学[M].北京:法律出版社,2004.93.
⑤ 同本页注①,第 42 页。
② BARTELT, SANDRA. Compulsory Licenses Pursuant to TRIPS Article 31 in the light of the Doha Declaration on The TRIPS Agreement and Public Health[EB/OL].http://www.iprsonline.org,2006-09-15.
③ 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.67.
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③ 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.383.
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③ 冯洁菡.全球公共健康危机、知识产权国际保护与 WTO 多哈宣言[J].法学评论,2003,(2):10-19.
① 冯洁菡.公共健康危机与 WTO 知识产权制度的改革-以 TRIPS 协议为中心[M].武汉:武汉大学出版社,2005.124.
② 同上,第 126 页。
③ CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.327.
④ Id.,p.320.
① CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.322.
② 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.227.
③ 同本页注①,第 319 页。
① CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.328.
② BARTEL,SANDRA. Compulsory Licenses Pursuant to TRIPS Article 31 in the light of the Doha Declaration on the TRIPS Agreement and Public Health.[EB/OL].http://www.iprsonline.org,2006-09-15.
① 贺小勇.从《多哈宣言》到《总理事会决议》看国际知识产权保护[J].法学,2004,(6):105-109.
② 魏淼.从“多哈宣言”看药品知识产权保护与公共健康利益间的平衡[J].兰州学刊,2004,(2):154-156.
③ 王丽华.公共健康危机与发展中国家的知识产权战略[J].法学,2004,(6):109-115.
④ SUN, HAOCHEN.A Wide Access to Patented Drugs under the TRIPS Agreement[J].B.U.Int’l L.J ,2003,21:116-122.
① BOURGOIS, JACQUES H.J. & BURNS, THADDEUS J, Implementing Paragraph 6 of the Doha Declaration on TRIPS and Public Health ---- the Waiver Solution[EB/OL].http://www.iprsonline.org,2006-09-12.
② Id.
③ Id.
④ SUN, HAOCHEN.A Wide Access to Patented Drugs under the TRIPS Agreement[J].B.U.Int’l L.J ,2003,21:110.
⑤ BARTEL,SANDRA. Compulsory Licenses Pursuant to TRIPS Article 31 in the light of the Doha Declaration on the TRIPS Agreement and Public Health[EB/OL].http://www.iprsonline.org,2006-09-15.
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:326.
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].A.J.I.L,2005,99:317.
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].A.J.I.L,2005,99:335.
② WTO 总理事会《关于<执行 TRIPS 协定与公共健康宣言第六段的决定>的声明》.
③ 同本页注①,第 336 页。
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:336.
② Id.
③ 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.315.
④ 同上,第 316 页。
⑤ 同上。
⑥ 同本页注①,第 345 页。
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:343.
② 林秀芹.TRIPS 体制下的专利强制许可制度研究[M].北京:法律出版社,2006.322-339.
③ 同上,第 340 页。
④ CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.366.
① 当符合条件的进口成员方对同一产品授予强制许可时,该成员方可不履行 TRIPS 协定第 31 条(h)款的义务,因为出口成员方已经给那些产品支付过报酬。
② CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.368.
③ Id.,p.340.
④ Id.
① CARVALHO,NUNO PIRES DE .The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.335.
② 周长玲.谈专利法中的强制许可制度[J].知识产权,2003,(6):46-48.
③ BOURGOIS, JACQUES H.J. & BURNS, THADDEUS J, Implementing Paragraph 6 of the Doha Declaration on TRIPS and Public Health ---- the Waiver Solution[EB/OL].http://www.iprsonline.org,2006-09-12.
④ UNCTAD-INTSD. Resource Book on TRIPS and Development[R].Britain: Cambidge Press,2005.463.
⑤ SANTORO, MICHAEL A. Human Rights and Human Needs: Diverse Moral Principles Justifying Third World Access to Affordable HIV/AIDS Drugs[J].N.C.J.Int’l. L.&Com.Reg.,2006, 31:926.
⑥ RJKUMAR, RAHUL. The Central American Free Trade Agreement: An End Run around the Doha Declaration on TRIPS and Public Health[J]. Alb.L.J.Sei.&Tech,2005, 15:24.
⑦ MUSUNG,SISULE F. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? [EB/OL]. http://www.southcentre.org,2006-10-20.
① MUSUNG,SISULE F. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? [EB/OL]. http://www.southcentre.org,2006-10-20.
② MATTHEWS, DUNCAN. Globalizing Intellectual Property Rights---The TRIPS Agreement[EB/OL].http://www.iprsonline.org,2006-10-15.
③ Id.
④ Id.
⑤ Id.
⑥ THUO GATHII, JAMES. The Legal Status of the Doha Declaration on TRIPS and Public Health under the Vienna Convention on the Law of Treaties[J]. Harv.J.Law&Tec.2002,15:478.
⑦ 那力,王作全.公共健康保护的主要争议评析[J].法学,2004,(6):98-104.
① 那力,王作全.公共健康保护的主要争议评析[J].法学,2004,(6):98-104.
② ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:321.
③ Id.,p.330.
④ MATTHEWS, DUNCAN.WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health : A Solution to the Access to Essential Medicines Problem?[J].Journal of International Economic Law,2004, 7:87.
⑤ BOURGOIS, JACQUES H.J. & BURNS, THADDEUS J, Implementing Paragraph 6 of the Doha Declaration on TRIPS and Public Health ---- the Waiver Solution[EB/OL].http://www.iprsonline.org,2006-09-12.
⑥ http://europa.eu/pol/health/index_en.htm.2006-11-02.
⑦ 同本页注②,第 335 页。
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:335.
② MATTHEWS, DUNCAN.WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health : A Solution to the Access to Essential Medicines Problem?[J].Journal of International Economic Law,2004, 7:88.
③ 药品利益论衡—2005 年药品数据保护国际研讨会综述[J].WTO 经济导刊,2005,(4):46-50.
① 郑海东.从乌拉圭回合看美国的知识产权战略[J].复旦学报,1995,(6):27-33.
② WILSON, CLARK A.D. The TRIPS Agreement: Is It Beneficial to the Developing World, or simply a Tool Used to Protect Pharmaceutical Profits for Developed World Manufacturers?[J]. J.Tech.L&Pol’y,2005, 10:251.
③ CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.340.
① CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.336.
② Id., p.361.
③ ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:346.
④ Id.
⑤ SUN, HAOCHEN.A Wide Access to Patented Drugs under the TRIPS Agreement[J].B.U.Int’l L.J ,2003,21:125.
① 曲三强.论药品专利许可与公共健康权[J].学术探讨,2006,(1):56-63.
② MUSUNG,SISULE F. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? [EB/OL]. http://www.southcentre.org/,2006-10-20.
③ ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:342.
④ Id.
⑤ Id.
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:342.
② MORIN, JEAN-FREDERIC. Tripping up TRIPS Debates IP and Health in Bilateral Agreements[EB/OL].http://www.iprsonline.org,2007-01-11.
③ Id.
④ 荣民.WTO“公共健康”议题谈判成果:执行的障碍和部分成员的实践[J].专利法研究[C].北京:知识产权出版社,2004. 57-65.
⑤ 同本页注①,第 350 页。
⑥ MUSUNG,SISULE F. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? [EB/OL]. http://www.southcentre.org,2006-10-20.
① MUSUNG,SISULE F. The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? [EB/OL]. http://www.southcentre.org.2006-10-20.
② 药品利益论衡—2005 年药品数据保护国际研讨会综述[J].WTO 经济导刊,2005,(4):46-50.
③ 同上。
⑤ CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.393.
⑥ RJKUMAR, RAHUL. The Central American Free Trade Agreement: An End Run around the Doha Declaration on TRIPS and Public Health[J]. Alb.L.J.Sei.&Tech,2005, 15:464.
① 中美洲六国(哥斯达尼加、萨尔多瓦、危地马拉、洪都拉斯、尼加拉瓜和多米尼加共和国)与美国于 2004年 5 月签订该协定。
② RJKUMAR, RAHUL. The Central American Free Trade Agreement: An End Run around the Doha Declaration on TRIPS and Public Health[J]. Alb.L.J.Sei.&Tech,2005, 15:465.
③ Id.,p.467.
④ Dying for Drugs: How CAFTA will Undermine Access to Essential Medicines[EB/OL]. http://www.essentialaction.org.2006-11-25.
⑤ CARVALHO,NUNO PIRES DE. The TRIPS Regime of Patent Rights[M].Britain: Kluwer Law Publisher,2005.2nd Edition.396.
① Public Health at Risk: A US Free Trade Agreement could Threat Access to Medicines in Thailand[z]. Oxfam Breifing Paper.
② Udermining Access to Medicines: Comparison of Five US FTAS[EB/OL].http://www.iprsonline.org,2006-11-20.
③ ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:339.
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:339.
② Id.,p.340.
③ Id.,p.339.
① AVAFIA, TENU BERGER , JONATHAN& HARTZENBERG, TRUDI. The Ability of Select Sub-Sahara African Countries to Utilize TRIPS Flexibilities and Competition Law to Ensure a Sustainable Supply of Essential Medicines: A Study of Providing and Importing Countries[EB/OL].http://www.iprsonline.org,2007-01-20.
② Id.
③ ABBOTT, FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:356.
④ THUO GATHII, JAMES. How Necessity may Precludes State Responsibility for Compulsory Licensing under the TRIPS Agreement[J]. N.C.J.Int’l L&Com.Reg.,2006,Summer,31:944.
① The Impact of AIDS/HIV on Africa[EB/OL].http://www.avert.org/aidsimpact.htm.2006-10-10.
② 津巴布韦自 20 世纪 80 年代艾滋病流行以来,每 6 个成年人中就有 1 人患有艾滋病。据世界卫生组织估计,到 2005 年年底,津巴布韦 15 岁—49 岁的人群中将有 17%患有艾滋病,其中 57%是妇女。见 HIV&AIDS Statistics.http://www.avert.org/aids_zambia.htm.2006-10-11.
③ SUN, HAOCHEN. TRIPS and Non-Violation Complaints ----from a Public Health Perspective[EB/OL].http://www.iprsonline.org,2006-10-20.
④ Bridge cutting edge pack on Gender and HIV/AIDS[EB/OL].http://www.eldis.org/gender/dossiers/socimpact.htm.2006-10-10
⑤ The Economic Impact of the HIV Epidemic[EB/OL]. http://www.undp.org/hiv/publications/issues/english/issue02e.htm.2006-10-10.
① The Economic Impact of the HIV Epidemic[EB/OL]. http://www.undp.org/hiv/publications/issues/english/issue02e.htm.2006-10-10.
② Id.
③ Id.
④ RJKUMAR, RAHUL. The Central American Free Trade Agreement: An End Run around the Doha Declaration on TRIPS and Public Health[J]. Alb.L.J.Sei.&Tech,2005, 15:435.
⑤ BOED,ROMAN. State of Necessity as a Justification for Internationally Wrongful Conduct.[J].Yale H.R.&Dev.L.J.,2000, 3:15.
⑥ Public Health at Risk: A US Free Trade Agreement could Threat Access to Medicines in Thailand[z]. Oxfam Breifing Paper.
⑦ 同本页注⑤,第 28 页。
⑧ THUO GATHII, JAMES. How Necessity may Precludes State Responsibility for Compulsory Licensing under the TRIPS Agreement[J]. N.C.J.Int’l L&Com.Reg.,2006,Summer(31):954.
① BOED,ROMAN. State of Necessity as a Justification for Internationally Wrongful Conduct.[J].Yale H.R.& Dev.L.J., 2000, 3:16.
② THUO GATHII, JAMES. How Necessity may Precludes State Responsibility for Compulsory Licensing under the TRIPS Agreement[J]. N.C.J.Int’l L&Com.Reg.,2006,Summer,31:948.
③ 冯晓青.利益平衡论:知识产权法的理论基础[J].知识产权,2003,(6):16-19.
④ 同上。
① ABBOTT,FRECERICH M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health[J].The American Journal of International Law.2005,99:358.
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