【作者】 张雪忠；

【导师】 朱榄叶；

【作者基本信息】 华东政法大学 ， 国际法学， 2007， 博士

【摘要】 TRIPS协议几乎为所有类型的知识产权确立了最低的全球保护和实施标准,其中包括与药品有关的知识产权。该协议是美国等发达国家产业界长达十余年不懈努力的结果。这些国家长期联合在一起,推动建立能通过贸易制裁强制实施的知识产权保护的国际标准与规则。看到世界知识产权组织似乎无力建立全球统一的知识产权保护标准,美国的药品、电脑软件、出版以及娱乐产业纷纷建立自己的联盟,游说政界支持加强对知识产权的保护。美国的产业联盟与其他发达国家的商业领袖一道,极力宣扬知识产权保护全球化的重要性。他们一方面不断加强这种洲际商业联盟,另一方面还先后说服美国、欧盟及日本的贸易代表,使他们相信关贸总协定可以成为知识产权保护的平台。尽管发展中国家也努力要建立一个反对联盟,美国却不断利用其特别301条款教训那些不听话的国家,并试图分化发展中国家。为了应对仿制药品生产商的竞争,美国和欧盟的药品工业在TRIPS协议谈判中发挥了重要的作用。当谈判结束时,发达国家的药品工业界几乎达到了全部目的,既控制了谈判程序,也决定了谈判内容。TRIPS协议包含了基本原则、标准、专利的使用、法律实施、争端解决机制以及其他一些议题,其内容往往对知识产权拥有者有利,而对技术使用者不利。根据TRIPS协定中与专利有关的主要条款,任何具有新颖性、独创性和工业应用性的发明,包括药用产品和药品生产方法,均可获得专利权的保护,各成员必须为专利提供自专利申请之日起至少20年的保护。以前发达国家之间和发展中国家之间的专利规则多边体系,都允许基于政策考虑对不同领域的发明进行差别对待,比如排除药品的专利保护等,但TRIPS协议第27.1条明确禁止此种差别对待。同样,TRIPS协议也不再允许为有利本地产品而歧视进口产品,主要药品公司可以自由选择生产地点,而发达国家做出的技术转让的许诺却极为空泛。根据TRIPS协定第28条规定,主要药品生产商可以禁止他人“制造、使用、标价出售、销售、或者进口”专利药品或通过专利方法制造的药品。另外,TRIPS协定第39.3条还保护秘密信息(包括临床试验数据)免于“不正当的商业使用”。因此,即使专利的障碍能够克服,这一条也可能阻碍仿制药品的审批登记。当然,TRIPS协定中也存在着一些对发展中国家极为重要的灵活性。根据TRIPS协定第6条的规定,各成员国有权自由建立国际穷尽规则,从而使平行进口成为可能。TRIPS协定第31条允许实施强制许可,而第30条则规定了对专利持有者垄断权利的有限例外。但无庸置疑,TRIPS协定进一步加强了药品工业产权持有者的垄断特权和经济力量。发达国家的药品工业本来就在研究和开发方面拥有优势,TRIPS协定进一步使其对发展中世界的药品工业拥有了绝对的竞争优势。这种优势最终将使成百亿的美元从贫穷的南方国家流向富裕的北方国家。在TRIPS协定刚刚通过时,发达国家和发展中国家公告健康领域的许多专家,都没有意识到专利保护的强化对疾病防治的消极影响。但迅速发展的艾滋病危机很快引起了人们的注意,而上世纪90年代中期投放市场的鸡尾酒疗法价格却高的惊人。发展中国家成百上千万的人感染艾滋病,但却无力购买昂贵的专利药品。因此,人们开始质疑乌拉圭回合谈判达成的交易,早期的批评者也开始得到国际主流社会的响应。英国的知识产权委员会、联合国开发署、世界银行、UNTACD/ICTSD,甚至世界贸易组织也和世界卫生组织一起对激进的知识产权保护主义提出了批评。在TRIPS协定为药品工业提供了更高水平的专利保护之后,美国仍在继续其有利于药品工业的贸易政策。由于一些发展中国家拒绝对专利持有者提供高于·TRIPS协议标准(TRIPS.plus)的权利保护;或者利用符合TRIPS协定的手段获取更便宜的药品,美国便威胁对它们进行贸易制裁。面对自身日益严重的公共健康问题,发展中国家有必要在今后的谈判中采取一致的立场,坚持对TRIPS协定进行必要的修改。在此之前,发展中国家也应尽量利用TRIPS协定及其他相关法律文件中存在的空间,采取对公共健康的解决最为有利的法律措施。本文主要目的是,通过对相关法律文件进行体系性的分析和考察,指出在现行的TRIPS协定框架中发展中国家可资利用的法律空间和灵活性,并为发展中国家今后在公共健康领域的具体决策提供初步的法律建议。本文共分为五章。第一章(TRIPS协定的产生)在简略回顾知识产权国际保护的历史以及GATT在加强知识产权保护方面所起的作用后,将重点回顾TRIPS协定是如何出现在乌拉圭回合多边贸易谈判之中的。这有助于人们理解TRIPS协定为何得以产生,特别是它为什么会融入关税与贸易总协定的框架之中。第二章(TRIPS协定与药品知识产权)将对TRIPS协定进行一种总体性的分析,并具体评估其对药品知识产权国际保护议程的影响。这种分析和评估对理解美国等发达国家药品工业与药品知识产权国际保护之间的相互关系,以及发展中国家及最不发达国家对药品知识产权的立场和态度极为必要。本章将首先分析TRIPS协定包含的重要要素,如一般规定与基本原则、争端解决、权利实施、TRIPS理事会以及通知制度等。另外,文章还将指出TRIPS协定的一些重大缺陷,这些缺陷包括无法有效消除知识产权持有人的反竞争行为,以及对低知识产权能力国家的援助不足等。最后,本章将重点考察和分析TRIPS协定中与药品知识产权有关的规定,并分析它们对未来的相关谈判将产生何种影响。通过在南北矛盾的背景下对TRIPS协定进行较为详细的分析后,作者认为,以TFRIPS协定为代表的最新的知识产权(特别是其中的专利权)国际保护体制,在很大程度上反映了发达国家药品工业的利益和立场。南北之间在知识产权国际保护方面存在的深刻分歧,并未随着’TRIPS协定的产生和生效而消融。相反,随着TRIPS协定对提高全球知识产权保护的革命性影响变得越来越明显,发展中国家和最不发达国家对TRIPS协定的抵制情绪也不断加强。第三章(南方国家对TRIPS协定中药品知识产权议程的反对)将着重分析对’I’RIPS协定,特别是对其中的药品知识产权议程的态度和立场。从1996年到1999年,南方国家对TRIPS协定的反对和抵制可大致分为两个阶段:在1996年至1998年间,发展中国家和最不发达国家对TRIPS协定的批评仍相当含糊,同时也并未提出什么具体明确的谈判要求;自1999年起,特别是在1999年11月的西雅图会议期间,发展中国家和最不发达国家对TRIPS协定的反对态度已经变得非常强烈,对TRIPS协定的批评也不再如以前那样空洞,而是包含着较为具体的立法和政策目标。发达国家药品工业与它们的知识产权盟友一道,通过巨大的努力使TRIPS协定得以产生,而保卫和充分利用TRIPS协定的成果似乎也并不轻松。随着围绕TRIPS协定的争议越来越强烈,发达国家的药品工业首次发现它们处于防守地位。第四章(发达国家药品工业保卫和利用TRIPS协定的战略和行动)联系欧盟对TRIPS协定的立场和态度,分析欧洲药品工业保卫和利用TRIPS协定的战略和行动。本章将考察欧盟及其成员国公开宣称的对TRIPS协定的立场,并详细分析欧盟以及欧洲药品工业就TRIPS协定采取的法律行动:自1995年至1998年,药品工业的行动主要是为了充分利用TRIPS协定带来的利益;自1998年底至西雅图部长会议期间,欧盟及其药品工业的行动重点转为保卫TRIPS协定。另外,本章还将着重分析欧洲药品工业与它们的地区和国际知识产权盟友,为促进知识产权的国际包含而采取的共同努力。这种分析可以提供一个较为全面的视觉,以便进一步看清知识产权国际保护者的共同立场、目标和战略。TRIPS协定很大程度上反应了发达国家药品工业的利益,但却对发展中国家和最不发达国家公共健康问题的解决带来了巨大的法律障碍。药品知识产权保护水平的提高必将影响药品的价格,并使南方国家身患疾病的人们更难以获取必需的药品。为了更好地解决公共健康问题,从长远的角度而言,WTO的发展中国家和最不发达国家成员必须在今后的TRIPS协定谈判中,团结一致地坚持自己的立场,争取对TRIPS协定进行有利于公开健康问题解决的修改。在这之前,发展中国家和最不发达国家应该对TRIPS协定进行最有利于公共健康的解释,并充分利用协定存在的法律空间和灵活性,以便使必需药品更易于获取。第五章是本文的主体部分。本章在简要谈及南方国家的公共健康问题及对专利药品的需求后,对TRIPS协定、多哈宣言、第6款实施决定以及主席声明进行体系性的分析和解释,充分发掘有利于公共健康问题解决的法律灵活性,并就发展中国家可以采取的法律对策提出建议。文中除了讨论第6款实施决定中“为出口而生产”的制度,还依次分析了发展中国家利用平行进口、普通的第31(b),(f)条强制许可、第31(k)条的基于竞争的强制许可,以及第30条中的有限例外规定的法律可行性。需要强调的是,这些建议只是为相关国家具体政策的制度提供初步的法律基础。不同的国家应该根据自身的实际情况,在严密的实证研究可分析的基础上,在公共健康领域制定最适合本国现实情况的IP政策。更多还原

【Abstract】 The TRIPS Agreement introduced a minimum global standard for the protection and enforcement of nearly all categories of intellectual property rights: patents, trademarks, copyrights, and undisclosed information, including those applying to Pharmaceuticals. The Agreement was the result of a decade-long campaign by a coalition of industries in the United States and other developed countries that united to secure a new international system for the protection of intellectual property that could be enforced through trade sanctions.Disappointed by the inability of WIPO to initiate global standardization and harmonization of IP standards, the pharmaceutical, computer software, publishing, and entertainment industries in the United States and other developed countries cooperated to form their own internal alliances and to lobby politicians to support enhanced intellectual property protection. This strengthened alliance then worked with industry and political leaders in developed world to motivate the importance of globalizing IP protection. While they were cementing their intercontinental business alliances, these forward thinking industries convinced first the U.S. Trade Representative and then the E.U. and Japanese trade representatives that GATT was the forum within which intellectual property protection should be pursued. Although developing countries tried to create a coalition of the unwilling, the United States used its new Section 301 to discipline recalcitrant nations and to split the alliance. Reacting to competition from generic producers, the U.S. and E.U. pharmaceutical industries played a lead role in TRIPS Agreement negotiations. At the end of the negotiation, its principal negotiator stated that the industry had achieved all of its aims: controlling the process and the content.The resulting TRIPS Agreement covers basic principles, standards, and use of patents, enforcement and dispute settlement mechanisms, and multiple other subjects, many of which are tilted in favor of IP owners and against the interests of IP users. Under its key patent provisions, member countries must provide patent protection for a minimum of twenty years from the filing date of a patent application for any invention, including a pharmaceutical product or process that fulfils the criteria of novelty, inventive step and usefulness. Although preceding multilateral agreements concerning patent rules in both the developed and developing world had allowed policy-based discrimination between fields of invention, for example by excluding medicines, Article 27.1 expressly outlawed such discrimination. Similarly, it was no longer permissible to discriminate routinely against imports in favor of locally produced nroducts, thus allowing major pharmaceutical companies to control the place of production despite illusory promises to undertake technology transfer. Because of Article 28, the major pharmaceutical producers secured exclusive rights to exclude others from "making, using, offering for sale, selling, or importing" patented pharmaceutical products or products made with a patented process. In addition, Article 39.3 protects undisclosed information (including clinical test data) from "unfair commercial use," a provision that may ultimately be interpreted to impede registration of generic drugs even where patent bars are overcome.Admittedly, there are important flexibilities in TRIPS Agreement, discussed in detail in Section 5, including autonomy under Article 6 to establish international exhaustion rules, which would thereby permit parallel importation, and authority under Article 31 to issue compulsory licenses and under Article 30 to grant limited exceptions to patent holders’ right to exclude competition, but the undeniable effect of the TRIPS Agreement has been to consolidate the economic power and monopoly privileges of the proprietary drug industry. Given its pre-existing advantage in conducting research and development, the developed world’s drug industry secured near absolute competitive advantage over the developing world’s via the TRIPS Agreement. This advantage will eventually result in the net transfer of billions of dollars from the impoverished south countries to the affluent north countries.At the time of its passage, many public health specialists in both developed and developing countries seemed unaware of the looming consequences of a rising tide of patent protection on the treatment of diseases. However, the burgeoning AIDS crisis quickly caught people’s attention, especially given the astronomical cost of triple-therapies brought to the market in the mid-1990s. As the developing world confronted the reality of tens of millions of HIV infections and the unaffordability of billions of patent-protected pills, critics questioned the deal that had been struck in the Uruguay Round. Early critics were joined later by more mainstream sources, many of whom offered their own critique of radical IP protectionism, including the prestigious U.K. Commission on Intellectual Property Rights, the UNDP, the World Bank, UNTACD, and even the WTO itself in collaboration with the WHO.Even after codifying a universally higher standard of patent protection for the pharmaceutical industry in the TRIPS Agreement, the United States and it allies continued its existing pro-pharmaceutical trade policy by threatening developing countries such as Thailand, South Africa, and Brazil with trade sanctions because they refused to grant greater TRIPS-plus rights to patent holders and/or because they proposed using TRIPS-compliant means to access more affordable medicines.Faced with the existing or emerging gravity of public health problem, it is an urgent need for developing countries to take combined effort in future related negotiations and try to make preferable amendments to the TRIPS Agreement. Before this long-term goal is attained, developing countries should utilize all the legal flexibilities within the TRIPS Agreement framework to help solve their public health problems. This article is mainly aimed at a systematic analysis of the relevant provisions of TRIPS Agreement and other legal documents, with a view to putting forward some specific policy suggestions for developing countries. This article is divided into five sections. Section 1 first looks back at the history of IP international protection and the role of GATT in enhancing its protection. Then will turn to the difficult emergence of TRIPS Agreement during the Uruguay Round of Multilateral Trade Negotiations. This will help understand how a revolution in IP protection brought about by TRIPS Agreement was possible and why it happened in the framework of the General Agreement on Tariffs and Trade.Section 2 analyses the TRIPS Agreement as a whole and assesses its specific impact on the international pharmaceutical IP agenda. The analysis and assessment are necessary steps to understand the interaction between the advanced pharmaceutical industry in developed countries and the international pharmaceutical IP agenda. First, the section analyses major elements of TRIPS Agreement (general provisions and basic principles, dispute settlements, enforcement, TRIPS Council and the system of notification). Second, the section reports on TRIPS Agreement major flaws, and focuses mainly on its lack of effectiveness in the elimination of anti-competitive practices and insufficient assistance to countries with low IP capacities. Finally, the section examines and elaborates on TRIPS Agreement pharmaceutical IP agenda. The section concludes that the newly established international pharmaceutical IP agenda, as well as the IP system generally, is highly correlated with the position and interests of the advanced pharmaceutical industry bases in developed countries.The deep divide between north and south did not vanish with the coming into effect of the TRIPS Agreement in 1995. On the contrary, the resentment of developing countries and LDCs increased as the revolution caused by TRIPS Agreement in terms of the global level of IP protection became more and more evident. Section 3 provides a brief overview of the opposition of developing countries and LDCs to TRIPS Agreement in general, and to its pharmaceutical IP agenda in particular, between 1996 and 1999. The section demonstrates the developing country’s resentment to TRIPS Agreement by examining the official statements and demands of WTO members during the ministerial conferences of 1996, 1998 and 1999.Although the establishment of the TRIPS Agreement clearly required a considerable effort on the part of IP advocates, exploiting TRIPS Agreement benefits and preserving its achievements proved to be an equally challenging task. As the controversy surrounding TRIPS Agreement intensified, particularly from 1999, IP advocates, such as the advanced pharmaceutical industry in developed countries, were, for the first time, on the defensive. Section 4 links the industry’s strategies and activities concerning the exploitation and preservation of TRIPS Agreement to the EU’s IP approach and operations. First, the section focuses on the declarative level, describing the views of the EU and of its member states concerning the TRIPS Agreement. Second, the section analyses the operational level, assessing TRIPS-related activities of both the advanced pharmaceutical industry in Europe and the EU itself. Finally, the section puts great emphasis on the combined efforts of the industry and of its regional and international IP allies. This provides a more comprehensive insight into the common sentiments, goals and strategies shared by IP advocates globally. While reflecting the interests of the pharmaceutical industry based in developed countries, the TRIPS Agreement constitute huge legal obstacles which will hinder the developing countries’ efforts to solve public health. Strengthened protection of pharmaceutical IP is to have significant impact on the prices of drugs, making it even more difficult for millions of patients in poor countries to access life-saving medicines. In Section 5, it is argued that, to help resolve public health problems in the long run, developing world should take combined effort in future related negotiations and try to make permanent and preferable amendments to the TRIPS Agreement. In the short term, however, developing countries should utilize all the legal flexibilities within the TRIPS Agreement framework to make life-saving drugs more accessible and affordable. The section focuses on a systematic analysis of the relevant provisions of the TRIPS Agreement, Doha Declaration, Paragraph 6 Implementation Decision and the General Council Chairman’s Statement and then put forward some specific policy suggestions for developing countries.更多还原