TRIPS协定对药品知识产权的保护及发展中国家的法律对策
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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。
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.
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。
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.
引文
1 参见 J.H. Reichman,The TRIPS Agreement Comes of Age: Conflict or Cooperation with the Developing Countries? Case Western Reserve Journal of International Law,Summer, 2000。
1 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 3 页。
2 参见 Suggested Charter for an International Organization of the United Nation, Washington DC, US Department of State Publication 2598, Commercial Policy Series 93,1946。
3 在此之前的 1947 年 1 月 20 日至 2 月 25 日,一个由技术专家组成的起草委员会已经在纽约的成功湖(Lake Success)举行过一次会议。参加起草委员会的报告,UN document EPTC/34 (March 5, 1947)。
1参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 5 页。
2参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 6 页;以及 GATT/CP/86 (December 7, 1950)。
2 该报告于 1987 年 11 月 10 日通过,参见 BISD 34S/83。根据 GATT 第 12 及 13 条、1979 年 11 月 28 日的《关于通知、磋商、争端解决及监督的谅解(Understanding on Notification, consultation, Dispute Settlement and Surveillance)》及其附件、1982 年 11 月 29 日的部长宣言、以及 1984 年 11 月 30 日的《关于争端解决的决定(Decision on Dispute Settlement)》,当一缔约方认为其根据 GATT 可直接或间接享有的利益受到“剥夺或损害(nullified and impaired)”,该缔约方可以要求与其认为有过错的其他缔约方进行磋商。如果磋商失败,它可以要求成立专家组就有争议的问题作出决定。专家组报告需要交由“全体缔约方(CONTRACTING PARTIES)批准。在 GATT 体制下,专家组报告的批准需得到各缔约方的一致同意。这意味着,败诉的一方可以投票反对专家组报告并将其否决。实际上,不少专家组报告的批准都被无限期地“推迟”。
3 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 290 页。
1 参见 BISD30S/107。
2 BISD30S/107,para.53.
3 参见 BISD 36S/345。
4 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 582 页。
5参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 583 页。
6 参见 Hartridge、Subramanian: “Intellectual Property Rights: The Issues in GATT”, (1989)22 Vanderbilt Journalof International Law。
1 参见 Hartridge、Subramanian: “Intellectual Property Rights: The Issues in GATT”, (1989)22 Vanderbilt Journal of International Law。
2 参见 L/4817 及 L/5382。序号以 L 开头的文件是指 GATT 秘书处自 1952 年以来出版的一般文件。
3 参见 BISD 29S/19。
4 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 582 页。
5 理事会平均每月举行一次会议。各缔约方一般都是派驻日内瓦的最高级别的贸易官员出席会议,同时由国内派来或驻日内瓦的各类专家陪同。
6 与此同时,一名 WIPO 的工作人员也参加了专家小组的讨论。根据专家小组的报告,该工作人员并未发挥积极作用。
1 参见 L/5878。
2 在 WIPO 网站(www.wipo.org)上可以获取这些协定的文本以及这些协定的最新成员情况。
1 参见 PREP.COM(86)SR/3(April 11,1986)。
2 参见 PREP.COM(86)W/47/Rev.2(July 30, 1986)。
3 参见 PREP.COM(86)W/47/Rev.1(July 16, 1986)。
4 参见 PREP.COM(86)W/49/Rev.2(July 29, 1986)。
5 参见 Document Min. DEC(September 20, 1986)。
1 参见 GATT Document 1405(February 5, 1987)。
2 参见 GATT Document 1405(February 5, 1987)。
1 参见下列国家提交的建议书:美国,MTN.GNG/NG11/W/14(October 20, 1987);瑞士,MTN.GNG/NG11/W/15(October 26, 1987);欧共体,MTN.GNG/NG11/W/16(October 20, 1987)及MTN.GNG/NG11/W/26(July 17, 1987);日本,MTN.GNG/NG11/W/17(November 23, 1987)。1988 年初,北欧国家也提交了一份建议书,MTN.GNG/NG11/W/22(February 12, 1988)。
2 泰国、墨西哥及巴西提交了书面声明,分别是 MTN.GNG/NG11/W/27(September 21, 1988),MTN.GNG/NG11/W/28(October 19, 1988)及 MTN.GNG/NG11/W/30(October 31, 1988)。其中巴西在声明中建议限制未来协定的范围。
3 参见 Document MTN.TNC/11(April 21,1989)。
1 参见 Document MTN.TNC/11(April 21,1989)。
2 参见 Document MTN.TNC/11(April 21,1989)。
3 澳大利亚,MTN.GNG/NG11/W/35(July 10, 1989);印度,MTN.GNG/NG11/W/37(July 10, 1989);北欧国家,MTN.GNG/NG11/W/36(July 10, 1989);瑞士,MTN.GNG/NG11/W/38(July 10, 1989)。
4 参见 MTN.GNG/NG11/W/57(December11, 1989)。
5 参见 MTN.GNG/NG11/W/48(October 26, 1989)。
6 参见 MTN.GNG/NG11/W/55(December 8, 1989)。
7 参见 MTN.GNG/NG11/W/51(November 29, 1989)。香港是 GATT 的缔约方,后来作为独立关税区成为WTO 的成员。
1 参见 MTN.GNG/NG11/W/68(March 29, 1990)。
2 参见 MTN.GNG/NG11/W/70(May 11, 1990)。
3 日本的建议书标题为“TRIPS 法律文本的主要内容(Main Elements of a Legal Text for TRIPS)”,参见MTN.GNG/NG11/W/74(May 15, 1990)。
4 瑞士的建议书标题为“保护与贸易有关的知识产权关税与贸易总协定修正案草案(Draft Amendment on General Agreement on Tariff and Trade on the Protection of Trade-Related Intellectual Property Rights)”,参见MTN.GNG/NG11/W/73(May 14, 1990)。
5 这 12 个发展中国家是阿根廷、巴西、智利、中国、哥伦比亚、古巴、埃及、印度、尼日利亚、秘鲁、坦桑尼亚和乌拉圭。参见 MTN.GNG/NG11/W/71(May 14, 1990)。
6 参见“Communication from Chile”, MTN.GNG/NG11/W/72(May 14, 1990)。
7 指上述发展中国家提交的建议草案。
8 “Draft text on Geographical Indications, Communication from Australia”,参见 MTN.GNG/NG11/W/75(July 13, 1990)。
1 MTN.GNG/NG11/W/68 表示是欧共体的文本;MTN.GNG/NG11/W/70 美国提交的文本;MTN.GNG/NG11/W/71 则是所谓的“发展中国家”文本;MTN.GNG/NG11/W/73 是瑞士的文本;MTN.GNG/NG11/W/74 则是日本的文本;MTN.GNG/NG11/W/75 则是澳大利亚关于地理标识的文本。
2 参见 MTN.GNG/NG11/W/76(July 23, 1990)。
3 这些部分有:第一部分(包括序言与协定目标);第四部分(关于争端解决与防止);第七部分(过渡安排);第八部分(组织安排)。
1 当谈到“相关的国际组织”时,发展中国家代表想到的可能是 WIPO。智利就在其意见书中公开提及 WIPO,参见“Communication from Chile”, MTN.GNG/NG11/W/72(May 14, 1990)。根据一些发展中国家的意见,WIPO 作为联合国的一个下属组织,是避免实施制裁的更好保障。不管怎样,在 WIPO 框架下的制裁都不会是“与贸易有关的”。
2 参见 MTN.GNG/NG11/W/76(July 23, 1990)。
1 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2212.
4 参见 MTN.GNG/NG11/25(October 8, 1990)。
5 参见 MTN.GNG/NG11/27(November 14, 1990)。
6 此处指发展中国家提交的草案文本,即 MTN.GNG/NG11/W/71(May 14, 1990)。
1 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2232.
3 参见 Document MTN.TNC/W/35/Rev.1(December 3, 1990)。
1 瑞士联邦知识产权办公室在国家事务局出版的《世界知识产权报告(World Intellectual Property Reports)》上发表了一份关于 TRIPS 谈判的直言不讳的报告,指出了仍然存在的分歧,并特别提到了专利的强制许可。 另参见 T. Cottier, “The Prospects for Intellectual Property in GATT”, (1991) 2 Common Market Law Review。
2 参见“Proposal for the Establishment of a Dispute Prevention System in Respect of Transfer of Technologies”, MTN.GNG/TRIPS/W/1(July 14, 1990)。
3 建议书由哥伦比亚代表该集团提交。参见 MTN.GNG/TRIPS/W/2(October 16, 1990)。
1 参见 Haochen Sun,A Wider Access to Patented Drugs under the TRIPS Agreement,Boston University International Law Journal, Spring, 2003。
2 参见 Rochelle Cooper Dreyfuss, Argentina’s Emerging Standard of Intellectual Property Protection: A Case Study of the Underlying Conflicts between developing Countries, TRIPS Standards, and the United States, Case Western Reserve Journal of International Law,Spring 2001。
3 参见 J.H. Reichman,The TRIPS Agreement Comes of Age: Conflict or Cooperation with the Developing Countries? Case Western Reserve Journal of International Law,Summer, 2000。
1 J.H.Reichman and David Lange, Bargaining around the TRIPS Agreement: the Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual Property Transaction, 9 Duke J. Comp. & Int’l L. 11, Fall, 1998.
2 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp501-543.
3 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp478-489.
4 Mohamed Omar Gad, Top-Down Rule-Making: Negotiating the TRIPS Pharmaceutical-Related Patent Provions, The London Institute of international Banking, Finance and Development Law Ltd, No. 45, 2003.
5 参见 GATT(1991), Document MTN.TNC/W/89/Add.1。
6 J. H. Reichman,“Securing Compliance with the TRIPS Agreement after US v. India”, J. Int' l Econ. L. p585, 1998.
1 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp453.
2 J.H.Reichman and David Lange, Bargaining around the TRIPS Agreement: the Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual Property Transaction, 9 Duke J. Comp. & Int’l L. 11, Fall, 1998.
3 Thomas F. Cotter, Market Fundamentalism and the TRIPS Agreement, 22 Cardozo Arts & Ent LJ 307, 2004.
4 Carlos M Correa, Intellectual Property Rihgts, the WTO and Developing Countries: The TRIPS Agreement and Policy Options, Zed Books Ltd, 2000, p7.
5 出于行文通顺的需要,本文可能会在某些地方将 WTO 的成员笼统地称为“成员国”,但实际上 WTO 成员中也包括一些非主权国家的独立关税区,如我国的香港地区、台湾地区等。
2 关于 WTO 自 1995 年以来的争端解决情况的详细和系统分析,可参见朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析》,法律出版社 2000 年版;朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析 1995-2002》,法律出版社 2004 年版;以及 WT/DS/OV30。
3 参见朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析 1995-2002》(下册),法律出版社 2004 年版,第 803 页,“加拿大-药品专利保护”。
1 转引自 James Thuo Gathii, What History Teaches Us about the International Protection of Intellectual Rights: The Case of Least Developed Countries, http://www.chicagoip.com/Gathii.pdf; 另请参见 Bolderin & Levine, Against Intellectual Monopoly, Chapter 4, p1, http://levine.sscnet.ucla.edu/papers/anew04.pdf。
1 Maskus, K.E., Intellectual Property in the Global Economy, Institute for International Economics, 2000.
2 参见 UNCTAD, Least Developed Countries 1998 Report (1999:162)。
1 参见 WTO—Council fro TRIPS(Annual Report 1998a:5)。
2 参见 Communication from Colombia, WT/GC/W/316(September 14, 1999)。
3 参见 Communication from Kenya on Behalf of the Africa Group, WT/GC/W/302(August 6, 1999)。
4 参见 WTO—Council fro TRIPS(Annual Report 1998a:5)。
1 UNCTAD, “TRIPS and Developing Countries”, p30, Document no. UNCTAD/ITE/1.
1 Michael Blakeney , Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement, Sweet & Maxwell, 1996, p85.
2 UNCTAD, “TRIPS and Developing Countries”, p33, Document no. UNCTAD/ITE/1.
3 Michael Blakeney , Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement, Sweet & Maxwell, 1996, p88.
4 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2292.
1 WTO, The World Health Report 1997, p29.
1 Mohamed Omar Gad, Top-Down Rule-Making: Negotiating the TRIPS Pharmaceutical-Related Patent Provions, The London Institute of international Banking, Finance and Development Law Ltd, No. 45, 2003.
2 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
3 如某成员 TRIPS 协定实施过渡期尚未届满,该成员并无义务实施该协定,因而也无需为药品提供专利保护。但它仍有义务提供某种方式,以便人们为药品和农药提出专利申请,申请人也可能因此获得优先权。
4 Bryan C. Mercurio, TRIPS, Patents, and Access to Life-Saving Drugs in the Developing World, 8 Marq. Intell. Prop. L. Rev. 211, Summer 2004.
5 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
1 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
1 参见 MTN/GNG/NG11/17。
2 根据 TRIPS 协定第 39.2 条的注释 10,“‘违反诚实商业行为的方式’应至少包括违反合同、泄密以及诱导违约,且应包括第三方取得未披露信息,如果该第三方知道或因严重疏忽未能知道未披露信息的取得涉及此类做法。(’a manner contrary to honest commercial practices’ shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by the third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.)”。
1 Frederich M. Abbott, The Enduring Enigma of TRIPS: A Challenge for the World Trading System, Journal of International Economic Law, 497, 1998, pp1-26.
2 WTO, The World Health Report 1997, p17.
3 EFPIA’s postion paper, TRIPS and the Millennium Round, 1999, p2.
1 关于新加坡部长会议的各类声明,可参见序号以 WT/MIN(96)/ST 开头的 WTO 文件。
2 Vice Minister of Foreign Trade, Colombia (WTO-Ministerial Conference 1996a), Document WT/MIN(96)/ST/23.
3 Minister of Commerce and Industry, Botswana (WTO-Ministerial Conference 1996b), Document WT/MIN(96)/ST/76.
1 Vice Minister of Foreign Relations, Paraguay (WTO-Ministerial Conference 1996c), Document WT/MIN(96)/ST/75.
2 Minister of Commerce and Industry, Bangladesh (WTO-Ministerial Conference 1998b), Document WT/MIN(98)/ST/60.
3 Minister of Trade, Kenya (WTO-Ministerial Conference 1998c), Document WT/MIN(98)/ST/43.
4 Minister of Commerce and Industry, Botswana (WTO-Ministerial Conference 1998d), Document WT/MIN(98)/ST/110.
5 Secretary of State for Industry and Trade, Dominican Republic (WTO-Ministerial Conference 1998e), Document WT/MIN(98)/ST/117.
1 参见 Communication from Kenya (WTO-General Council 1999h), Document WT/GC/W/302。
2 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
3 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
4 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
5 参见 Communication from Colombia (WTO-General Council 1999i), Document WT/GC/W/316。
6 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352。
1 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352,第 2 页。
2 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352,第 3 页。
3 参见 Communication from CEFTA and Latvia (WTO-General Council 1999g), Document WT/GC/W/275。
4 参见 Communication from CEFTA and Latvia (WTO-General Council 1999g), Document WT/GC/W/275。
5 参加 Communications from the Africa Group, Colombia, Venezuela。另参见 Communication from Canada, (WTO-General Council 1999f), Document WT/GC/W/256。
6 参见 Communication from Canada, (WTO-General Council 1999f), Document WT/GC/W/256。
1 Minister of Commerce, Industry and Production, Pakistan (WTO-Ministerial Conference 1999b), Document WT/MIN(99)/ST/9; Minister of Commerce and Industry, Bangladesh (WTO-Ministerial Conference 1999c), Document WT/MIN(99)/ST/17; Minister of Industry and Trade and Development, Cameroon (WTO-Ministerial Conference 1999g), Document WT/MIN(99)/ST/88; Minister of Commerce, Industry and Handicrafts, Morocco (WTO-Ministerial Conference 1999d), Document WT/MIN(99)/ST/29; Minister of Commerce and Handicrafts, Senegal (WTO-Ministerial Conference 1999e), Document WT/MIN(99)/ST/61.
2 Minister of Commerce, Industry and Production, Pakistan (WTO-Ministerial Conference 1999b), Document WT/MIN(99)/ST/9.
3 Minister of Commerce and Handicrafts, Senegal (WTO-Ministerial Conference 1999e), Document WT/MIN(99)/ST/61.
1 参见 WIPO—International Bureau (2000), Document WIPO/IPTK/RT/99/7; WIPO Secretariat(2001), Document WIPO/GRTKF/IC/1/3。
3 参见 WIPO—International Bureau (1999), Document WIPO/IPTK/RT/99/2。
4 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n), Document WT/GC/W/362;Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k), Document WT/GC/W/329;Minister of Commerce and Industry, India (WTO-Ministerial Conference 1999a), Document WT/MIN(99)/ST/16。
5 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1)。
6 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1)。
1 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1-2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k)。
2 参加 Statement by Pakistan (WTO-Ministerial Conference 1999b:4)。
3 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E。
4 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 2-3 页。
5 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 2 页。
6 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 3 页。
7 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k:2)。
8 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k:2)。
1 Secretary of State for Industry and Trade, Honduras (WTO-Ministerial Conference 1999f); Communication from Venezuela (WTO-General Council 1999e:2); Communication from India (WTO-General Council 1999h:3-4).
2 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3)。
3 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3);Communication from Cuba, Dominican Republic, Egypt, El Salvador, Honduras, India, Indonesia, Malaysia, Nigeria, Pakistan, Sri-Lanka and Uganda (WTO-General Council 1999m:4), Document WT/GC/W/355。
4 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3)。
5 Jan McGirk, A Tribe Goes Into Battle Over the 'Evil Twins' of Colombia,Independent (London), 1999, p8.
1 Office of Prime Minister, United Kingdom, (2000)。
2 参见 Communication from India (WTO—General Council 1999b), Document WT/GC/W/225;Communication from Venezuela (WTO-General Council 1999e:2);Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3-4)。
3 参见 Communication from Venezuela (WTO-General Council 1999e:2); Communication from Cuba, Dominican Republic, Egypt, El Salvador, Honduras, India, Indonesia, Malaysia, Nigeria, Pakistan, Sri-Lanka and Uganda (WTO-General Council 1999m:27)。
1 Commission of the European Communities—DG Trade(1999c).
2 参见 Statement circulated by Sir Leon Brittan QC, Vice President of the European Commission, Document WT/MIN(98)/ST/76(WTO—Ministerial Conference, Second Session,1998a)。
3 Commission of the European Communities—DG Trade(1998a).
4 参见 European Parliament Committee on External Economic Relations,(1996:8), Document A4—0320/96。
1 UK, Department of International Development, Report on World Trade, 2000, p45.
1 IFPMA, Position Paper on TRIPS, 1995, p16.
2 VFA, 1999 Annual Report, 2000, p19.
1 EFPIA, Position Paper on TRIPS, 1999, p2.
1 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Request for Consultation by the EC(1997b), Document WT/DS79/1。关于该争端的详细分析与评述,可参见朱榄叶编著:《世界贸易组织国际贸易争端案例评析》,法律出版社 2000 年版,第 426-439 页。
2参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Request for the establishment of a Panel by the EC(1997c), Document WT/DS79/2。
1 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products(1997c:2), Document WT/DS50/R。
2 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products(1997c:2), Document WT/DS50/R。
3 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Notification of an Appeal by India under paragraph 4 of Article 16 of the Understanding on Rules and Procedures Governing the Settlement of Disputes(1997a), Document WT/DS50/6。
4 参见 WTO-Appellate Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Reports of the Appellate Body(1997:34), Document WT/DS50/AB/R。
5 参见 WTO-Dispute Settlement Body(1998a:1-7), Document WT/DSB/M/40;WTO-Dispute Settlement Body(1998b:16), Document WT/DSB/M/45。
6 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
7 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
1 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
2 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
3 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
4 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
5 参见 WTO-Dispute Settlement Body(1998d:14), Document WT/DSB/M/48。
6 参见 WTO-Dispute Settlement Body(1998b:25), Document WT/DSB/M/51。
7 参见 WTO-Dispute Settlement Body Status Report by India (1999a), Document WT/DS50/10/Add.4。
1 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R,Annex 4。
2 参见 EC—India patent dispute, report issued by DSB, Document WT/DS50/R,Annex3。
3 关于该争端的详细分析与评述,可参见朱榄叶编著:《世界贸易组织国际贸易争端案例评析 1995-2002》(下册),法律出版社 2004 年版,第 803-816 页。
1 参见 SPCs—EEC Directive No.1768/92。
1 参见 United Nations Development Programme: Millennium Development Goals (Goal 6: Combat HIV/AIDS, malaria and other diseases" targets), http://www.undp.org/mdg/。
2 2003 年 9 月 22 日,世界卫生组织艾滋病的传播已成为全球性危机。 参见 WHO Fact Sheet 274 (Sept. 2003), http://www.who.int/mediacentre/factsheets/2003/fs274/en/print.html/html。
3 据世界卫生组织 2003 年的统计,有近六百万的艾滋病感染者迫切需要进行药物治疗,否则他们将在两年内死亡。尽管如此,仍只有不到 40 万发展中国家的艾滋病患者能得到抗逆转录病毒治疗,其中非洲约有10 万人。参见 WHO & UNAIDS, Treating 3 Million by 2005: Making it Happen: The WHO Strategy, 5 (2003), http://www.Who.int/3by5/publications/documents/en/Treating3millionby2005.pdf。
4 在非洲各国,诸如心血管疾病、癌症以及糖尿病等非传染性疾病的发病人数正明显上升。根据世界卫生组织非洲地区办公室的报告,如果这一趋势得不到控制,到 2020 年,非洲地区 60%的死亡将是由非传染性疾病所导致的。而在 1990 年,这一比例是 41%。 参见 WHO, Noncommunicable Diseases: Regional Strategy for 2000-2010(Aug.28-Sept.2, 2000), http://www.afro.who.int/press/2000/regionalcommittee/rc5006.html。
1 在过去的三十多年里,《财富》杂志全球 500 强的公司中,药品行业一直最盈利的行业。参见 Scott Gottlieb, Drug Companies Maintain "Astounding" Profits, 324 B.M.J. 1054 (2002)。
2 参见 Donald G. McNeil Jr., Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa N.Y. TIMES, Feb. 7, 2001,http://www.nytimes.com/2001/02/07/health/ 07 AIDS.html。
3 Mark Schoofs, Clinton Program Would Help Poor Nations Get AIDS Drugs, WALL ST. J., Oct. 23, 2003.
4 各大药品公司也曾通过 WHO 的加速药品获取倡议(Accelerating Access Initiative)提供折扣药品。但是,该倡议进展迟缓,在2000年5月至2002年3月之间,只有36000病人因该倡议而受益。参见WHO & UNAIDS Progress Report, Accelerating Access Initiative: Widening access to care and support for people living withHIV/AIDS 1-2 (June 2002)。
1 参见 Report of the Commission on Macroeconomics and Health, Analysis of the Costs of Scaling Up Priority Health Interventions in Low-and Selected Middle-Income Countries (Appendix 2),http://www3.who.int/whosis/cmh/cmh_report/e/report.cfm?path= cmh, cmh_report&language=english。
2 关于美国利用双边和地区论坛进一步提供知识产权保护水平的承诺,可参见 Peter Drahos, Bilateralism in Intellectual Property (2001), http://www.oxfam.org.uk/what_we_do/issues/trade/bilateralism_ip.htm。
1 参见 Michael Bailey, Ruth Mayne & Dr. Mohga Smith, Fatal Side Effects: Medicine Patents under the Microscope, (Feb. 2001), http://www.oxfam.org.uk/what_we_do/issues/health/fatal_side_effects.htm。
2 用 Edmund Pratt of Pfizer 先生自己的话说,“药品工业的团结使我们能够建立全球性的私人与政府相结合的强大网络,并为 TRIPS 协定的产生奠定了基础”。出处?
3 实际上,在 TRIPS 协定通过不久,智利、南非等一些发展中国家外资药品生产设施便不断减少。
4 仿制药生产者如果可以将仿制药与专利药品进行生物成分和特性的比较,便可以避免昂贵、费时且充分性的临床试验。关于未披露数据合理使用的详尽分析,可参见 Carlos Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (2002)。
1 参见 World Bank, World Development Indicators 2000, Table 5-12 (2000)。
2 毫无疑问,美国和欧洲的谈判代表深知,专利保护的强化将对药品价格产生何种影响。他们正是在药品公司代表的要求和帮助下进行谈判的。同样,印度和巴西似乎也知道新的知识产权保护协定意味着什么,但美国却使用威胁和分化战略,阻止发展中国家形成一个立场一致的联盟。这些发展中国家原本反对将以垄断为基础的知识产权保护置于多边“自由贸易”协定之中。美国分化发展中国家的主要工具便是特别 301条款,以及 19U.S.C. § 2242 (2003) 中规定的贸易制裁手段。关于美国使用双边威慑的历史,可参见 Peter Drahos & John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy (2003)。
3 参见 Report of the Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (2002),http://www.iprcommission.org/ papers/pdfs/final_report/ciprcoverintrofinal.pdf。
4 参见 United Nations Development Programme, Human Development Report 2001: Making New Technologies Work for Human Development (2001), http://hdr.undp.org/reports/global/2001/en/pdf/completenew.pdf。
5 World Bank, Intellectual Property: Balancing Incentives with Competitive Access in GLOBAL ECONOMIC PROSPECTS, 129-50 (Washington, D.C. 2001), http://www.worldbank.org/prospects/gep2002/chapt5.pdf.
6 UNCTAD-ICTSD, Intellectual Property Rights: Implications for Development, http://www.ictsd.org/pubs/ictsd_series/iprs/pp/pp_1intro.pdf.
7 WTO Agreement and Public Health: A Joint Study by the WHO and the WTO Secretariat (2002).
8 知识产权原教旨主义泛指一种较为激进的知识产权保护理论,该理论认为知识产权和一般的财产权一样,是一种自然权利,甚至可以包含在人权的范围之内。根据这一理论,一个国家不管其经济和社会发展水平如何,也不管其是否面临严重的公共危机,都应该对知识产权提供充分的保护。与之相对立的理论则主张,知识产权保护主要是一个公共政策问题,各国可以根据自身经济和社会发展水平,来决定是否保护以及如何保护知识产权。
9 1999 年至 2000 年期间,泰国在国内一些非政府组织的要求下,根据 TRIPS 协定的规定利用强制许可进行药品生产。但由于美国威胁对泰国进行贸易制裁,泰国最终只能放弃这一计划。
1 关于美国对巴西在这方面进行的 WTO 申诉,可参见 Ellen t'Hoen, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha, 3 Cm. J. INT'LL. 27, 30-33 (2002)。
2 参见 Pharm. Mfrs. Ass'n of S. Africa v. President of the Republic of S. Africa, Case No. 4193/98 (filed Feb. 18, 1998)。在引起强烈的国际公愤后,该案件被无条件撤诉。
3 发展中国家并不认为差别定价的办法能够解决它们的问题。关于发展中国家所做努力的详尽分析,可参见 Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. INT'L ECON. L. 469, 480-90 (2002)。
4 参见 U.S. Statement at TRIPS Council Meeting, http://lists.essential.org/ pipermail/pharm-policy/2001-June/001175.html。
5 参见 Communication from the European Communities and Their Member States, IP/C/W/280 (June 12, 2001)。
1 参见 Developing Country Group's Paper, IP/C/W/296 (June 29, 2001); Draft Ministerial Declaration -- Proposal from a Group of Developing Countries, IP/C/W/312 (Oct. 4, 2001)。
2 参见 Ministerial Declaration pmbl., Contribution from Australia, Canada, Japan, Switzerland and the United States, IP/C/W/313 (Oct. 4, 2001),http://www.wto.org/english/tratop_e/trips_e/mindecdraft.w313_e.htm; Non-Paper, Contribution from Canada, the Czech Republic, Japan, New Zealand, Switzerland and the United States,http://lists.essential.org/pipermail/ip-health/2001-September/001899.html。
1 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
2 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
3 第 6 款谈到的是强制许可(compulsory licenses),而 TRIPS 协定第 31 条使用的含义更广泛的“未经授权使用(unauthorized use)。后者既包括强制许可,也包括非商业性的政府使用。
2 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
3 参见 Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products, IP/C/25 (July 1, 2002)。
4 参见 Least-Developed Country Members -- Obligations under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products, WT/L/478 (July 12, 2002)。
6 参见 Statement on the Considerations for Paragraph 6 Modalities Delivered by Kenya on Behalf of the African Group, Brazil, Cuba, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Malaysia, Sri Lanka and Thailand at the TRIPS Council Meeting on March 5, 2002, IP/C/M/35 (Mar. 22, 2002);Joint Communication from the African Group in the WTO, IP/C/W/351 (June 24, 2002);Communication from Brazil on behalf of Bolivia, Brazil, Cuba, China, Dominican Republic, Ecuador, India, Indonesia, Pakistan, Peru, Sri Lanka, Thailand and Venezuela, IP/C/W/355 (June 24, 2002);South African Non-Paper on Substantive and Procedural Elements of a Report to the General Council under Paragraph 6 of the Declaration on the TRIPS Agreement and Public Health, Job(02)/156 (Nov. 5, 2002);Communication from Kenya, the Coordinator of the African Group, IP/C/W/389 (Nov. 14, 2002)。
1 2002 年 9 月 17 日,世界卫生组织表示,“第 30 条中的有限例外与公共原则最为契合。这种解决办法可以使 WTO 成员获取迅速有效的授权,以许可第三方生产、出售和出口药品或其他健康技术,并满足公共健康需要。英国知识产权委员会也持相同的看法。参见 WTO Council for Trips, Statement by the Representative of the WHO, Sept. 17, 2002, http://www.cptech.org/ip/health/who/who091722002.html。
2 这些措施包括平行进口、放松 TRIPS 协定第 31(f)条中的“主要供应国内市场(predominantly for the supply of domestic market)”规则,以及使用 TRIPS 协定第 30 条中的有限例外规则等。
3 Communication from the United States, IP/C/W/340 (Mar. 14, 2002); Second Communication from the United States, IP/C/W/358 (July 9, 2002).
2 参见 Draft Implementation 28 of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, JOB(02)/217 (Dec. 16, 2002), http://www.cptech.org/ip/wto/p6/wto12162002.html。
1 美国在疾病范围问题上的立场是,第六款解决方案只能涉及有艾滋病、疟疾、肺结核及其他同等规模和同等严重的传染病有关的重大健康危机。参见Second Communication from the United States, IP/C/W/358 (July 9, 2002)。
2 2002 年 12 月 20 日,TRIPS 协定理事会主席(墨西哥的 Eduardo Perez Motta 大使)告诉 WTO 总理事会,紧张的措施未能解决在疾病范围方面存在的分歧。参见 WTO Press Release, Press/329, Supachai Disappointed Over Governments' Failure to Agree on Health and Development Issues (Dec. 20, 2002), http://www.wto.org/english/news_e/pres02_e/pr329_e.htm。
4 WTO, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540. 2005 年 12 月,WTO 各成员同意将第 6 款实施决定作为对 TRIPS 协定的永久性修改。这一修改须得到 WTO 三分之二的成员批准才能生效。到 2007 年 4 月底,只有美国、瑞士、萨尔瓦多、韩国、挪威、印度和菲律宾 7 个成员批准了该修改。但在此之前,实施决定本身仍具有豁免性的效力。
5 The General Council Chairperson's Statement (Aug. 30, 2003), http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm.
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
2 巴西曾在 2003 年表示,它要从印度进口三种仿制的抗逆转录病毒药品。这很好地表明了未来的争吵将如何进行。参见 Brazil May Break Patents on Merck & Co., Roche, Abbott Labs AIDS Drugs (Aug. 21, 2003), http://lists.essential.org/pipermail/ip-health/2003-August/005140.html。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
3 它们分别是 Organisation Africaine de la Propriete Intellectuelle (非洲知识产权组织,共有 16 个成员国) 和 African Regional Industrial Property Association (非洲地区工业产权协会,共有 15 个成员国)。
4 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
2 美国政府和药品行业一直担心,巴西、中国和印度的仿制药品行业将会“滥用”这种“为出口而生产”的体制,来获取仿制药品出口市场。参见 U.S. Latest Conditions on Paragraph 6 -- Illusory Humanitarian Sales, http://lists.essential.org/pipermail/ip-health/2003-August/005105.htm。
1 参见 Tamar Kahn, Clinton Aspen to Cut Price of AIDS Drugs, Bus. DAY (Cape Town), Oct. 24, 2003, http://allafrica.com/stories/printable/200310240136.html。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 The General Council Chairperson's Statement (Aug. 30, 2003), http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm.
1 参见 Rene Shen, WTO to Close Deal on Medicines Supply, http://lists.essential.org/ pipermail/ip-health/2003-August/005139.html。
2 参见 Rene Shen, WTO to Close Deal on Medicines Supply, http://lists.essential.org/ pipermail/ip-health/2003-August/005139.html。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Novartis Receives EMR for Glivec, http://lists.essential.org/pipermail/ip-health/2003-November/005611.html。
2 参见 Carlos Correa, Integrating Public Health Concerns into Patent Legislation in Developing Countries, Section X.2 (2000), http://www.southcentre.org/publications/publichealthHoc.htm。
1 参见 Bernard Simon, Curtailing Medicines from Canada, N.Y. TIMES, Nov. 11, 2003, C1。
2 参见 Medecins Sans Frontieres Access to Essential Medicines Campaign and the Drugs for Neglected Disease Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, http://www.msf.org/source/access/ 2001/fatal/fatal.pdf。
3 参见 World Health Organization, Accelerating Access Initiative, Widening Access to Care and Support for People Living with HIV/AIDS Progress Report (June 2002), http://www.who.int/hiv/pub/prev_care/aai/en/。
4 参见 Medecins Sans Frontieres Access to Essential Medicines Campaign and the Drugs for Neglected Disease Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, http://www.msf.org/source/access/ 2001/fatal/fatal.pdf。
1 参见 James Love, Compulsory Licensing: Models for State Practice in Developing Countries, Access to Medicine and Compliance with WTO TRIPS Accord paras. 35-42,http://www.cptech.org/ip/health/cl/recommendedstatepractice.html。
1 参见 Robert Weissman, A Long, Strange TRIPS: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries, 17 U. PA. J. INT'L ECON. L. 1069, 1075-94 (1996)。
1 这种药品是由三种不同的抗逆转录病毒药品合成的单个片剂,也被 WHO 认为是在世界范围内抗击艾滋病的重要药品。参见 WHO, Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach, 9-13, http://www.who.int/3by5/publications/guidelines/en/arv_ guidelines.pdf。
2 参见 Kaiser Daily HIV/AIDS Report, FDA Approves Antiretroviral Drug Combination of Roche's Invirase, Abbott's Norvir, http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=l&DR_ID=21549;Lawrence K. Altman, U.S. Speeding Up Approval Steps for AIDS Drugs, N.Y. Times, May 17, 2004。
1 Colleen Chien, Cheap Drugs at What Price to Innovation: Does Compulsory Licensing of Pharmaceuticals Hun Innovation?, 18 BERKELEY TECH. L. J. 853 (2003).
2 Competition Commission Finds pharmaceutical firms in contravention of the Competition Act, 16 October, 2003. http://www.cptech.org/ip/health/sa/cc10162003.html
3 Competition Commission Finds pharmaceutical firms in contravention of the Competition Act, 16 October, 2003. http://www.cptech.org/ip/health/sa/cc10162003.html
4 Competition Commission concludes an agreement with pharmaceutical firms, 10 December, 2003. http://www.cptech.org/ip/health/sa/cc12102003.html
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 WTO, Canada -- Patent Protection of Pharmaceutical Products, Report of the Panel, WT/DS114/R (March 17, 2000)。
1、唐广良、董炳和著:《知识产权的国际保护》,知识产权出版社 2002 年版。
1、朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析》,法律出版社 2000 年版。
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32.Kirsten M.Koepsel,How Do Developed Countries Meet Their Obligations under Article 67 of the TRIPS Agreement?IDEA:The Journal of Law and Technology,2004.
33.James Thuo Gathii,The Legal Status of the Doha Declaration on Trips and Public Health Under the Vienna Convention on the Law of Treaties,1 5 Harv.J.Law &Tec291,Spring,2002.
34.Larry A.DiMatteo,Kiren Dosanjh,Paul L.Frantz,Peter Bowal,Clyde Stoltenberg,The Doha Declaration and Beyond:Giving a Voice to Non.Trade Concems Within the WTO Trade Regime,36 Vand.J.Transnat’1 L.95,January,2003.
3 5.Stephanie A.Barbosa,Implementation of the Doha Declaration:Its Impact on American Pharmaceuticals,36 Rutgers L.J.205,Fall,2004.
36.Johanna Kiehl,TRIPS Article 3 1(B)and the HIV/AIDS Epidemic,1 0 J.Intell.Prop.L.143,Fall,2002.
37.Alain J.Lapter,The WTO’S Dispute Resolution Mechanism:Does the United States Take It Seriously?4 Chi.-Kent J.Intell.Prop.217,Spring,2005.
3 8.Martin J.Adelman,Sonia Baldia,Prospects and Limits of the Patent Provision in the TRIPS Agreement:The Case ofIndia.29 Vand.J.Transnat'l L.507, May,1996.
39.Jennifer Berman,USING the Doctrine of Informed Consent to Improve HIV Vaccine Access in the Post.TRIPS Era,22 Wis.Int'l L.J.273,Spring,2004.
40.Stephen Barnes,Pharmaceutical Patents and TRIPS:A Comparison of India and SouthAfrica,91 ICy.L.J.911,Summer 2002/2003.
41.Bryan C.Mercurio,TRIPS,Patents and Access to Life-Saving Drugs in the Developing World,8 Marq.Intell.Prop.L.Rev.211,Summer,2004.
1. James Thuo Gathi i.What History Teaches Us about the International Protection of Intellectual Rights:The Case of Least Developed Countries, at http://www.chicagoip.com/Gathii.pdf,September 6,2005.
2.Bolderin&Levine,Against Intellectual Monopoly,Chapter 4,pl, at http://levine.sscnet.ucla.edu/papers/anew04.pdf, Apri l5, 2007.
3.WTO Press Release,Press/329, Supachai Disappointed Over Governments’Fai lure to Agree on Health and Development Issues, at http://www.wto.0rg/english/news—e/pres02 一 e/pr329_e.htm,December 17,2006.
4.Brazil May Break Patents on Merck&Co.,Roche,Abbott Labs AIDS Drugs at,http://lists.essential.org/pipermail/ip-health/2003-August/005140.html,August 1 2,2004.
5.James Love,Compulsory Licensing:ModelS for State Practice in Developing Countries,Access to Medicine and Compl iance with WT0 TRIPS Accord paras. 35—42,at htto://www.cptech.org/ip/health/cl recommendedstatepractice.html,May 5,2005.
1 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 3 页。
2 参见 Suggested Charter for an International Organization of the United Nation, Washington DC, US Department of State Publication 2598, Commercial Policy Series 93,1946。
3 在此之前的 1947 年 1 月 20 日至 2 月 25 日,一个由技术专家组成的起草委员会已经在纽约的成功湖(Lake Success)举行过一次会议。参加起草委员会的报告,UN document EPTC/34 (March 5, 1947)。
1参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 5 页。
2参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 6 页;以及 GATT/CP/86 (December 7, 1950)。
2 该报告于 1987 年 11 月 10 日通过,参见 BISD 34S/83。根据 GATT 第 12 及 13 条、1979 年 11 月 28 日的《关于通知、磋商、争端解决及监督的谅解(Understanding on Notification, consultation, Dispute Settlement and Surveillance)》及其附件、1982 年 11 月 29 日的部长宣言、以及 1984 年 11 月 30 日的《关于争端解决的决定(Decision on Dispute Settlement)》,当一缔约方认为其根据 GATT 可直接或间接享有的利益受到“剥夺或损害(nullified and impaired)”,该缔约方可以要求与其认为有过错的其他缔约方进行磋商。如果磋商失败,它可以要求成立专家组就有争议的问题作出决定。专家组报告需要交由“全体缔约方(CONTRACTING PARTIES)批准。在 GATT 体制下,专家组报告的批准需得到各缔约方的一致同意。这意味着,败诉的一方可以投票反对专家组报告并将其否决。实际上,不少专家组报告的批准都被无限期地“推迟”。
3 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 290 页。
1 参见 BISD30S/107。
2 BISD30S/107,para.53.
3 参见 BISD 36S/345。
4 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 582 页。
5参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 583 页。
6 参见 Hartridge、Subramanian: “Intellectual Property Rights: The Issues in GATT”, (1989)22 Vanderbilt Journalof International Law。
1 参见 Hartridge、Subramanian: “Intellectual Property Rights: The Issues in GATT”, (1989)22 Vanderbilt Journal of International Law。
2 参见 L/4817 及 L/5382。序号以 L 开头的文件是指 GATT 秘书处自 1952 年以来出版的一般文件。
3 参见 BISD 29S/19。
4 参见 WTO, Guide to GATT LAW and Practice, 6th ed., Geneva, 1995, 第 582 页。
5 理事会平均每月举行一次会议。各缔约方一般都是派驻日内瓦的最高级别的贸易官员出席会议,同时由国内派来或驻日内瓦的各类专家陪同。
6 与此同时,一名 WIPO 的工作人员也参加了专家小组的讨论。根据专家小组的报告,该工作人员并未发挥积极作用。
1 参见 L/5878。
2 在 WIPO 网站(www.wipo.org)上可以获取这些协定的文本以及这些协定的最新成员情况。
1 参见 PREP.COM(86)SR/3(April 11,1986)。
2 参见 PREP.COM(86)W/47/Rev.2(July 30, 1986)。
3 参见 PREP.COM(86)W/47/Rev.1(July 16, 1986)。
4 参见 PREP.COM(86)W/49/Rev.2(July 29, 1986)。
5 参见 Document Min. DEC(September 20, 1986)。
1 参见 GATT Document 1405(February 5, 1987)。
2 参见 GATT Document 1405(February 5, 1987)。
1 参见下列国家提交的建议书:美国,MTN.GNG/NG11/W/14(October 20, 1987);瑞士,MTN.GNG/NG11/W/15(October 26, 1987);欧共体,MTN.GNG/NG11/W/16(October 20, 1987)及MTN.GNG/NG11/W/26(July 17, 1987);日本,MTN.GNG/NG11/W/17(November 23, 1987)。1988 年初,北欧国家也提交了一份建议书,MTN.GNG/NG11/W/22(February 12, 1988)。
2 泰国、墨西哥及巴西提交了书面声明,分别是 MTN.GNG/NG11/W/27(September 21, 1988),MTN.GNG/NG11/W/28(October 19, 1988)及 MTN.GNG/NG11/W/30(October 31, 1988)。其中巴西在声明中建议限制未来协定的范围。
3 参见 Document MTN.TNC/11(April 21,1989)。
1 参见 Document MTN.TNC/11(April 21,1989)。
2 参见 Document MTN.TNC/11(April 21,1989)。
3 澳大利亚,MTN.GNG/NG11/W/35(July 10, 1989);印度,MTN.GNG/NG11/W/37(July 10, 1989);北欧国家,MTN.GNG/NG11/W/36(July 10, 1989);瑞士,MTN.GNG/NG11/W/38(July 10, 1989)。
4 参见 MTN.GNG/NG11/W/57(December11, 1989)。
5 参见 MTN.GNG/NG11/W/48(October 26, 1989)。
6 参见 MTN.GNG/NG11/W/55(December 8, 1989)。
7 参见 MTN.GNG/NG11/W/51(November 29, 1989)。香港是 GATT 的缔约方,后来作为独立关税区成为WTO 的成员。
1 参见 MTN.GNG/NG11/W/68(March 29, 1990)。
2 参见 MTN.GNG/NG11/W/70(May 11, 1990)。
3 日本的建议书标题为“TRIPS 法律文本的主要内容(Main Elements of a Legal Text for TRIPS)”,参见MTN.GNG/NG11/W/74(May 15, 1990)。
4 瑞士的建议书标题为“保护与贸易有关的知识产权关税与贸易总协定修正案草案(Draft Amendment on General Agreement on Tariff and Trade on the Protection of Trade-Related Intellectual Property Rights)”,参见MTN.GNG/NG11/W/73(May 14, 1990)。
5 这 12 个发展中国家是阿根廷、巴西、智利、中国、哥伦比亚、古巴、埃及、印度、尼日利亚、秘鲁、坦桑尼亚和乌拉圭。参见 MTN.GNG/NG11/W/71(May 14, 1990)。
6 参见“Communication from Chile”, MTN.GNG/NG11/W/72(May 14, 1990)。
7 指上述发展中国家提交的建议草案。
8 “Draft text on Geographical Indications, Communication from Australia”,参见 MTN.GNG/NG11/W/75(July 13, 1990)。
1 MTN.GNG/NG11/W/68 表示是欧共体的文本;MTN.GNG/NG11/W/70 美国提交的文本;MTN.GNG/NG11/W/71 则是所谓的“发展中国家”文本;MTN.GNG/NG11/W/73 是瑞士的文本;MTN.GNG/NG11/W/74 则是日本的文本;MTN.GNG/NG11/W/75 则是澳大利亚关于地理标识的文本。
2 参见 MTN.GNG/NG11/W/76(July 23, 1990)。
3 这些部分有:第一部分(包括序言与协定目标);第四部分(关于争端解决与防止);第七部分(过渡安排);第八部分(组织安排)。
1 当谈到“相关的国际组织”时,发展中国家代表想到的可能是 WIPO。智利就在其意见书中公开提及 WIPO,参见“Communication from Chile”, MTN.GNG/NG11/W/72(May 14, 1990)。根据一些发展中国家的意见,WIPO 作为联合国的一个下属组织,是避免实施制裁的更好保障。不管怎样,在 WIPO 框架下的制裁都不会是“与贸易有关的”。
2 参见 MTN.GNG/NG11/W/76(July 23, 1990)。
1 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2212.
4 参见 MTN.GNG/NG11/25(October 8, 1990)。
5 参见 MTN.GNG/NG11/27(November 14, 1990)。
6 此处指发展中国家提交的草案文本,即 MTN.GNG/NG11/W/71(May 14, 1990)。
1 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2232.
3 参见 Document MTN.TNC/W/35/Rev.1(December 3, 1990)。
1 瑞士联邦知识产权办公室在国家事务局出版的《世界知识产权报告(World Intellectual Property Reports)》上发表了一份关于 TRIPS 谈判的直言不讳的报告,指出了仍然存在的分歧,并特别提到了专利的强制许可。 另参见 T. Cottier, “The Prospects for Intellectual Property in GATT”, (1991) 2 Common Market Law Review。
2 参见“Proposal for the Establishment of a Dispute Prevention System in Respect of Transfer of Technologies”, MTN.GNG/TRIPS/W/1(July 14, 1990)。
3 建议书由哥伦比亚代表该集团提交。参见 MTN.GNG/TRIPS/W/2(October 16, 1990)。
1 参见 Haochen Sun,A Wider Access to Patented Drugs under the TRIPS Agreement,Boston University International Law Journal, Spring, 2003。
2 参见 Rochelle Cooper Dreyfuss, Argentina’s Emerging Standard of Intellectual Property Protection: A Case Study of the Underlying Conflicts between developing Countries, TRIPS Standards, and the United States, Case Western Reserve Journal of International Law,Spring 2001。
3 参见 J.H. Reichman,The TRIPS Agreement Comes of Age: Conflict or Cooperation with the Developing Countries? Case Western Reserve Journal of International Law,Summer, 2000。
1 J.H.Reichman and David Lange, Bargaining around the TRIPS Agreement: the Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual Property Transaction, 9 Duke J. Comp. & Int’l L. 11, Fall, 1998.
2 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp501-543.
3 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp478-489.
4 Mohamed Omar Gad, Top-Down Rule-Making: Negotiating the TRIPS Pharmaceutical-Related Patent Provions, The London Institute of international Banking, Finance and Development Law Ltd, No. 45, 2003.
5 参见 GATT(1991), Document MTN.TNC/W/89/Add.1。
6 J. H. Reichman,“Securing Compliance with the TRIPS Agreement after US v. India”, J. Int' l Econ. L. p585, 1998.
1 Terence P. Stewart, ed. The GATT Uruguay Round: A Negotiating History(1986-1994), Kluwer Law Internatioal, 1999, pp453.
2 J.H.Reichman and David Lange, Bargaining around the TRIPS Agreement: the Case for Ongoing Public-Private Initiatives to Facilitate Worldwide Intellectual Property Transaction, 9 Duke J. Comp. & Int’l L. 11, Fall, 1998.
3 Thomas F. Cotter, Market Fundamentalism and the TRIPS Agreement, 22 Cardozo Arts & Ent LJ 307, 2004.
4 Carlos M Correa, Intellectual Property Rihgts, the WTO and Developing Countries: The TRIPS Agreement and Policy Options, Zed Books Ltd, 2000, p7.
5 出于行文通顺的需要,本文可能会在某些地方将 WTO 的成员笼统地称为“成员国”,但实际上 WTO 成员中也包括一些非主权国家的独立关税区,如我国的香港地区、台湾地区等。
2 关于 WTO 自 1995 年以来的争端解决情况的详细和系统分析,可参见朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析》,法律出版社 2000 年版;朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析 1995-2002》,法律出版社 2004 年版;以及 WT/DS/OV30。
3 参见朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析 1995-2002》(下册),法律出版社 2004 年版,第 803 页,“加拿大-药品专利保护”。
1 转引自 James Thuo Gathii, What History Teaches Us about the International Protection of Intellectual Rights: The Case of Least Developed Countries, http://www.chicagoip.com/Gathii.pdf; 另请参见 Bolderin & Levine, Against Intellectual Monopoly, Chapter 4, p1, http://levine.sscnet.ucla.edu/papers/anew04.pdf。
1 Maskus, K.E., Intellectual Property in the Global Economy, Institute for International Economics, 2000.
2 参见 UNCTAD, Least Developed Countries 1998 Report (1999:162)。
1 参见 WTO—Council fro TRIPS(Annual Report 1998a:5)。
2 参见 Communication from Colombia, WT/GC/W/316(September 14, 1999)。
3 参见 Communication from Kenya on Behalf of the Africa Group, WT/GC/W/302(August 6, 1999)。
4 参见 WTO—Council fro TRIPS(Annual Report 1998a:5)。
1 UNCTAD, “TRIPS and Developing Countries”, p30, Document no. UNCTAD/ITE/1.
1 Michael Blakeney , Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement, Sweet & Maxwell, 1996, p85.
2 UNCTAD, “TRIPS and Developing Countries”, p33, Document no. UNCTAD/ITE/1.
3 Michael Blakeney , Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement, Sweet & Maxwell, 1996, p88.
4 Ross and Wasserman, “Trade- Related Aspects of Intellectual Property” , The GATT Uruguay Round: A Negotiating History(1986-1992), vol.Ⅱ, T.P. Stewart, ed., p2292.
1 WTO, The World Health Report 1997, p29.
1 Mohamed Omar Gad, Top-Down Rule-Making: Negotiating the TRIPS Pharmaceutical-Related Patent Provions, The London Institute of international Banking, Finance and Development Law Ltd, No. 45, 2003.
2 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
3 如某成员 TRIPS 协定实施过渡期尚未届满,该成员并无义务实施该协定,因而也无需为药品提供专利保护。但它仍有义务提供某种方式,以便人们为药品和农药提出专利申请,申请人也可能因此获得优先权。
4 Bryan C. Mercurio, TRIPS, Patents, and Access to Life-Saving Drugs in the Developing World, 8 Marq. Intell. Prop. L. Rev. 211, Summer 2004.
5 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
1 Jacques J Gorlin, An Analysis of the Pharmaceutical-Related Provisions of the TRIPS Agreement, Gorlin Group, 2000.
1 参见 MTN/GNG/NG11/17。
2 根据 TRIPS 协定第 39.2 条的注释 10,“‘违反诚实商业行为的方式’应至少包括违反合同、泄密以及诱导违约,且应包括第三方取得未披露信息,如果该第三方知道或因严重疏忽未能知道未披露信息的取得涉及此类做法。(’a manner contrary to honest commercial practices’ shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by the third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition.)”。
1 Frederich M. Abbott, The Enduring Enigma of TRIPS: A Challenge for the World Trading System, Journal of International Economic Law, 497, 1998, pp1-26.
2 WTO, The World Health Report 1997, p17.
3 EFPIA’s postion paper, TRIPS and the Millennium Round, 1999, p2.
1 关于新加坡部长会议的各类声明,可参见序号以 WT/MIN(96)/ST 开头的 WTO 文件。
2 Vice Minister of Foreign Trade, Colombia (WTO-Ministerial Conference 1996a), Document WT/MIN(96)/ST/23.
3 Minister of Commerce and Industry, Botswana (WTO-Ministerial Conference 1996b), Document WT/MIN(96)/ST/76.
1 Vice Minister of Foreign Relations, Paraguay (WTO-Ministerial Conference 1996c), Document WT/MIN(96)/ST/75.
2 Minister of Commerce and Industry, Bangladesh (WTO-Ministerial Conference 1998b), Document WT/MIN(98)/ST/60.
3 Minister of Trade, Kenya (WTO-Ministerial Conference 1998c), Document WT/MIN(98)/ST/43.
4 Minister of Commerce and Industry, Botswana (WTO-Ministerial Conference 1998d), Document WT/MIN(98)/ST/110.
5 Secretary of State for Industry and Trade, Dominican Republic (WTO-Ministerial Conference 1998e), Document WT/MIN(98)/ST/117.
1 参见 Communication from Kenya (WTO-General Council 1999h), Document WT/GC/W/302。
2 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
3 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
4 参见 Communication from Venezuela (WTO-General Council 1999e), Document WT/GC/W/282。
5 参见 Communication from Colombia (WTO-General Council 1999i), Document WT/GC/W/316。
6 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352。
1 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352,第 2 页。
2 参见 Communication from India (WTO-General Council 1999l), Document WT/GC/W/352,第 3 页。
3 参见 Communication from CEFTA and Latvia (WTO-General Council 1999g), Document WT/GC/W/275。
4 参见 Communication from CEFTA and Latvia (WTO-General Council 1999g), Document WT/GC/W/275。
5 参加 Communications from the Africa Group, Colombia, Venezuela。另参见 Communication from Canada, (WTO-General Council 1999f), Document WT/GC/W/256。
6 参见 Communication from Canada, (WTO-General Council 1999f), Document WT/GC/W/256。
1 Minister of Commerce, Industry and Production, Pakistan (WTO-Ministerial Conference 1999b), Document WT/MIN(99)/ST/9; Minister of Commerce and Industry, Bangladesh (WTO-Ministerial Conference 1999c), Document WT/MIN(99)/ST/17; Minister of Industry and Trade and Development, Cameroon (WTO-Ministerial Conference 1999g), Document WT/MIN(99)/ST/88; Minister of Commerce, Industry and Handicrafts, Morocco (WTO-Ministerial Conference 1999d), Document WT/MIN(99)/ST/29; Minister of Commerce and Handicrafts, Senegal (WTO-Ministerial Conference 1999e), Document WT/MIN(99)/ST/61.
2 Minister of Commerce, Industry and Production, Pakistan (WTO-Ministerial Conference 1999b), Document WT/MIN(99)/ST/9.
3 Minister of Commerce and Handicrafts, Senegal (WTO-Ministerial Conference 1999e), Document WT/MIN(99)/ST/61.
1 参见 WIPO—International Bureau (2000), Document WIPO/IPTK/RT/99/7; WIPO Secretariat(2001), Document WIPO/GRTKF/IC/1/3。
3 参见 WIPO—International Bureau (1999), Document WIPO/IPTK/RT/99/2。
4 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n), Document WT/GC/W/362;Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k), Document WT/GC/W/329;Minister of Commerce and Industry, India (WTO-Ministerial Conference 1999a), Document WT/MIN(99)/ST/16。
5 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1)。
6 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1)。
1 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:1-2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k)。
2 参加 Statement by Pakistan (WTO-Ministerial Conference 1999b:4)。
3 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E。
4 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 2-3 页。
5 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 2 页。
6 参见 WIPO(1998b), Document WIPO/INDIP/RT/98/4E,第 3 页。
7 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k:2)。
8 参见 Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru (WTO-General Council 1999n:2);Communication from Cuba, Honduras, Paraguay, and Venezuela (WTO-General Council 1999k:2)。
1 Secretary of State for Industry and Trade, Honduras (WTO-Ministerial Conference 1999f); Communication from Venezuela (WTO-General Council 1999e:2); Communication from India (WTO-General Council 1999h:3-4).
2 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3)。
3 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3);Communication from Cuba, Dominican Republic, Egypt, El Salvador, Honduras, India, Indonesia, Malaysia, Nigeria, Pakistan, Sri-Lanka and Uganda (WTO-General Council 1999m:4), Document WT/GC/W/355。
4 参见 Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3)。
5 Jan McGirk, A Tribe Goes Into Battle Over the 'Evil Twins' of Colombia,Independent (London), 1999, p8.
1 Office of Prime Minister, United Kingdom, (2000)。
2 参见 Communication from India (WTO—General Council 1999b), Document WT/GC/W/225;Communication from Venezuela (WTO-General Council 1999e:2);Communication from Kenya on behalf of the Africa Group (WTO-General Council 1999h:3-4)。
3 参见 Communication from Venezuela (WTO-General Council 1999e:2); Communication from Cuba, Dominican Republic, Egypt, El Salvador, Honduras, India, Indonesia, Malaysia, Nigeria, Pakistan, Sri-Lanka and Uganda (WTO-General Council 1999m:27)。
1 Commission of the European Communities—DG Trade(1999c).
2 参见 Statement circulated by Sir Leon Brittan QC, Vice President of the European Commission, Document WT/MIN(98)/ST/76(WTO—Ministerial Conference, Second Session,1998a)。
3 Commission of the European Communities—DG Trade(1998a).
4 参见 European Parliament Committee on External Economic Relations,(1996:8), Document A4—0320/96。
1 UK, Department of International Development, Report on World Trade, 2000, p45.
1 IFPMA, Position Paper on TRIPS, 1995, p16.
2 VFA, 1999 Annual Report, 2000, p19.
1 EFPIA, Position Paper on TRIPS, 1999, p2.
1 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Request for Consultation by the EC(1997b), Document WT/DS79/1。关于该争端的详细分析与评述,可参见朱榄叶编著:《世界贸易组织国际贸易争端案例评析》,法律出版社 2000 年版,第 426-439 页。
2参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Request for the establishment of a Panel by the EC(1997c), Document WT/DS79/2。
1 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products(1997c:2), Document WT/DS50/R。
2 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products(1997c:2), Document WT/DS50/R。
3 参见 WTO-Dispute Settlement Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Notification of an Appeal by India under paragraph 4 of Article 16 of the Understanding on Rules and Procedures Governing the Settlement of Disputes(1997a), Document WT/DS50/6。
4 参见 WTO-Appellate Body, India—Patent Protection For Pharmaceutical and Agricultural Chemical Products—Reports of the Appellate Body(1997:34), Document WT/DS50/AB/R。
5 参见 WTO-Dispute Settlement Body(1998a:1-7), Document WT/DSB/M/40;WTO-Dispute Settlement Body(1998b:16), Document WT/DSB/M/45。
6 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
7 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
1 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
2 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
3 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
4 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R。
5 参见 WTO-Dispute Settlement Body(1998d:14), Document WT/DSB/M/48。
6 参见 WTO-Dispute Settlement Body(1998b:25), Document WT/DSB/M/51。
7 参见 WTO-Dispute Settlement Body Status Report by India (1999a), Document WT/DS50/10/Add.4。
1 参见 EC—India patent dispute, report issued by DSB, Document WT/DS79/R,Annex 4。
2 参见 EC—India patent dispute, report issued by DSB, Document WT/DS50/R,Annex3。
3 关于该争端的详细分析与评述,可参见朱榄叶编著:《世界贸易组织国际贸易争端案例评析 1995-2002》(下册),法律出版社 2004 年版,第 803-816 页。
1 参见 SPCs—EEC Directive No.1768/92。
1 参见 United Nations Development Programme: Millennium Development Goals (Goal 6: Combat HIV/AIDS, malaria and other diseases" targets), http://www.undp.org/mdg/。
2 2003 年 9 月 22 日,世界卫生组织艾滋病的传播已成为全球性危机。 参见 WHO Fact Sheet 274 (Sept. 2003), http://www.who.int/mediacentre/factsheets/2003/fs274/en/print.html/html。
3 据世界卫生组织 2003 年的统计,有近六百万的艾滋病感染者迫切需要进行药物治疗,否则他们将在两年内死亡。尽管如此,仍只有不到 40 万发展中国家的艾滋病患者能得到抗逆转录病毒治疗,其中非洲约有10 万人。参见 WHO & UNAIDS, Treating 3 Million by 2005: Making it Happen: The WHO Strategy, 5 (2003), http://www.Who.int/3by5/publications/documents/en/Treating3millionby2005.pdf。
4 在非洲各国,诸如心血管疾病、癌症以及糖尿病等非传染性疾病的发病人数正明显上升。根据世界卫生组织非洲地区办公室的报告,如果这一趋势得不到控制,到 2020 年,非洲地区 60%的死亡将是由非传染性疾病所导致的。而在 1990 年,这一比例是 41%。 参见 WHO, Noncommunicable Diseases: Regional Strategy for 2000-2010(Aug.28-Sept.2, 2000), http://www.afro.who.int/press/2000/regionalcommittee/rc5006.html。
1 在过去的三十多年里,《财富》杂志全球 500 强的公司中,药品行业一直最盈利的行业。参见 Scott Gottlieb, Drug Companies Maintain "Astounding" Profits, 324 B.M.J. 1054 (2002)。
2 参见 Donald G. McNeil Jr., Indian Company Offers to Supply AIDS Drugs at Low Cost in Africa N.Y. TIMES, Feb. 7, 2001,http://www.nytimes.com/2001/02/07/health/ 07 AIDS.html。
3 Mark Schoofs, Clinton Program Would Help Poor Nations Get AIDS Drugs, WALL ST. J., Oct. 23, 2003.
4 各大药品公司也曾通过 WHO 的加速药品获取倡议(Accelerating Access Initiative)提供折扣药品。但是,该倡议进展迟缓,在2000年5月至2002年3月之间,只有36000病人因该倡议而受益。参见WHO & UNAIDS Progress Report, Accelerating Access Initiative: Widening access to care and support for people living withHIV/AIDS 1-2 (June 2002)。
1 参见 Report of the Commission on Macroeconomics and Health, Analysis of the Costs of Scaling Up Priority Health Interventions in Low-and Selected Middle-Income Countries (Appendix 2),http://www3.who.int/whosis/cmh/cmh_report/e/report.cfm?path= cmh, cmh_report&language=english。
2 关于美国利用双边和地区论坛进一步提供知识产权保护水平的承诺,可参见 Peter Drahos, Bilateralism in Intellectual Property (2001), http://www.oxfam.org.uk/what_we_do/issues/trade/bilateralism_ip.htm。
1 参见 Michael Bailey, Ruth Mayne & Dr. Mohga Smith, Fatal Side Effects: Medicine Patents under the Microscope, (Feb. 2001), http://www.oxfam.org.uk/what_we_do/issues/health/fatal_side_effects.htm。
2 用 Edmund Pratt of Pfizer 先生自己的话说,“药品工业的团结使我们能够建立全球性的私人与政府相结合的强大网络,并为 TRIPS 协定的产生奠定了基础”。出处?
3 实际上,在 TRIPS 协定通过不久,智利、南非等一些发展中国家外资药品生产设施便不断减少。
4 仿制药生产者如果可以将仿制药与专利药品进行生物成分和特性的比较,便可以避免昂贵、费时且充分性的临床试验。关于未披露数据合理使用的详尽分析,可参见 Carlos Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (2002)。
1 参见 World Bank, World Development Indicators 2000, Table 5-12 (2000)。
2 毫无疑问,美国和欧洲的谈判代表深知,专利保护的强化将对药品价格产生何种影响。他们正是在药品公司代表的要求和帮助下进行谈判的。同样,印度和巴西似乎也知道新的知识产权保护协定意味着什么,但美国却使用威胁和分化战略,阻止发展中国家形成一个立场一致的联盟。这些发展中国家原本反对将以垄断为基础的知识产权保护置于多边“自由贸易”协定之中。美国分化发展中国家的主要工具便是特别 301条款,以及 19U.S.C. § 2242 (2003) 中规定的贸易制裁手段。关于美国使用双边威慑的历史,可参见 Peter Drahos & John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy (2003)。
3 参见 Report of the Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy (2002),http://www.iprcommission.org/ papers/pdfs/final_report/ciprcoverintrofinal.pdf。
4 参见 United Nations Development Programme, Human Development Report 2001: Making New Technologies Work for Human Development (2001), http://hdr.undp.org/reports/global/2001/en/pdf/completenew.pdf。
5 World Bank, Intellectual Property: Balancing Incentives with Competitive Access in GLOBAL ECONOMIC PROSPECTS, 129-50 (Washington, D.C. 2001), http://www.worldbank.org/prospects/gep2002/chapt5.pdf.
6 UNCTAD-ICTSD, Intellectual Property Rights: Implications for Development, http://www.ictsd.org/pubs/ictsd_series/iprs/pp/pp_1intro.pdf.
7 WTO Agreement and Public Health: A Joint Study by the WHO and the WTO Secretariat (2002).
8 知识产权原教旨主义泛指一种较为激进的知识产权保护理论,该理论认为知识产权和一般的财产权一样,是一种自然权利,甚至可以包含在人权的范围之内。根据这一理论,一个国家不管其经济和社会发展水平如何,也不管其是否面临严重的公共危机,都应该对知识产权提供充分的保护。与之相对立的理论则主张,知识产权保护主要是一个公共政策问题,各国可以根据自身经济和社会发展水平,来决定是否保护以及如何保护知识产权。
9 1999 年至 2000 年期间,泰国在国内一些非政府组织的要求下,根据 TRIPS 协定的规定利用强制许可进行药品生产。但由于美国威胁对泰国进行贸易制裁,泰国最终只能放弃这一计划。
1 关于美国对巴西在这方面进行的 WTO 申诉,可参见 Ellen t'Hoen, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha, 3 Cm. J. INT'LL. 27, 30-33 (2002)。
2 参见 Pharm. Mfrs. Ass'n of S. Africa v. President of the Republic of S. Africa, Case No. 4193/98 (filed Feb. 18, 1998)。在引起强烈的国际公愤后,该案件被无条件撤诉。
3 发展中国家并不认为差别定价的办法能够解决它们的问题。关于发展中国家所做努力的详尽分析,可参见 Frederick M. Abbott, The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO, 5 J. INT'L ECON. L. 469, 480-90 (2002)。
4 参见 U.S. Statement at TRIPS Council Meeting, http://lists.essential.org/ pipermail/pharm-policy/2001-June/001175.html。
5 参见 Communication from the European Communities and Their Member States, IP/C/W/280 (June 12, 2001)。
1 参见 Developing Country Group's Paper, IP/C/W/296 (June 29, 2001); Draft Ministerial Declaration -- Proposal from a Group of Developing Countries, IP/C/W/312 (Oct. 4, 2001)。
2 参见 Ministerial Declaration pmbl., Contribution from Australia, Canada, Japan, Switzerland and the United States, IP/C/W/313 (Oct. 4, 2001),http://www.wto.org/english/tratop_e/trips_e/mindecdraft.w313_e.htm; Non-Paper, Contribution from Canada, the Czech Republic, Japan, New Zealand, Switzerland and the United States,http://lists.essential.org/pipermail/ip-health/2001-September/001899.html。
1 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
2 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
3 第 6 款谈到的是强制许可(compulsory licenses),而 TRIPS 协定第 31 条使用的含义更广泛的“未经授权使用(unauthorized use)。后者既包括强制许可,也包括非商业性的政府使用。
2 Declaration on the TRIPS Agreement and Public Health, Ministerial Conference, Fourth Session, Doha, Nov. 9-14 2001, WT/MIN(01)/DEC/2 (Nov. 20, 2001).
3 参见 Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products, IP/C/25 (July 1, 2002)。
4 参见 Least-Developed Country Members -- Obligations under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products, WT/L/478 (July 12, 2002)。
6 参见 Statement on the Considerations for Paragraph 6 Modalities Delivered by Kenya on Behalf of the African Group, Brazil, Cuba, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Malaysia, Sri Lanka and Thailand at the TRIPS Council Meeting on March 5, 2002, IP/C/M/35 (Mar. 22, 2002);Joint Communication from the African Group in the WTO, IP/C/W/351 (June 24, 2002);Communication from Brazil on behalf of Bolivia, Brazil, Cuba, China, Dominican Republic, Ecuador, India, Indonesia, Pakistan, Peru, Sri Lanka, Thailand and Venezuela, IP/C/W/355 (June 24, 2002);South African Non-Paper on Substantive and Procedural Elements of a Report to the General Council under Paragraph 6 of the Declaration on the TRIPS Agreement and Public Health, Job(02)/156 (Nov. 5, 2002);Communication from Kenya, the Coordinator of the African Group, IP/C/W/389 (Nov. 14, 2002)。
1 2002 年 9 月 17 日,世界卫生组织表示,“第 30 条中的有限例外与公共原则最为契合。这种解决办法可以使 WTO 成员获取迅速有效的授权,以许可第三方生产、出售和出口药品或其他健康技术,并满足公共健康需要。英国知识产权委员会也持相同的看法。参见 WTO Council for Trips, Statement by the Representative of the WHO, Sept. 17, 2002, http://www.cptech.org/ip/health/who/who091722002.html。
2 这些措施包括平行进口、放松 TRIPS 协定第 31(f)条中的“主要供应国内市场(predominantly for the supply of domestic market)”规则,以及使用 TRIPS 协定第 30 条中的有限例外规则等。
3 Communication from the United States, IP/C/W/340 (Mar. 14, 2002); Second Communication from the United States, IP/C/W/358 (July 9, 2002).
2 参见 Draft Implementation 28 of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, JOB(02)/217 (Dec. 16, 2002), http://www.cptech.org/ip/wto/p6/wto12162002.html。
1 美国在疾病范围问题上的立场是,第六款解决方案只能涉及有艾滋病、疟疾、肺结核及其他同等规模和同等严重的传染病有关的重大健康危机。参见Second Communication from the United States, IP/C/W/358 (July 9, 2002)。
2 2002 年 12 月 20 日,TRIPS 协定理事会主席(墨西哥的 Eduardo Perez Motta 大使)告诉 WTO 总理事会,紧张的措施未能解决在疾病范围方面存在的分歧。参见 WTO Press Release, Press/329, Supachai Disappointed Over Governments' Failure to Agree on Health and Development Issues (Dec. 20, 2002), http://www.wto.org/english/news_e/pres02_e/pr329_e.htm。
4 WTO, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540. 2005 年 12 月,WTO 各成员同意将第 6 款实施决定作为对 TRIPS 协定的永久性修改。这一修改须得到 WTO 三分之二的成员批准才能生效。到 2007 年 4 月底,只有美国、瑞士、萨尔瓦多、韩国、挪威、印度和菲律宾 7 个成员批准了该修改。但在此之前,实施决定本身仍具有豁免性的效力。
5 The General Council Chairperson's Statement (Aug. 30, 2003), http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm.
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
2 巴西曾在 2003 年表示,它要从印度进口三种仿制的抗逆转录病毒药品。这很好地表明了未来的争吵将如何进行。参见 Brazil May Break Patents on Merck & Co., Roche, Abbott Labs AIDS Drugs (Aug. 21, 2003), http://lists.essential.org/pipermail/ip-health/2003-August/005140.html。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
3 它们分别是 Organisation Africaine de la Propriete Intellectuelle (非洲知识产权组织,共有 16 个成员国) 和 African Regional Industrial Property Association (非洲地区工业产权协会,共有 15 个成员国)。
4 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 The General Council Chairperson's Statement (Aug. 30, 2003)。
2 美国政府和药品行业一直担心,巴西、中国和印度的仿制药品行业将会“滥用”这种“为出口而生产”的体制,来获取仿制药品出口市场。参见 U.S. Latest Conditions on Paragraph 6 -- Illusory Humanitarian Sales, http://lists.essential.org/pipermail/ip-health/2003-August/005105.htm。
1 参见 Tamar Kahn, Clinton Aspen to Cut Price of AIDS Drugs, Bus. DAY (Cape Town), Oct. 24, 2003, http://allafrica.com/stories/printable/200310240136.html。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 The General Council Chairperson's Statement (Aug. 30, 2003), http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm.
1 参见 Rene Shen, WTO to Close Deal on Medicines Supply, http://lists.essential.org/ pipermail/ip-health/2003-August/005139.html。
2 参见 Rene Shen, WTO to Close Deal on Medicines Supply, http://lists.essential.org/ pipermail/ip-health/2003-August/005139.html。
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
2 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 Novartis Receives EMR for Glivec, http://lists.essential.org/pipermail/ip-health/2003-November/005611.html。
2 参见 Carlos Correa, Integrating Public Health Concerns into Patent Legislation in Developing Countries, Section X.2 (2000), http://www.southcentre.org/publications/publichealthHoc.htm。
1 参见 Bernard Simon, Curtailing Medicines from Canada, N.Y. TIMES, Nov. 11, 2003, C1。
2 参见 Medecins Sans Frontieres Access to Essential Medicines Campaign and the Drugs for Neglected Disease Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, http://www.msf.org/source/access/ 2001/fatal/fatal.pdf。
3 参见 World Health Organization, Accelerating Access Initiative, Widening Access to Care and Support for People Living with HIV/AIDS Progress Report (June 2002), http://www.who.int/hiv/pub/prev_care/aai/en/。
4 参见 Medecins Sans Frontieres Access to Essential Medicines Campaign and the Drugs for Neglected Disease Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases, http://www.msf.org/source/access/ 2001/fatal/fatal.pdf。
1 参见 James Love, Compulsory Licensing: Models for State Practice in Developing Countries, Access to Medicine and Compliance with WTO TRIPS Accord paras. 35-42,http://www.cptech.org/ip/health/cl/recommendedstatepractice.html。
1 参见 Robert Weissman, A Long, Strange TRIPS: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries, 17 U. PA. J. INT'L ECON. L. 1069, 1075-94 (1996)。
1 这种药品是由三种不同的抗逆转录病毒药品合成的单个片剂,也被 WHO 认为是在世界范围内抗击艾滋病的重要药品。参见 WHO, Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach, 9-13, http://www.who.int/3by5/publications/guidelines/en/arv_ guidelines.pdf。
2 参见 Kaiser Daily HIV/AIDS Report, FDA Approves Antiretroviral Drug Combination of Roche's Invirase, Abbott's Norvir, http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=l&DR_ID=21549;Lawrence K. Altman, U.S. Speeding Up Approval Steps for AIDS Drugs, N.Y. Times, May 17, 2004。
1 Colleen Chien, Cheap Drugs at What Price to Innovation: Does Compulsory Licensing of Pharmaceuticals Hun Innovation?, 18 BERKELEY TECH. L. J. 853 (2003).
2 Competition Commission Finds pharmaceutical firms in contravention of the Competition Act, 16 October, 2003. http://www.cptech.org/ip/health/sa/cc10162003.html
3 Competition Commission Finds pharmaceutical firms in contravention of the Competition Act, 16 October, 2003. http://www.cptech.org/ip/health/sa/cc10162003.html
4 Competition Commission concludes an agreement with pharmaceutical firms, 10 December, 2003. http://www.cptech.org/ip/health/sa/cc12102003.html
1 参见 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, (Sept. 1, 2004) WT/L/540。
1 参见 WTO, Canada -- Patent Protection of Pharmaceutical Products, Report of the Panel, WT/DS114/R (March 17, 2000)。
1、唐广良、董炳和著:《知识产权的国际保护》,知识产权出版社 2002 年版。
1、朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析》,法律出版社 2000 年版。
2、朱榄叶编著:《世界贸易组织国际贸易纠纷案例评析》,法律出版社 2004 年版。
3、刘剑文主编:《TRIPS 视野下的中国知识产权制度研究》,人民出版社 2003 年版。
1、张乃根:“论 TRIPS 协议义务”,载《浙江社会科学》,2002 年第 5 期。
2、万鄂湘、冯洁菡:“知识产权国际保护的新发展",载《法律适用》2003 年第 7 期。
3、赵生祥:“WT0 对知识产权国际保护制度的继承和发展”,载《现代法学》 2000 年第 3 期。
4、张今:“平行进口法律问题研究”,载《政法论坛》1999 年第 3 期。
5、丁丽瑛:“论知识产权国际保护的新体制”,载《厦门大学学报》1998 年 第 l 期。
6、郑成思:“知识产权的国际保护与涉外保护”,载《中国社会科学院研究 生院学报》1997 年第 l 期。
1、孙皓琛:“论 TRIPS 协定协议与公共健康”,载唐广良主编:《知识产权研究》(第十四卷),中国方正出版社,第 109 页。
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