India,TRIPS-plus free trade agreements and the future of access to essential medicines

The issue of TRIPS-plus standards and its implications of access to essential medicines are discussed in this article in the Indian context. As a leading country in the manufacture and supply of generic drugs, the case of India is crucial when considered from the perspective of the TRIPS-plus regime and its negative consequences. Given the absence of a free trade agreement between the USA and India, a hypothetical approach is adopted in this article to analyse the potential implications of such an agreement in the future. The argument extended in this article relates to the existing norms of TRIPS-plus standards in US trade negotiations and an analysis is provided about the application of a TRIPS-plus model in the Indian context. It is argued that both for public health and trade policy reasons, India should not engage in any TRIPS-plus trade agreement with the USA as it would harm its interests on domestic and foreign fronts. India has recently adopted a new patent policy and a reasonable time should be given to relevant institutions to build an operational framework and capacity before further changes are made. This task will not be less than challenging as there is very little evidence about any positive change in the position of the USA and it would continue imposing TRIPS-plus standards through a variety of trade instruments. It is further argued in this article that the best mitigating strategy for developing countries like India lies in the combination of multilateralism and networking along the lines of a rights-based approach.     

Parallel imports and unparallel laws: an examination of the exhaustion doctrine through the lens of pharmaceutical products

Parallel imports, the natural consequence of exhaustion doctrine, represent a complex interaction between the issue of free flow of international trade and the protection of intellectual property rights. There is considerable divergence among scholars, both economic and legal, about the need for harmonisation of principles of exhaustion, and consequently parallel import laws. In this article, we examine the need for harmonisation of parallel import laws through the lens of pharmaceutical products. We highlight the necessity for the affirmative norm of exhaustion doctrine in the Trade Related Intellectual Property Rights (TRIPS) Agreement and suggest amendment to TRIPS Agreement Article 6 mandating international exhaustion doctrine as international legal standard with limited exceptions as an intermediate approach to strike a balance between the interests of the IP owners and consumers, and concurrently addressing the concerns of developed and developing countries.     

葡萄酒、白酒地理标志保护的扩大

由于酒类产品的品质与特定的地域联系紧密,地理标志对于酿酒业来讲有着极其重要的意义.中国是一个酒类产品生产大国,在加入WTO后,酒类产品生产企业在着眼于提升酿酒技术的同时更应该关注当今世界酿酒业相关领域的最新发展动态,以免使自己在酒类产品的国际竞争中处于劣势.本文笔者主要介绍了WTO中酒类产品地理标志的保护问题,以期引起我国酒类产品生产企业对此问题的关注.     

《TRIPS协议》中知识产权保护几个方面的探讨

探讨了我国加入WTO后,我省科研管理工作者在知识产权保护方面应注意的几个方面。     

Brazil's implementation of TRIPS flexibilities: ambitious missions,early implementation,and the plans for reform

The flexibilities introduced in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement were aimed at providing the developing countries with the option to adopt suitable measures to address access to patent-protected pharmaceutical products. The flexibilities include the grant of compulsory licences, exceptions to the exclusive right conferred by patent, allowing for parallel imports, and defining the criteria of patentability to achieve the goal of public health. While these flexibilities are available to all developing countries, only a few have implemented the flexibilities into their patent legislation. This paper examines the TRIPS compliant patent laws introduced in Brazil in the post-TRIPS era. It will be argued that the TRIPS Agreement was implemented too soon in Brazil, and the TRIPS flexibilities, although available had not been fully utilised due to pressure from transnational pharmaceutical corporations backed by developed countries, fear of exclusion from major trading blocs, and also due to a gap in the knowledge economy. It will also be argued that the World Trade Organization did not create a level playing field in the TRIPS negotiation in the lead up to the entry into force of the Agreement in 1995, which effectively handed over the advantage to the developed countries, thereby creating a two-tier system in the intellectual property rights arena and making it impossible for developing countries and least-developed countries to achieve the objective of access to affordable medicines.     

Vaccine R&D in Brazil: The effectiveness of push and pull regulations

Government regulations can guide the technological progress, investment in research and development (R&D), and institutional organization of a specific sector. In this context, using patent data, this study aimed to analyze the effectiveness of three laws that pertain to R&D in Brazilian pharmaceutical market for vaccines. The results reveal an increasing international interest in the Brazilian market since the promulgation of the Industrial Property Law. Despite its limitations, this study reveals significant efforts and promising results in Brazil with respect to ensuring that technological and industrial policies and strategies incorporate innovation in vaccine R&D and change the economy's competitive circumstances.     

Access to medicines and the TRIPS Agreement: what next for sub-Saharan Africa?

When the proposal for an international intellectual property (IP) rights protection was included as an item in the agenda for negotiation in the Uruguay Round of World Trade Organization negotiations, it was strongly opposed by developing countries including Brazil, India, Argentina and others. The developing countries and least developed countries (LDCs) from Africa, realising the difficulties the Agreement would put them in, had vigorously campaigned against the inclusion of IP rights protection within the multilateral trading system. One of the chief areas of concern for the developing countries and LDCs was the difficulty of accessing affordable medicines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) regime. While the resistance was gradually eroded and eventually neutralised during the long drawn Uruguay Round of Negotiations, the developing countries and the LDCs gained a few concessions in the post-TRIPS era in the form of Doha Declaration, which in their opinion would have given them the opportunity to invoke the emergency provisions of the Agreement in times of need to access essential medicines for their citizens. This was not to be the case, as the ground realities were difficult to manoeuvre and there were more impediments to invoking the flexibilities than originally perceived. This article will suggest that the best option available for sub-Saharan Africa is seeking an outright amendment of the TRIPS Agreement, as working within the parameters of the Agreement to achieve the goal of access to affordable medicines is not a viable option. It will also be argued that unless it acts urgently to seek the amendment it may be too late, as it could find itself left behind by both developing countries from other continents and patent-holding developed countries alike.     

Compulsory licensing of patents

The compulsory license is a concept that has been an accepted part of American intellectual property ever since the US Copyright Act of 1909. It has been recognized internationally via the Berne Convention for the Protection of Literary and Artistic Works since 1908. US patent law, however, has not paralleled its intellectual property sister copyright; historically compulsory licenses have not been common in the patent field. But change is occurring due to the World Trade Organization’s TRIPS and Doha Declaration which have brought to the international stage what copyright has accepted for more than a century: the compulsory patent license sanctified in international law. Developed countries – that is, patent-rich countries – have an ethical obligation to help those less fortunate. If not, the compulsory license can now be considered as an essential tool readily available in every poor country’s toolkit to help gain access to otherwise inaccessible but desperately needed patented innovation, especially in the area of public health and the accessibility of pharmaceuticals.     

多边贸易体制下的竞争政策研究

介绍了多边贸易体制下竞争政策谈判的背景,分析了WTO主要协议与竞争政策的关系和各成员国对建立多边竞争政策的态度,得出最可能的结果是建立一套只包括原则内容的多边竞争规则的判断.     

食品地理标志与商标的本质区别

从地理标志与商标的定义、特性、功能、构成条件等方面剖析这2个知识产权概念的内涵,阐述了地理标志与商标的本质区别,澄清地理标志与商标为不同的知识产权范畴,并分析地理标志保护模式的问题,探讨了地理标志优先权与商标权的冲突,提出我国应建立地理标志保护特别法的建议。由于地理标志与商标有着本质的区别,TRIPS协议才对地理标志建立了与商标权不同的特殊保护原则。因此,我国应建立与商标相区别的地理标志及其保护系统。