(2003; 82 pages)
2.4 Latin America
Ahlert IB. New Brazilian industrial property law. International Review of Industrial Property and Copyright Law (IIC), 1997, 26(5).
After five years of discussions in the National Congress and ratification of the WTO TRIPS Agreement, the new industrial property law was signed in 1996. It includes several innovations in the patent chapter, most of them following present international trends. As a result, the new law mostly favours strong patent protection in Brazil, although a few points still need to be reviewed in order to achieve full harmonization with TRIPS.
Bermudez JA, Epsztein R, Oliveira MA, Hasenclever L. The WTO TRIPS Agreement and patent protection in Brazil: recent changes and implications for local production and access to medicines. Rio de Janeiro, WHO/PAHO Collaborating Center for Pharmaceutical Policies, National School of Public Health, and Oswaldo Cruz Foundation, 2000.
Brazil signed the Final Act of the Uruguay Round in 1994 and is consequently obliged to abide by the TRIPS Agreement. The industrial property law was passed in 1996 to meet the requirements of the TRIPS Agreement, including the patentability of pharmaceutical products. This report analyses the implications of the implementation of the TRIPS Agreement and the changes in Brazilian legislation in the field of patent protection. The study indicates that recent changes have failed to produce obvious benefits for the domestic pharmaceutical industry. There has been no reduction in drug prices, nor any increase in access of the low-income population to essential drugs. The authors conclude that the greatest beneficiaries of recent changes in Brazilian legislation and the implementation of the TRIPS Agreement are transnational companies with their persistent domination in the market.
Correa CM. Implementation of the TRIPS Agreement in Latin America and the Caribbean. European Intellectual Property Review, 1997, 8, 435-443.
In accordance with the transitional periods of the TRIPS Agreement, the new minimum standards of protection are being adopted in the various areas of intellectual property in many developing countries at a very different pace. This article describes first the framework for implementation of the TRIPS Agreement and some aspects relating to the incorporation of the Agreement's provisions into national laws. It then discusses interpretation and instrumental problems that have arisen, and some of the problems faced by developing countries in the process of implementation. The main changes introduced in Latin American and Caribbean countries to implement the TRIPS Agreement are then briefly analysed, followed by the main conclusions.
Correa CM. Reforming the intellectual property rights system in Latin America. World Economy, 2000, 851-872.
During the 1990s, significant changes took place in Latin America in order to comply with the TRIPS Agreement that was adopted as part of the Final Act of the Uruguay Round. This paper reviews the changes in IPR laws in Latin American countries by examining the introduction of substantive amendments, the main problems faced and some implications of the changes. For example, in relation to foreign direct investment, the paper shows that, in some countries where product protection for pharmaceuticals is accepted, a large number of foreign-owned plants for formulating pharmaceuticals have been closed down. This is contrary to the situation in Argentina where patents for pharmaceutical products are not granted, and a significant flow of foreign direct investment has been reported as mainly targeting the acquisition of local firms.
FIEL. Protection of intellectual property rights: the case of the pharmaceutical industry in Argentina. Buenos Aires, Fundación de Investigaciones Económicas Latinoamericanas, 1990.
Argentina belonged to the group of developing countries that did not recognize IPR in the pharmaceutical field. Although this situation gave rise to a major legal controversy, from the economic point of view it has provided scarce elements for analysis. The need for a critical revision of the legislation became evident, as Argentina would have to adopt a position regarding relevant international changes and the Uruguay Round. This paper aims to point out the issues that allow for an impartial weighting of the effects of the policy of not recognizing pharmaceutical patents, and to make a contribution to evaluating the economic effects deriving from the adoption of alternative systems.
Galvao J. Access to antiretroviral drugs in Brazil. The Lancet, 7 December 2002, 360(9348): 1862-1865.
Since 1996, the Brazilian Ministry of Health guarantees free and universal access to antiretroviral treatment for people living with HIV/AIDS. Implementation of this policy has had political, financial and logistical challenges. The author has investigated the history and context of antiretroviral policy in Brazil, the logistics of drug distribution and the Government's strategies for the acquisition of drugs. Many antiretrovirals used in Brazil are produced domestically; the remainder, including some of the most expensive drugs, are purchased from abroad. Although the Brazilian policy of antiretroviral distribution has had notable success, it remains threatened by the high cost of the acquisition of drugs, which has led to disputes with international pharmaceutical companies over prices and patents. Much can be learnt from the Brazilian model of guaranteeing access to antiretroviral treatment for people living with HIV/AIDS.
Gonzalez E. Juridical action for the protection of collective rights and its legal impact: a case study. Journal of Law, Medicine and Ethics, 2002, 30, 644-654.
The development in 1996 of a new generation of antiretroviral drugs was a major pharmaceutical breakthrough in the struggle against the HIV/AIDS pandemic. Due mainly to their high costs, access to these new drugs was almost impossible for most HIV-positive people. This situation was even more dramatic for people living in developing countries. Many of the organizations struggling for the rights of HIV-positive people have since developed human rights advocacy and legal strategies to try to achieve universal access to treatment. These organizations are also fighting for state compliance with human rights obligations under health-related international human rights treaties and conventions. This paper draws upon the experience gained in Latin America, focusing on the legal strategies that have been explored in Venezuela and the legal consequences for domestic law. The article refers to the main legal cases recently heard by the Venezuela Constitutional Court, the rulings of which have had important consequences for granting access to drugs for important sectors of Venezuela's population.
Gosain R. Brazil's new patent law. Patent World, June/July 1996, 30-34.
After having been in and out of the limelight for five years, Brazil's new patent law has been approved. This paper focuses on the major changes brought about by the new law as regards patentability and pipeline protection, biotechnology, state of the art legislation, cost reduction of priority claim, filing and examination of application, term of a patent, compulsory licences and working requirements, restrictions on the rights of the patentee, etc.
Gosain R. Extension of patent term and pipeline route in Brazil. Patent World, January 1997, 31-33.
Although the new Brazilian patent law came into force on 15 May 1997, some issues are still controversial and will need to be clarified by the courts, such as the question of patent term extension for pending Brazilian patent applications and existing patents, and the use of the pipeline provisions.
Gosain R. Patent law reform in Brazil: an update. Patent World, October 1994, 38-41.
This article develops the essential points of the reform of the Brazilian law on patents, following international pressures: patent protection of microorganisms, chemical and pharmaceutical products, pipeline protection, exhaustion of rights and regulation of compulsory licences.
Gosain R, Sherrill HK. The effects of GATT/TRIPS on Brazil's patent legislation. Patent World, May 1995, 24-26.
This is an analysis of the reform of the Brazilian patent law: extension of the domain of patentability, duration of protection, compulsory licences, local working of the patent, and registration of applications for patents on new materials.
Medina I. Patentability of pharmaceuticals and the new trends in Brazilian legislation. Patent World, November 1990, 33-35.
This paper focuses on the trend towards harmonizing national patent protection with legislation in developed countries, in particular that which deals with the question of the patentability of pharmaceutical processes and products. It presents the Brazilian legislation prior to the signing of the TRIPS Agreement, and the debate on drug patentability in Brazil.
Redwood H. Brazil: the future impact of pharmaceutical patents. Felixstowe, UK, Oldwicks Press Ltd, 1995.
As a strong emerging market for pharmaceuticals and a leader in Latin America's science and technology, Brazil is a signatory of the WTO Agreements, including the TRIPS Agreement, and was consequently committed to introducing pharmaceutical patent protection. This book is based on interviews with those of all shades of opinion on the subject in Brazil, with an extensive study of relevant published sources. It examines the conflict of attitudes over pharmaceutical patent protection in Brazil and considers the prospects. In addition, it evaluates the consequences of eventual patent legislation for the national and multinational pharmaceutical and chemical industries and the trade balance, the pharmaceutical market in Brazil, drug prices and the cost to health care and, finally, R&D in pharmaceuticals and biotechnology.
Rozanski F. Nueva legislación argentina de patentes de invencíon. Derechos Intelectuales, vol. 7, Editorial Astrea, 1996.
The author considers the complex evolution of the regime of invention patents and utility models in Argentina. After having pointed out the main principles governing the TRIPS Agreement, he deals with the most controversial aspects of the new Argentine regime, such as the transitional period for pharmaceutical patents, the filing of revalidation patents, the term of protection, the compulsory licensing regime and the enforcement of IPR. Having identified the ambiguous and controversial aspects of these provisions, the author ends by emphasizing the need for their improvement, so that they respect both the Constitution and the international treaties in force.
SELA/IDB. The TRIPS Agreement and international trade: effects on Latin America and the Caribbean. Workshop on the application of the TRIPS Agreement, Mexico City, 20-24 May 1994.
In the context of the Summit of the Americas, the Uruguay Round and the North American Free Trade Agreement (NAFTA), intellectual property is one of the issues proposed for discussion. This document is a contribution to the initial stage of dealing with the issue. It first examines the relationship between trade and intellectual property, and the relevance of intellectual property as a factor which can help or hinder legitimate trade. It then analyses data about the extent to which international trade is affected by intellectual property. It describes the general characteristics of the TRIPS Agreement and examines specific issues such as trade in counterfeit goods, parallel imports, the control of abuses of IPR and the transfer of technology. Finally, it overviews the consequences of the TRIPS Agreement in Latin America and the Caribbean, with the resulting amendments to legislation, and the regional agreements on intellectual property.
Tobias G. Patent protection: the Argentinean divide. SCRIP Magazine, November 1992, 26-28.
Proposals to introduce pharmaceutical patents in Argentina rekindled the debate between national and multinational companies over the benefits of IPP in developing countries. The pricing issue is particularly contentious since both sides tend to gather data most favourable to their own viewpoint. Likewise, the true benefits and/or disadvantages of compulsory licensing may be permanently lost in a fog of partisan wrangling. This article explores the stubborn divisions between the two camps.
Yamin A. Promoting and protecting the right to health in Latin America: selected experiences from the field. Health and Human Rights, 2000, 5(1): 117-148.
Through a description of the four major challenges faced by Latin American human rights groups and the strategies that they have adopted to overcome these challenges, this article seeks to incorporate the human rights perspective into the discussion of how to make health a universally recognized human right. The ill-defined normative content of the right to health, the lack of precedents and procedures for enforceability and the lack of consciousness of health as a right have presented major obstacles to the implementation of this right in the Region. Also, it is proposed that Latin American human rights groups move beyond traditional legal methods and expertise to work in an interdisciplinary fashion with health professionals and grass root health groups. The author concludes that, despite the obvious obstacles, Latin American human rights groups cannot afford not to become involved in advocacy and promotion of the right to health.
Zuccherino DR. Breve panorama de la legislación sobre patentes de invención en la República Argentina. Revista La Información, 1995, 71(786).
This article first analyses the objective and rationale of the patent system and the social importance of patents. It then discusses the new Argentine patent law, international trends in IPP and the hierarchy between national laws and international treaties.
Zuccherino DR. Propiedad intelectual y dinámica competitiva. Revista La Información, 1996, 73(797).
This article examines the relationship between the patent system and competition, the economic perspective and the benefits of patents in stimulating competition and economic development.