Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques
Par Carlos M Correa
Ce document fait suite à un document antérieur, Directives applicables à l’examen des brevets pharmaceutiques: examen des brevets pharmaceutiques du point de vue de la santé publique, publié en 2007 comme document de travail par le Centre international pour le commerce et le développement durable (CICDD), la Conférence des Nations Unies sur le commerce et le développement (CNUCED) et l’Organisation mondiale de la santé (OMS).
Le présent document tient compte des évolutions survenues depuis la publication du document de travail CICDD-CNUCED-OMS en 2007. Il comprend de nouveaux exemples de demandes et/ou de délivrance de brevets, ainsi qu’une analyse et des références aux initiatives d’un certain nombre de pays qui ont adopté des lois et/ou des politiques visant à prendre en compte les considérations de santé publique dans l’examen des demandes de brevets.
Avec ce document, l’objectif est de fournir des orientations pour l’élaboration ou la révision de directives sur les processus d’examen des brevets dans les pays en développement, en réponse aux préoccupations concernant l’augmentation du nombre de brevets dans le secteur pharmaceutique. À cette fin, un certain nombre de recommandations sont formulées en ce qui concerne l’examen des demandes de brevetabilité relatives aux produits et procédés pharmaceutiques.
Ce document est une traduction de la version originale des “Directives pour l’examen des demandes de brevet relatives aux produits pharmaceutiques” publiées en anglais par le Programme des Nations Unies pour le Développement (PNUD). Le South Centre remercie le PNUD pour l’aimable autorisation de publier cette version non officielle. Traduit pour le South Centre par M. Natanael França.
South Centre Statement on the extension of the TRIPS waiver for diagnostics and therapeutics for COVID-19
Developing countries should consider options that can be implemented now to deal with IP barriers to expand production and access to COVID-19 therapeutics and diagnostics, while the so far elusive decision on whether to extend a TRIPS waiver to cover these products is taken by WTO.
The world was unprepared prior to the Covid-19 crisis and remains so for new ones. The Covid-19 response was faulty. Covid-19 recovery has been slow and painful, in particular for developing countries. Read the South Centre opening statement at the WHO, WIPO & WTO Trilateral Symposium 2022: Lessons from Covid-19.
Pautas para el Examen de Solicitudes de Patentes Relacionadas con Productos Farmacéuticos
Por Carlos M Correa
Este documento representa un seguimiento de un documento anterior, Pautas para el examen de patentes farmacéuticas – Una perspectiva desde la Salud Pública, que se publicó en 2007 como documento de trabajo por el Centro Internacional de Comercio y Desarrollo Sostenible (ICTSD), Estados Unidos, Conferencia de las Naciones Unidas sobre Comercio y Desarrollo (UNCTAD) y la Organización Mundial de la Salud (OMS).
El presente documento toma en cuenta los desarrollos desde la publicación del documento de trabajo ICTSD-UNCTAD-OMS en 2007. Incluye nuevos ejemplos de solicitudes y/o subvenciones de patentes, además analiza y hace referencia a las iniciativas de varios países que han adoptado leyes y/o políticas dirigidas a considerar temas de salud pública en el examen de solicitudes de patentes.
El objetivo de este documento es proporcionar orientación para el desarrollo o la revisión de directrices sobre los procesos de examen de patentes en países en desarrollo en respuesta a las preocupaciones sobre el aumento del número de patentes en el sector farmacéutico. A tal fin, se formulan varias recomendaciones con respecto al examen de la patentabilidad de las solicitudes relativas a productos y procesos farmacéuticos.
Este documento es una traducción de la versión original de las “Directrices para el examen de solicitudes de patentes relacionadas con productos farmacéuticos” publicadas en inglés por la Programa de las Naciones Unidas para el Desarrollo (PNUD). El South Centre agradece al PNUD por la amable autorización para publicar esta versión no oficial. Traducido para el South Centre por el Sr. Natanael França.
Left on Our Own: COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health
By Melissa Omino and Joanna Kahumbu
The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter “the Declaration”) was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter “TRIPS”) Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus (“the TRIPS waiver”). These citizens are especially vulnerable because of their inability to access vaccines due to their prices and supply shortages caused by the refusal to share manufacturing technology. The Doha Declaration aimed at reaffirming the interpretation and implementation of the TRIPS Agreement to support WTO members’ right to protect public health and promote access to medicines. However, the operationalization of the Declaration via Article 31bis of TRIPS has been cumbersome and procedurally difficult to navigate. This paper argues that the current iteration of the Doha Declaration within TRIPS fails to meet the objectives of the Declaration as demonstrated by the need for a further waiver of the TRIPS agreement. It also attempts to “reimagine” Article 31 bis in light of the TRIPS waiver from the position of the Global South to make it more equitable and practicable and maintain the spirit of the Declaration.
The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?
By Carlos M. Correa and Nirmalya Syam
The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.
TRIPS Flexibilities and Access to Medicines: An Evaluation of Barriers to Employing Compulsory Licenses for Patented Pharmaceuticals at the WTO
By Anna S.Y. Wong, Clarke B. Cole, Jillian C. Kohler
Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner’s authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel originator manufacturers to license their patents to generic manufacturers before patent expiry, increasing the supply and reducing the price of patented pharmaceuticals domestically.
This paper evaluates the three primary barriers to employing compulsory licenses for pharmaceuticals underscored by members during TRIPS waiver discussions at the WTO: (1) a lack of enabling domestic legislation, (2) a lack of domestic manufacturing capacity coupled with an unworkable Article 31bis importation system, and (3) consistent political pressure from other members to refrain from issuing compulsory licenses. A survey of members’ domestic compulsory license legislation finds that virtually all members have enacted enabling legislation under Article 31 for the issuance of compulsory licenses to supply their local markets. However, implementation of Article 31bis is limited by a lack of enabling compulsory license export legislation, streamlined administrative processes, or both across all members, preventing members lacking domestic manufacturing capacity from importing pharmaceuticals. An analysis of USTR Special 301 Reports from 1994-2021 further reveals that countries have consistently been placed on the Special 301 Report Priority Watch List for issuing pharmaceutical compulsory licenses, with instances as recent as 2020. As such, general reluctance by members to issue compulsory licenses due to overt political pressure through the Special 301 Report is likely warranted. These results highlight a range of barriers preventing the full use of compulsory licenses for pharmaceuticals under the current Article 31 and 31bis framework, with the effects disproportionately borne by member states lacking domestic manufacturing capacity.
Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health
By Nanditta Batra
The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence, including patented AZT for HIV/AIDS treatment, showed that patents could make life saving drugs prohibitively expensive. Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions “in all fields of technology”. While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States’ rights to use them. It is in this background that the historic Doha Declaration on the TRIPS Agreement and Public Health assumed importance as it reaffirmed the rights of the Member States to take measures to protect public health, reconciled the interpretative tensions in the text of TRIPS Agreement and clarified the scope of some of the flexibilities and attempts to find solutions to the problems faced by countries that do not have sufficient manufacturing facilities. The Declaration which was initially dismissed by some scholars as “non-binding,” “soft law” has been held by WTO Dispute Settlement Body (DSB) to constitute a “subsequent agreement” which must be followed in interpreting the provisions of TRIPS Agreement (Australia-Tobacco Plain Packaging Case).
Webinar: The Future of the TRIPS Agreement (Part 2)
11 October 2022
Time: 10:00 – 11:30 CET
Sustainable recovery from the COVID-19 pandemic requires availability of medical technologies in all countries. To date, inequity in access continues. The interface of intellectual property and promotion of public health is central to this question. This session is a follow-up to the South Centre’s 2021 WTO Public Forum working session, which kick-started a discussion on the future of the TRIPS Agreement after the Covid-19 pandemic.
This session will bring together various stakeholders to discuss whether a reform of the TRIPS Agreement and/or authoritative interpretations of some its key provisions are needed, having in view the proposals made in response to a request for a waiver for the Covid-19 pandemic and other possible public-health oriented solutions. What are the existing limitations and opportunities within the current framework? What further actions could be taken under the WTO rules in order to promote access to medical technologies for a sustainable and equitable future?
Brazilian Competition Law and Access to Health in Brazil: Exploitative Pricing in the Pharmaceutical Sector
By Bruno Braz de Castro
This paper aims to analyze the interfaces between Brazilian Competition Law and the issue of access to medicines, with a special focus on abuse of industrial property rights and related exclusionary and exploitative effects. The paper analyzes the case law of Brazilian Administrative Council for Economic Defense (CADE) in the pharmaceutical sector and discusses abusive practices such as illegitimately imposing non-existent or invalid intellectual property rights with anticompetitive purposes. It then addresses abusive strategies in the exercise of industrial property rights which are, in essence, valid: i.e., exclusionary practices, aimed at artificially raising barriers to entry; and exploitative practices, directly translated as the exercise of market power to the detriment of the consumer. The latter ultimately result in exploitative excessive prices; contractual, quality or privacy degradation; and restrictions on supply, such as by hoarding/preventing the exploitation of industrial property rights. The paper concludes that the prohibition of exploitative pricing under the current competition law is legally valid and effective, with certain methodological concerns towards reducing the risk of wrongful convictions (for instance, by applying screening tests to determine the markets that are candidates for intervention). In view of such guidelines, the pharmaceutical industry appears to be an important candidate for antitrust attention, given the magnitude of the harm potentially derived from non-intervention against the practice. Remedies in this area, importantly, should focus on identifying and solving the sector’s structural competitive problems. In the case of medicines subject to price regulation by the Drug Market Regulation Chamber (CMED), the technical expertise of the competition authority may be of great value in terms of competition advocacy, a fact that is demonstrated in light of recent discussions on extraordinary price adjustments because of competitive problems in certain markets.
Competition Law and Intellectual Property: A Study Drawing from The Eli Lilly Case on ‘Sham Litigation’ in Brazil
By Pablo Leurquin
Competition authorities may be the best equipped institutions to penalize certain illicit practices that involve intellectual property rights. This article analyzes the decision by the Brazilian Administrative Council for Economic Defense (Conselho Administrativo de Defesa Econômica – CADE) in the Eli Lilly case, in which the company was convicted for abusive use of the right to petition (sham litigation) with anti-competitive effects. It examines general aspects of technological dependence in the Brazilian pharmaceutical industry, presents the legal premises necessary for the understanding of the decision made by the competition authority, and analyzes the legal grounds for the sanction imposed on Eli Lilly.