Compulsory Licenses

Policy Brief 80, June 2020

Intellectual Property, Innovation and Access to Health Products for COVID-19: A Review of Measures Taken by Different Countries

By Nirmalya Syam

The rising incidence of COVID-19 will require all countries, particularly developing and least developed countries, to be able to procure and manufacture the products required for the diagnosis, prevention and treatment of COVID-19. Intellectual property (IP) rights over such products can constrain the ability of countries to rapidly procure and produce and supply the products required at a mass scale. This Policy Brief describes the measures and actions taken by different countries to address potential IP barriers to access to the products required for COVID-19. A number of countries, both developed and developing, have adopted measures to enable governments to take action to overcome IP barriers in case they constrain access to the products required for COVID-19. In addition to these measures, the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) also allows considerable flexibility to adopt a number of other possible measures which can be considered by developing countries where necessary.

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SouthViews No. 200, 16 June 2020

Making Covid-19 Medical Products Affordable: Voluntary Patent Pool and TRIPS Flexibilities

By Sudip Chaudhuri

The proposal of Costa Rica to create a voluntary pool mechanism for medical products and technologies for COVID-19 has evoked huge interest and optimism. The World Health Organization (WHO) and Costa Rica have followed it up through a Solidarity Call emphasizing the need for voluntary licensing on non-exclusive basis to the Medicines Patent Pool (MPP). The success of a voluntary pool critically depends on the willingness of the patentees to join the pool. In a public health crisis, boundaries of public policy must not be determined by the patentees. MPP will work much better if the patentees are compelled or induced to join the pool. International cooperation is important in this regard. Highlighting the virtues of voluntary measures and promoting MPP without adequate emphasis on the use of compulsory licensing and other TRIPS flexibilities, actually weakens the MPP. In the light of the experience of MPP, the basic objective of this paper is to analyze to what extent voluntary pool mechanisms can be relied upon to make COVID-19 medical products affordable and accessible. It is important to appreciate the achievements of MPP. But the constraints under which it operates, and its limitations must also be kept in mind.

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Research Paper 109, May 2020

Non-Violation and Situation Complaints under the TRIPS Agreement: Implications for Developing Countries

By Nirmalya Syam

While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provided for the applicability of non-violation and situation complaints to the settlement of disputes in the area of intellectual property (IP), when the World Trade Organization (WTO) agreements were adopted in 1994, a moratorium was put in place until WTO Members could agree on the scope and modalities for the application of such complaints. However, for more than two decades, discussions in the TRIPS Council on the subject have remained inconclusive. The biannual WTO Ministerial Conference has granted extensions of the moratorium with regularity. This paper reviews the debate on the applicability of non-violation and situation complaints under the TRIPS Agreement, including the arguments consistently held by two WTO Members that if the moratorium is not extended by consensus, non-violation and situation complaints would become automatically applicable. This paper argues that a consensus decision by the WTO Ministerial Conference is required to determine the scope and modalities and, hence, the applicability of such complaints under the TRIPS Agreement. Even if the moratorium was not extended, the WTO Ministerial Conference should still adopt a decision calling on the TRIPS Council to continue examination of the scope and modalities of such complaints. It also argues that in the absence of an extension of the moratorium on initiating such complaints—and although they would not be applicable—a situation of uncertainty would be created that may lead to a de facto limitation in the use of flexibilities allowed under the TRIPS Agreement.

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Research Paper 107, April 2020

Guide for the Granting of Compulsory Licenses and Government Use of Pharmaceutical Patents

By Dr. Carlos M. Correa

Like other rights, patent rights are not absolute. There are situations in which their exercise can be limited to protect public interests. Such situations may arise, for instance, when access to needed pharmaceutical products must be ensured. Compulsory licenses and government use for non-commercial purposes are tools, provided for under most laws worldwide, that can specifically be used to address public health needs. This document is intended to provide legal guidance for the effective use of such tools, consistently with the international law.

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Policy Brief 76, April 2020

Evolution of Data Exclusivity for Pharmaceuticals in Free Trade Agreements

By Wael Armouti

Free trade agreements (FTAs) introduce higher intellectual property (IP) protection than those established in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS-plus provisions) that deprive the parties from benefits of the use of flexibilities found in the TRIPS Agreement to protect public health. One such TRIPS-plus requirement is that of data exclusivity. It establishes that the government should provide an exclusivity period for the test data developed by the originator company, on the grounds of an incentive rationale and considerations of fairness. The negative impact of the data exclusivity approach in developing countries means that the entry of cheap generic products is delayed, even under a compulsory license, which will affect access to affordable medicines. Countries that have already signed the FTAs can mitigate its effects on public health by limiting the scope of and providing exceptions to data exclusivity in national legislation.

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SC Working Paper: Trade-Related Agenda, Development and Equity

Intellectual Property Rights and the use of Compulsory Licenses: Options for Developing Countries

By Dr. Carlos M. Correa

In view of the forthcoming review of the implementation of the TRIPS Agreement, and of a possible revision of its provisions in future WTO negotiations, it seems important that information is available to developing countries on the ways in which compulsory licenses have been provided for and used in developed and developing countries. The purpose of this paper is to provide concrete examples on how compulsory licenses have been provided for in national laws and, in particular, to illustrate the grounds and conditions on which such licenses have been granted in specific instances. The emphasis of the paper is not on the general principles relevant to the matter, but on the ways in which compulsory licenses have been actually provided for or used in order to satisfy diverse public interests. Many of the decisions pertaining to the granting of compulsory licenses in the developed countries may be useful in indicating the options available to developing countries wishing to have adequate legislation at the national level on this matter. The decisions referred to also make it clear that compulsory licensing is firmly rooted in the legal systems of developed countries, including those that seem to oppose that concept in international fora.

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Call for Action: IP and Trade Measures to Address the Covid-19 Crisis

Intellectual Property and Trade Measures to Address the Covid-19 Crisis by the South Centre 

The South Centre views with concern the attempts by some governments and industry players to monopolize the availability of treatments, diagnostics, medicines, medical supplies and devices needed for their own nationalist agenda or to maximize profit, ahead of societal interest in tackling the Covid-19 pandemic. The private enforcement of patents and government trade restrictions may pose a dire threat to the containment of this global public health emergency. Governments should act swiftly to put in place legislation and plans to ensure that patents and trade measures do not become barriers for access to those products.

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Documento de Investigación 105, Marzo 2020

Intersección entre Competencia y Patentes: Hacia un Ejercicio Pro- Competitivo de los Derechos de Patente en el Sector Farmacéutico

Por María Juliana Rodríguez Gómez

La interacción entre propiedad industrial, particularmente patentes farmacéuticas, y el derecho de la competencia, tiene un impacto en asuntos de interés general como los derechos a la salud, al acceso a los beneficios de la tecnología y a la libre competencia. La cuestión es cómo hacer compatible un mercado farmacéutico competitivo y dinámico, con el sistema de patentes, que otorga monopolios legales significativamente amplios sobre productos considerados innovaciones. A partir de un análisis legislativo y casuístico, se concluye que son necesarias mejores políticas pro competitivas -en especial en países en desarrollo- para enfrentar prácticas como el reverdecimiento (‘evergreening’) de patentes, los acuerdos para demorar la entrada de competidores y la negativa a licenciar, entre otras usadas en el sector farmacéutico para bloquear la entrada de la competencia. Los competidores, los consumidores y los sistemas de salud son vulnerables al creciente número de patentes y a esas prácticas.  Diversas medidas pueden adoptarse, sin embargo, para lograr un balance entre la protección de la innovación y la competencia.

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Research Paper 103, February 2020

Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa

By Yousuf A Vawda and Bonginkosi Shozi

As we observe the 18th anniversary of the Doha Declaration on the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health, it is appropriate to take stock of intellectual property developments and endeavour to present a comprehensive account of the situation in the African continent in respect of the implementation of TRIPS flexibilities, specifically those regarding access to medicines. This research paper provides an overview of the extent to which selected African countries have adopted legal and policy frameworks with regard to TRIPS flexibilities, examines the actual use of these flexibilities in enabling access to medicines in those countries, and suggests some recommendations for optimising the use of the flexibilities in pursuing public health imperatives.

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Training Paper 1, December 2019

Intellectual Property and Access to Medicines: An Introduction to Key Issues – Some Basic Terms and Concepts

Intellectual property and patents in particular, have become one of the most debated issues on access to medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant, or even determinant, role. During the term of patent protection, the patent holder’s ability to determine prices, in the absence of competition, can result in the medicine being unaffordable to the majority of people living in developing countries. This first issue of the “South Centre Training Materials” aims, in its first part, to provide an introduction to key issues in the field of access to medicines and intellectual property. The second part describes and defines some basic terms and concepts of this relatively new area of pharmaceuticals policies which are the trade related aspects of intellectual property rights that regulate the research, development and supply of medicines and health technologies in general.

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Research Paper 97, August 2019

Intellectual Property under the Scrutiny of Investor-State Tribunals

Legitimacy and New Challenges

By Clara Ducimetière

In 2009, C.S. Gibson was suggesting that: “With this early coverage of intellectual property in BITs, it is perhaps surprising that there has yet to be a publicly reported decision concerning an IPR-centered investment dispute. Given the trajectory of the modern economy, however, in which foreign investments reflect an increasing concentration of intellectual capital invested in knowledge goods protected by IPRs, this could soon change”. A couple of years later, the first investment cases dealing with IP issues were made public.

In this context, this paper first addresses the conditions that have to be fulfilled in order to bring intellectual property claims in investment arbitration, by touching upon the question of the definition of an investment in theory and in practice. It also tries to shed light on some of the implications of recent arbitral awards touching upon this interaction between intellectual property and investment protection, from a legal and regulatory perspective.

On the other hand, the specific situation of the European Union is scrutinized, and in particular the project put forward by the European Commission to adapt the dispute settlement system for the protection of investments.

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Documento de Investigación 96, Agosto 2019

Antivirales de acción directa para la Hepatitis C: evolución de los criterios de patentabilidad y su impacto en la salud pública en Colombia

Por Francisco A. Rossi B. y Claudia M. Vargas P.

La hepatitis C en el siglo XXI y el VIH en el final del siglo XX han representado los más relevantes retos de salud pública para la comunidad internacional. No solamente por ser enfermedades infecciosas y transmisibles (razón de ser de la salud pública) sino por su carácter mortal si no se recibe tratamiento de manera oportuna. En Octubre de 2015, la fundación IFARMA solicitó que todos los medicamentos antivirales para la hepatitis C, utilizables para curar una infección crónica transmisible potencialmente mortal, fueran declarados de interés público, dado que su precio amenazaba la sostenibilidad financiera del sistema de salud. Una declaración de interés público para estos medicamentos sería el primer paso para la emisión de licencias obligatorias. Este trabajo se ha llevado a cabo para identificar las patentes existentes en Colombia para estos productos, su alcance y sus consecuencias, en el marco de una discusión sobre la transparencia del sistema de patentes y la evolución del rigor con que se evalúan las solicitudes y se conceden las patentes.

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