Compulsory Licenses

Book by the South Centre, 2021

Uso Público No Comercial y Licencias Obligatorias en América Latina: Estado de Situación

Descripción:

Este libro examina cómo han sido regulados en el derecho latinoamericano el uso público no comercial y las licencias obligatorias de patentes de invención, una de las importantes flexibilidades en el marco del acuerdo sobre propiedad intelectual de la Organización Mundial de Comercio. Igualmente, indaga y compendia las experiencias registradas en cuanto al uso efectivo de esos instrumentos, el que no se agota en el ámbito de la salud pública, si bien han sido especialmente utilizados tanto por países desarrollados como en desarrollo para facilitar el acceso a medicamentos, incluso en el contexto de la pandemia del COVID-19.

Autor: Guillermo Vidaurreta es Abogado de la Universidad de Buenos Aires, Magister en Propiedad Intelectual por FLACSO – Argentina. Profesor de la Universidad de Buenos Aires y FLACSO – Argentina. Investigador principal y subdirector del Centro de Estudios Interdisciplinarios de Derecho Industrial y Económico de la Facultad de Derecho de la UBA (CEIDIE).

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Research Paper 136, September 2021

Canada’s Political Choices Restrain Vaccine Equity: The Bolivia-Biolyse Case

By Muhammad Zaheer Abbas, PhD

The COVID-19 pandemic has already claimed more than 4.6 million lives and caused significant economic harm. The Coronavirus is still circulating to cause further damage. In this context, this research paper argues that Canada’s political choices have restrained the equitable distribution of COVID-19 vaccines. Part I evaluates Canada’s nationalistic approach of procuring COVID-19 vaccines more than its needs through secretly concluded pre-purchase agreements with brand-name pharmaceutical corporations as advised by a secretly born task force having clear ties with the vaccine industry. Part II examines Canada’s wavering and non-committal position on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver proposal. Canada’s confusing position of ‘not blocking’ the TRIPS Waiver while not supporting it either lacks legal clarity. Part III analyses the Bolivia-Biolyse case which highlights clear contradictions between statements and actions of the Canadian government. Since March 2021, Biolyse Pharma has been hamstrung by the first step in Canada’s Access to Medicines Regime (CAMR), where a preliminary requirement is that the COVID-19 vaccine must be added to Schedule 1 of the Canadian federal Patent Act before applying for an export-oriented compulsory licence. The Bolivia-Biolyse case is important as a test case for the CAMR system. Workability of this export-oriented compulsory licensing regime is critical for low- and middle-income countries in the Global South lacking the domestic capacity to manufacture COVID-19 vaccines. The Bolivia-Biolyse case is also important as Canada has argued at the World Trade Organization (WTO) that the TRIPS Waiver is not required because the existing mechanisms are working as intended.

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Policy Brief 102, September 2021

Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer

By Dr. Olga Gurgula

This policy brief explains that the currently discussed proposals at the WTO related to increasing the production of COVID-19 vaccines, including the EU proposal to clarify the use of compulsory licensing and the submission by South Africa and India on the intellectual property (IP) waiver, require complementary mechanisms to rapidly improve the production of COVID-19 vaccines that are urgently needed today. The key problem is that to accelerate the manufac- ture of COVID-19 vaccines, access to knowledge and know-how, that are protected by trade secrets owned by several pharmaceutical companies, is required. It is therefore important that governments implement an additional mechanism of compulsory licensing of trade secrets that would allow an involuntary transfer of COVID-19 vaccine technologies. Such a mechanism would be compliant with the TRIPS Agreement and relevant whether the TRIPS waiver is adopted or not agreed upon. While this mechanism must provide full access to the information necessary to manufacture the vaccines in question, it must also ensure the protection of the transferred trade secrets.

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Policy Brief 100, August 2021

EU Proposals regarding Article 31bis of the TRIPS Agreement in the Context of the COVID-19 Pandemic

 By Nirmalya Syam

This Policy Brief presents an analysis of the proposal by the European Union (EU) with regards to Article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as part of a Declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic. It discusses the EU’s proposed clarifications, why Article31bis does not provide an effective solution to promote access to pharmaceutical products and possible options.

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SouthViews No. 225, 21 July 2021

Vaccine Nationalism 

By Prof. Ujal Singh Bhatia

The author posits that the global public health impact of the Covid-19 pandemic along with the economic and distributional aspects of vaccines and treatments, involves a market failure without the underlying institutional safety nets for an effective, globally coordinated response. He proposes strong, self-standing institutions with clear mandates and resources to make effective interventions at three levels: political, financial and regulatory. Also, the WTO rules regarding export restrictions are at present too accommodative to allow for a quick response. For Intellectual Property, both manufacturing and licensing, and relaxation of IP rules should be considered.

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Research Paper 132, June 2021

Interpreting the Flexibilities Under the TRIPS Agreement

By Carlos M. Correa

While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.

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Material de capacitación 1, Junio 2021

Propiedad intelectual y acceso a medicamentos: una introducción a cuestiones clave – algunos términos y conceptos básicos 

Por Germán Velásquez

La propiedad intelectual y las patentes en particular se han convertido en uno de los temas más debatidos sobre el acceso a los medicamentos, desde la creación de la Organización Mundial del Comercio (OMC) y la entrada en vigor del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). Las patentes no son de ninguna manera las únicas barreras para el acceso a medicamentos que salvan vidas, pero pueden desempeñar un papel significativo, o incluso determinante. Durante el período de protección de la patente, la capacidad del titular de la patente para determinar los precios, en ausencia de competencia, puede hacer que el medicamento resulte inalcanzable para la mayoría de las personas que viven en los países en desarrollo. Este primer número de los “Materiales de capacitación del South Centre” pretende, en su primera parte, ofrecer una introducción a cuestiones clave en el ámbito del acceso a los medicamentos y la propiedad intelectual. La segunda parte describe y define algunos términos y conceptos básicos de esta área relativamente nueva de las políticas farmacéuticas, que son los aspectos comerciales de los derechos de propiedad intelectual que regulan la investigación, el desarrollo y el suministro de medicamentos y las tecnologías sanitarias en general.

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Policy Brief 92, April 2021

Expanding the production of COVID-19 vaccines to reach developing countries

Lift the barriers to fight the pandemic in the Global South

By Carlos M. Correa

The unfolding of COVID-19 has shown that the international system has been unable to ensure equal access to the vaccines and other products necessary to fight the pandemic. While the need for a strong response remains obvious, proposals for scaling up the production of COVID-19 vaccines across the globe are still blocked in the World Trade Organization.

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Policy Brief 91, April 2021

Compulsory license in Germany: Analysis of a landmark judicial decision

By Christoph Spennemann and Clara Warriner

This policy brief analyzes how the German Federal Court of Justice addressed compulsory licensing under German patent law, where the request for a compulsory license was used in preliminary proceedings as a defense against alleged patent infringement.

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Statement, March 2021

South Centre Statement on World TB Day

Countries need to step up the response to tuberculosis and take all possible measures to expand access to treatment.

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COVID-19 Compulsory Licenses Table, March 2021

Scope of Compulsory License and Government Use of Patented Medicines in the Context of the COVID-19 Pandemic

To meet public health needs, such as in the current COVID-19 emergency, governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines.

These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted (read our Call for Action on Intellectual Property and Trade Measures to Address the Covid-19 Crisis here).

The South Centre offers a guide for the issuance of compulsory licenses and government use, see here, aquí en español.

The table below provides information of instances of their use.

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COVID-19 Compulsory Licenses Table, February 2021

Scope of Compulsory License and Government Use of Patented Medicines in the Context of the COVID-19 Pandemic

To meet public health needs, such as in the current COVID-19 emergency, governments can use compulsory licenses and government use as a tool for procurement and import of patented medicines.

These mechanisms are provided for in most laws worldwide. The WTO TRIPS Agreement, as reaffirmed by the Doha Declaration on TRIPS and Public Health, recognises the right of WTO members to grant compulsory licenses and their freedom to determine the grounds upon which such licenses may be granted (read our Call for Action on Intellectual Property and Trade Measures to Address the Covid-19 Crisis here).

The South Centre offers a guide for the issuance of compulsory licenses and government use, see here, aquí en español.

The table below provides information of instances of their use.

(more…)

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