Patent Linkage

Research Paper 115, July 2020

Special Section 301:US Interference with the Design and Implementation of National Patent Laws

By Dr. Carlos M. Correa

The continuous application of Special Section 301 by the Office of the United States Trade Representative (USTR) undermines the rule of law as a fundamental principle of a multilateral system based on the sovereign equality of states and the respect for international law. Interference with foreign countries’ national intellectual property (IP) policies—which have significant socio-economic effects—negates their right to determine independently the level and modalities of protection of such property within the framework and policy space allowed by the international law. This paper examines the patent-related claims made by the USTR in relation to the developing countries on the USTR Priority Watch List. It argues that the regulations and practices identified by the USTR show a legitimate use of the flexibilities provided for by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and that the ignorance of the public interests of the countries concerned (for instance, with regard to access to affordable medicines) has contributed to the discredit (and ineffectiveness) of the Special Section 301.

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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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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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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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Informe Sobre Políticas 64, Agosto 2019

USMCA debe ser enmendado para asegurar el acceso a medicamentos en México

Por Maria Fabiana Jorge

El capítulo del U.S.-Mexico-Canada Agreement (USMCA)/Tratado entre México, los Estados Unidos y el Canadá (T-MEC) dedicado a los derechos de propiedad intelectual (DPI) otorga monopolios más prolongados y amplios a las empresas de medicamentos originales que los que están actualmente en vigor en México, a costa de los pacientes y los contribuyentes. Entre otras cosas, México tendría que conceder a las ampliaciones de la vigencia de las patentes períodos de exclusividad más amplios y prolongados, también para los medicamentos biológicos costosos, tanto por las demoras en la concesión de patentes como para aquellas que se encuentren en el proceso reglamentario de aprobación, y ampliar las normas de patentabilidad, por ejemplo, exigiendo la concesión de patentes para nuevos usos. México es, sin lugar a dudas, el país del T-MEC que se verá más perjudicado, pero si los miembros del Partido Demócrata de la Cámara de Representantes de los Estados Unidos pueden renegociar algunas de estas disposiciones para restablecer cierto equilibrio entre la necesidad de fomentar la innovación y la competencia, el Gobierno del presidente López Obrador y el Congreso de México todavía pueden cambiar la situación.

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Policy Brief 64, July 2019

The USMCA must be amended to ensure access to affordable drugs in Mexico

By Maria Fabiana Jorge

The intellectual property rights (IPRs) chapter of the U.S.-Mexico-Canada-Agreement (USMCA) grants longer and broader monopolies to originator pharmaceutical companies than those currently in force in Mexico, at the expense of patients and taxpayers. Among other things, Mexico would be required to provide patent term extensions both for delays in the granting of patents and for those incurred in the regulatory approval process, broader and longer exclusivity periods, including for expensive biologic drugs, as well as to adopt broader patentability standards, for example by requiring the granting of patents for new uses. Mexico is, without doubt, the country in the USMCA that will be most negatively impacted, but  if the  Democratic Members of the US House of Representatives are able to renegotiate some of these provisions to restore some balance between the need to foster innovation and competition, the Administration of President López Obrador and the Mexican Congress can still make a difference.

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Regional training for patent office representatives in Kyiv, jointly organized by South Centre & partners

Title:                Regional training for patent office representatives

Date:                4 June, 2019

Venue:              Kyiv, Ukraine

Organizers:     The South Centre, International Treatment Preparedness Coalition (ITPC Global), Scientific Research Institute of Intellectual Property (National Academy of Law Sciences of Ukraine) and All-Ukrainian Network of People Living with HIV 

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Policy Brief 61, May 2019

The US-Mexico-Canada Agreement: Putting Profits Before Patients

By Maria Fabiana Jorge

In the US-Mexico-Canada Agreement (USMCA, NAFTA 2.0), the U.S. Trade Representative negotiated intellectual property provisions related to pharmaceuticals that would enshrine long and broad monopolies. This policy brief focuses primarily on the negative effects of the USMCA intellectual property provisions on access to medicines in the U.S.  Such effects may be even worse for Canada and Mexico. The impact of this trade agreement goes well beyond the three countries involved as this is the first one negotiated by the Trump Administration and is likely to set a precedent for future trade agreements.  A careful review of the USMCA text raises very serious concerns about the impact that this agreement would have on the  generic/biosimilar industry and therefore on access to more affordable drugs throughout the world.

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Research Paper 62R, July 2017

Intellectual Property in the Trans-Pacific Partnership: Increasing the Barriers for the Access to Affordable Medicines (revised)

Most free trade agreements (FTAs) signed by the United States, the European Union and the members of the European Free Trade Association (EFTA) in the last 15 years contain chapters on intellectual property rights with provisions applicable to pharmaceuticals. Such provisions considerably expand the rights recognized to pharmaceutical companies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established in the context of the World Trade Organization (WTO). (more…)

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