Patent Law

Documento de investigación 196, 19 de abril de 2024

Licencias obligatorias para exportación: operacionalización en el orden jurídico argentino  

Por Valentina Delich

En el año 2017, entró en vigor la enmienda del Acuerdo sobre los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC), por la cual se incluyó el artículo 31 bis en su texto. Esta disposición permite las licencias obligatorias para exportación a terceros países sin o con insuficiente capacidad de producción local. El objetivo es paliar las dificultades de los países sin infraestructura de producción de medicamentos para que puedan hacer un uso efectivo de las licencias obligatorias y así fortalecer el acceso a los medicamentos a un menor precio. Argentina es un país que tiene infraestructura de producción de medicamentos y potencialmente podría devenir en un exportador eficiente. Este documento explora la posible instrumentación del art. 31 bis en la legislación de Argentina, proponiendo incorporar en la ley de patentes nacional el instituto de la licencia obligatoria humanitaria.

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Documento de investigación 195, 6 de marzo de 2024

Régimen de licencias obligatorias y uso público no comercial en Argentina 

Por Juan Ignacio Correa

Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.

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Research Paper 180, 9 August 2023

Neglected Dimension of the Inventive Step as Applied to Pharmaceutical and Biotechnological Products: The case of Sri Lanka’s patent law

By Ruwan Fernando

Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in Sri Lanka. The current statutory definition is highly insufficient to evaluate the standard of obviousness in relation to biotechnological and pharmaceutical claims based on a combination or modification of a prior art reference.

The Courts in both developed and developing countries have adopted a variety of tests to evaluate the obviousness standard of a claimed invention based on a combination or modification of a prior art reference. Sri Lanka, as a developing country, should look at the development that has taken place in other jurisdictions and adapt the patent law to local conditions when developing tests or guidelines in a manner that is compatible with the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its biotechnology/pharmaceutical policy guidelines.

This approach that is appropriate to Sri Lanka is twofold. First, it is most likely to prevent the issuance of patents on trivial or incremental inventions that do not provide any technical advance to the existing prior art and are a mere extension of what is already known in the prior art. Second, it is most likely to protect genuine technical advances to the existing prior art while at the same time enhancing competition and promoting local innovations so that the local researchers will be able to draw on the existing knowledge for the purpose of follow-on innovations.

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Research Paper 173, 7 February 2023

Analysis of COVID-Related Patents for Antibodies and Vaccines

By Kausalya Santhanam

This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The antibody combination considered for the patent analysis in this paper are Casirivimab and Imdevimab. The vaccines considered for the patent analysis are mRNA-1273, Sputnik, ChAdOx1 nCoV-19 vaccine (AZD1222). The analysis was completed in May 2022.

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Research Paper 158, 15 June 2022

Twenty Years After Doha: An Analysis of the Use of the TRIPS Agreement’s Public Health Flexibilities in India

By Muhammad Zaheer Abbas, PhD  

The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to provide latitude to the Member States to tailor their national patent laws to fit their individual needs. In 2001, the Doha Declaration further clarified and reaffirmed the existing TRIPS flexibilities. This paper argues that India has taken the lead role in enacting the TRIPS Agreement’s substantive and procedural patent flexibilities by introducing unique legislative measures to deal with the problem of access to medicines. This article evaluates India’s use of section 3(d) as a subject matter exclusivity provision. It examines constitutional validity and TRIPS compliance of section 3(d). It also evaluates India’s use of the flexibility to define the term “inventive step”. Moreover, this article evaluates India’s use of compulsory licensing, the most notable exception to patent rights provided under the TRIPS Agreement. This empirical study is important in the context of the COVID-19 pandemic, which has once again highlighted the same public health issues that the Doha Declaration sought to address twenty years ago.

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