Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
Desafíos actuales y posibles escenarios futuros de la salud mundial
By Germán Velásquez
Hace cuatro décadas los principales actores en la salud global eran la Organización Mundial de la salud (OMS), el Fondo de las Naciones Unidas para la Infancia (UNICEF) y los Estados Unidos de América y los países de Europa del Norte (mediante cooperación bilateral). Hoy asistimos a la proliferación de actores en este campo si bien con diferentes roles , ámbito de acción y niveles de influencia: La OMS, UNICEF, el Programa Conjunto de las Naciones Unidas sobre el VIH/SIDA (ONUSIDA), UNITAID, la Organización Mundial del Comercio (OMC), la Organización Mundial de la Propiedad Intelectual (OMPI), el Programa de las Naciones Unidas para el Desarrollo (PNUD), la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO), el Fondo Monetario Internacional (FMI), el Banco Mundial, el G7 y el G20, el G77+China, el Movimiento de No Alineados, los BRICS (Brasil, Rusia, India, China y Sudáfrica), el Fondo Global, GAVI, COVAX, la industria farmacéutica, Bill & Melinda Gates y otras fundaciones y organizaciones no gubernamentales (ONGs) sin o con ánimo de lucro.
Este documento de investigación analiza el papel de los múltiples actores (públicos, privados y filantrópicos) en la salud global y, con base a ello, procura esbozar posibles escenarios futuros. En particular, examina el papel de la OMS bajo cuyos auspicios los países miembros están, desde hace dos años, negociando una reforma del Reglamento Sanitario Internacional (RSI) del 2005 y la posible adopción de un nuevo instrumento internacional para prevenir y dar una respuesta a futuras pandemias como la del COVID-19. La aplicación de estos instrumentos, si se adoptaran, estaría en manos de la OMS, uno de los principales actores de la salud mundial.
Pautas para el examen de patentes sobre anticuerpos monoclonales
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
La investigación tiene como objetivo conocer el estado de las solicitudes de patente en materia de anticuerpos monoclonales (mAbs). El documento analiza las distintas estrategias en materia de reivindicaciones que utilizan los solicitantes con el fin de obtener protección por derecho de patentes. Se utilizó como fuente de información la base de datos construida y descrita en el Documento de Investigación No. 186 de South Centre. Se indaga sobre las principales reivindicaciones utilizadas en el campo de los mAbs, el tipo de clasificación CIP y el tipo de invención (producto o proceso) más frecuente en las patentes concedidas vigentes o caducas en Argentina. Finalmente, se analiza la utilización de las directrices de patentamiento argentinas en el caso de mAbs y se hacen recomendaciones respecto de posibles reformas a dichas directrices.
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
Implementing the Doha Declaration in OAPI Legislation: Do Transition Periods Matter?
By Patrick Juvet Lowé Gnintedem
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provided for a number of transition periods allowing countries to engage in a phased implementation of their TRIPS obligations. More specifically, transition periods targeted the patenting of pharmaceutical products. The original deadlines for transition periods have expired for developed and developing country WTO members. However, based on the Doha Declaration on the TRIPS Agreement and Public Health and subsequent TRIPS Council decisions, least developed countries (LDCs) continue to benefit from extended transition periods. In the African Intellectual Property Organization (OAPI), after an amendment in 1999, the legal framework has evolved with the amendment of the Bangui Agreement, i.e., the Act of Bamako of 14 December 2015. As for the previous text, the newly amended Bangui Agreement consecrates the unification on industrial property amongst its seventeen Member States. The main objective of such an amendment remains to adapt its legal framework to the international environment and to the economic and social development needs of Member States. Yet only five OAPI Member States are developing countries; the twelve others are LDCs. Then the question arises: do transition periods consecrated pursuant to the Doha Declaration still matter for LDCs who have agreed to be subjected to the OAPI legislation? This paper points out that transition periods remain relevant in OAPI countries by application of the more favorable rule between the Bangui Agreement and the WTO TRIPS Council decisions. It is however noted that the OAPI current legal framework is still problematic, while its LDCs members are underutilizing this flexibility.
Status of Permanent Establishments under GloBE Rules
By Kuldeep Sharma
The objective of this Research Paper is to comprehensively identify and analyse all Permanent Establishment (PE) related provisions under the global minimum tax of the Organisation for Economic Co-operation and Development (OECD), which is implemented through the Global Anti Base Erosion (GloBE) Model Rules. The analysis has led to the conclusion that PEs hold a significant position and facilitate application of GloBE Rules.
The GloBE Rules have introduced certain new facets involving application of PE provisions when there is no tax treaty; no Corporate Income Tax (CIT) in the source state, and have brought in the concept of stateless PEs. These newly-introduced facets have widened the scope of PEs to enable application of the GloBE Rules in specific situations which would otherwise have remained outside the ambit of taxation.
The paper concludes with an observation that the OECD’s Inclusive Framework is drafting the provisions of Amount A in a manner that results in consistency with GloBE Rules. Likewise, acceptance of “deemed PE” for GloBE rules should be extended to Amount A as well. By doing so, a tax nexus would be provided in source jurisdictions, which will allow profits attributable to Multinational Enterprises (MNEs) in a digitalized economy (without physical presence) getting taxed under domestic rules of these source (market) jurisdictions. This would have been a much simpler solution and would have eliminated the complexity of Amount A rules to a large extent, as we see today.
The Intersection Between Intellectual Property, Public Health and Access to Climate-Related Technologies
By Lívia Regina Batista
On the 20th anniversary of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health adopted by the World Trade Organization, we realize that its impact is beyond issues of public health stricto sensu. The Doha Declaration has inspired discussions at the Council for TRIPS regarding access to climate-related technologies. Climate change is the main and most globalized environmental problem with adverse effects on public health, especially for the vulnerable communities in the Global-South. The main argument of the proponents of the discussion in the TRIPS Council is the need to rebalance public interests (such as public health and environmental/climate issues) with the private/economic interests of the most powerful countries and corporations. This debate addresses both the recognition of intellectual property rights as an important means for the promotion of technological innovation, and the required wider dissemination of technologies – be they medicines or climate-related technologies. This research paper explores the possibilities that the TRIPS Agreement and the Doha Declaration create for international transfer of climate-related technologies. Even though such discussions on climate-related technologies have initially failed in linking climate change and public health, as well as the rhetoric of human rights, the relevance of the topic remains. Besides that, the response to public health issues also must learn from the experience in climate change, such as the case studies evidencing the insufficiency and inefficiency of fast-tracking programs to provide for a wider dissemination of technologies – which have now been widely replicated to address the COVID-19 pandemic. Such comparison can also be an entrance point to discuss the public health implications for the international regime on climate change, highlighting that such issues are deeply intertwined, and need to be addressed jointly as well.
The Global Digital Compact: opportunities and challenges for developing countries in a fragmented digital space
By Carlos Correa, Danish, Vitor Ido, Jacquelene Mwangi and Daniel Uribe
The adoption of a Global Digital Compact (GDC) as one of the outcomes of the Summit of the Future opens up the opportunity to address in a systematic manner issues that are of critical importance for the digital global governance. It also poses a challenge to developing countries, as most of them lack the infrastructure and capabilities to fully participate in the digital transformation. Many inequalities, including a deep digital divide, do exist and would need to be addressed by the GDC for it to become a real instrument of change and improvement in the living conditions and the prospects of a better future for most of the world population. This paper examines the current fragmentation in the digital governance and some of the issues raised by the proposals made by the UN Secretary-General for adoption of the GDC.
Patentamiento de anticuerpos monoclonales. El caso de Argentina
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
Este documento de investigación tiene como objeto identificar, describir y analizar las patentes concedidas por el Instituto Nacional de la Propiedad Industrial (INPI) de Argentina, en materia de anticuerpos monoclonales desde el año 2010 al 2020 inclusive. La investigación incluye la materia protegida y el universo de solicitantes, entre otros aspectos. Para ello, se procedió a construir una base de datos de patentes y solicitudes, donde se examinan las características de las patentes solicitadas y concedidas, titularidad y nacionalidad de los solicitantes, estado de las solicitudes, tiempo que demora la resolución de una patente solicitada y patentes divisionales. El documento presenta también recomendaciones de política pública aplicables a las patentes sobre anticuerpos monoclonales.
Foreign Investment Flows in a Shifting Geoeconomic Landscape
The economic shocks from the pandemic and rising geoeconomic tensions have triggered an accelerated restructuring of foreign investment flows in global value chains. As the previous determinants of foreign investment are rapidly changing, many new risks and opportunities abound for developing countries looking to attract FDI into their economies. This paper therefore looks at some of the important issues affecting foreign investment flows to developing countries both now and in the future. It then lays out some policy imperatives which can help countries ensure that the inbound foreign investment is responsible, sustainable and contributes to achieving the national development priorities.