Second Medical Use Patents – Legal Treatment and Public Health Issues
By Clara Ducimetière
This paper attempts to give an overview of the debate surrounding the patentability of new therapeutic uses for known active ingredients, both in developed and developing countries. After close scrutiny of international patentability standards, this paper concludes that second medical uses do not qualify per se for patent protection and have only been protected in several jurisdictions by means of a legal fiction. The increasing acceptance of second medical use patents seems to result from strategic patent filing from pharmaceutical companies to extend the life of existing patents, justified mainly for financial reasons. However, these practices have a detrimental impact on generic competition and, hence, on the access to medicines and the public health, in particular in developing countries. Therefore, this paper argues that a sound patent policy in line with public health objectives, in particular, an enhanced access to medicines, should not allow for the grant of second medical use patents.
Medicines and Intellectual Property: 10 Years of the WHO Global Strategy
By Dr. Germán Velásquez
The negotiations of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) (2006-2008), undertaken by the Member States of the World Health Organization (WHO), were the result of a deadlock in the 2006 World Health Assembly where the Member States were unable to reach an agreement on what to do with the 60 recommendations in the report on Public Health, Innovation and Intellectual Property submitted to the Assembly in the same year by a group of experts designated by the Director-General of the WHO. The result of these negotiations was the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) that was approved by the World Health Assembly in 2008. One of the objectives of the IGWG’s Global Strategy and Plan of Action was to substantially reform the pharmaceutical innovation system in view of its failure to produce affordable medicines for diseases that affect the greater part of the world’s population living in developing countries. The intellectual property (IP) rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the trade agreements could become some of the main obstacles to accessing medicines. The GSPOA made a critical analysis of this reality and opened the door to the search for new solutions to this problem. Ten years after the approval of the GSPOA, the results are uncertain and poor.
Ensuring an Operational Equity-based Global Stocktake under the Paris Agreement
By Hesham Al-Zahrani, Chai Qimin, Fu Sha, Yaw Osafo, Adriano Santhiago De Oliveira, Anushree Tripathi, Harald Winkler and Vicente Paolo Yu III
One of the key provisions of the Paris Agreement that was adopted in December 2015 at the 21st session of the Conference of the Parties to the United Nations Framework Convention on Climate Change is Article 14 on the global stocktake (GST). The GST is intended to be the mechanism by which the Convention Parties that are Parties to the Paris Agreement would be able to periodically take stock of the implementation of the Paris Agreement and to assess collective progress towards achieving the purpose of the Agreement and its long-term goals. This research paper discusses how equity as a principle and a concept played a key role in shaping the modalities for the GST, and looks in detail at the operational modalities for the GST that were agreed upon in Katowice in December 2018 in relation to how equity should be considered and made operational.
Developing Country Coalitions in Multilateral Negotiations: Addressing Key Issues and Priorities of the Global South Agenda
By Adriano José Timossi
The recent increasing and unprecedented attacks on multilateralism and its institutions as well as the growing dangers of weakening international cooperation are regrettably leading to an enormous setback in the history of the international system. These developments could reverse decades of collective efforts to establish a more stable, equitable and inclusive path of development and social justice for all. An immediate impact is that international negotiations, which have increasingly become important for developing countries over the past decades, are now becoming even more complex. If the resurging path of unilateralism and protectionism adopted by some powerful countries is maintained, the risks of further deterioration grow even larger. The instabilities of the contemporary world pose serious risks to the achievement of the longstanding development goals of the Global South such as poverty eradication, the South’s ability to successfully address emerging challenges such as climate change, and to overall global stability, a pattern not seen since the Second World War. In this context, developing countries’ negotiating coalitions such as the Group of 77 (G77) + China and the Non-Aligned Movement (NAM), while respecting and adapting to the differences that might emerge within these large groups, need to remain together and ensure that their coalitions are preserved and strengthened. Working collectively will improve negotiating capacity and leverage and increase bargaining power of developing countries in the multilateral negotiations in order to get more balanced outcomes.
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.
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.
Mainstreaming or Dilution? Intellectual Property and Development in WIPO
By Nirmalya Syam
In 2007 Member States of the World Intellectual Property Organization (WIPO) unanimously adopted a set of 45 recommendations which constitute the WIPO Development Agenda. Developing countries sought to give new direction to WIPO through the Development Agenda, away from the pursuit of facilitating and strengthening protection, acquisition and enforcement of intellectual property (IP) rights as an end in itself towards an approach that would be sensitive to the impact of IP on development, both in terms of opportunities as well as costs. This paper explores whether development considerations have been adequately addressed by WIPO since its creation as the United International Bureau for the Protection of Intellectual Property (BIRPI) in the nineteenth century. The paper also analyses whether the implementation of the WIPO Development Agenda adopted in 2007 has shaped the current vision of the WIPO Secretariat and its Member States to address the impact of IP on development; and whether implementation of the Development Agenda has facilitated the use of IP law and policy as a tool that responds to advancing innovation, industrial, health, agricultural, education and other development policies in developing countries. The paper finds that the approach towards IP in WIPO continues to be dominated by a perspective that pursues acquisition, protection, management and enforcement of IP rights as an end in itself. Conflicting interpretations of development orientation have adversely impacted the implementation of the Development Agenda in the spirit in which the developing countries had proposed the Development Agenda. The paper recommends developing countries to undertake cross regional coordination to enhance their level of engagement on IP and development, advance specific suggestions for achieving greater impact on addressing development challenges through specific activities including projects in the areas of technical assistance as well as norm-setting, pursue governance reforms in WIPO to ensure greater representation of developing countries in the decision making bodies of WIPO and in the staff composition of the WIPO Secretariat, amend the WIPO Convention to align its mandate on IP promotion to the development needs and challenges of its Member States and the development goals of the United Nations (UN), and also pursue a review of the relationship between the UN and WIPO as a UN specialized agency in the UN Economic and Social Council.
Access to Medicines: Experiences with Compulsory Licenses and Government Use – The case of Hepatitis C
By Dr. Carlos M. Correa and Dr. Germán Velásquez
This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States’ observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).
Tax Haven Listing in Multiple Hues: Blind, Winking or Conniving?
By Jahanzeb Akhtar and Verónica Grondona
Tax havens are among the biggest challenges faced by developing countries in achieving their national development goals. States, international organisations, multilateral agencies and non-governmental organisations have all made several efforts at compiling ‘lists’ of tax havens at the multilateral and national levels, with varying levels of seriousness and outcomes. This research paper examines these efforts by analysing the objectivity of criteria used and the clarity of the final outcome in a comparative manner. The paper is organized into four sections dealing with the tax haven blacklisting by the Organisation for Economic Co-operation and Development (OECD), the countries of the South, the European Union (EU) and an analysis across lists. The concluding section offers some suggestions.
Regulating the Digital Economy: Dilemmas, Trade Offs and Potential Options
By Padmashree Gehl Sampath
The digital economy has been growing exponentially in recent years thanks to new technologies that are promoting a global transformation. Key technologies responsible for this transformation have become the subject of intense discussions under the umbrella term ‘fourth industrial revolution’. This paper offers a discussion on the differentiated impact of digital technologies on unemployment, capabilities building and technological catch-up for developing countries. It articulates some of the key issues and tradeoffs for developing countries that should be considered in policy discussions and deliberations.
Notification and Transparency Issues in the WTO and the US’ November 2018 Communication
By Aileen Kwa and Peter Lunenborg
Various WTO Members submitted a Communication to the WTO in November 2018 which, if accepted, would affect the implementation of Members’ transparency and notification obligations at the WTO. It would strengthen the already burdensome notification obligations and introduce new punitive administrative measures should obligations not be complied with. This paper provides information about WTO Members’ current notification obligations and their level of compliance; looks at the history of discussions on notifications, particularly in the Working Group on Notification Obligations and Procedures which took place in 1995 – 1996; and provides an analysis of the Communication. The analysis focuses on the extent to which the elements are consistent with or go beyond the current WTO disciplines. It concludes that non-compliance with notification obligations is real. However, rather than expanding obligations and introducing punitive measures, constructive and effective solutions should be based on nuancing of obligations in the context of a Special and Differential Treatment approach and through the use of incentives. It also acknowledges that countries with a chronic lack of capacities will continue to struggle with the WTO’s complex notification obligations and requirements until they attain higher levels of development and, thus, improved institutional capacities.
Key Issues for BAPA+40: South-South Cooperation and the BAPA+40 Subthemes
By Vicente Paolo B. Yu III
Developing countries today face multiple interlinked macroeconomic, financial, climate, and development challenges. South-South cooperation is an important element for developing countries to meet these challenges individually and collectively, and in multilateral North-South dialogue and global governance. The overall theme of the Second High-level United Nations Conference on South-South Cooperation (40 years after the Buenos Aires Plan of Action for Promotion and Implementing Technical Cooperation among Developing Countries/BAPA+40) is the “Role of South-South cooperation and the implementation of the 2030 Agenda for Sustainable Development: challenges and opportunities”, with sub-themes. This research paper will present some concepts relating to South-South cooperation that have been developed by the South and the United Nations system, and looks at some issues that would be relevant to discussions that may be undertaken with respect to Subthemes (i) “Comparative advantages and opportunities of South-South cooperation”; (ii) “Challenges and the strengthening of the institutional framework of South-South cooperation and triangular cooperation”; and (iv) “Scaling up the means of implementation of the 2030 Agenda for Sustainable Development in support of South-South cooperation and triangular cooperation”. It concludes by providing recommendations for the consideration of developing countries in response to the various subthemes, as inputs to support the active engagement by developing countries in the negotiations for the BAPA+40 outcome document.