Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
Health, Intellectual Property and Biodiversity Programme, November 2024
The following matrix provides a factual overview and analysis of the standing and non-standing agenda items of the regular session of the WTO TRIPS Council of 6-7 November. The matrix also discusses the TRIPS Implementation issues as part of the WTO Doha Development Round of negotiations.
Towards a Balanced WIPO Design Law Treaty (DLT) for Developing Countries
By Nirmalya Syam
The WIPO Design Law Treaty (DLT) aims to harmonize and simplify global industrial design registration procedures, encourage digital applications and reduce costs. While the reforms required by the DLT could boost efficiency, they will mainly benefit enterprises from developed countries with resources to secure global design rights. This policy brief highlights the key concerns for developing countries, particularly the treaty’s potential impacts on small and medium-sized enterprises (SMEs) and indigenous communities. It advocates for critical adjustments in the DLT negotiation texts to allow for policy space in the DLT – binding technical assistance, flexible grace periods, enabling disclosure of the origin and source of traditional knowledge and traditional cultural expressions used in designs that are sought to be registered, and optional divisional and electronic filing provisions.
A Fair Solution for Access and Sharing of Benefits of Digital Sequence Information? Decision for the CBD COP in November 2024
By Viviana Munoz Tellez
A decision is expected from the Conference of the Parties of the Convention on Biological Diversity (CBD) by 1 November 2024 on a solution to the fair and equitable sharing of benefits from the use of digital sequence information (DSI) on genetic resources. There are different forms of non-monetary and monetary benefits from the use of DSI that are being considered. This paper argues that for monetary benefit sharing, the focus should be on when DSI is used commercially, as part of products or services. Calculations should be based on revenue that includes sales and intellectual property licencing.
Comments to the Global Digital Compact Third Revision
South Centre
Geneva, August 2024
The Global Digital Compact to be agreed in September 2024 is a step towards equitable digital transformation.
Implementation of the Global Digital Compact will require inclusive, strengthened multilateralism, international cooperation and financing to close digital divides.
Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines
By Behrang Kianzad
The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.
Statements on Understanding on Intellectual Property Rights at time of Signature or Ratification of the BBNJ Treaty
South Centre
The Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ) negotiations did not fully address issues of intellectual property rights (IPRs), but countries can make statements on IPRs at the time of signature and/or on ratification of the BBNJ. Read our recommendations:
South Centre Statement at the 9th session of the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response
March 2024
The South Centre underscores the imperative for an international binding pandemic treaty to prevent the recurrence of past failures like those witnessed during the COVID-19 crisis.
How Should the WHO Pandemic Treaty Negotiations Tackle Intellectual Property?
By Viviana Muñoz Tellez
The WHO pandemic instrument should commit the Parties to limit the exclusionary effects that government-granted patents and other IPRs may have during pandemics in support of rapid diffusion of new vaccines, diagnostics, medicines and other tools and facilitate collaboration and freedom to operate. The current draft text of Article 11 would not make any change to the status quo.
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.
Identifying Legal Challenges for Farmers’ Innovation
By Saurav Ghimire
On 9 October 2023, an expert workshop on “Identifying Legal Challenges for Farmers’ Innovation” was organised at the Centre for Private and Economic Law, Vrije Universiteit Brussel, in collaboration with the South Centre and Université Catholique de Louvain. The hybrid event gathered experts to discuss the challenges for farmers’ innovation, particularly those emerging from regulatory regimes. The workshop brainstormed policy and regulatory hindrances to farmers’ involvement in plant breeding, namely, in access to breeding materials, access to the market and reward/protection for the innovation.
The expert workshop was organised as a part of a joint research project, “Farmers as Plant Breeders: Legal Mechanisms to Foster Farmers’ Innovation”, led by Prof. Christine Frison (Université Catholique de Louvain), Prof. Kim Van der Borght (Vrije Universiteit Brussel), and Prof. Carlos Correa (South Centre). The research project is funded by the Research Foundation Flanders (FWO).
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.
