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.
International Regulation of Industrial Designs: The TRIPS Agreement in the Light of European Union Law
By Adèle Sicot
This paper analyzes the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) on industrial designs, and the manner in which the narrow aspects dealt with by the Agreement have been addressed by European Union (EU) legislation. The paper highlights the absence of a definition of protectable subject matter, and the considerable flexibility left to the member countries of the World Trade Organization to determine the framework of protection, notably on the basis of copyright. The paper also notes certain areas in which European legislation is more elaborate, and others which could be considered incompatible with the TRIPS Agreement.
Navigating the WTO’s Working Group on Trade and Transfer of Technology: A Critical Analysis from the Perspective of Developing Countries
By Nirmalya Syam
This paper critically analyzes the operations and effectiveness of the World Trade Organization’s (WTO) Working Group on Trade and Transfer of Technology (WGTTT). Despite the establishment of the WGTTT in 2001 with a mandate to enhance technology flows to developing countries, the Group has struggled to produce meaningful outcomes due to divergent priorities between developed and developing countries. This paper finds that the WGTTT remains an exploratory discussion forum rather than a negotiation platform with the capacity to generate new initiatives that address the technology transfer needs of developing countries. Key reforms are proposed, including transitioning to a negotiation-oriented approach, improving the balance of member priorities, and focusing on actionable themes to enhance the WGTTT effectiveness in fostering technology transfer to developing countries.
South Centre Statement to the 49th WIPO IGC Session
2 December 2024
We support the work by the World Intellectual Property Organization (WIPO) Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) to contribute to a more inclusive and just international intellectual property system and sustainable development.
African researchers continue to face information-access barriers owing to copyright exclusivity preserved by the global copyright system that is designed and skewed towards protecting rights holders’ interests. A specific explicit human right to research is an important mechanism that can ensure an equitable balance between the private commercial interest of copyright owners and the public interest in promoting access to information for research in Africa. This article demonstrates how the right to research can be constructed from the normative content and scope of the rights to science and culture, education, property and freedom of expression provided for in international, regional and national human rights regimes in Africa.
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.
Régulation internationale des dessins et modèles industriels : l’Accord sur les ADPIC à l’aune du droit de l’Union européenne
Par Adèle Sicot
Ce document analyse les dispositions de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (l’Accord sur les ADPIC) sur les dessins et modèles et la manière dont les aspects limités traités par l’Accord ont été abordés par la législation de l’Union Européenne (l’UE). Il note l’absence d’une définition de la matière susceptible de protection et une considérable flexibilité laissée aux pays membres de l’Organisation Mondiale du Commerce pour déterminer le cadre de protection, notamment sur la base du droit d’auteur. Le document note aussi certains aspects dans lesquels la législation européenne est plus élaborée et d’autres dans lesquels on pourrait observer une incompatibilité avec l’Accord sur les ADPIC.
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.
Can international law promote innovation from genetic resources and benefit sharing while recognizing the rights of traditional knowledge holders?
By Henry de Novion
Indigenous peoples and local communities have been innovating for millennia and contributing to the development of new products and processes. For international law to promote innovation, it is indispensable to promote indigenous peoples and local communities’ rights to prior informed consent, to benefit sharing, and to guaranteeing their territories, culture, and existence.
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.
Decision 15/9 and the Nagoya Protocol: Who should get what in the Multilateral Benefit-Sharing Mechanism?
By Joseph Henry Vogel, Natasha C. Jiménez-Revelles, Xavier A. Maldonado-Ramírez de Arellano
Article 10 of the Nagoya Protocol (NP), “Global Multilateral Benefit-Sharing Mechanism” (GMBSM), asks Parties to consider the distribution of benefits derived from the utilization of genetic resources in transboundary situations. A literature exists which applies the economics of information to genetic resources, when interpreted as “natural information”. The policy implication would incentivize reduction in the drivers of mass extinction, through economic rents in royalty obligations. Fifteen cases become thought experiments on how to share royalty income. A sixteenth case addresses the TP53 gene in elephants, which may revolutionize oncology. In parallel to Article 10 of the NP is Decision 15/9 of the fifteenth Conference of the Parties to the Convention on Biological Diversity. That Decision establishes a “multilateral benefit-sharing mechanism from the use of digital sequence information on genetic resources”. Redundancy with the GMBSM is only apparent. The Decision omits rents and thus renders its mechanism inefficient, unfair and inequitable.
