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.
Las nuevas pandemias son inevitables. ¿Cómo podemos estar mejor preparados para ellas y, sobre todo, cómo podemos evitar los errores e injusticias cometidos durante la pandemia de COVID19? Actualmente se están llevando a cabo negociaciones para formular un tratado internacional vinculante sobre prevención y preparación que garantice respuestas más justas a futuras pandemias. Este libro pretende ser una contribución crítica a estos debates en curso.
¿Cómo garantizar un acceso equitativo a los medicamentos y diagnósticos cuando la mayoría de ellos se producen en un número reducido de países? ¿Cómo explicar que la financiación actual de la cooperación sanitaria esté en manos de un pequeño grupo de países y fundaciones del Norte? ¿Cómo reforzar el papel de la Organización Mundial de la Salud, que actualmente desempeña un papel secundario en la coordinación de las políticas de salud pública? ¿Por qué se ha sustituido el concepto de «medicamentos esenciales», gran avance de la política de salud pública, por el de «contramedidas médicas», término más acorde con el afán de lucro del sector privado?
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
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.
De nouvelles pandémies sont inéluctables. Comment mieux s’y préparer et surtout comment éviter les erreurs et injustices commises durant la pandémie du Covid-19 ? Des négociations sont en cours pour formuler un traité international contraignant sur la prévention et la préparation pour des réponses plus justes aux futures pandémies. Ce livre se veut une contribution critique aux débats en cours.
Comment garantir l’accès équitable aux médicaments et diagnostics, alors que la majorité d’entre eux sont produits dans un petit nombre de pays ? Comment expliquer que le financement actuel de la coopération en matière de santé se retrouve entre les mains d’un groupe réduit de pays et fondations du Nord ? Comment renforcer le rôle de l’Organisation mondiale de la santé, qui ne joue plus qu’un rôle mineur dans la coordination des politiques de santé publique ? Comment se fait-il que le concept de « médicaments essentiels », une avancée majeure dans les politiques de santé publique, soit remplacé par celui de « contre-mesures médicales », un terme qui s’accorde plutôt à la logique de profit du secteur privé ?
La préparation aux futures pandémies nous oblige à nous interroger : comment préserver l’intérêt général, la défense des droits de l’homme et la santé publique ?
Auteur: Germán Velásquez est conseiller spécial en matière de politique et de santé au South Centre à Genève.
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.
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