Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
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.
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.
Knocking Down Business-related Human Rights Abuses with a Feather: Is the European Corporate Sustainability Due Diligence Directive Sufficient to Tackle Corporate Impunity?
By Daniel Uribe
In April 2024, the European Parliament approved the Corporate Sustainability Due Diligence Directive (CSDDD), aiming to ensure that European firms and their partners uphold human rights and environmental standards in their supply chains. This Directive applies to large EU and non-EU companies, with a phased implementation starting in 2027. The CSDDD mandates the integration of due diligence in corporate policies and the development of transition plans aligned with the Paris Agreement. Despite these advancements, the Directive’s scope and civil liability provisions are limited to effectively hold corporations accountable for human rights abuses. The ongoing negotiations on an International Legally Binding Instrument on Business and Human Rights offer an opportunity to adopt common standards on due diligence and jurisdiction to improve access to justice and remedies for victims of corporate-related abuses.
What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?
By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul
Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding that may facilitate the granting of unwarranted patents.
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.
How the EU’s Carbon Border Adjustment Mechanism discriminates against foreign producers
By Peter Lunenborg and Vahini Naidu
In April 2023, the European Parliament adopted the final text of the Carbon Border Adjustment Mechanism (CBAM) and revisions to the European Union (EU) Emissions Trading System (ETS). One of the stated objectives of CBAM is to create a level playing field for selected sectors in the EU market and to protect against the risk of ‘carbon leakage’. Based on an analysis and comparison between the legal texts of CBAM and ETS, this paper finds that CBAM discriminates against foreign producers in favour of EU domestic producers in many areas including with regard to the scope and type of emissions covered, free allocation of allowances, exemptions under EU ETS not mirrored in CBAM, buying and selling of ETS allowances in comparison with CBAM certificates, verification, penalties, authorization, use of credits from the Carbon Development Mechanism (CDM) and guarantees.
The paper also provides a brief overview of how the CBAM and ETS align with WTO rules, highlighting the potential discrepancies in the implementation as they apply to foreign and EU producers respectively. The paper provides several suggestions on how to make EU’s CBAM more WTO-compatible and a recommendation for further legal research.
Data Access and the EU Data Strategy: Implications for the Global South
By Marc Stuhldreier
This study explores the value of data in the digital economy and the challenges surrounding data ownership, access rights, and equitable distribution of the value. It examines the European Data Strategy and highlights its shortcomings as well as its implications for the Global South. This contribution emphasises the need for unlocking the potential of collected data by enhancing accessibility and challenging protectionist measures and discusses the importance of fair competition and innovation. It also discusses the importance of balancing access rights with legitimate privacy concerns, trade secrets, and intellectual property rights. The paper concludes by highlighting the importance for developing countries to introduce tailored regulations that suit their specific needs, empowering them to seize opportunities and navigate the digital economy effectively.
Understanding the Functioning of EU Geographical Indications
By Andrea Zappalaglio
This contribution investigates the functioning of the EU sui generis Geographical Indication (GI) system, with a specific focus on the regime for the protection of agricultural products and foodstuffs within the scope of EU Regulation 1151/2012. In particular, based on the results of the recent “Study on the Functioning of the EU Geographical Indications System” of the Max Planck Institute for Innovation and Competition (February 2022), this paper: (1) clarifies the nature of EU GIs as it emerges from an empirical assessment of the specifications of all the products that appear on the EU register; (2) comparatively analyses the national practices of the EU Member States and explores the discrepancies that exist among them to date; (3) provides an in-depth assessment of the structures of the specifications of EU GIs, highlighting the domestic specificities; (4) investigates the contents and functions of the amendments to the specifications of the registered products. It concludes by emphasizing the importance of the present research in light of the current EU international agenda, with a specific focus on the bilateral agreements recently or currently negotiated.
Reducing the Unnecessary Use of Antimicrobials in Animal Farming
By Dr. Viviana Muñoz Tellez
Antimicrobial resistance is aggravated due to excessive and inappropriate use of antimicrobials in human and animal health and in plant and animal agriculture. While international standards are being developed, governments are rolling out regulations with the aim to curb the overuse and misuse of antimicrobials, to preserve their efficacy for as long as possible. This Policy Brief discusses two new regulations introduced by the European Union (EU) on medicated animal feed (Regulation (EU) 2019/4 and veterinary medicinal products (Regulation (EU) 2019/6) that entered into effect on 28 January 2022. As part of the implementation of the regulations, the EU should devise a comprehensive plan to help implementation by countries and producers of animal food products of the Global South, linked to supporting the transition to sustainable agricultural systems and development.
Harnessing the Multilateral Patent and Plant Variety Protection Regimes to Advance Food Security:
Implications of the EU-ECOWAS Economic Partnership Agreement
Description:
This thesis analyzes the provisions of contemporary intellectual property (IP) and trade agreements to explore whether these provisions advance, or compromise, food security in West Africa. The agreements have been examined for how their provisions integrate IP and food security norms and policies, and the extent to which the IP frameworks are adaptable to the regional conditions that determine food security in the West African context. Critical analysis is made of a regional agreement signed between the Economic Community of West African States (ECOWAS) and the European Union (EU), the 2014 EU-ECOWAS Economic Partnership Agreement (EPA), to assess what implications the agreement may have for food security in West Africa. Interdisciplinary research is carried out to identify the characteristics needed to advance food security in the region of West Africa. Also, philosophical and doctrinal analysis of IP laws and legal theories is conducted to identify which legal principles are best suited for advancing food security in the region. Based on the findings, the thesis draws up a model framework for IP protection that is more suitable for enhancing food security in West Africa.
Author: Uchenna Felicia Ugwu is a lawyer and academic researcher with over ten years’ experience extensively investigating the relationship between Intellectual Property (IP) norms and socio-economic development in developing countries. She recently received a PhD in International IP Law and Development from the University of Ottawa.
Description: