|
|
|
|
|
South Centre seminars for African Judges on IP and Public Health note the pivotal importance of TRIPS Flexibilities
|
|
The South Centre conducted in April - May 2022 a series of four seminars for African judges on intellectual property (IP) and public health. Participants were members of Supreme Courts and high courts from 14 African countries (Algeria, Angola, Cameroon, Egypt, eSwatini, Kenya, Malawi, Morocco, Namibia, Nigeria, South Africa, Sudan, Tanzania, and Togo), as well as from the African Court of Peoples’ and Human Rights. Judges from various jurisdictions participated to exchange experiences, together with scholars from both the global South and North.
The African continent has made progress towards the use of flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) relevant to access to medicines, but further action is still needed to enable the full utilization of such flexibilities.[1] Landmark cases from the continent and beyond were discussed during the seminars. Some of the key takeaways include the particular need to balance IP protection and public health in the context of less-resourced countries, the transformative role and robust set of rights – including right to health – enshrined by many African Constitutions and the African charter on human and peoples’ rights, strategies to deal with pressures against courts, and the recognition of the matter of IP and public health as both an African and global issue. A summary of the main points of the sessions follows.
First Seminar (22 April)
Dr. Germán Velásquez, Special Advisor on Health, South Centre
The African continent may be regarded as the origin of a global movement to address the relationship between intellectual property and access to medicines. In the late 1990s, a lawsuit was filed by 39 pharmaceutical companies against the government of South Africa challenging provisions relating to two important TRIPS flexibilities (parallel importation and compulsory licenses). The continent was going through an acute point of the HIV/AIDS epidemic and while access to antiretrovirals had been ascertained for citizens of high-income countries, African countries were ‘left behind’. The case, eventually dropped by the multinational companies, was a clear example of the role of the Judiciary in IP and public health cases. The specificities of the case and its interaction with the broader access to medicines and medical technologies were discussed by Dr. Germán Velásquez, Special Advisor on Health, South Centre.
The presentation was followed by Dr. Carlos Correa, Executive Director of the South Centre, on the tension between the right to health and the protection of IP, and on how legal provisions and court decisions may affect access to medicines. He stressed the pivotal role played by courts in shaping IP law, and that courts in developing countries need not follow doctrines and standards adopted in implementing patent laws in high-income countries that may negatively affect the realization of the right to health.
Prof. Caroline Ncube, University of Cape Town, South Africa
Day 1 was concluded with an overview of the implementation of TRIPS flexibilities at the national and regional levels by Prof. Caroline Ncube, from the University of Cape Town, South Africa. She noted existing divergences with respect to the level of legal implementation of TRIPS flexibilities in the continent, and that free trade agreements and the implementation of the African Continental Free Trade Area (AfCFTA) – Phase 2 (which will include an IP chapter) have important implications in enabling such flexibilities. She provided a comprehensive analysis that included, inter alia, political and institutional reasons that help explain the extent of use of TRIPS flexibilities in Africa.
Second Seminar (29 April)
Prof. Faizel Ismail, Director, Nelson Mandela School of Public Governance, University of Cape Town and former Ambassador of South Africa to the World Trade Organization in Geneva
At the second seminar, which took place on 29 April, Prof. Faizel Ismail, Director, Nelson Mandela School of Public Governance, University of Cape Town and former Ambassador of South Africa to the WTO in Geneva, discussed the TRIPS waiver proposal at the World Trade Organization (WTO), as well as how manufacturing capacity for pharmaceuticals could be enhanced in Africa.
Subsequently, Prof. Joshua Sarnoff, DePaul University, United States, provided an overview on IP enforcement and remedies, and how to ensure a balance between protection of IP and access to health technologies. Provisional injunctions should, for example, not be granted automatically – and so is the case law in the US after the US Supreme Court e-Bay v. MercExchange case. Considerations of public interest and discretion with respect to which measures are to be adopted in cases of alleged violations of IP are needed, considering in particular the essentiality of health products.
Honorable Judge Mumbi Ngugi, Court of Appeals of Kenya
After a brief introduction on the consideration of the right to health in IP judicial cases across various jurisdictions, Judge Mumbi Ngugi from the Court of Appeals of Kenya discussed the importance of the right to health and the role of judicial authorities in its realization. She discussed in detail the Kenyan High Court case Patricia Asero Ochieng v. Attorney General, which declared unconstitutional provisions of the Anti-Counterfeit Law, including a provision that conflated the generic with counterfeit medicines. The case is considered a landmark in balancing IP protection with public health and in the utilization of a right to health rationale.
Finally, Mr. Nirmalya Syam, Senior Programme Officer, South Centre, made a presentation on exclusions and exceptions in patent law, with a focus on the variations across the African continent’s laws. He also presented the US Supreme Court decision in the Association for Molecular Pathology v. Myriad Genetics, Inc. case, which restricted the patentability of isolated DNA.
Third Seminar (6 May)
Dr. Carlos Correa, Executive Director, South Centre
The seminar began with a presentation by Dr. Carlos Correa on patentability standards, delving deeper into typical claims in pharmaceutical patent applications and providing concrete examples of how countries’ examination practices differ in concrete cases. Judges often receive cases that challenge administrative decisions on patentability and therefore also need to be aware of their discretion (as well as the lack of uniform rules at the global level), to make decisions balancing IP and public health.
A series of cases were discussed. Judge Prabha Sridevan (retired), former Chairperson of the IPAB (Intellectual Property Appellate Board, India), in a pre-recorded message, discussed the role of judges and discussed the details and implications of the landmark India’s Supreme Court Novartis v. Union of India & Others (2013), which ruled Section 3(d) of the Indian Patent Act constitutional. This provision incorporated a high threshold for patentability, which is fully aligned with the flexibilities enshrined in the TRIPS Agreement. Mr. Ermias Biadgleng, Senior Legal Officer, UNCTAD, discussed two other cases, the Pfizer v. Cipla in South Africa and the Actavis v. ICOS in the UK, which further highlight examples of how countries vary and may take decisions which safeguard public health in patentability cases.[2]
Prof. Yousuf Vawda, University of Kwa-Zulu Natal, South Africa
The third seminar dealt with compulsory licenses (CLs). Prof. Yousuf Vawda, from the University of Kwa-Zulu Natal, South Africa, presented what they are and the reasons for their relative low implementation in the continent (which include political constraints and legislations which are not conducive to that aim). He also described the possible role of courts in the grant of CLs, and how many legal doctrines are often used in a manner that de facto impede their utilization. The session concluded with a presentation by Judge Caroline Tauk, from the Federal Court of Rio de Janeiro, Brazil, on the Merck Sharp and Dohme (MSD) v. Shionogi (2017) case by the German Federal Court of Justice. In this case, the court issued a compulsory license, showing both the pivotal role that judicial authorities may have and how developed countries also make use of such TRIPS flexibilities.
Fourth Seminar (13 May)
Prof. Duncan Matthews, Queen Mary University London
The fourth seminar dealt with the use of competition policy and law, its interface with IP, and how decisions in the African continent have catalyzed the use of such TRIPS flexibility. Prof. Duncan Matthews, from Queen Mary University London, discussed the interaction between competition law and IP, listing recent trends in the EU – which clearly recognizes instances of IP abuse with anti-competitive implications –, various international debates at multilateral fora (such as UNCTAD and the OECD), and recent cases and debates in the context of the Covid-19 pandemic. He stressed that countries have the flexibility to investigate and sanction conducts such as pay-for-delay agreements, sham litigation, product hopping and switching, and excessive pricing.
Prof. Yousuf Vawda discussed the Hazel Tau & others v. GlaxoSmithKline, Boehringer Ingelheim & others (2002) case, where individuals and civil society organizations in South Africa requested the Competition Commission to determine the anti-competitive effects of excessive pricing of patented antiretrovirals in the country. The case was ultimately settled by an agreement but clearly highlights the potential role of competition law to lower prices of medicines. South Africa has also applied competition law under Covid-19 for price gouging of medical products.
Honorable Judge Brian Spilg, High Court of South Africa
Honorable Judge Stella Anukam, African Court of Human and Peoples’ Rights
The series of seminars concluded with a roundtable moderated by Judge Brian Spilg, High Court of South Africa, which reflected on the different approaches of the jurisdictions involved, responded to the issue of whether and how courts may take actions in the light of political pressures and in accordance with their mandates, the arguments potentially used in IP litigation, and more generally what sorts of capabilities and perspectives should judicial authorities have to address IP and public health.
The series of seminars was closed by Dr. Viviana Muñoz-Tellez, Coordinator of the Health, Intellectual Property and Biodiversity Programme, South Centre.
The South Centre continues to provide technical assistance to developing countries’ officials, including judicial and competition authorities, patent examiners and policymakers. Requests may be made by email or via: https://ipaccessmeds.southcentre.int/.
[2] Please see the South Centre-UNCTAD case database of notable judgements around the world on issues of intellectual property and public health, including several on the application of patentability requirements: https://ipaccessmeds.southcentre.int/case-law-database/.
Author: Vitor Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme, South Centre.
|
|
SOUTHNEWS is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.
To view other articles in SouthNews, please click here.
For more information, please contact Anna Bernardo of the South Centre: Email abernardo@southcentre.int, or telephone +41 22 791 80 50.
|
|
|
|
|
|
|
