South Centre Statement for the Third Session of the WIPO Conversation on AI and IP
The South Centre is an intergovernmental organization of 54 developing countries working across various policy areas, including intellectual property. This statement focuses on increasing capacity on artificial intelligence (AI) and intellectual property (IP) matters in the context of the widening technological gap and the Fourth Industrial Revolution.
Creative imitation at the front of pharma biotechnology opportunities: some lessons from late late industrialization countries
By Pablo Lavarello and Sebastián Sztulwark
Given that high-cost biopharmaceutical drug patents have started to expire since the early 2000s, biotechnology opens up opportunities for developing countries to pursue an upgrading process by entering the sector as early imitators. Developing these opportunities was transformed on priority needs of health systems since the outbreak of COVID-19. Certain developing countries have advanced in a strategy of imitating biotechnological reference drugs once their patents have expired, opening a possibility for a catching up process.
Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19
By Srividya Ravi
This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications.
The medicines considered for the patent analysis in this report are remdesivir, ruxolitinib and favipiravir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.
TRIPS Flexibilities on Patent Enforcement: Lessons from Some Developed Countries Relating to Pharmaceutical Patent Protection
By Joshua D. Sarnoff
Authority for national judiciaries to issue permanent and preliminary injunctions is required by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Articles 44 and 50. But the TRIPS Agreement does not require the issuance of injunctions in any particular circumstances, and does not harmonize the laws on which national jurisdictions derive their injunctive relief authorities. Thus, countries remain free to refuse prohibitory injunctive relief for adjudicated or likely patent infringement, particularly if “reasonable compensation” is offered in the form of an “ongoing royalty” or an “interim royalty” payment, which acts similarly to a compulsory license. This paper explains the existing legal standards for permanent and preliminary injunctions in the United States and Canada and discusses trends regarding the issuance or denial of injunctions for pharmaceutical patents in those jurisdictions (with occasional reference to other common-law jurisdictions). Although judges in these jurisdictions more routinely deny preliminary prohibitory injunctions, legislation linking generic pharmaceutical regulatory approvals to the patent system and imposing stays of such approvals normally avoid the need for such preliminary injunctions. Consistent with the TRIPS Agreement, developing country judges may make different choices, based on the ability to provide reasonable compensation for harms or based on a different weighing of the importance of assuring affordable access to medicines relative to providing innovation incentives.
PROPOSAL BY INDIA AND SOUTH AFRICA TO WAIVE CERTAIN PROVISIONS OF THE WTO TRIPS AGREEMENT TO SUPPORT THE GLOBAL COVID-19 PANDEMIC RESPONSE
The prolongation of the coronavirus COVID-19 pandemic threatens developing countries disproportionately, deepening the catastrophic social and economic crisis and reversing the gains made to date to eradicate extreme poverty and meet the Sustainable Development Goals (SDGs). In this situation, ensuring timely access to essential commodities by overcoming acute shortages faced by countries due to high demand and disruptions in the supply chain is critical. There is also an urgent need to speed up development of new vaccines, treatments and diagnostics, at scale, and make these widely available.
As reaffirmed by many delegations in the special session of the WHO Executive Board, transfer of technology and know-how is fundamental for scaling up manufacturing of medical products and equipment. In this regard, India and South Africa have made a joint proposal to the World Trade Organization (WTO) to temporarily waive certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to support the global Covid-19 pandemic response.
Today the judicial authority may be faced with balancing patent rights and patients’ rights or right to life. It shall use all the tools at its command and innovate if necessary, but shall rule in favour of life.
A New Trend in Trade Agreements: Ensuring Access to Cancer Drugs
By Maria Fabiana Jorge
A World Health Organization (WHO) report on cancer indicates that the cancer burden will increase at least by 60% over the next two decades, straining health systems and communities. Companies develop cancer drugs in part because payers are less resistant to paying high drug prices for these drugs. As Barbara Rimer, Dean of the University of North Carolina and Chair of the U.S. President’s Cancer Panel stated, “[m]ost cancer drugs launched in the United States between 2009 and 2014 were priced at more than $100,000 per patient for one year of treatment.” Many of the new cancer drugs are biologics. Such prices are clearly out of reach for most patients who will need them increasingly more to stay alive. While competition is critical to ensure lower drug prices, we have seen a number of strategies, including through trade agreements, to prevent competition and extend monopolies over these drugs and their very high drug prices. It is no accident that the exclusivity granted to biologic drugs has been one of the most conflictive provisions in recent trade agreements such as the United States-Mexico-Canada Agreement (USMCA) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). Nevertheless a new trend in trade agreements started in 2007 when U.S. Members of Congress pushed back against the interests of powerful economic groups seeking longer monopolies for drugs. These Members of the U.S. Congress prevailed then in restoring some balance in the trade agreements with Peru, Colombia and Panama and further consolidated this new trend in 2019 in the USMCA. Moreover, following the U.S. withdrawal from the original Trans-Pacific Partnership (TPP), the negotiators of the remaining 11 countries also pushed back to ensure a better balance between innovation and access in the CPTPP. People around the world need to be aware of these precedents and ensure that they also work for access to medicines for their own citizens.
South Centre Semester Report, 1 January to 30 June 2020
This Semester Report summarizes the activities undertaken by the South Centre during the period 1st January to 30 June 2020. It is intended to provide information, organized by themes, about recent developments in the areas covered by the Centre’s Work Program, meetings organized or co-organized by the Centre to examine particular issues or provide analytical support for negotiations taking place in various international fora, and conferences and other meetings where the Centre has participated. It also informs about publications made.
Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base
Par Germán Velásquez
La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.
The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic
By Frederick Abbott
The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.
United States: An Obsolete Trade Practice Undermines Access to the Most Expensive Drugs at More Affordable Prices
By Maria Fabiana Jorge
Access to affordable drugs is a top policy priority for the United States with real bipartisan support but it increasingly seems to be an unreachable goal, in part, due to conflicting government policies. While the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted the importance of competition to ensure lower drug prices, U.S. trade policy in general, and the Special 301 Annual Review in particular, do exactly the opposite: broaden and lengthen the monopolies granted to pharmaceutical companies thus delaying or deterring the launch of generic and biosimilar drugs and with that, the chances of lowering drug prices. The pharmaceutical industry has changed a great deal in the past 30 years, among other things by developing complex biotechnology drugs that while critical for the treatment of illnesses such as cancer, are out of reach for many patients. While some parts of the government are trying to increase access to medicines through competition provided by generic and biosimilar drugs, their efforts are being undermined by a trade policy that was defined 30 years ago. It is time to adjust U.S. trade policy to the realities of 2020 and stop acting as if it was still 1989.