TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

Patents, access to health and COVID-19 – the role of compulsory and government-use licensing in Ireland

As the race for effective vaccines and treatments for COVID-19 continues, attention must turn to how such health-technologies will be accessed globally once developed. Patents play a significant role in this context because they give the patent-holder the right to stop others using patented inventions. Patents are available on diagnostics, medicines and vaccines and could form significant access obstacles for COVID-19. Moreover, whilst many patent-holders may be willing to license health-technologies reasonably, others may not. Therefore, it is imperative that national governments ensure effective avenues exist to intervene with patent-holder discretion via compulsory licensing. This article focuses on the legal framework applicable in Ireland for such compulsory licensing interventions, interrogating the effectiveness of the current framework in alleviating access issues posed by patents for COVID-19. It demonstrates how the current framework could be reformed to make it more effective in tempering patent-holder control, where needed, whilst remaining in compliance with Ireland’s international obligations.

Proposals for copyright law and education during the COVID-19 pandemic

This article asks whether the catastrophic impact of the COVID-19 pandemic justifies new limitations or interventions in copyright law so that UK educational institutions can continue to serve the needs of their students. It describes the existing copyright landscape and suggests ways in which institutions can rely on exceptions in the Copyright, Designs and Patents Act 1988 (CDPA), including fair dealing and the exemption for lending by educational establishments. It then considers the viability of other solutions. It argues that issues caused by the pandemic would not enliven a public interest defence to copyright infringement (to the extent this still exists in UK law) but may be relevant to remedies. It also argues that compulsory licensing, while permissible under international copyright law, would not be a desirable intervention, but that legislative expansion to the existing exceptions, in order to encourage voluntary collective licensing, has a number of attractions. It concludes by observing that the pandemic highlights issues with the prevailing model for academic publishing and asks whether COVID may encourage universities to embrace in-house and open access publishing more swiftly and for an even greater body of material.

GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

Conditions for Granting Compulsory License for Dependent Invention Use

The paper deals with the institution of compulsory licensing for dependent inventions. Currently, its most important application is in the pharmaceutical industry. In order to launch generic drugs that are dependent inventions pharmaceutical companies have to enter into licensing agreements with the developers of original drugs. The law enforcement practice that began in 2018 in the Russian Federation showed that paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation, which establishes the conditions for granting a compulsory license for the use of a dependent invention, needs to be harmonized and supplemented in order to protect and regulate the balance of private and public interests. To solve this problem, the author analyses the wording of the corresponding legal norm found in international agreements, in particular in the TRIPS Agreement, and in the national legislation of different countries as well as the effectiveness of its application. Based on the results of the study, possible clarifications are given to the conditions for granting a compulsory license for the use of a dependent invention under paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation.

Waiving COVID-19 Vaccine Patents: A Bad Idea and a Dangerous Precedent

The Biden Administration believes that suspending COVID-19 vaccine patents will expedite the swift development of high quality “cheap” versions of existing vaccines and hasten the pandemic’s end. This view is dangerously wrong. Vaccinating the world is essential, but temporarily waiving patent rights for COVID-19 vaccines (also known as “compulsory licensing”) will actually slow their availability to the developing world. While providing no gain, compulsory licensing promises lots of pain. Waiving patent protection discourages cutting-edge research investments, which in turn produce breakthrough treatments not just for COVID-19, but for other diseases, like cancer. Weakening these protections would be anti-patient and counterproductive. The reality is that, in order to save the world, we must all work together as partners. The remarkable speed with which we developed diagnostics, therapeutics, and vaccines to combat COVID-19 points to the need for more collaboration, not less. Patents are a foundational principle upon which that success rests. While the policy of temporarily waiving patents seems fair and humanitarian, the devil is in the details. Such a policy will not result in a single citizen of the developing world getting vaccinated one minute sooner. In fact, the unintended consequences are the reverse. More confusion, lower quality, less transnational cooperation. A triple play of disastrous global proportions.