Category Access to Medicine

USTR Requests International Trade Commission Study of COVID-19 Diagnostics and Therapeutics

[Mike Palmedo] U.S. Trade Representative Katherine Tai has requested that the International Trade Commission conduct a study on the market dynamics of COVID-19 diagnostics and therapeutics. She is requesting a wide variety of subtopics be included in the report, including "The relationship between patent protection and innovation in the health sector and between patent protection and access to medicine in LICs, LMICs, UMICs, and HICs; "Actions taken by WTO Members to use or attempt to use compulsory licenses for the production, importation, or exportation of pharmaceutical products and the outcomes of those actions, including the effect on product access, innovation, and global health"

WHO Proposed Instrument on Pandemics: the Conceptual Zero Draft Needs Substantial Improvement to Address Global Public Health Needs

[South Centre] We welcome the discussions in the WHO on a new instrument on pandemic prevention, preparedness, response and recovery. While we appreciate the preparation and sharing with WHO members of the Conceptual Zero Draft (hereinafter ‘the Draft’), we note that more work is needed to address the insufficiency of the tools at the disposal of the WHO that became evident with the COVID-19 pandemic.

Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities

[Sébastien Morin, et. al.] Abstract: Biotherapeutics, such as recombinant proteins and monoclonal antibodies, have become mainstays of modern medicine as shown by their increasing number in the WHO Model List of Essential Medicines. However, despite frequently offering clinical advantages over standards of care, they remain largely out of reach for populations in low-income and middle-income countries (LMICs), partly because of high costs. Accordingly, the WHO Model List of Essential Medicines Expert Committee has requested that the Medicines Patent Pool explore intellectual property licensing to address this challenge.

Left on Our Own: COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health

[Melissa Omino and Joanna Kahumbu] The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter “the Declaration”) was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter “TRIPS”) Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus.

India-UK FTA Leaked Draft Reveals Nobody’s Gain Except Big Pharma

[Shirin Syed] The draft of the UK-India Free Trade Agreement (FTA) chapter on intellectual property, leaked on October 31, reveals that there are several TRIPS-plus provisions which will devastate the global supply of generic medicines. The FTA contains harmful IP provision such as diluting the patentability standards, overriding section 3(d) of the Indian Patents Act and eliminating pre-grant opposition. If implemented, these provisions would pose a serious threat to the accessibility and affordability of medicines in India and globally.

The WTO TRIPS Decision on COVID-19 Vaccines: What is Needed to Implement it?

[Carlos M. Correa and Nirmalya Syam] The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.

Switzerland and Mexico’s Communication to the TRIPS Council Is Replete with Disinformation and Their Questions Easily Answered

[Brook Baker] Switzerland and Mexico have recently filed a communication entitled “TRIPS Council discussions on COVID-19 therapeutics and diagnostics: Evidence and questions on intellectual property challenges experienced by Members” at the TRIPS Council. This communication (IP/C/W/693) purportedly provides evidence on the supply and demand landscape of therapeutics and diagnostics, voluntary licensing and the affordability and accessibility of these products, but it does so on a highly misleading basis. Switzerland and Mexico claim, based on their self-selected information, that the international community is not facing a situation where there is an IP-induced lack of manufacturing capacity or affordable access to COVID-19 therapeutics and diagnostics. As a consequence, they argue that no adjustments to the IP system are required and further that the WTO TRIPS Decision, if extended, would have a significant detrimental effect leaving the world ill-equipped to fight the COVID-19 and future pandemics effectively.

IP Reveries: Class 5.1 – Drugs, Secrets, and Innovation: Brooding Over The Basics

[Lokesh Vyas and Swaraj Paul Barooah] ... After a few sessions on conceptual and theoretical ideas around IP, this set of sessions will now take the class on a different not-so-theoretical topic and deliberates upon IP issues that crop up around clinical trial test data, drug innovation, Indian drug regulatory regulation etc. If this is your first time coming across the IP Reveries series, you can see what its about as well as get links to our previous classes in the introductory post here.

Lessons From India’s Implementation of Doha Declaration on TRIPS and Public Health

[Nanditta Batra] Abstract: ... Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions “in all fields of technology”. While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States’ rights to use them.

From Patents to Secrets

[Michael Risch] Abstract: Beginning in 2010, the U.S. Supreme Court limited the type of inventions that were patentable. In the aftermath of these limits, patent plaintiffs began to lose cases—especially software patent cases—in a way they had not before. Commentators predicted that, faced with waning patent protection, inventors would look to trade secrecy to protect their creations. This chapter is the first to empirically test this prediction.

Zooming in on Education: An Empirical Study on Digital Platforms and Copyright in the United Kingdom, Italy, and the Netherlands

[Bernd Justin Jütte, Guido Noto La Diega, Giulia Priora, Guido Salza] Abstract: The COVID-19 pandemic has led to a significant change in the types of teaching infrastructure used in higher education. This article examines how the use of commercial digital platforms for educational purposes impacted on teaching practices. At the same time, it shines a light on the experiences and (legal) perceptions of educators as an essential category of stakeholders within the EU copyright legal framework. Against the background of the outbreak of the COVID-19 pandemic, the study reflects on the process of ‘platformisation’ of education and delves into copyright-related aspects of the online teaching and learning environments.

Rewarding Failure with Patents

[Robin Feldman] Abstract: It is axiomatic that patents promote success. And yet, a contrary notion—that the patent incentive for medicine should be sufficient to compensate for the losses incurred when research fails—is quietly permeating modern court decisions, commentary, and Congressional discussions, coloring debates relating to pricing and regulation of medicine. The conceptualization is moving forward unchallenged, as if failure compensation follows logically from the innovation incentives built into the patent construct. As this article demonstrates, however, the notion is antithetical to patent law, putting modern conceptualizations on a collision course with the history and theory of patents reaching back to this nation’s inception.