Category Access to Medicine

Inequitable COVID-19 Vaccine Distribution and Intellectual Property Rights Prolong the Pandemic

[Emrah Altindis] Introduction: ...Ending this global pandemic seems unlikely with the current patent and technology sharing systems because (i) the number of available vaccine doses is limited by the production capacity of the companies owning the patents, recipes, and technology and (ii) the inequitable distribution of the limited supply of vaccines throughout the world. India and South Africa put forward a proposal at the World Trade Organization (WTO) to temporarily suspend intellectual property rights and gained the support of over two-thirds of the member countries including the USA. However, several wealthy countries still oppose this proposal, including the European Union, which procured 6.9 doses for each inhabitant, as well as the United Kingdom and Canada, which respectively procured 8.2 and 10.1 vaccines doses for each inhabitant.

Competition Law and Intellectual Property: A Study Drawing from The Eli Lilly Case on ‘Sham Litigation’ in Brazil

[Pablo Leurquin] Competition authorities may be the best equipped institutions to penalize certain illicit practices that involve intellectual property rights. This article analyzes the decision by the Brazilian Administrative Council for Economic Defense (Conselho Administrativo de Defesa Econômica – CADE) in the Eli Lilly case, in which the company was convicted for abusive use of the right to petition (sham litigation) with anti-competitive effects. It examines general aspects of technological dependence in the Brazilian pharmaceutical industry, presents the legal premises necessary for the understanding of the decision made by the competition authority, and analyzes the legal grounds for the sanction imposed on Eli Lilly.

The Incentive Argument in Pharmaceutical Patent Law

[Aaron Poynton] Abstract: This working paper critically examines the pharmaceutical industry and the incentive argument in patent law. It begins by framing an overview of the industry and patent law, focusing on U.S. and U.K. law, and multilateral agreements, and efforts by international organizations, such as the World Trade Organization (WTO). Next, the paper considers patent incentive arguments on both sides of the issue to provide a well-researched and more balanced perspective. It then views the longstanding debate through the lenses of contemporary issues related to Covid-19 vaccines and the recent patent waivers considered by many countries. Lastly, this paper provides concluding opinions supporting the argument that intellectual property protection is core to innovation in the pharmaceutical industry, but patent waivers may be a necessary tool in certain situations. It concludes by recommending fixing the TRIPS compulsory licensing provision flaws and carefully finding a TRIPS waiver solution that could strike the desired balance between protecting intellectual property (IP) and providing for the common good.

The Divisional Game: Using Procedural Rights to Impede Generic/Biosimilar Market Entry

[Katarina Foss-Solbrekk] Abstract: Despite being used frequently by practitioners in a wide array of technical fields, divisional patent applications (“divisionals”) seldom attract scholarly attention. The lack of scholarly attention is an error, particularly in the pharmaceutical field. Recent case law in the UK reveals that after generic/biosimilar manufacturers successfully revoke patents standing in the way of market entry, divisionals claiming protection for similar subject-matter as the patent that has just been revoked can crop up, hindering generic/biosimilar medicines from entering the market. Moreover, right before or after proceedings start, rightsholders de-designate countries to avoid a negative judgment that may affect a court elsewhere, meaning generic/biosimilar manufacturers initiated legal proceedings for nothing. Such practices demonstrate that divisionals deserve our attention. This article thus fills the scholarly gap by showing how divisionals are (mis)used in practice, before arguing that patent reform is necessary to prevent this from occurring.

Territorial and Indirect Territorial Coverage ViiV/MPP CAB-LA License

[Brook Baker] The voluntary licensing agreement reached between ViiV and the Medicines Patent Pool for long-acting cabotegravir has received significant media attention, criticism, and protests because of the millions of people excluded from direct or indirect access to in upper-middle-income countries excluded from the license. ... One aspect of the licenses that has not yet received much attention is the precise listing of: (1) the 90 countries included in the licensed territory (including those having public sector access only and a 5% royalty obligation); (2) the 31 countries/territories that can be supplied by ViiV/MPP licensees in the future because of a provision in the license agreement that allows supply to a country if there is no pending or granted patent on CAB-LA in that countries; and (3) the 19 upper-middle-income countries totally excluded supply by a ViiV/MPP license unless a compulsory license is issued in the country of importation or use.

International Copyright Flexibilities for Prevention, Treatment and Containment of COVID-19

[Sean Flynn, Erica Nkrumah and Luca Schirru] Abstract: Most policymaking attention with respect to intellectual property barriers to COVID-19 prevention, treatment and containment has been focused on patents. This focus is reflected in the World Trade Organisation (WTO) Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, which provides a limited waiver of TRIPS rules on compulsory licences for production of COVID-19 vaccines. The original WTO proposal for a TRIPS waiver, however, explicitly applied to all forms of intellectual property, including copyright. This article outlines the numerous ways in which copyright can create barriers to addressing COVID-19. It also provides a description of international copyright treaty provisions that permit uses of copyright materials in response to the barriers identified, despite the exclusion of copyright from the final TRIPS waiver.

TRIPS Waiver and its (Jabby) Journey: Side by Side Comparison of the (Waiver?) Drafts from 2020 – 2022

[Lokesh Vyas] This is a short descriptive post highlighting the vitriolic waiving of TRIPS Waiver - which began with a proposal (by India & South Africa) waiving all the Intellectual Properties (IP) limitedly but ended up with a (pre-decided?) decision giving some leeway on compulsory licensing of patents (that’s it!). In sum, the journey is Intellectual Property Waiver to Compulsory Licensing Leeway.

A Pandemic Treaty for Equitable Global Access to Medical Countermeasures: Seven Recommendations for Sharing Intellectual Property, Know-How and Technology 

[Katrina Perehudoff, Ellen 't Hoen, Kaitlin Mara, Thirukumaran Balasubramaniam, Frederick Abbott, Brook Baker, Pascale Boulet, Mohga Kamal-Yanni, Manuel Martin, Viviana Munoz Tellez, Yannis Natsis, Vicente Ortún-Rubio, Sandeep Rathod, Maties Torrent, Yousuf Vawda, Luis Villarroel, James Love] ... We recommend that a pandemic treaty ensures sufficient financing for biomedical research and development (R&D), creates conditions for licensing government-funded R&D, mandates technology transfer, shares intellectual property, data and knowledge needed for the production and supply of products, and streamlines regulatory standards and procedures to market medical countermeasures. We also recommend that a pandemic treaty ensures greater transparency and inclusive governance of these systems. The aim of these components in a pandemic treaty should be to craft a better collective response to global health threats, consistent with existing international law, political commitments and sound public health practice.

The COVID-19 TRIPS Waiver and the WTO Ministerial Decision

[Peter Yu] Abstract: .. This chapter traces the TRIPS waiver debate from the submission of the original proposal by India and South Africa in October 2020 to the final adoption of the Ministerial Decision on the TRIPS Agreement in June 2022. The chapter further evaluates the strengths and weaknesses of this newly adopted decision, comparing it with the earlier TRIPS waiver proposal. It concludes by offering suggestions for future actions that WTO members on both sides of the waiver debate could take to help combat the COVID-19 pandemic.

TRIPS-Compliant Alternatives for Overcoming Intellectual Property Barriers to COVID-19 Countermeasures

[Brook Baker] In the aftermath of the recent WTO Ministerial Decision on the TRIPS Agreement (adopted June 17, 2022), there may be some confusion about the many options that countries have for overcoming intellectual property barriers to allow alternative production, distribution, and use of COVID-19 countermeasures.  Of course, visibility into the patent landscape for particular products is essential to understanding freedom to operate in terms of products, ingredient, and manufacturing processes, and that work is complicated, though aided by the Medicines Patent Pool MedsPaL  and VaxPaL databases and work done by other researchers on COVID-19 vaccine and therapeutics patents .  Overcoming patent barriers on ingredients will not be a significant barrier if existing, patent-owning/licensed suppliers have adequate supplies and will sell at an affordable price.  If compulsory licenses need to be issued that cover export/import sources of ingredients, the process for gaining freedom to operate becomes that more difficult.

100 Members of Congress Write Biden Administration Urging Compulsory Licenses for Drugs Produced with Taxpayer Funding

[Mike Palmedo] A group of 100 Members of Congress led by Sen. Elizabeth Warren and Rep. Lloyd Doggett has sent a letter to DHHS Secretary Xavier Becerra, asking him to take actions to lower U.S. drug prices. The letter specifically asks him to "utilize administrative authorities, including government patent use compulsory licensing under 28 U.S.C. 1498 and march-in and royalty-free rights under the Bayh-Dole Act." These actions would introduce generic and biosimilar competition for drugs developed with U.S.-taxpayer funding.

WTO Ministerial Decision: ‘TRIPped’ the Waiver

[Shirin Syed] The 12th Ministerial Conference (MC12) concluded on Friday, June 17, 2022, with a “Ministerial Decision on the TRIPS Agreement”, to facilitate exportation of Covid-19 vaccines under the compulsory licence to enhance availability and accessibility for poor countries... The TRIPS Decision no longer remains an IP waiver as proposed originally by India and South Africa and 65 co-sponsors. It lacks the comprehensive measures as in the original proposal to address the concern of production and supply of Covid-19 vaccines to meet global demand, especially from lower-income countries who are deprived of their fair share of vaccines in the current pandemic.