Category Access to Medicine

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in the way of market entry, divisionals claiming protection for similar subject-matter as the patent that has just been revoked can crop up, hindering generic/biosimilar medicines from entering the market.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.

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.

TRIPS WAIVER: AN INSUFFICIENT MULTILATERAL RESPONSE. TRIPS-CONSISTENT NATIONAL ACTIONS ARE CALLED FOR

[South Centre] ...The process leading to the Decision confirms the need to fully use the TRIPS flexibilities to address emergency and other situations where public health and other public interests are at stake, and to review the current international IP regime (including article 31bis of the TRIPS Agreement) to accelerate the sharing of technology, including know-how.

Doha Twenty Years On – Has The Promise Been Betrayed?

[Yousuf Vawda and Bonginkosi Shozi] The Doha Declaration’s twentieth anniversary in November 2021 has taken place in the midst of the COVID-19 pandemic. The experience of the past two years has demonstrated that the very factors that necessitated the Declaration—the problems of inequitable access to medicines and other health technologies for the world’s poor—continue to plague us.

Revisiting Canada’s Access to Medicines Regime in Response to COVID-19: A Review of the Legislation and its Underlying Objectives

[Muhammad Zaheer Abbas] Abstract: The current COVID-19 pandemic has highlighted the significance of the export-oriented compulsory licensing mechanism for countries lacking domestic manufacturing capacity. Article 31bis, the first amendment to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), is aimed at giving effect to the WTO General Council Decision 2003, which waived the domestic market requirement of compulsory licensing. In 2005, Canada became the first country to amend its patent laws to provide for Canada’s Access to Medicines Regime (CAMR) as enabling legislation to implement the WTO General Council Decision 2003. Canada clearly described its regime as a humanitarian initiative aimed at helping developing countries that lack sufficient drug and/or vaccine manufacturing capacity of their own and rely upon imports to address their public health problems. The legislation was compromised, however, by the conflicting desire to protect the corporate interests of patent-holding corporations.

Time to Walk Away from the WTO Proposed Text

[Brook Baker] Twenty months ago, India and South Africa proposed a comprehensive but temporary waiver of enforcement of WTO intellectual property monopolies on COVID-19 vaccines, medicines, diagnostics, and other medical supplies that would have triggered a faster, more affordable, and more equitable COVID response. Rather than respond with alacrity and solidarity, the rich countries of the world, acting on behalf of Big Pharma, united with delay, distortion, and disinformation. The result is an illusory, do-nothing text, cobbled together by the WTO Secretariat, that the U.S., European Commission, Germany, Switzerland, and the U.K. are trying to cram down the neck of developing countries already choking on a steady diet of broken promises and immeasurable death, suffering, and economic disruption.

Intellectual Property Framework Responses to Health Emergencies – Options for Africa

[Fernando dos Santos, Caroline B. Ncube, and Marisella Ouma] Abstract: We debate whether intellectual property (IP) protection of medical products and devices required to prevent, treat and contain COVID-19 should be waived, as proposed by South Africa and India, under the World Trade Organization (WTO)’s Agreement on Trade-related aspects of Intellectual Property Rights (TRIPS Agreement). We discuss existing public policy mechanisms under the TRIPS Agreement and how these have been implemented at national level in Africa, and find that these have proven inadequate and that they have been sub-optimally implemented. We then consider the TRIPS Waiver proposal which has been tabled due to the inadequacy of existing mechanisms and outline the EU’s counter proposal which is founded on existing mechanisms.