A blog post by Alexis Francis, Junior Associate.
In January of 2020, the World Health Organization (WHO) first classified COVID-19 as a “public health emergency of international concern” and later a “pandemic.”[1] It was then that most governments became aware of how the virus posed a serious and potentially fatal threat to human health.[2] As a result, many scientists reacted swiftly to develop vaccines at an unprecedented rate.[3] The scientists and developers of these vaccines have sought out and been granted patents for their inventions, which grant them a limited monopoly in the marketplace to help recover the costs of research and development.[4]
In late 2020, a group of Low and Middle Income Countries (LMICs), led by India and South Africa, submitted a proposal to the World Trade Organization (WTO) on May 25, 2021 to temporarily waive the patent rights associated with COVID-19 vaccines.[5] This waiver would allow generic pharmaceutical companies to access the inventions before the patents expire.[6] The request proposes a three-year waiver of IP protection for products and technologies related to COVID-19 prevention, treatment, and containment.[7] Obtaining an IP waiver entails submitting a request to the Trade- Related Intellectual Property Rights Agreement (TRIPS) Council, an international forum, which will recommend it to the WTO’s General Council if it merits approval.[8] For full approval, the waiver needs the support of all member states; however, it can be adopted with three-fourths support to apply only to affirming nations.[9]
Although the TRIPS Agreement permits member states to license patents during a national emergency, like COVID, doing so is not always warranted or agreed upon.[10] There are still unanswered questions involving the scope of the waiver, the licensing technicalities, imports, and compensation to the vaccine patent holders that warrant discussion.[11]
Ultimately, issuing a waiver on international COVID-19 vaccine patents raises an important question of how we can balance intellectual property rights with serving the general public and what considerations should be given to the critical legal issues involved.
[1] Novel Coronavirus (2019-nCoV) Situation Report 1, World Health Organization [WHO] (Jan. 21, 2020), https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200121-sitrep-1-2019-ncov.pdf.
[2] Id.
[3] Anshu Siripurapu, The Debate Over a Patent Waiver for COVID-19 Vaccines: What to Know, Council on Foreign Relations (May 26, 2021), https://www.cfr.org/in-brief/debate-over-patent-waiver-covid-19-vaccines-what-know [hereinafter Siripurapu]
[4] Mario Gaviris & Burcu Kilic, A network analysis of COVID-19 mRNA vaccine patents, Volume. 39 Nature Biotechnology 548 (May 12, 2021), https://www.nature.com/articles/s41587-021-00912-9.pdf.
[5] Harvey Rubin and Nicholas Saidel, Innovation beyond patent waivers: Achieving global vaccination goals through public-private partnerships (Brookings Institute, Working Paper 2016), https://www.brookings.edu/blog/up-front/2021/08/31/innovation-beyond-patent-waivers-achieving-global-vaccination-goals-through-public-private-partnerships/ [hereinafter Rubin & Saidel].
[6] Id.
[7] Panel Report, Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment, and Treatment of COVID-19, WTO Doc. IP/C.W/669/Rev.1 (May 25, 2021) https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True [hereinafter Panel Report].
[8] Robert Clarke, R. Lee Fraley P.C., Jeffrey Morton, Ph.D. P.C., Home of the Free, Land of the Waive? Patent Waivers in the Time of Covid-19, (2021), https://www.jdsupra.com/legalnews/home-of-the-free-land-of-the-waive-9865563/ (last visited Feb 17, 2022).
[9] Id.
[10] Christoph J. Crutzen & Maximillian Kucking, The Waiver of Patent Protection for COVID-19 Vaccines — On Practicability and Purpose of Such Measure, Mayer Brown (July 7, 2021) https://www.mayerbrown.com/en/perspectives-events/publications/2021/07/ger-the-waiver-of-patent-protection.
[11] Id.