Moderna breaks 2020 pledge not to enforce its COVID-19-related patents

By Sophie Gu

Sophie Gu is a second-year student in the School of Engineering and Applied Sciences at the University of Pennsylvania. She plans to double major in bioengineering and cognitive science with a concentration in computation and cognition.
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Moderna’s recent mRNA patent infringement suit against Pfizer and BioNTech may signal a step towards the end of the two and a half year long COVID-19 Public Health Emergency. Despite Biden’s declaration that the “pandemic is over,” the Department of Health and Human Services has continued to renew PHE (Public Health Emergency) since its implementation in January 2020 [1] — it was last renewed this October. Since its first implementation in 2005 in response to Hurricane Katrina, section 319 of the Public Health Service Act has been used to address issues ranging from the Opioid Crisis to Monkeypox [2]. Although the United States is no stranger to PHEs, the COVID-19 Public Health Emergency has been one of the longest and most expensive PHEs to date [3].

In October of 2020, Moderna pledged to waive its COVID-related patents during the pandemic. On its website, Moderna stated that “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic” [4]. This pledge was meant to ensure access to mRNA technology and facilitate COVID-19 vaccine development across the world.​

Moderna has now revoked its pledge, claiming that Pfizer and BioNTech’s COVID-19 vaccine infringes mRNA patents Moderna filed between 2010 and 2016. Pfizer has denied allegations of copying a full-length spike protein in a lipid nanoparticle formulation, claiming its mRNA research began prior to Moderna’s disputed patents [5]. Moderna is now seeking damages and lost profits from its COVID-related patents in “wealthier” countries.

In an effort to continue supporting pandemic relief efforts in low and middle-income countries, Moderna will not enforce the patents in the 92 low to middle low income countries listed in the Gavi COVAX Advance Market Commitment (AMC) [6]. However, this exception is provided that the COVID-19 vaccines will only be for use within those countries. Moderna will additionally not pursue any damages against the U.S. government, which has bought hundreds of millions of doses of the Pfizer-BioNTech vaccine.

By altering its 2020 pledge, Moderna is effectively suggesting that the pandemic is over, says Rochelle C. Dreyfuss, a professor at the New York University School of Law [7]. However, the fact that the US has continued to funnel billions of dollars into COVID-19 vaccine development and remains in a state of Public Health Emergency may complicate the outcome of Moderna's patent infringement lawsuit. Furthermore, decades of compounding mRNA research may also complicate Moderna’s claims to its mRNA patents. Both Moderna and Pfizer additionally utilized mRNA research from other previously filed patents, including an mRNA patent from the University of Pennsylvania in 2005 [8].
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Though Moderna has launched a likely expensive and prolonged legal battle, SVB Securities analysts predict that Moderna’s litigation is unlikely to stall access to COVID-19 vaccines or stunt the development of mRNA innovation [9]. Notably, Moderna does not seek to eliminate Pfizer vaccines from the market, but rather expects its mRNA rivals to "respect its intellectual property rights and would consider a commercially reasonable license” [10]. The outcome of the case could ultimately decide whether Pfizer, BioNTech, or Moderna control the lucrative medical technology that mRNA promises.

Sources

[1] Sullivan, Becky, and Rob Stein. “How Biden’s Declaring the Pandemic ‘over’ Complicates 
Efforts to Fight COVID.” NPR.org, 20 Sept. 2022, 
www.npr.org/sections/health-shots/2022/09/20/1123883468/biden-pandemic-over-compli
cates-fight.

[2]“Federal Emergency Authorities :” MACPAC, 18 Mar. 2021, 
www.macpac.gov/subtopic/federal-emergency-authorities.

[3]“Federal Emergency Authorities :” MACPAC, 18 Mar. 2021, 
www.macpac.gov/subtopic/federal-emergency-authorities. 
[4] Moderna Sues Pfizer and BioNTech for Infringing Patents Central to Moderna’s Innovative 
mRNA Technology Platform.
investors.modernatx.com/news/news-details/2022/Moderna-Sues-Pfizer-and-BioNTech-f
or-Infringing-Patents-Central-to-Modernas-Innovative-mRNA-Technology-Platform/defa
ult.aspx.

[5] Taylor, Chloe. “Pfizer-BioNTech ‘Surprised’ by Moderna Lawsuit Alleging They Copied 
COVID-19 Vaccine Technology.” Fortune, 26 Aug. 2022, 
fortune.com/2022/08/26/pfizer-biontech-surprised-by-moderna-lawsuit-alleging-they-cop
ied-their-covid-19-vaccine-technology.

[6] Gavi COVAX AMC. www.gavi.org/gavi-covax-amc. 
[7] Vitale, Gina. “Moderna Sues Pfizer and BioNTech over COVID-19 Vaccine.” Cen.acs.org, 
https://cen.acs.org/policy/intellectual-property/Moderna-sues-Pfizer-BioNTech-over/100/
web/2022/08#.

[8] “The Tangled History of mRNA Vaccines.” Nature, 22 Oct. 2021, 
www.nature.com/articles/d41586-021-02483-w?error=cookies_not_supported&code=a14
c70c3-91a3-4d37-9ed2-fce90f3adf06.

[9] “Pfizer-BioNTech ‘Surprised’ by Moderna Lawsuit Alleging They Copied COVID-19 
Vaccine Technology.” Fortune, 26 Aug. 2022, 
fortune.com/2022/08/26/pfizer-biontech-surprised-by-moderna-lawsuit-alleging-they-cop
ied-their-covid-19-vaccine-technology.

[10] “Moderna Sues Pfizer and BioNTech for Infringing Patents Central to Moderna's Innovative 
Mrna Technology Platform.” Moderna Sues Pfizer and BioNTech for Infringing Patents 
Central to Moderna's Innovative MRNA Technology Platform, 
https://investors.modernatx.com/news/news-details/2022/Moderna-Sues-Pfizer-and-BioN
Tech-for-Infringing-Patents-Central-to-Modernas-Innovative-mRNA-Technology-Platfor
m/. 
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The opinions and views expressed in this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients.