Vying for Vaccines: Moderna’s Patent Battle for mRNA Technology

By Shahana Banerjee

Shahana Banerjee is a sophomore in the College of Arts of Sciences at the University of Pennsylvania studying Health and Societies. 

​After two grueling years of the COVID-19 pandemic, Moderna, Inc. announced on August 26th, 2022, that the pharmaceutical giant would be suing its rival drugmakers Pfizer and BioNTech. The lawsuit filed by the company in the U.S. and Germany alleges that the latter two companies used Moderna’s patented mRNA technology to develop their joint COVID-19 vaccine Comirnaty®, infringing patents that Moderna had filed between 2010 and 2016. 

The allegations came as a shock to most, since Moderna had pledged in October 2020 that it would not enforce its COVID-19-related patents for the duration of the pandemic. [1] However, through this commitment to global health, Moderna had essentially placed themselves in a position to decide when the pandemic had ended. This implication was emphasized by its Complaint, which claimed: “By early 2022… the collective fight against COVID-19 had entered a new endemic phase and vaccine supply was no longer a barrier to access in many parts of the world, including the United States.” [2]

Moderna CEO Stéphane Bancel stated that the company aims to “protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the COVID-19 pandemic.” [3] He emphasized that Moderna had begun working on its foundational mRNA technology in 2010, allowing it to develop the coronavirus vaccine Spikevax®. According to Bancel: “Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation.” [4] 

However, according to New York patent attorney Josh Mertzlufft, “Pfizer may try and claim some sort of immunity based on a principle of sovereign immunity and the fact they were instructed by the government, they were supported and endorsed by the US government in the development of this vaccine… that may add an interesting wrinkle to this case that would not normally be seen in a patent infringement case.” [5]

The lawsuit may wind up in a simplified inter partes review, a trial proceeding conducted by the U.S. Patent Trial and Appeal Board. Otherwise, similar to other patent suits, it could escalate into a billion-dollar invention battle. Moderna v. Pfizer could set the stage for lawsuits in other areas that mRNA may tackle in the future. The outcome of this legal battle could dictate whether Moderna holds preeminence in mRNA technology and even the healthcare industry going forward. Pharmaceutical law and policy experts have recognized that Moderna’s primary mission is to establish dominance in the field of vaccines, which dictates the profits they make off of their innovations. In the future, competing drugmakers may have to rethink whether they could proceed into the mRNA field due to the potential cost of development.

Moderna v. Pfizer set the stage for what could become one of the most expensive and highlighted legal battles between companies whose technologies have saved millions of lives and have set a foundation for future innovations stemming from mRNA technology. Regardless of the outcome, Moderna’s litigation is very unlikely to hinder global progress in the field of medicine, and in the future, the company hopes to extend the scope of mRNA technology beyond COVID-19 vaccines. [6] 
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References
[1] Wroth, Carmel, and Joe Palca. “Moderna Sues Pfizer over Covid-19 Vaccine Patents.” NPR. NPR, August 26, 2022. https://www.npr.org/sections/health-shots/2022/08/26/1119608060/moderna-sues-pfizer-over-covid-19-vaccine-patents. 
[2] Woessner, Warren. “Moderna to Pfizer: ‘The Pandemic Is over.’” The National Law Review, September 6, 2022. https://www.natlawreview.com/article/moderna-to-pfizer-pandemic-over. 
[3] Becker, Zoey. “Clash of the Titans: Moderna Sues Pfizer, BioNTech for Mrna Patent Infringement.” Fierce Pharma, August 26, 2022. https://www.fiercepharma.com/pharma/clash-titans-moderna-sues-pfizer-and-biontech-patent-infringement. 
[4] “Scientists Question Moderna Invention Claim in Covid-19 Vaccine Dispute.” accessed September 8, 2022, https://www.science.org/content/article/scientists-question-moderna-invention-claim-covid-19-vaccine-dispute.
[5] “WNY Patent Attorney Says Moderna Lawsuit May Have Big Implications.” WNY Patent Attorney: Moderna Suit May Have Big Implications, August 29, 2022. https://spectrumlocalnews.com/nys/central-ny/politics/2022/08/29/wny-patent-attorney-says-moderna-lawsuit-may-have-big-implications. 
[6] Robbins, Rebecca, and Jenny Gross. “Moderna Sues Pfizer and BioNTech over Covid Vaccine Technology.” The New York Times. The New York Times, August 26, 2022. https://www.nytimes.com/2022/08/26/business/moderna-covid-vaccine-lawsuit.html. 
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.