Pfizer and BioNTech will have to answer in court to legal claims by Moderna that they copied its innovative messenger RNA (mRNA) technology in the making of their COVID-19 biologic, Comirnaty. The patent infringement lawsuit filed in U.S. District Court for the District of Massachusetts and the Regional Court of Dusseldorf in Germany alleges that Moderna filed patents from 2010-2016 for its mRNA technology, which the company ultimately used to create the COVID biologic, Spikevax, and that that Moderna’s technology was unlawfully copied by Pfizer and BioNTech.1
The lawsuit demands that Moderna be financially compensated for the allegedly stolen technology but does not ask that their competitor’s vaccine be removed from the market. Moderna contends that Pfizer and BioNTech stole two critical pieces of technology from Moderna and used it to produce Comirnaty. They allege that Pfizer and BioNTech copied Moderna’s mRNA chemical modifications that “encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus.”2
Moderna states that it developed this technology when Moderna researchers first worked on developing a biologic for Middle East Respiratory Syndrome (MERS) in 2015 and 2016, long before the SARS-CoV-2 virus appeared in 2020.3
Moderna Announced in 2020 That It Would Not Enforce Its mRNA Technology Patent Rights
Moderna has only been operating for a decade-old, but it has been a leader in mRNA technology. BioNTech had also been actively developing biologics using mRNA technology prior to partnering with Pfizer to fast track the development of Comirnaty in response to the declaration of a global coronavirus pandemic by the World Health Organization (WHO) in early 2020. In December 2020, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to the Pfizer/BioNTech team and then to Moderna a week later to distribute the experimental COVID shots.4
Initially, Moderna announced that it would not enforce its mRNA technology patent rights in order to assist other drug companies with the development of COVID vaccines that could curtail the pandemic. However, in March 2022 the Massachusetts-based company declared that they would be enforcing their intellectual property rights after all. The Moderna lawsuit does not seek damages for Pfizer sales activity prior to Mar. 8, 2022 or for sales made to 92 lower and middle-income countries.5
Moderna’s CEO, Stéphane Bancel, said:
We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic… This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective Covid-19 vaccine in record time after the pandemic struck.6
Pfizer Will “Vigorously” Defend Against the Allegations
Pfizer and BioNTech deny all patent infringement claims by Moderna.7 Jorge Contreras, law professor at the University of Utah and expert on patents, believes that Moderna’s original announcement that it would not enforce its patent was a binding commitment and may protect Pfizer and BioNTech from liability. Moderna’s March announcement that it was rescinding part of its offer to share their patented technology did not overrule its initial pledge. Contreras said:
This was a public, formal statement from a public company through a press release, so it’s reasonable for other companies to rely on it.8
Moderna’s lawsuit is not the only lawsuit contending that Pfizer and BioNTech infringed on other company patents when developing Comirnaty. CureVac of Germany has also sued BioNTech for patent infringement.9
Pfizer claims it was surprised by the lawsuit and contends it will “vigorously defend against the allegations.”10
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1 Burke M. Moderna sues Pfizer and BioNTech alleging patent infringement over Covid vaccine. NBC News Aug. 20, 2022.
3 Press Release. Moderna Sues Pfizer And BioNtech For Infringing Patents Central To Moderna’s Innovative mRNA Technology Platform. Moderna Aug. 26, 2022.
4 Press Release. Moderna Sues Pfizer And BioNtech For Infringing Patents Central To Moderna’s Innovative mRNA Technology Platform. Moderna Aug. 26, 2022.
5 Reuters. Moderna sues Pfizer and BioNTech for patent infringement over Covid vaccines. CNBC Aug. 26, 2022.
6 Burke M. Moderna sues Pfizer and BioNTech alleging patent infringement over Covid vaccine. NBC News Aug. 20, 2022.
8 Langreth R, Peebles A. Moderna sues Pfizer, BioNTech over COVID vaccine technology. Seattle Times Aug. 26, 2022.
9 Burke M. Moderna sues Pfizer and BioNTech alleging patent infringement over Covid vaccine. NBC News Aug. 20, 2022.
10 Halpert M. Moderna Sues Pfizer And BioNTech Over Covid-19 Vaccine. Forbes Aug. 26, 2022.