Biotechnology company Moderna has filed a patent infringement lawsuit against Pfizer and BioNTech in relation to the use of its messenger RNA (mRNA) technology and Pfizer and BioNTech’s Covid-19 Comirnaty vaccine.
The lawsuits, which were made in the United States and Germany, state that Pfizer and BioNTech’s Covid-19 vaccine Comirnaty infringes Moderna’s patents for its mRNA technology filed between 2010 and 2016. Moderna alleges that Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty.
In particular, Moderna believes Pfizer and BioNTech copied two featured of its mRNA technologies. First, Moderna says when developing clinical candidates for Covid-19, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of its own approach to vaccine development. However, Pfizer and BioNTech decided to proceed with a vaccine that has the same mRNA chemical modification to Moderna’s own Spikevax Covid-19 vaccine.
Moderna first started developing this chemical modification in 2010 and validated it in human trials in 2015.
Moderna also alleges Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna says it developed this approach when creating a vaccine for Middle East Respiratory Syndrome (MERS) years before Covid-19 first emerged.
The patent infringement lawsuits don’t relate to any intellectual property generated during Moderna’s collaboration with the National Institutes of Health to combat Covid-19. They are related to the earlier cases of Moderna’s patented technologies which were clinically tested in 2015 and 2016.
To ensure equitable access for its Covid-19 vaccine, in October 2020, Moderna pledged not to enforce its Covid-19 related patents while the pandemic continued. The company updated its stance in March 2022 when supply was less of a barrier in parts of the world. The company stated that it wouldn’t enforce its patents for any Covid-19 vaccine used in the 92 low-and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92). However, it expected other companies to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Something it alleges Pfizer and BioNTech have failed to do.
Official comments
“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,” said Moderna Chief Executive Officer Stéphane Bancel. “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. As we work to combat health challenges moving forward, Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer.”
“We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission,” said Moderna Chief Legal Officer Shannon Thyme Klinger. “Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies. 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.”
Moderna is not looking to remove Comirnaty from the market or to prevent future sales. The company is also not seeking damages related to Pfizer’s sales to AMC 92 countries and is not seeking damages for Pfizer’s sales where the US Government would be responsible for any damages. The company is also not seeking damages for activities occurring before March 8, 2022.
