Moderna is today (August 26) filing patent infringement lawsuits against Pfizer and its partner BioNTech in both the U.S and Germany.
The mRNA-focused biotech claims the companies’ Covid-19 vaccine Comirnaty infringes patents it led between 2010 and 2016 covering Moderna’s foundational mRNA technology which the company says was critical to the development of its own vaccine, Spikevax.
Covid vaccine lawsuit: what is it about?
Moderna believes Pfizer and BioNTech copied this technology without its permission to make Comirnaty.
“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 CEO 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.”
Covid vaccine lawsuit: the pledge
In October 2020, Moderna pledged not to enforce its Covid-19 related patents while the pandemic continued.
In March 2022, when the collective fight against the virus entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge.
Moderna said it made clear that while it would never 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), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets.
Moderna said it believes Pfizer and BioNTech have failed to do so.
Without permission
Moderna chief legal officer Shannon Thyme Klinger, said: “We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission.
“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.”
Continued access
Moderna says it recognizes the need to ensure continued access to these lifesaving vaccines and is not seeking to remove Comirnaty from the market and is not asking for an injunction to prevent its future sale.
A spokesperson for Pfizer and BioNTech said: “Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given the Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer.
“We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
Legal analyst
Aron Solomon, chief legal analyst at Esquire Digital, told Labiotech: “This really was inevitable (that one of the vaccine manufacturers would sue another) given the insane revenue numbers we’re looking at since the beginning of the pandemic.
“While claimed damages have, at this point, not been made known to the public, it could be in the tens of billions, if not more, given that Moderna is already PR-spinning that this IP violation is in light of Moderna having spent “billions” in vaccine R&D.”
Moderna says it is not seeking damages related to Pfizer’s sales to AMC 92 countries and is not seeking damages for Pfizer’s sales where the U.S. Government would be responsible for any damages.