Moderna sues Pfizer and BioNTech in U.S. and Germany over patent infringement.  

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Moderna has announced on Friday that it is filing a complaint against Pfizer and BioNTech in both the U.S. and German courts for infringing patents central to Moderna’s innovative mRNA technology platforms Moderna filed between 2010 to 2016. 

The lawsuits are expected to be filed in U.S. District Court for the District of Massachusetts and the Regional Court of Dusseldorf in Germany. Moderna headquarters is in Massachusetts and BioNTech is a German company. 

Moderna alleges that “Moderna's own mRNA COVID-19 vaccine, Spikevax®. Pfizer and BioNTech copied their technology, without Moderna's permission, to make Comirnaty®,” reads their press release. In other words, Moderna is accusing the defendants of theft. 

“We are filling 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." 

In their statement, Moderna alleges that “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. Pfizer and BioNTech have failed to do so.”

"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." 

To make it even more confusing, Moderna claims it is not seeking to remove Comirnaty® from the market and not asking for an injunction to prevent its future sale. And, furthermore, 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”.

“Consistent with Moderna's patent pledge, the Company is also not seeking damages for activities occurring before March 8, 2022. 

Moderna claims that “when COVID-19 emerged, neither Pfizer nor BioNTech had Moderna's level of experience with developing mRNA vaccines for infectious diseases.”

Moderna also alleges that “Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna's innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax®,” reads Moderna’s press release. 

The most curious part of Moderna release is near the end. 

“None of the patent rights which Moderna is seeking to enforce relate to any intellectual property generated during Moderna's collaboration with the National Institutes of Health to combat COVID-19. That collaboration began only after the patented technologies at issue here were proven successful in clinical trials in 2015 and 2016.”

This story is developing. 

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