The US company filed the lawsuits on Friday, August 26, in US and German courts.
The company attests that Pfizer and BioNTech's COVID-19 vaccine, Comirnaty, infringes patents Moderna filed between 2010 and 2016 covering its mRNA technology.
"We believe that Pfizer and BioNTech unlawfully copied Moderna's inventions, and they have continued to use them without permission," said Moderna’s chief legal officer, Shannon Thyme Klinger.
The developer alleges that Pfizer and BioNTech copied two key features of Moderna's patented technologies that it said are critical to the success of mRNA vaccines.
Moderna claims that when COVID-19 emerged, neither Pfizer nor BioNTech had its level of experience with developing mRNA vaccines for infectious diseases, and 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. Moderna scientists began developing this chemical modification that avoids provoking an undesirable immune response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015.”
Moderna claims that Pfizer and BioNTech copied its approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. The company said its scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.
BioNTech, in a response to the lawsuit filing, said its work is original, and that it would vigorously defend against all allegations of patent infringement. “BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”
In a statement emailed to us, Pfizer said it and BioNTech have not yet fully reviewed the complaint but both companies, it continued, were surprised by the litigation given that the Pfizer/BioNTech COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer.
Damages sought
Moderna’s statement does not specify the actual damages it is pursuing in terms of the alleged infringement.
It said it is not seeking to remove Comirnaty from the market and is not asking for an injunction to prevent its future sale. In addition, it said it is not looking for damages related to Pfizer's sales to the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), and is not seeking damages for Pfizer's sales where the US government would be responsible for any damages.
Nor is it pursuing damages for activities occurring before March 8, 2022.
Thyme Klinger did outline what Moderna is looking for: "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."
Pending action
BioNTech also faces patent infringement claims from CureVac, and, again, it said it would defend the company against such allegations.
In July this year, CureVac filed a lawsuit in a German regional court against BioNTech SE: seeking ‘fair compensation for infringement… of CureVac’s intellectual property rights’ regarding tech used in the manufacture of the Pfizer/BioNTech COVID-19 vaccine.
CureVac – whose own first-generation mRNA COVID-19 vaccine was withdrawn from regulatory review last year in favor of developing a second-generation candidate – believes its tech played a fundamental part in fellow German mRNA specialist BioNTech’s creation of a vaccine against the virus.
