Moderna Sues Pfizer and BioNTech Over COVID Vaccine

CAMBRIDGE, Mass. — Pharma giant Moderna sued Pfizer and BioNTech on Friday, claiming that their popular COVID vaccine was copied from groundbreaking science Moderna performed.

In a statement posted on its website, Moderna said Pfizer and BioNTech infringed on patents it filed between 2010 and 2016 involving mRNA, a kind of genetic code that directs how cells produce certain proteins.

Like the computer code that makes Windows or any other software work, mRNA is the key to the efficacy of the COVID vaccines.

“When COVID-19 emerged, neither Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for infectious diseases, and they knowingly followed Moderna’s lead in developing their own vaccine,” Moderna claims.

“First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path,” it continues. 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,” it says.

Stéphane Bancel, Moderna’s chief executive, said in a written statement that the company filed its lawsuits against Pfizer and BioNTech in the federal court in Boston and the Regional Court of Düsseldorf in Germany, “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 … enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck,” Bancel said.

In October 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. In March, however, the company updated its position. It said that since the “collective fight against COVID” had “entered a new phase” in which vaccine supply was no longer a barrier to access, it expected companies such as Pfizer and BioNTech to respect its intellectual property rights and reach an agreement on a “commercially reasonable license.” 

Pfizer and BioNTech, Moderna says, have failed to do that.

“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 the ongoing use of Comirnaty®, [one 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,” Klinger added.

The AMC 92 countries to which she is referring are the 92 low- and middle-income economies eligible to get access to COVID-19 vaccines through the Gavi Vaccine Alliance, an independent group founded through a partnership of the World Health Organization, UNICEF, the World Bank and the Bill & Melinda Gates Foundation.

Moderna on Friday said that it was not seeking damages for activities before March 8 and that it was not seeking to remove Pfizer and BioNTech’s vaccines from the market.

It also said that it was not asking for an injunction to prevent its future sale, given the need for access to coronavirus vaccines.

A spokeswoman for Pfizer said Friday morning that the company had not yet been served with the lawsuit and therefore could not comment on it.

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