Moderna sues Pfizer and BioNTech for using mRNA technology in their COVID-19 vaccine

Moderna is suing fellow vaccine developers Pfizer and its German partner BioNTech, accusing it of infringing  on patents related to mRNA technology used in their COVID-19 vaccine, the company announced Friday.

The Cambridge, Massachusetts, company claims Pfizer-BioNTech’s vaccine Comirnaty infringes on patents it filed between 2010 and 2016 related to its mRNA technology, according to a Moderna news release.

“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.

The lawsuit against Pfizer was to be filed Friday in the United States District Court in Massachusetts, Moderna said. The complaint against BioNTech will be filed in the Regional Court of Düsseldorf in Germany.

Pfizer spokeswoman Jerica Pitts said the companies have not yet fully reviewed the complaint but were "surprised by the litigation" and plan to "vigorously defend against the allegations of the lawsuit." Their COVID-19 vaccine, she said, was based on BioNTech's proprietary mRNA technology. 

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Moderna accuses Pfizer and BioNTech of copying two key features of the company’s patented technologies, which they say are “critical to the success of mRNA vaccines.”

One of the patented technologies was a chemical modification that helps avoid an undesirable immune response when mRNA is introduced to the body. Scientists in Cambridge began developing the new modification in 2010 and in 2015 were the first to validate it in human trials, according to the news release. 

Moderna also claims Pfizer and BioNTech’s approach to encoding the spike protein in a lipid molecule was copied from a vaccine created to fight Middle East respiratory syndrome years before the COVID-19 pandemic.

The company said Pfizer and BioNTech had four vaccine candidates that didn’t infringe on Moderna’s patents but ultimately decided to go with a vaccine that did. 

In the news release, Moderna said it pledged in October 2020 not to enforce the COVID-19-related patents during the pandemic but in March 2022 determined that the “collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier.”

The company said it wouldn't enforce its COVID-19 vaccine patents in low- and middle-income countries but expected Pfizer, BioNTech and other vaccine makers to respect its intellectual property rights in other markets.

In a COVID-19 vaccine, mRNA spurs cells to make a protein normally found on the surface of the coronavirus. That way, when the immune system sees the actual virus, it will recognize the protein and attack the virus before it can do serious damage.

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COVID-19 vaccines rely on breakthroughs from scientists at the National Institutes of Health on how to precisely mimic the protein of a virus. The two vaccines now available to Americans, by Moderna and Pfizer-BioNTech, both depend on that advancement.

None of the patent rights Moderna is seeking to enforce applies to intellectual property generated during its collaboration with the NIH during the pandemic, the company said.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneers, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” said Moderna Chief Executive Officer Stéphane Bancel.

The new release said, "Moderna is not seeking removal of Comirnaty from market or injunction against future sales."

More than 360 million doses of Pfizer-BioNTech's COVID-19 vaccine have been administered in the U.S., and nearly 230 million doses of Moderna's vaccine have been administered, according to data from the Centers for Disease Control and Prevention. 

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT. 

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