Moderna is suing fellow vaccine developers Pfizer and its German partner BioNTech for 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.
A Pfizer spokesman said the company cannot comment as it has not yet been served with the lawsuit, which Moderna said it is filing Friday in United States District Court in Massachusetts. The complaint against BioNTech will be filed in the Regional Court of Düsseldorf in Germany.
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Moderna alleges Pfizer and BioNtech copied 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 encode the spike protein in a lipid molecule was copied from a vaccine created to fight Middle East Respiratory Syndrome (MERS) 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 the “collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier.”
The company said it won’t enforce its COVID-19 vaccine patents in low- and middle-income countries, but expects Pfizer, BioNTech and other vaccine makers to respect its intellectual property rights in other markets.
In the 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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The COVID-19 vaccine relies on breakthroughs from scientists at the National Institutes of Health on how to precisely mimic the protein on 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 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 crating, 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.” So far in the U.S., more than 360 million doses of Pfizer-BioNTech’s COVID-19 vaccine have been administered; nearly 230 million doses of Moderna’s vaccine have been administered, according to data from the Centers for Disease Control and Prevention.