Moderna Sues Pfizer, BioNTech Over COVID-19 mRNA Vaccine Patents

Moderna, Inc. (NASDAQ:MRNA), one of the biotechnology pioneers in messenger RNA (mRNA) therapeutics and vaccines, earlier today filed a patent infringement lawsuit against both Pfizer and BioNTech in the United States District Court for the District of Massachusetts. Moderna says a similar patent infringement lawsuit was also filed in the Regional Court of Düsseldorf in Germany.

Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringes patents Moderna filed between 2010 and 2016 covering Moderna’s mRNA technology. This technology, Moderna claims, was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax®.

In October 2020, Moderna pledged not to enforce its COVID-19 related patents while the pandemic continued. In March 2022, when the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its pledge. It explained that while it would not 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.

According to the complaint filed in the District of Massachusetts, because of “a decade of foundational research in the area of mRNA medicines” the company was uniquely able to within a matter of weeks “develop a COVID-19 vaccine that was ready to test in clinical trials”. The complaint further reminds the reader that “[w]hile others were predicting that vaccine development could take years, Moderna’s COVID-19 vaccine was first administered by the NIH in clinical trials on March 16, 2020, just two months after the genetic sequence for the virus that causes COVID-19 was published.”

“We are filing 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.”

“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.”

Because the company says it recognizes the need to ensure continued access to these lifesaving vaccines, Moderna is not seeking to remove Comirnaty® from the market and is not asking for an injunction to prevent its future sale. Moderna is also 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 earlier patent pledge, the Company is also not seeking damages for activities occurring before March 8, 2022.

Moderna is represented by Wilmer Cutler Pickering Hale and Dorr. The patents asserted in the complaint filed in the District of Massachusetts are: U.S. Patent Nos. 10,898,574 (the “’574 patent”), 10,702,600 (the “’600 patent”), and 10,933,127 (the “’127 patent”).

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