Moderna Inc. sued Pfizer Inc. and BioNTech SE, claiming the technology in their COVID-19 shot infringes on its patents, a move that sets the stage for a massive legal clash between the vaccine titans.

Moderna accused Pfizer and BioNTech of violating intellectual property rights on key elements of its messenger RNA technology in developing the Comirnaty vaccine. Cambridge, Massachusetts-based Moderna said it had patents from 2010 to 2016 on the mRNA technology that made its Spikevax shot possible but that the other two companies copied the technology without permission.

Pfizer and BioNTech “took four different candidates into clinical testing, including options that would have steered clear of Moderna’s innovative path by using unmodified mRNA,” according a lawsuit filed Friday in the U.S. District Court in Massachusetts. “Ultimately, however, Pfizer and BioNTech discarded those alternatives and copied Moderna’s patented technology.”

Moderna said it’s also filing suit in Germany. That complaint couldn’t immediately be verified. Pfizer and BioNTech haven’t fully reviewed the U.S. complaint but are “surprised” by the litigation and will “vigorously defend” themselves, according to an emailed statement.

Pfizer shares fell 1.1 per cent at 10:31 a.m. in New York, while BioNTech’s American depositary receipts fell 2.3 per cent. Moderna shares lost 1.7 per cent.

What Bloomberg Intelligence Says: 

Moderna’s lawsuit against Pfizer-BioNTech is unsurprising, given the broad U.S. patents directed toward its mRNA technology, though they may be vulnerable to invalidity under the current case-law trends on written description and enablement... Pfizer-BioNTech could be liable for at least mid-single-digit royalties on past and future Covid vaccine sales if Moderna is successful. 

-Bloomberg Intelligence analysts John Murphy and Sam Fazeli

Moderna said it’s not asking the courts to pull the Pfizer-BioNTech Covid vaccine from the market nor to block future sales. The company is seeking damages for the period starting March 8 of this year and says it will not seek damages for Pfizer’s sales to 92 lower- and middle-income countries. 

Early in the COVID crisis, Moderna promised not to enforce its intellectual property rights during the pandemic, but on March 7 it modified that pledge to apply only to lower-income countries, essentially making this litigation possible.

“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,” Moderna Chief Executive Officer Stephane Bancel said in a statement.

Pfizer and BioNTech made “the exact same chemical modification to their mRNA that Moderna scientists first developed years earlier, and which the company patented and uses in Spikevax,” the suit said. In addition, “the Pfizer and BioNTech vaccine encoded for the exact same type of coronavirus protein (i.e., the full-length spike protein), which is the coronavirus vaccine design that Moderna had pioneered based off its earlier work on coronaviruses and which the company patented and uses in Spikevax.”

The mRNA vaccines have played a crucial role in the pandemic response, particularly in the US. Pfizer last year recorded almost $37 billion in sales from Comirnaty, while Moderna posted roughly $18 billion of revenue from Spikevax. 

PATENT PLEDGE

Moderna’s original pledge not to enforce its patent during the pandemic gives Pfizer and BioNTech a solid defense, since it hasn’t officially ended, said Jorge Contreras, a law professor at the University of Utah and an expert on patent pledges. Public promises are viewed as binding commitments under the law, he said, and the tweaking of the pledge that Moderna did earlier this year doesn’t negate the original one, he said. 

“This was a public, formal statement from a public company through a press release, so it’s reasonable for other companies to rely on it,” Contreras said. 

It’s possible Moderna is using the lawsuit to prod Pfizer and BioNTech into licensing Moderna’s technology, a “classic way” to pressure companies into making such agreements, he said.

Intellectual property battles over technology used in both the Moderna and Pfizer-BioNTech vaccines are proliferating. Alnylam Pharmaceuticals Inc. earlier this year sued Moderna, Pfizer and BioNTech over the lipid nanoparticle technology used in both of their Covid vaccines. Moderna has sparred with the National Institutes of Health over whether to list the agency’s scientists as inventors on patents for Moderna’s Covid vaccine. 

The case is Moderna v. Pfizer, 22-cv-11378, US District Court, District of Massachusetts.