Moderna is suing Pfizer and BioNTech, claiming that the companies’ COVID-19 vaccine infringes on Moderna’s patents. The COVID-19 vaccines from Moderna and Pfizer-BioNTech both use messenger RNA (mRNA) and are the only two vaccines approved in the US to do so.
One patent in question has to do with a modification to the mRNA delivered in the vaccine. A big hurdle in creating mRNA medicines was that the immune system would destroy the mRNA before it could act, Moderna describes in the complaint.
Four different units, called nucleosides, make up mRNA. Moderna says it discovered that swapping out one of them, uridine, with 1-methylpseudouridine resulted in better protein production than previous modification attempts and diminished the problematic immune response. Moderna says it patented this research and that Pfizer and BioNTech used the same modification.
Moderna also claims that Pfizer and BioNTech infringed two patents it had filed related to methods of targeting coronaviruses. Moderna says that while working on Middle East Respiratory Syndrome (MERS) in the 2010s, the company discovered that it could make an effective coronavirus vaccine by delivering mRNA encoding a complete spike protein within a lipid nanoparticle. Pfizer and BioNTech also used mRNA encoding the entire spike protein in their vaccine and packaged it in a lipid nanoparticle, despite having considered multiple options for how to design their vaccine, Moderna says.
But neither Moderna nor Pfizer and BioNTech built their vaccine platforms from scratch, notes Robert Cook-Deegan, an Arizona State University professor who also founded the Duke Center for Genome Ethics, Law and Policy. For instance, researchers at the University of Pennsylvania reported swapping a pseudouridine into mRNA to calm the inflammatory response in 2005, and 1-methylpseudouridine is even mentioned in their patent. Moderna and BioNTech both licensed that pseudouridine technology.
Also, none of the companies invented the lipid nanoparticle delivery, Cook-Deegan says. A sprawling web of litigations over lipid nanoparticles is ongoing that includes patent infringement lawsuits against both Pfizer and Moderna by the company Alnylam Pharmaceuticals over the use of lipid nanoparticles in their vaccines.
“Judges and juries generally don’t like people who are trying to pull the wool over their eyes,” Cook-Deegan says. “And Moderna nowhere in this complaint actually acknowledges that it was building on a mountain of other science.”
Another complication is Moderna’s October 2020 pledge not to enforce its COVID-19-related patents against anyone developing vaccines for the pandemic. Now, Moderna is effectively claiming that the pandemic is over, says Rochelle C. Dreyfuss, a professor at the New York University School of Law. However, groups like the World Health Organization have not downgraded COVID-19 from pandemic status, calling into question whether Moderna will continue to be held to the pledge. “I imagine the parties will litigate that seriously,” Jacob S. Sherkow, a law professor at the University of Illinois at Urbana-Champaign, says in an email.
In the suit, Moderna is requesting damages for infringement that took place after March 8, 2022, with exceptions including sales to 92 low- and middle-income countries—and sales for which the US government would be on the hook for damages. It’s not asking for the Pfizer-BioNTech vaccine to be taken off the market.
“Basically, they’re saying . . . as soon as it’s not a super health emergency, they should be paying us money for having based their technology on our technology,” Dreyfuss says. “In that sense, all that Moderna’s asking for is licensing fees.”
It’s hard to say what this lawsuit could mean for RNA technologies going forward. More information will likely come to light as the suit progresses. “This is just the opening gun of . . . what could be a really complicated case,” Cook-Deegan says.