As part of a global web of patent litigation over COVID-19 vaccines and mRNA technology, Pfizer and its partner BioNTech traded blows this week with rival Moderna as dueling decisions came down in the U.S. and Germany.
On Wednesday, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) ruled that all challenged claims on two of Moderna's COVID-19 vaccine patents are "unpatentable." The news came in the form of two docket updates on the PTAB's website, and the decisions are sealed.
For Moderna, the PTAB decisions likely mark a surprise defeat given that the company had sued Pfizer and BioNTech in federal court in Massachusetts for alleged infringement of three patents in 2022, including the two recently invalidated by the PTAB.
In its 2022 lawsuit, Moderna argued it was the first to discover that "using mRNA encoding for a full-length coronavirus spike protein in a lipid nanoparticle formulation was highly effective at producing neutralizing antibodies." The company's "’600 and ’127 patents" covered that work, according to the lawsuit.
While Pfizer and BioNTech defended their position that Moderna's patents are invalid in that court case, the companies separately went to the PTAB to get its opinion on the two patents. Now, they've prevailed in that effort.
"Pfizer and BioNTech believe in the value and strength of our innovative science and our own intellectual property and are therefore pleased that the decision confirms this stance," a BioNTech spokesperson told Fierce Pharma.
Moderna could choose to appeal the decision to the U.S. Court of Appeals for the Federal Circuit, Reuters noted.
Modern "respectfully disagrees" with the PTAB decision and is "evaluating its options to appeal," a company spokesperson said. The decision doesn't affect the company's '574 patent, which is included in the Massachusetts lawsuit.
"We continue to believe in the strength and validity of our intellectual property and look forward to presenting our case at trial at the appropriate time," Moderna's spokesperson added.
It wasn't all positive for Pfizer and BioNTech on the patent front this week, though. In Germany, the Düsseldorf Regional Court ruled for Moderna in a case that also dates back to 2022.
The court ruled that Pfizer and BioNTech violated one of Moderna's European patents and should pay "appropriate compensation," according to the AFP news wire. Moderna is "pleased" with that decision, the company's spokesperson said.
"Today's decision has no immediate impact on Pfizer, BioNTech or Comirnaty," BioNTech's spokesperson added. "We continue to believe that EP949 is invalid, and therefore not infringed, and will appeal the Düsseldorf District Court’s decision on this patent."
Throughout the pandemic, Pfizer, BioNTech and Moderna racked up tens of billions of dollars selling their COVID-19 vaccines. It wasn't until partway through the pandemic that the patent lawsuits started to fly, with the companies filing claims against one another—and other smaller players also getting into the mix.
In the U.S. alone, there are more than a dozen pending COVID-19 vaccine patent lawsuits, according to a roundup from Big Molecule Watch. The litigation spans far beyond the U.S., with COVID-19 vaccine patent suits also reaching courts in the U.K., Europe, Canada, Switzerland and Japan.
Given the lucrative nature of the COVID-19 vaccines, the patent litigation could come with serious financial repercussions for any losing party.