Blake Brittain wrote this article in Reuters:
A tangle of high-stakes U.S. patent disputes over COVID-19 vaccines could be tamed by court rulings or grow even more complex next year.
In the headlining fight, Moderna sued Pfizer and BioNTech in August, accusing them of infringing three patents on mRNA-related innovations Moderna said it developed before the COVID-19 pandemic.
Pfizer and BioNTech responded earlier this month that Moderna had overstated its contributions to the field of mRNA technology. They asked a Massachusetts federal court to declare Moderna's patents in the lawsuit invalid and dismiss the case.
The companies also argued Moderna had waived its right to bring the lawsuit when it pledged not to sue other vaccine makers during the pandemic.
Biopharma company CureVac has also filed a patent lawsuit against BioNTech over mRNA technology in Germany. Pfizer and BioNTech responded with a Massachusetts lawsuit seeking a ruling that they did not infringe CureVac's U.S. patents.
The U.S. lawsuit said CureVac was trying to profit from their vaccine's success after its own COVID-19 shot failed.
In another federal lawsuit in Delaware, Arbutus Biopharma and its joint-venture partner Genevant Sciences accused Moderna's vaccines of infringing patents related to lipid nanoparticles (LNP) used to deliver mRNA into the body. Pfizer's Canadian partner Acuitas Therapeutics, which makes the mRNA-delivery system for the Pfizer shots, filed its own lawsuit in New York federal court to head off potential Arbutus infringement claims.
Alnylam Pharmaceuticals has also sued Moderna, Pfizer and BioNTech in Delaware for allegedly violating its LNP patent rights.
Moderna has responded in those cases that the lawsuits should have been brought against the U.S. government, not the company, thanks to its agreement to supply the shots for the federal government's vaccination effort. A judge rejected an early Moderna motion to end the Arbutus dispute based on the argument in November, though Moderna could still win on that issue later in the case.
LNPs may be important to future mRNA-based vaccines and treatments being developed to fight a myriad of other diseases including cancer, influenza and HIV. More patent lawsuits over the nanoparticles and related mRNA-delivery technology may be around the corner in a field with many players and high financial hopes.
Pfizer earned over $26.4 billion from sales of its vaccines in the first nine months of 2022, while Moderna sold over $13.5 billion worth of its vaccine over the same period, according to company filings with the U.S. Securities and Exchange Commission.
All of the infringement lawsuits are requesting money damages. None of the companies have asked courts to stop production or sales of the allegedly infringing vaccines.
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