Pfizer and BioNTech’s COVID-19 vaccine infringed on a patent held by rival Moderna, the High Court in London, England, found in a decision released on July 2.
The Pfizer-BioNTech and Moderna COVID-19 vaccines both utilize messenger ribonucleic acid (mRNA) technology.
Moderna patented mRNA processes that replace the nucleoside uridine with N1-methylpseudouridine, a modified RNA. The patent is titled, “ribonucleic acids containing n1-methyl-pseudouracils and uses thereof.”
The patent “is valid,” the court stated, adding that it was infringed “given that Pfizer/BioNTech conceded that it would be infringed if valid.”
The court rejected arguments made by Pfizer and BioNTech, including the argument that Moderna’s patent was not novel. It said parts of the patent were novel, from a method developed by the University of Pennsylvania.
The District Court of the Hague in 2023 found the patent to be invalid due to lack of novelty versus the method, but the London court said it weighed other evidence and found some factors persuasive that the Hague did not.
Moderna in 2020 said it would not enforce patents related to COVID-19 against rival manufacturers. However, in 2022, it revoked the declaration, meaning Pfizer and BioNTech came into violation of the patent, the high court said in a related decision.
Justice Jonathan Richards wrote in the ruling, that “Even if the pledge was an express waiver of rights, it was validly retracted by the March 2022 statement since Pfizer/BioNTech had not by that date materially changed its position in reliance on the pledge.”
The court also ruled that a second patent held by Moderna was invalid.
Possible Appeals
All three companies said they disagreed with the parts of the court’s decision on which they lost, and it is expected that all parties will seek permission to appeal.
Pfizer and BioNTech said in a statement:
“These proceedings have no bearing on the safety and efficacy profile of our vaccine, as established by regulators worldwide.
“Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine in line with our agreements and established supply schedules.”
A spokesperson for Moderna said the company was pleased the court “recognized the innovation of Moderna scientists by confirming the validity and infringement” of one of its patents.
Pfizer, BioNTech, and Moderna are also involved in parallel proceedings in Germany, the Netherlands, Belgium, and the United States, much of which has been put on hold, as well as at the European Patent Office.
The London ruling comes at a time of financial strain for Moderna, whose shares have plummeted by more than 70 percent since the peak of the pandemic as demand and sales for Spikevax have fallen. Shares of Pfizer, meanwhile, are down about 29 percent since mid-2021.
