BioNTech Sues Moderna Over mNEXSPIKE COVID-19 Vaccine Patent Infringement

German biopharmaceutical company BioNTech sued Moderna in Delaware federal court on Thursday, alleging that Moderna's COVID-19 vaccine mNEXSPIKE infringes a patent related to BioNTech and Pfizer's competing shot Comirnaty. The lawsuit said that mNEXSPIKE, Moderna's next-generation COVID shot approved by the U.S. Food and Drug Administration in 2025, violates BioNTech's rights in technology for a streamlined messenger RNA-based vaccine design that can be given to patients at a lower dosage.

BioNTech alleged that Moderna's shot infringes US Patent No. 12,133,899, related to a streamlined mRNA vaccine design the German biotech said it developed while creating the Comirnaty Covid-19 shot with its partner. A Moderna spokesperson said that the company would defend itself against BioNTech's case. BioNTech did not immediately respond to a request for comment on the new lawsuit.

The lawsuit represents the latest development in ongoing patent disputes between the two companies. Moderna sued BioNTech and its partner Pfizer for patent infringement over Comirnaty in 2022, in a lawsuit that is ongoing. The cases are among a wave of patent lawsuits from biotech companies seeking royalties for the technology used in the blockbuster vaccines.

mNEXSPIKE is expected to account for 55% of Moderna's COVID vaccine revenue through the 2025-26 respiratory virus season, BioNTech's lawsuit said. COVID vaccine revenues have dropped sharply since the height of the pandemic, when Moderna's Spikevax and Pfizer and BioNTech's Comirnaty earned the companies billions in revenue. Vaccine revenues in general have also slumped following U.S. President Donald Trump's appointment of vaccine skeptic Robert F. Kennedy Jr. as health secretary.

Spokespeople for Pfizer, which is not directly involved in the lawsuit, also did not immediately comment.