BioNTech Initiates Patent Lawsuit Against Moderna Over COVID Vaccine

German biopharmaceutical company BioNTech has filed a lawsuit against Moderna in a federal court in Delaware, alleging that Moderna’s COVID-19 vaccine, mNEXSPIKE, infringes on a patent associated with BioNTech’s competing vaccine, Comirnaty. This legal action was taken on Thursday and highlights ongoing tensions between the two companies regarding their respective vaccine technologies.

According to the lawsuit, mNEXSPIKE, which received approval from the U.S. Food and Drug Administration in 2025, violates BioNTech’s intellectual property rights related to a streamlined messenger RNA-based vaccine design. BioNTech claims that their technology allows for the administration of a lower dosage to patients, which they argue is a significant advantage.

This lawsuit follows a counteraction by Moderna, which filed a similar patent infringement case against BioNTech and its partner, Pfizer, in 2022. That case is still ongoing, reflecting a broader trend of patent disputes among biotechnology firms seeking royalties from the successful vaccines that emerged during the pandemic.

Moderna has publicly stated that it intends to vigorously defend itself against BioNTech’s claims. A representative from the company emphasized their commitment to contesting the lawsuit. Meanwhile, BioNTech did not immediately provide a comment regarding the ongoing legal proceedings. Pfizer, not directly implicated in this latest lawsuit, also refrained from making a statement.

The lawsuit further notes that mNEXSPIKE is projected to generate approximately 55% of Moderna’s COVID vaccine revenue through the 2025-26 respiratory virus season. This forecast comes at a time when revenues from COVID vaccines have significantly declined compared to the peak of the pandemic when both Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty generated billions in revenue.

The decline in vaccine sales has been exacerbated by various factors, including public skepticism towards vaccines. Notably, the appointment of vaccine skeptic Robert F. Kennedy Jr. as health secretary under former President Donald Trump has been cited as a contributing factor to the downturn in vaccine uptake.

As both companies navigate this legal landscape, the outcomes of these lawsuits could have significant implications for the future of mRNA technology and the competitive dynamics of the COVID-19 vaccine market. The ongoing legal battles underscore the complex interplay between innovation, intellectual property rights, and public health in the biopharmaceutical industry.