BioNTech Files Patent Infringement Suit Against Moderna in US Court

BioNTech files lawsuit alleging Moderna's new COVID-19 vaccine infringes its mRNA technology patent, with billions in potential revenue at stake.

In a significant legal escalation within the mRNA vaccine sector, BioNTech SE has initiated a patent infringement lawsuit against its rival, Moderna. The complaint was filed on February 19 at a federal court in Delaware, targeting Moderna's recently approved COVID-19 vaccine, mNEXSPIKE, which received FDA authorization in 2025. The financial stakes of this litigation are substantial.

Core of the Legal Dispute

The legal action centers on proprietary mRNA vaccine architecture. According to court documents cited by Reuters, BioNTech alleges that Moderna's mNEXSPIKE vaccine infringes on a patent protecting a specific technological approach. This method utilizes only selected key regions of the coronavirus spike protein, rather than the complete version. BioNTech contends that this innovation, which it developed in partnership with Pfizer for the Comirnaty vaccine, allows for effective immunization with a lower dosage.

The scale of the alleged infringement is highlighted by BioNTech's court filing. The company estimates that mNEXSPIKE could account for approximately 55% of Moderna's COVID-19 vaccine revenue during the 2025/2026 respiratory season. Moderna has stated its intention to vigorously defend against the claims. BioNTech described the lawsuit as a necessary step to protect its "mRNA-based innovations, which the company has developed and patented."

A History of Reciprocal Legal Challenges

This lawsuit is part of an ongoing series of legal battles between the two biotech leaders. Moderna previously sued BioNTech and Pfizer in 2022 over alleged patent infringement related to the Comirnaty vaccine, a case that remains active. These mutual accusations reflect a broader industry trend of patent disputes, as companies seek to secure licensing fees from the multi-billion dollar pandemic vaccine market.

Upcoming Financial Results and Strategic Focus

Investor attention will turn to BioNTech's upcoming financial report scheduled for March 10, when the company will disclose its fourth-quarter and full-year 2025 results. During the J.P. Morgan Healthcare Conference in January, management outlined key priorities for 2026. These include advancing 15 Phase 3 trials in oncology by year-end and completing seven data readouts from late-stage studies. BioNTech's cash and investment position stood at a robust €17.2 billion as of the end of 2025.

The vaccine market continues to face headwinds, with COVID-19-related revenues having retreated significantly from pandemic-era peaks. For the full year 2025, BioNTech has guided revenue expectations to between €2.6 billion and €2.8 billion. The company does not anticipate generating revenue from its oncology product pipeline in 2026.