BioNTech Sues Moderna for Infringing Patent on Spike Protein Vaccine Design
BioNTech has filed a patent infringement lawsuit against Moderna, alleging its mNEXSPIKE vaccine infringes U.S. Patent No. 12,133,899 covering domain-based SARS-CoV-2 spike protein design. BioNTech highlights Moderna’s $1.168 billion COVID-19 vaccine sales through Q3 2025 and projects mNEXSPIKE will account for 55% of sales in the 2025–2026 season.
1. BioNTech Files Patent Infringement Lawsuit
BioNTech has initiated legal action against Moderna, alleging its mNEXSPIKE COVID-19 vaccine relies on proprietary domain-based spike protein technology protected under U.S. Patent No. 12,133,899.
2. Patent Scope and Allegations
The patent covers selective domains of the SARS-CoV-2 spike protein to elicit strong immune response at lower doses and improve storage stability, which BioNTech claims Moderna replicated without a license.
3. Financial Implications
Moderna generated $1.168 billion in COVID-19 vaccine revenue through Q3 2025, with mNEXSPIKE expected to represent 55% of COVID vaccine sales in the 2025–2026 respiratory season, prompting BioNTech to seek monetary damages and potential royalties.
4. Context of Previous Legal Disputes
This lawsuit follows a series of patent battles between Moderna, BioNTech and Pfizer, including Moderna’s 2022 suits and decisions by European and London courts on related mRNA technology patents.