BioNTech SE (NASDAQ:BNTX) has filed a patent infringement lawsuit against Moderna Inc. (NASDAQ:MRNA), alleging that Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, relies on proprietary technology developed and patented by BioNTech.
Legal Battle Over COVID-19 Vaccine Tech
BioNTech, widely recognized for its partnership with Pfizer Inc. (NYSE:PFE) in delivering the first FDA-approved mRNA COVID-19 vaccine, Comirnaty, claims Moderna is using its patented streamlined vaccine design without authorization.
Thomson Reuters published a copy of the lawsuit online Thursday.
The company asserts that this technology focuses on specific domains of the SARS-CoV-2 spike protein rather than the entire structure — an approach it says produces a strong immune response at lower doses while improving storage stability.
According to the complaint, BioNTech developed this domain-based vaccine concept alongside its pandemic response efforts and secured intellectual property protection through U.S. Patent No. 12,133,899, issued in November 2024.
BioNTech maintains that its research demonstrated that targeting select portions of the spike protein — including the receptor binding domain along with additional structural elements — can mimic the full spike protein's immune presentation.
The approach allows for reduced dosage requirements and improved durability during transport and storage.
The company alleges that Moderna's mNEXSPIKE adopts this same strategy. Moderna has described its product as a "streamlined vaccine design" targeting key parts of the spike protein instead of the full structure — a formulation BioNTech says mirrors its patented invention.
BioNTech argues that Moderna has neither sought licensing rights nor provided compensation for the use of this technology, despite promoting mNEXSPIKE as a major advancement over its earlier SPIKEVAX vaccine.
Financial disclosures cited in the filing indicate Moderna generated $1.168 billion in COVID-19 vaccine sales through the third quarter of 2025, with mNEXSPIKE expected to represent 55% of COVID vaccine sales during the 2025–2026 respiratory season.
BioNTech is seeking monetary damages, claiming Moderna's manufacture, marketing, and sale of mNEXSPIKE constitute deliberate and ongoing infringement of its patented technology.
Earlier Lawsuits
In 2022, Moderna filed patent infringement lawsuits against Pfizer and BioNTech in the U.S. and Germany.
Moderna believed that Pfizer/BioNTech’s COVID-19 vaccine infringes patents filed between 2010 and 2016 covering foundational mRNA technology, critical in creating Moderna’s mRNA COVID-19 vaccine.
In 2023, the European Patent Office's Opposition Division upheld the validity of one of Moderna's crucial patents, boosting the mRNA vaccine maker's efforts to reclaim pandemic profits from its competitors.
In 2024, the London Court's ruling declared one of Moderna's mRNA technology patents invalid but upheld another, confirming that Pfizer and BioNTech's Comirnaty vaccine had infringed on it.
All three companies expressed disagreement with the parts of the decision that went against them and are expected to seek permission to appeal.
Price Action: BNTX stock is down 0.45% at $109.92, and MRNA stock is down 0.82% at $49.29 at the last check on Friday, according to Benzinga Pro data.
Photo: jittawit21/Shutterstock
