BioNTech Sues Moderna Over mRNA Technology in Next-Generation COVID Vaccine
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
BioNTech SE filed a patent infringement complaint in Delaware federal court on Thursday against Moderna, Inc., alleging that Moderna's recently approved mNEXSPIKE vaccine utilizes proprietary technology without authorization. The German biotech firm claims Moderna's next-generation COVID-19 vaccine, which received U.S. Food and Drug Administration approval for use in 2025, uses proprietary mRNA technology without permission.
The core of the allegation concerns a specific mRNA innovation that BioNTech contends Moderna is unlawfully employing. The disputed technology involves an advanced messenger RNA vaccine formula that allows for smaller doses to be administered to patients while maintaining effectiveness. This technology is credited with enabling the administration of the vaccine at a lower dosage, a technical advancement for which BioNTech claims ownership. BioNTech developed this innovation alongside partner Pfizer for their Comirnaty vaccine.
This latest filing represents a significant escalation in an ongoing intellectual property dispute. It comes in response to a 2022 suit where Moderna initially sued both BioNTech and its partner Pfizer Inc. over their Comirnaty vaccine. BioNTech is now pursuing this specific action independently, without its U.S. collaborator Pfizer. Pfizer representatives, who are not named as defendants in this particular case, declined to comment.
According to the legal documents, mNEXSPIKE is projected to be a major revenue driver for Moderna during the 2025-2026 respiratory disease season. While overall COVID-19 vaccine sales are softening, they continue to represent a crucial financial foundation for both companies' commercial operations. The legal fight is fundamentally a struggle over the valuable remaining market segments and the future licensing landscape for mRNA platforms.
Moderna has stated it will vigorously defend itself against these new claims. The outcome of such complex patent litigation often takes years to resolve, creating a layer of uncertainty for investors monitoring the sector.
Investors initially showed a muted response to the news. BioNTech shares concluded the week trading at 93.40 euros, largely unaffected by the announcement of the fresh legal confrontation. However, the long-term implications for the companies' intellectual property positions and royalty streams remain uncertain.
These competing lawsuits are part of a broader trend across the biotechnology industry, where companies are pursuing legal claims seeking compensation for intellectual property used in the highly profitable COVID-19 vaccines. This aggressive legal posture underscores the immense pressure within the biotechnology industry to protect foundational technological advantages. As the era of blockbuster pandemic earnings recedes, defending proprietary research has become a critical front in the competition between these leading mRNA developers.