The Mainz-based vaccine pioneer BioNTech is intensifying the legal conflict with its US competitor Moderna in a federal court in Delaware.
• BioNTech accuses Moderna of infringing US Patent No. 12,133,899, which protects an optimized, domain-based mRNA structure
• According to the lawsuit, technology enables significantly reduced dosages while maintaining the same immune response and improving stability
• Legal dispute concerns Moderna’s hopeful mNEXSPIKE, which is expected to generate over 50 percent of the US group’s COVID sales in the future
Technology transfer without permission: The core of the “899 patent”
In the lawsuit filed on February 19, 2026, BioNTech accuses its US competitor Moderna of having copied a fundamental innovation in the field of mRNA vaccines. While the original COMIRNATY vaccine was based on the sequence of the complete spike protein, BioNTech’s proprietary process describes a design that uses only specific fragments – so-called domains. According to the filing in the U.S. District Court for the District of Delaware (Case 1:26-cv-00183-UNA), this approach allows for a “streamlined” messenger RNA that can be administered in significantly smaller quantities. In the introduction to the lawsuit, BioNTech emphasizes that it had already developed this alternative at the beginning of the pandemic in parallel to COMIRNATY and successfully tested it clinically.
The legal dispute focuses on Moderna’s drug mNEXSPIKE (also known as mRNA-1283), which was recently approved by the FDA. BioNTech argues that Moderna is aggressively marketing the benefits of this technology – particularly the increased stability at refrigerator temperatures and the reduction of the dose to a fifth of the standard amount – without respecting copyrights. “Key to BioNTech’s patented technology is the philosophy: Less is more,” lead attorney Daniel M. Silver said in court documents. The company is now demanding a declaration of intentional patent infringement as well as appropriate compensation in the form of royalties and damages.
Economic dimension: mNEXSPIKE criticized as a sales driver
The importance of this procedure for Moderna’s balance sheet can hardly be underestimated. In the lawsuit, BioNTech points to projections that mNEXSPIKE will account for approximately 55 percent of Moderna’s COVID vaccine revenue in the 2025-2026 respiratory season. As sales in the sector are under pressure following the end of the pandemic emergency and in view of political changes in the USA, companies are fighting doggedly for the remaining market shares. A Moderna spokesman told Reuters that the company would vigorously defend itself against the allegations. It is not the first confrontation: Moderna had already initiated a lawsuit against BioNTech and its partner Pfizer in 2022, which has not yet been finally decided.
For the entire biotechnology industry, this case sets a precedent for valuing intellectual property in the post-pandemic era. Analysts will be watching closely to see whether the courts grant the pioneers of mRNA technology extensive exclusivity rights for refined mechanisms of action. If BioNTech prevails, Moderna could face billions in repayments, which would further strain the company’s already strained cash position. While Pfizer is not officially a party to this specific process, the outcome will still have a signaling effect for the entire alliance.
Current market reaction: price gains despite legal turbulence
Investors on international trading venues were initially unimpressed by the new escalation level, which indicates that legal uncertainty has already been priced in. BioNTech shares were listed on the NASDAQ yesterday with a gain of 2.29 percent at $110.42, while they fell slightly by 0.11 percent to $110.30 in after-hours trading. In comparison, Moderna shares were significantly more robust and climbed 6.65 percent to $49.70 yesterday, remaining almost unchanged at $49.71 after trading. Experts see the increase in Moderna primarily as a technical recovery after previous sales that were triggered by the appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services. Market participants currently seem to rate the long-term effects of the patent lawsuit as secondary to the general mood in the biotech sector. Nevertheless, a tightening of the tone between Mainz and Cambridge (Massachusetts) could increase the volatility of the papers in the coming weeks as soon as the first hearing dates in Delaware are set.
Editorial team finanzen.net
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