KEY POINTS
- BioNTech filed a federal lawsuit in Delaware against Moderna, claiming its rival’s next-generation COVID-19 vaccine, mNEXSPIKE, infringes on proprietary mRNA technology.
- The dispute centers on a specific patent for a streamlined vaccine design that enables effective immune responses at lower dosages.
- This legal action marks a significant “counter-strike” in a multiyear patent war, as Moderna previously sued BioNTech and Pfizer in 2022 over their original vaccine.
German biotechnology firm BioNTech has officially taken legal action against its American competitor Moderna, filing a patent infringement lawsuit in the United States District Court for the District of Delaware. The lawsuit alleges that Moderna’s recently approved COVID-19 vaccine, known as mNEXSPIKE, utilizes BioNTech’s proprietary innovations without authorization. This development represents a major escalation in the ongoing intellectual property battles between the primary architects of the world’s most successful messenger RNA vaccines.
At the heart of the complaint is U.S. Patent No. 12,133,899. BioNTech asserts that its researchers developed a specific, streamlined mRNA design that allows for a more efficient manufacturing process and, more importantly, a lower clinical dosage for patients. BioNTech claims this technology was a foundational element of Comirnaty, the vaccine it co-developed with Pfizer. According to the filing, Moderna’s mNEXSPIKE—which received FDA approval in 2025—infringes on these rights as it seeks to capture a larger share of the evolving respiratory virus market.
The financial stakes of this litigation are substantial. BioNTech’s legal team pointed out that mNEXSPIKE has quickly become a cornerstone of Moderna’s commercial strategy. The lawsuit notes that the newer shot accounted for approximately 55 percent of Moderna’s COVID-19 vaccine revenue during the 2025–2026 respiratory season. By targeting this specific product, BioNTech is challenging Moderna’s primary growth driver in a post-pandemic economy where vaccine demand has stabilized at much lower levels than in previous years.
This move is widely seen by industry analysts as a retaliatory step in a long-running legal saga. In 2022, Moderna initiated its own massive patent infringement campaign against BioNTech and Pfizer, alleging they had copied Moderna’s foundational mRNA chemical modifications. While those cases are still winding through various international courts—with mixed results in Germany and the United Kingdom—BioNTech is now asserting its own intellectual property rights to level the playing field.
The broader pharmaceutical industry is closely watching these cases, as they will likely define the boundaries of mRNA intellectual property for decades to come. Beyond COVID-19, both companies are using their respective platforms to develop treatments for cancer, influenza, and shingles. A definitive ruling on these patents could dictate which company holds the keys to the future of genetic medicine. For now, Moderna has stated it intends to vigorously defend itself against BioNTech’s claims, maintaining that its own research is original and independent.
Despite the intense courtroom conflict, neither company has sought an injunction that would pull vaccines off the market. Both organizations have acknowledged the continued importance of vaccine access for public health. Instead, the focus remains on securing future royalty payments and establishing dominance over the underlying technology. As the case moves forward in Delaware, it adds yet another layer of complexity to a legal landscape already crowded with competing claims from smaller biotech firms seeking a share of the “blockbuster” vaccine profits.
