A new legal battle has erupted between two of the leading manufacturers of COVID-19 vaccines, BioNTech and Moderna, . BioNTech has filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging that Moderna’s updated COVID-19 vaccine, mNEXSPIKE, infringes upon BioNTech’s patented technology.
The core of the dispute centers around BioNTech’s patent, US Patent No. 12,133,899, which covers a technology for optimized mRNA vaccine design. According to the lawsuit, this technology allows for a lower dosage of the vaccine to be administered to patients while maintaining efficacy. Moderna’s mNEXSPIKE vaccine received FDA approval in 2025.
This lawsuit is not an isolated incident, but rather part of a broader, complex web of patent litigation surrounding the groundbreaking mRNA technology used in the COVID-19 vaccines. In 2022, Moderna itself initiated a patent infringement lawsuit against Pfizer and BioNTech, alleging that Comirnaty, the Pfizer-BioNTech vaccine, violated Moderna’s patents. That case remains ongoing.
The current legal action reflects a larger trend within the biotechnology industry, where companies are aggressively pursuing license fees for technologies utilized in the development of these highly successful vaccines. The financial stakes are considerable, given the billions of dollars in revenue generated by both Comirnaty and Moderna’s COVID-19 vaccine.
The specific technology at the heart of BioNTech’s claim relates to the design of the mRNA component of the vaccine. Messenger RNA (mRNA) vaccines work by delivering genetic instructions to the body’s cells, prompting them to produce a harmless piece of the virus – in this case, the spike protein of SARS-CoV-2. This triggers an immune response, preparing the body to fight off the actual virus if exposed. The optimization of this mRNA sequence, as claimed by BioNTech’s patent, is crucial for maximizing the vaccine’s effectiveness and minimizing potential side effects.
The implications of this lawsuit extend beyond the immediate financial interests of BioNTech and Moderna. The outcome could significantly shape the future landscape of mRNA vaccine development and intellectual property rights in the biotechnology sector. A ruling in favor of BioNTech could strengthen the protection of mRNA technology patents, potentially encouraging further innovation. Conversely, a ruling in favor of Moderna could weaken patent protections, potentially leading to increased competition and lower vaccine prices.
The development of mRNA vaccines represented a monumental scientific achievement during the COVID-19 pandemic, allowing for the rapid creation and deployment of effective vaccines. However, the speed of development also led to complex intellectual property issues, as multiple research groups and companies contributed to the underlying technology. The current legal battles are a consequence of these complexities, as companies seek to protect their investments and secure their positions in the market.
As of , spokespeople for Moderna, BioNTech, and Pfizer have not issued official comments regarding the new lawsuit. It is anticipated that the legal proceedings will be lengthy and complex, potentially involving expert testimony, detailed analysis of patent claims, and arguments over the scope of intellectual property rights. The case is filed in the US District Court for the District of Delaware under case number 1:26-cv-183.
This ongoing legal dispute underscores the critical importance of intellectual property protection in driving innovation within the pharmaceutical and biotechnology industries. While access to vaccines is paramount, ensuring that companies are adequately incentivized to invest in research and development is equally crucial for preparing for future public health challenges.
