BioNTech Files Patent Infringement Lawsuit Against Moderna Over COVID Vaccine Technology

In a significant legal development, German biopharmaceutical company BioNTech has initiated a lawsuit against Moderna in Delaware federal court. The suit alleges that Moderna’s COVID-19 vaccine, mNEXSPIKE, infringes upon a patent associated with BioNTech and Pfizer’s competing vaccine, Comirnaty.

The lawsuit claims that mNEXSPIKE, which received approval from the U.S. Food and Drug Administration in 2025, violates BioNTech’s intellectual property rights. Specifically, it pertains to technology that enables a more efficient messenger RNA-based vaccine design, allowing for administration at a lower dosage to patients.

This legal battle is not the first between these two companies. In 2022, Moderna filed its own lawsuit against BioNTech and Pfizer, alleging patent infringement related to Comirnaty. That case is still ongoing, reflecting a broader trend of patent disputes among biotech firms seeking royalties for the technologies that underpin these highly successful vaccines.

A spokesperson for Moderna stated that the company is prepared to defend itself against BioNTech’s allegations. Meanwhile, BioNTech has not yet provided a response to inquiries regarding the new lawsuit. Pfizer, which is not directly implicated in this particular case, also refrained from commenting at this time.

According to BioNTech’s lawsuit, mNEXSPIKE is projected to generate 55% of Moderna’s COVID vaccine revenue during the 2025-26 respiratory virus season. This highlights the financial stakes involved in the ongoing legal disputes.

It’s important to note that revenues from COVID vaccines have seen a significant decline since the peak of the pandemic. During that time, Moderna’s Spikevax and the Comirnaty vaccine from Pfizer and BioNTech brought in billions. The downturn in vaccine sales has been exacerbated by political factors, including the appointment of vaccine skeptic Robert F. Kennedy Jr. as health secretary under former President Donald Trump.

(Reporting by Blake Brittain in Washington; editing by Barbara Lewis and Deepa Babington)

Topics
Lawsuits

In a significant legal development, German biopharmaceutical company BioNTech has initiated a lawsuit against Moderna in Delaware federal court. The suit alleges that Moderna’s COVID-19 vaccine, mNEXSPIKE, infringes upon a patent associated with BioNTech and Pfizer’s competing vaccine, Comirnaty.

The lawsuit claims that mNEXSPIKE, which received approval from the U.S. Food and Drug Administration in 2025, violates BioNTech’s intellectual property rights. Specifically, it pertains to technology that enables a more efficient messenger RNA-based vaccine design, allowing for administration at a lower dosage to patients.

This legal battle is not the first between these two companies. In 2022, Moderna filed its own lawsuit against BioNTech and Pfizer, alleging patent infringement related to Comirnaty. That case is still ongoing, reflecting a broader trend of patent disputes among biotech firms seeking royalties for the technologies that underpin these highly successful vaccines.

A spokesperson for Moderna stated that the company is prepared to defend itself against BioNTech’s allegations. Meanwhile, BioNTech has not yet provided a response to inquiries regarding the new lawsuit. Pfizer, which is not directly implicated in this particular case, also refrained from commenting at this time.

According to BioNTech’s lawsuit, mNEXSPIKE is projected to generate 55% of Moderna’s COVID vaccine revenue during the 2025-26 respiratory virus season. This highlights the financial stakes involved in the ongoing legal disputes.

It’s important to note that revenues from COVID vaccines have seen a significant decline since the peak of the pandemic. During that time, Moderna’s Spikevax and the Comirnaty vaccine from Pfizer and BioNTech brought in billions. The downturn in vaccine sales has been exacerbated by political factors, including the appointment of vaccine skeptic Robert F. Kennedy Jr. as health secretary under former President Donald Trump.

(Reporting by Blake Brittain in Washington; editing by Barbara Lewis and Deepa Babington)

Topics
Lawsuits