BioNTech filed a patent infringement lawsuit against Moderna in federal court in Delaware, alleging that Moderna’s Covid-19 vaccine mNEXSPIKE unlawfully uses technology covered by BioNTech patents.

In its complaint, the German biotechnology company claims that mNEXSPIKE, Moderna’s next-generation Covid shot approved by the FDA in 2025, infringes intellectual property related to a streamlined messenger RNA (mRNA) vaccine design.

BioNTech claims the patented approach enables vaccines to be administered at lower doses while maintaining effectiveness, representing a key innovation in mRNA platform development.¹

Is this the first legal dispute over Covid vaccines?

The lawsuit marks the latest escalation in a broader legal dispute between the rival vaccine makers. In 2022, Moderna sued BioNTech and its partner Pfizer, alleging that their Covid-19 vaccine, Comirnaty, infringed Moderna’s own mRNA-related patents.

That case remains ongoing. Together, the disputes are part of a wider wave of litigation among biotechnology companies seeking compensation or royalties tied to the highly profitable COVID-19 vaccines developed during the pandemic.

A spokesperson for Moderna said the company intends to vigorously defend itself against BioNTech’s claims. BioNTech said in a statement that the lawsuit was necessary to “protect its mRNA-based innovations that the company has pioneered and patented.”¹

Pfizer, which partnered with BioNTech on Comirnaty but is not directly named in the new case, did not immediately respond to requests for comment.

What are the financial implications?

The financial stakes surrounding mNEXSPIKE could be significant. According to BioNTech’s filing, Moderna expects the shot to generate roughly 55% of its Covid-19 vaccine revenue during the 2025–2026 respiratory virus season.¹

Although pandemic-era demand has eased, updated Covid boosters continue to represent a meaningful portion of Moderna’s commercial vaccine business.

Revenue from Covid-19 vaccines has declined sharply from peak pandemic levels, when Moderna’s Spikevax and the Pfizer-BioNTech Comirnaty vaccine generated billions of dollars in annual sales.¹ As vaccination rates fell and emergency procurement programs ended, sales across the vaccine sector slowed considerably.

Industry observers also note that broader vaccine revenues have faced additional headwinds following U.S. President Donald Trump’s appointment of vaccine skeptic Robert F. Kennedy Jr. as U.S. health secretary, a move that has drawn scrutiny from public health advocates and investors.¹

On the heels of a Type A meeting with the FDA’s Center for Biologics Evaluation and Research (CBER), Moderna’s seasonal influenza vaccine candidate, mRNA-1010, has been formally accepted for regulatory review.

The review follows a prior Refusal-to-File (RTF) letter, which flagged Moderna’s use of a licensed standard-dose seasonal influenza vaccine as a comparator in its Phase III Glow trial as the sole reason for refusal, noting that it did not reflect the “best-available standard of care.”

In response, Moderna revised its regulatory strategy, seeking full approval for adults 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing commitment to study older populations.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026, potentially allowing mRNA-1010 to be available in time for the 2026–2027 flu season.

Sources

1. BioNTech sues Moderna for patent infringement over COVID shots Reuters February 20, 2026 https://www.reuters.com/world/biontech-sues-moderna-patent-infringement-over-covid-19-shots-2026-02-19/
2. Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission Moderna February 18, 2026 https://feeds.issuerdirect.com/news-release.html?newsid=8923338804483797&symbol=MRNA
3. Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010 Moderna February 10, 2026 https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA