The Moderna lawsuit landscape centers on patent fights over the technology behind the Spikevax COVID-19 vaccine. Since 2022, at least nine patent holders have sued Moderna, the biggest of them ending in a settlement worth up to $2.25 billion with Arbutus Biopharma and Genevant Sciences in March 2026. Moderna is also the plaintiff in its own suits against Pfizer and BioNTech, and it settled a separate royalty dispute with the U.S. government. Personal injury claims over vaccine side effects, by contrast, have almost all been blocked by federal law.
The $2.25 Billion Arbutus and Genevant Settlement
The largest case against Moderna was filed by Arbutus Biopharma on February 28, 2022, in the U.S. District Court for the District of Delaware.1U.S. District Court for the District of Delaware. Arbutus Biopharma Corp. v. Moderna, Inc., No. 1:22-cv-00252 Arbutus and Genevant Sciences, a Roivant subsidiary formed in 2018 to commercialize Arbutus’s lipid nanoparticle platforms, alleged that Moderna built Spikevax on their patented LNP delivery technology without a license.2SEC. Genevant Sciences Joint Venture Formation LNPs are the fatty shells that carry fragile mRNA into human cells; without them, an mRNA vaccine does not work.
By early 2026, Moderna’s defenses had been narrowed sharply. A February 17, 2026 ruling by Judge Joshua D. Wolson barred Moderna from arguing that the patents were obvious, citing estoppel from an earlier loss at the Patent Trial and Appeal Board, and rejected Moderna’s claim that Arbutus had derived the technology from someone else.3IPWatchdog. Delaware Court Narrows Moderna’s Invalidity Defenses Ahead of Arbutus LNP Patent Trial Only an enablement defense survived.
Moderna also argued that under 28 U.S.C. § 1498, the federal government, not Moderna, should be liable because Spikevax was manufactured under federal contracts. The district court accepted that argument only for the roughly 6.2 million doses delivered directly to U.S. government employees, leaving the hundreds of millions of doses sold to the general public exposed.4Bloomberg Law. Moderna Vaccine Patent Deal Sets Up High-Stakes Immunity Appeal
On March 3, 2026, the parties announced a global settlement worth up to $2.25 billion covering all U.S. and international claims.5Genevant Sciences. Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement With Moderna The deal has two pieces:
- A $950 million upfront payment due in July 2026.
- A contingent payment of up to $1.3 billion tied to the Federal Circuit’s ruling on the § 1498 defense. If the appellate court affirms that Moderna is not shielded for doses sold to the public, Moderna owes the money within 90 days. If Moderna wins the appeal, the payment plus interest is refunded.6IPWatchdog. Moderna Settles With Genevant, Arbutus, Ending LNP Patent Dispute
Moderna consented to a judgment of infringement and “no invalidity” on all four asserted patents. In exchange, Genevant granted Moderna a global, non-exclusive license to use its LNP delivery technology for SM-102-containing mRNA vaccines targeting infectious diseases, with no ongoing royalties owed on future sales.7Yahoo Finance. Moderna Rises on $2.25 Billion Settlement Shares rose about 10% the day after the announcement, with analysts noting the price came in below the $3 billion figure some had feared.
Other Patent Holders Suing Moderna
Arbutus and Genevant were far from alone. As of mid-2026, at least nine patent holders have taken Moderna to court, with four of those cases filed in 2026 alone.8IAM Media. Moderna Sued by CureVac
Alnylam Pharmaceuticals sued in March 2022 in Delaware, also over LNP patents. Moderna won. The Federal Circuit affirmed a judgment of noninfringement in June 2025, finding that Moderna’s SM-102 lipid did not meet the patent’s definition of “branched alkyl.”9U.S. Court of Appeals for the Federal Circuit. Alnylam Pharmaceuticals v. Moderna, No. 2023-2357
GlaxoSmithKline filed two Delaware actions in October 2024, one targeting Spikevax and the other targeting Moderna’s RSV vaccine mRESVIA. GSK is seeking damages and a permanent injunction against mRESVIA.10Big Molecule Watch. GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement
Northwestern University sued in Delaware the same month, asserting three LNP patents and seeking damages.10Big Molecule Watch. GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement
Bayer filed in early 2026 in Delaware, asserting U.S. Patent No. 7,741,118. Moderna has moved to dismiss, arguing the patent actually covers plant and insecticidal genes rather than human mRNA technology.11Bloomberg Law. Moderna, Pfizer Press to Toss Bayer’s COVID Shot Patent Suits
CureVac, which was acquired by BioNTech in 2025, sued Moderna on April 24, 2026 in Delaware, asserting ten patents on mRNA-stabilization and delivery technologies and seeking royalties on Spikevax sales.12CourtListener. CureVac SE v. Moderna, Inc., No. 1:26-cv-0047513European Biotechnology. CureVac Takes Moderna to Court Over mRNA Vaccine Patents
BioNTech filed its own countersuit on February 19, 2026, in Delaware, alleging that Moderna’s next-generation vaccine mNEXSPIKE infringes U.S. Patent No. 12,133,899. Moderna answered and counterclaimed on June 10, 2026, and the case is in early stages before Judge Gregory B. Williams.14CourtListener. BioNTech SE v. ModernaTX, Inc., No. 1:26-cv-0018315Big Molecule Watch. Vaccine Patent Litigation Tracker
Moderna’s Own Lawsuits Against Pfizer and BioNTech
Moderna has also been the plaintiff. In August 2022, it sued Pfizer and BioNTech in the District of Massachusetts and in courts in Germany, the UK, Ireland, the Netherlands, and Belgium, accusing them of copying two core innovations for the Comirnaty vaccine: the use of N1-methylpseudouridine to stabilize mRNA, and a design encoding the full-length SARS-CoV-2 spike protein.16National Center for Biotechnology Information. Patent Landscape of mRNA Vaccine Technology Moderna sought royalties rather than removal of Comirnaty from the market.
Results have been mixed. In the United States, the Patent Trial and Appeal Board ruled in March 2025 that all challenged claims in two of Moderna’s three U.S. patents were unpatentable as obvious. The Massachusetts case continues on the third patent, U.S. Patent No. 10,898,574.17IPWatchdog. mRNA Patent Wars Update The UK Court of Appeal unanimously found that Comirnaty infringes Moderna’s EP 949 patent and that the patent is valid, and the UK Supreme Court refused Pfizer permission to appeal in December 2025.18UK Supreme Court. UKSC/2025/0161 A second Moderna patent, EP 565, was invalidated by both the High Court and the Court of Appeal.19JUVE Patent. Moderna and Freshfields Win Against BioNTech and Pfizer at UK Court of Appeal In Germany, the Düsseldorf Regional Court ruled in March 2025 that Pfizer and BioNTech infringed Moderna’s European patent; damages remain to be set, and an appeal is pending.
The NIH Royalty Dispute
A separate fight involved the U.S. government. In July 2021, Moderna filed a patent application for Spikevax without naming three National Institutes of Health scientists as co-inventors. Former NIH director Francis Collins publicly criticized Moderna, saying the researchers had “played a major role” in the work.20Syracuse Law Review. United States v. Moderna: Explaining the Side Effects of the Patent Battle
In late 2022, Moderna and the National Institute of Allergy and Infectious Diseases reached a partial resolution. Moderna paid a $400 million “catch-up” fee and agreed to low single-digit royalties on future COVID-19 vaccine sales, covering a separate set of patent rights on stabilizing coronavirus spike proteins. The payment was shared between the NIH and two universities.21Fierce Pharma. Moderna Pays U.S. Government $400M Catch-Up Payment Under New COVID-19 Vaccine License The broader inventorship dispute over who designed the vaccine’s core mRNA sequence has not been resolved.22The New York Times. Moderna and NIH Patent Dispute Over COVID Vaccine
Personal Injury Lawsuits Are Almost Always Blocked
Individuals injured after receiving the Moderna vaccine generally cannot sue the company. The Public Readiness and Emergency Preparedness Act, invoked by the Secretary of Health and Human Services in February 2020, gives vaccine manufacturers broad immunity from liability for covered countermeasures except in cases of willful misconduct.23CNBC. COVID Vaccine Side Effects Compensation
Courts have enforced that shield. In September 2024, a federal judge in Washington state dismissed a suit by a woman who suffered a stroke after receiving the Moderna vaccine, ruling that the PREP Act barred all of her claims.24American Health Law Association. U.S. Court in Washington Tosses COVID-19 Vaccine Injury Suit COVID-19 vaccines remain covered through the end of 2029, and the only official route to compensation is the government’s Countermeasures Injury Compensation Program, which has approved fewer than 1% of the roughly 11,000 COVID-19 vaccine-related petitions filed as of May 2026.25KFF. Federal Vaccine Injury Compensation Programs Overview and Current Issues
What the Litigation Costs Moderna
The financial exposure is significant. The Arbutus settlement alone could reach $2.25 billion, and pending suits from GSK, Northwestern, CureVac, BioNTech, and Bayer add unknown further demands. Moderna booked a $900 million non-recurring litigation charge in the first quarter of 2026.26Trefis. Moderna Financial Overview The company projected cash reserves of $4.5 billion to $5 billion in 2026; Bernstein analysts noted that if the full Arbutus payment comes due, reserves could fall to about $3.2 billion.7Yahoo Finance. Moderna Rises on $2.25 Billion Settlement Whether that happens turns on the Federal Circuit’s ruling on the § 1498 defense, which was still pending as of mid-2026.4Bloomberg Law. Moderna Vaccine Patent Deal Sets Up High-Stakes Immunity Appeal