Nearly four years after the lawsuit was filed, and against a backdrop of significant changes in the COVID-19 vaccine landscape, Moderna has resolved its long-standing patent dispute.
Moderna will pay $950 million upfront with no future royalties to settle a patent lawsuit over its mRNA-based vaccine Spikevax. The lawsuit, filed in 2022 by Roivant subsidiary Genevant and infectious disease biotech Arbutus, alleges Moderna infringed their patents with the lipid nanoparticle (LNP) delivery technology included in the blockbuster.
The lawsuit ultimately led to the adoption of Moderna’s respiratory syncytial virus (RSV) vaccine, mRESVIA, which was approved by the FDA in 2024.
Evercore ISI analysts said in a letter to clients this week that the case was “close to being resolved” with less than a week until a jury trial was scheduled to begin.
Under the terms of the agreement, Moderna may pay Geneva and Arbutus an additional $1.3 billion, subject to Moderna’s potential liability for vaccine sales through government contracts, the companies said in a March 3 press release.
Moderna is addressing the issue in the Court of Appeals and said in a company release Tuesday that it does not expect a claim for potential additional payments because it does not believe that outcome is “likely.”
But Moderna said it expects to have cash and cash equivalents of $4.5 billion to $5 billion at the end of 2026, with the upfront payment on its books.
“Resolving this legacy issue from our pandemic response removes uncertainty and allows us to focus on Moderna’s exciting near-term future,” Moderna CEO Stéphane Bancel said in a statement. “We expect to return to revenue growth in 2026 and end the year with a strong balance sheet with more than $5 billion of liquidity on track to breakeven in 2028.”
Despite Moderna’s “significant” upfront payment, Evercore analysts said they had an “overall positive view” of the settlement, noting that investors’ expectations for how the case would turn out were “across the board.” The deal “appears to be manageable and eliminates significant tail risks,” the Evercore team said, given that some expected Genevant and Arbutus’ fees to be even higher due to sales of Moderna’s tens of billions of dollars in COVID-19 shots.
Analysts at Jefferies were also optimistic about Moderna’s deal, noting that the $950 million to $2.5 billion it could end up owed would effectively represent a royalty rate of 2% to 5% on Moderna’s total global vaccine sales of $48 billion. This eliminates the “worst-case scenario of potentially double-digit royalties,” the Jefferies team wrote in a March 3 memo.
Overall, Moderna is poised for a “cleaner” story in 2026, Jefferies analysts added, noting that the lawsuit resolution provides more certainty regarding Moderna’s next-generation COVID-19 vaccine mNexspike, its experimental COVID-19 combination vaccine mCombriax, and the company’s broader influenza pipeline.
Moderna stock rose nearly 9% in Wednesday trading.
Genevant and Arbutus first filed suit against Moderna in February 2022, following Moderna’s failed efforts to invalidate two of Arbutus’ patents.
In a lawsuit filed in Delaware federal court, Genevant and Arbutus say they are seeking damages for six patents they say Moderna infringed. Importantly, the companies said they do not intend to prevent Moderna from selling and supplying the vaccine, but instead are seeking compensation equal to “substantial royalties on all infringing sales.”
Genevat and Arbutus announced on Tuesday that the settlement grants Moderna a non-exclusive worldwide license to its LNP delivery technology for infectious disease applications, in a move that will allow Moderna to continue selling its vaccine, and also provides a pledge not to “sue certain Genevant and Arbutus patents and Moderna products.”
Moderna, on the other hand, has committed not to challenge the validity of certain Genevant and Arbutus patents.
Genevant and Arbutus announced this week that the settlement resolves all global LNP litigation between the companies.
“Nobel Prize winners, industry executives, and prominent researchers have long recognized that Arbutus scientists have changed the landscape of drug development by inventing LNP delivery technology, making it possible to use nucleic acids, including mRNA, in drugs, opening a world of new possibilities,” Lindsey Androski, CEO of Arbutus, said in a statement. “Today, Moderna finally acknowledged the same thing.”
Meanwhile, James Heyes, head of Gevvant, said: “The Gevvant team is extremely pleased to finally be recognized for their vital contribution to restoring normality around the world in the face of a once-in-a-lifetime pandemic.”
The lawsuit is still ongoing
The legal battle between Genevant, Arbutus and Moderna is just one part of a broader patent litigation that has arisen in the wake of Moderna and Pfizer’s approval of their respective mRNA vaccines, Spikevax and Comilnati, during the COVID-19 pandemic.
About a year after filing suit against Moderna, the companies zeroed in on Pfizer and its German mRNA partner BioNTech, alleging infringement on similar LNP delivery technology claims.
“This resolution with Moderna reduces uncertainty, vindicates our intellectual property and provides a significant infusion of cash in the near term as we continue our ongoing litigation against Pfizer/BioNTech, whose sales of Cominati account for approximately two-thirds of global COVID-19 vaccine sales,” Roivant CEO Matt Grein said on Tuesday.
Meanwhile, Moderna and Pfizer are also locked in a fierce battle over intellectual property claims in multi-country lawsuits.
And earlier this year, Bayer filed separate complaints against Moderna, Pfizer, Delaware’s BioNTech and New Jersey’s Johnson & Johnson over claims that its COVID-19 vaccine overrode technology to improve mRNA stability patented by Monsanto, the crop science company Bayer acquired a decade ago.
GSK has also been involved in a series of COVID-19 vaccine lawsuits, and last summer mRNA licensor CureVac settled its own COVID-19 lawsuit against Pfizer and BioNTech in the U.S., securing a $320 million payout.
