Moderna Settles LNP Lawsuit for $2.25B
Roivant's Genevant Sciences and Arbutus Biopharma have reached a massive $2.25 billion global settlement with Moderna. The deal resolves the long-running patent dispute over the lipid nanoparticle (LNP) delivery technology crucial to Moderna's COVID-19 vaccine, ending a major IP battle in the nucleic acid delivery space.
The initial lawsuit from Arbutus and Genevant, first filed in February 2022, alleged that Moderna's Spikevax vaccine infringed on six U.S. patents related to lipid nanoparticle (LNP) delivery technology. This legal battle began after Moderna's earlier attempts, starting in 2018, to invalidate Arbutus's LNP patents through inter partes reviews had mixed results, with a key patent's validity being upheld by the Federal Circuit. The settlement involves a $950 million upfront payment from Moderna in the third quarter of 2026. An additional $1.3 billion is contingent on the outcome of a Federal Circuit appeal concerning Moderna's government-contractor immunity defense under 28 U.S.C. § 1498. In exchange, Moderna secures a global non-exclusive license for the LNP technology for its infectious disease portfolio, including its RSV vaccine mRESVIA and future pipeline products, with no future royalties owed. The agreement also includes Moderna consenting to a judgment of infringement and no invalidity on four of the asserted patents. This LNP technology is a cornerstone of nucleic acid delivery, extending far beyond COVID-19. Genevant's platform, developed over 20 years, was also behind the first FDA-approved siRNA-LNP therapeutic, Alnylam's ONPATTRO®, showcasing its broad utility in gene therapy and other applications. Just before the settlement, a federal judge had weakened Moderna's position by rejecting two of its key defenses—obviousness and derivation—leaving only its enablement defense for a jury trial that was set to begin. This case is a single front in a broader mRNA patent war. Moderna remains in litigation with Pfizer and BioNTech over separate mRNA technology patents, and other major players like GlaxoSmithKline and Alnylam are also involved in disputes over the foundational technologies for mRNA vaccines.
