On June 19, 2026, the U.S. Department of Justice filed an amicus brief on behalf of the United States in Arbutus Biopharma Corp. et al. v. Moderna Inc. et al., No. 26-1581 (Fed. Cir.), supporting Moderna’s appeal from the district court’s ruling on 28 U.S.C. § 1498(a), which addresses patent infringement claims arising from use or manufacture of patented inventions by or for the United States with government authorization or consent. Under this clause, the exclusive remedy for patent infringement is a suit against the government.
In the underlying litigation, Arbutus Biopharma Corp. and Genevant Sciences GmbH asserted U.S. Patent Nos. 8,492,359, 9,364,435, 9,504,651, and 11,141,378 against Moderna relating to its COVID-19 vaccine purchased by the government. The United States argues that patent infringement claims arising from Moderna’s performance under a U.S. Army procurement contract for 500 million COVID-19 vaccine doses fall within § 1498(a) and therefore should be brought, if at all, against the United States in the Court of Federal Claims rather than against Moderna. The United States states in its brief that, in addressing the § 1498(a) issue, it does not admit infringement or address the merits of plaintiffs’ claims or any government defenses.
In February 2026, the district court partially granted cross-motions for summary judgment, holding that § 1498(a) did not fully transfer liability to the government because not all of the 500 million purchased vaccine doses were “for the government.” The statute did apply to direct infringement claims based on six million doses the government distributed to its own employees, but it did not apply to infringement claims based on the remaining 494 million vaccine doses made available to the general public. The United States argues that the public doses were still procured for the government because they supported federal COVID-19 response objectives during a national public health emergency.
The brief states that the U.S. Army contract included an express authorization-and-consent clause and argues that the district court’s interpretation of § 1498(a) could have implications for government procurement by creating uncertainty about whether authorization-and-consent clauses in government contracts would shift patent-infringement claims to the United States. The United States also argues that the district court’s approach could be difficult to apply where the government does not know at the time of procurement who the ultimate recipient of procured goods will be, including for emergency medicines, vaccines, and other supplies.
In opposition to the DOJ, a group of drugmakers, federal judges, a conservative advocacy group and others have filed amicus briefs urging the Federal Circuit to adopt Arbutus’s position, arguing that shifting liability to the government would undermine patent rights.
Moderna is pursuing the appeal following a reported March 2026 settlement with Arbutus. According to the reported settlement terms, Moderna agreed to pay $950 million, and the settlement permits the appeal to proceed on whether the claims should have been brought against the United States. If the Federal Circuit rejects Moderna’s § 1498(a) argument, the settlement requires an additional $1.3 billion payment.
For more information about these and other biologic drug patent disputes, please visit BiologicsHQ.
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The authors would like to thank April Breyer Menon for her contributions to this article.
