Moderna is facing a significant legal challenge in the United States over patent claims involving its COVID-19 vaccine, Spikevax, after a federal appeals court heard arguments on November 5, 2026.
A three-judge panel of the US Court of Appeals for the Federal Circuit heard arguments from Moderna and the parties involved in the dispute, Arbutus Biopharma and Genevant Sciences. The central issue is whether a federal law, known as Section 1498 of Title 28 of the US Code, protects Moderna from certain patent infringement claims involving vaccine doses supplied under a government contract.
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Key Highlights
Important points readers should notice.
The US Court of Appeals for the Federal Circuit heard Moderna's appeal on November 5, 2026.
The dispute involves Moderna, Arbutus Biopharma and Genevant Sciences. The case concerns patent claims involving lipid nanoparticle technology used in Spikevax.
Moderna argues that Section 1498 protects it in relation to vaccine doses supplied under a government contract.
The US Department of Justice supported Moderna's legal position.
Moderna paid $950 million under a settlement agreement on July 8, 2026.
A further payment of up to $1.3 billion is contingent on the outcome of the appeal.
Moderna argues that the US government should be treated as the proper defendant because the disputed vaccine doses were produced under a contract connected to Operation Warp Speed, the federal programme established to accelerate the development and supply of COVID-19 vaccines.
Section 1498 allows certain patent claims involving products made or used for the US government, with its authorisation or consent, to be pursued against the federal government rather than the private contractor. Moderna maintains that the provision applies to the disputed vaccine production.
However, a federal district court in Delaware rejected Moderna's defence in February 2026 in relation to the doses at issue in the appeal. The court's ruling distinguished doses supplied to the government for its employees from doses purchased for distribution to the wider public.
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Why This Matters
The case could have major financial implications for Moderna. The settlement links a potential payment of up to $1.3 billion to the outcome of the appeal, making the court's interpretation of federal patent law particularly significant for the company. The dispute also raises broader questions about the relationship between government procurement and intellectual property rights. Companies supplying products under federal contracts may rely on Section 1498 protections in certain circumstances, while patent owners seek to protect their rights against unauthorised use. The ruling could therefore influence how similar patent disputes involving private contractors and government-supported programmes are handled in the United States.
During the November 5 hearing, members of the appeals panel questioned the scope of Moderna's interpretation of the law. The judges examined whether the company's position could extend government-contractor protection too broadly and affect the ability of patent owners to pursue claims against private companies.
The US Department of Justice supported Moderna's position during the appeal. The government's argument focused on the potential implications of the case for federal contracting arrangements.
The dispute originated in a lawsuit filed by Arbutus and Genevant in 2022. The companies alleged that Moderna used their patented lipid nanoparticle technology in its COVID-19 vaccine without appropriate compensation. Lipid nanoparticles are used to deliver the messenger RNA component of the vaccine into cells.
The companies reached a settlement with Moderna in March 2026. Under the agreement, Moderna paid $950 million on July 8, 2026. The settlement also provides for an additional contingent payment of up to $1.3 billion, depending on the outcome of the Section 1498 appeal.
If the Federal Circuit upholds the rejection of Moderna's defence in its entirety, or determines that Section 1498 does not bar the companies' claims for all the doses covered by the appeal, the full contingent payment may become payable under the settlement terms.
If the court determines that the legal protection applies to some, but not all, of the disputed doses, the additional payment may be reduced proportionately. The settlement also contains provisions under which a contingent payment may have to be returned if the relevant legal outcome is subsequently overturned in Moderna's favour in a final, non-appealable decision.
If Moderna succeeds in establishing that Section 1498 bars the relevant claims, no additional payment would be due under the agreement.
The appeals court had not announced a decision as of November 8, 2026. Its ruling could have financial implications for Moderna and provide further guidance on how federal government-contractor protections apply in patent disputes.
