A federal judge in Delaware has dismissed two of Moderna’s key defenses in an ongoing patent dispute with Arbutus Biopharma over the mRNA COVID-19 vaccine. The ruling, issued by Judge Joshua Wolson, represents a significant development in a case that centers on the lipid nanoparticles used to deliver mRNA vaccines.
Judge Wolson rejected Moderna's argument that Arbutus' invention was obvious and therefore unpatentable. He wrote, “Moderna already challenged several claims in the . . . patent and lost.” The judge also dismissed Moderna’s claim that Arbutus derived its technology from a prior invention, stating, “Moderna failed to demonstrate that there was a prior conception of Arbutus’s invention by another.”
Arbutus filed its lawsuit against Moderna in February 2022. According to the court order, Moderna first accessed Arbutus’ vaccine delivery technology through a sublicense agreement in 2015. However, the order noted that Moderna “never entered a license agreement that covered the use of [the technology] to fight the coronavirus that causes COVID-19.”
In response, Moderna filed a countersuit in May 2024. The company argued that Arbutus’ patents were invalid based on obviousness, derivation, and enablement grounds.
Following Judge Wolson’s decision, only the enablement defense remains for Moderna. This defense asserts that Arbutus’ patents do not provide enough information for someone skilled in the field to make and use its delivery technology. Leerink analysts commented Tuesday that Moderna will now focus on persuading a jury about this issue.
The court setback follows another recent challenge for Moderna: last week, the U.S. Food and Drug Administration (FDA) declined to review its mRNA flu vaccine because it did not use what the agency called the “best-available standard of care” during studies. While Moderna argued this decision contradicted earlier guidance from regulators, the Department of Health and Human Services supported the FDA’s stance.
However, on Wednesday, Moderna announced that after further discussions with the FDA, both parties have agreed to proceed with an amended submission for review.
