Court Rejects Two Moderna Defenses in mRNA Vaccine Patent Row With Arbutus

 

Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.

The setbacks continue to pile up for Moderna. Tuesday, a federal judge for the District of Delaware junked two of the biotech’s cornerstone defenses against a patent infringement case filed by Arbutus Biopharma concerning Moderna’s mRNA COVID-19 vaccine.

In the summary order, Judge Joshua Wolson threw out Moderna’s obviousness defense—that Arbutus’ invention of the lipid nanoparticles that encase mRNA vaccines would be obvious to any person and thus unpatentable—because it had already made a similar argument to the U.S. Patent and Trademark Office.

“Moderna already challenged several claims in the . . . patent and lost,” Wolson wrote.

The Judge also tossed another of Moderna’s defenses, which argued that Arbutus merely derived its lipid nanoparticle technology from a similar invention, thus rendering its patent invalid. “Moderna failed to demonstrate that there was a prior conception of Arbutus’s invention by another,” Wolson continued.

Arbutus sued Moderna in February 2022, according to the court order on Tuesday, which said the vaccine-maker first accessed Arbutus’ vaccine delivery technology in 2015 by sublicensing it from another company. Moderna, however, “never entered a license agreement that covered the use of [the technology] to fight the coronavirus that causes COVID-19,” the order read.

Moderna hit back in May 2024 with its own countersuit, largely claiming that Arbutus’ patents were invalid due to obviousness, derivation—that the inventor derived the invention from another, and enablement.

With Wolson’s decision, only Moderna’s enablement defense stands. Moderna argues that Arbutus’ patents do not enable a person of ordinary skill in the art to make and use its delivery technology. In a note to investors on Tuesday, Leerink analysts said Moderna’s play will now be to convince a jury that Arbutus fails the enablement test.

This patent setback comes after the FDA refused last week to review Moderna’s mRNA flu vaccine, noting that the company failed to use “best-available standard of care” in its studies. Moderna has insisted that the regulator’s refusal is “inconsistent” with what it had told the biotech during the vaccine’s development, but the Department of Health and Human Services has come out in support of the agency’s decision.

On Wednesday, however, Moderna revealed that the FDA will, in fact, review the vaccine, as the two parties have agreed on an amended filing.

https://www.biospace.com/policy/court-rejects-two-moderna-defenses-in-mrna-vaccine-patent-row-with-arbutus