A Delaware District Court has delivered a significant ruling against Moderna in an ongoing patent infringement lawsuit filed by Roivant subsidiary Arbutus Biopharma and Genevant Sciences. The case centers on the lipid nanoparticle delivery system used in Moderna's COVID-19 vaccine.
In a 37-page opinion issued Wednesday, Judge Mitchell Goldberg sided with Arbutus and Genevant on two of the three disputed patent claims, potentially strengthening their position as the case moves toward trial.
Key Patent Disputes Resolved
The first disputed claim concerned the total percentage of lipids present in the delivery particle. Moderna had argued for a narrow interpretation, insisting that the "particle" should refer only to a "finished lipid particle" requiring no further processing. The company also maintained that lipid percentages must be understood as exact ranges explicitly stated in the claim.
Judge Goldberg rejected Moderna's position, instead agreeing with Arbutus and Genevant that the "plain and ordinary meaning" of the term should apply. The court found that nothing in the patent language required the lipid particle to be completely free from further processing.
On the precision of lipid percentages, Goldberg wrote that "Moderna has not established that Plaintiffs' removal of the word 'about' constituted a clear and unmistakable disclaimer of the rules of rounding." He added that a person with ordinary skill in the art would "understand that the rules of rounding and significant figures apply to the claimed ranges."
The second claim involved the definition of a "cationic lipid having a protonatable tertiary amine." Here again, the court favored Arbutus and Genevant's interpretation, ruling that the plain and ordinary meaning should apply rather than Moderna's proposal to include additional qualifiers.
Background of the Lawsuit
Arbutus and Genevant first filed their patent infringement lawsuit against Moderna in February 2022. The patents in question were licensed to Genevant, a joint venture between Arbutus and Roivant Sciences.
The plaintiffs allege that Moderna used their lipid nanoparticle technology—critical for delivering mRNA into cells—without proper license or compensation. Lipid nanoparticles are essential components of mRNA vaccines, serving as protective vehicles that deliver genetic material into cells.
"We seek fair compensation for Moderna's use of our patented technology... without which Moderna's COVID-19 vaccine would not have been successful," Arbutus CEO William Collier stated when the lawsuit was filed.
Implications and Next Steps
This ruling on claim construction represents a significant procedural victory for Arbutus and Genevant. Claim construction is a critical phase in patent litigation as it establishes the scope and meaning of the patent claims at issue, directly impacting the determination of whether infringement occurred.
The favorable interpretation of these claims could strengthen Arbutus and Genevant's position that Moderna's COVID-19 vaccine infringes on their intellectual property related to lipid nanoparticle delivery systems.
According to Reuters, the trial for this case is scheduled to begin in April 2024. The outcome could have substantial financial implications for Moderna, which has generated billions in revenue from its COVID-19 vaccine.
The case highlights the complex intellectual property landscape surrounding COVID-19 vaccines and the underlying technologies that made rapid vaccine development possible during the pandemic.
