Court sides with Arbutus on claims in Moderna COVID vaccine patent row
Delaware district court more convinced by Arbutus on claim construction points | Canadian biotech “pleased” with outcome in latest round of dispute over lipid nanoparticles delivery system.
Arbutus Biopharma has welcomed the ruling of a district court on disputed claim terms in its patent infringement suit against Moderna, after the judge affirmed its position on several key points.
Last week (April 3), the US District Court for the District of Delaware issued a memorandum opinion in favour of Arbutus on several matters regarding the patents it is asserting against Moderna over its COVID-19 vaccine, mRNA-1273.
Judge Mitchell Goldberg agreed with the Canadian biotech’s position on three disputed claim constructions from the patents-in-suit, which are divided into two categories.
US patent number 9,504,651 is referred to as the ‘encapsulation patent’ and represents the first category, and claims a new method for developing lipid nanoparticles (LNPs) which involves mixing two solutions to form lipid vesicles that can encapsulate nucleic acids.
The second category holds the ‘molar ratio patents’, which includes US patent numbers 11,141,378, 8,058069, 8,492,359, 8,822,668 and 9,364,435, which claim particles comprising a nucleic acid and specific molar ratio amounts of phospholipids, cationic lipids, PEG lipids, and cholesterol.
Arbutus sued Moderna in 2022, alleging that it had used its LNP delivery system in its COVID-19 vaccine without payment or a licence.
Commenting on last week’s development, Michael McElhaugh, interim president and chief executive officer of Arbutus Biopharma, said: “We are pleased with how the court construed the disputed claim terms.
“We remain committed to protecting and defending our intellectual property and look forward to the next steps in the litigation.”
Moderna position ‘not supported by evidence’
The court was persuaded by Arbutus’ position that claimed molar percentage ranges in the second category of patents could be met by any particle and was not limited to “finished” particles that are not subjected to further process steps.
“I decline to find that Moderna’s position is supported by the intrinsic evidence,” said Judge Goldberg.
The judge also agreed with Arbutus’ construction that the claimed ranges included standard variation based on the number of significant figures recited in the claim.
“The Federal Circuit has cautioned against interpreting ‘endpoints of the claimed range with greater precision than the claim language warrants’,” he wrote.
Regarding the ‘378 patent, the court affirmed Arbutus’ position that there was no limitation as to the molecular percentage of the claimed cationic lipid.
In April last year, the Federal Circuit sided with Moderna by affirming the invalidation of another Arbutus patent, US number 9,404,127.
Earlier that year, the US government waded into the dispute and urged the Delaware district court to throw out the patent infringement claims.
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