US court dismisses COVID-19 vaccine suit against Genevant, Arbutus

New Jersey federal judge said Acuitas had failed to show case or controversy | Acuitas had sought declaratory judgment that Pfizer’s Comirnaty vaccine did not infringe patents.

A New Jersey court has said that Acuitas Therapeutics failed to plead a case or controversy in its suit against Genevant Sciences and Arbutus Biopharma over the Comirnaty COVID-19 vaccine, granting the defendants’ motion to dismiss.

The court delivered the decision earlier this week.

Acuitas supplied and licensed lipid nanoparticle (LNP) formulations to Pfizer and BioNTech for use in their Comirnaty COVID-19 vaccine.

The Canadian biotech sought a declaratory judgment from the US District Court for the District of New Jersey that the Comirnaty vaccine did not infringe ten patents held by Arbutus.

However, District Judge Quraishi held that the complaint lacked the “requisite allegations” that Acuitas had induced infringement of the patents by supplying LNPs to Pfizer and BioNTech.

The patent infringement claims over Comirnaty will be decided in a pending suit filed by Genevant and Arbutus in April 2023 against Pfizer and BioNTech, also in New Jersey.

The ‘threat’ of patent infringement

The dispute over Comirnaty began in November 2020, when Genevant and Arbutus sent Pfizer and BioNTech a letter notifying them that the vaccine might infringe eight of their patents.

In 2021 and 2022, Genevant and Arbutus sent letters identifying additional patents that might be infringed.

Last year, the duo filed a suit in New Jersey alleging that Pfizer and BioNtech had infringed five patents, referred to as the ‘New Jersey suit’.

Acuitas then sought a declaratory judgment that ten of Genevant and Arbutus’ patents were invalid and not infringed.

It said the action was in response to the defendants’ “threat to sue, and suit against, Pfizer and BioNTech, based in part on their use of Acuitas’s LNP and lipids”.

Acuitas told the court that without the declaratory judgment, it faced “uncertainty with respect to the use of its technology free from the threat of patent infringement”, and that its LNP technology was designed for use “far beyond COVID-19”.

‘Devoid of allegations’

Genevant and Arbutus filed a motion to dismiss the suit on the basis that the complaint failed to allege an actual controversy between the parties.

The court agreed with this position, finding that Acuitas’s assertion based on Microsoft v DataTern that there need only be a reasonable potential that a claim might be brought “divorces that broad statement of principle from the detailed infringement analyses that are both required and applied by the Federal Circuit”.

It also found Acuitas’s reliance on Arris v British Telecoms in support of its induced infringement position to be “misplaced”.

Judge Quraishi held that the complaint was “devoid of allegations with respect to patent claims that are being asserted in the New Jersey suit” that would support Acuitas’s declaratory judgment claims in this case.

Regarding Acuitas’s concerns about its freedom to use LNPs without the threat of infringement, the court found that the complaint “alleges no facts supporting such a claim”.

Co-pending suit

The judge concluded that even if a justifiable controversy had been pleaded, the suit would be dismissed in favour of the co-pending New Jersey infringement suit.

“Clearly, a dismissal would have the benefit of avoiding duplicative litigation,” the judge said.

Although that suit only concerned five patents, the judge said it was likely that the ruling on those patents would inform parties’ decision as to whether to litigate the remaining five, and that it was broader in scope regarding the relief sought.

Acuitas was understandably “eager to present its own inventorship story” the court said, but concluded that it had not given a reason why its evidence could not be presented in the New Jersey suit “particularly given its claims that it is already coordinating efforts with Pfizer and BioNTech”.

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