Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging mRNA-Delivery Specific Patents

Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus), challenging U.S. Patent Nos. 9,364,435; 8,058,069; 8,492,359; 8,822,668; 9,006,417; 9,504,651; 9,518,272; 11,141,378; 11,298,320; and 11,318,098 relating to messenger RNA-delivery technology. Acuitas is seeking declaratory judgment that these ten patents are not infringed by the manufacture, use, offer for sale, sale, or importation into the United States of the Pfizer/BioNTech COVID-19 vaccine COMIRNATY® and are, in any event, invalid. Acuitas alleges that Acuitas “invented and provides an essential component of [COMIRNATY®]” and it is “vital to Acuitas’s business that [Pfizer/BioNTech] and prospective partners can use [Acuitas’s lipid nanoparticle] technology free and clear of interference by threats of suit arising from third party patents”.

We reported in April that Arbutus filed a complaint for patent infringement, also in the District of New Jersey, against Pfizer, Inc. and BioNTech SE alleging that COMIRNATY® and any COVID-19 mRNA lipid nanoparticle vaccine products infringe five of the ten Arbutus patents listed above. In its present complaint, Acuitas argues that Arbutus’s “willingness to sue Acuitas’s customers that use [Acuitas’s lipid nanoparticle] technology, despite the fact that Arbutus and Genevant did not invent and had nothing to do with the success of Acuitas’s lipids or vaccines that use them” and that the “threat to other customers and potential customers, and thus the threat to Acuitas itself, would remain even if Arbutus and Genevant were to resolve [this] dispute with Pfizer and BioNTech” means that without a declaratory judgment holding Acuitas faces “(i) uncertainty with respect to the use of its technology free from the threat of patent infringement, (ii) the possibility of liability under 35 U.S.C. § 271(b) for inducing its customers’ infringement or under § 271(c) for contributing to it, or (iii) the possibility of indemnity obligations to its customers under their contracts”.

Acuitas also alleges that Arbutus had nothing to do with COMIRNATY®’s success and only sued Pfizer and BioNTech after COMIRNATY® achieved “worldwide commercial success,” adding that Arbutus are seeking “hundreds of millions, if not billions, of dollars in wholly unjustified payments.”

Stay tuned to Big Molecule Watch for updates on this litigation.