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Arbutus Is Sued Over Pfizer’s Covid Vaccine Delivery Tech (1)

March 18, 2022, 6:50 PMUpdated: March 18, 2022, 7:02 PM

The company whose delivery technology Pfizer Inc. licenses for use in its Covid-19 vaccine sued Arbutus Biopharma Corp. in Manhattan federal court Friday, seeking a judgment that the shot doesn’t infringe nine patents over which Arbutus and its partner Genevant Sciences GmbH have threatened to sue.

Acuitas Therapeutics Inc., a closely held biotech company based in Vancouver, said Arbutus and Genevant “had nothing to do with” the success of the vaccine, called Comirnaty, according to a complaint filed in the U.S. District Court for the Southern District of New York. Pfizer and BioNTech SE, which helped develop it, “have delivered billions of doses of Comirnaty worldwide,” including more than 320 million doses in the U.S., the complaint says.

All doses contain “the lipids and lipid nanoparticles innovated by Acuitas that deliver this critical mRNA therapeutic,” the suit says.

Only after Comirnaty’s success “did Arbutus and Genevant emerge to make the spurious claim” that the vaccine “may infringe” Arbutus’ patents and “to demand hundreds of millions, if not billions, of dollars in wholly unjustified payments,” said Acuitas, which also wants the court to cancel Arbutus’ patents.

Non-party Roivant Sciences Ltd. owns about 84% of Genevant, and Arbutus owns the rest, the suit says. Roivant “has acted as an agent” for its stakeholders “with respect to acts giving rise to this complaint.”

Pfizer in January announced a deal that gives it the option to license Acuitas’ technology on a nonexclusive basis for as many as 10 vaccine or therapeutic targets.

The license allows Pfizer to use one of Acuitas’ lipid nanoparticles, or LNPs, to protect the fragile messenger-RNA molecule from rapidly degrading upon injection. The mRNA-LNP is a tiny bubble of fat that coats and protects the mRNA after it’s injected into a person and transports the mRNA into the person’s cells, where it helps create proteins to generate an immune response.

Acuitas says Arbutus, which was founded as Inex Pharmaceuticals and changed its name to Tekmira before becoming Arbutus, developed LNPs to deliver new classes of drugs based on a type of nucleic acid called “small interfering RNA,” or siRNA. Those are “short pieces of RNA that interfere with the body’s ability to make certain proteins that may cause disease,” the suit says.

But by 2008, Acuitas says, the company that now is Arbutus wasn’t interested in supporting the work that two of its founders—three “leading LNP scientists”—were pursuing. It fired the pair, who then joined the third scientist in founding another LNP-development company, AlCana Technologies, later renamed Acuitas.

Whereas Acuitas had decided by 2012 to focus on developing LNP technology for the delivery of mRNA, Arbutus “chose to focus its business on the much less challenging problem of developing LNP carriers to encapsulate siRNA.”

Pfizer and Moderna Inc. were sued Thursday by Alnylam Pharmaceuticals Inc., which alleges the companies’ Covid-19 vaccines infringe its patents for LNP technology. Moderna said it designed proprietary lipids after discovering years ago that the Alnylam-style lipids didn’t work for delivering mRNA directly into the arm.

Cause of Action: Declaratory judgment.

Relief: Judgments declaring that Comirnaty doesn’t infringe Acuitas’ patents and that the patents are invalid; attorneys’ fees; costs and expenses.

Response: A representative of Genevant declined to comment. Arbutus didn’t immediately respond to a request for comment.

Attorneys: Acuitas is represented by Paul, Weiss, Rifkind, Wharton & Garrison LLP.

The case is Acuitas Therapeutics Inc. v. Genevant Scis. GmbH, S.D.N.Y., No. 22-cv-2229, complaint filed 3/18/22.

(Updates to add Genevant's response to request for comment.)

To contact the reporter on this story: Christopher Yasiejko in Wilmington, Del., at cyasiejko@bloombergindustry.com

To contact the editors responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com; Patrick L. Gregory at pgregory@bloomberglaw.com