Moderna, not U.S. gov’t, must defend COVID-19 vaccine patent case for now

(Reuters) – Moderna Inc must face a patent infringement lawsuit over its COVID-19 vaccines, a federal judge in Delaware ruled Wednesday, finding that the biotech company has not shown that the U.S. government should have been sued instead.

U.S. District Judge Mitchell Goldberg said he was not yet convinced that the lawsuit by Arbutus Biopharma Corp and Genevant Sciences GmbH should have been brought against the government instead of Cambridge, Massachusetts-based Moderna.

Genevant said in a statement that it was pleased the court “rejected Moderna’s attempt to shift liability for its actions to U.S. taxpayers.”

A spokesperson for Moderna said the company looks forward to “proving not only that Arbutus and Genevant sued the wrong party in the wrong court, but also, at the appropriate time, that there was no patent infringement here.”

The U.S. Department of Health and Human Services and U.S. Food and Drug Administration did not immediately respond to requests for comment.

Moderna and Pfizer’s COVID-19 vaccines have been subject to several patent lawsuits this year from companies that say they pioneered key technologies related to the shots. Moderna sued Pfizer for patent infringement in August.

Warminster Township, Pennsylvania-based Arbutus and Genevant — a joint venture between Arbutus and Roivant Sciences Ltd — sued Moderna for royalties on its multi-billion-dollar vaccines in February. They said the lipid nanoparticles used to transport genetic material from Moderna’s shots into human cells infringe their patents.

Moderna told the court in May that the lawsuit should have been filed against the federal government instead of the company because the shots were made for the government’s nationwide vaccination effort. It asked the court to dismiss the case, citing a federal law that was previously used to keep patent claims from interfering with the supply of war materials during World War One.

But Goldberg said Wednesday he could not rule at an early stage of the case that the vaccines were made “for the government” under the law.

“Based on the allegations of the Complaint, which I must accept as true, the development and sale of the vaccines was for the benefit of the vaccine’s recipients,” and the federal government was “an incidental beneficiary who bore an interest in ensuring the safety of its citizens,” Goldberg said.

Goldberg also said Moderna had not yet shown the vaccines were made with the United States’ “authorization and consent” as required by the law.

Moderna could still win on the issue after the record is more fully developed, Goldberg said.

Moderna has raised the same argument in another Delaware patent lawsuit brought by Alnylam Pharmaceuticals Inc. The court has not yet ruled on Moderna’s motion in that case.

The case is Arbutus Biopharma Corp v. Moderna Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-00252.

For Moderna: Patricia Carson and James Hurst of Kirkland & Ellis

For Arbutus and Genevant: David Berl of Williams & Connolly; and Daralyn Durie of Durie Tangri

Read more:

Arbutus files patent infringement lawsuit against Moderna related to COVID shot

Moderna says U.S. on the hook in COVID-19 vaccine patent case

Moderna again points at U.S. gov’t in COVID-19 vaccine patent lawsuit

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