Moderna Fails to Convince Judge that US Government Should Have Been Sued for its COVID-19 Vaccine Patent Not Them

On Friday, Moderna failed to convince a federal judge that it should not have to face a patent lawsuit over its COVID-19 vaccine and that the US government should have been sued instead.

In 2022, Arbutus Biopharma Corp and Genevant Sciences filed a lawsuit against Moderna in the U.S. District Court for the District of Delaware, accusing the vaccine manufacturer of patent infringement on its COVID-19 vaccine.

The two biotech companies sued Moderna over infringement claims on six patents concerning the manufacture and sale of Moderna’s Covid-19 vaccine.

More from BioPharmaDive:

Arbutus and Genevant’s lawsuit escalates a yearslong dispute with Moderna that’s already wound its way through a federal patent appeal board and a federal appeals court.

At issue are microscopic fat-like particles that Arbutus scientists developed to shield messenger RNA delivered into the body — inventions awarded several U.S. patents which Arbutus and partner Genevant allege Moderna infringed with its COVID-19 vaccine Spikevax.

In court documents, the two cited several disclosures in scientific publications describing early studies of what would become Spikevax, including one coauthored by National Institutes of Health scientists that was published in The New England Journal of Medicine. The papers, Arbutus and Genevant claim, show Moderna’s vaccine uses so-called lipid nanoparticles that are covered by six separate patents they hold.

Arbutus and Genevant are not seeking an injunction on sales of Spikevax, which last year earned Moderna nearly $19 billion.

But they’re hoping to win a judgement that Moderna infringed six of their patents and to secure damages no less than a “reasonable royalty” on Moderna’s sales. Mani Foroohar, an analyst at SVB Leerink who covers Moderna, expects a single-digit royalty could be expected should the court rule against Moderna, which would still equate to a significant sum.

Moderna released a statement to The Hill and denied these allegations of patent infringement.

For the second time, U.S. District Judge Mitchell Goldberg has ruled that Moderna has failed to prove that the government should be the appropriate target of a case brought by Arbutus Biopharma Corp and Genevant Sciences GmbH.

“The U.S. Justice Department said in a court filing last month that it supports Moderna’s position, arguing that the company should not be liable for shots provided under its contract with the government as part of Operation Warp Speed,” AP reported.

“Goldberg ruled Friday that Moderna’s request was still premature and said details were still emerging about the scope of the company’s government agreements,” it added.

Moderna said that the US government was the appropriate target of the claims because the company manufactured its vaccine for the government’s nationwide vaccination effort.

But it contradicts what was said by the company’s CEO, Stephane Bancel, who said that 100,000 doses of COVID-19 vaccine were manufactured in 2019 before the pandemic began.

CNBC host Rebecca Quick also revealed that Bancel told her during a WEF meeting in 2020 that Moderna was already working on a COVID-19 vaccine, even though the disease did not yet exist at the time.

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