US govt wades into Moderna COVID row

The pharma company is accused of using patented tech for a drug-delivery system without authorisation | Moderna sought to escape the suit by claiming that its contract with the US government conferred immunity.

The US government has urged a federal court to throw out patent infringement claims brought against Moderna in a suit focused on its COVID-19 vaccine.

In a statement of interest, filed on February 14 at the US District Court for the District of Delaware, the US government explained that Moderna had its “authorisation and consent” to manufacture and use inventions covered by US patents to produce a COVID-19 vaccine and was therefore shielded from patent litigation.

Back in March last year, Arbutus Biopharma and Genevant Sciences jointly sued Moderna over royalties from the sales of its COVID-19 vaccine, which they claimed uses their technology for a drug-delivery system without authorisation.

According to the complaint, Moderna’s breakthrough vaccine would not have been possible without the use of the technology Arbutus had already created and patented—a revolutionary lipid nanoparticle (LNP) delivery platform.

Moderna attempted to escape the suit by claiming that its contract with the US government conferred immunity. Moderna relied on 28 USC section 1498, which specifies that when an allegedly infringing product is used or manufactured by or for the US, the only remedy for the alleged infringement is an action against the US in the US Court of Federal Claims.

However, in November, the Delaware court denied Moderna’s motion to dismiss the claims.

District Judge Mitchell Goldberg, on behalf of the court, said: ”While discovery may reveal that all, some, or none of the alleged infringing activity was ‘for the government’, the limited record appropriate for consideration at this stage does not allow me to make any such determination.”

Now, the US government has intervened to state that the effect of its “authorisation and consent” is to relieve Moderna of any liability for patent infringement resulting in the performance of their contract (the -0100 Contract).

As a result, any liability for the manufacture or use of the inventions claimed in the patents-in-suit resulting from the authorised and consented acts is transferred to the US, said the government.

“And to the extent that any doubt otherwise existed, the government’s filing of this statement of interest and confirmation of its authorisation and consent should resolve the issue,” said the filing.

It added: “Accordingly, to the extent that any liability exists for infringement of the patents-in-suit by the manufacture or use of vaccine procured under the -0100 Contract, the patentee is limited to pursuing a claim against the US in the Court of Federal Claims.”

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