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2 December 2021AmericasMuireann Bolger

Moderna exposed after losing COVID-19 vaccine patent decision

Moderna has failed to reverse an unfavourable ruling related to its COVID-19 vaccine technology, after the  US Court of Appeals for the Federal Circuit upheld the validity of a patent owned by  Arbutus Biopharma.

A three-judge Federal Circuit panel delivered its  decision yesterday, December 1, holding that Moderna could not overturn a ruling by the  Patent Trial and Appeal Board (PTAB).

The patents, US numbers 8,058,069 and 9,364,435, relate to a composition based on lipid nanoparticle technology that delivers nucleic acid payloads to allow the human body to make its own therapeutic proteins.

Back in 2020, Moderna petitioned for an inter partes review of the Arbutus patents that covered this tech, a key component of its COVID-19 vaccine. But the board found in favour of the majority of the arguments presented by Arbutus defending the validity of the patents.

Moderna appealed the board’s decision that it had failed to show that claims 7–8, 10–11, 13, and 16–20 of the ‘435 patent were not anticipated and/or would not have been obvious.

But the Federal Circuit agreed with Arbutus that the technology was novel at the time of its development.

The panel also found that Moderna fell short of its burden to demonstrate that at the time it filed this appeal, it had suffered or was suffering a “concrete” injury from the existence of the ’435 patent.

The Federal Circuit also cast doubt on Moderna’s claims that if the patents were upheld, that it would be exposed to an infringement suit by Arbutus, holding that “it was impossible to determine whether Moderna was already sufficiently underway with its development of a COVID-19 vaccine to ‘create[] a substantial risk of future infringement or likely cause the patentee to assert a claim of infringement’.”

Conversely, the court found that Arbutus had standing to appeal the board’s decision that claims 1–6, 9, 12, and 14–15 of the’435 patent were unpatentable.

The Federal Circuit dismissed Moderna’s appeal for lack of standing and affirmed Arbutus’ cross appeal. The trading price of Arbutus shares jumped as much as 95% after the court posted its opinions on its electronic docket, according to a  post by law firm Wilson Sonsini Goodrich & Rosati, which represented Arbutus.

This latest blow to Moderna comes as it is locked in a  dispute with the US National Institute of Health over its alleged failure to give due recognition to three scientists as inventors on its COVID-19 vaccine application.

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