Court Rejects Moderna’s Challenge to Arbutus Biopharma Patents

A federal appeals court has struck down Moderna’s coronavirus vaccine-related challenge to patents held by Arbutus Biopharma.

The decision by the U.S. Court of Appeals for the Federal Circuit paves the way for a possible patent infringement complaint to be filed by Arbutus over its lipid nanoparticle technology allegedly used to help manufacture Moderna’s messenger RNA (mRNA)-based COVID-19 jab. Lipid nanoparticles are used to hold the genetic material in the vaccine and act as a delivery mechanism within the body.

Moderna previously challenged the patents before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, which found certain aspects of Arbutus’ patents invalid but signed off on other portions ― a decision that the federal court upheld.

So, what happens next?

Conceivably, Arbutus could file a lawsuit against Moderna seeking royalties from vaccine sales over aspects of the patents that were deemed infringed. And it might already be eyeing a piece of the action as the vaccine maker recently projected healthy full-year 2021 product sales of between $15 to $18 billion and 2022 sales between $17 to $22 billion.

Arbutus could not be reached for comment on the matter, while Moderna told FDAnews it welcomed the federal circuit court’s decision confirming that certain patent claims were invalid but that the company disagreed “with the remainder of the decisions maintaining certain other claims.”

“We are confident that Moderna’s COVID-19 vaccine is not covered by those claims,” the spokesperson added, asserting that the company developed its own proprietary lipid nanoparticle technology.

Moderna was also recently locked in a patent dispute with the National Institutes of Health (NIH) over who deserves credit for the mRNA substance used in the company’s COVID-19 vaccine (DID, Nov. 11).

Moderna disputed that three NIH scientists helped co-invent the mRNA sequence, but later said it was willing to list the government as co-owners on its patent applications, which would enable the government to license the patent to other companies.

Neither Moderna nor the NIH returned a request for comment on whether the matter had been fully resolved.

Read the federal circuit court’s ruling on the Arbutus Biopharma patents here: https://fdanews.com/moderna-v-arbutus.pdf. ― Jason Scott