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Merck’s appeal to restore hepatitis C patent verdict against Gilead fails

US Supreme Court rejects Merck’s appeal over patent dispute verdict of $2.54bn

Merck & Co’s appeal to restore a verdict against Gilead for infringing on a patent relating to a hepatitis C virus (HCV) treatment has been rejected by the US Supreme Court.

In 2016, a US federal court sided with Merck in a patent claim which stipulated that Gilead’s sofosbuvir – which features in its blockbuster Sovaldi and Harvoni HCV drugs – infringed on a patent held by Merck subsidiary Idenix Pharmaceuticals.

This patent covers a particular family of compounds that have the same basic chemical structure with properties that are effective against HCV.

The court awarded $2.54bn in damages to Merck as a result – this, however, was overturned by the US Court of Appeals for Federal Circuit in 2019, after the court determined that the patent was invalid.

The patent dispute dates back to August 2013, when Merck first contacted Gilead requesting that the company pay royalties on sofosbuvir and obtain a licence to patent.

Gilead also filed a lawsuit seeking a declaratory judgment that the Merck patent is invalid and not infringed on the basis that they "cover compounds which do not include, but may relate to, sofosbuvir".

Gilead alleged in the lawsuit that Merck had amended its patent application in an attempt to extend its coverage to include sofosbuvir.

“Idenix discovered that a single type of modified ribonucleoside inhibits the hepatitis C virus,” said Gilead.

“Yet it sought a patent covering a vast genus of billions of untested and largely unmade compounds that might later prove to have similar effect,” the company added.

Merck, when filing for its appeal to the Supreme Court, said that the 2019 ruling undermined biotechnology breakthroughs.

“The true innovation frequently consists of discovering a family of related compounds that produce a desired effect,” said Merck.

“Once that foundational discovery is made, making and testing any individual chemical variant in the family for that desired effect can be routine,” the company added.

Article by
Lucy Parsons

20th January 2021

From: Regulatory

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