Gilead Wins Reversal of $2.54-Billion Hep C Patent Verdict

Feb 28, 2018
By BioPharm International Editors

On Feb. 16, 2018, a federal judge in Wilmington, DE reversed a 2016 jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead’s two best-selling Hepatitis C drugs, Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir). The judge, United States District Judge Leonard Stark, also ruled against Merck’s claims to royalties on sofosbuvir, an active ingredient in the two drugs, on the grounds that the claims were invalid and “too broad”.

According to the US District Court for the District of Delaware, after a two week-trial in December 2016, a jury found that Gilead failed to prove that asserted claims against it were invalid and awarded Merck and its subsidiary, Idenix Pharmaceuticals, $2.54 billion in damages. Idenix, which Merck acquired for $3.85 billion in 2014, had charged that Harvoni and Solvadi infringed on US Patent No. 7,608,597 (‘597 patent), which covers the methods and compositions for treating hepatitis C virus.

The case began in 2013 when Idenix, , sued Gilead for patent infringement involving the methods used in the development of sofosbuvir. Gilead received sofosbuvir when it acquired Pharmasset, a clinical-stage pharmaceutical company, in 2012 for $11.2 billion.

In August 2013, Idenix requested that Gilead pay royalties for sofosbuvir sales and that Gilead obtain a license to its US patents 7,105,499 and 8,481,712, which both describe nucleoside derivatives as inhibitors of RNA-dependent RNA viral polymerase. Gilead then filed a lawsuit in August 2013 in a federal district court in California seeking a declaratory judgment that the Merck patents were invalid and not infringed.

Judge Stark’s ruling states that “Idenix' s point only effectively reduces the ‘scope’ of the structural limitations from billions of compounds to, likely, millions or at least many, many thousands.” The judge concluded in his ruling that the '597 patent is invalid for “lack of enablement”and granted Gilead's renewed motion for judgment.

Source: United States District Court for the District of Delaware

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