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Federal jury rules in MSD’s favour in Gilead blockbuster hepatitis C drug dispute

Published on 23/03/16 at 09:34am

Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD and Ionis Pharmaceuticals, who claimed to hold crucial patents related to sofosbuvir, a compound key to Gilead’s global hepatitis C drug sales of $19 billion last year alone.

Following the ruling in their favour, MSD and Ionis Pharmaceuticals are set to claim royalties from Gilead’s global sales of their branded hepatitis C drugs, Harvoni and Sovaldi. In the original lawsuit filed by MSD, the company claimed 10% of royalties due to Gilead’s alleged infringement of two 2002 patents of nucleosides related to sofosbuvir. Ionis Pharmaceuticals, a co-inventor of these patents, is set to receive 20% of the damages awarded to Merck, as well as a 20% cut of all future royalty payments.

Hailed as a game-changer in the hepatitis C space, Sovaldi was awarded Drug Discovery of the Year 2016 by the British Pharmacological Society. Meeting a previously unmet medical need, the highly effective drug can cure a very high proportion of hepatitis C sufferers. The high demand, as well as high cost of the treatment which can cost between $84,000 and $94,500 per 12-week, has yielded very high sales for California-based Gilead. In Q1 2015 alone, Harvoni and Sovaldi were responsible for 60% of Gilead’s revenue.

These sales are set to take a hit, not only from this lawsuit, but from MSD’s recent FDA approval for competing drug, Zepatier, which some analysts suggested could end Gilead’s dominance in the sector.

Gilead spokesperson Michele Rest comments: “Although we are disappointed by the jury’s verdict today, there are a number of remaining issues to be decided by the jury and the judge.” She did not indicate whether or not an appeal would be made.

Ionics CEO Stanley Crooke reacts: “The verdict today confirms the validity and value of the intellectual property covering the nucleoside analogues and methods we and Merck invented to treat HCV.” According to Reuters, an MSD’s spokesperson said the verdict “accurately reflects the evidence in this case.”

Sean Murray

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