Judge reverses verdict in MSD/Gilead hepatitis C dispute

pharmafile | June 7, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Gilead, MSD, Merck, dispute, patent, reversal, sovaldi 

A US district judge has reversed a previous court decision which favoured MSD, called Merck in the US, over Gilead in a dispute related to patents on blockbuster hepatitis C drugs.

In the original court decision, MSD’s claim of patent protection related to sofosbuvir, a key compound in Gilead’s $19 billion a year blockbusters Harvoni and Sovaldi, was upheld. MSD’s case pointed to an alleged infringement of two 2002 patents of nucleosides related to sofosbuvir. A Californian federal jury ordered Gilead to pay MSD, and their partners on the patent Ionis Pharmaceuticals, $200 million as a result.

However, in the latest court hearing, US District Judge Beth Labson Freeman indicated that Gilead proved that in the process of applying for its patents, MSD deceptively used confidential information obtained from Pharmasset, a company bought by Gilead in 2011.

In her ruling, Freeman said that a retired MSD scientist “intentionally fabricated testimony” and that the company supported his “bad faith conduct”. She even went so far as to say that MSD’s own lawyer gave misleading and inconsistent testimony during the trial. She continued: “Merck’s acts are even more egregious because the main perpetrator of its misconduct was its attorney.”

This latest ruling will mean that Merck’s claim of patent protection regarding sofosbuvir is no longer valid. As well as the $200 million punitive measure now no longer required to be paid, the demand from MSD for an ongoing royalty of at least 12% of all future sales of the drugs would now appear void.

MSD, unsurprisingly, now plan to appeal this ruling. In a statement to Bloomberg, they said: “In its decision, the jury recognised that patent protections are essential to the development of new medical treatments. The compounds and methods at issue in this case facilitated significant advances in the treatment of patients with HCV infection, and achieving these advancements required many years of research and significant investment by Merck and its partners.”

They also added that the judge’s decision “does not reflect the facts of the case”.

Gilead also issued a statement, where they said: “We are pleased the court has ruled in Gilead’s favour and determined that Merck’s patents are unenforceable against Gilead, and therefore, Merck is not entitled to recover any damages.”

Sean Murray

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