Court Orders Gilead to Pay Merck in Hepatitis C Drug Patent Lawsuit

Gilead Sciences has been ordered by a federal jury to pay billions to pharmaceutical giant Merck in another round of court battles over a hepatitis C drug.

The case in United States District Court for the District of Delaware involved claims that Gilead had infringed on a patent for methods used to develop medicines that were based on sofosbuvir, the generic name for Sovaldi, Gilead’s blockbuster hepatitis C drug. In a decision announced in mid-December, the jury ordered Gilead to pay $2.54 billion in damages to Merck for infringing upon a patent held by Idenix Pharmaceuticals, Inc, a Merck-owned company.

“The jury awarded the damages as compensation for infringement through August 2016,” noted a news release from Merck. “In its decision, the jury also concluded that Gilead “willfully” infringed upon the patent. As a result, Judge Leonard P. Stark, may, at his discretion, increase the damages award up to a multiple of three times.”

The patent allowed for significant progress in treatment of hepatitis C and had been “appropriately granted.”

“Achieving these advancements required many years of research and significant investment by our subsidiary and its partners,” the release stated.

The court rejected Gilead’s claim that a patent owned by Idenix was invalid. The damages set by the jury are 10% of royalties on $25.4 billion generated from Gilead’s US sales of its hepatitis C drugs Sovaldi and Harvoni, according to court documents.

Gilead officials did not issue a statement, but an emailed comment from its public affairs department to MD Magazine stated that the company will appeal the decision. “Gilead respectfully disagrees with the jury's verdict and damage award, and intends to vigorously challenge this outcome through the appeal process,” the email said. “We remain steadfast in our opinion that Idenix's US patent is invalid, and since they made no contribution and assumed none of the risk in the discovery and development of sofosbuvir and its metabolites, do not believe they are entitled to any level of damages.”

The Gilead email added that the company did not expect the ruling to have an impact on its ability to make the drug sofosbuvir available in the US.

This is just the latest round in a battle over patents involving sofosbuvir between Merck and Gilead. Earlier this year, a California federal judge, citing attorney misconduct, overturned a jury decision that required Gilead to pay Merck $200 million in damages in a different patent lawsuit.

Gilead began making headlines almost as soon as Sovaldi was approved by the US Food and Drug Administration (FDA) in late 2013. Sovaldi was one of the first of several new direct-acting antiviral hepatitis C drugs now on the market to treat the liver-damaging virus faster and with fewer side effects than older interferon-based treatments.

The news release was provided by Merck.

Related Coverage:

Federal Judge Denies Merck Jury Award in Hepatitis C Suit

Gilead Seeks FDA Approval for New Hepatitis C Treatment

Federal Jury Awards Merck $200 Million in Patent Case Against Gilead