Merck suffers blow as $2.5bn Gilead fine overturned
District Judge Leonard Stark has reversed the record $2.54 billion verdict against Gilead Sciences for patent infringement, instead finding the patent in question to be invalid.
Stark overturned the jury verdict, delivered in December 2016, at the US District Court for the District of Delaware on Friday, February 16.
The damages verdict, which was the largest ever awarded in a US patent case, was the result of a dispute regarding “groundbreaking” work in developing direct-acting antiviral treatments for the hepatitis C virus (HCV), according to Stark.
The jury had found that biopharmaceutical company Gilead had infringed a patent held by rival through its HCV drugs Sovaldi (ledipasvir/sofosbuvir) and Harvoni (sofosbuvir). The patent in question, US number 7,608,597, covers a compound used in treatments for HCV.
Idenix, which was bought my Merck in 2014, applied for the patent in 2009. Idenix brought the lawsuit against Gilead in 2013, on the grounds that Gilead’s patents relating to Sovaldi were too similar to its earlier registered patent for HCV treatment.
The jury awarded $2.54 billion in damages, equating to a 10% running royalty on Gilead’s adjusted net sales revenue from the infringing products. The court rejected the request by Idenix for enhanced damages based on wilful infringement, LSIPR reported.
Gilead claimed the earlier registered patent had insufficient detail to be valid and filed a motion for judgment as a matter of law. It requested that the court set aside the jury’s verdict on the basis that Idenix’s asserted claims fail to meet the necessary standard of written description and enablement.
Stark agreed, finding that the ‘597 patent failed to disclose how to make and use the treatment it sought to cover. Gilead’s motion for judgment as a matter of law was granted on that basis, but was denied in relation to written description.
“A reasonable jury, even taking all the evidence in the light most favourable to Idenix and drawing all reasonable inferences in favour of Idenix, could only have concluded that Idenix’s ‘597 patent is invalid due to lack of enablement,” Stark said.
A spokesperson for Merck said the company plans to appeal against the decision, as the ruling does not reflect the facts.
“The patent 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,” they continued.
This is not the first time Gilead and Merck have met in court. LSIPR reported that in a separate patent infringement dispute related to hepatitis C treatments, Gilead was ordered to pay Merck $200 million in damages.
However in June 2016 District Judge Beth Freeman ruled that Gilead did not have to pay the damages, due to a “pervasive pattern of misconduct” from Merck, as reported by LSIPR.
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