A record-breaking jury verdict in December 2016 declared that Gilead has infringed on patents over its Hepatitis C Drugs sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) and was charged $2.54 billion. This was the largest ever in a U.S. Patent Case. California-based Gilead reported that in 2017 it earned $9.1 billion on its four products to treat hepatitis C, including Harvoni and Sovaldi.
However, U.S. District Judge Leonard Stark has overturned the original verdict by confirming Merck & Company’s patent that was allegedly infringed on to be invalid. The Judge said it did not meet a requirement that it disclose how to make the treatment it covered without undue experimentation.
Gilead in a statement said it always believed the patent was invalid and was pleased the judge confirmed that opinion. Merck in a statement said it planned to appeal and believed the judge’s ruling did not reflect the facts of the case.
Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure. Direct-acting antivirals, such as Gilead’s Sovaldi and Harvoni, have revolutionized treatment, with cure rates of more than 90% shown in clinical trials. But there was a backlash from health insurers and other payers when Gilead launched Sovaldi at a price of $84,000 for a 12-week course.
Merck sells its own hepatitis C drug, elbasvir/grazoprevir (Zepatier). The company won a $200 million jury verdict in a separate patent infringement case against Gilead over hepatitis C drugs. But in June 2016, a federal judge in San Jose, California, overturned that verdict after finding that Merck engaged in a pattern of unethical conduct, including lying under oath. Merck has disputed the judge’s ruling and is appealing.