A federal judge has overturned a jury’s judgement requiring Gilead Sciences, Inc. (NASDAQ:GILD) to pay a record amount of $2.54 billion as its hepatitis C drugs Harvoni and Sovaldi infringed a patent owned by peer Merck & Co Inc. The decision had been the biggest ever in a United States patent case however, Leonard Stark, the U.S. District Judge in Wilmington, ruled Merck’s patent was unacceptable. He stated it didn’t fulfill a requirement that it reveal how to make the drug it covered without unwarranted experimentation.
Last week, Gilead reported that it always considered the patent was invalid and was delighted the judge validated that opinion. Merck stated that it intended to appeal and believed the ruling did not highlight the facts of the case. The verdict of December 2016 followed a trial in which judges established that Merck’s patent was valid.
Hepatitis C, anticipated to infect around 3.2 million people in America, is a viral ailment that causes liver inflammation that can result in failure of liver. Direct-acting antivirals, like Gilead’s Harvoni and Sovaldi, have revolutionized treatment, with treatment rates of over 90% demonstrated in clinical studies. But there was a criticism from health insurers as well as other payors when company introduced Sovaldi priced at $84,000 for a twelve-week course. Gilead stated that in 2017 it earned around $9 billion on its four offerings to cure hepatitis C, including Sovaldi and Harvoni.
Idenix sued Gilead Sciences in 2013 in an attempt to block the release of Sovaldi, which was permitted by the U.S. FDA in December 2013. Harvoni was permitted in October 2014. Merck offers its own hepatitis C medication named Zepatier. The firm won a jury verdict in March 2017 in a separate patent infringement litigation against Gilead Sciences over hepatitis C drugs. However, in June 2016, this verdict was overturned by a federal judge in San Jose, after noting that Merck involved in an arrangement of unethical conduct. Merck has disputed the ruling and is appealing.