Posts Tagged: "Sovaldi"

On Wednesday, April 25th, the Court of Appeals for the Federal Circuit issued a precedential decision in Gilead Sciences v. Merck & Co. et. al., which affirmed a lower court’s ruling that Merck could not assert claims from two patents against Gilead because Merck had unclean hands regarding the patents. The case, coming out of the Northern District of California, involves patents covering methods for effectively treating the hepatitis C virus (HCV)… Reviewing the facts of the case, the Federal Circuit panel found sufficient evidence supporting the district court’s findings of serious business misconduct by Merck, that Merck’s misconduct was related to the litigation and that litigation misconduct had occurred based on false testimony provided by Merck’s non-firewalled patent lawyer, who had originally testified that he was not a party to the March 2004 phone call with Pharmasset.

On Thursday, December 15th, a subsidiary of Kenilworth, NJ-based pharmaceutical developer Merck & Co. (NYSE:MRK) was awarded $2.54 in royalty damages in a case involving one of the most popular available treatments for combating the hepatitis C virus (HCV). A federal jury decided that Gilead Sciences Inc. (NASDAQ:GILD), an American biotech firm headquartered in Foster City, CA, owed these royalties as a result of its infringement of patents for HCV treatments held by Merck’s Cambridge, MA-based subsidiary Idenix Pharmaceuticals. According to coverage of the verdict by Bloomberg, this $2.54 billion royalties award is the largest verdict for patent infringement in the history of the United States. The case was decided by jury in the U.S. District Court for the District of Delaware (D. Del.).

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.