March 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff
FOSTER CITY, Calif. – Gilead Sciences could owe Merck more than $3 billion in a patent dispute over its block buster hepatitis C treatment if a jury finds Merck’s own hepatitis C patents are still viable, Bloomberg reported this morning.
Merck challenged the patents for California-based Gilead’s hepatitis C treatments Sovaldi and Harvoni, both of which provide a near cure for the disease. Last month, a judge found that Gilead did infringe on Merck’s patents. Now, it’s up to the jury to determine if those patents are valid and how much Merck could be awarded in damages, Bloomberg reported. Merck is seeking 10 percent of sales of the drugs. At stake is billions of dollars in annual revenue for Gilead. Harvoni generated nearly $20 billion in sales in 2015. Harvoni and Sovaldi helped drive Gilead to a record revenue year in 2015, nearly $32 billion—more than three times what the company generated in 2012.
Gilead will argue that its scientists were working on the hepatitis C compounds before Merck secured its own patents. The company will argue that the compound has its roots at Pharmasset Inc. , which Gilead acquired in 2011 for $11 billion, Bloomberg said. Merck will assert that its patents are its own and was used by Pharmasset to develop sofosbuvir, which became Harvoni. While there is a lot of money at stake, Merck is not seeking for Gilead to cease sales of Harvoni and Sovaldi in favor of its own recently approved hepatitis C drug, Zepatier.
Zepatier was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
But Gilead isn’t done developing treatments for hepatitis. In January, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for tenofovir alafenamide, an investigational, once-daily treatment for adults with chronic hepatitis B virus infection. The company is also continuing to use Sovaldi in combination with other drugs, including a triplet drug comprised of Sovaldi, velpatasvir, and a protease inhibitor for the treatment of genotype 3 HCV patients. Also, in the waning days of 2015, Harvoni was approved for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV by the FDA. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis.
Additionally, Gilead announced that the FDA granted priority review to the company’s NDA for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir, better known as Sovaldi, and velpatasvir, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus infection. Gilead filed the NDA for SOF/VEL on Oct. 28 and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016. The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options, Gilead said.
