Idenix Pharmaceuticals has filed patent infringement and interference lawsuits against Gilead Sciences regarding the first-in-class, once-daily oral nucleotide inhibitor sofosbuvir that recently gained unanimous approval from the FDA’s Antiviral Drugs Advisory Committee.
“Idenix has invested significant resources in nucleoside drug discovery and in building an intellectual property portfolio that aids in the discovery and development of drugs for the treatment of the hepatitis C virus and other viral diseases,” Maria Stahl, senior vice president and general counsel at Idenix, said in the release. “While we have attempted to resolve this matter with Gilead without resorting to infringement litigation, we intend to diligently and vigorously protect our patent rights for the benefit of our company and our shareholders and prevent infringing use by others.”
Idenix filed a patent infringement lawsuit in the U.S. District Court in Boston alleging Gilead infringed on two patents co-owned by Idenix that cover HCV treatment using 2'-methyl nucleosides, the release said. Idenix is seeking a ruling that the imminent distribution, importation, use, sale or offer to sell sofosbuvir infringes on Idenix’s patents.
Idenix also filed a patent infringement and interference suit in the U.S. District Court in Wilmington, Del., alleging that Gilead is infringing on another Idenix co-owned patent covering methods of treating the hepatitis C virus using 2'-methyl-2'-fluoro nucleosides, the release said. Idenix is seeking a declaration that Gilead is infringing and also is seeking to have a separate patent owned by a Gilead subsidiary declared invalid.
The actions by Idenix were not unexpected, Cara Miller, senior director of public affairs for Gilead, told Healio.
"We are not surprised by the Idenix lawsuit and expected the company to file around the time of the sofosbuvir launch," she said. "We do not believe that sofosbuvir will infringe any valid patent claims of Idenix and we believe the lawsuits have no merit. We remain confident in and will defend our [intellectual property] and our right to make this product available to patients."
The companies have another patent interference case before the U.S. Patent and Trademark Office, and Gilead has previously filed lawsuits in several jurisdictions to potentially invalidate Idenix’s patents.
The FDA has set a target review date by Dec. 8 for a final decision on sofosbuvir. The advisory panel suggested FDA approval for sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection and sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naive adult patients with genotype 1 and 4 infection.