CORONA, Calif. The United States District Court for the Southern District of Florida ruled that Watson Pharmaceuticals’ naproxen sodium extended-release tablets, a generic version of the pain medication Naprelan, infringes the brand drug manufacturer’s patent, Watson announced Wednesday.
Elan initially brought the suit in October 1998 after Andrx filed an application for a generic version of the drug. In March 2002, the District Court ruled that Elan's '320 patent was invalid. Watson acquired Andrx in November 2006.
In May 2004, the United States Court of Appeals for the Federal Circuit reversed the District Court's finding of invalidity and remanded the case for further proceedings. In January 2005, Elan filed a related case against Andrx in the United States District Court for the Southern District of Florida alleging that Andrx's generic drug infringes the patent and is seeking damages for willful infringement. In late 2005, the parties completed briefing the District Court on the validity of the patent and whether Andrx's product infringes it, and the matter has been under submission to the District Court since then.
Watson said it intends to appeal the ruling.
Watson’s naproxen sodium tablets had sales of $4 million over the year ending June 30, according to IMS data.