Depomed Inc. said a ruling Tuesday preserves its monopoly on the pain drug Gralise for a decade, allowing the small pharmaceutical company and its investors to breathe a huge sigh of relief.
According to a Depomed press release, U.S. District Judge Joel Pisano in Newark, N.J., upheld the validity of all seven of Depomed’s patents relating to Gralise, the company’s best-selling drug. The ruling, which followed a bench trial earlier this year, was still under seal at press time.
Gralise is prescribed to treat postherpetic neuralgia, the nerve pain that persists after a shingles outbreak. Sales of Gralise have been steadily growing, and it now pulls in more than $50 million in annual revenue for Newark, Calif.-based Depomed, making it the most profitable of the company’s quartet of pain meds.
Actavis sought regulatory approval in 2012 to market a low-cost version of Gralise. The application prompted Depomed to sue Actavis for patent infringement under the framework laid out in the Hatch-Waxman Act, the statute governing disputes between brand-name and generic companies.
Pisano held a bench trial in the case in May 2014. William Gaede III of McDermott Will & Emery made the case for Depomed, squaring off against Chad Landmon of Axinn Veltrop & Harkrider.
Depomed CEO Jim Schoeneck said in Tuesday’s press release that “this ruling provides for nearly 10 years of additional market exclusivity.”
Gaede, Depomed’s lead counsel, told us that Pisano’s ruling will most likely be unsealed this week.
Depomed’s lawyers also include David Larson and Bhanu Sadasivan of McDermott Will and Leda Dunn Wettre of Robinson Wettre & Miller. Actavis’ legal lineup also includes Jeremy Lowe and Jason Murata of Axinn Veltrop and Arnold Calmann of Saiber.