King & Spalding life sciences patent litigators Gerald Flattmann, Vanessa Yen, and Evan Diamond secured another major victory for Galderma Laboratories.
After Sun Pharmaceuticals sought to market a product bioequivalent to Galderma’s Oracea® Capsules, but with a purportedly “differentiated” formulation, Galderma brought claims under the Hatch-Waxman Act alleging patent infringement.
Following a three-day bench trial in December 2018, Chief Judge Leonard P. Stark of the United States District Court for the District of Delaware ruled that Sun’s product directly infringed on Galderma’s formulation patents, despite Sun’s claims of being specifically designed with different formulation. Judge Stark also rejected Sun’s assertion that Galderma’s patents were invalid. As a result, the market exclusivity for Galderma’s flagship Oracea® product continues to be protected through December 24, 2025.