“The district court did not clearly err in finding Galderma did not prove the two-stage dissolution test represented in Lupin’s product,” Judge Moore wrote. The Federal Circuit also sided with Judge Bibas’ choice to credit Lupin’s expert testimony over Galderma’s.
Following the court’s ruling, Lupin announced the launch of what it described as the “first generic version of Oracea,” marking a significant victory for the Indian pharmaceutical company in the competitive generic drug market.
The patents in question are U.S. Patent Nos. 7,749,532 and 8,206,740, covering aspects of the Oracea formulation. Galderma, a former subsidiary of Nestlé and L’Oréal, had sought to protect its product from generic competition. However, the Federal Circuit’s ruling now opens the door for Lupin to market its generic version.
Representatives for both companies declined to comment on the ruling. The case is Galderma Laboratories L.P. v. Lupin Inc., case number 24-1664, in the U.S. Court of Appeals for the Federal Circuit.
