United Therapeutics says wins appeal in dry powder inhaler patent litigation

United Therapeutics (UTHR) announced that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc (LQDA). The Federal Circuit affirmed that Liquidia’s proposed Yutrepia product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793. As a result, the U.S. FDA cannot grant Liquidia final approval for its Yutrepia product until expiration of the ‘793 patent, May 14, 2027, except in certain circumstances. The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ‘793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ‘066 patent), are either invalid or not infringed by Liquidia. The ‘066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso Inhalation Solution and Tyvaso DPI Inhalation Powder. “Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property,” said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics.