Press release
United Therapeutics Prevails in Dry Powder Inhaler Patent Litigation
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced
About this update from United Therapeutics Corporation
[{"type":"text","content":" SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States District Court for the District of Delaware issued an opinion in the pending litigation concerning United Therapeutics’ U.S. patents 9,593,066 (the ’066 patent) and 10,716,793 (the ’793 patent). This litigation concerns whether Liquidia Technologies, Inc.’s proposed treprostinil inhalation powder, YutrepiaTM, would infringe the ’066 and ’793 patents.\n\nThe Court determined that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Court also concluded that Liquidia failed to prove that any claim of the ’793 patent at issue is invalid.\n\nAs a result of the Court’s decision, United Therapeutics expects the Court to enter an injunction barring the U.S. Food and Drug Administration from granting final approval for Yutrepia until expiration of the ’793 patent, May 14, 2027, as required by 35 U.S.C. § 271(e)(4)(A).\n\nThe Court also determined that Yutrepia would infringe several claims of the ’066 patent, but found those claims to be invalid. The ‘066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI™ (treprostinil) Inhalation Powder.\n\nBoth parties have the right to appeal. United Therapeutics is evaluating the Court’s opinion and next steps, including the potential for appealing the Court’s decisions on the ’066 patent.\n\n“We’re pleased with the Court’s decision on the ’793 patent, and our legal team is evaluating options for the ’066 patent,” said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics. “Today’s decision vindicates our claims that Yutrepia is an infringing product, and we will continue to vigorously defend our intellectual property.”\n\nThe Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office recently issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia. That final written decision held that the ’793 patent is invalid. United Therapeutics has requested rehearing regarding that de...