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United Therapeutics Announced It Prevailed in Dry Powder Inhaler Patent Litigation Vs Liquidia Technologies

Benzinga Real-time News ·  Aug 31, 2022 18:41

United 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. The 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. As 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). The 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. Both 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. The 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 decision, and if the PTAB does not reverse itself, the company will appeal. The '793 patent remains valid during the pendency of all appeals. United Therapeutics expects any IPR appeal process will likely take at least a year. During that time, the company expects that the Court's forthcoming injunction will remain in place and will not be lifted until such time, if ever, that the '793 patent is held invalid or not infringed after all appeals have been exhausted.

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