United Therapeutics Corporation于2025年5月9日向美国北卡罗来纳州中区地方法院提起诉讼，指控Liquidia侵犯美国专利第11，357，782号。

2025-05-12 18:13

Additionally, the complaint seeks to enjoin Liquidia from commercializing YUTREPIA (treprostinil) inhalation powder if approved by the U.S. Food and Drug Administration (FDA) to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The ‘782 patent, which issued on June 14, 2022, arises out of the same patent family as U.S. Patent No. 10,716,793 (the ‘793 patent) and claims the same general method of administering inhaled treprostinil to pulmonary hypertension patients. As disclosed in July 2022, the ‘793 patent was held to be invalid in a proceeding before the Patent Trial and Appeal Board (PTAB). The PTAB's decision was affirmed by the U.S. Court of Appeals for the Federal Circuit in December 2023. The United States Supreme Court rejected UTHR's petition for a writ of certiorari, thereby upholding PTAB's decision which found that all claims of the ‘793 patent are unpatentable due to prior art as final and not subject to further appeal.
UTHR is currently not seeking any injunction against the FDA to prevent final approval of the New Drug Application (NDA) for YUTREPIA. As previously announced, the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025.