Liquidia says Supreme Court rejects United Therapeutics’ petition

Liquidia Corporation (LQDA) announced that the United States Supreme Court has rejected United Therapeutics’ (UTHR) petition for a writ of certiorari, which requested permission to appeal prior decisions which found that all claims of U.S. Patent No. 10,716,793 are unpatentable due to prior art. As a result, the decision by the Patent Trial and Appeal Board in July 2022, which was affirmed by the U.S. Court of Appeals for the Federal Circuit in December 2023, is now final and not subject to further appeal. On August 16, 2024, the U.S. Food and Drug Administration granted tentative approval of YUTREPIA inhalation powder to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. In doing so, FDA confirmed that the amendment to add PH-ILD to the YUTREPIA New Drug Application was proper and that application otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act. Final approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025. There are no patents that are preventing final FDA approval of YUTREPIA. None of the valid claims of the three patents asserted by UTHR in original Hatch-Waxman litigation have been found to be infringed. All of the decisions are final and not subject to further appeal. Additionally, the U.S. District Court of the District of Delaware denied UTHR’s request for a preliminary injunction with respect to a fourth patent, U.S. Patent No. 11,826,327 in a separate patent lawsuit filed by UTHR in September 2023. A trial in the ‘327 Patent lawsuit is scheduled for June 2025.