Liquidia says court denies motion for preliminary injunction filed by United Therapeutics

Liquidia (LQDA) announced that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that sought to block the launch of Liquidia’s YUTREPIA inhalation powder to treat pulmonary hypertension associated with interstitial lung disease. The ruling reinforces the clear path for the U.S. Food and Drug Administration to issue a final decision on the amended New Drug Application for YUTREPIA. The motion for preliminary injunction was filed in the lawsuit filed by UTHR in September 2023 in which it has alleged YUTREPIA would infringe U.S. Patent No. 11,826,327. While this ruling maintains the status quo in which there is no legal impediment to the FDA granting final approval to YUTREPIA, this lawsuit will continue forward to trial, which is currently scheduled for June 2025. Friday’s ruling follows earlier legal rulings from multiple bodies finding that YUTREPIA does not infringe any valid claim of the patents previously asserted by UTHR, including the decision by the Patent Trial and Appeal Board, affirmed by the U.S. Court of Appeals for the Federal Circuit, that all claims of U.S. Patent No. 10,716,793 to be unpatentable. UTHR has stated that it plans to appeal the Federal Circuit’s affirmation of the invalidity of the ‘793 Patent to the United States Supreme Court. Separately, UTHR has also appealed Judge Andrews’ ruling to set aside an injunction that he had previously issued blocking the launch of YUTREPIA based solely on the ‘793 Patent.