LQDA - District Court Issues Favorable Ruling and Denies United Therapeutics' Request to Block YUTREPIA™ Launch | Benzinga
- On May 31, Judge Andrews denied United Therapeutics' motion for a preliminary injunction to block the launch of YUTREPIA in the PH-ILD indication
- Ruling reinforces the clear path for FDA to issue final decision on amended NDA for YUTREPIA to treat both PAH and PH-ILD
MORRISVILLE, N.C., June 03, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA) announced today that on May 31, Judge Andrews of the U.S. District Court for the District of Delaware (District Court) denied the motion for preliminary injunction filed by United Therapeutics (UTHR) that sought to block the launch of Liquidia's YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The ruling reinforces the clear path for the U.S. Food and Drug Administration (FDA) to issue a final decision on the amended New Drug Application (NDA) for YUTREPIA.
Dr. Roger Jeffs, Chief Executive Officer of Liquidia, said: "We are pleased that Judge Andrews ruled that United Therapeutics' request for an injunction failed on critical grounds, including UTHR's failure to show our obviousness challenge lacks substantial merit and UTHR's failure to show that the public interest weighs in favor of an injunction. While we await a final FDA action, we will continue to intensify our commercial preparations as we work to make this important treatment option available to pulmonary arterial hypertension (PAH) and PH-ILD patients."
The motion for preliminary injunction was filed in the lawsuit (Case No. 23-975) filed by UTHR in September 2023 in which it has alleged YUTREPIA would infringe U.S. Patent No. 11,826,327 (‘327 patent). 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 (Federal Circuit), that all claims of U.S. Patent No. 10,716,793 (‘793 Patent) to be unpatentable. UTHR has stated that it plans to appeal the Federal Circuit's affirmation of the invalidity ...