Court Rules on Patent Validity in Pulmonary Hypertension Drug Dispute
A Delaware district court ruled that two of six patent claims for Liquidia's YUTREPIA inhalation powder are valid and infringed, while finding the remaining claims invalid. The company disagrees with the ruling and plans to pursue appellate options while submitting a supplemental New Drug Application to remove the pulmonary hypertension with interstitial lung disease indication from the product label. The court will determine remedies following submission of judgment forms from both parties.
Liquidia's YUTREPIA, an inhaled powder formulation of treprostinil approved in 2025, treats two types of pulmonary hypertension. The company uses proprietary PRINT technology to create uniformly sized drug particles optimized for lung delivery. The Delaware court's mixed ruling invalidated four of six patent claims while upholding two claims specific to treating pulmonary hypertension combined with interstitial lung disease, creating uncertainty about the product's market position.
The company plans to voluntarily remove the PH-ILD indication from YUTREPIA's label while pursuing appeals. United Therapeutics, the patent holder, has requested injunctive relief that could severely restrict or block market availability. The court will soon determine remedies after both parties submit proposed judgments, though the exact consequences remain unclear given multiple ongoing legal proceedings.
This patent dispute could significantly impact patient access to a recently approved treatment option for a serious respiratory condition. If broad injunctive relief is granted, patients with PH-ILD may face limited therapeutic alternatives, potentially affecting disease management strategies. Conversely, Liquidia's label modification may allow continued patient access while the appeal proceeds. The outcome may also influence how companies develop and commercialize novel drug delivery technologies, particularly in rare respiratory disease markets where innovation and patent protection intersect.