Liquidia loses partial Hatch-Waxman patent case to United Therapeutics

The U.S. District Court for the District of Delaware ruled that two claims in United Therapeutics Corporation's patent portfolio are valid and infringed by Liquidia Corporation, affecting the company's lead product, YUTREPIA (treprostinil) inhalation powder. The decision, issued on September 30, 2026, found that claims 1 and 14 of U.S. Patent No. 11,826,327 were infringed, while the remaining asserted claims were deemed invalid. This outcome stems from litigation filed by United Therapeutics under the Hatch-Waxman Act concerning the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Liquidia, which trades on the Nasdaq under the ticker LQDA, stated that it respectfully disagrees with the ruling regarding the two upheld claims. Chief Executive Officer Roger Jeffs said the company is fully prepared to pursue all available appellate options. Jeffs also noted that Liquidia intends to submit a supplement to YUTREPIA's New Drug Application to the Food and Drug Administration to remove the PH-ILD indication from the product label. The company emphasized that its commitment to patients remains unchanged despite the legal setback.

The court has directed both parties to submit a proposed form of judgment within one week, which will specify the remedies they propose for the infringement of claims 1 and 14. While the exact remedy remains uncertain, potential outcomes could range from removing the PH-ILD indication from YUTREPIA's label to a broader restriction on product availability. In post-trial briefs, United Therapeutics requested injunctive relief that would restrict YUTREPIA's availability on the market.

YUTREPIA was approved in 2025 for the treatment of pulmonary arterial hypertension (PAH) and PH-ILD to improve exercise ability. It is an inhaled dry-powder formulation of treprostinil delivered through a palm-sized device using Liquidia's proprietary PRINT technology. The company is also developing L606, an investigational extended-release formulation of treprostinil, and currently markets generic Treprostinil Injection for PAH. Given variables such as potential appeals and further proceedings, Liquidia stated that it is not possible at this time to reasonably estimate the range of potential outcomes or financial exposure.