Court Rules YUTREPIA® Infringes Two Claims of United Therapeutics Patent

Liquidia Corporation announced an adverse ruling in its Hatch-Waxman patent litigation with United Therapeutics. The U.S. District Court for the District of Delaware found that Liquidia's lead product, YUTREPIA®, infringes on two claims of U.S. Patent No. 11,826,327. The company intends to appeal the decision and take steps to remove the affected indication from its product label.

Key Details

• Ruling: The Court ruled that claims 1 and 14 of the patent, which cover treating pulmonary hypertension with interstitial lung disease (PH-ILD) with inhaled treprostinil, are valid and infringed.
• Next Steps: Both parties must submit a proposed form of judgment and remedy to the Court within one week. Potential remedies could range from removing the PH-ILD indication from YUTREPIA's label to broader market restrictions.
• Company Response: Liquidia stated it will pursue all available appellate options and intends to submit a supplement to the FDA to remove the PH-ILD indication from YUTREPIA's label. The financial exposure from the ruling is currently not estimable.