Liquidia Corporation, a biopharmaceutical company, is facing new litigation filed by United Therapeutics Corporation. The complaint, filed in the U.S. District Court for the Middle District of North Carolina, alleges infringement of U.S. Patent No. 11,357,782 (the ‘782 patent) and seeks to enjoin Liquidia from commercializing Yutrepia™ (treprostinil) inhalation powder if approved by the U.S. Food and Drug Administration (FDA) to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The ‘782 patent, issued on June 14, 2022, claims the same general method of administering inhaled treprostinil to pulmonary hypertension patients as the previously invalidated ‘793 patent. The ‘793 patent was held to be invalid in a proceeding before the Patent Trial and Appeal Board (PTAB) and the decision was affirmed by the U.S. Court of Appeals for the Federal Circuit in December 2023. The United States Supreme Court rejected United Therapeutics' petition for a writ of certiorari, upholding the PTAB’s decision that found all claims of the ‘793 patent unpatentable due to prior art as final and not subject to further appeal.
Despite the new litigation, it does not impact the FDA’s ability to take final action on the New Drug Application (NDA) for Yutrepia, as the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025.
Liquidia Corporation, led by Dr. Roger Jeffs, is standing firm against the litigation, stating, “We are not surprised by UTHR’s repeated, last-minute attempts to deny PAH and PH-ILD patients access to an alternative therapy. We have invalidated similar claims covering the treatment of pulmonary hypertension patients with inhaled treprostinil in the past and will continue to defend the rights of patients suffering with these critical illnesses to choose the therapy that works best for them.”
In the midst of the litigation, Liquidia Corporation remains focused on developing and commercializing products in pulmonary hypertension and other applications of its proprietary PRINT® technology, including the lead candidate, Yutrepia™ (treprostinil) inhalation powder, and the investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, L606. Liquidia Corporation also currently markets generic treprostinil injection for the treatment of PAH. As a result of these announcements, the company's shares have moved -0.59% on the market, and are now trading at a price of $15.26. For more information, read the company's full 8-K submission here.
