Liquidia Corporation, a biopharmaceutical company, has been the subject of new litigation filed by United Therapeutics Corporation (UTHR) regarding the alleged infringement of U.S. Patent No. 11,357,782 (the '782 patent). The complaint 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 claims the same general method of administering inhaled treprostinil to pulmonary hypertension patients as UTHR's previously invalidated '793 patent. Liquidia's CEO, Dr. Roger Jeffs, expressed the company's commitment to defending the rights of patients suffering from critical illnesses to choose the therapy that works best for them.
It's worth noting that the '793 patent was held to be invalid in a proceeding before the Patent Trial and Appeal Board (PTAB), and this decision was affirmed by the U.S. Court of Appeals for the Federal Circuit in December 2023. Furthermore, the United States Supreme Court rejected UTHR's petition for a writ of certiorari, upholding 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 ongoing litigation, UTHR is not currently seeking any injunction against the FDA to prevent final approval of the new drug application (NDA) for Yutrepia. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, for the NDA.
Liquidia Corporation's current focus includes the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® technology. This technology enabled the creation of Yutrepia™ (treprostinil) inhalation powder, an investigational drug for the treatment of PAH and PH-ILD. Additionally, the company is developing L606, an investigational sustained-release formulation of treprostinil administered twice daily with a next-generation nebulizer, and currently markets generic treprostinil injection for the treatment of PAH.
These developments mark a significant point in the ongoing legal and regulatory challenges faced by Liquidia Corporation as it seeks to advance its therapies for rare cardiopulmonary diseases. The market has reacted to these announcements by moving the company's shares -0.59% to a price of $15.26. For the full picture, make sure to review Liquidia Corp's 8-K report.
