Supreme Court Declines to Review United Therapeutics' Patent, Clearing Path for YUTREPIA
Key Insights
The U.S. Supreme Court rejected United Therapeutics (search)' appeal regarding the invalidation of its U.S. Patent No. 10,716,793.
This decision finalizes rulings that Liquidia (search)'s YUTREPIA (search) does not infringe any valid claims of United Therapeutics (search)' patents.
Tentative FDA approval for YUTREPIA (search) to treat pulmonary arterial hypertension (search) (PAH) and pulmonary hypertension associated with interstitial lung disease (search) (PH-ILD) was previously granted.
Liquidia (search) Corporation announced that the United States Supreme Court has denied United Therapeutics (search)’ (UTHR) petition for a writ of certiorari, which requested permission to appeal prior decisions which found that all claims of U.S. Patent No. 10,716,793 are unpatentable due to prior art. The denial clears the path for Liquidia's YUTREPIA (search) (treprostinil) inhalation powder, a treatment for adults with pulmonary arterial hypertension (search) (PAH) and pulmonary hypertension associated with interstitial lung disease (search) (PH-ILD). The Supreme Court's decision affirms the previous rulings by the Patent Trial and Appeal Board (PTAB) and the U.S. Court of Appeals for the Federal Circuit.
Implications for YUTREPIA
With the patent dispute resolved, Liquidia (search) anticipates the final FDA approval of YUTREPIA (search) for PAH and PH-ILD after May 23, 2025, following the expiration of the 3-year regulatory exclusivity for Tyvaso DPI (search). According to Liquidia CEO Dr. Roger Jeffs, the company will continue to fight for the earliest possible launch of YUTREPIA so that patients and physicians have access to the unique benefits that YUTREPIA can provide.
YUTREPIA: A Novel Inhaled Therapy
YUTREPIA (search) is an inhaled dry-powder formulation of treprostinil, administered via a user-friendly, palm-sized device. The drug is formulated using Liquidia (search)’s PRINT technology, which ensures precise and uniform drug particles for enhanced lung deposition after oral inhalation. Clinical trials, including the INSPIRE Phase 3 study, have evaluated YUTREPIA in PAH patients, demonstrating its safety and pharmacology. The ongoing ASCENT trial is further assessing YUTREPIA's dosing and tolerability profile in PH-ILD patients.
Current Status and Future Outlook
The FDA granted tentative approval for YUTREPIA (search) on August 16, 2024, confirming the suitability of the New Drug Application (NDA) amendment for PH-ILD. Liquidia (search) is also developing L606, a sustained-release treprostinil formulation administered twice-daily via a next-generation nebulizer, and currently markets generic Treprostinil Injection for PAH treatment.