U.S. Federal Circuit Affirms All District Court Rulings in Patent Litigation – L… – Press Release


  • Infringement case now only focused on ‘793 patent, previously found to be invalid by PTAB in IPR
  • Federal Circuit expected to hear appeal of PTAB decision in late 4th quarter 2023 to early 2024
  • If PTAB decision affirmed, Liquidia will request final regulatory approval for YUTREPIA™ (treprostinil) inhalation powder

MORRISVILLE, N.C., July 24, 2023 (GLOBE NEWSWIRE) — Liquidia Corporation LQDA announced today that the Court of Appeals for the Federal Circuit (Federal Circuit) has affirmed all rulings by the United States District Court for the District of Delaware (District Court) in litigation filed by United Therapeutics (UTHR) under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman litigation), which alleged that Liquidia’s YUTREPIA™ (treprostinil) inhalation powder infringes U.S. Patent No. 9,593,066 (‘066 Patent) and U.S. Patent No. 10,716,793 (‘793 Patent). The District Court had previously ruled in August 2022 that five of the six asserted claims of the ‘066 patent are invalid, that the only valid asserted claim of the ‘066 patent is not infringed by Liquidia, and that Liquidia would induce infringement of the five asserted claims in the ‘793 patent based on the arguments presented at the District Court.

Today’s ruling does not affect the decision by the Patent Trial and Appeal Board (PTAB) in July 2022, which the PTAB re-affirmed in February 2023, that all claims in the ‘793 patent are unpatentable as supported by the inter partes review (IPR) filed by Liquidia. UTHR has appealed the PTAB’s decision to the Federal Circuit and briefing should be completed in the fourth quarter of 2023. The Federal Circuit has ordered that oral arguments are to be heard after briefing is completed on the next available date in the oral argument calendar, which is expected to be in late fourth quarter 2023 to early 2024. Once argued, the Federal Circuit could rule within a few days after oral argument, in the case of summary affirmance, or…