LQDA - U.S. Federal Circuit Affirms Earlier PTAB Decision to Invalidate All Claims of United Therapeutics Patent No. 10716793 ('793 Patent) | Benzinga
- Liquidia will pursue final FDA approval for YUTREPIA™ (treprostinil) inhalation
- Liquidia will immediately request that District Court set aside injunction tied to ‘793 patent
MORRISVILLE, N.C., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA) (Liquidia or the Company) announced that the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) today affirmed the earlier decision by the Patent Trial and Appeal Board (PTAB) which found all claims of U.S. Patent No. 10,716,793 (‘793 Patent) to be unpatentable due to the existence of prior art cited by Liquidia in inter partes review (IPR) proceedings. As a result of today's decision, Liquidia will immediately seek to set aside the injunction issued by the U.S. District Court for the District of Delaware (District Court) in the lawsuit filed by United Therapeutics (UTHR) under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) and pursue final regulatory approval of YUTREPIA by the U.S. Food and Drug Administration (FDA).
Roger Jeffs, Chief Executive Officer of Liquidia, stated: "We are thrilled with the court's swift decision. We now have rulings from the Federal Circuit confirming that YUTREPIA does not infringe any valid claim in any of the three patents that were initially asserted by United Therapeutics. We will now direct our attention towards the more important goal of improving patients' lives and addressing unmet needs by seeking final FDA approval of YUTREPIA to treat PAH and, subsequently, PH-ILD."
As a result of today's decision, Liquidia will also seek to dismiss all claims related to the ‘793 patent in the second Hatch-Waxman lawsuit filed by UTHR in association with Liquidia's amended New Drug Application (NDA) to add the indication to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the YUTREPIA label. On November 30, 2023, UTHR filed an amended complaint in Hatch-Waxman litigation adding allegations that the Company infringes a newly issued patent, U.S. Patent No. 11,826,327 ('327 Patent). Because neither the '793 Patent nor the '327 Patent was issued prior to the filing of the original NDA for YUTREPIA, the Company believes UTHR is not entitled to a statutory 30-month stay with respect to either of these patents. The Company intends to vigorously defend itself against these allegations, so that patients suffering from PAH and PH-ILD can have the potential to access the Company's products.
The FDA tentatively approved YUTREPIA to treat pulmonary arterial hypertension (PAH) in November 2021. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024, for the PH-ILD indication.
About YUTREPIA™(treprostinil) inhalation powder
YUTREPIA is an investigational, inhaled dry powder formulation of treprostinil delivered through a ...