According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal Board (PTAB) invalidating all of the claims of US Patent No. 10,716,793. Earlier this year, the Court of Appeals upheld a District Court ruling that Yutrepia would infringe some of the claims in the ‘793 patent, as alleged by Tyvaso maker United Therapeutics. The FDA tentatively approved Yutrepia in November 2021 for the treatment of pulmonary arterial hypertension (PAH).
In July 2023, Liquidia submitted an sNDA for the use of Yutrepia for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). In response, United Therapeutics filed a new suit alleging infringement of the ‘793 patent. Liquidia says that it will also now ask to have all of the claims in that suit related to the ‘793 patent dismissed.
Liquidia CEO Roger Jeffs commented, “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.”
Read the Liquidia press release.
