According to Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia’s submission of an sNDA for Yutrepia treprostinil DPI to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. Yutrepia was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH).
Liquidia notes that United Therapeutics is asserting infringement of US patent No. 10,716,793 and that the US Patent Trial and Appeal Board (PTAB) inter partes review in July 2022 found that none of the claims in ‘793 are patentable; however, litigation is ongoing.
In August 2022, the District Court ruled that Yutrepia would infringe on claims in the ‘793 patent. In February 2023, the PTAB declined to revisit its decision, leaving in place its determination that none of the claims are valid. The Court of Appeals recently upheld the District Court ruling saying that Yutrepia would infringe on the ‘793 patent. Liquidia says that it expects the current United Therapeutics appeal of the PTAB ruling to be concluded no later than mid-2024.
Liquidia CEO Roger Jeffs commented, “Our focus is and will always be on bringing better therapies and treatment options to patients. While we are disappointed that United Therapeutics has elected to file this lawsuit alleging that Yutrepia infringes this same patent that has already been litigated and already found by the PTAB to be invalid, it was expected. We will use the same aggressive and dedicated approach to defending this lawsuit as we have used in successfully resolving prior litigation that has been brought against us by United Therapeutics.”
Read the Liquidia Corporation press release.
