According to Liquidia Corporation, United Therapeutics has agreed to a court judgment finding that Liquidia did not infringe United Therapeutic’s US Patent No. 9,604,901. In October 2021, an inter partes review by the US Patent Trial and Appeal Board (PTAB) determined that 7 of the 9 claims in that patent were invalid.
United Therapeutics initially filed suit against Liquidia in June 2020 alleging infringement of the ‘901 patent and US Patent No. 9,593,066, both of which cover Tyvaso treprostinil inhalation solution. The move came after the FDA accepted Liquidia’s NDA for Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) in April 2020.
The FDA tentatively approved the Yutrepia NDA in November 2021, and the stipulation regarding the ‘901 patent leaves only the dispute over US Patent No. 9,593,066 as an impediment to final approval. The PTAB has declined to institute an inter partes review of the ‘066 patent Liquidia noted, but said, “The Company remains confident in its arguments of non-infringement and invalidity to be made in district court with respect to the ‘066 patent.” Liquidia reports that trial is scheduled for the end of March 2022, and the company is being allowed by the court to file a motion for summary judgment to declare the ‘066 and ‘901 patents invalid.
United Therapeutics added claims related to infringement of US Patent No. 10,716,793 (“Treprostinil administration by inhalation”) to the suit in July 2020; however, the ‘793 patent cannot affect final approval of Yutrepia because it was not listed in the Orange Book to cover Tyvaso prior to submission of the Yutrepia NDA, Liquidia said. In addition, the PTAB initiated an inter partes review of that patent in August 2021. The regulatory stay will extend until October 27, 2022 unless the case is resolved prior to that date.
Liquidia CEO Damian deGoa commented, “We continue to methodically make our legal arguments in concurrent proceedings in district court and before the Patent Trial and Appeal Board (PTAB) that the patents that have been asserted against us by UTC are invalid and not infringed by our product. Today’s announcement adds to our confidence in our position when combined with the favorable ruling in the inter partes review (IPR) of the ‘901 patent, the PTAB’s decision to institute an IPR with respect to US Patent No. 10,716,793 (‘793 patent) and the favorable ruling with respect to the terms under consideration in the claim construction hearing. We will defend our right to bring Yutrepia to market for the benefit of PAH patients.”
In October 2021, the FDA issued a CRL to United Therapeutics’s NDA for its own dry powder treprostinil for PAH, Tyvaso DPI. The company licensed Treprostinil Technosphere from MannKind in September 2018 and submitted the NDA in April 2021.
Read the Liquidia Corporation press release.
