According to Liquidia, the US Patent Trial and Appeal Board (PTAB) has denied a request by United Therapeutics to revisit the board’s July 2022 determination that none of the claims in US Patent No. 10,716,793, covering Tyvaso inhaled treprostinil, are patentable. Liquidia said that it expects United Therapeutics to appeal the denial of the rehearing to the US Court of Appeals.
United Therapeutics initially sued Liquidia for violating Tyvaso patents in June 2020 after the FDA accepted Liquidia’s NDA for Yutrepia treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA tentatively approved the NDA for Yutrepia in November 2021.
In August 2022, The US District Court for the District of Delaware determined that Yutrepia would infringe claims on the ‘793 patent. Liquidia notes that if the Court of Appeals upholds the most recent PTAB decision, the District Court ruling will not matter because the ‘793 patent would be cancelled.
Liquidia CEO Roger Jeffs said, “We are pleased that the PTAB has confirmed its earlier determination that all claims of the ‘793 patent are invalid. Our focus remains to bring Yutrepia treprostinil inhalation powder as a differentiated treatment choice to patients and their providers. This decision takes us one important step closer to that goal as the countdown towards final resolution of the litigation, and potential full approval of Yutrepia, has now begun. Depending on the outcome of the appeals, the scheduling of oral arguments and the possibility of summary affirmance, we remain confident that we will reach final legal resolution in late 2023 or the first half of 2024.”
Read the Liquidia press release.
