litigation
confidence high
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materiality 0.85
Federal Circuit cancels key Tyvaso patent; Liquidia may launch Yutrepia sooner
UNITED THERAPEUTICS Corp
- Court affirmed IPR decision canceling claims of U.S. Patent No. 10,716,793 covering Tyvaso and Tyvaso DPI.
- Liquidia can seek final FDA approval for Yutrepia unless the decision is reversed on further appeal.
- United Therapeutics can request rehearing or petition the Supreme Court; patent claims remain valid until appeals exhausted.
- Separate lawsuit filed Sep 2023 alleges Yutrepia amendments infringe new patent (11,826,327) expiring Jan 2042.
- FDA tentatively approved Yutrepia for PAH in Nov 2021; final approval also requires lifting of District Court order.