Liquidia Provides Update on U.S. Patent Trial and Appeal Board Decision on Inter Partes Review of Two United Therapeutics’ Tyvaso Patents

PTAB Institutes Inter Partes Review Proceeding Against United Therapeutics’ ‘901 Patent and Denies Institution on ‘066 Patent for Tyvaso

RESEARCH TRIANGLE PARK, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (NASDAQ: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT technology, today announced that the U.S. Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) against U.S. Patent No. 9,604,901 (‘901) and concurrently denied institution on 9,593,066 (‘066), both owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso (treprostinil).

For ‘901, the PTAB Institution Decision states that “based on the information presented, we institute an inter partes review of claims 1–9 of the ’901 patent.”

Conversely, for ‘066, the PTAB denied institution of IPR stating that the petition “has not established a reasonable likelihood that it would prevail in showing that at least one of the challenged claims is unpatentable.”

“The PTAB’s decision to institute an IPR proceeding against the ‘901 patent for Tyvaso is another important step forward for Liquidia’s ongoing effort to bring LIQ861, a convenient and well tolerated treatment option, to the PAH community,” stated Neal Fowler, Chief Executive Officer at Liquidia. “We believe PTAB’s decision on ‘066 to be in error and while there are options for reconsideration, we remain confident in the arguments of non-infringement and invalidity to be made in district court.”

Mr. Fowler added, “The Liquidia management team and our board are committed to providing PAH patients with alternative treatment options, like LIQ861, that we believe they need and deserve. We will not be deterred by any effort to limit our ability to deliver on this goal for patients and are confident in our options to bring LIQ861 to commercialization.”

Liquidia’s 505(b)(2) New Drug Application (NDA) for LIQ861, a dry powder inhalation of treprostinil, is currently under active review by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). Tyvaso, a nebulized treprostinil solution, is the Reference Listed Drug for the LIQ861 NDA.

On June 4th, UTC filed a lawsuit against Liquidia under the Hatch-Waxman Act, based on the LIQ861 NDA, for infringement of Tyvaso patents that triggered a 30-month stay on an FDA regulatory approval. The 30-month stay expires on the earlier of October 24, 2022 or resolution of the litigation, whichever occurs first.