MORRISVILLE – Triangle drug firm Liquidia’s legal battle with United Therapeutics over patent issues and a new drug to treat pulmonary arterial hypertension is still headed for a court trial in March, but the company’s CEO is encouraged by a “partial judgment” in ongoing legal proceedings.
“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,” CEO Damian deGoa said earlier this week. “[The Dec. 29] 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 U.S. 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.”
Liquidia earlier this year has gained tentative approval from theFDA for Yutrepia, its inhalation powder for treating pulmonary arterial hypertension (PAH).
Tentative approval means that Yutrepia, a formulation of treprostinil, a pulmonary and systemic vasodilator, has met all regulatory standards for quality, safety and efficacy required for approval in the United States.
The battle with United Therapeutics, which also has a major presence in the Triangle, is an extremely complicated one involving multple patent questions. Liquidia noted that United Therapeutics “has filed a stipulation of partial judgment with respect to U.S. Patent No. 9,604,901 (‘901 patent) in the on-going litigation under the Hatch-Waxman Act (Hatch-Waxman). Under the stipulation of partial judgment, UTC has agreed to the entry of judgment of Liquidia’s non-infringement of the ’901 patent based on the Court’s construction of certain terms in the patent. UTC has preserved its appellate rights with respect to the ‘901 patent in the event the Court’s construction of those terms is reversed. With this stipulation of partial judgment, only U.S. Patent No. 9,593,066 (‘066 patent) will now serve as a basis for the on-going regulatory stay for final approval of Yutrepia (treprostinil) inhalation powder by the U.S. Food and Drug Administration (FDA).”