Stipulation of Partial Judgment In Favor of Liquidia Filed In Hatch-Waxman Litigation

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[{"type":"text","content":"MORRISVILLE, N.C., Dec. 29, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that United Therapeutics Corporation (UTC) 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). Damian deGoa, Chief Executive Officer of Liquidia said: “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 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.” In June 2020, UTC filed a lawsuit against Liquidia under Hatch-Waxman for infringement of the ‘901 and ‘066 patents. Upon initiation of the lawsuit, the FDA triggered a statutory regulatory stay on the final approval of YUTREPIA until October 27, 2022, or earlier resolution or settlement of the ongoing litigation. UTC later amended the lawsuit to include the ‘793 patent, but the ‘793 patent is not subject to the FDA’s regulatory stay because it was not listed in the Orange Book for Tyvaso® when Liquidia submitted the New Drug Application (NDA) for YUTREPIA. In October 2020, the PTAB denied institution of an IPR against the ‘066 patent, a patent entitled “Process to Prepare Treprostinil, the Ac...

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