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Liquidia Responds to United Therapeutics Corporation Lawsuit Alleging Infringement of Tyvaso Patents
RESEARCH TRIANGLE PARK, N.C., June 05, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company
About this update from Liquidia Corporation
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., June 05, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT® technology, today announced that United Therapeutics Corporation (UTC) filed a patent infringement action under the Hatch-Waxman Act against the Company in the U.S. District Court for the District of Delaware asserting infringement of U.S. Patent Nos. 9,604,901 (‘901) and 9,593,066 (‘066) relating to UTC’s Tyvaso, a nebulized treprostinil solution for the treatment of pulmonary arterial hypertension (PAH).\n This lawsuit is in response to the New Drug Application (NDA) the Company filed with the U.S. Food and Drug Administration (FDA) requesting approval to market LIQ861, a dry powder inhalation of treprostinil for the treatment of PAH. The LIQ861 NDA was filed under the 505(b)(2) regulatory pathway with Tyvaso® as the reference listed drug. Under the Hatch-Waxman Act, the FDA is automatically precluded from approving the LIQ861 NDA for up to 30 months or until resolution of the lawsuit, absent an earlier judgment unfavorable to UTC by the court. Although the Company believes its LIQ861 dry powder inhaler (DPI) for the treatment of PAH is highly differentiated from Tyvaso®, since the Company is seeking approval of the LIQ861 NDA under the 505(b)(2) regulatory pathway, the LIQ861 NDA is subject to the provisions of the Hatch-Waxman Act. “We believe these patents to be invalid and/or not infringed by the practice of LIQ861 and we will vigorously defend the suit and our freedom to pursue the commercialization of LIQ861,” stated Neal Fowler, Chief Executive Officer at Liquidia. “We are acutely aware of the need that exists among PAH patients to have access to treatments beyond those which are currently available and are dedicated to addressing that need in the most expedient way possible.” The Company previously filed two petitions for inter partes review (\"IPR\") before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) seeking a determination that all claims in the ‘066 and ‘901 patents are invalid. Both the ‘066 patent and the ‘901 patent are continuation patents of U.S. Patent No. 8,497,393 which was granted to UTC and subsequentl...