Liquidia Responds to United Therapeutics Corporation Lawsuit Alleging Infringement of New Tyvaso Patent

RESEARCH TRIANGLE PARK, N.C., July 24, 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 an amended complaint in its patent infringement action under the Hatch-Waxman Act against the Company in the U.S. District Court for the District of Delaware. The amended complaint asserts infringement of an additional recently issued U.S. Patent No. 10,716,793 (‘793) allegedly relating to UTC’s Tyvaso, a nebulized treprostinil solution for the treatment of pulmonary arterial hypertension (PAH).

The lawsuit was originally filed in June 2020 in response to Liquidia’s filing of a New Drug Application (NDA) for LIQ861 with the U.S. Food and Drug Administration (FDA). The original complaint asserted infringement of U.S. Patent Nos. 9,604,901 (’901) and 9,593,066 (’066) and triggered the statutory 30-month regulatory stay on the FDA approval of LIQ861. On July 16, 2020, Liquidia filed its Answer to UTC’s original Complaint including Counterclaims of invalidity, non-infringement, and Orange Book de-listing of the ’901 and ’066 patents.

Although UTC’s amended complaint brings the ‘793 patent into the pending lawsuit, the statutory 30-month stay on regulatory approval is not associated with the allegations of infringement of the ‘793 patent and the allegations of infringement of this patent should have no effect on the FDA’s review of the LIQ861 NDA.

“We firmly believe that, if approved, LIQ861 will benefit PAH patients and the physicians who treat them by providing an alternative treatment option that delivers higher, tolerable doses through a convenient, inhaled route of administration,” said Neal Fowler, Chief Executive Officer of Liquidia. “We stand firm in our commitment to PAH patients and will vigorously defend against any attempt to hinder our ability to bring LIQ861 forward.”

About Liquidia

Liquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT technology to transform the lives of patients. PRINT is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension (PAH) and LIQ865 for the treatment of local post-operative pain. Liquidia is headquartered in Research Triangle Park, NC. For more information, please visit www.liquidia.com.