Press release
United Therapeutics Corporation Files Lawsuit Against Liquidia For Infringement Of Tyvaso Patents
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 5, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has
About this update from United Therapeutics Corporation
[{"type":"text","content":"SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 5, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia Technologies, Inc. (Liquidia) for infringement of the following patents relating to United Therapeutics' product Tyvaso® (treprostinil) Inhalation Solution: U.S. Patent Nos. 9,604,901 (the '901 patent) and 9,593,066 (the '066 patent), both of which expire in December 2028.\nThe lawsuit is based on a New Drug Application (NDA) filed by Liquidia with the U.S. Food and Drug Administration (FDA) requesting approval to market LIQ861, a dry powder inhalation formulation of treprostinil. The NDA was filed under the 505(b)(2) regulatory pathway with Tyvaso as the reference listed drug. In April 2020, United Therapeutics received a Paragraph IV notification letter from Liquidia indicating that Liquidia's NDA contains a certification alleging that LIQ861 will not infringe any of the patents then listed in the Orange Book for Tyvaso because those patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of LIQ861. In March 2020, Liquidia filed petitions for inter partes review seeking to invalidate the '901 and '066 patents. \nUnited Therapeutics filed its lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing. As a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. \nUnited Therapeutics intends to vigorously enforce its intellectual property rights relating to Tyvaso. However, given the unpredictability inherent in litigation, United Therapeutics cannot predict the outcome of this matter or guarantee the outcome of this litigation.\nAbout United Therapeutics\nUnited Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture, and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment,...