Press release
United Therapeutics Corporation Asserts New Tyvaso Patent Against Liquidia
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 23, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today the United
About this update from United Therapeutics Corporation
[{"type":"text","content":"SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 23, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today the United States Patent and Trademark Office issued a new patent on July 21, 2020, relating to Tyvaso® (treprostinil) Inhalation Solution. The new patent, U.S. Patent No. 10,716,793, expires May 14, 2027, and is listed in the U.S. Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book, for Tyvaso.\nYesterday, United Therapeutics filed an amended complaint against Liquidia Technologies, Inc. (Liquidia) in its pending patent infringement litigation in the U.S. District Court for the District of Delaware to include a claim for infringement of this new patent. The new patent relates to a method of administering treprostinil via inhalation, and it includes claims covering the dosing regimen used to administer Tyvaso.\nUnited Therapeutics initiated a lawsuit in June 2020 based on a New Drug Application (NDA) filed by Liquidia with the U.S. Food and Drug Administration 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, and earlier this month, United Therapeutics filed preliminary responses to those petitions. \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 ...