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Vanda Pharmaceuticals Intends to Petition the U.S. Supreme Court in its HETLIOZ® ANDA Litigation
WASHINGTON, Oct. 20, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its intention to file a petition for a writ of
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"WASHINGTON, Oct. 20, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its intention to file a petition for a writ of certiorari in its HETLIOZ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp.\n\n \n \n \n \n \n \n\n \nVanda seeks to demonstrate that the United States Court of Appeals for the Federal Circuit (Federal Circuit) applied a flawed standard in assessing obviousness when it affirmed a lower court decision finding several of Vanda's HETLIOZ® patents invalid. Vanda's petition seeks to show that the Federal Circuit's approach to obviousness has deviated materially from KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), which trains the obviousness inquiry on whether the claimed innovations \"do more than yield a predictable result.\" Vanda believes that the Federal Circuit's approach improperly invalidates critical patent rights, which are necessary to ensure robust pharmaceutical research and development.\n\"Properly calibrated patent protection is essential to pharmaceutical innovation, which is in turn critical for advances in public health. Vanda intends to pursue its interest in this matter and the interests of innovators, patients and the American public in the proper interpretation of the U.S. patent laws,\" said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.\nChief Justice Roberts extended the time for the filing of Vanda's forthcoming petition, which Vanda expects to file by January 12, 2024.\nAbout Vanda Pharmaceuticals Inc.\nVanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.\nAbout HETLIOZ®\nFor full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.\nCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS\nVarious statements in this press release, including, but not limited to statements regarding Vanda's intentions to petition the U.S. Supreme Court and continue to protect its HETLIOZ® patents, the expected timing of the petition filing and the subst...