Vanda Pharmaceuticals Inc. 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.
Vanda 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.
"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.
Chief Justice Roberts extended the time for the filing of Vanda's forthcoming petition, which Vanda expects to file by January 12, 2024.
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