Federal Circuit Denies Petition for Rehearing En Banc of Its Obviousness-Type Double Patenting Decision in Favor of Venable Fitzpatrick's Client Novartis

2 min

On February 8, 2019, the Court of Appeals for the Federal Circuit denied petitions for panel rehearing and rehearing en banc of its December 7, 2018 decision holding in favor of Venable Fitzpatrick's clients Novartis Pharmaceuticals Corporation and Novartis AG. The Federal Circuit had reversed the District Court's holding that U.S. Patent No. 5,665,772 ("the '772 patent") was invalid for obviousness-type double patenting. The '772 patent claims the compound everolimus, which is the active ingredient in Novartis's Zortress® and Afinitor® products. West-Ward Pharmaceuticals International Limited, Par Pharmaceutical, Inc., and Breckenridge Pharmaceutical, Inc. each filed Abbreviated New Drug Applications seeking to make generic versions of these products.

In finding for Novartis, the Federal Circuit had rejected the arguments advanced by West-Ward, Par, and Breckenridge, seeking to extend the decision in Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), to the facts of this case where, because of the Uruguay Round Agreements Act (URAA) change in patent term laws, a later-filed post-URAA patent expires before an earlier-filed pre-URAA patent in the same family. The Federal Circuit in its December 7, 2018 decision explained that Gilead's focus on expiration dates in the double patenting analysis was on the facts of that case, where both patents were post-URAA patents. Applying Gilead's holding to this case would unfairly abrogate Novartis's right to enjoy one full patent term on its invention.

Novartis was represented by Venable Fitzpatrick attorneys Christina Schwarz, Nicholas Kallas, Christopher Loh, Susanne Flanders, Jared Stringham, Shannon Clark, and Laura Fishwick.