Novartis Pharmaceuticals Corporation v. West-Ward Pharmaceuticals International Limited, Par Pharmaceutical, Inc., and Breckenridge Pharmaceutical, Inc.


On December 7, 2018, the Court of Appeals for the Federal Circuit ruled in favor of Venable Fitzpatrick’s clients Novartis Pharmaceuticals Corporation and Novartis AG, by reversing 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®, Afinitor®, and Afinitor Disperz® 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 one or more of these products.

In finding for Novartis, the Federal Circuit 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 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 explained that Gilead’s focus on expiration dates in the double patenting analysis was limited to the facts of that case, where both patents were post-URAA patents. Applying Gilead’s holding here would unfairly abrogate Novartis’s right to enjoy one full patent term on its invention.

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

Involved fees earner: Shannon Clark – Venable LLP; Laura Fishwick – Venable LLP; Susanne Flanders – Venable LLP; Nicholas Kallas – Venable LLP; Christopher Loh – Venable LLP; Christina Schwarz – Venable LLP; Jared Stringham – Venable LLP;

Law Firms: Venable LLP;

Clients: Novartis AG;