On May 13, 2019, the Court of Appeals for the Federal Circuit ruled in favor of Venable Fitzpatrick's clients Novartis Pharmaceuticals Corporation and Novartis AG and against West-Ward Pharmaceuticals International Limited, affirming the District Court's holding that claims 1-3 of U.S. Patent No. 8,410,131 ("the '131 patent") are valid and non-obvious. The '131 patent claims cover the use of Novartis's Afinitor® (everolimus) to treat adults with advanced renal cell carcinoma ("RCC") after failure of sunitinib or sorafenib. West-Ward filed an Abbreviated New Drug Application seeking to market a generic version of Afinitor® for this indication.
In finding for Novartis, the Federal Circuit agreed that the District Court did not clearly err in concluding that the prior art failed to provide a reasonable expectation of successfully achieving the claimed methods. Rather, the District Court based its decision on findings that the molecular biology of advanced RCC was not fully understood and there were limitations on the phase I data that West-Ward relied on, such that that data did not provide a person of ordinary skill with a reasonable expectation of success.