In Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals Int’l Ltd., [2018-1434] (May 13, 2019), the Federal Circuit affirmed the district court’s determination that claims 1–3 of U.S. Patent No. 8,410,131 for treating treat advanced renal cell carcinoma would not have been obvious in view of the prior art.
The Federal Circuit held that the district court erred in finding no motivation to combine the prior art references, but found no clear error in the district court’s finding that a person of ordinary skill would not have reasonably expected success, and thus agreed with the district court’s ultimate determination that the challenged claims would not have been obvious.
As to motivation to combine, the Federal Circuit noted that its case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention. Thus it was improper to have required defendants to prove that a person of ordinary skill would have selected the claimed compound over the other prior art treatment methods in the reference.
However on the issue of reasonable expectation of success, the Federal Circuit agreed with the district court. In particular the district court relied upon on the prior art and expert testimony to support subsidiary findings that (1) the phase I data for a related compound had diminished weight, (2) the claimed compound had different pharmacological properties than the prior art compound, and (3) the molecular biology of advanced RCC was not completely understood. The Federal Circuit affirm the district court’s conclusion that claims 1–3 of the ’131 patent would not have been obvious in view of the asserted prior art