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Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals International Ltd.

“Motivation to Combine” Does Not Require That Claimed Approach Be Preferred

Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals International Ltd., __ F.3d __, 2019 WL 2079879 (Fed. Cir. May 13, 2019) (STOLL, Plager, Clevenger) (D. Del.: Andrews) (3 of 5 stars)

Fed Cir affirms Hatch-Waxman judgment confirming non-obviousness. Novartis’s patent related to use of everolimus (sold by Novartis as Afinitor) to treat advanced renal cell carcinoma. The district court erred in its analysis of whether there was a motivation to combine West-Ward’s cited references. Per In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004), the motivation to combine analysis did not require proof that a person of ordinary skill would have decided to investigate everolimus as the preferred, or most desirable, course of investigation. “The proper inquiry is whether a person of ordinary skill would have been motivated to modify the prior art disclosing use of temsirolimus to treat advanced [renal cell carcinoma] with the prior art disclosing everolimus.” Op. at 15.

The error was harmless because the evidence supported the district court’s determination that a person of ordinary skill would not have had a reasonable expectation of success in such a modification. The opinion is in this respect fact-specific.

KEYWORDS: HATCH-WAXMAN; OBVIOUSNESS (NO); MOTIVATION TO COMBINE; REASONABLE EXPECTATION OF SUCCESS