In Novartis Pharm. v. West-Ward Pharm., Appeal no. 2018-1434 (Fed. Cir., May 12, 2019), a three judge panel of Stoll, Plager and Clevenger affirmed the district court’s ruling that the claims of Novartis’ U.S. Pat. No. 8,410,131, directed to using a rapamycin analog 40-O-(2-hydroxyethyl) rapamycin (“everolimus”) to treat renal cell carcinoma (RCC) were valid over two prior art Novartis patents disclosing this analog and disclosing that it is generally useful to treat “tumors” and two papers disclosing phase I studies of another rapamycin analog, temsirolimus, which showed some efficacy against RCC.
The panel held that the district court erred in finding that the POSA “would have been motivated to pursue everolimus as one of several potential treatment options for…advanced RCC.” The panel continued:
“This finding should have affirmatively answered the question whether there would have been a motivation to combine. Yet, the district court continued its analysis and found that West-Ward ‘failed to prove by clear and convincing evidence that a POSA would have been motivated to select everolimus.’ The district court erred in applying this heightened standard. ‘[O]ur 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.”