Novartis Pharma Co. v. West-Ward Pharms. Int’l

Case Name: Novartis Pharma Co. v. West-Ward Pharms. Int’l, No. 2018-1434, 2019 U.S. App. LEXIS 14122 (Fed. Cir. May 13, 2019) (Circuit Judges Stoll, Plager, and Clevenger presiding; Opinion by Stoll, J.) (Appeal from D. Del., Andrews, J.) 

Drug Product and Patent(s)-in-Suit: Afinitor® (everolimus); U.S. Pat. No. 8,410,131 (“the ’131 patent”) 

Nature of Case and Issue(s) Presented: Novartis owned the ʼ131 patent, which claimed methods of using everolimus to treat advanced renal cell carcinoma (“RCC”). After filing its ANDA, Novartis filed suit and West-Ward argued that the ’131 patent was invalid as obvious based on (i) the molecular biology of advanced RCC, (ii) the antitumor activity of mTOR inhibitors, and (iii) phase I temsirolimus (another mTOR inhibitor) clinical-trial results, and (iv) safe dosing ranges of everolimus. The district court agreed that a POSA would have been motivated to pursue everolimus as one of several potential treatment options for RCC, but ultimately concluded that West-Ward “failed to prove by clear and convincing evidence that a POSA would have been motivated to select everolimus” or that a POSA would have had a reasonable expectation of success in using everolimus. The district court held that the asserted claims were not invalid for obviousness. West-ward appealed and the Federal Circuit affirmed the district court’s decision.

Why Novartis Prevailed: With regard to motivation to combine, the Federal Circuit held that the district court erred. In particular, after determining that a POSA “would have been motivated to pursue everolimus as one of several potential treatment options” for RCC, the district court erred by requiring West-Ward to demonstrate that a POSA would have selected everolimus over the other prior-art combinations. This heightened standard was incorrect; the Federal Circuit explained that “our case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art.” In other words, it was enough that a POSA would have been motivated to pursue everolimus as one of several potential treatment options.

But the Federal Circuit also explained that a POSA would not have had a reasonable expectation of success in using everolimus to treat advanced RCC. West-Ward had argued that as of the effective filing date: (i) RCC patients had shown responses to temsirolimus treatment in phase I clinical trials, (ii) everolimus was an mTOR inhibitor that was available in oral formulations, and (iii) inhibiting mTOR in prostate cancer cells inhibited HIF-1, which was hypothesized to inhibit tumor-promoting angiogenesis. The Federal Circuit provided, however, that the temsirolimus phase I date resulted from small sample sizes and came from studies that were designed to test safety, not efficacy. The Federal Circuit also noted that everolimus and temsirolimus—although both mTOR inhibitors—were “pharmacologically different” drug molecules. Finally, the Federal Circuit explained that Novartis presented several prior-art references stating that the role of HIF-1 and mTOR in the molecular biology of advanced RCC was not fully understood and that some studies found that inhibiting mTOR did not necessarily result in tumor growth inhibition. In sum, the Federal Circuit found that because West-Ward failed to demonstrate a reasonable expectation of success, the ’131 patent was not invalid as obvious.