NOVARTIS PHARMACEUTICALS CORP v. WEST-WARD PHARMACEUTICALS
- May 13 2019 |
- Category: CAFC Updates
West-Ward Pharmaceuticals appeals the decision of the District Court holding that claims of U.S. Patent No. 8,410,131 which claims methods of using the compound everolimus (an mTOR inhibitor and the active ingredient in Novartis’s Afinitor product) to treat advanced renal cell carcinoma (“RCC”), would not have been obvious in view of the prior art. The CAFC holds that the district court erred in its analysis of whether there was a motivation to combine. Because the patent claims methods of using everolimus to inhibit growth of solid tumors, not the everolimus compound itself, this case does not require lead compound analysis or analysis of whether a particular dose in a range of prior art doses would have been obvious. The district court, however, required clear and convincing evidence that a person of ordinary skill would have been motivated to select everolimus. 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 RCC with the prior art disclosing everolimus. However, the CAFC discerns no clear error in the district court’s finding that a person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC as of February 2001 based on the prior art and expert testimony that supported subsidiary findings that (1) the temsirolimus phase I data had diminished weight, (2) everolimus and temsirolimus had different pharmacological properties, and (3) the molecular biology of advanced RCC was not completely understood. The CAFC thus agrees with the district court’s ultimate determination that the challenged claims would not have been obvious, and affirms.