IPR2016-01461 (US 9,006,224 B2)
Decision denying institution
February 13, 2017
Brief Summary: Roxane’s petition for IPR of Novartis’ US 9,006,224 related to the use of Afinitor® (everolimus) to treat pancreatic cancer dismissed as a reasonable likelihood of success in showing obviousness was not presented.
Summary: Roxane petitioned for IPR of Novartis’ US 9,006,224 related to methods for treating pancreatic neuroendocrine tumors (PNETs) by administering a rapamycin analogue (Afinitor® (everolimus)) “as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.” The decision notes that two infringement actions are pending against Roxane and Par, respectively. Par has also challenged claims 1-3 of the ‘224 patent in IPR2016-01479. In this IPR, Roxane challenged claims 1 and 2 as obvious in view of two (Lane and Tabernero) or three (von Wichert, Dutcher, Cottens, and Tabernero) references. The Board agreed with Novartis that “advanced” means “metastatic or unresectable” under the broadest reasonable interpretation (BRI) in view of specification (e.g., which implies “that not all solid tumors are ‘advanced’”) and “evidence of ordinary and customary usage, such as the ACS Cancer Glossary. The Board also agreed with Novartis that ‘advanced,’ in the usage of claim 1, is different than ‘after failure of cytotoxic chemotherapy’” (“advanced tumors…are present prior to” treatment failure). Tabernero is an abstract “regarding a Phase I study of the use of everolimus in patients with advanced solid tumors” which the Board, agreeing with Novartis, found does not “contain an explicit reference to either advanced PNETs or the failure of cytotoxic chemotherapy.” The Board saw “no reason to conclude that Tabernero intended to depart from” the above-mentioned “ordinary and customary usage” of “advanced” and, therefore, could not conclude the reference “would have been understood by a person of ordinary skill in the art as describing tumors that have failed to respond to cytotoxic chemotherapy.” It explained that Roxane’s expert testimony was only a “bare conclusion” which is therefore “entitled to little or no weight” (citing Monsanto, IPR2013-00022) (“Where, as here, the conclusory testimony is the sole basis for establishing that a claim limitation is taught or suggested by the prior art, we find it insufficient to establish a reasonable likelihood of prevailing regarding that claim.”) This rationale was applied to both combinations of references. The Board therefore concluded a reasonable likelihood of success was not shown.