Novartis Pharmaceuticals Corp. et al. v. West-Ward Pharmaceuticals Int. Ltd.

Docket No. 2018-1434

May 13, 2019

Brief summary: DC’s “ultimate determination that the challenged claims would not have been obvious” due to no reasonable expectation of success affirmed.

Summary: WW (which filed ANDA 207486 for generic Afinitor®) appealed DC holding that claims 1-3 Novartis’s US 8,410,131 claiming methods for using the mTOR (the mammalian target of rapamycin) inhibitor everolimus (the active ingredient in Novartis’s Afinitor® product; the ‘131 patent being one of seven Orange Book-listed patents) to treat “solid excretory system tumors” (e.g., advanced renal cell carcinoma (“RCC”)) were not shown to be obvious by clear and convincing evidence. The FC panel opinion explains that as of the ‘131 priority date, the prior art “disclosed that mTOR inhibitors produced effects, such as inhibition of hypoxia-inducible factor 1 (‘HIF-1’), that were hypothesized to inhibit tumor growth” and “had shown responses in RCC patients in phase I clinical trials”, and “recognized that the effect of the mTOR pathway ‘may provide a basis for therapeutic efficacy,’ but noted that additional studies are required to determine the precise mechanism” of action. WW alleged that the claims would have been obvious over one of two temsirolimus references (Hildago (including a summary of Phase I trials showing “major tumor responses in RCC” but noting “which tumors will be particularly sensitive…remains a developmental challenge”)), Hutchinson (update Phase I results and disclosing phase II trials including one in RCC) and an everolimus patent (US 5,665,772 or 6,004,973), “in view of the general knowledge in the art.” While the DC “found that a person of ordinary skill ‘would have been motivated to pursue everolimus as one of several potential treatment options for advanced solid tumors, including advanced RCC”, it also found that WW “failed to prove by clear and convincing evidence that a POSA would have been motivated to select everolimus” or “would have reasonably expected everolimus to effectively treat advanced RCC.” The FC panel held that the DC “erred in its analysis of whether there was a motivation to combine” (“erred in applying this heightened standard” since the “law does not require that a particular combination must be the preferred, or most desirable combination described in the prior art in order to provide motivation for the current invention” (In re Fulton, FC 2004; Bayer, FC 2013; Takeda, FC 2007 (lead compound analysis not required here)). However, the FC panel found no clear error in the DC’s determination of no reasonable expectation of success (e.g., evidence that “temsirolimus phase I data had diminished weight”, “everolimus and temsirolimus had different pharmacological properties”, “the molecular biology of advanced RCC was not completely understood”, POSA “would not make a determination or reasonable suggestion simply based in isolation upon whether a drug enters phase II”, “no dispute that more than seventy percent of oncology drugs failed at phase II”). The FC panel therefore affirmed the DC’s “ultimate determination that the challenged claims would not have been obvious.”

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