Novartis AG et al. v. Noven Pharmaceuticals Inc.

Docket No. 2016-1678, -1679 (IPR2014-00549 and -00550; IPR2015-00265 and -00268)

April 4, 2017

Brief Summary: PTAB decisions that claims related to Novartis’s Exelon® patch for treatment of dementia are unpatentable for obviousness affirmed because, e.g., “a motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art”.

Summary: Novartis appealed two separate final written decisions (FWDs), each finding various claims of US 6,316,023 and US 6,335,031 (‘023 issued as a CON of ‘031) relating to rivastigmine (sold as the Exelon® patch for treatment of dementia) invalid for obviousness (pre-AIA § 103). The FC panel first explained that it “review[s] the PTAB’s factual findings for substantial evidence and its legal conclusions de novo” (Redline Detection, FC 2015), “substantial evidence” being “evidence as a reasonable mind might accept as adequate” (In re Nuvasive, FC 2016). It also explained that “[i]nstead of raising arguments on the basis of a specific claim, patent, or Final Written Decision, Novartis raises broad legal and factual arguments with application to both of the” FWDs. Novartis’ main allegation is the the PTAB committed a “fundamental legal error” by “unlawfully reach[ing] different conclusions than” the FC and the DE DC (Novartis, FC 2015 (v. Watson) and Novartis, D. Del. 2015 (v. Noven)), relying “substantially on a single sentence from” In re Baxter (FC 2012). However, the FC panel did not accept this argument because “Watson…does not control here because…Noven…has presented additional prior art…and declaratory evidence that was not before the [c]ourt” and some that was not before the DE DC (and “Novartis tacitly concedes that the record here is different.”) The FC panel also concluded, however, that “even if the record were the same, Novartis’s argument would fail as a matter of law” because in an IPR unpatentability must only be shown “by a preponderance of the evidence (see 35 U.S.C. § 316(e)) rather than by clear and convincing evidence” as required in DC litigation. Thus, “the PTAB properly may reach a different conclusion based on the same evidence” (Cuozzo, US 2016). The FC panel also explained that although in Baxter it “stated that the USPTO ‘ideally should not arrive at a different conclusion’ if it faces the same evidence and argument as a” DC, its use of the term “‘ideally’…recognized that Congress has provided a separate review mechanism before the USPTO with its own standards.” The FC panel first confirmed that the PTO correctly determined “what [the references] disclose”, which Novartis did not challenge. Novartis argued “that the record contains no evidence that a PHOSITA ‘would have been motivated to add an antioxidant’ to rivastigmine ‘absent evidence of oxidative degradation.” The FC panel disagreed, writing that “Novartis ignores the PTAB’s findings as to the PHOSITA’s skill in the art” (“knowledge of organic chemistry and been able to analyze…a compound based on its chemical structure” and understand “‘that the presence of particular functional groups in a molecule has consequences,’ such as degradation”). As to the art’s failure to mention rivastigmine, the FC panel explained that “a motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art” (In re Kahn, FC 2006). And it would not “give greater weight to the testimony of” Novartis’s expert “than did the PTAB” (In re Warsaw, FC 2016). Thus, the PTAB decisions were affirmed.

This entry was posted in Inter Parties Review (IPR), IPR, Obviousness. Bookmark the permalink.

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