Novartis AG, et al. v. Torrent Pharmaceuticals Limited et al.

Docket No. 2016-1352 (IPR2014-00784, IPR2015-00518)

April 12, 2017

Brief Summary: Board decision of invalidity for obviousness of Novartis’ ‘283 patent relating to fingolimod (marketed as Gileyna® for treating MS) affirmed (Novartis had a chance to be heard on prior art even though separate challenges based on that prior art were dismissed; there is “no requirement that the Board expressly discuss each and every negative and positive piece of evidence”; and, there is no nexus “[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim”).

Summary: This appeal relates to a Final Written Decision (FWD) regarding two consolidated IPRs against Novartis’ US 8,324,283 (relating to compositions of a Markush group of sphingosine-1 phosphate (S1P) receptor agonists and a sugar alcohol for treatment of autoimmune conditions) in which all original claims and Novartis’ substitute claims were found unpatentable as obvious (see September 24, 2015 post on this blog for a review of the original IPR decision). Claim 19 is directed to one S1P receptor agonist (fingolimod, marketed as Gileyna® for treating MS) and a sugar alcohol. The FC panel explained that it reviews the Board’s legal conclusions de novo but any underlying factual determinations for substantial evidence (“as a reasonable mind might accept as adequate” (Consol. Edison, US 1938). In this appeal, Novartis argued the Board violated the “notice and opportunity to be heard” provisions of the APA when it relied on a reference (Sakai) without affording it proper notice and a chance to be heard, and erred in its analysis of the motivation to combine and treatment of alleged secondary considerations.

Regarding Sakai, Novartis argued “the Board ruled Sakai entirely out of the case” by denying “institution of the two proposed grounds based on Sakai” which caused Novartis to submit a “‘vastly different’ record that it would have if it had known Sakai was still a live issue.” The FC panel disagreed because the Board reliance on Sakai in its FWD “was not inconsistent with its review of Sakai in the Institution Decision” (“Sakai merely reinforced its finding that the person of ordinary skill in the art would have expected mannitol to be compatible with fingolimod because Sakai discloses a stable combination of these two ingredients suitable for long-term preservation.”) And “[t]he parties debated Sakai at length throughout the proceeding and in the same context that it was discussed by the Board in the” FWD. FN2 notes that “had Novartis believed the Board eliminated Sakai from the proceeding, it had various procedural mechanism at its disposal to respond” such as moving to exclude Sakai (Genzyme, FC 2016). Novartis also argued the Board “failed to read the prior art as a whole and overlooked critical evidence of mannitol’s known disadvantages as an excipient for solid compositions”, citing Medichem’s (FC 2006) “‘apparently conflicting’ teachings” principle (“consider the degree to which one reference might accurately discredit another”). The FC panel disagreed that the Board failed to consider all of the evidence relating to mannitol (“at least commensurate with Novartis’ presentation of those issues to the Board…there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument” (Carolina Tobacco, FC 2005)). It concluded that substantial evidence supports the Board’s finding that, despite mannitol’s potentially negative characteristics, it was nevertheless a valid consideration as an excipient” and therefore the requisite motivation was present. The FC panel also found Novartis’ unexpected success arguments waived except as to claim 19.

The FC panel also rejected Novartis’ commercial success arguments (“Gileyna being the first commercially-available solid oral” MS treatment) since treatment of MS “with a solid oral composition…was indisputably known in the prior art” and there is no nexus “[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim” (In re Kao, FC 2011; Tokai, FC 2011; Asyst, FC 2008 (“proferred evidence lacked a nexus to any feature of the invention’s commercial embodiments that was not already disclosed in a prior art patent”)). Thus, the Board decision was affirmed.

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

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