IPR decisions of no obviousness of Wyeth’s vaccine claims vacated and remanded as “too cryptic to survive judicial review”

Merck Sharpe & Dohme Corp. v. Wyeth LLC

Docket Nos. 2018-2133, -2134 (IPR2017-00378, -00380)
November 26, 2019

Brief Summary: Board IPR decisions regarding Wyeth’s vaccine claims vacated and remanded as “too cryptic to survive judicial review”.

Summary: Merck appealed Board IPR decision declining to find claim 18 of Wyeth’s US 8,562,999 directed to formulations for stabilizing polysaccharide-protein conjugate vaccines (e.g., against silicone-induced aggregation) unpatentable as obvious. Sole independent claim 1 of the ‘999 patent “recites a formulation comprising of: (1) a pH-buffered saline solution, (2) an aluminum salt, and (3) one or more polysaccharide-protein conjugates.” Dependent claim 18 “recites a specific 13-valent pneumococcal polysaccharide conjugate with CRM197 as the sole carrier protein for use with the formulation recited in claim 1.” In each IPR, “the Board found all the challenged claims except one-claim 18-to be unpatentable as obvious”. The FC panel reviewed “the Board’s factual findings for substantial evidence” (e.g., a motivation to combine references, “a pure question of fact”, and a reasonable expectation of success (Int. Bio-Systems, FC 2016; Par Pharm., FC 2014) and “its legal conclusions de novo” (“ultimate determination of obviousness” (In re Cuozzo, FC 2015)). And the Board’s explanation “must suffice for us to see that the agency has done its job and must be capable of being ‘reasonably…discerned’ from a relatively concise [Board] discussion” (In re NuVasive, FC 2016). Merck alleged obviousness in view of three prior art references, including Pena which the Board found to disclose a “13-valent pneumococcal conjugate vaccine with the same serotypes recited by claim 18…as being in an ‘advanced phase of study’”. However, the Board also found that “Merck failed to ‘direct [the Board] to any disclosure in Pena, or other evidence of record, further characterizing the vaccine or the study’” and that it was therefore “unable to assess whether the study involved” the claimed conjugate “or if such an attempt was even considered, tried, and successful.” In addition, “[t]he Board concluded that Merck ‘ha[d] not provided a reason” for modifying “Chiron’s formulation to comprise a thirteen valent conjugate” with a reasonable expectation of success, and “Wyeth made little effort to counter Merck’s contentions” regarding the prior art disclosures. “[T]he question”, the FC panel wrote, “was whether it was obvious to conjugate the 13 serotypes to the CRM197 protein in a single vaccine”. The FC panel found that the Board’s “considered, tried, and successful” rationale “[s]tanding alone”, was not enough since “[o]bviousness, unlike anticipation, does not require a prior art successful formulation” (Par. Pharm., FC 2014) and “there was conflicting evidence as to motivation and reasonable expectation of success” (Dome Patent, FC 2015; KSR, US 2007). The differences in expert testimony were summarized by the FC panel as being “primarily concerned” with “whether a skilled artisan would have been dissuaded from using a single carrier protein (i.e. CRM197) due to ‘immune interference’”. And on this point the FC panel found “the Board’s decision” to be “too cryptic to survive judicial review” and therefore reversed and remanded the IPR decisions (In re Van Os, FC 2017).

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

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