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Yeda Research & Development Co. v. Mylan Pharmaceuticals Inc.

PTAB May Rely on Non-Statutory Prior Art for Collateral Issues

Yeda Research & Development Co. v. Mylan Pharmaceuticals Inc.906 F.3d 1031 (Fed. Cir. Oct. 12, 2018) (REYNA, Bryson, Stoll) (PTAB) (3 of 5 stars)

Fed Cir affirms IPR cancellation of claims in three Yeda patents as obvious. Yeda’s patents describe and claim a treatment for relapsing-remitting multiple sclerosis using glatiramer acetate (“GA”), sold as Copaxone. The PTAB did not violate Yeda’s due process rights by relying in part on an expert declaration submitted on reply. Per Genzyme Therapeutic Products, 825 F.3d 1360 (Fed. Cir. 2016), introduction of new evidence is permissible under the APA so long as the opposing party receives adequate notice and an opportunity to respond. Here, Yeda deposed the expert and moved to exclude part of the expert’s declaration. And although the declaration referenced a study that was not itself statutory prior art, the PTAB did not err in relying on it. Per § 312(a)(3), the PTAB may receive (and thus rely on) “supporting evidence and opinions” beyond the patents or publications at the heart of an IPR petition. The opinion endorses past PTAB rulings that such may not be applied as an independent teaching, but may be relied on to prove, e.g., “the level of ordinary skill in the art, what certain terms would mean to one with ordinary skill in the art, and how one with ordinary skill in the art would have understood a prior art disclosure.” 906 F.3d at 1041 (quoting Dominion Dealer, 2014 WL 5035359 (PTAB Oct. 6, 2014)).

The opinion substantially reproduces the discussion of In re Cyclobenzaprine, 676 F.3d 1063 (Fed. Cir. 2012), from In re Copaxone Consolidated Cases, 906 F.3d 1013 (Fed. Cir. Oct. 12, 2018), issued the same day, and rejects Yeda’s argument that the absence of detailed pharmacokinetic and pharmacodynamic (“pk/pd”) data for GA in the prior art precluded an obviousness finding as to dosing and frequency limitations in the claims.

The opinion also rejects Yeda’s argument that the Board’s selection of a lead reference after the fact was hindsight. Yeda waived this argument by not raising it until reply. And in any event, the Board’s analysis was not hindsight because the record contained a “finite and known pool” of dose and frequency options. 906 F.3d at 1045.

The opinion also rejects Yeda’s various factual challenges to the Board’s decision.

KEYWORDS: INTER PARTES REVIEW; OBVIOUSNESS (YES); STATUTORY PRIOR ART