Yeda Res. Dev. Co., Ltd. v. Mylan Pharm., Amneal Pharm.

Docket No. 2017-1594-56 (IPR2015-00643, -0064, -00830, -01976, -01980-81

October 12, 2018

Brief summary: Board IPR decisions finding Yeda’s patents relating to relating to COPAXONE® invalid for obviousness affirmed.

Summary: Yeda appealed PTAB final written decisions (FWDs) finding US 8,232,250; 8,399,413; and 8,969,302 relating to COPAXONE® (glatiramer acetate (GA), “a mixture of polypeptides”; 40 mg/ml for relapsing-remitting multiple sclerosis (RRMS)) unpatentable as obvious following three IPRs. FN1 indicates the “companion” Teva decision (also Oct. 12, 2018) concerns the appeal of the DC decision invalidating the same three patents and US 9,155,776. The FC panel opinion explains that “a key limitation of the claims is the administration of a 40 mg GA dose in three subcutaneous injections over seven days with at least one day between every subcutaneous injection” (representative ‘250 claim 1; ‘302 claim 1 does not require “at least one day between” injections). Mylan’s and Amneal’s IPRs (-00643-44, -00830) were instituted regarding the ‘250, ‘413, and ‘302 patents on obviousness grounds based on prior art relating to clinical trials. The Board credited Mylan/Amneal’s expert in its conclusion that there would have been a motivation to use a 40 mg dose and a motivation to modify those regimens by eliminating “one injection every other week to increase patient compliance” and a reasonable expectation of success in doing so. The FC panel reviewed the Board’s decision for substantial evidence. Yeda argued that its due process rights and the ADA were violated because it did not have notice of, and an opportunity to respond to a non-statutory prior art reference (Khan 2009) that was raised as part of an expert declaration but the FC panel disagreed (e.g. “Yeda could have, but did not, address Kahn 2009 at the oral hearing”). The FC panel also found that while “Khan 2009 indisputably does not qualify as prior art”, “the Board can rely on evidence other than prior art” (§ 312(a)(3), 42.104(b); “non-prior art evidence of what was known ‘cannot be applied, independently, as teachings separately combinable; with other prior art, but ‘can be relied on for their proper supporting roles’” (Dominion, IPR2014-00684 (2014)). The FC panel did find the Board improperly relied on Khan 2009 to find a reasonable expectation of success, but found this error to be harmless based on other evidence. Yeda also appealed the Board’s obviousness findings, arguing “this case is ‘indistinguishable from In re Cyclobenzaprine” (FC 2012 (“bioequivalence alone could not establish obviousness…there were no prior art clinical studies to suggest what would be a therapeutically effective formulation”)) and “that a reasonable expectation of success is categorically impossible in the absence of a pk/pd profile”. But the FC panel disagreed since, e.g., “the expectation of success need only be reasonable, not absolute” (Pfizer, FC 2007), “[t]he only difference” being “thrice weekly and every other day administration” and “far from a ‘sea of prior art,’ the references…presented a finite and known pool of dose and frequency options” (WBIP, FC 2016; Ortho-McNeil, FC 2008; KSR, US 2007). Yeda also argued the Board erred in not discussing its “minimum effective dose principle” arguments in the FWDs but the FC panel found this not to be reversible error (Synopsys, FC 2016). The FC panel also disagreed with Yeda that the Board did not sufficiently address the tolerability, side effect, and “particular three-day schedule” limitations. Thus, the Board decisions were affirmed.

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

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