• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, and vacated the original final written decision.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner

    “with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3

  • Expert testimonyPatent owner expert discountedDecided for petitioner
  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). evidence of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,399,413

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