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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
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`Petitioners
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`v.
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`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
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`Patent Owner
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`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`1 The word-for-word identical paper is filed in each proceeding identified in the
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`caption.
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`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
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`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
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`Pursuant to 37 C.F.R. § 42.64(c) and Section II.K of the Office Patent Trial
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`Practice Guide, Patent Owner Yeda Research and Development Co. (“Yeda” or
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`“Patent Owner”) hereby moves to exclude Exhibits 1068, 1086, 1089, 1098, and
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`1140 submitted by Petitioners Mylan Pharmaceuticals Inc. and Amneal
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`Pharmaceuticals LLC (“Petitioners”).
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`I.
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`Statement of Precise Relief Requested
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`Patent Owner seeks to exclude Petitioners’ Exhibits 1068, 1086, 1089, 1098,
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`and 1140. See 37 C.F.R. § 42.22(a)(1).
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`Exhibit 1068 is a copy of a 2009 abstract by O. Khan et al., entitled
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`Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections:
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`results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-
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`year study in relapsing-remitting multiple sclerosis, published in MULTIPLE
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`SCLEROSIS. Petitioners refer to this abstract as “Khan 2009.”
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`Exhibit 1086 is a printout from the Shared Solutions® website sponsored by
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`Teva Neuroscience, Inc., which provides online resources and support for
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`Copaxone® users.
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`Exhibit 1089 is a copy of a 2009 abstract by O. Khan et al., entitled
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`Glatiramer acetate 20mg subcutaneous twice-weekly versus daily injections:
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`results of a pilot, prospective, randomised, and rater-blinded clinical and MRI 2-
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`1
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`year study in relapsing-remitting multiple sclerosis, published in MULTIPLE
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`SCLEROSIS. It is the same abstract identified in Exhibit 1068.3
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`Exhibit 1098 is a copy of a 2012 article by Lauren LeBano entitled Gray
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`Matter Atrophy in Multiple Sclerosis: A Longitudinal Study, published in ANNALS
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`OF NEUROLOGY.
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`Exhibit 1140 is the redacted transcript of the February 15, 2016 deposition
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`of Jerry S. Wolinsky, M.D., in connection with the consolidated, related district
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`court litigation, In re Copaxone 40 mg, Case No. 14-1171-GMS (D. Del.)
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`(“Wolinsky Deposition Transcript”).
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`II. Evidence Relied Upon In Support Of This Motion
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`The evidence relied upon in support of this motion includes: (1) Petitioners’
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`Reply filed on March 9, 2015 (IPR2015-00643, Paper 58 (“Petitioners’ Reply”));
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`(2) Patent Owner’s Objections to Evidence Pursuant to 37 C.F.R. § 42.64, filed
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`March 16, 2016 (id. at Paper 64); (3) the Expert Report of Ari Green, M.D. In
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`Support Of Petitioner’s Reply To Patent Owner’s Response (Exhibit 1085, or the
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`“Green Reply Report”); and (4) the transcript of the April 6, 2016 deposition of Ari
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`Green, M.D. (Exhibit 1142).
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`3 Exhibit 1068 is the deposition copy of Khan 2009, used in the Deposition of
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`Edward J. Fox, M.D. (see Ex. 2146 at 86:10-23).
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`2
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`III.
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`Identification Of Original Objections
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`Patent Owner timely objected to Exhibits 1068, 1086, 1089, and 1098 on
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`March 16, 2016. IPR2015-00643, Paper 64 at ¶¶ 2, 16, 19, 28; see 37 C.F.R.
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`§ 42.64(b)(1). In its timely-filed objections, Patent Owner maintained that
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`Exhibits 1068, 1086, 1089, and 1098 were, inter alia, dated after August 20, 2009,
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`and thus irrelevant under Federal Rules of Evidence (“FRE”) 402 and 403 to the
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`extent they were relied upon for any teaching prior to August 20, 2009. The
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`Petitioner did not respond, with supplemental evidence or otherwise, to these
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`objections.
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`Petitioners introduced Exhibit 1140 during the deposition of their own
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`expert, Dr. Ari Green. Exhibit 1142 at 396:12-16. Patent Owner timely objected
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`to Exhibit 1140 during the deposition as not being part of the record of the
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`proceeding and outside the scope of Dr. Green’s opinion and Mylan’s Reply.
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`Exhibit 1142 at 396:6-10 (“Before you ask any further questions, I want to object
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`to this document being offered. It’s not part of the record in this proceeding. So I
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`just object to any testimony on the document.”); see also id. at 396:23-397:7. The
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`Petitioners did not provide evidence to cure this objection at the deposition, as
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`required by 37 C.F.R. § 42.64(a).
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`IV.
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`Identification Of Where Evidence Was Relied Upon By Petitioner
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`Petitioners cite to Exhibits 1068/1089, the 2009 abstract authored by O.
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`Khan, on pages 17-18 of the Green Reply Report. See Exhibit 1085 at ¶ 32. The
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`abstract is cited in support of the following assertions made in the Green Reply
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`Report: “[B]efore the priority date, POSAs had completed a clinical trial
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`investigating 20 mg administered twice weekly, for a total weekly dose of only 40
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`mg” and “Although the results suggesting that 20 mg administered twice weekly is
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`safe, efficacious, and well-tolerated were not officially published until three weeks
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`after the priority date, [Exhibit 1068/1089] demonstrates that—counter to what
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`Patent Owner claims—POSAs were motivated before the priority date to explore
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`less frequent alternative dosing regimens.” Id. This portion of the Green Reply
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`Report is cited by Petitioners on Pages 9 and 13-14 of the Petitioners’ Reply, in
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`support of the following statements: “As of 2009, the prior art expressly taught that
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`less frequent administration of GA was efficacious, and further development was
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`warranted” (Page 9); “And for the greatest expectation of success, a POSA would
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`choose a total weekly dose (120 mg) comparable to the known 20 mg daily
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`regimen (140 mg)” (Pages 13-14); and “[An 80 hour] half-life is consistent with
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`the clinical data, which suggests that less frequent dosing may be efficacious”
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`(Page 14).
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`4
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`Petitioners cite to Exhibit 1086, the web printout from Teva’s ‘Shared
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`Solutions’ website, on page 9 of the Green Reply Report. See Exhibit 1085 at ¶19.
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`The abstract is cited in support of the following assertions made in the Green
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`Reply Report: “GA has long been known to be a forgiving drug, meaning that
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`some variability in patient compliance will not sacrifice GA’s efficacy, safety, or
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`tolerability… For example, Teva instructs patients to skip a missed dose rather
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`than take a double dose, indicating that the therapy’s efficacy will not suffer from
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`isolated adherence failures.” Id. This portion of the Green Reply Report is cited by
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`Petitioners on Pages 9, 10, and 14 of the Petitioners’ Reply, in support of the
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`following statements: “40 mg TIW administration of GA fell precisely in the
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`middle of a range of doses known in the prior art to be efficacious” (Page 9); “GA
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`was also well known to be forgiving, meaning occasional missed doses do not
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`impact efficacy” (Page 10); “Therefore, for a POSA looking to develop a less
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`frequently administered GA dosing regimen, 40 mg TIW was an obvious choice.”
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`(Page 10); “And for the greatest expectation of success, a POSA would choose a
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`total weekly dose (120 mg) comparable to the known 20 mg daily regimen (140
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`mg)” (Pages 13-14); and “[An 80 hour] half-life is consistent with the clinical data,
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`which suggests that less frequent dosing may be efficacious” (Page 14).
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`Petitioners cite to Exhibit 1098, the 2012 article authored by Lauren
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`LeBano, on pages 64-65 of the Green Reply Report. See Exhibit 1085 at ¶ 96.
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`The abstract is cited in support of the following assertions made in the Green
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`Reply Report: “Before recent improvements in software used to analyze MRI
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`output, such as introduction of the FreeSurfer software, it was difficult and time
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`consuming to routinely study gray matter atrophy (as opposed to whole brain
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`atrophy as measured by brain volume) requiring MRI acquisition capabilities and
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`post processing analytical capability that were expensive and difficult to deploy in
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`a multicenter clinical trial.” Id. This portion of the Green Reply Report is cited by
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`Petitioners on Page 20 of the Petitioners’ Reply, in support of the following
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`statement: “Finally, as Dr. Green explains, the GALA extension trial finding that
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`GA slows gray matter brain atrophy was not unexpected.”
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`Petitioners have not cited to Exhibit 1140 in either its Petition or in its
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`Reply. Nor do Petitioners cite to Exhibit 1140 in the Green Reply Report.
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`V. Objections And Explanation Thereof
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`Exhibits 1068, 1086, 1089, 1098, and 1140 should be excluded for at least
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`the following reasons.
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`A. Exhibits 1068/1089 Should Be Excluded Under FRE 402/403
`Petitioners have submitted copies of an abstract by O. Khan et al. as Exhibits
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`1068 and 1089. Petitioners attempt to use this abstract to prove the state of the art
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`prior to August 20, 2009 (the shared priority date of the three patents in these
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`proceedings). Ex. 1085 at ¶ 32 (“Although the results…were not officially
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`published until… after the priority date, the Khan 2009 reference demonstrates
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`that…POSAs were motivated before the priority date to explore less frequent
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`alternative dosing regimens” (emphasis added)). The Petitioners have not directly
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`cited to these Exhibits for any other purpose. See supra at IV. Accordingly,
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`because Petitioners have exclusively used a document that is not prior art and is
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`dated after August 20, 2009, to establish a purported teaching prior to August 20,
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`2009, Petitioners’ Exhibits 1068 and 1089 should be excluded as irrelevant.
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`Further, any possible probative value of Exhibits 1068 and 1089 is substantially
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`outweighed by a danger of confusing the issues and wasting time.
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`Exhibit 1086 Should Be Excluded Under FRE 402/403
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`B.
`Petitioners have submitted a 2016 printout from Teva’s ‘Shared Solutions’
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`website, which provides online resources and assistance for Copaxone® users, as
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`Exhibit 1086. Petitioners use this web printout to assert in the Green Reply Report
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`that “GA has long been known to be a forgiving drug[.]” Ex. 1085 at ¶ 19 (“GA
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`has long been known to be a forgiving drug, meaning that some variability in
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`patient compliance will not sacrifice GA’s efficacy, safety, or tolerability. See, e.g.,
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`Ex. 1004 ¶ 33. For example, Teva instructs patients to skip a missed dose rather
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`than take a double dose, indicating that the therapy’s efficacy will not suffer from
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`isolated adherence failures.”). The Petitioners have not directly cited to this
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`Exhibit for any other purpose. See supra at IV. Accordingly, because Petitioners
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`have exclusively used this exhibit, that is not prior art and is dated after August 20,
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`2009, to establish a purported teaching prior to August 20, 2009, Petitioners’
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`Exhibit 1086 should be excluded as irrelevant. Further, any possible probative
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`value of Exhibit 1086 is substantially outweighed by a danger of confusing the
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`issues and wasting time.
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`C. Exhibit 1098 Should Be Excluded Under FRE 402/403
`Petitioners have submitted a copy of a 2012 article by Lauren LeBano as
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`Exhibit 1098. Petitioners, again, have attempted to use this article to prove the
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`state of the art prior to August 20, 2009. Ex. 1085 at ¶ 96 (“Before recent
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`improvements in software used to analyze MRI output… it was difficult and time
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`consuming to routinely study gray matter atrophy…”). The Petitioners have not
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`directly cited to this Exhibit for any other purpose. See supra at IV. Accordingly,
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`because Petitioners have exclusively used an article that is not prior art and is dated
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`after August 20, 2009 for a teaching prior to August 20, 2009, Petitioners’ Exhibit
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`1098 should be excluded as irrelevant. Further, any possible probative value of
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`Exhibit 1098 is substantially outweighed by a danger of confusing the issues and
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`wasting time.
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`8
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`D. Exhibit 1140 Should Be Excluded Because It Is Outside The Scope
`Of Mylan’s Reply And Was Not Properly Introduced Into The
`Record.
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`On April 12, 2016, Petitioners filed new Exhibit 1140 concurrently with the
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`transcript of the April 6, 2016 deposition of Ari Green, M.D. Exhibit 1140, the
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`Wolinsky Deposition Transcript from a co-pending district court litigation, was
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`introduced by Petitioners during redirect examination they conducted of their
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`expert, Dr. Green, at the conclusion of his deposition. This examination did not
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`respond to any questioning conducted by Patent Owner and was merely intended
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`as an improper bootstrap to submit Exhibit 1140. As noted supra, Petitioners did
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`not cite to this exhibit in their Reply, nor did Petitioners cite to Exhibit 1140 in the
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`Green Reply Report. Nor have Petitioners sought any relief from the Board to
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`submit this document as supplemental evidence under 37 C.F.R. § 42.123(b).
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`Instead, Petitioners chose to shoehorn this exhibit into the deposition of their own
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`expert after filing their Reply. Exhibit 1140 should be excluded because (a) it is
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`outside the scope of Mylan’s reply evidence, (b) was improperly introduced during
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`the Green deposition despite being outside the scope of Patent Owner’s
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`questioning, and (c) Mylan has not sought permission to submit the document as
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`supplemental evidence under 37 C.F.R. § 42.123(b), as the rules require.
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`VI. Conclusion
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`For at least the foregoing reasons, Patent Owner respectfully requests that
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`this motion be granted and that Petitioners’ Exhibits 1068, 1086, 1089, 1098, and
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`1140 be excluded.
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`Dated: April 13, 2016
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`Respectfully submitted,
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`/Elizabeth J. Holland/
`Elizabeth J. Holland
`Registration No. 47,657
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10019-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that I caused the PATENT OWNER’S
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`MOTION TO EXCLUDE EVIDENCE to be served electronically via e-mail on
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`April 13, 2016 on the following:
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`Jeffrey W. Guise
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`jguise@wsgr.com
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`Brandon M. White
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`BMWhite@perkinscoie.com
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`Shannon Bloodworth
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`sbloodworth@perkinscoie.com
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`David Anstaett
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`DAnstaett@perkinscoie.com
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`Richard Torczon
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`rtorczon@wsgr.com
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`Vince Capuano
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`vcapuano@duanemorris.com
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`Christopher Kroon
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`CSKroon@duanemorris.com
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`/April E. Weisbruch/
`April E. Weisbruch
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`Dated:
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`April 13, 2016