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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD., MYLAN
`LABORATORIES LIMITED, TEVA PHARMACEUTICALS USA, INC.,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG,
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`Petitioners
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`v .
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`ELI LILLY AND COMPANY,
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`Patent Owner.
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`Case IPR2016-003181
`U.S. Patent 7,772,209
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`PETITIONER SANDOZ INC.’S REPLY IN SUPPORT OF ITS MOTION
`TO EXCLUDE
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`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
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`with the instant proceeding.
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`I.
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`DR. NIYIKIZA’S PRIOR TESTIMONY SHOULD BE EXCLUDED
`A. Dr. Niyikiza’s Prior Testimony Should Be Excluded As Hearsay
`Lilly does not refute the facts establishing that Dr. Niyikiza’s testimony
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`(Ex. 2116) is hearsay: Dr. Niyikiza’s prior testimony was not made while testifying
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`in this IPR; and that testimony is offered to prove the truth of the matter asserted.
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`Instead, Lilly suggests Dr. Niyikiza’s cross-examination in the Teva
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`Litigation allows it to rely on his former testimony. This is not so. Fed. R. Evid.
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`804(b)(1) provides that former testimony is only exempted from the hearsay rule if
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`“the declarant is unavailable as a witness.” Lilly states that Dr. Niyikiza is not
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`under Lilly’s “control,” but never asserts that he is unavailable. Paper 72 at 1.
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`Notably, Petitioners’ Motion To Cross-Examine Dr. Niyikiza is still pending,
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`which could have been avoided had Lilly cooperated in producing Dr. Niyikiza.
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`Moreover, the former testimony exception is limited to prior testimony offered
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`against a party who had a chance to cross-examine the witness, an opportunity
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`Sandoz never had. See Fed. R. Evid. 804(b)(1)(B). Nothing suggests Teva’s
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`cross-examination can serve as a substitute – particularly since Teva did not
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`examine the context of the particular hearsay testimony on which Lilly now relies.
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`Lilly’s cases do not hold otherwise. In Petroleum Geo-Services Inc. v.
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`WesternGeco LLC, prior testimony was admissible “because Petitioner had the
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`opportunity to cross-examine [the witness] in this proceeding[.]” IPR2014-01477,
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`1
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`Paper 71 at 75-76 (July 11, 2016) (emphasis added). Arceo and Inadi did not
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`involve hearsay testimony used to circumvent cross-examination. See Arceo v.
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`City of Junction City, 182 F. Supp. 2d 1062, 1080-81 (D. Kan. 2002) (noting no
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`right to cross-examine existed at summary judgment stage and thus permitting
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`transcript); United States v. Inadi, 475 U.S. 387, 394 (1986) (recognizing one of
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`many rationales behind the hearsay treatment of prior testimony).
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`By contrast, the Board’s holding that prior testimony was entitled to no
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`weight in Organik Kimya AS v. Rohm & Haas Co. is directly on point. IPR2014-
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`00185, Paper 42 at 2 (Dec. 18, 2014). Lilly vaguely argues that the issues were not
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`“the same” in the prior proceeding in Organik (Paper 72 at 8), but this is belied by
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`the fact that prior anticipation-related testimony was considered relevant to
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`whether the motion to amend in the later proceeding overcame the anticipatory art.
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`Like Organik, Lilly’s end-run around the Board’s rules requiring an affidavit – and
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`cross-examination – should result in exclusion, or at minimum, the testimony being
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`given no weight. See 37 C.F.R. §§ 42.53(a), 42.51(b)(1)(ii). Further, Lilly cannot
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`hide behind the “prepared for the proceeding” clause of the affidavit rule here
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`where Dr. Niyikiza’s testimony was “affirmatively relied upon by a patent owner”
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`and thus interjected into the current proceeding. See Altaire Pharm., Inc. v.
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`Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 2 (Apr. 1, 2016).
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`Lilly disingenuously argues that Sandoz put Dr. Niyikiza’s testimony into
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`2
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`evidence because the petition cites Dr. Niyikiza’s summary of FDA documents
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`relied on by Lilly to show purported skepticism. Paper 72 at 1-2; Paper 2 at 45
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`(citing Ex. 1036 at 808-10, 874-76). Sandoz only cited this testimony because the
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`documents themselves were not accessible at the time. Ex. 2019, 28:15-29:1.
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`Now that Lilly has reluctantly produced the documents (id. at 23:23-24), there is
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`no need to consider the testimony. Further, under Fed. R. Evid. 801(d)(2)(B), Dr.
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`Niyikiza’s testimony is not considered hearsay when Sandoz cites it against the
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`opposing party (Lilly) because it is a party admission.
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`Finally, corroboration cannot salvage Dr. Niyikiza’s hearsay. See Paper 72
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`at 2. Rather than corroborating Dr. Niyikiza’s testimony, Dr. Ross disagreed that
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`the FDA believed folic acid would reduce efficacy. Ex. 2132 at 116:10-117:5.
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`Moreover, the hearsay exception for statements against interest is the only one that
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`includes a corroboration provision. See Fed. R. Evid. 804(b)(3)(B). Dr. Niyikiza’s
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`self-serving hearsay certainly does not qualify and thus corroboration is irrelevant.
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`B. Dr. Niyikiza’s Double Hearsay Should Be Excluded
`Lilly defends Dr. Niyikiza’s self-serving double hearsay about others’
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`statements of skepticism by arguing these statements are not offered for their truth
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`because “what matters to skepticism is that they were said.” Paper 72 at 10. This
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`is false. A third party’s hearsay statement, e.g., “I am skeptical,” can have no
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`bearing on whether skepticism existed unless offered for the truth. Further, it is
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`3
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`telling that the district court’s stated reasoning for allowing such hearsay was, “I’ll
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`overrule it. It’s interesting. I would like to hear it.” Ex. 2116 at 722-23.
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`II.
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`PARAGRAPHS 24-28 AND 44-78 OF DR. ZEISEL’S DECLARATION
`(EXHIBIT 2118) SHOULD BE EXCLUDED
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`“Lilly agrees that Dr. Zeisel is not an oncologist, and by himself does not
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`have all the skills of the POSA.” Paper 72 at 12. Lilly even admits that Dr. Zeisel
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`“may not be able to speak with confidence to everything the POSA would
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`think . . . .” Id. at 14. Despite this, Dr. Zeisel purports to offer opinions from the
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`perspective of a POSA. See id. These improper opinions should be excluded.
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`Federal Circuit precedent requires exclusion of experts like Dr. Zeisel who
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`offer opinions beyond their area of expertise. Paper 64 at 12 (citing Sundance, Inc.
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`v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir. 2008); Flex-Rest,
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`LLC v. Steelcase, Inc., 455 F.3d 1351, 1360-61 (Fed. Cir. 2006)). These cases do
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`not support Lilly’s claim that having any relevant experience suffices to avoid
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`exclusion. See Paper 72 at 13-14. For example, in Flex-Rest, the invention applied
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`ergonomic principles. 455 F.3d at 1360-61. Nonetheless, the court excluded an
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`ergonomics expert’s opinions on anticipation and obviousness because the POSA
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`was a keyboard designer. Id. Similarly, the Board should exclude Dr. Zeisel, a
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`nutritionist, from opining as a POSA who is indisputably an oncologist.
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`Lilly’s presentation of an admitted non-POSA to present testimony on a
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`POSA’s opinions runs counter to Lilly’s own cases, which involved experts
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`4
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`opining only on matters within their expertise. See CaptionCall, L.L.C. v. Ultratec,
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`Inc., IPR2015-00636, Paper 97 at 8-10 (Sept. 7, 2016) (speech recognition expert
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`opining on patent for assisting deaf individuals to use telephones); Mytee Prods.,
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`Inc. v. Harris Research, Inc., 439 F. App’x 882, 886-87 (Fed. Cir. 2011) (anyone
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`qualified as expert where POSA was layman); SEB S.A. v. Montgomery Ward &
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`Co., 594 F.3d 1360, 1372-73 (Fed. Cir. 2010) (expert knowledgeable in polymers
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`opining on polymer materials of deep fryer); Lupin Ltd. v. Senju Pharm. Co.,
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`IPR2015-01099, Paper 69 at 43 (Sept. 12, 2016) (expert with Ph.D. in Pharmacy
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`who taught several chemistry classes qualified to opine on organic and medicinal
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`chemistry); SK Innovation Co. v. Celgard, LLC, IPR2014-00680, Paper 57 at 30-
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`31 (Sept. 25, 2015) (finding expert had sufficient experience with lithium
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`batteries).
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`Lilly’s attack on Sandoz’s nutrition expert, Dr. Stover, misses a critical
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`distinction. See Paper 72 at 14-15. Unlike Dr. Zeisel, Dr. Stover never opines as a
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`POSA. Ex. 1091. Instead, he opines from the perspective of a nutritional scientist
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`about the knowledge available to a POSA. Id. ¶ 15. Dr. Stover also explained the
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`relevance of nutritional science to oncologists and how nutritional scientists and
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`oncologists work together both in research and clinical settings. Ex. 2137 at 22:7-
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`14, 23:24-24:14, 25:2-26:22, 108:7-109:25.
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`5
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`Dated: February 28, 2017
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`Respectfully submitted,
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
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`6
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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the foregoing document were
`served on February 28, 2017, via email to the following individuals at the email
`addresses below.
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`Dov P. Grossman (Reg. No. 72,525)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
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`David M. Krinsky (Reg. No. 72,339)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
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`Adam L. Perlman
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5244
`aperlman@wc.com
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`James P. Leeds (Reg. No. 35,241)
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
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`John C. Demeter (Reg. No. 30,167)
`Eli Lilly and Company
`Lilly Corporate Center
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`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
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`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`Email: demeter_john_c@lilly.com
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