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`Case IPR 2016-00318
`Patent 7,772,209
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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., and 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,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG
`Petitioners,
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`v.
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`ELI LILLY & COMPANY,
`Patent Owner.
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`Case No. IPR2016-003181
`Patent No. 7,772,209
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`PATENT OWNER ELI LILLY AND COMPANY’S
`OPPOSITION TO MOTION TO EXCLUDE EVIDENCE
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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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`Case IPR 2016-00318
`Patent 7,772,209
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`TABLE OF CONTENTS
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`I. 
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`DR. NIYIKIZA’S TRIAL TESTIMONY SHOULD NOT BE
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`EXCLUDED .................................................................................................... 1 
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`II.  DR. ZEISEL’S TESTIMONY SHOULD NOT BE EXCLUDED ............... 11 
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`A.  Dr. Zeisel Is Fully Qualified To Opine on the Issues He
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`Discussed ............................................................................................. 11 
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`B. 
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`If Dr. Zeisel’s Testimony Is Not Considered, Then the
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`Testimony of Sandoz’s Folate Biochemistry Expert, Dr. Stover,
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`Should Not Be Considered .................................................................. 14 
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`TABLE OF AUTHORITIES
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`Case IPR 2016-00318
`Patent 7,772,209
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`CASES
`Arceo v. City of Junction City, 182 F. Supp.2d 1062 (D. Kan. 2002) ....................... 6
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`CaptionCall, LLC, et al. v. Ultratec, Inc., IPR2015-00636, Paper 97
`(PTAB Sept. 7, 2016) ................................................................................... 11, 12
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`Eli Lilly & Co. v. Teva Parenteral Medicines, et al., Case No. 1:10-
`cv-1376-TWP-DKL (S.D. Ind.) ........................................................................ 8, 9
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`Flex-Rest, LLC v. Steelcase, Inc., 455 F.3d 1351 (Fed. Cir. 2006) ......................... 13
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`Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01099, Paper 69
`(PTAB Sept. 12, 2016) ................................................................................. 13, 14
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`Mytee Prods., Inc. v. Harris Research, Inc., 439 F. App’x 882 (Fed.
`Cir. 2011) ............................................................................................................ 12
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`Petroleum Geo-Services, Inc. v. WesternGeco, LLC, IPR2014-01477,
`Paper 71 (PTAB July 11, 2016) ........................................................................ 4, 6
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`SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360 (Fed. Cir. 2010) ................. 12
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`SK Innovation Co. v. Celgard, LLC, IPR2014-00680, Paper 57 (PTAB
`Sept. 25, 2015) .................................................................................................... 14
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`Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir.
`2008) ................................................................................................................... 12
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`United States v. Inadi, 475 U.S. 387 (1986) .............................................................. 6
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.51 ............................................................................................... 2, 3, 4
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`37 C.F.R. § 42.53 ................................................................................................... 3, 4
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`37 C.F.R. § 42.64 ..................................................................................................... 10
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`Federal Rule of Evidence 702 .................................................................................. 14
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`Federal Rule of Evidence 804 ................................................................................ 7, 9
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`McCormick on Evidence § 301 ................................................................................. 6
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`iii
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`Patent Owner Eli Lilly and Company (“Lilly”) respectfully submits this
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`Case IPR 2016-00318
`Patent 7,772,209
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`Opposition to the Motion to Exclude (Paper 64, “Mot.”) filed by Petitioner Sandoz
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`Inc. (“Sandoz”). Sandoz’s motion is a transparent attempt to garner additional
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`pages within which to make merits arguments. Nothing it argues justifies the
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`exclusion of evidence, and its motion should be denied.
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`I.
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`DR. NIYIKIZA’S TRIAL TESTIMONY SHOULD NOT BE
`EXCLUDED
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`Sandoz challenges the admissibility of Exhibit 2116, which contains trial
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`testimony of the inventor, Dr. Clet Niyikiza, from the district court case against
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`Teva and Fresenius. Sandoz advances a number of theories as to why Dr.
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`Niyikiza’s testimony should be excluded, but they all stem from the same
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`underlying complaint: that Dr. Niyikiza was not deposed in this proceeding.
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`Sandoz’s arguments are without merit, and Exhibit 2116 should not be excluded.
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`A.
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`Some background is useful to understand Sandoz’s arguments. Dr.
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`Niyikiza was a Lilly employee when he conceived of the invention, but today, he is
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`the founder and CEO of L.E.A.F. Pharmaceuticals, an independent pharmaceutical
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`company not involved in this case. Paper 46 at 9; Ex. 2116 at 712. He is not under
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`Lilly’s control.
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`Sandoz itself put the district court’s findings of fact and excerpts of Dr.
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`Niyikiza’s testimony from the district court into evidence, and no party has
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`challenged their admissibility. Ex. 1003; Ex. 1036. With its POR, Lilly submitted
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`additional, undisputedly relevant excerpts of Dr. Niyikiza’s testimony from the
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`district court. Having put part of Dr. Niyikiza’s testimony in evidence, Sandoz
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`cannot now credibly argue that Lilly’s introduction of a more fulsome version of
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`Dr. Niyikiza’s testimony is inadmissible.
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`In any event, Sandoz makes much of the number of times Lilly cited that
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`testimony, but the citations generally fall into two categories. First, several
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`citations are addressed to the background of the invention, to provide this Board
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`with the same context the district court had. Ex. 1003 at 6-8; Paper 36 at 9-12.
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`Second, the principal purpose of his testimony, as relevant here, is to provide
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`evidence that—as the district court found, Ex. 1003 at 7, 25-26—Dr. Niykiza’s
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`“idea was met with consistent skepticism, and was not adopted until after the
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`priority date, when deaths occurred in the Phase III clinical trials.” Paper 36 at 57.
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`Key documents that Dr. Niyikiza discussed in the disputed testimony are now
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`undisputedly in evidence and corroborate his testimony. Sandoz’s own expert Dr.
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`Ross has now also testified that in 1998, the FDA stated to Lilly that “by providing
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`vitamins, that might reduce the efficacy of pemetrexed.” Ex. 2132 at 112; Ex.
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`2100 at ELAP00008719; cf. Ex. 2116 at 790-92.
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`After Lilly submitted its POR, Neptune and Sandoz jointly sought and
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`received permission to file a motion to obtain Dr. Niykiza’s deposition. Paper 43.
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`In response, Lilly explained that Dr. Niyikiza’s deposition would not be “routine
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`discovery” under 37 C.F.R. § 42.51(b)(1)(ii) and was not warranted as “additional”
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`discovery under the Garmin factors. Paper 46 at 2, 5-9. Lilly noted that
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`Petitioners had the entirety of Dr. Niyikiza’s trial-court deposition and trial
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`testimony. In the district court proceeding, Joinder-Petitioners Teva and Fresenius
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`examined him thoroughly about exactly the same issues present here. Id. at 5-8.
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`Tellingly, Petitioners refused to limit the scope of Dr. Niykiza’s deposition to any
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`particular topics or to the submitted trial testimony; the logical inference is that
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`Petitioners’ real motivation was to depose Dr. Niyikiza about their prima facie
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`obviousness case, which relies on Dr. Niyikiza’s publications but was not the
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`subject of the submitted trial testimony. The Board has not ruled on Petitioners’
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`motion.
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`B.
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`In its motion to exclude, Sandoz reiterates the procedural arguments
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`from its motion seeking Dr. Niyikiza’s deposition and accuses Lilly of violating
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`the Board’s procedural regulations. Mot. at 5, 9-11. Sandoz is mistaken.
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`The lynchpins of Sandoz’s arguments are 37 C.F.R. §§ 42.51 and 42.53.
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`Section 42.53 states that “[u]ncompelled direct testimony must be submitted in the
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`form of an affidavit.” Section 42.51(b)(1)(ii) permits cross-examination by
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`deposition of “affidavit testimony prepared for the proceeding.” 37 C.F.R.
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`§ 42.51(b)(1)(ii) (emphasis added). Based on these two regulations, Sandoz argues
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`that the submission of testimony in other forms, from other proceedings, is thus
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`forbidden; in Sandoz’s view, the only testimony that can be considered is affidavit
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`testimony, and all affidavit testimony must be subject to cross-examination. But
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`that is plainly wrong. Sandoz’s reading would mean that the “prepared for the
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`proceeding” language of 37 C.F.R. § 42.51(b)(1)(ii) is surplusage, as under that
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`reading, all affidavits, prepared for any proceeding, would have to be followed by
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`cross-examination. Alternatively, if affidavits were permitted without cross-
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`examination but 37 C.F.R. § 42.53 were read as a blanket prohibition on prior
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`testimony in other forms, affidavit testimony from other proceedings without
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`cross-examination would be favored over transcripts of trials and hearings that did
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`feature cross-examination. Neither possibility makes any sense.
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`In fact, the regulations, taken together, have a different, internally consistent
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`reading. When uncompelled testimony is “prepared for the proceeding,” it must be
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`submitted in the form of an affidavit, and the other party is then entitled to cross-
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`examine the affiant. Neither regulation has any bearing on whether or when
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`testimony prepared for other proceedings—in whatever form—can be submitted.
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`In fact, the Board routinely considers such testimony. See, e.g., Petroleum Geo-
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`Services, Inc. v. WesternGeco, LLC, IPR2014-01477, Paper 71, at 54-55 (PTAB
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`July 11, 2016) (analyzing testimony from district-court trial involving same patent
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`as evidence of praise).
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`4
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`C.
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`Sandoz also asserts that unless Dr. Niyikiza is shown to be
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`“unavailable,” his trial testimony is hearsay because it is not “at the current trial or
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`hearing.” Mot. at 2-4. Its position is curious, given its prior arguments that the
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`Board “should give no weight to Dr. Niyikiza’s testimony if he cannot be cross-
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`examined.” Paper 43 at 9 (emphasis added). If Sandoz were correct that testimony
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`from other proceedings must be treated as hearsay here unless the witness is
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`unavailable, the ability to depose Dr. Niyikiza would not have made his trial
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`testimony admissible, and its original position would have made no sense. Sandoz
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`was right the first time; the relevant question is one of weight. Sandoz cites a
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`number of cases for the proposition that when testimony is submitted as a
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`declaration from another proceeding—and there has thus been no opportunity to
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`challenge the testimony through cross-examination—the declarations should be
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`given little weight. Mot. at 9-11 (collecting cases). Those cases are inapplicable
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`here because the testimony is from a trial where, unlike a declaration from a prior
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`proceeding, full cross-examination occurred. But if Sandoz were correct that prior
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`testimony must be treated as hearsay in PTAB proceedings absent a showing of
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`unavailability, the declarations would not have been admissible in those cases, and
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`there would have been no question in the cases it cites about how much weight to
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`give them.
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`In fact, the Board has rejected hearsay challenges like Sandoz’s on the
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`ground that “prior trial testimony” is “similar to a declaration in this proceeding for
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`which Petitioner had the opportunity to conduct cross-examinations and is thus not
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`inadmissible.” PGS, IPR2014-01477, Paper 71 at 75-76. This approach is
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`consistent with that taken in other contexts, such as consideration of summary
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`judgment in district court, where live testimony is unavailable and prior testimony
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`is not disfavored over written testimony from the same proceeding. E.g., Arceo v.
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`City of Junction City, 182 F. Supp.2d 1062, 1080–81 (D. Kan. 2002).
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`At a trial or hearing in open court, transcripts of prior proceedings are not
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`admissible evidence if the witness is available to testify live, but the reasons for
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`that are inapplicable to PTAB proceedings that are decided on the papers. As the
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`Supreme Court has observed, “[i]f the declarant is available and the same
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`information can be presented to the trier of fact in the form of live testimony, with
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`full cross-examination and the opportunity to view the demeanor of the declarant,
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`there is little justification for relying on” prior testimony. United States v. Inadi,
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`475 U.S. 387, 394 (1986); see McCormick on Evidence § 301 (recognizing that the
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`rationale behind the hearsay treatment of prior testimony is “the strong preference
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`to have available witnesses testify in open court”). These principles offer no
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`justification for excluding Dr. Niyikiza’s testimony here, where he was cross-
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`examined in court, and where Sandoz’s proffered alternative—an affidavit
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`followed by cross-examination by deposition—would not provide any opportunity
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`to view his demeanor.
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`Sandoz’s only response is to argue that only Joinder-Petitioners, not Sandoz
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`itself, got to cross-examine Dr. Niyikiza at trial. Mot. at 6-8. But those Joinder-
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`Petitioners who did examine Dr. Niyikiza at deposition and trial had exactly the
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`same incentive to cross-examine Dr. Niyikiza as Sandoz does here—they had even
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`more than the “an opportunity and similar motive to develop” cross-examination
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`testimony that the evidence rules recite. FRE 804(b)(1)(B). The subjects on which
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`Dr. Niyikiza’s testimony is offered in this proceeding are not dependent on the
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`precise invalidity theories being pressed (although it bears noting that while the
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`precise combination of references may differ, the thrust of the argument made by
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`Sandoz and that made in the district court are basically the same). The invention
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`about which others expressed skepticism is the same in both proceedings, and the
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`skepticism has no relationship to the precise invalidity theory being advanced.2
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`2 Sandoz also now raises an additional laundry list of issues that it says it would
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`have liked to ask Dr. Niyikiza about (Mot. at 7-8), only some of which relate to
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`skepticism. But to the extent they do not relate to skepticism, they are still issues
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`about which Teva and Fresenius had exactly the same incentive to cross-examine
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`Dr. Niyikiza. Sandoz’s selection of topics also makes clear that, while Lilly is not
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`Moreover, that the issues here are the same as in the prior proceeding where Dr.
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`Niyikiza was previously examined distinguishes this case from Organik Kimya, the
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`only case Sandoz cites where the declarant was previously cross-examined. See
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`Mot. at 9.
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`Moreover, the issues relating to skepticism about which Sandoz says it
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`would have examined Dr. Niyikiza were issues Joinder-Petitioners argued
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`extensively at trial. For example, Teva and Fresenius specifically addressed “the
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`possibility that his allegation of ‘skepticism’ was premised on matters unrelated to
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`the claimed invention” and the reliability of his recollections of others’ statements
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`expressing skepticism about his invention. Eli Lilly & Co. v. Teva Parenteral
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`Medicines, et al., Case No. 1:10-cv-1376-TWP-DKL, ECF No. 331 at 40-42 (S.D.
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`attempting to use Dr. Niyikiza as an expert witness in this proceeding, Sandoz
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`would have liked to. Sandoz, for example, suggests that Dr. Niyikiza’s factual
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`testimony that he had never heard a suggestion to treat antifolate patients with
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`vitamin B12 before his invention might somehow change if Sandoz confronted him
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`with prior art Sandoz has located and now (incorrectly) argues is a precedent for
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`such treatment. What Sandoz misses is that this is not an issue on which Dr.
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`Niyikiza is expressing an opinion; he is a fact witness.
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`Ind. Oct. 11, 2013). Likewise, Sandoz highlights Dr. Niyikiza’s testimony that
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`after data from the pemetrexed registration trial were presented at the plenary
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`session of a meeting of the American Society of Clinical Oncology, the principal
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`investigator, Dr. Nicholas Vogelzang, approached Dr. Niyikiza and praised his
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`contribution to the drug’s development. Dr. Vogelzang said, “Thanks for what you
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`did. If you didn’t do it, this drug would probably be dead.” Ex. 2116 at 845; see
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`Paper 36 at 59. Sandoz’s complaint about this evidence ignores that it also was
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`highlighted, and was equally relevant evidence of praise, in the district court, and
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`Teva and Fresenius had every incentive to cross-examine Dr. Niyikiza about it.
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`E.g., Eli Lilly & Co. v. Teva Parenteral Medicines, et al., Case No. 1:10-cv-1376-
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`TWP-DKL, ECF No. 332 at 11 (S.D. Ind. Nov. 22, 2013). Once again, because
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`Teva and Fresenius had even more than “an opportunity and similar motive to
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`develop it” by cross-examination, the fact that Sandoz itself did not do so is beside
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`the point. FRE 804(b)(1)(B).3
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`3 As Lilly argued in district court and the court agreed, the testimony is also not
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`hearsay because “whether [Dr. Vogelzang] meant it or not, it’s still praise for the
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`invention that Dr. Niyikiza heard, and that’s admissible as an objective indicia.”
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`Ex. 2116 at 846. It is not being admitted for the truth of the matter asserted.
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`Finally, Sandoz argues that Dr. Niyikiza’s testimony is double hearsay to the
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`extent he testified about the statements made by others. Mot. at 2. But as the
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`district court correctly ruled at trial, these statements are not being offered for their
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`truth; what matters to skepticism is that they were said. Ex. 2116 at 748-49, 763-
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`64, 788. They are therefore not double hearsay. (Lilly does not ask the Board to
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`consider the one answer in the pages Sandoz cites that was excluded as hearsay by
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`the district court. Ex. 2116 at 747-48; see Mot. at 4.)
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`D.
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`Sandoz also complains that Dr. Niyikiza is not an expert. Mot. at 4.
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`But he is not being offered to provide expert testimony, as the district court
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`recognized in overruling identical objections, but merely explained his own use of
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`terminology and thought processes. Ex. 2116 at 734-737. Sandoz also complains
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`that Dr. Niyikiza testified about matters about which he had no personal
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`knowledge, but with regard to the history of the Lilly antifolate program, Sandoz
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`has not established (or even clearly articulated) what information Dr. Niyikiza
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`supposedly testified about without adequate foundation or why this issue, too, does
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`not go to the testimony’s weight rather than admissibility. Mot. at 4. These
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`arguments do not provide a basis to exclude any of Dr. Niyikiza’s testimony, much
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`less all of it.
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`E.
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`Finally, Sandoz faults Lilly for omitting the remainder of Dr.
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`Niyikiza’s testimony. Lilly served the entirety of Dr. Niyikiza’s trial testimony as
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`supplemental evidence under 37 C.F.R. § 42.64(b)(2). Sandoz had every
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`opportunity to submit any other portions it desired to submit or to submit the
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`testimony in its entirety. It did not, and then amazingly seeks to use that as a basis
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`for exclusion. In any event, this issue is easily resolved. Lilly is filing with this
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`paper the entirety of Dr. Niyikiza’s testimony as Exhibit 2125, Ex. A.
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`II. DR. ZEISEL’S TESTIMONY SHOULD NOT BE EXCLUDED4
`A. Dr. Zeisel Is Fully Qualified To Opine on the Issues He Discussed
`Sandoz also seeks the exclusion of large portions of Dr. Zeisel’s declaration,
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`Exhibit 2118, on the ground that he lacks the skills of the POSA, who all parties
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`agree is an oncologist, and thus cannot provide testimony regarding what the
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`4 Sandoz moves to exclude Dr. Zeisel’s testimony, but Neptune does not move to
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`exclude the exact same testimony in its co-pending cases, IPR2016-00237 and -
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`00240. IPR2016-00237, Paper 57. Meanwhile, Neptune moves to exclude Lilly’s
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`other expert, Dr. Chabner, but Sandoz does not seek to exclude his testimony. Id.
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`at 1-7. Sandoz and Neptune clearly coordinated, however, as their sections about
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`Dr. Niyikiza share large blocks of text. Compare id. at 7-15 with Mot. at 1-11.
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`Whether the Petitioners are actually encouraging the Board to render inconsistent
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`admissibility decisions, do not believe in each other’s arguments, or simply are
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`trying to get more space, their arguments should be rejected.
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`POSA would have known. Mot. at 11-14. Lilly agrees that Dr. Zeisel is not an
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`oncologist, and by himself does not have all the skills of the POSA. But that does
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`not make his testimony inadmissible.
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`Where Sandoz’s argument goes astray is that the POSA “is a hypothetical
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`construct that, for example, is aware of all prior art in existence” in the relevant
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`field. CaptionCall, LLC, et al. v. Ultratec, Inc., IPR2015-00636, Paper 97 at 9
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`(PTAB Sept. 7, 2016). Accordingly, to determine that an expert is sufficiently
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`“qualified in the pertinent art” that his or her testimony is admissible, the Board
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`“need not find a complete overlap between the witness’s technical qualifications
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`and the problem confronting the inventor or the field of endeavor.” Id. at 8-9. A
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`witness who concededly lacks all of the skills of the POSA can therefore qualify as
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`an expert so long as the witness “ha[s] experience relevant to the field of the
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`invention.” Id. at 9 (quoting Mytee Prods., Inc. v. Harris Research, Inc., 439 F.
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`App’x 882, 886-87 (Fed. Cir. 2011)); see SEB S.A. v. Montgomery Ward & Co.,
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`594 F.3d 1360, 1372-73 (Fed. Cir. 2010) (upholding admission of testimony from
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`expert who had knowledge relevant to one aspect of the POSA’s knowledge).
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`Dr. Zeisel’s testimony is therefore both relevant and admissible. As Lilly’s
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`oncology expert, Dr. Chabner, opined, the POSA “would need to have an
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`understanding of how nutritional issues relate to the use of chemotherapy” and
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`“would have an understanding of the interrelationships between antifolates, the
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`folic acid pathway, and pathways related to vitamin B12.” Ex. 2120 ¶ 25. Dr.
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`Zeisel is amply qualified to speak to these issues. As he testified, he is an expert in
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`nutritional science, with a particular specialization in “one-carbon metabolism,
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`which relates to both the folic acid pathway and pathways involving vitamin B12.”
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`Ex. 2118 ¶¶ 4-6, 9-10. He also has “done extensive research regarding folates,” as
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`well as “research relating to the toxicities and biochemical effects of compounds
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`that are used in the treatment of cancer.” Id. ¶ 7. He is even a physician “on the
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`faculty of the Lineberger Cancer Center at UNC.” Id. ¶¶ 4, 8. That he is not also
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`an oncologist is completely immaterial.
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`Sandoz’s cases (Mot. at 12) are not to the contrary. In Sundance, Inc. v.
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`DeMonte Fabricating Ltd., 550 F.3d 1356, 1362-64 (Fed. Cir. 2008), the Federal
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`Circuit disapproved of testimony from a patent practice expert who concededly had
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`no relevant technical expertise whatsoever. Likewise, in Flex-Rest, LLC v.
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`Steelcase, Inc., 455 F.3d 1351, 1360-61 (Fed. Cir. 2006), the Federal Circuit
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`affirmed the decision of a district court, after “a hearing to fully investigate [the
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`proposed expert’s] qualifications,” that an expert in “ergonomics” did not have
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`expertise in the relevant field of “designs of keyboard systems.” Neither of these
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`cases supports exclusion of a witness like Dr. Zeisel who may not individually
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`possess every aspect of the POSA’s skill set, but who clearly has relevant technical
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`expertise relating to an aspect of what the POSA would know.
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`Sandoz’s criticisms ultimately to go the weight of Dr. Zeisel’s testimony, not
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`its admissibility. Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01099, Paper 69
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`at 43-44 (PTAB Sept. 12, 2016). While he may not be able to speak with
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`confidence to everything the POSA would think, he is amply qualified to say what
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`a physician who, like the POSA, has an “understanding of the interrelationships
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`between antifolates, the folic acid pathway, and pathways related to vitamin B12”
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`would have known as of 1999. See Ex. 2120 ¶ 25. The Board should not exclude
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`his testimony and is well equipped, as a tribunal of specialist judges, to weigh it
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`appropriately. Lupin, IPR2015-01099, Paper 69 at 44.
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`B.
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`If Dr. Zeisel’s Testimony Is Not Considered, Then the Testimony
`of Sandoz’s Folate Biochemistry Expert, Dr. Stover, Should Not
`Be Considered
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`Sandoz’s efforts to exclude Dr. Zeisel’s testimony are striking given that in
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`Reply, it adduced testimony from its own expert in one-carbon metabolism, Dr.
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`Stover. Ex. 1091. Dr. Stover is in many ways farther removed from the POSA
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`than Dr. Zeisel. Unlike Dr. Zeisel, he is not a physician. And unlike Dr. Zeisel, he
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`did not even attempt to speak to what the POSA would have known or believed.
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`For example, he testified expressly that because he is “not a clinician,” he “can’t
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`speak to what a POSA would—would infer.” Ex. 2137 at 20. Dr. Stover provided
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`extended speculations about how folic acid and vitamin B12 pretreatment might
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`affect pemetrexed’s efficacy and toxicity, but did not even try to connect them to
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`what an oncologist, and thus the POSA, would have known or thought. Id. at 23,
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`26, 28, 56, 58, 105-09, 125-26, 128, 164, 173, 178, 235, 237.
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`Lilly did not move to exclude Dr. Stover’s testimony because the
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`deficiencies in his testimony go to its weight. While his testimony is of minimal
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`value, given the total lack of any connection between his musings and the relevant
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`perspective of the POSA, there is no need for that to be litigated in the context of a
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`motion to exclude. The Board can weigh his testimony appropriately without
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`invoking the “gatekeeping” function of FRE 702. Lupin, IPR2015-01099, Paper
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`69 at 44; SK Innovation Co. v. Celgard, LLC, IPR2014-00680, Paper 57 at 31
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`(PTAB Sept. 25, 2015).
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`However, Sandoz has now moved to exclude Dr. Zeisel’s testimony, while
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`Lilly has not moved to exclude Dr. Stover’s. The Board should note that Sandoz
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`acknowledged in its Reply that Dr. Stover was intended only as a counterpoint to
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`Dr. Zeisel, stating that “[t]o the extent the Board affords Dr. Zeisel’s opinions any
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`weight, Sandoz provides rebuttal testimony from its own nutrition expert, Dr.
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`Stover.” Paper 49 at 22. Sandoz should be taken at its word. If the Board
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`excludes any of Dr. Zeisel’s testimony, it should similarly exclude, or accord no
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`weight to, the testimony of Dr. Stover. And if—as it should—the Board does
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`consider Dr. Zeisel’s testimony, it should bear in mind that Dr. Zeisel, unlike Dr.
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`Stover, is a physician who opined about what the relevant POSA would know.
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`Case IPR 2016-00318
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`Dated: February 21, 2017
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`Respectfully submitted,
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`
`
`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`Telephone: 202-434-5338
`Facsimile: 202-434-5029
`Email: dkrinsky@wc.com
`
`Back-up Counsel for
`Patent Owner
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`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the document above was served on
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`this 21st day of February, 2017, on the Petitioners by delivering a copy via
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`electronic mail to the following individuals at the email addresses below:
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`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
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`Joshua H. James
`Reg. No. 72,568
`jjames@brinksgilson.com
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`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
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`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
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`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
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`Counsel for Sandoz Inc.
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
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`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
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`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
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`William A. Rakoczy
`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
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`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
`
`Attorneys for Apotex Inc. and Apotex
`Corp.
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`Thomas J. Parker
`Reg. No. 42,062
`thomas.parker@alston.com
`
`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`P: 212-210-9529/F: 212-210-9444
`
`Counsel for Mylan Laboratories
`Limited
`
`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5135/F: 917-591-6921
`
`Counsel for Glenmark
`Pharmaceuticals Inc., USA, Glenmark
`Holding SA, and Glenmark
`Pharmaceuticals Ltd.
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`
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`Case IPR 2016-00318
`Patent 7,772,209
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`Patrick C. Kilgore
`Reg. No. 69,131
`pkilgore@rmmslegal.com
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`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5290/F: 917-332-3063
`
`Counsel for Emcure Pharmaceuticals
`Ltd., Heritage Pharma Labs Inc., and
`Heritage Pharmaceuticals Inc.
`
`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
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`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
`
`Counsel for Wockhardt Bio AG
`
`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
`
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
`
`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
`
`Case IPR 2016-00318
`Patent 7,772,209
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`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
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`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
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`Case IPR 2016-00318
`Patent 7,772,209
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`/David M. Krinsky/
`David M. Krinsky
`Attorney for Patent Owner
`Registration No. 72,339
`Back-up Counsel for
`Patent Owner
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`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Fresenius Kabi USA,
`LLC
`
`Date: February 21, 2017
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