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 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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`

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`B. 
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`C. 
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`2. 
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`III. 
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`I. 
`II. 
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1 
`EXHIBIT 2116 (DR. NIYIKIZA’S TESTIMONY IN A PRIOR
`PROCEEDING) SHOULD BE EXCLUDED ................................................ 1 
`A. 
`Exhibit 2116 Constitutes Hearsay (And Double Hearsay)
`Because The Testimony Was Not Given In This Proceeding ............... 2 
`Dr. Niyikiza Is Not An Expert And Exhibit 2116 Includes
`Content Over Which He Had No Personal Knowledge ........................ 4 
`Dr. Niyikiza Was Never Made Available for Deposition, and
`Therefore His Prior Testimony Violates the Board’s Rules ................. 4 
`1. 
`Lilly’s violation of 37 C.F.R. § 42.53 has deprived Sandoz
`of cross-examination of Dr. Niyikiza ......................................... 5 
`The Board has repeatedly limited reliance on testimony
`that does not comply with its rules ............................................. 9 
`Exhibit 2116 Is Not A Complete Exhibit ............................................ 11 
`D. 
`PARAGRAPHS 24-28 AND 44-78 OF DR. ZEISEL’S
`DECLARATION (EXHIBIT 2118) SHOULD BE EXCLUDED ................ 11 
`IV.  CONCLUSION .............................................................................................. 14 
`
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`
`
`i
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`

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`TABLE OF AUTHORITIES
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`
`CASES 
`Altaire Pharm., Inc. v. Paragon Bioteck, Inc.,
`PGR2015-00011 (P.T.A.B. Apr. 1, 2016) ....................................................... 9, 10
`Coalition for Affordable Drugs V LLC v. Biogen MA Inc.,
`IPR 2015-01993 (P.T.A.B. Apr. 19, 2016) ............................................................ 9
`Eli Lilly & Co. v. Teva Parenteral Meds., Inc.,
`No. 1:10-CV-1376 (S.D. Ind.) ................................................................................ 1
`Flex-Rest, LLC v. Steelcase, Inc.,
`455 F.3d 1351 (Fed. Cir. 2006) ............................................................................ 12
`GEA Process Eng’g, Inc. v. Steuben Foods, Inc.,
`IPR2014-00041 (PTAB June 11, 2014) ............................................................... 10
`Maxliner, Inc. v. Cresta Tech. Corp.,
`IPR2015-00594 (PTAB Jan. 15, 2016) ................................................................ 11
`Organik Kimya AS v. Rohm & Haas Co.,
`IPR2014-00185 (P.T.A.B. Dec. 18, 2014) ............................................................. 9
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) ............................................................................ 12
`RULES 
`Fed. R. Evid. 106 ................................................................................................ 1, 11
`Fed. R. Evid. 602 ............................................................................................ 1, 4, 14
`Fed. R. Evid. 702 ...................................................................................... 1, 4, 12, 14
`Fed. R. Evid. 801 ....................................................................................................... 2
`Fed. R. Evid. 802 ...................................................................................................1, 4
`Fed. R. Evid. 803 ....................................................................................................... 3
`Fed. R. Evid. 804 ....................................................................................................... 3
`Fed. R. Evid. 805 ....................................................................................................... 4
`Fed. R. Evid. 807 ....................................................................................................... 3
`ii
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`

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`REGULATIONS 
`37 C.F.R. § 42.51 ............................................................................................. passim
`37 C.F.R. § 42.53 ...................................................................................................1, 5
`37 C.F.R. § 42.64 ....................................................................................................... 1
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`
`iii
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`I.
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`INTRODUCTION
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`Petitioner Sandoz Inc. (“Sandoz”) moves pursuant to 37 C.F.R. § 42.64(c) to
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`exclude Exhibit 2116 and Paragraphs 24-28 and 44-78 of Exhibit 2118. Sandoz
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`moves to exclude these exhibits as inadmissible pursuant to Fed. R. Evid. 106, 602,
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`702, 802, and 37 C.F.R. § 42.53.
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`II. EXHIBIT 2116 (DR. NIYIKIZA’S TESTIMONY IN A PRIOR
`PROCEEDING) SHOULD BE EXCLUDED
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`On October 7, 2016, Sandoz timely objected to Exhibit 2116, which consists
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`of 102 pages from the August 22, 2013 direct trial testimony of Dr. Clet Niyikiza,
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`the sole inventor listed on the face of the patent at issue in this IPR. Paper No. 39,
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`Pet. Obj. at 7-8. This testimony was given in litigation, to which Sandoz was not a
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`party, Eli Lilly & Co. v. Teva Parenteral Meds., Inc., No. 1:10-CV-1376 (S.D.
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`Ind.) (“Teva Litigation”). Lilly relies on 37 pages of Exhibit 2116 in its Patent
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`Owner Response, citing to the exhibit nine times. See Paper No. 36, PO Resp. at
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`10-12, 57, 59. As explained below, the testimony in Exhibit 2116 should be
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`excluded for multiple reasons: (A) as hearsay under Fed. R. Evid. 802; (B)
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`improper expert testimony under Fed. R. Evid. 602 and 702; (C) an improper
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`attempt to circumvent the right to cross-examination in violation of the Board’s
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`rules under 37 C.F.R. § 42.51(b)(1)(ii); and (D) incomplete under Fed. R. Evid.
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`106.
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`1
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`

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`A. Exhibit 2116 Constitutes Hearsay (And Double Hearsay) Because
`The Testimony Was Not Given In This Proceeding
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`The testimony from Dr. Niyikiza (Ex. 2116) cited by and relied on by Lilly
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`is impermissible hearsay. Dr. Niyikiza’s testimony falls squarely into the
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`definition of hearsay because he gave the testimony during a 2013 trial in the Teva
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`Litigation, not “while testifying at the current trial or hearing,” i.e., this IPR. See
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`Fed. R. Evid. 801(c)(1).
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`In addition, much of Dr. Niyikiza’s trial testimony constitutes double
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`hearsay because the testimony as given in the district court was itself hearsay. For
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`example, Dr. Niyikiza testified about statements made by FDA officials during a
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`meeting in 1998. (Ex. 2116, Niyikiza Tr. at 787-88.) These alleged statements
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`were made by individuals other than Dr. Niyikiza. The same applies to Dr.
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`Niyikiza testifying about comments made by certain advisory panels (id. at 750-58,
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`760-65, 771-75, 798-99), FDA employee responses at a meeting with Lilly (id. at
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`821-22), and comments made by an investigator at a conference (id. at 845).
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`Further, Lilly is offering Dr. Niyikiza’s testimony for the truth of the matters
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`asserted in the testimony. See Fed. R. Evid. 801(c)(2). For example, Lilly relies
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`on Dr. Niyikiza’s hearsay testimony about purported views expressed by FDA
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`employees to argue that “the FDA was skeptical of folic acid and vitamin B12
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`pretreatment because they feared a reduction of pemetrexed’s efficacy.” Paper 36,
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`PO Resp. at 11 (citing Ex. 2116, Niyikiza Tr. at 821-22). Lilly also relies on Dr.
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`2
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`Niyikiza’s testimony for the truth of Dr. Niyikiza’s statements about the
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`sufficiency of his data prior to June 1999, Dr. Niyikiza’s representations to his
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`employer, Lilly, and Lilly’s beliefs about the risks of vitamin pretreatment. Id. at
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`10-12, 57 (citing Ex. 2116, Niyikiza Tr. at 733-34, 742-48, 750-58, 760-65, 771-
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`75, 798-99, 821-22, 824); see also id. at 11 (citing Ex. 2116, Niyikiza Tr. at 787-
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`88).
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`No hearsay exception applies and thus Dr. Niyikiza’s testimony should be
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`excluded in its entirety. See Fed. R. Evid. 803, 804, 807. Lilly cannot rely on Fed.
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`R. Evid. 804(b)’s exception for former testimony because there is no indication
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`that Dr. Niyikiza “is unavailable as a witness” to testify in this proceeding. Dr.
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`Niyikiza was a Vice President at Merrimack Pharmaceuticals in Boston at the time
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`he voluntarily traveled to Washington, D.C., to testify at his deposition and
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`Indianapolis to testify at trial, in the Teva Litigation. (See Dkt. 2116, Niyikiza Tr.
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`at 712.) In addition, Dr. Niyikiza may be contractually obligated to assist Lilly in
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`future matters involving the patent at issue – common practice in the
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`pharmaceutical industry. In fact, a representation that Dr. Niyikiza is unavailable
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`was conspicuously absent from Lilly’s response to Sandoz’s prior request – and
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`motion – for Dr. Niyikiza’s deposition. See Paper 43, Sandoz Mot. at 9 (noting
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`likely availability of Dr. Niyikiza for deposition); Paper 46, Lilly Opp. (silent on
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`Dr. Niyikiza’s availability). Even if Lilly could establish that a hearsay exception
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`3
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`

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`exists for Dr. Niyikiza’s testimony generally, at least his double hearsay testimony
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`about statements made by other scientists and third parties over a decade earlier, as
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`discussed above, must be excluded under Fed. R. Evid. 802 and 805.
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`B. Dr. Niyikiza Is Not An Expert And Exhibit 2116 Includes Content
`Over Which He Had No Personal Knowledge
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`Dr. Niyikiza’s trial testimony (Ex. 2116) also should be excluded because it
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`includes extensive content over which he had no personal knowledge under Fed. R.
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`Evid. 602 and for which he is not qualified to testify as an expert witness under
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`Fed. R. Evid. 702. Dr. Niyikiza is not offered as an expert in this IPR and has
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`admitted he has no background in oncology, nutrition, or vitamins. (Ex. 2116,
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`Niyikiza Tr. at 717:15-20.) However, Dr. Niyikiza’s trial testimony includes
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`repeated discussion of these areas – topics over which he had no personal
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`knowledge or expertise. For example, Dr. Niyikiza testified regarding failures in
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`programs that he did not participate in, the interactions of folic acid and
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`pemetrexed, cancer therapy protocols, the folate pathway, and pemetrexed toxicity.
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`(See id. at 733-34, 742-48, 824.) Dr. Niyikiza also effectively provided expert
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`testimony regarding statistical principles such as collinearity, but Dr. Niyikiza is
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`not offered as an expert and was not deposed in this IPR. (See id. at 733-37.)
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`Accordingly, Exhibit 2116 should be excluded under Fed. R. Evid. 602 and 702.
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`C. Dr. Niyikiza Was Never Made Available for Deposition, and
`Therefore His Prior Testimony Violates the Board’s Rules
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`4
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`

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` Dr. Niyikiza’s trial testimony also should be excluded, or, at a minimum, be
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`entitled to no weight, because it violates the applicable regulations governing this
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`proceeding, which require that “[u]ncompelled direct testimony must be submitted
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`in the form of an affidavit” and that affidavit testimony be subject to cross
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`examination under 37 C.F.R. § 42.51(b)(1)(ii). See 37 C.F.R. § 42.53(a). Dr.
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`Niyikiza was never made available for deposition in this IPR. This is not just a
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`formalistic complaint: Lilly relies on select portions of Dr. Niyikiza’s prior
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`testimony it considers favorable in violation of the Board’s rules, with the effect of
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`depriving Sandoz an opportunity for cross-examination. As such, Dr. Niyikiza’s
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`prior testimony (Ex. 2116) should be excluded, or, at a minimum, be entitled to no
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`weight.
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`1.
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`Lilly’s violation of 37 C.F.R. § 42.53 has deprived
`Sandoz of cross-examination of Dr. Niyikiza
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`Lilly has refused to provide Dr. Niyikiza for deposition and thus Lilly’s
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`violation of the 37 C.F.R. § 42.51(b)(1)(ii) cannot be cured. On October 10,
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`Sandoz requested the availability of Dr. Niyikiza to sit for his deposition. (Ex.
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`1133, Email Lydigsen to Krinsky.) Lilly responded that it did not intend to make
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`Dr. Niyikiza available. (Ex. 1134, Email from Krinsky to Counsel.) With the
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`Board’s authorization (Ex. 1062, Tr. at 4:18-5:4, 16:12-18), Sandoz then filed a
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`Motion To Cross-Examine Dr. Niyikiza on November 9 (Paper 43), which Lilly
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`opposed (Paper 46). The Board has not ruled on Sandoz’s motion, and Lilly has
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`5
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`

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`not otherwise changed its position and provided Dr. Niyikiza for deposition. Thus,
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`Sandoz has had no opportunity to cross-examine Dr. Niyikiza in this IPR.
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`Dr. Niyikiza’s prior cross-examination in the Teva Litigation does not
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`excuse Lilly from complying with the Board’s rules or cure the prejudice to
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`Sandoz here. In particular, Lilly’s maneuver around the Board’s rules for
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`affidavits in 37 C.F.R. § 42.51(b)(1)(ii) will deprive Sandoz of an opportunity to
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`obtain testimony from Dr. Niyikiza on issues raised in Dr. Niyikiza’s direct
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`examination that were not the subject of cross-examination in the prior Teva
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`Litigation. (Ex. 1135, Niyikiza Cross and Redirect.) One example is that Sandoz
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`was not given the opportunity to explore with Dr. Niyikiza the possibility that his
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`view of “skepticism” relates to the ability to design a study with sufficient
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`statistical power to ensure FDA approval – not skepticism that vitamin
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`pretreatment would work with pemetrexed. Another striking example is Lilly’s
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`reliance on Dr. Niyikiza’s hearsay testimony that a principal investigator allegedly
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`“praised Dr. Niyikiza’s contribution to pemetrexed’s development, stating that ‘[i]f
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`you didn’t do it, the drug would probably be dead,’” a hearsay quote that anchors
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`Lilly’s assertion of skepticism in these IPRs. Paper 36, PO Resp. at 59. Because
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`the questioning on cross-examination in the Teva Litigation does not touch on this
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`statement, Sandoz has been deprived the ability to elicit testimony about any
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`additional statements and/or comments exchanged between Dr. Niyikiza and the
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`6
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`

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`investigator, which may have revealed that the investigator’s reference to “it”
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`merely concerned Dr. Niyikiza’s multivariate analysis published prior to the June
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`1999 critical date. (Exs. 1006 (Niyikiza I) and 1016 (Niyikiza II)).
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`Further, lack of cross-examination of Dr. Niyikiza precluded Sandoz from
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`exploring with Dr. Niyikiza whether the investigator was informed or otherwise
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`made aware of the relevant prior art in this IPR, such as studies suggesting the use
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`of pemetrexed with folic acid (Exs. 1005 (’974 patent), 1013 (Worzalla), 1014
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`(Hammond II), 1015 (Hammond I)) and both pemetrexed and other antifolates
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`with vitamin B12 (Exs. 1007 (Calvert), 1009 (Farber), 1012 (Mendelsohn), 1028
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`(Tisman), 1023 (Arsenyan), 1032 (Carrasco), 1033 (EP005)). If the investigator
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`were unaware of this prior art at the time he/she made the alleged statements, then
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`Lilly’s allegations of “skepticism” must fail.
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`There is more. These examples of issues that were raised in direct
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`examination, but not on cross, are not alone. Lilly’s strategy of relying on select
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`excerpts from Niyikiza’s prior direct testimony deprives Sandoz of an opportunity
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`to explore Dr. Niyikiza’s bases for his testimony and, in some instances, confront
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`him with evidence not raised in the Teva litigation that might have changed his
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`testimony, including:
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` Sandoz had no opportunity to explore whether Dr. Niyikiza’s testimony that
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`lometrexol “failed” would change had he been confronted with evidence
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`7
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`

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`showing that another company, Tularik, continued to pursue development of
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`lometrexol with folic acid after Lilly had decided to pursue other options for
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`business reasons.2 (Compare Ex. 1099, ClinicalTrials.gov, and Ex. 1075,
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`Schiff Reply ¶ 49 with Paper 36, PO Resp. at 10 (citing Ex. 2116, Niyikiza
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`Tr. at 745:25-746:1).)
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` Dr. Niyikiza was not asked in the Teva Litigation to explain whether his
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`claim that he had never heard a suggestion to treat antifolate patients with
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`vitamin B12 prior to his idea, Paper 36, PO Resp. at 10 (citing Ex. 2116,
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`Niyikiza Tr. at 746:16-20), would change if confronted with numerous prior
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`art publications disclosing the use of vitamin B12 with antifolates. (E.g.,
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`Ex. 1023, Arsenyan; Ex. 1009, Farber at 792; Ex. 1028, Tisman; Ex. 1033,
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`EP005.)
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` Sandoz had no opportunity to explore the details of the purported
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`conversations on which Dr. Niyikiza based his view that skepticism existed
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`prior to June 1999, and the reliability of those recollections. See Paper 36,
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`PO Resp. 57 (citing Ex. 2116, Niyikiza Tr. at 750:9-753:20, 757:16-758:5,
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`762:1-765:5, 771:25-775:10).
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`2 Tularik was purchased by Amgen in March 2004. (Ex. 1136, Amgen Press
`Release.)
`
`8
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`

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`2.
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`The Board has repeatedly limited reliance on
`testimony that does not comply with its rules
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`Where, as here, a party relies on prior testimony but does not make a witness
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`available for deposition as required by the Board’s rules, the Board has repeatedly
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`held that the testimony is entitled to no weight. See Coalition for Affordable Drugs
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`V LLC v. Biogen MA Inc., IPR 2015-01993, Paper 34 at 3 (P.T.A.B. Apr. 19, 2016)
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`(explaining that in order for a declaration submitted during patent prosecution to
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`“be given any weight” in an IPR, the declarant/affiant must be made available for
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`cross-examination in the manner specified in 37 C.F.R. § 42.51(b)(1)(ii)); Altaire
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`Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 3 (P.T.A.B.
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`Apr. 1, 2016) (warning that no weight will be given to a declaration if the declarant
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`is not made available for cross-examination).
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`In Organik Kimya AS v. Rohm & Haas Co., the petitioner submitted a
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`declaration in the IPR that had been originally submitted in a prior trial at the
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`International Trade Commission (“ITC”). IPR2014-00185, Paper 42 at 2
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`(P.T.A.B. Dec. 18, 2014). The patent owner had deposed the declarant in the ITC
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`proceeding but still sought a deposition in the IPR. Id. The Board held that the
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`declaration would be “entitled to little or no weight, as it has not been subject to
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`cross-examination as it pertains to the instant proceeding.” Id. at 3. Similarly, Dr.
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`Niyikiza’s trial testimony should be given no weight. Indeed, the facts are even
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`more compelling here than Organik because Sandoz has never had any opportunity
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`9
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`

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`to depose Dr. Niyikiza, unlike the Organik patent owner who had previously
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`deposed the witness in the ITC proceeding.
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`The fact that Dr. Niyikiza testified in a different proceeding, the Teva
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`Litigation, does not automatically make his testimony admissible in this IPR. Lilly
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`previously relied on the regulatory history behind 37 C.F.R. § 42.51(b)(1) to argue
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`that Dr. Niyikiza’s deposition was not routine discovery – and thus excused from
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`the Board’s rules requiring cross-examination – because his trial testimony was not
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`“affidavit testimony prepared for the proceeding.” Paper 46, Lilly Opp. at 2
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`(emphasis in original). However, even after “prepared for the proceeding” was
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`added to 37 C.F.R. § 42.51(b)(1)(ii) in 2015, the Board has required cross-
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`examination of declarants from prior proceedings where, as here, the testimony is
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`“affirmatively relied upon by a patent owner” and thus interjected into the current
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`IPR. Altaire at 2. Further, even in the decisions Lilly cited in its opposition to Dr.
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`Niyikiza’s deposition where cross-examination was not ordered, the Board
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`acknowledged either that the weight given to the testimony would be reduced in
`
`light of the lack of cross-examination in the IPR or did not rule on admissibility.
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`See GEA Process Eng’g, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper No.
`
`41 at 3 (P.T.A.B. June 11, 2014) (“We will take into consideration that GEA did
`
`not have the opportunity to cross examine Mr. Taggart and Dr. Buchner and will
`
`give the declarations appropriate weight, if any, in our final decision.”); Maxliner,
`
`10
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`

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`Inc. v. Cresta Tech. Corp., IPR2015-00594, Paper 32 at 2 (P.T.A.B. Jan. 15, 2016)
`
`(expunging a notice of deposition without assessing admissibility of the affidavit).
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`Dr. Niyikiza’s cross-examination trial testimony does not excuse Lilly’s
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`failure to make Dr. Niyikiza available for a deposition in these proceedings,
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`particularly here where Sandoz never had the opportunity to examine Dr. Niyikiza
`
`at trial. By relying on Dr. Niyikiza’s trial testimony as if it were an affidavit, Lilly
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`injected Dr. Niyikiza into this IPR and because Lilly opted not to make him
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`available for deposition, Exhibit 2116 should be excluded due to the violation of
`
`the Board’s rules, or, at a minimum, the testimony should be given no weight.
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`D. Exhibit 2116 Is Not A Complete Exhibit
`Exhibit 2116 is a transcript of portions of the direct testimony of Dr.
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`Niyikiza in a prior action, but it omits the cross-examination and redirect of Dr.
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`Niyikiza, and thus violates the rule of completeness and should be excluded under
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`Fed. R. Evid. 106.
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`III. PARAGRAPHS 24-28 AND 44-78 OF DR. ZEISEL’S DECLARATION
`(EXHIBIT 2118) SHOULD BE EXCLUDED
`
`On October 7, 2016, Sandoz timely objected to Exhibit 2118, which is the
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`declaration of Dr. Steven H. Zeisel. Paper No. 39, Pet. Obj. at 8-9. Lilly relies on
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`54 paragraphs of Exhibit 2118 in its Patent Owner Response, citing to the exhibit
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`51 times. See Paper No. 36, PO Resp. at 4-8, 10, 14, 19-21, 36-40, 42, 44-45, 51.
`
`11
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`

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`Paragraphs 24-28 and 44-78 of Dr. Zeisel’s declaration (Exhibit 2118)
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`should be excluded because they pertain to topics within the expertise of an
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`oncologist for which Dr. Zeisel is not qualified to testify under Fed. R. Evid. 702.
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`Dr. Zeisel purports to provide opinions regarding the knowledge of a person of
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`ordinary skill (“POSA”), which both parties agree must be an oncologist. (Ex.
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`2120, Chabner Decl. ¶ 23; Ex. 1004, Schiff Decl. ¶ 13.) At his deposition
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`however, Dr. Zeisel acknowledged that he is a nutritional scientist, and “not an
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`oncologist,” and thus does not meet any party’s definition of a POSA. (Ex. 1086,
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`Zeisel Dep. 61:6-7, 118:15, and 128:19.) As such, Dr. Zeisel lacks the knowledge,
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`skill, experience, training, and education to opine as to what a POSA would have
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`understood in an obviousness inquiry. Sundance, Inc. v. DeMonte Fabricating
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`Ltd., 550 F.3d 1356, 1363-64 (Fed. Cir. 2008) (“[W]here an issue calls for
`
`consideration of evidence from the perspective of one of ordinary skill in the art, it
`
`is contradictory to Rule 702 to allow a witness to testify on the issue who is not
`
`qualified as a technical expert in that art.”); Flex-Rest, LLC v. Steelcase, Inc., 455
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`F.3d 1351, 1360-61 (Fed. Cir. 2006) (excluding testimony of an expert, finding
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`that he was not one of ordinary skill in the art of keyboard design at the time of the
`
`invention because his area of expertise was in ergonomics rather than keyboard
`
`design support systems).
`
`12
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`

`

`Dr. Zeisel’s testimony should be excluded because he goes beyond opining
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`on the information that a nutritionist might provide a POSA and instead purports to
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`opine on the views of the POSA – a perspective for which he is not qualified to
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`offer opinions. Dr. Zeisel begins, “I have been asked to opine about what, from a
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`mechanistic perspective, the POSA would believe . . . .” (E.g., Ex. 2118, Zeisel
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`Decl. ¶ 44.) He then repeatedly offers views from the perspective of a POSA.
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`E.g., id. ¶ 47 (“[T]he POSA would have been concerned . . . .”); see also id. ¶¶ 46-
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`51, 53, 54, 56, 59, 64, 66, 67, 69, 71, 75, 77, 78 (similar statements). Moreover, at
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`his deposition, Dr. Zeisel demonstrated a lack of knowledge of the very
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`“mechanistic” issues on which he purports to provide expertise, i.e., the
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`“interrelationships between antifolates, the folic acid pathway, and pathways
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`related to vitamin B12.” (Ex. 1075, Schiff Reply ¶ 8; Ex. 2118, Zeisel Decl. ¶ 18;
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`Ex. 1086, Zeisel Dep. 19:16-25, 21:13-21, 24:13-20.)
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`Dr. Zeisel’s admission as an expert in the prior Teva Litigation has no
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`bearing here because the Southern District of Indiana adopted a definition of a
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`POSA that differs from the one agreed upon by all experts in this IPR.
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`Specifically, the district court in the Teva Litigation adopted the following
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`definition of the POSA:
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`a medical doctor who specializes in oncology or a medical doctor
`with extensive experience in the areas of nutritional sciences
`involving vitamin deficiencies. However, as to the latter person, this
`individual would need to have collaborated with medical oncologists
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`13
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`who have knowledge and experience in the treatment of cancer
`through the use of antifolates.
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`(Ex. 1003, Op. at 9 (emphasis added).) By contrast, both parties’ experts in this
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`proceeding agree that a POSA is an oncologist. (Ex. 2120, Chabner Decl. ¶ 23;
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`Ex. 1004, Schiff Decl. ¶ 13.) While Dr. Zeisel may have met the Southern District
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`of Indiana’s definition of a POSA, he is indisputably not an oncologist and thus
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`does not qualify as a POSA under the definition applied in this proceeding.
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`Finally, there can be no dispute that the testimony presented in Paragraphs
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`24-28 and 44-78 purports to express expert opinions and does not pertain to subject
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`matter over which Dr. Zeisel has personal knowledge under Fed. R. Evid. 602.
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`Accordingly, Paragraphs 24-28 and 44-78 of Exhibit 2118 should be excluded
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`under Fed. R. Evid. 602 and 702.
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`IV. CONCLUSION
`For the foregoing reasons, Sandoz respectfully requests that the Board
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`exclude Exhibit 2116 and Paragraphs 24-28 and 44-78 of Exhibit 2118, and strike
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`all references thereof from Lilly’s Response and Sur-Reply and prohibit Lilly from
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`making any references to these exhibits during oral argument.
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`Dated: February 14, 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)
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`14
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`
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`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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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the foregoing document were
`served on February 14, 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
`
`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
`
`Adam L. Perlman
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5244
`aperlman@wc.com
`
`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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`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`Email: demeter_john_c@lilly.com
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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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