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.
`and FRESENIUS KABI USA, LLC,
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`Petitioners
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`v .
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`ELI LILLY AND COMPANY,
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`Patent Owner.
`
`Case IPR2016-003181
`U.S. Patent 7,772,209
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`PETITIONER SANDOZ INC.’S OBJECTIONS TO EVIDENCE
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`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`proceeding.
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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.
`and FRESENIUS KABI USA, LLC,
`
`Petitioners
`
`v .
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`ELI LILLY AND COMPANY,
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`Patent Owner.
`
`Case IPR2016-003181
`U.S. Patent 7,772,209
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`PETITIONER SANDOZ INC.’S OBJECTIONS TO EVIDENCE
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`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`proceeding.
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`Petitioner Sandoz Inc. (“Sandoz”) hereby objects pursuant to 37 C.F.R.
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`§ 42.64(b)(1) and the Federal Rules of Evidence to the admissibility of the
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`purported evidence listed below, which was served by Eli Lilly and Company
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`(“Lilly”) in connection with its Patent Owner’s Response on September 30, 2016,
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`in IPR2016-00318. Sandoz further objects to Lilly’s reliance on and citations to
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`the evidence subject to the following objections.
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`I.
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`Exhibit 2020 (1999 PDR)
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`Sandoz objects to Exhibit 2020 under Fed. R. Evid. 402 and 403 because it
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`is irrelevant and its probative value is substantially outweighed by its potential to
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`cause unfair prejudice and waste time or needlessly prolong the proceedings.
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`Exhibit 2020 includes a date of 1999, but it is not clear when in 1999 this reference
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`was published. In Lilly’s Patent Owner’s Response, Lilly asserts that the “relevant
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`date for analyzing Sandoz’s obviousness arguments is June 29, 1999 . . . .” Paper
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`No. 36, PO Resp. at 13. It is not possible to determine whether Exhibit 2020
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`qualifies as prior art and thus it is unclear whether it has any relevance as to what a
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`person of ordinary skill would have understood as of the relevant date for the
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`obviousness inquiry.
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`1
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`
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`II. Exhibit 2026 (Schiff Transcript)
`Sandoz objects to Exhibit 2026 under Fed. R. Evid. 106 as an incomplete
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`and inaccurate copy of the deposition transcript of Dr. Ronald Schiff as it omits Dr.
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`Schiff’s errata sheet, which was properly served on September 23, 2016.
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`III. Exhibit 2032 (ViDAL)
`Sandoz objects to Exhibit 2032 under Fed. R. Evid. 901 and 902 as not
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`being properly authenticated or self-authenticating. The certificate of translation
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`indicates a publication date of 1988 for the 74th edition; however, the scanned
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`cover page images indicate a copyright date of 1998. It is not clear whether this
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`translation certification pertains to the translated material of Exhibit 2032.
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`IV. Exhibit 2044 (Boritzki)
`Sandoz objects to Exhibit 2044 under Fed. R. Evid. 402 and 403 because it
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`is irrelevant and its probative value is substantially outweighed by its potential to
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`cause unfair prejudice, waste time, or needlessly prolong the proceedings.
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`Exhibit 2044 does not include any publication date and thus it has no relevance as
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`to what a person of ordinary skill would have understood as of the relevant date for
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`the obviousness inquiry.
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`V. Exhibit 2076 (Grem)
`Sandoz objects to Exhibit 2076 under Fed. R. Evid. 402 and 403 because it
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`is irrelevant and its probative value is substantially outweighed by its potential to
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`2
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`cause unfair prejudice, waste time, or needlessly prolong the proceedings. Exhibit
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`2076 lists a copyright date of “1999” but does not indicate on its face when in 1999
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`it was published. In Lilly’s Patent Owner’s Response, Lilly asserts that the
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`“relevant date for analyzing Sandoz’s obviousness arguments is June 29,
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`1999 . . . .” Paper No. 36, PO Resp. at 13. It is not possible to determine whether
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`Exhibit 2076 qualifies as prior art and thus it is unclear whether it has any
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`relevance as to what a person of ordinary skill would have understood as of the
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`relevant date for the obviousness inquiry.
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`VI. Exhibit 2091 (Wall Street Journal Article)
`Sandoz objects to Exhibit 2091 under Fed. R. Evid. 402, 403, and 802.
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`Exhibit 2091 is an article listing a publication date of 2004, which is after the
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`relevant June 30, 1999 date for the obviousness inquiry, and thus includes
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`information that is irrelevant to obviousness of the patent at issue and its probative
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`value is substantially outweighed by its potential to cause unfair prejudice, waste
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`time, or needlessly prolong the proceedings. Sandoz also objects to Exhibit 2091
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`under Fed. R. Evid. 802 to the extent Lilly’s Patent Owner’s Response relies on
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`Exhibit 2091 for inadmissible hearsay purposes. Paper No. 36, PO Resp. at 58
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`(quoting Ex. 2091 at 3).
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`3
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`VII. Exhibit 2098 (Letter to FDA)
`Sandoz objects to Exhibit 2098 under Fed. R. Evid. 402 and 403. Exhibit
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`2099 is not cited in the Patent Owner’s Response or the accompanying declarations
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`of Lilly’s experts and should be excluded as irrelevant under Fed. R. Evid. 402 and
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`403. Sandoz reserves it right to submit additional objections to this exhibit if Lilly
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`later cites or relies on this exhibit.
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`VIII. Exhibit 2099 (Letter to FDA)
`Sandoz objects to Exhibit 2099 under Fed. R. Evid. 106, 402, 403, 901, and
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`902. Exhibit 2099 contains a number of unexplained redactions (see, e.g.,
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`ELAP00007715), which call into question whether Exhibit 2099 is complete as
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`required under Fed. R. Evid. 106 and is a true and correct copy of the document.
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`As such, the document is also not sufficiently authenticated under Fed. R. Evid.
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`901 or 902. Finally, Exhibit 2099 is not cited in the Patent Owner’s Response or
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`the accompanying declarations of Lilly’s experts and should be excluded as
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`irrelevant under Fed. R. Evid. 402 and 403. Sandoz reserves it right to submit
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`additional objections to this exhibit if Lilly later cites or relies on this exhibit.
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`IX. Exhibit 2101 (Letter to FDA)
`Sandoz objects to Exhibit 2101 under Fed. R. Evid. 106, 402, 403, 901, and
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`902. Exhibit 2099. Exhibit 2101 contains an unexplained redaction (see, e.g.,
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`ELAP00008711), which calls into question whether Exhibit 2101 is complete as is
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`4
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`required under Fed. R. Evid. 106 and is a true and correct copy of the document.
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`As such, the document is also not sufficiently authenticated under Fed. R. Evid.
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`901 or 902. Finally, Exhibit 2101 is not cited in the Patent Owner’s Response or
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`the accompanying declarations of Lilly’s experts and should be excluded as
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`irrelevant under Fed. R. Evid. 402 and 403. Sandoz reserves it right to submit
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`additional objections to this exhibit if Lilly later cites or relies on this exhibit.
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`X. Exhibit 2102 (Letter to FDA)
`Sandoz objects to Exhibit 2102 under Fed. R. Evid. 402 and 403. Exhibit
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`2102 is not cited in the Patent Owner’s Response or the accompanying declarations
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`of Lilly’s experts and should be excluded as irrelevant under Fed. R. Evid. 402 and
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`403. Sandoz reserves it right to submit additional objections to this exhibit if Lilly
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`later cites or relies on this exhibit.
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`XI. Exhibit 2111 (Core Team Meeting Minutes)
`Sandoz objects to Exhibit 2111 under Fed. R. Evid. 402, 403, 802, 901, and
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`902. Sandoz objects to Exhibit 2111, which appears to be a non-public document
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`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
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`the claimed invention would have been obvious based on the information publicly
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`available in the prior art. Any purported probative value of this exhibit is
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`substantially outweighed by its potential to cause unfair prejudice, waste time, or
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`needlessly prolong the proceedings and should thus be excluded under Fed. R.
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`5
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`Evid. 402 and 403. Sandoz further objects to the statements in the document as
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`impermissible hearsay under Fed. R. Evid. 802. In addition, Exhibit 2111 appears
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`to be an internal Lilly document that has not been properly authenticated under
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`Fed. R. Evid. 901 or 902.
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`XII. Exhibit 2112 (Lilly Minutes)
`Sandoz objects to Exhibit 2112 under Fed. R. Evid. 402, 403, 802, 901, and
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`902. Sandoz objects to Exhibit 2112, which appears to be a non-public document
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`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
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`the claimed invention would have been obvious based on the information publicly
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`available in the prior art. Any purported probative value of this exhibit is
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`substantially outweighed by its potential to cause unfair prejudice, waste time, or
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`needlessly prolong the proceedings and should thus be excluded under Fed. R.
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`Evid. 402 and 403. Sandoz further objects to the statements in the document as
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`impermissible hearsay under Fed. R. Evid. 802. In addition, Exhibit 2112 appears
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`to be an internal Lilly document that has not been properly authenticated under
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`Fed. R. Evid. 901 or 902.
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`XIII. Exhibit 2113 (Antifolate Advisory Panel Meeting Minutes)
`Sandoz objects to Exhibit 2113 under Fed. R. Evid. 402, 403, 802, 901, and
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`902. Sandoz objects to Exhibit 2113, which appears to be a non-public document
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`concerning Lilly’s development of antifolates, as irrelevant to the issue of whether
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`6
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`the claimed invention would have been obvious based on the information publicly
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`available in the prior art. Any purported probative value of this exhibit is
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`substantially outweighed by its potential to cause unfair prejudice, waste time, or
`
`needlessly prolong the proceedings and should thus be excluded under Fed. R.
`
`Evid. 402 and 403. Sandoz further objects to the statements in the document as
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`impermissible hearsay under Fed. R. Evid. 802. Further, Exhibit 2113 appears to
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`be an internal Lilly document that has not been properly authenticated under Fed.
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`R. Evid. 901 or 902.
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`XIV. Exhibit 2116 (Excerpts from Testimony of Clet Niyikiza)
`Sandoz objects to the Exhibit 2116 under Fed. R. Evid. 106, 402, 403, 602,
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`702, and 802, and as in violation of 37 C.F.R. § 42.53. Exhibit 2116 is a transcript
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`of the direct testimony of Clet Niyikiza in a prior action, but omits the cross-
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`examination of Dr. Niyikiza, and thus violates the rule of completeness and should
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`be excluded under Fed. R. Evid. 106.
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`Much of the content of Dr. Niyikiza’s testimony in the excerpts from the
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`transcript concerns topics that are not relevant or for which any relevance is
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`substantially outweighed by its potential to cause unfair prejudice, waste time, or
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`needlessly prolong the proceedings and should thus be excluded under Fed. R.
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`Evid. 402 and 403.
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`7
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`Sandoz further objects to the extent that Dr. Niyikiza’s trial testimony
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`includes content over which he had no personal knowledge under Fed. R. Evid.
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`602 and for which he is not qualified to testify as an expert witness under Fed. R.
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`Evid. 702.
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`Further, Dr. Niyikiza’s trial testimony is not only inadmissible hearsay in
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`this proceeding under Fed. R. Civ. P. 802, but much of it constitutes double
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`hearsay, including at least one passage on which Lilly relies in its Patent Owner’s
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`Response. Paper No. 36, PO Resp. at 59 (quoting Ex. 2116 at 845).
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`Finally, Dr. Niyikiza’s trial testimony should be excluded as in violation of
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`the applicable regulations governing this proceeding, which require that
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`“[u]ncompelled direct testimony must be submitted in the form of an affidavit” and
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`that such testimony be subject to cross examination under 37 C.F.R.
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`§ 42.51(b)(1)(ii). 37 C.F.R. § 42.53(a).
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`XV. Exhibit 2118 (Zeisel Declaration)
`Sandoz objects to Exhibit 2118 under Fed. R. Evid. 402, 403, 602, 702, and
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`703. Exhibit 2118 is the declaration of Dr. Steven H. Zeisel, who purports to
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`provide opinions regarding the knowledge of a person of ordinary skill despite his
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`acknowledgement that he is a nutritional scientist and “not a medical oncologist”
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`(Ex. 2118, ¶ 17) and thus does not meet any party’s definition of the level of
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`ordinary skill. Thus, Dr. Zeisel lacks the knowledge, skill, experience, training,
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`8
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`and education to opine as to what a person of ordinary skill would have understood
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`in an obviousness inquiry. Accordingly, Sandoz objects to Dr. Zeisel’s testimony
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`because it is irrelevant and its probative value is substantially outweighed by its
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`potential to cause unfair prejudice, waste time, or needlessly prolong the
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`proceedings and should thus be excluded under Fed. R. Evid. 402 and 403. Sandoz
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`further objects because Dr. Zeisel’s testimony includes content over which he had
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`no personal knowledge under Fed. R. Evid. 602 and for which he is not qualified to
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`offer an expert opinion under Fed. R. Evid. 702.
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`Dated: October 7, 2016
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`Respectfully submitted,
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`9
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`
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`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing document was
`served on October 7, 2016 via email to the following individuals at the email
`addresses below.
`
`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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`
`
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`/s/ Ralph J. Gabric
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`Dated: October 7, 2016
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`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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