UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`
`
`
`
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owner Merck Sharp & Dohme Corp.
`
`(“Merck”) submits the following objections to the exhibits filed by Petitioner Mylan
`
`Pharmaceuticals Inc. (“Mylan”) with its Petition.
`
`1. Merck objects to Exhibit 1002 (“Chorghade Decl.”) under Federal
`
`Rules of Evidence (“FRE”) 702, 703 and 37 C.F.R. § 42.65 as offering inadmissible
`
`expert testimony. Dr. Chorghade’s assertion, inter alia, that the “[s]itagliptin base
`
`can only be mono-pronated at the primary amine, which results in the formation of
`
`the dihydrogenphosphate salt every time,” EX1002 ¶ 76; see also id. ¶ 100 n.15, is
`
`not based on sufficient facts or data, the product of reliable principles and methods,
`
`and Dr. Chorghade has not reliably applied such principles and methods in providing
`
`his testimony; nor has Dr. Chorghade disclosed the underlying facts or data on which
`
`his assertion is based.
`
`2. Merck objects to Exhibit 1005 (“Brittain”) under FRE 106, 401, 402,
`
`and 403 as an incomplete excerpt. Merck further objects to Exhibit 1005 under FRE
`
`401, 402, 403, and 901 as insufficiently authenticated and not self-authenticating
`
`under FRE 902. Merck further objects to Exhibit 1005 under FRE 801, 802, 803 as
`
`containing inadmissible hearsay not falling within any exception and for which
`
`Mylan relies upon for the truth of the matters asserted. See, e.g., Paper 1 at 59–61
`
`(citing EX1005 at 126–29).
`
`1
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`
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`3. Merck objects to Exhibit 1006 (“Bastin”) under FRE 801, 802, and
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`803, as containing inadmissible hearsay not falling within any exception and for
`
`which Mylan relies upon for the truth of the matters asserted. See, e.g., Paper 1 at
`
`46–47, 53–54 (citing EX1006 at 428).
`
`4. Merck objects to Exhibit 1008 under FRE 401, 402, 403, and 901 as
`
`insufficiently authenticated and not self-authenticating under FRE 902. Merck
`
`further objects under FRE 401, 402, and 403 to Exhibit 1008 as an irrelevant post-
`
`priority document. Merck further objects to Exhibit 1008 under FRE 801, 802, 803
`
`as containing inadmissible hearsay not falling within any exception and for which
`
`Mylan relies upon for the truth of the matters asserted. See, e.g., Paper 1 at 5, 66.
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`5. Merck objects to Exhibit 1009 under FRE 401, 402, 403, and 901 as
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`insufficiently authenticated and not self-authenticating under FRE 902. Merck
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`further objects under FRE 401, 402, and 403 to Exhibit 1009 as an irrelevant post-
`
`priority document. Merck further objects to Exhibit 1009 under FRE 801, 802, 803
`
`as containing inadmissible hearsay not falling within any exception and for which
`
`Mylan relies upon for the truth of the matters asserted. See, e.g., Paper 1 at 5, 66.
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`6. Merck objects to Exhibit 1013 under FRE 401, 402, 403, and 901 as
`
`insufficiently authenticated and not self-authenticating under FRE 902. Merck
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`further objects under FRE 401, 402, and 403 to Exhibit 1013 as an irrelevant post-
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`priority document
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`2
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`
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`7. Merck objects to Exhibit 1014 under FRE 401, 402, 403, and 901 as
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`insufficiently authenticated and not self-authenticating under FRE 902. Merck
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`further objects under FRE 401, 402, and 403 to Exhibit 1014 as an irrelevant post-
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`priority document.
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`8. Merck objects to Exhibit 1016 (“Brown”) under FRE 401, 402, 403,
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`and 901 as insufficiently authenticated and not self-authenticating under FRE 902.
`
`Merck further objects to Exhibit 1016 under FRE 106, 401, 402, and 403 as an
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`incomplete excerpt. Merck further objects to Exhibit 1016 under FRE 801, 802, 803
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`as containing inadmissible hearsay not falling within any exception and for which
`
`Mylan relies upon for the truth of the matters asserted. See, e.g., Paper 1 at 52 n.23.
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`
`Date: May 27, 2020
`
`
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Elise M. Baumgarten
`(Pro Hac Vice motion pending)
`Alexander S. Zolan
`(Pro Hac Vice motion pending)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`
`3
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`
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`jberniker@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`
`
`4
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
`
`Pursuant to 37 C.F.R. 42.6(e), the undersigned hereby certifies that a true and
`
`correct copy of the foregoing was served on May 27, 2020, by delivering a copy via
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`electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`
`
`
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`5
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