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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
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`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`U.S. Patent 7,326,708
`__________________
`
`PATENT OWNER’S SECOND OBJECTIONS TO EVIDENCE
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`
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`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as parties to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
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`
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`
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner Merck Sharp & Dohme Corp.
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`(“Merck”) submits the following objections to the exhibits filed by Petitioners
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`Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., Watson Laboratories,
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`Inc., Dr. Reddy’s Laboratories, Inc., Dr. Reddy’s Laboratories, Ltd., and Sun
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`Pharmaceuticals Industries Ltd. (“Petitioners”) with Paper 65 (“Petitioner’s Reply”).
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`1. Merck objects to Exhibit 1019 (“Wenslow Affidavit”) under Federal
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`Rules of Evidence (“FRE”) 401, 402, and 403 as an irrelevant post-priority
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`document.
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`2. Merck objects to Exhibit 1020 (“’659 Patent”) under FRE 401, 402,
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`and 403 as an irrelevant post-priority document. Merck further objects to Exhibit
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`1020 under FRE 801, 802, and 803 as containing inadmissible hearsay not falling
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`within any exception and for which Petitioners rely upon for the truth of the matters
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`asserted. See, e.g., Paper 65 at 12.
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`3. Merck objects to Exhibit 1021 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 to Exhibit 1021 under FRE 401, 402, and 403 as an irrelevant post-
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`priority document. Merck further objects to Exhibit 1021 under FRE 801, 802, and
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`803 as containing inadmissible hearsay not falling within any exception and for
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`which Petitioners rely upon for the truth of the matters asserted.
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`1
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`4. Merck objects to Exhibit 1026 (“Myerson Declaration”) under FRE
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`401, 402, and 403 as an irrelevant post-priority document. Merck further objects to
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`Exhibit 1026 under FRE 801, 802, and 803 as containing inadmissible hearsay not
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`falling within any exception and for which Petitioners rely upon for the truth of the
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`matters asserted. See, e.g., Paper 65 at 18–19 n.9.
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`5. Merck objects to Exhibit 1027 (“Markman Order”) under FRE 801,
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`802, and 803 as containing inadmissible hearsay not falling within any exception
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`and for which Petitioners rely upon for the truth of the matters asserted. See, e.g.,
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`Paper 65 at 18–19 & n.9.
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`6. Merck objects to Exhibit 1030 (“Chyall Notebook”) under FRE 401,
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`402, 403, and 901 as insufficiently authenticated and not self-authenticating under
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`FRE 902. Merck further objects to Exhibit 1030 under FRE 602 and 901 for lack of
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`foundation due to insufficient personal knowledge. Merck further objects to Exhibit
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`1030 under FRE 401, 402, and 403 as an irrelevant post-priority document. Merck
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`further objects to Exhibit 1030 under FRE 801, 802, and 803 as containing
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`inadmissible hearsay not falling within any exception and for which Petitioners rely
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`upon for the truth of the matters asserted. See, e.g., Exhibit 1035 at 35–37.
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`7. Merck objects to Exhibit 1033 (“US 2010/0041885”) under FRE 401,
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`402, and 403 as an irrelevant post-priority document. Merck further objects to
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`Exhibit 1033 under FRE 801, 802, and 803 as containing inadmissible hearsay not
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`2
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`falling within any exception and for which Petitioners rely upon for the truth of the
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`matters asserted. See, e.g., Exhibit 1035 at 36 n.32.
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`8. Merck objects to Exhibit 1034 (“Joint Claim Construction Brief”)
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`under FRE 401, 402, and 403 as an irrelevant post-priority document. Merck further
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`objects to Exhibit 1034 under FRE 801, 802, and 803 as containing inadmissible
`
`hearsay not falling within any exception and for which Petitioners rely upon for the
`
`truth of the matters asserted. See, e.g., Paper 65 at 17–18.
`
`9. Merck objects to Exhibit 1035 (“Chorghade Reply Declaration”) under
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`FRE 401, 402, and 403, including for the reasons discussed below. Merck further
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`objects to Exhibit 1035 under FRE 702 because it is not the product of reliable
`
`principles and methods and not helpful to the factfinder, including to the extent it
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`purports to interpret the motivations of Dr. Chyall. Merck further objects to Exhibit
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`1035 under FRE 703 as containing facts or data that are not those kinds of facts or
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`data on which an expert in Dr. Chorghade’s field would reasonably rely. Merck
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`further objects to Exhibit 1035 under FRE 801, 802, 803, and 805 as containing
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`hearsay and hearsay within hearsay. Merck further objects to Exhibit 1035 as not
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`satisfying the requirements of 37 C.F.R. § 42.65(b). Merck further objects to Exhibit
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`1035 as improperly including new evidence or argument in reply that could have
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`been presented earlier. Merck further objects to Exhibit 1035 to the extent it relies
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`on Exhibit 2225, for the reasons set forth below in connection with Exhibit 2225.
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`3
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`10. Merck objects to Petitioners’ use of Exhibit 2225 (“Chyall First
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`Declaration”) in Paper 65 and Exhibit 1035 under FRE 801, 802, and 803 as
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`inadmissible hearsay not falling within any exception and for which Petitioners rely
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`upon for the truth of the matters asserted, and that is not provided in the form of
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`direct testimony meeting the requirements of 37 C.F.R. § 42.53. See, e.g., Paper 65
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`at 1, 4, 6–7, 10, 12. Merck further objects to Petitioners’ use of Exhibit 2225 under
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`FRE 401, 402, and 403. Merck further objects to Petitioners’ use of Exhibit 2225 as
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`not satisfying the requirements of 37 C.F.R. § 42.65(b). Merck further objects to
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`Petitioners’ use of Exhibit 2225 under FRE 702, 703 and 37 C.F.R. § 42.65 as
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`offering inadmissible expert testimony. See E-mail from J. Malik (Aug. 3, 2020)
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`(“To the extent Merck wants to depose Dr. Chyall, enter into a stipulation regarding
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`Dr. Chyall, or do anything else with connection with Dr. Chyall, I remind you that
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`Mylan’s expert in IPR2020-00040 is Dr. Chorghade not Dr. Chyall.”).
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`
`Date: November 24, 2020
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`
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`David M. Krinsky (Reg. No. 72,339)
`Elise M. Baumgarten (Pro Hac Vice)
`Alexander S. Zolan (Pro Hac Vice)
`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
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`4
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`dkrinsky@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`
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`5
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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
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`correct copy of the foregoing was served on November 24, 2020, by delivering a
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`copy via 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
`
`Russell W. Faegenburg
`Tedd W. Van Buskirk
`Michael H. Teschner
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK, LLP
`20 Commerce Drive
`Cranford, New Jersey 07016
`(908) 518-6367
`Rfaegenburg.ipr@ldlkm.com
`Tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`MTeschner.ipr@ldlkm.com
`
`
`
`
`Keith A. Zullow
`Sarah J. Fischer
`Emily L. Rapalino
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eight Avenue
`New York, NY 10018
`kzullow@goodwinprocter.com
`sfischer@goodwinprocter.com
`erapalino@goodwinprocter.com
`
`Jovial Wong
`Charles B. Klein
`Claire A. Fundakowski
`Zachary B. Cohen
`WINSTON & STRAWN LLP
`1901 L. Street, N.W.
`Washington, D.C. 20036
`(202) 282-5000
`Sunipr@winston.com
`
`
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`6
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`
`
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