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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Bausch Health Ireland
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Limited hereby submits a current listing of Patent Owner Exhibits. Exhibit 2066
`
`wasfiled on P-TACTSandserved via email to counsel of record for the Petitioner.
`
`EXHIBIT
`
`DESCRIPTION
`
`
`
`2001
`
`2002
`
`5003
`
`004
`
`005
`
`2006
`
`2007
`
`2008
`
`2009
`
`Bausch Health Ireland Ltd. et al. v. MSN Lab’ys Private Ltd. etal.,
`Civil Action No. 2:21-cv-10057 (D.N.J.), ECF No. 51, Amended
`Scheduling Order, Entered January 5, 2022.
`
`Bausch Health Ireland Ltd. et al. v. Mylan Pharms. Inc, Civil Action
`No. 1:22-cv-00020 (N.D. W. Va.), ECF No. 98-1, Parties Proposed
`Scheduling Order Checklists, Submitted May 16, 2022.
`
`MSNDefendants’ First Set of Requests For Production to Plaintiffs
`(Nos. 1-50), Served on January 11, 2022.
`
`Case Docket of Bausch Health Ireland Ltd. et al. v. MSN Lab’ys
`Private Ltd. et al., Civil Action No. 2:21-cv-10057 (D.N.J.)
`
`Mylan Defendants’ First Set ofRequests For Production to Plaintiffs
`(Nos. 1-132), Served on May 19, 2022.
`
`MSN’s Notice of Paragraph IV Certification Re: MSN’s Plecanatide
`Tablets, 3mg, U.S. Patent Nos. 7,041,786; 9,610,321: 9,616,097;
`9,919,024; 9,925,231; 10,011,637, Dated March 15, 2021 (Excerpt).
`
`Mylan’s Notice of Paragraph IV Certification Re: Mylan’s
`Plecanatide Tablets, 3mg, U.S. Patent Nos. 7,041,786; 9,610,321;
`9,616,097; 9,919,024: 9.925.231; 10,011,637, Dated March 18, 2021.
`
`Hidaka et al., “In Vitro Disulfide-Coupled Folding of Guanylyl
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`Vol. 37, No. 23, 8498-8507 (1998).
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`Hidakaetal., “Dual Function of the Propeptide of Prouroguanylin in
`the Folding of the Mature Peptide,” The Journal of Biological
`Chemistry, Vol. 275, No. 33, 25155-25162 (2000).
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`EXHIBIT
`
`DESCRIPTION
`
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`two topologies:
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`EXHIBIT
`
`DESCRIPTION
`
`021
`
`International Publication Number WO 01/25266,titled “Uroguanylin
`as an Intestinal Cancer Inhibiting Agent.”
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`2022 (Served A file history of EP1379224, titled “Guanylate Cyclase Receptor
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`for
`the Treatment of Tissue
`Inflammation
`and
`y
`Carcinogenesis.”
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`2023
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`2024
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`2025
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`CONFIDENTIAL Declaration of Kunwar Shailubhai. (Under Seal
`.
`:
`and Public versions)
`
`CONFIDENTIAL Declaration of Stephen G. Davies. (Under Seal
`and Public versions)
`
`CONFIDENTIAL Declaration of Scott A. Waldman. (Under Seal
`and Public versions)
`
`2026
`
`Transcript of November 1, 2022 Deposition of Blake R. Peterson.
`
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`
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`
` SP-304
`on
`“Studies
`K.,
` Shailubhai,
`CONFIDENTIAL
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`No. SP-PH-004, TRUL00018260-77 (2008).
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`2029
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`Curriculum Vitae of Scott A. Waldman.
`
`Dressman,et al., “Upper Gastrointestinal (GI) pH in Young, Healthy
`Men and Women”, Pharmaceutical Research, Vol. 7, No. 7, 756-61
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`
`
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`
`DESCRIPTION
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Rudin, “Chapter 4 - Effects of Polymer Isomerism on Conformational
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`al.,
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`
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`
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`(March 31, 2004).
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`
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`U.S. Patent No. 7,041,786
`
`EXHIBIT
`
`DESCRIPTION
`
`Jeng et al., “Direct Measurement of the Aspartic Acid 26 pK,for
`Reduced Escherichia coli Thioredoxin by ‘°C NMR”, Biochemistry,
`Vol. 35, No. 1, 1-6 (1996).
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`DESCRIPTION
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`2055
`
`2056
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`
`EXHIBIT
`
`DESCRIPTION
`
`2064
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`2066
`
`Supplemental Declaration of Kunwar Shailubhai
`
`
`
`(Filed on May
`31, 2023)
`
`2067
`
`Supplemental Declaration of Stephen G. Davies, D. Phil.
`
`(Served Only)
`
`Supplemental Declaration of Scott A. Waldman, M.D., Ph.D., FDP,
`(Served Only) FAHA, FNAL, FASPET
`
`2069
`
`2070
`
`Deposition Transcript of Blake R. Peterson, Ph.D., dated April 25,
`2023
`
`Deposition Transcript of Michael Samuel Epstein, M.D., dated April
`11, 2023
`
`Date: May 31, 2023
`
`Respectfully submitted,
`
`By:__/Justin J. Hasford/
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
`Joshua L. Goldberg, Reg. No. 59,369
`Back-up Counsel
`Kassandra M.Officer Reg. No. 74,083
`Back-up Counsel
`Lauren J. Robinson Reg. No. 74,100
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`
`8
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
`
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for the Patent Owner
`
`9
`
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`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Updated Exhibit List and Exhibit 2066 served electronically via email on May 31,
`
`2023, to counsel of record for the Petitioner at the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Tasha M. Thomas
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`tthomas@wsgr.com
`
`
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`dgregory@wsgr.com
`
`4863-5899-2145@mail.vault.netdocuments.com
`
`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
`
`
`
`
`
`
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`
`Melissa Hayworth
`Merchant & Gould, P.C.
`1900 Duke, Street, Suite 600
`Alexandria, VA 22314
`mhayworth@merchantgould.com
`
`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
`
`plecanatidemerchant@merchantgould.com
`
`
`
`
`Dated: May 31, 2023
`
`
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`
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
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