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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.
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Bausch Health Ireland
`
`Limited hereby submits a current listing of Patent Owner Exhibits. Pursuant to the
`
`Board’s Order (Paper No. 63), Exhibits 2023, 2024, 2025, 2027, and 2028 werere-
`
`filed without a confidentiality designation. Exhibit 2071 was newly filed. The filed
`
`exhibits were served via email to counsel of record for the Petitioner.
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`Bausch Health Ireland Ltd. et al. v. MSN Lab’ys Private Ltd. et al.,
`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
`2002
`Scheduling Order Checklists, Submitted May 16, 2022.
`
`
`Vol. 37, No. 23, 8498-8507 (1998).
`
`3003
`
`004
`
`005
`
`2006
`
`2007
`
`2008
`
`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
`Cyclase-Activating Peptide and Its Precursor Protein,” Biochemistry,
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`EXHIBIT
`
`DESCRIPTION
`
`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).
`
`and
`structure
`two topologies:
`“One peptide,
`al.,
`Marx et
`interconversion dynamics of human uroguanylin isomers,” J. Peptide
`Res. 52, 229-240 (1998).
`
`Chino et isomers of human_uroguanylin:al., “Topological
`
`
`
`interconversion between biologically active and inactive isomers,”
`FEBSLetters, 421, 27-31 (1998).
`
`Hamra et al., “Uroguanylin: Structure and activity of a second
`endogenous peptide that stimulates intestinal guanylate cyclase,”
`Proc. Natl. Acad. Sci. USA, Vol. 90, 10464-10468 (1993).
`
`PharmaResPer, Vol. 5, Iss. 2, 1-10 (2017).
`
`Ironwood Press Release, “Ironwood Pharmaceuticals Promotes Dr.
`Mark Currie to Senior Vice President, Chief Scientific Officer, and
`President of R&D,” Dated February 11, 2013.
`
`US. Patent No. 7,371,727, titled “Methods and Compositionsfor the
`Treatment of Gastrointestinal Disorders.”
`
`US. Patent No. 7,704,947,titled “Methods and Compositions for the
`Treatment of Gastrointestinal Disorders.”
`
`U.S. Patent No. 7,745,409, titled “Methods and Compositions for the
`Treatment of Gastrointestinal Disorders.”
`
`U.S. Patent No. 8,080,526 titled “Methods and Compositionsfor the
`Treatment of Gastrointestinal Disorders.”
`
`U:S. Patent No. 8,110,553, titled “Methods and Compositions for the
`Treatment of Gastrointestinal Disorders.”
`
`Brancale et al, “Therapeutically targeting guanylate cyclase-C:
`computational modeling of plecanatide, a uroguanylin analog,”
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Klodt et al., “Synthesis, biological activity and isomerism of
`guanylate cyclase C-activating peptides guanylin and uroguanylin,”
`J. Peptide Res. 50, 222-230 (1997).
`
`International Publication Number WO 01/25266,titled “Uroguanylin
`as an Intestinal Cancer Inhibiting Agent.”
`
`2022 (Served
`Only)
`
`A file history of EP1379224, titled “Guanylate Cyclase Receptor
`Agonists
`for
`the Treatment of Tissue
`Inflammation
`and
`Carcinogenesis.”
`
`(1990).
`
`“FDAapproves Trulance for Chronic Idiopathic Constipation”, FDA
`News Release (January 19, 2017), https://www.fda.gov/news-
`events/press-announcements/fda-approves-trulance-chronic-
`idiopathic-constipation.
`
`Stimulation of Intracellular cGMP
`Shailubhai, K., “SP-304:
`Synthesis in T84 Cells”, Study No. SP-PH-001, TRUL00018203-24
`(2008).
`
`Shailubhai, K., “Studies on SP-304 Thermostability, pH Dependency
`and
`Topoisomeric
`Stability’,
`Study
`No.
` SP-PH-004,
`TRUL00018260-77 (2008).
`
`2029
`
`2030
`
`Curriculum Vitae of Stephen G. Davies.
`
`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
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Rudin, “Chapter 4 - Effects of Polymer Isomerism on Conformational
`Changes”, Elements of Polymer Science & Engineering (1999), PP.
`121-153.
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`Nugent, et al., “Intestinal luminal pH in inflammatory boweldisease:
`possible
`determinants
`and
`implications
`for
`therapy with
`aminosalicylates and other drugs”, Gut, Vol. 48, No. 4, 571-77
`(2001).
`
`and Peptides, Cambridge University Press (1998), Pp. 120-129.
`
`Jonson, et al., “A critical view on conservative mutations”, Protein
`Engineering, Vol. 14, No. 6, 397-402 (2001).
`
`Fiser, et al., “Conservation of amino acids in multiple alignments:
`aspartic acid has unexpected conservation”, FEBSLetters, 397, 225-
`229 (1996).
`
`“Processing and Characterization of Human
`al.,
`et
`Garcia
`Proguanylin Expressed in Escherichia coli’, Journal of Biological
`Chemistry, Vol. 268, No. 30, 22397-22401 (1993).
`
`Takada et al., “Alternation of a Single Amino Acid in Peroxisome
`Proliferator-Activated Receptor-a (PPARa) Generates a PPARS
`Phenotype”, Molecular Endocrinology, Vol. 14, No. 5, 733-740
`(2000).
`
`Sood,et al., “Peroral Route: An Opportunity for Protein and Peptide
`Drug Delivery’, Chem. Rev., Vol. 101, No. 11, 3275-3303 (2001).
`
`Letter from Michael Pennington, Ph.D. to Dr. Kunwar Shailubhai
`(March 31, 2004).
`
`Gastrin’”’,
`Pure
`a
`of
`“Characterization
`Grossman,
`Proceedings of a Conference Held in September
`Gastrin:
`1964, University of California Press, Los Angeles (1966), Pp. 26-47.
`
`2042
`
`Barrett et al., “Chapter 6: Synthesis of Amino Acids”, Amino Acids
`
`
`
`Case No. IPR2022-00722
`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).
`
`Nguyenetal., “X-ray and thermodynamicstudies of staphylococcal
`nuclease variants I92E and 192K: insights into polarity of the protein
`interior”, Journal of Molecular Biology, Vol. 341, No. 2, 565-74
`(2004).
`
`Harmsetal., “The pK, values of acidic and basic residues buried at
`the same internal location in a protein are governed by different
`factors”, Journal of Molecular Biology, Vol. 389, No. 1, 34-47
`(2009).
`
`challenges”, Gut, Vol. 48, Iss. 1, 125-31 (2001).
`
`Liu et al., “Jn Vivo Imaging of Human Colorectal Cancer Using
`Radiolabeled Analogs of the Uroguanylin Peptide Hormone”,
`Anticancer Research, Vol. 29, 3777-3784 (2009).
`
`2048
`
`2049
`
`2050
`
`Borgaonkaret al., “Quality of life measurement in gastrointestinal
`and liver disorders”, Gut, Vol. 47, Iss. 3, 444-54 (2000).
`
`Franciset al., “The irritable bowel syndrome”, Postgraduate Medical
`Journal, Vol. 73, 1-7 (1997).
`
`Wald, “Chapter 41: Approach to the Patient with Constipation”,
`Textbook of Gastroenterology, (Tadataka Yamadaed., 3°? Ed., Vol.
`1, Lippincott Williams & Wilkins 1999).
`
`Thompson et al., “Functional bowel disorders and functional
`abdominal pain”, Gut, Vol. 45, Suppl. II, 1143-7 (1999).
`
`2052
`
`Collinset al., “The putative role ofinflammationin the irritable bowel
`syndrome”, Gut, Vol. 49, Iss. 6, 743-5 (2001).
`
`2053
`
`Camilleri et al., “Visceral hypersensitivity: facts, speculations, and
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`and Pharmacology, Vol. 52, No. 3, 351-75 (2001).
`
`Zalewski, “Cisapride Withdrawal Requires Alternative Therapy”,
`Cleveland Clinic, Center for Continuing Education, Pharmacotherapy
`Update,
`Vol.
`3,
`No.
`2
`(2000),
`https://www.clevelandclinicmeded.com/medicalpubs/pharmacy/may
`june2000/cisapride.htm.
`
`Suareset al., “Prevalence of, and risk factors for, chronic idiopathic
`constipation in the community:
`systematic review and meta-
`analysis”, The American Journal of Gastroenterology, Vol. 106, No.
`9, 1582-91 (2011).
`
`Sandler et al., “Demographic and dietary determinants of constipation
`in the US population”, The American Journal of Public Health, Vol.
`80, No.2, 185-9 (1990).
`
`Faigel, “A clinical approach to constipation”, Clinical Cornerstone,
`Vol. 4, Iss. 4, 11-18 (2002).
`
`Bharucha et al., “Mechanisms, Evaluation, and Management of
`Chronic Constipation”, Gastroenterology, Vol. 158, No. 5, 1232-
`1249 (2020).
`
`Chey et al., “Randomized Trial of 2 Delayed-Release Formulations
`of Linaclotide in Patients With Irritable Bowel Syndrome With
`Constipation”, The American Journal of Gastroenterology, Vol. 116,
`Iss. 2, 354-361 (2021).
`
`Carpicket al., “The Escherichia coli heat-stable enterotoxin is a long-
`lived superagonist ofguanylin”, Infection and Immunity, Vol. 61, No.
`11, 4710-5 (1993).
`
`Lucas et al., “Guanylyl cyclases and signaling by cyclic GMP”,
`Pharmacological Reviews, Vol. 52, No. 3, 375-413 (2000).
`
`2062
`
`Beltowski, “Guanylin and related peptides”, Journal of Physiology
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`EXHIBIT
`
`DESCRIPTION
`
`2064
`
`Trulance® Label (October 2020).
`
`Kita et al., “Characterization of human uroguanylin: a memberof the
`guanylin peptide family”, The American Journal of Physiology, Vol.
`266, Iss. 2, F342-8 (1994).
`
`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
`
`2071
`
`Patent Owner’s Demonstratives
`
`Date: June 12, 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
`
`8
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`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
`
`
`
`
`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 Exhibits 2023, 2024, 2025, 2027, 2028, 2071 served
`
`electronically via email on June 12, 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: June 12, 2023
`
`
`
`
`
`
`
`
`
`
`
`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`
`
`
`
`
`
`
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