UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MSN LABORATORIES PRIVATE LTD. AND MSN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner
`_____________________
`
`Case No. IPR2023-00016
`Patent No. 7,041,786
`_____________________
`
`PETITIONER’S EXHIBIT LIST UPDATED NOVEMBER 3, 2022
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MSN LABORATORIES PRIVATE LTD. AND MSN PHARMACEUTICALS INC.
`Petitioners
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner
`_____________________
`
`Case No. IPR2023-00016
`Patent No. 7,041,786
`_____________________
`
`PETITIONER’S EXHIBIT LIST UPDATED NOVEMBER 3, 2022
`
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`
`
`Exhibit No
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`
`
`LIST OF EXHIBITS
`
`Description
`U.S. Patent No. 7,041,786, Guanylate Cyclase Receptor Agonists for
`the Treatment of Tissue Inflammation and Carcinogenesis, issued
`May 9, 2006 to Shailubhai, K., et al.
`
`Expert Declaration of Blake R. Peterson, Ph.D. (Corrected Version)
`
`Curriculum Vitae of Blake R. Peterson, Ph.D.
`
`Prosecution History of U.S. Patent No. 7,041,786
`U.S. Patent No. 5,489,670, Human Uroguanylin, issued Feb. 6, 1996
`to Currie, M. G., et al.
`
`Li, Z., et al., Purification, cDNA Sequence, and Tissue Distribution
`of Rat Uroguanylin, REGUL. PEPT., 68, 1997, 45-56
`
`Narayani, R., et al., Polymer-Coated Gelatin Capsules as Oral
`Delivery Devices and their Gastrointestinal Tract Behaviour in
`Humans, J. BIOMATER. SCI. POLYM. ED., 7(1), 1995, 39-48
`Campieri, M., et al., Oral Budesonide Is as Effective as Oral
`Prednisolone in Active Crohn’s Disease, GUT, 41, 1997, 209-214
`U.S. Patent No. 5,359,030, Conjugation-Stabilized Polypeptide
`Compositions, Therapeutic Delivery and Diagnostic Formulations
`Comprising Same, and Method of Making and Using the Same,
`issued Oct. 25, 1994 to Ekwuribe, N. N.
`King, R. E., Chapter 89: Tablets, Capsules, and Pills, REMINGTON’S
`PHARMACEUTICAL SCIENCES, 16th ed., (ed. A. Oslo,
`ed., Mack Publishing Co.) 1980
`Rehfeld, J. F., The New Biology of Gastrointestinal Hormones,
`PHYSIOL. REV., 78(4), 1998, 1087-1108
`
`-1-
`
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`
`
`Exhibit No
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`
`
`Description
`Nelson, D. L., et al., Chapters 4-5, 7, LEHNINGER PRINCIPLES OF
`BIOCHEMISTRY, 3rd ed. (eds. Ryan, M., et al., Worth Publishers)
`2000
`
`Segaloff, D. L., et al., Chapter 9: Internalization of Peptide
`Hormones and Hormone Receptors, HORMONES AND THEIR
`ACTIONS, PART I, (eds. Cooke, B. A., et al., Elsevier) 1988, 133- 149
`
`Chipens, G., et al., Recognition of Peptide Hormones and Kinins:
`Molecular Aspects of the Problem, FRONTIERS OF BIOORGANIC
`CHEMISTRY AND MOLECULAR BIOLOGY, (ed. Ananchenko, S. N.,
`Pergamon Press) 1980, 99-103
`Unson, C. G., et al., Positively Charged Residues at Positions 12, 17,
`and 18 of Glucagon Ensure Maximum Biological Potency, J. BIOL.
`CHEM., 273(17), 1998, 10308-10312
`
`Fan, X., et al., Structure and Activity of Uroguanylin and Guanylin
`from the Intestine and Urine of Rats, AM. J. PHYSIOL. ENDOCRINOL.
`METAB., 273(5), 1997, E957-E964
`Thomson, A. B. R., et al., Small Bowel Review: Part I, CAN. J.
`GASTROENTEROL., 14(9), 2000, 791-816
`Joo, N. S., et al., Regulation of Intestinal Cl- and HCO3
`- Secretion by
`Uroguanylin, AM. J. PHYSIOL., 274(4), 1998, G633-G644
`Hamra, F. K., et al., Opossum Colonic Mucosa Contains
`Uroguanylin and Guanylin Peptides, AM. J. PHYSIOL.
`GASTROINTEST. LIVER PHYSIOL., 270, 1996, G708-G716
`Nakazato, M., Guanylin Family: New Intestinal Peptides Regulating
`Electrolyte and Water Homeostasis, J. GASTROENTEROL., 36, 2001,
`219-225
`Hamra, F. K., et al., Regulation of Intestinal Uroguanylin/Guanylin
`Receptor-Mediated Responses by Mucosal Acidity, PROC. NATL.
`ACAD. SCI. USA, 94, 1997, 2705-2710
`
`-2-
`
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`
`
`Exhibit No
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`
`
`Description
`Mergler, M., et al., Systematic Investigation of the Aspartimide
`Problem, PEPTIDES: THE WAVE OF THE FUTURE, (ed. Lebl, M., et
`al., American Peptide Society) 2001, 63-64
`Wade, J. D., et al., Base-Induced Side Reactions in Fmoc-Solid
`Phase Peptide Synthesis: Minimization by Use of Piperazine as Nα-
`Deprotection Reagent, LETT. PEPT. SCI., 7, 2000, 107-112
`Lauer, J. L., et al., Sequence Dependence of Aspartimide Formation
`during 9-Fluorenylmethoxycarbonyl Solid-Phase Peptide Synthesis,
`LETT. PEPT. SCI., 1, 1994, 197-205
`Karten, M. J., et al., Gonadotropin-Releasing Hormone Analog
`Design. Structure-Function Studies Toward the Development of
`Agonists and Antagonists: Rationale and Perspective, ENDOCR.
`REV., 7(1), 1986, 44-66
`French, S., et al., What is a Conservative Substitution?, J. MOL.
`EVOL., 19, 1983, 171-175
`Tager, H. S., et al., Peptide Hormones, ANN. REV. BIOCHEM., 43,
`1974, 509-538
`Noble, S. L., et al., Insulin Lispro: A Fast-Acting Insulin Analog,
`AM. FAM. PHYSICIAN, 57(2), 1998, 279-286
`Galloway, J. A., New Directions in Drug Development: Mixtures,
`Analogs, and Modeling, DIABETES CARE, 16(Supp 3), 1993, 16-23
`Mishra, V. K., et al., Interactions of Synthetic Peptide Analogs of the
`Class A Amphipathic Helix with Lipids: Evidence for the Snorkel
`Hypothesis, J. BIOL. CHEM., 269(10), 1994, 7185-7191
`Currie, M. G., et al., Guanylin: An Endogenous Activator of
`Intestinal Guanylate Cyclase, PROC. NATL. ACAD. SCI. USA, 89,
`1992, 947-951
`Visweswariah, S. S., et al., Characterization and Partial Purification
`of the Human Receptor for the Heat-Stable Enterotoxin, EUR. J.
`BIOCHEM., 219, 1994, 727-736
`
`-3-
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`Exhibit No
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Description
`Krause, W. J., et al., Distribution of Escherichia coli Heat-Stable
`Enterotoxin/Guanylin/ Uroguanylin Receptors in the Avian
`Intestinal Tract, ACTA ANAT., 153, 1995, 210-219
`Forte, L. R., et al., Escherichia coli Enterotoxin Receptors:
`Localization in Opossum Kidney, Intestine, and Testis, AM. J.
`PHYSIOL., 257(2), 1989, F874-F881
`Hyun, C. S., et al., Interaction of Cholera Toxin and Escherichia coli
`Enterotoxin with Isolated Intestinal Epithelial Cells, AM. J.
`PHYSIOL., 247(6:1), 1984, G623-G631
`Nguyen, T. D., et al., Stimulation of Secretion by the T84 Colonic
`Epithelial Cell Line with Dietary Flavonols, BIOCHEM.
`PHARMACOL., 41(12), 1991, 1879-1886
`Guarino, A., et al., T84 Cell Receptor Binding and Guanyl Cyclase
`Activation by Escherichia coli Heat-Stable Toxin, AM. J. PHYSIOL.,
`253, 1987, G775-G780
`Bakre, M. M., et al., Dual Regulation of Heat-Stable Enterotoxin-
`Mediated cGMP Accumulation in T84 Cells by Receptor
`Desensitization and Increased Phosphodiesterase Activity, FEBS
`LETT., 408, 1997, 345-349
`Lin, M., et al., Heat-Stable Toxin from Escherichia coli Activates
`Chloride Current via cGMP-Dependent Protein Kinase, CELL
`PHYSIOL. BIOCHEM., 5, 1995, 23-32
`Tien, X.-Y., et al., Neurokinin A Increases Short-Circuit Current
`Across Rat Colonic Mucosa: A Role for Vasoactive Intestinal
`Polypeptide, J. PHYSIOL., 437, 1991, 341-350
`Muflih, I. W., et al., Sugars and Sugar Derivatives which Inhibit the
`Short‐Circuit Current of the Everted Small Intestine of the Rat,
`J. PHYSIOL., 263, 1976, 101-114
`Helbock, H. J., et al., The Mechanism of Calcium Transport by Rat
`Intestine, BIOCHIM. BIOPHYS. ACTA, 126, 1966, 81-93
`
`-4-
`
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`
`
`Exhibit No
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`
`
`Description
`Baldrick, P., Pharmaceutical Excipient Development: The Need for
`Preclinical Guidance, REGUL. TOXICOL. PHARMACOL., 32, 2000,
`210-218
`Duncan, J. D., et al., Comparative Analysis of Oral Delivery Systems
`for Live Rotavirus Vaccines, J. CONTROL. RELEASE, 41, 1996, 237-
`247
`Gerogiannis, V. S., et al., Floating and Swelling Characteristics of
`Various Excipients Used in Controlled Release Technology, DRUG
`DEV. IND. PHARM., 19(9), 1993, 1061-1081
`Mynott, T. L., et al., Oral Administration of Protease Inhibits
`Enterotoxigenic Escherichia coli Receptor Activity in Piglet Small
`Intestine, GUT, 38, 1996, 28-32
`Mynott, T. L., et al., Efficacy of Enteric-Coated Protease in
`Preventing Attachment of Enterotoxigenic Escherichia coli and
`Diarrheal Disease in the RITARD Model, INFECT. IMMUN., 59(10),
`1991, 3708-3714
`Rao, S. S. C., et al., Symptoms and Stool Patterns in Patients with
`Ulcerative Colitis, GUT, 29, 1988, 342-345
`Jalan, K. N., et al., Faecal Stasis and Diverticular Disease in
`Ulcerative Colitis, GUT, 11, 1970, 688-696
`Silverman, R. B., Chapter 3: Receptors, THE ORGANIC CHEMISTRY
`OF DRUG DESIGN AND DRUG ACTION, (Academic Press, Inc.) 1992,
`52-97
`Whitaker, T. L., et al., Uroguanylin and Guanylin: Distinct but
`Overlapping Patterns of Messenger RNA Expression in Mouse
`Intestine, GASTROENTEROLOGY, 113, 1997, 1000–1006
`Murphy, W. J., et al., Molecular Phylogenetics and the Origins of
`Placental Mammals, NATURE, 409, 2001, 614-618
`Forte, L. R., et al., Guanylin Peptides: Cyclic GMP Signaling
`Mechanisms, BRAZ. J. MED. BIOL. RES., 32, 1999, 1329-1336
`
`-5-
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`Exhibit No
`
`Description
`
`1054
`
`1055
`
`1056
`
`U.S. Provisional Patent Application No. 60/348,646, Guanylate
`Cyclase Receptor Agonists for the Treatment of Tissue Inflammation
`and Carcinogenesis, filed Jan. 17, 2002 by Shailubhai, K., et al.
`
`Highlights of Prescribing Information, TRULANCE (Plecanatide)
`Tablets for Oral Use (2017)
`Declaration of Christopher J. Sorenson in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`
`Dated: November 3, 2022
`
`Respectfully submitted,
`
`/Andrew Larsen/
`Andrew O. Larsen, Reg. No. 59,315
`Counsel for Petitioners MSN Laboratories
`Private Ltd. and MSN Pharmaceuticals Inc.
`
`Andrew O. Larsen, Ph.D., Esq.
`Reg. No. 59,315
`MERCHANT & GOULD P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`Main Telephone: (212) 223-6658
`Main Facsimile: (212) 223-6521
`alarsen@merchantgould.com
`
`Christopher J. Sorenson, Esq.
`Pro Hac Vice
`MERCHANT & GOULD P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`Main Telephone: (612) 336-4645
`Main Facsimile: (612) 332-9081
`csorenson@merchantgould.com
`
`-6-
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`Melissa Hayworth, Esq.
`Registration No. 45,774
`MERCHANT & GOULD P.C.
`1900 Duke Street, Suite 600
`Alexandria, VA 22314
`Main Telephone: (703) 684-2522
`Main Facsimile: (612) 332-9081
`mhayworth@merchantgould.com
`
`Counsel for Petitioners
`
`-7-
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that this Appendix of Exhibits and
`
`accompanying Exhibit 1056 - Declaration of Christopher J. Sorenson in Support of
`
`Petitioner’s Motion for Admission Pro Hac Vice were served via email directed to
`
`counsel of record for the Patent Owner at the following:
`
`Justin J. Hasford (justin.hasford@finnegan.com)
`Bryan C. Diner (bryan.diner@finnegan.com)
`Joshua L. Goldberg (joshua.goldberg@finnegan.com)
`Kassandra M. Officer (kassandra.officer@finnegan.com)
`Lauren J. Robinson (lauren.robinson@finnegan.com)
`Caitlin E. O’Connell (caitlin.o’connell@finnegan.com)
`Kyu Yun Kim (kyuyun.kim@finnegan.com)
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
`
`Courtesy Copy to Mylan Pharmaceuticals LLC
`
`Jad A. Mills (jmills@wsgr.com)
`Richard Torczon (rtorczon@wsgr.com)
`Nicole W. Stafford (nstafford@wsgr.com)
`Dennis D. Gregory (dgregory@wsgr.com)
`4863-5899-2145@mail.vault.netdocuments.com
`WILSON SONSINI GOODRICH & ROSATI
`PC 701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`
`-1-
`
`
`
`Case No. IPR2023-00016
`U.S. Patent 7,041,786
`
`Date: November 3, 2022
`
`/Andrew Larsen/
`By:
`Andrew O. Larsen, Ph.D., Esq.
`Reg. No. 59,315
`MERCHANT & GOULD P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`Main Telephone: (212) 223-6658
`Main Facsimile: (212) 223-6521
`alarsen@merchantgould.com
`
`Counsel for Petitioners
`
`-2-
`
`
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