Paper No. ___
`Filed: May 10, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`Filed: May 10, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-007221
`Patent 7,041,786
`————————————————
`
`
`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`
`1 IPR2023-00016 has been joined with this proceeding.
`
`
`
`Case IPR2022-00722
`U.S. Patent 7,041,786
`
`Exhibit No
`
`1001
`
`1002
`(Corrected)
`
`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.
`
`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
`
`-2-
`
`
`
`Case IPR2022-00722
`U.S. Patent 7,041,786
`
`Exhibit No
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`(Corrected)
`
`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
`
`-3-
`
`
`
`Case IPR2022-00722
`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
`
`-4-
`
`
`
`Case IPR2022-00722
`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
`
`-5-
`
`
`
`Case IPR2022-00722
`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
`
`-6-
`
`
`
`Case IPR2022-00722
`U.S. Patent 7,041,786
`
`Exhibit No
`1054
`(Corrected)
`
`1055
`
`1056
`
`1057
`(Served Only)
`
`1058
`(Served Only)
`
`1059
`(Served Only)
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`Description
`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)
`Transcript of PTAB Video Conference Hearing held on July 28,
`2022.
`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 (Supplemental
`evidence for EX1016)
`Noble, S. L., et al., Insulin Lispro: A Fast-Acting Insulin Analog,
`AM. FAM. PHYSICIAN, 57(2), 1998, 279-286 (Supplemental
`evidence for EX1028)
`CONFIDENTIAL Supplemental Declaration of Kunwar
`Shailubhai (deposition copy of Bausch EX2066) PROTECTIVE
`ORDER MATERIAL
`CONFIDENTIAL Transcript of the Deposition of Stephen G.
`Davies, Ph.D. held on February 16, 2023 - PROTECTIVE
`ORDER MATERIAL and REDACTED versions
`Transcript of the Deposition of Kunwar Shailubhai, Ph.D. held
`on February 23, 2023
`Transcript of the Deposition of Scott A. Waldman, M.D. held on
`March 8, 2023
`CONFIDENTIAL Second Declaration of Blake R. Peterson,
`Ph.D. - PROTECTIVE ORDER MATERIAL and
`REDACTED versions
`CONFIDENTIAL Declaration of Michael S. Epstein -
`PROTECTIVE ORDER MATERIAL and REDACTED
`versions
`
`-7-
`
`
`
`Case IPR2022-00722
`U.S. Patent 7,041,786
`
`Exhibit No
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`Description
`R. Urbanski, et al., Internalization of E. Coli ST Mediated by
`Guanylyl Cyclase C in T84 Human Colon Carcinoma Cells,
`Biochimica et Biophysica Acta 1245 (1995) 29-36.
`A.M. Evans, Comparative Pharmacology of S(+)Ibuprofen
`and (RS)-Ibuprofen, Clin >Rheumatology (2001) (Suppl 1):
`S9-14.
`Excerpts from File History of EP App. 02721604.3, retrieved
`from https://register.epo.org/regviewer (last visited March 23,
`2023)
`U.S. Patent No. 11,319,346 to Shailubhai et al.
`
`Pharmacology Review(s), “TRULANCE (Plecanatide)
`Tablets”, Application No. 208745Orig1s000, Dec. 2, 2016, p.
`1-322,
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/20
`8745Orig1s000PharmRedt.pdf (last visited March 23, 2023)
`J.W. Fara, Physiological limitations: gastric emptying and
`transit of dosage forms, in RATE CONTROL IN DRUG THERAPY
`(L.F. Prescott, W.S. Nimmo eds.), Churchill Livingstone,
`1985:144-150.
`Curriculum Vitae of Michael S. Epstein, M.D.
`
`Linzess® Label (March 2017),
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/2
`02811s013lbl.pdf (last visited March 23, 2023)
`
`
`Dated: May 10, 2023
`
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`/Jad A. Mills/
`Jad A. Mills, Reg. No. 63,344
`Counsel for Mylan Pharmaceuticals Inc.
`
`-8-
`
`
`
`Case IPR2022-00722
`U.S. Patent 7,041,786
`
`CERTIFICATE OF SERVICE
`
`I certify that today this Exhibit List, a Public Redacted Version of Petitioner’s
`
`Reply (Paper 38), and Public Redacted Versions of EX1063-EX1064 were served
`
`today on the Patent Owner at the email correspondence addresses of the Patent Owner
`
`as follows:
`
`
`
`Justin J. Hasford
`
`Bryan C. Diner
`
`justin.hasford@finnegan.com
`
`bryan.diner@finnegan.com
`
`Joshua L. Goldberg
`
`joshua.goldberg@finnegan.com
`
`Caitlin E. O’Connell
`
`caitlin.o’connell@finnegan.com
`
` Kyu Yun Kim
`
`kyuyun.kim@finnegan.com
`
` Kassandra Office
`
`kassandra.officer@finnegan.com
`
`and on joinder counsel as follows:
`
`
`
` Andrew Larsen
`
`alarsen@merchantgould.com
`
` Melissa Hayworth
`
`mhayworth@merchantgould.com
`
`
`
`
`
`
`
`
`
`
`Dated: May 10, 2023
`
`
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`
`/Chris Kielman/
`
` Chris Kielman
`
`-9-
`
`
`
`
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