throbber

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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`ELI LILLY AND COMPANY
`Petitioner
`v.
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH
`Patent Owner
`______________________
`
`IPR2018-01425
`Patent No. 9,890,210
`______________________
`
`PETITIONER’S UPDATED EXHIBIT LIST AS OF SEPTEMBER 10, 2019
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`Further to 37 C.F.R. § 42.63(e), Petitioner Eli Lilly and Company hereby
`
`IPR2018-01425
`Patent No. 9,890,210
`
`submits a current listing of Lilly Exhibits.
`
`Exhibit
`
`Description
`
`Ex. 1001
`
`U.S. Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`
`Ex. 1002
`
`Reserved
`
`Ex. 1003
`
`Reserved
`
`Ex. 1004
`
`Reserved
`
`Ex. 1005
`
`Reserved
`
`Ex. 1006
`
`Reserved
`
`Ex. 1007
`
`Reserved
`
`Ex. 1008
`
`Reserved
`
`Ex. 1009
`
`Reserved
`
`Ex. 1010
`
`Ex. 1011
`
`Declaration of Andrew Charles, M.D. (U.S. Patent No.
`9,890,210)
`
`Declaration of Alain P. Vasserot (U.S. Patent No.
`9,890,210)
`
`Ex. 1012
`
`Reserved
`
`Ex. 1013
`
`Reserved
`
`Ex. 1014
`
`Reserved
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`Ex. 1015
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`Reserved
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`Ex. 1016
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`Reserved
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`1
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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1017
`
`Reserved
`
`Ex. 1018
`
`Reserved
`
`Ex. 1019
`
`Teva’s U.S. Provisional Application No. 60/736,623
`
`Ex. 1020
`
`Teva’s PCT Application No. WO 2007/054809
`
`Ex. 1021
`
`Ex. 1022
`
`Tan et al., “Demonstration of the Neurotransmitter Role of
`Calcitonin Gene-Related Peptides (CGRP) by
`Immunoblockade with Anti-CGRP Monoclonal
`Antibodies,” Br. J. Pharmacol. (1994) 111: 703-710
`
`Tan et al., “Calcitonin Gene-Related Peptide as an
`Endogenous Vasodilator: Immunoblockade Studies in vivo
`with an Anti-Calcitonin Gene-Related Peptide Monoclonal
`Antibody and Its Fab’ Fragment,” Clinical Sci. (1995) 89:
`565-573
`
`Ex. 1023
`
`Queen et al., U.S. Patent No. 6,180,370
`
`Ex. 1024
`
`Ex. 1025
`
`Doods et al., “Pharmacological Profile of BIBN4096BS,
`the First Selective Small Molecule CGRP Antagonist,” Br.
`J. Pharmacol. (2000) 129: 420-423
`
`Olesen et al., “Calcitonin Gene-Related Peptide Receptor
`Antagonist BIBN 4096 BS for the Acute Treatment of
`Migraine,” N. Engl. J. Med. (2004) 350: 1104-1110
`
`Ex. 1026
`
`Sveinsson, International Publication No. WO 2004/014351
`
`Ex. 1027
`
`Salmon et al., U.S. Patent Application Publication No. US
`2002/0162125
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`Ex. 1028
`
`De Lacharriere et al., U.S. Patent No. 6,344,438
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`2
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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1029
`
`Ex. 1030
`
`Ex. 1031
`
`Olesen et al., “S26 CGRP Antagonism as a New
`Therapeutic Principle in Acute Migraine,” Neuropeptides
`(2004) 38: 110-131
`
`Arndt et al., “CGRP Antagonism — A Valid New Concept
`for the Treatment of Migraine Pain,” Neuropeptides (2004)
`38: 110-131
`
`Arulmani et al., “Calcitonin Gene-related Peptide and Its
`Role in Migraine Pathophysiology,” Eur. J. Pharmacol.
`(2004) 143: 315-330
`
`Ex. 1031A Arulmani et al., “Calcitonin Gene-related Peptide and Its
`Role in Migraine Pathophysiology,” Eur. J. Pharmacol.
`(2004) 143: 315-330
`
`Ex. 1032
`
`Frobert et al., “A Sensitive Sandwich Enzyme
`Immunoassay for Calcitonin Gene-Related Peptide
`(CGRP): Characterization and Application,” Peptides
`(1999) 20: 275-284
`
`Ex. 1032A Frobert et al., “A Sensitive Sandwich Enzyme
`Immunoassay for Calcitonin Gene-Related Peptide
`(CGRP): Characterization and Application,” Peptides
`(1999) 20: 275-284
`
`Ex. 1033 Wong et al., “Monoclonal Antibody to Rat α-CGRP:
`Production, Characterization, and in vivo
`Immunoneutralization Activity,” Hybridoma (1993) 12: 93-
`106
`
`Ex. 1033A Wong et al., “Monoclonal Antibody to Rat α-CGRP:
`Production, Characterization, and in vivo
`Immunoneutralization Activity,” Hybridoma (1993) 12: 93-
`106
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`X
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`X
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`3
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`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Exhibit
`
`Ex. 1034
`
`Rist et al., “From Micromolar to Nanomolar Affinity: A
`Systematic Approach to Identify the Binding Site of CGRP
`at the Human Calcitonin Gene-Related Peptide 1
`Receptor,” J. Med. Chem. (1998) 41: 117-123
`
`Ex. 1034A Rist et al., “From Micromolar to Nanomolar Affinity: A
`Systematic Approach to Identify the Binding Site of CGRP
`at the Human Calcitonin Gene-Related Peptide 1
`Receptor,” J. Med. Chem. (1998) 41: 117-123
`
`Ex. 1035
`
`Edvinsson and Hargreaves, The Headaches 289-299 (3rd
`ed. 2006)
`
`Ex. 1035A Edvinsson and Hargreaves, The Headaches 289-299 (3rd
`ed. 2006)
`
`Ex. 1036
`
`Reserved
`
`Ex. 1037
`
`Reserved
`
`Ex. 1038 Mason et al., “Release of the Predicted Calcitonin Gene-
`Related Peptide from Cultured Rat Trigeminal Ganglion
`Cells,” Nature (1984) 308: 653-655
`
`Ex. 1038A Mason et al., “Release of the Predicted Calcitonin Gene-
`Related Peptide from Cultured Rat Trigeminal Ganglion
`Cells,” Nature (1984) 308: 653-655
`
`Ex. 1039
`
`Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
`
`Ex. 1039A Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
`
`Ex. 1040
`
`Arulmozhi et al., “Migraine: Current Concepts and
`Emerging Therapies,” Vascular Pharmacol. (2005) 43:
`176-187
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`4
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`X
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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1040A Arulmozhi et al., “Migraine: Current Concepts and
`Emerging Therapies,” Vascular Pharmacol. (2005) 43:
`176-187
`
`Ex. 1041
`
`Durham, “CGRP-Receptor Antagonists — A Fresh
`Approach to Migraine Therapy?” N. Engl. Med. (2004)
`350(11): 1073-1075
`
`Ex. 1041A Durham, “CGRP-Receptor Antagonists — A Fresh
`Approach to Migraine Therapy?” N. Engl. Med. (2004)
`350(11): 1073-1075
`
`Ex. 1042
`
`Ex. 1042A
`
`Iovino et al., “Safety, Tolerability and Pharmacokinetics of
`BIBN 4096 BS, the First Selective Small Molecule
`Calcitonin Gene-related Peptide Receptor Antagonist,
`Following Single Intravenous Administration in Healthy
`Volunteers,” Cephalalgia (2004) 24: 645-656
`
`Iovino et al., “Safety, Tolerability and Pharmacokinetics of
`BIBN 4096 BS, the First Selective Small Molecule
`Calcitonin Gene-related Peptide Receptor Antagonist,
`Following Single Intravenous Administration in Healthy
`Volunteers,” Cephalalgia (2004) 24: 645-656
`
`Ex. 1043
`
`Goadsby et al., “Vasoactive Peptide Release in the
`Extracerebral Circulation of Humans During Migraine
`Headache,” Annals of Neurology (1990) 28(2): 183-187
`
`Ex. 1043A Goadsby et al., “Vasoactive Peptide Release in the
`Extracerebral Circulation of Humans During Migraine
`Headache,” Annals of Neurology (1990) 28(2): 183-187
`
`Ex. 1044
`
`Goadsby and Edvinsson, “The Trigeminovascular System
`and Migraine: Studies Characterizing Cerebrovascular and
`Neuropeptide Changes Seen in Humans and Cats,” Annals
`of Neurology (1993) 33(1): 48-56
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`X
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`X
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`X
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`X
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`5
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`

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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1044A Goadsby and Edvinsson, “The Trigeminovascular System
`and Migraine: Studies Characterizing Cerebrovascular and
`Neuropeptide Changes Seen in Humans and Cats,” Annals
`of Neurology (1993) 33(1): 48-56
`
`Ex. 1045
`
`Ex. 1045A
`
`Ex. 1046
`
`Juhasz et al., “NO-induced Migraine Attack: Strong
`Increase in Plasma Calcitonin Gene-Related Peptide
`(CGRP) Concentration and Negative Correlation with
`Platelet Serotonin Release,” Pain (2003) 106: 461-470
`
`Juhasz et al., “NO-induced Migraine Attack: Strong
`Increase in Plasma Calcitonin Gene-Related Peptide
`(CGRP) Concentration and Negative Correlation with
`Platelet Serotonin Release,” Pain (2003) 106: 461-470
`
`Goadsby and Edvinsson, “Human in vivo Evidence for
`Trigeminovascular Activation in Cluster Headache:
`Neuropeptide Changes and Effects of Acute Attacks
`Therapies,” Brain (1994) 117: 427-434
`
`Ex. 1046A Goadsby and Edvinsson, “Human in vivo Evidence for
`Trigeminovascular Activation in Cluster Headache:
`Neuropeptide Changes and Effects of Acute Attacks
`Therapies,” Brain (1994) 117: 427-434
`
`Ex. 1047
`
`Lassen et al., “CGRP May Play a Causative Role in
`Migraine,” Cephalagia (2002) 22: 54-61
`
`Ex. 1047A Lassen et al., “CGRP May Play a Causative Role in
`Migraine,” Cephalagia (2002) 22: 54-61
`
`Ex. 1048
`
`Louis et al., “Antibodies to Calcitonin-Gene Related
`Peptide Reduce Inflammation Induced by Topical Mustard
`Oil But Not that Due to Carrageenin in the Rat,”
`Neuroscience Letters (1989) 102: 257-260
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`X
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`X
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`X
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`X
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`6
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1048A Louis et al., “Antibodies to Calcitonin-Gene Related
`Peptide Reduce Inflammation Induced by Topical Mustard
`Oil But Not that Due to Carrageenin in the Rat,”
`Neuroscience Letters (1989) 102: 257-260
`
`Ex. 1049
`
`Dockray et al., “Immunoneutralization Studies with
`Calcitonin Gene-Related Peptide,” Annals of N.Y. Acad.
`Scis. (1992) 258-267
`
`Ex. 1049A Dockray et al., “Immunoneutralization Studies with
`Calcitonin Gene-Related Peptide,” Annals of N.Y. Acad.
`Scis. (1992) 258-267
`
`Ex. 1050
`
`Louis et al., “The Role of Substance P and Calcitonin
`Gene-Related Peptide in Neurogenic Plasma Extravasation
`and Vasodilation in the Rat,” Neuroscience (1989) 32(3):
`581-586
`
`Ex. 1050A Louis et al., “The Role of Substance P and Calcitonin
`Gene-Related Peptide in Neurogenic Plasma Extravasation
`and Vasodilation in the Rat,” Neuroscience (1989) 32(3):
`581-586
`
`Ex. 1051
`
`Ex. 1052
`
`Sigma-Aldrich, Biochemicals & Reagents for Life Science
`Research 350-352 (2004)
`
`Escott and Brain, “Effect of a Calcitonin Gene-Related
`Peptide Antagonist (CGRP8-37) on Skin Vasodilatation and
`Oedema Induced by Stimulation of the Rat Saphenous
`Nerve,” Br. J. Pharmacol. (1993) 110: 772-776
`
`Ex. 1052A Escott and Brain, “Effect of a Calcitonin Gene-Related
`Peptide Antagonist (CGRP8-37) on Skin Vasodilatation and
`Oedema Induced by Stimulation of the Rat Saphenous
`Nerve,” Br. J. Pharmacol. (1993) 110: 772-776
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`X
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`7
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`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1053
`
`Reserved
`
`Ex. 1054
`
`Reserved
`
`Ex. 1055
`
`Andrew et al., “Monoclonal Antibodies Distinguishing α
`and β Forms of Calcitonin Gene-Related Peptide,” J.
`Immunol. Methods (1990) 154: 87-94
`
`Ex. 1055A Andrew et al., “Monoclonal Antibodies Distinguishing α
`and β Forms of Calcitonin Gene-Related Peptide,” J.
`Immunol. Methods (1990) 154: 87-94
`
`Ex. 1056
`
`Reichert et al., “Monoclonal Antibody Successes in the
`Clinic,” Nature Biotechnol. (2005) 23: 1073-1078
`
`Ex. 1056A Reichert et al., “Monoclonal Antibody Successes in the
`Clinic,” Nature Biotechnol. (2005) 23: 1073-1078
`
`Ex. 1057
`
`Projan et al., “Small Molecules for Small Minds? The Case
`for Biologic Pharmaceuticals,” Expert Opin. Biol. Ther.
`(2004) 4: 1345-1350
`
`Ex. 1057A Projan et al., “Small Molecules for Small Minds? The Case
`for Biologic Pharmaceuticals,” Expert Opin. Biol. Ther.
`(2004) 4: 1345-1350
`
`Ex. 1058
`
`Janeway et al., Immunobiology 93-122 (5th ed. 2001)
`
`Ex. 1059
`
`Janeway et al., Immunobiology 123-154 (5th ed. 2001)
`
`Ex. 1060
`
`Janeway et al., Immunobiology 341-380 (5th ed. 2001)
`
`Ex. 1061
`
`Van Valen et al., “Calcitonin Gene-Related Peptide
`(CGRP) Receptors are Linked to Cyclic Adenosine
`Monophosphate Production in SK-N-MC Human
`Neuroblastoma Cells,” Neuroscience Letters (1990) 119:
`195-198
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`8
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`

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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1061A Van Valen et al., “Calcitonin Gene-Related Peptide
`(CGRP) Receptors are Linked to Cyclic Adenosine
`Monophosphate Production in SK-N-MC Human
`Neuroblastoma Cells,” Neuroscience Letters (1990) 119:
`195-198
`
`Ex. 1062
`
`Kipriyanov and Le Gall, “Generation and Production of
`Engineered Antibodies,” Mol. Biotechnol. (2004) 26: 39-60
`
`Ex. 1062A Kipriyanov and Le Gall, “Generation and Production of
`Engineered Antibodies,” Mol. Biotechnol. (2004) 26: 39-60
`
`Ex. 1063
`
`Elgert, Immunology: Understanding the Immune System
`58-78 (1st ed. 1996)
`
`Ex. 1064 Wright and Morrison, “Effect of Glycosylation on
`Antibody Function: Implications for Genetic Engineering,”
`Trends Biotechnol. (1997) 15: 26-32
`
`Ex. 1064A Wright and Morrison, “Effect of Glycosylation on
`Antibody Function: Implications for Genetic Engineering,”
`Trends Biotechnol. (1997) 15: 26-32
`
`Ex. 1065
`
`Brüggemann et al., “Comparison of the Effector Functions
`of Human Immunoglobulins Using a Matched Set of
`Chimeric Antibodies,” J. Exp. Med. (1987) 166: 1351-1361
`
`Ex. 1065A Brüggemann et al., “Comparison of the Effector Functions
`of Human Immunoglobulins Using a Matched Set of
`Chimeric Antibodies,” J. Exp. Med. (1987) 166: 1351-1361
`
`Ex. 1066
`
`Presta, “Selection, Design, and Engineering of Therapeutic
`Antibodies,” J. Allergy Clin. Immunol. (2005) 116: 731-
`736
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`X
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`9
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`

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`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1066A Presta, “Selection, Design, and Engineering of Therapeutic
`Antibodies,” J. Allergy Clin. Immunol. (2005) 116: 731-
`736
`
`Ex. 1067
`
`Tao and Morrison, “Studies of Aglycosylated Chimeric
`Mouse-Human IgG: Role of Carbohydrate in the Structure
`and Effector Functions Mediated by the Human IgG
`Constant Region,” J. Immunol. (1989) 143: 2595-2601
`
`Ex. 1067A Tao and Morrison, “Studies of Aglycosylated Chimeric
`Mouse-Human IgG: Role of Carbohydrate in the Structure
`and Effector Functions Mediated by the Human IgG
`Constant Region,” J. Immunol. (1989) 143: 2595-2601
`
`Ex. 1068 Maynard and Georgiou, “Antibody Engineering,” Annu.
`Rev. Biomed. Eng. (2000) 2: 339-376
`
`Ex. 1068A Maynard and Georgiou, “Antibody Engineering,” Annu.
`Rev. Biomed. Eng. (2000) 2: 339-376
`
`Ex. 1069
`
`Chester and Hawkins, “Clinical Issues in Antibody
`Design,” Trends Biotechnol. (1995) 13: 294-300
`
`Ex. 1069A Chester and Hawkins, “Clinical Issues in Antibody
`Design,” Trends Biotechnol. (1995) 13: 294-300
`
`Ex. 1070
`
`Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
`
`Ex. 1070A Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
`
`Ex. 1071
`
`Gavilondo and Larrick, “Antibody Engineering at the
`Millennium,” BioTechniques (2000) 29: 128-145
`
`Ex. 1071A Gavilondo and Larrick, “Antibody Engineering at the
`Millennium,” BioTechniques (2000) 29: 128-145
`
`X
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`10
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1072
`
`Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
`
`Ex. 1072A Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
`
`Ex. 1073
`
`Carter, “Improving the Efficacy of Antibody-Based Cancer
`Therapies,” Nature Revs. Cancer (2001) 1: 118-129
`
`Ex. 1073A Carter, “Improving the Efficacy of Antibody-Based Cancer
`Therapies,” Nature Revs. Cancer (2001) 1: 118-129
`
`Ex. 1074
`
`Kettleborough et al., “Humanization of a Mouse
`Monoclonal Antibody by CDR-Grafting: The Importance
`of Framework Residues on Loop Conformation,” Protein
`Eng. (1991) 4: 773-783
`
`Ex. 1074A Kettleborough et al., “Humanization of a Mouse
`Monoclonal Antibody by CDR-Grafting: The Importance
`of Framework Residues on Loop Conformation,” Protein
`Eng. (1991) 4: 773-783
`
`Ex. 1075
`
`Queen et al., “A Humanized Antibody that Binds to the
`Interleukin 2 Receptor,” Proc. Natl. Acad. Sci. USA (1989)
`86: 10029-10033
`
`Ex. 1075A Queen et al., “A Humanized Antibody that Binds to the
`Interleukin 2 Receptor,” Proc. Natl. Acad. Sci. USA (1989)
`86: 10029-10033
`
`Ex. 1076
`
`Friend et al., “Phase I Study of an Engineered
`Aglycosylated Humanized CD3 Antibody in Renal
`Transplant Rejection,” Transplantation (1999) 68: 1632-
`1637
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`X
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`X
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`X
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`X
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`11
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1076A Friend et al., “Phase I Study of an Engineered
`Aglycosylated Humanized CD3 Antibody in Renal
`Transplant Rejection,” Transplantation (1999) 68: 1632-
`1637
`
`Ex. 1077
`
`Brekke and Sandlie, “Therapeutic Antibodies for Human
`Diseases at the Dawn of the Twenty-First Century,” Nature
`Revs. Drug Discov. (2003) 2: 52-62
`
`Ex. 1077A Brekke and Sandlie, “Therapeutic Antibodies for Human
`Diseases at the Dawn of the Twenty-First Century,” Nature
`Revs. Drug Discov. (2003) 2: 52-62
`
`Ex. 1078
`
`Reserved
`
`Ex. 1079
`
`Huse et al., International Publication No. WO 2001/27160
`
`Ex. 1080
`
`Reserved
`
`Ex. 1081
`
`Reserved
`
`Ex. 1082
`
`Vater et al., “Short Bioactive Spiegelmers to Migraine-
`Associated Calcitonin Gene-Related Peptide Rapidly
`Identified by a Novel Approach: Tailored-SELEX,”
`Nucleic Acids Res. (2003) 31: 1-7
`
`Ex. 1083
`
`Reserved
`
`Ex. 1084
`
`Reserved
`
`Ex. 1085
`
`Reserved
`
`Ex. 1086
`
`Reserved
`
`Ex. 1087
`
`Johnstone et al., “The Effect of Temperature on the
`Binding Kinetics and Equilibrium Constants of Monoclonal
`
`12
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Antibodies to Cell Surface Antigens,” Mol. Immunol.
`(1990) 27: 327-333
`
`Ex. 1088
`
`Reserved
`
`Ex. 1089
`
`Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
`
`Ex. 1089A Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
`
`Ex. 1090
`
`Petersen et al., “Inhibitory Effect of BIBN4096BS on
`Cephalic Vasodilation Induced by CGRP or Transcranial
`Electrical Stimulation in the Rat,” Br. J. Pharm. (2004)
`143: 697-704
`
`Ex. 1090A Petersen et al., “Inhibitory Effect of BIBN4096BS on
`Cephalic Vasodilation Induced by CGRP or Transcranial
`Electrical Stimulation in the Rat,” Br. J. Pharm. (2004)
`143: 697-704
`
`Ex. 1091
`
`Purves et al., Neuroscience 763-773 (3rd ed. 2004)
`
`Ex. 1092
`
`Reserved
`
`Ex. 1093
`
`Reserved
`
`Ex. 1094
`
`Reserved
`
`Ex. 1095
`
`Conner et al., “Interaction of Calcitonin-Gene-Related
`Peptide with Its Receptors,” Biochemistry Society
`Transactions (2002) 30(4): 451-455
`
`Ex. 1095A Conner et al., “Interaction of Calcitonin-Gene-Related
`Peptide with Its Receptors,” Biochemistry Society
`Transactions (2002) 30(4): 451-455
`
`
`
`
`
`X
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`
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`X
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`
`
`
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`X
`
`13
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1096 Wimalawansa, “Calcitonin Gene-Related Peptide and Its
`Receptors: Molecular Genetics, Physiology,
`Pathophysiology, and Therapeutic Potentials,” Endocrine
`Revs. (1996) 17(5): 533-585
`
`Ex. 1097 Williamson et al., “Intravital Microscope Studies on the
`Effects of Neurokinin Agonists and Calcitonin Gene-
`Related Peptide on Dural Vessel Diameter in the
`Anaesthetized Rat,” Cephalalgia (1997) 17: 518-524
`
`Ex. 1098
`
`Hong et al., “Pharmacological Coupling and Functional
`Role for CGRP Receptors in the Vasodilation of Rat Pial
`Arterioles,” Am. J. Physiol. (1996) 270: H317-H323
`
`Ex. 1099
`
`Reserved
`
`Ex. 1100
`
`Reserved
`
`Ex. 1101
`
`Jones et al., “Replacing the Complementarity-Determining
`Regions in a Human Antibody with Those from a Mouse,”
`Nature (1986) 321: 522-525
`
`Ex. 1101A
`
`Jones et al., “Replacing the Complementarity-Determining
`Regions in a Human Antibody with Those from a Mouse,”
`Nature (1986) 321: 522-525
`
`Ex. 1102
`
`Reserved
`
`Ex. 1103
`
`Ex. 1104
`
`Ex. 1105
`
`Tysabri® Letter from the Food and Drug Administration
`(2004)
`
`Pollack, “F.D.A. Approves a Multiple Sclerosis Drug,”
`New York Times (November 24, 2004)
`
`Sandborn and Yednock, “Novel Approaches to Treating
`Inflammatory Bowel Disease: Targeting Alpha-4 Integrin,”
`Am. J. Gastroenterol (2003) 98: 2372-2382
`
`
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`X
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`
`
`14
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1105A Sandborn and Yednock, “Novel Approaches to Treating
`Inflammatory Bowel Disease: Targeting Alpha-4 Integrin,”
`Am. J. Gastroenterol (2003) 98: 2372-2382
`
`Ex. 1106
`
`Hamann P.R., Berger M.S. (2002) Mylotarg. In: Pagé M.
`(eds) Tumor Targeting in Cancer Therapy. Cancer Drug
`Discovery and Development. Humana Press, Totowa, NJ.
`
`Ex. 1106A Hamann P.R., Berger M.S. (2002) Mylotarg. In: Pagé M.
`(eds) Tumor Targeting in Cancer Therapy. Cancer Drug
`Discovery and Development. Humana Press, Totowa, NJ.
`
`Ex. 1107
`
`Reserved
`
`Ex. 1108
`
`Reserved
`
`Ex. 1109
`
`Reserved
`
`Ex. 1110
`
`Tsurushita et al., “Design of Humanized Antibodies: From
`anti-Tac to Zenapax,” Methods (2005) 36: 69-83
`
`Ex. 1111
`
`Reserved
`
`Ex. 1112
`
`Reserved
`
`Ex. 1113
`
`Reserved
`
`Ex. 1114
`
`Reserved
`
`Ex. 1115
`
`Reserved
`
`Ex. 1116
`
`Reserved
`
`Ex. 1117
`
`Reserved
`
`Ex. 1118
`
`Reserved
`
`Ex. 1119
`
`Reserved
`
`15
`
`X
`
`
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`X
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`
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`
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1120
`
`Reserved
`
`Ex. 1121
`
`Reserved
`
`Ex. 1122
`
`Reserved
`
`Ex. 1123
`
`Reserved
`
`Ex. 1124
`
`Reserved
`
`Ex. 1125
`
`Reserved
`
`Ex. 1126
`
`Reserved
`
`Ex. 1127
`
`Lilly’s U.S. Provisional Application No. 60/753,004
`
`Ex. 1128
`
`U.S. Provisional Application No. 60/711,950
`
`Ex. 1129
`
`Reserved
`
`Ex. 1130
`
`Janeway et al., Immunobiology 626-627 (5th ed. 2001)
`
`Ex. 1131
`
`Reserved
`
`Ex. 1132
`
`Reserved
`
`Ex. 1133
`
`Reserved
`
`Ex. 1134
`
`Reserved
`
`Ex. 1135
`
`Reserved
`
`Ex. 1136
`
`September 5, 2013 Teva’s Response to Office Action (U.S.
`Patent No. 8,597,649 prosecution history)
`
`Ex. 1137
`
`Reserved
`
`Ex. 1138
`
`Reserved
`
`16
`
`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1139
`
`Reserved
`
`Ex. 1140
`
`Reserved
`
`Ex. 1141
`
`Reserved
`
`Ex. 1142
`
`Reserved
`
`Ex. 1143
`
`Reserved
`
`Ex. 1144
`
`Reserved
`
`Ex. 1145
`
`Reserved
`
`Ex. 1146
`
`Reserved
`
`Ex. 1147
`
`Reserved
`
`Ex. 1148
`
`Reserved
`
`Ex. 1149
`
`Reserved
`
`Ex. 1150
`
`Reserved
`
`Ex. 1151
`
`Reserved
`
`Ex. 1152
`
`Reserved
`
`Ex. 1153
`
`Reserved
`
`Ex. 1154
`
`Reserved
`
`Ex. 1155
`
`Reserved
`
`Ex. 1156
`
`Reserved
`
`Ex. 1157
`
`Reserved
`
`Ex. 1158
`
`Reserved
`
`17
`
`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1159
`
`Reserved
`
`Ex. 1160
`
`Reserved
`
`Ex. 1161
`
`Reserved
`
`Ex. 1162
`
`Reserved
`
`Ex. 1163
`
`Reserved
`
`Ex. 1164
`
`Reserved
`
`Ex. 1165
`
`Reserved
`
`Ex. 1166
`
`Reserved
`
`Ex. 1167
`
`Reserved
`
`Ex. 1168
`
`Reserved
`
`Ex. 1169
`
`Reserved
`
`Ex. 1170
`
`Reserved
`
`Ex. 1171
`
`Reserved
`
`Ex. 1172
`
`Reserved
`
`Ex. 1173
`
`Reserved
`
`Ex. 1174
`
`Reserved
`
`Ex. 1175
`
`Reserved
`
`Ex. 1176
`
`Reserved
`
`Ex. 1177
`
`Reserved
`
`Ex. 1178
`
`Reserved
`
`18
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1179
`
`Reserved
`
`Ex. 1180
`
`Reserved
`
`Ex. 1181
`
`Reserved
`
`Ex. 1182
`
`Reserved
`
`Ex. 1183
`
`Reserved
`
`Ex. 1184
`
`Reserved
`
`Ex. 1185
`
`Reserved
`
`Ex. 1186 May 5, 2017 Application Data Sheet (U.S. Patent No.
`9,890,210 prosecution history)
`
`Ex. 1187
`
`Ex. 1188
`
`Ex. 1189
`
`June 23, 2017 Office Action (U.S. Patent No. 9,890,210
`prosecution history)
`
`August 23, 2017 Teva’s Response to Office Action (U.S.
`Patent No. 9,890,210 prosecution history)
`
`August 23, 2017 Terminal Disclaimers (U.S. Patent No.
`9,890,210 prosecution history)
`
`Ex. 1190 May 26, 2017 Information Disclosure Statement (U.S.
`Patent No. 9,890,210 prosecution history)
`
`Ex. 1191
`
`October 27, 2017 Information Disclosure Statement (U.S.
`Patent No. 9,890,210 prosecution history)
`
`Ex. 1192
`
`Reserved
`
`Ex. 1193
`
`Reserved
`
`Ex. 1194
`
`Reserved
`
`19
`
`
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`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1195
`
`Reserved
`
`Ex. 1196
`
`Reserved
`
`Ex. 1197
`
`Reserved
`
`Ex. 1198
`
`Reserved
`
`Ex. 1199
`
`Reserved
`
`Ex. 1200
`
`Reserved
`
`Ex. 1201
`
`Reserved
`
`Ex. 1202
`
`Reserved
`
`Ex. 1203
`
`Reserved
`
`Ex. 1204
`
`Reserved
`
`Ex. 1205
`
`Reserved
`
`Ex. 1206
`
`Reserved
`
`Ex. 1207
`
`Reserved
`
`Ex. 1208
`
`Reserved
`
`Ex. 1209
`
`Reserved
`
`Ex. 1210
`
`Reserved
`
`Ex. 1211
`
`Reserved
`
`Ex. 1212
`
`Reserved
`
`Ex. 1213
`
`Reserved
`
`Ex. 1214
`
`Reserved
`
`20
`
`
`
`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1215
`
`Reserved
`
`Ex. 1216
`
`Reserved
`
`Ex. 1217
`
`Reserved
`
`Ex. 1218
`
`Reserved
`
`Ex. 1219
`
`Reserved
`
`Ex. 1220
`
`Reserved
`
`Ex. 1221
`
`Reserved
`
`Ex. 1222
`
`Reserved
`
`Ex. 1223
`
`Reserved
`
`Ex. 1224
`
`Reserved
`
`Ex. 1225
`
`Reserved
`
`Ex. 1226
`
`Reserved
`
`Ex. 1227
`
`Reserved
`
`Ex. 1228
`
`Reserved
`
`Ex. 1229
`
`Reserved
`
`Ex. 1230
`
`Reserved
`
`Ex. 1231
`
`Reserved
`
`Ex. 1232
`
`Reserved
`
`Ex. 1233
`
`Reserved
`
`Ex. 1234
`
`Reserved
`
`21
`
`
`
`
`
`
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`
`
`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1235
`
`Reserved
`
`Ex. 1236
`
`Reserved
`
`Ex. 1237
`
`Reserved
`
`Ex. 1238
`
`Reserved
`
`Ex. 1239
`
`Reserved
`
`Ex. 1240 Messlinger et al., “Inhibition of Neurogenic Blood Flow
`Increases in the Rat Cranial Dura Mater by a CGRP-
`Binding Spiegelmer,” Cephalalgia (2005) 25: 923 (F022)
`
`Ex. 1241
`
`Reserved
`
`Ex. 1242
`
`Reserved
`
`Ex. 1243
`
`Reserved
`
`Ex. 1244
`
`Reserved
`
`Ex. 1245
`
`Reserved
`
`Ex. 1246
`
`Reserved
`
`Ex. 1247
`
`Covell et al., “Pharmacokinetics of Monoclonal
`Immunoglobulin G1, F(ab’)2, and Fab’ in Mice,” Cancer
`Res. (1986) 46: 3969-3978
`
`Ex. 1248
`
`Reserved
`
`Ex. 1249
`
`Reserved
`
`Ex. 1250
`
`Reserved
`
`Ex. 1251
`
`Reserved
`
`22
`
`
`
`
`
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`
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`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1252
`
`Reserved
`
`Ex. 1253
`
`Reserved
`
`Ex. 1254
`
`Reserved
`
`Ex. 1255
`
`Reserved
`
`Ex. 1256
`
`Reserved
`
`Ex. 1257
`
`Reserved
`
`Ex. 1258
`
`Reserved
`
`Ex. 1259
`
`Reserved
`
`Ex. 1260
`
`Reserved
`
`Ex. 1261
`
`Clayton et al., U.S. Patent No. 6,861,441
`
`Ex. 1262
`
`Foord et al., U.S. Patent Publication No. US 2002/0137892
`
`Ex. 1263
`
`Ex. 1264
`
`Arulmani et al., “Effects of the Calcitonin Gene-Related
`Peptide (CGRP) Receptor Antagonist BIBN2096BS on α-
`CGRP-Induced Regional Haemodynamic Changes in
`Anaesthetized Rats,” Pharmacology & Toxicology (2004)
`94: 291-297
`
`Bernardis et al., “Human Domain Antibodies Against
`Virulence Traits of Candida Albicans Inhibit Fungus
`Adherence to Vaginal Epithelium and Protect Against
`Experimental Vaginal Candidiasis,” J. Infectious Diseases
`(2007) 195: 149-157
`
`Ex. 1265
`
`Ignatovich et al., “The Creation of Diversity in the Human
`Immunoglobulin Vλ Repertoire,” J. Mol Biol. (1997) 268:
`69-77
`
`23
`
`
`
`
`
`
`
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`
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`
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1266
`
`Ex. 1267
`
`Ex. 1268
`
`Tomlinson, “Next-Generation Protein Drugs,” Nature
`Biotechnology (2004) 22(5): 521-522
`
`Enever et al., “Engineering High Affinity Superantigens by
`Phage Display,” J. Mol Biol. (2005) 347: 107-120
`
`Holt et al., “Domain Antibodies: Proteins for Therapy,”
`TRENDS in Biotechnology (2003) 21(11): 484-490
`
`Ex. 1269 Miyamoto et al., “Heparin-Binding EGF-Like Growth
`Factor Is a Promising Target for Ovarian Cancer Therapy,”
`Cancer Research (2004) 64: 5720-5727
`
`Ex. 1270
`
`Challenged Patents and Claims Table
`
`Ex. 1271
`
`Glaxo Grp. Ltd. v. Genentech Inc., EWHC 1416, Chancery
`Division (Patents Court) (2007)
`
`Ex. 1272
`
`Bigal, U.S. Patent Publication No. 2017/0088612
`
`Ex. 1273
`
`Poulsen et al., U.S. Patent No. 9,328,167
`
`Ex. 1274
`
`Poulsen et al., U.S. Patent No. 8,293,239
`
`Ex. 1275
`
`Corradini et al., U.S. Patent No. 8,298,536
`
`Ex. 1276
`
`Pios et al., U.S. Patent No. 8,623,366
`
`Ex. 1277
`
`Bigal et al., U.S. Patent No. 9,896,502
`
`Ex. 1278
`
`Bigal et al., U.S. Patent Publication No. 2018/0127490
`
`Ex. 1279
`
`Zeller et al., U.S. Patent No. 9,328,168
`
`Ex. 1280
`
`Reserved
`
`
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`
`
`24
`
`

`

`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ferrari and Saxena, “Clinical Effects and Mechanism of
`Action of Sumatriptan in Migraine,” Clinical Neurology &
`Neurosurgery (1992) 94 (Supp.): 573-577
`
`
`
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`
`
`
`
`
`
`
`
`Exhibit
`
`Ex. 1281
`
`Ex. 1282
`
`Physicians’ Desk Reference, Imitrex® (2004)
`
`Ex. 1283
`
`Källner et al., “Calcitonin Gene-Related Peptide in
`Myocardial Ischaemia and Reperfusion in the Pig,”
`Cardiovascular Research (1998) 38: 493-499
`
`Ex. 1284 Wu et al., “Effects of Calcitonin Gene-Related Peptide and
`BIBN4096BS on Myocardial Ischemia in Anesthetized
`Rats,” Acta Pharmacol. Sin. (2001) 22(7): 588-594
`
`Ex. 1285
`
`Ex. 1286
`
`Ex. 1287
`
`Ex. 1288
`
`Shen et al., “Effects of Inhibition of α-CGRP Receptors on
`Cardiac and Peripheral Vascular Dynamics in Conscious
`Dogs with Chronic Heart Failure,” J. Cardiovasc.
`Pharmacol. (2003) 42(5): 656-661
`
`Hargreaves, Chapter 9: Triptans to Calcitonin Gene-
`Related Peptide Modulators – Small molecules to
`Antibodies – the Evolution of a New Migraine Drug Class,
`Neurological Basis of Migraine 157-174 (1st ed. 2017)
`
`Tan, “Application of Monoclonal Antibodies to the
`Investigation of the Role of Calcitonin Gene-Related
`Peptide as a Vasodilatory Neurotransmitter,” Dissertation
`Submitted to the University of Cambridge (1994)
`
`Lu et al., “Mice Lacking α-Calcitonin Gene-Related
`Peptide Exhibit Normal Cardiovascular Regulation and
`Neuromuscular Development,” Molecular & Cellular
`Neuroscience (1999) 14: 99-120
`
`Ex. 1289
`
`Reserved
`
`25
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1290
`
`Ex. 1291
`
`Ex. 1292
`
`Ex. 1293
`
`Ex. 1294
`
`Ex. 1295
`
`Ex. 1296
`
`Ex. 1297
`
`Stam et al., “Migraine: New Treatment Options from
`Molecular Biology,” Expert Rev. Neurotherapeutics (2005)
`5(5): 653-661
`
`Saper et al., “Intranasal Civamide for the Treatment of
`Episodic Cluster Headaches,” Arch Neurol. (2002) 59: 990-
`994
`
`Diamond et al., “Intranasal Civamide for the Acute
`Treatment of Migraine Headaches,” Cephalalgia (2000)
`20: 596-602
`
`Rapoport et al., “Which Triptan for Which Patient?,”
`Neurol. Sci. (2006) 27: S123-S129
`
`Rapoport et al., “Naratriptan in the Preventive Treatment of
`Refractory Chronic Migraine: A Review of 27 Cases,”
`Headache (2003) 43: 482-489
`
`Sheftell et al., “Naratriptan in the Preventive Treatment of
`Refractory Transformed Migraine: A Prospective Pilot
`Study,” Headache (2005) 45: 1400-1406
`
`Ho et al., “Randomized Controlled Trial of an Oral CGRP
`Receptor Antagonist, MK-0974, in Acute Treatment of
`Migraine,” Neurology (2008) 70: 1304-1312
`
`Rapoport and Bigal, “Migraine Preventive Therapy:
`Current and Emerging Treatment Options,” Neurol. Sci.
`(2005) 26: S111-S120
`
`Ex. 1298
`
`Reserved
`
`Ex. 1299
`
`Reserved
`
`Ex. 1300
`
`Deposition Transcript of Steven M. Foord, Ph.D.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`26
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1301
`
`Deposition Transcript of Ian M. Tomlinson, M.A., Ph.D.
`
`Ex. 1302
`
`Deposition Transcript of Robert D. Stoner, Ph.D.
`
`Ex. 1303
`
`Deposition Transcript of Michel D. Ferrari, M.D., Ph.D.
`
`Ex. 1304
`
`Deposition Transcript of Alan M. Rapoport, M.D.
`
`Ex. 1305
`
`Reserved
`
`Ex. 1306
`
`Reserved
`
`Ex. 1307
`
`Reserved
`
`Ex. 1308
`
`Ex. 1309
`
`Ferrari et al., “Oral Triptans (Serotonin 5-HT18/10 Agonists)
`in Acute Migraine Treatment: A Meta-Analysis of 53
`Trials,” (2001) Lancet 358: 1668-1675
`
`Pendergrast et al., “Nucleic Acid Aptamers for Target
`Validation and Therapeutic Applications,” J. Biomolecular
`Techniques (2005) 16: 224-234
`
`Ex. 1310
`
`Reserved
`
`Ex. 1311
`
`Evers and Mylecharane, The Headaches 553-566 (3rd ed.
`2006)
`
`Ex. 1312
`
`Reserved
`
`Ex. 1313
`
`Ho et al., “Efficacy and Tolerability of MK-0974
`(Telcagepant), A New Oral Antagonist of Calcitonin Gene-
`Related Peptide Receptor, Compared with Zolmitriptan for
`Acute Migraine: A Randomised, Placebo-Controlled,
`Parallel-Treatment Trial,” Lancet (2008) 372: 2115-2123
`
`Ex. 1314
`
`Silberstein et al., “The International Classification of
`Headache Disorders, 2nd Edition (ICHD-II)—Revision of
`
`27
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Exhibit
`
`Description
`
`IPR2018-01425
`Patent No. 9,890,210
`
`Served
`Not
`Filed
`
`Ex. 1315
`
`Ex. 1316
`
`Ex. 1317
`
`Ex. 1318
`
`Criteria for 8.2 Medication-Overuse Headache,”
`Cephalalgia (2005) 25: 460-465
`
`Petitti et al., “Incidence of Stroke and Myocardial
`Infarction in Women of Reproductive Age,” Stroke (1997)
`28: 280-283
`
`Tfelt-Hansen

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