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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
`______________________
`
`IPR2018-01423
`Patent No. 9,266,951
`______________________
`
`PETITIONER’S EXHIBIT LIST AS OF AUGUST 8, 2018
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Exhibit
`Exhibit 1001 U.S. Patent No. 9,266,951
`
`Description
`
`Exhibit 1002 Reserved
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`Exhibit 1003 Reserved
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`Exhibit 1004 Declaration of Andrew Charles, M.D. (U.S. Patent No. 9,266,951)
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`Exhibit 1005 Declaration of Alain P. Vasserot (U.S. Patent No. 9,266,951)
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`Exhibit 1006 Reserved
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`Exhibit 1007 Reserved
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`Exhibit 1008 Reserved
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`Exhibit 1009 Reserved
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`Exhibit 1010 Reserved
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`Exhibit 1011 Reserved
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`Exhibit 1012 Reserved
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`Exhibit 1013 Reserved
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`Exhibit 1014 Reserved
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`Exhibit 1015 Reserved
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`Exhibit 1016 Reserved
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`Exhibit 1017 Reserved
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`Exhibit 1018 Reserved
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`Exhibit 1019 Teva’s U.S. Provisional Application No. 60/736,623
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`Exhibit 1020 Teva’s PCT Application No. WO 2007/054809
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
`Exhibit
`Exhibit 1021 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
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`Exhibit 1022 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
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`Exhibit 1023 Queen et al., U.S. Patent No. 6,180,370
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`Exhibit 1024 Doods et al., “Pharmacological Profile of BIBN4096BS, the First
`Selective Small Molecule CGRP Antagonist,” Br. J. Pharmacol.
`(2000) 129: 420-423
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`Exhibit 1025 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
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`Exhibit 1026 Sveinsson, International Publication No. WO 2004/014351
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`Exhibit 1027 Salmon et al., U.S. Patent Application Publication No. US
`2002/0162125
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`Exhibit 1028 De Lacharriere et al., U.S. Patent No. 6,344,438
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`Exhibit 1029 Olesen et al., “S26 CGRP Antagonism as a New Therapeutic
`Principle in Acute Migraine,” Neuropeptides (2004) 38: 110-131
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`Exhibit 1030 Arndt et al., “CGRP Antagonism — A Valid New Concept for the
`Treatment of Migraine Pain,” Neuropeptides (2004) 38: 110-131
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`Exhibit 1031 Arulmani et al., “Calcitonin Gene-related Peptide and Its Role in
`Migraine Pathophysiology,” Eur. J. Pharmacol. (2004) 143: 315-
`330
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`Exhibit
`Exhibit 1032 Frobert et al., “A Sensitive Sandwich Enzyme Immunoassay for
`Calcitonin Gene-Related Peptide (CGRP): Characterization and
`Application,” Peptides (1999) 20: 275-284
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`Exhibit 1033 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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`Exhibit 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
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`Exhibit 1035 Edvinsson and Hargreaves, The Headaches 289-299 (3rd ed. 2006)
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`Exhibit 1036 Peterson et al., “Presence and Function of the Calcitonin Gene-
`Related Peptide Receptor on Rat Pial Arteries Investigated in vitro
`and in vivo,” Cephalalgia (2005) 24: 424-432
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`Exhibit 1037 Reserved
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`Exhibit 1038 Mason et al., “Release of the Predicted Calcitonin Gene-Related
`Peptide from Cultured Rat Trigeminal Ganglion Cells,” Nature
`(1984) 308: 653-655
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`Exhibit 1039 Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
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`Exhibit 1040 Arulmozhi et al., “Migraine: Current Concepts and Emerging
`Therapies,” Vascular Pharmacol. (2005) 43: 176-187
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`Exhibit 1041 Durham, “CGRP-Receptor Antagonists - A Fresh Approach to
`Migraine Therapy?” N. Engl. Med. (2004) 250(11): 1073-1075
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`Exhibit
`Exhibit 1042
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
`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
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`Exhibit 1043 Goadsby et al., “Vasoactive Peptide Release in the Extracerebral
`Circulation of Humans During Migraine Headache,” Annals of
`Neurology (1990) 28(2): 183-187
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`Exhibit 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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`Exhibit 1045 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
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`Exhibit 1046 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
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`Exhibit 1047 Lassen et al., “CGRP May Play a Causative Role in Migraine,”
`Cephalagia (2002) 22: 54-61
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`Exhibit 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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`Exhibit 1049 Dockray et al., “Immunoneutralization Studies with Calcitonin
`Gene-Related Peptide,” Annals of New York Academy of Sciences
`(1992) 258-267
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
`Exhibit
`Exhibit 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
`
`Exhibit 1051 Sigma-Aldrich, Biochemicals & Reagents for Life Science
`Research 350-352 (2004)
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`Exhibit 1052 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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`Exhibit 1053 Reserved
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`Exhibit 1054 Reserved
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`Exhibit 1055 Andrew et al., “Monoclonal Antibodies Distinguishing α and β
`Forms of Calcitonin Gene-Related Peptide,” J. Immunol. Methods
`(1990) 154: 87-94
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`Exhibit 1056 Reichert, “Monoclonal Antibody Successes in the Clinic,” Nat
`Biotechnol (2005) 23: 1073-1078
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`Exhibit 1057 Projan et al., “Small Molecules for Small Minds? The Case for
`Biologic Pharmaceuticals,” Expert Opin Biol Ther (2004) 4: 1345-
`1350
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`Exhibit 1058 Janeway et al., Immunobiology 93-122 (5th ed. 2001)
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`Exhibit 1059 Janeway et al., Immunobiology 123-154 (5th ed. 2001)
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`Exhibit 1060 Janeway et al., Immunobiology 341-380 (5th ed. 2001)
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`Exhibit 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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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
`Exhibit
`Exhibit 1062 Kipriyanov and Le Gall, “Generation and Production of Engineered
`Antibodies,” Mol. Biotechnol. (2004) 26: 39-60
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`Exhibit 1063 Elgert, Immunology: Understanding the Immune System 58-78 (1st
`ed. 1996)
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`Exhibit 1064 Wright and Morrison, “Effect of Glycosylation on Antibody
`Function: Implications for Genetic Engineering,” Trends
`Biotechnol. (1997) 15: 26-32
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`Exhibit 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
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`Exhibit 1066 Presta, “Selection, Design, and Engineering of Therapeutic
`Antibodies,” J. Allergy. Clin. Immunol. (2005) 116: 731-736
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`Exhibit 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
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`Exhibit 1068 Maynard and Georgiou, “Antibody Engineering,” Annu. Rev.
`Biomed. Eng. (2000) 2: 339-376
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`Exhibit 1069 Chester and Hawkins, “Clinical Issues in Antibody Design,”
`Trends Biotechnol. (1995) 13: 294-300
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`Exhibit 1070 Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
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`Exhibit 1071 Gavilondo and Larrick, “Antibody Engineering at the Millennium,”
`BioTechniques (2000) 29: 128-145
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`Exhibit 1072 Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
`Exhibit
`Exhibit 1073 Carter, “Improving the Efficacy of Antibody-Based Cancer
`Therapies,” Nature Revs. Cancer (2001) 1: 118-129
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`Exhibit 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
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`Exhibit 1075 Queen et al., “A Humanized Antibody that Binds to the Interleukin
`2 Receptor,” Proc. Natl. Acad. Sci. USA (1989) 86: 10029-10033
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`Exhibit 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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`Exhibit 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
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`Exhibit 1078 Reserved
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`Exhibit 1079 Huse et al., International Publication No. WO 2001/27160
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`Exhibit 1080 Reserved
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`Exhibit 1081 Mallee et al., “Receptor Activity-Modifying Protein 1 Determines
`the Species Selectivity of Non-peptide CGRP Receptor
`Antagonists,” J. Biol. Chem. (2002) 277: 14294-14298
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`Exhibit 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
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`Exhibit 1083 Reserved
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`Exhibit 1084 Reserved
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`Exhibit 1085 Reserved
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
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`Exhibit
`Exhibit 1086 Reserved
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`Exhibit 1087 Reserved
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`Exhibit 1088 Reserved
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`Exhibit 1089 Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
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`Exhibit 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
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`Exhibit 1091 Purves et al., Neuroscience 763-773 (3rd ed. 2004)
`
`Exhibit 1092 Reserved
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`Exhibit 1093 Reserved
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`Exhibit 1094 Reserved
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`Exhibit 1095 Conner et al., “Interaction of Calcitonin-Gene-Related Peptide with
`Its Receptors,” Biochemistry Society Transactions (2002) 30(4):
`451-455
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`Exhibit 1096 Wimalawansa, “Calcitonin Gene-Related Peptide and Its
`Receptors: Molecular Genetics, Physiology, Pathophysiology, and
`Therapeutic Potentials,” Endocrine Revs. (1996) 17(5): 533-585
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`Exhibit 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
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`Exhibit 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
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
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`Exhibit
`Exhibit 1099 Reserved
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`Exhibit 1100 Reserved
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`Exhibit 1101 Jones et al., “Replacing the Complementarity-Determining Regions
`in a Human Antibody with Those from a Mouse,” Nature (1986)
`321: 522-525
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`Exhibit 1102 Reserved
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`Exhibit 1103 Reserved
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`Exhibit 1104 Reserved
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`Exhibit 1105 Reserved
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`Exhibit 1106 Reserved
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`Exhibit 1107 Reserved
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`Exhibit 1108 Reserved
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`Exhibit 1109 Reserved
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`Exhibit 1110 Reserved
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`Exhibit 1111 Reserved
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`Exhibit 1112 Reserved
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`Exhibit 1113 Reserved
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`Exhibit 1114 Reserved
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`Exhibit 1115 Reserved
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`Exhibit 1116 Reserved
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`Exhibit 1117 Reserved
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
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`Exhibit
`Exhibit 1118 Reserved
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`Exhibit 1119 Reserved
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`Exhibit 1120 Reserved
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`Exhibit 1121 Reserved
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`Exhibit 1122 Reserved
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`Exhibit 1123 Reserved
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`Exhibit 1124 Reserved
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`Exhibit 1125 Reserved
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`Exhibit 1126 Reserved
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`Exhibit 1127 Lilly’s U.S. Provisional Application No. 60/753,004
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`Exhibit 1128 U.S. Provisional Application No. 60/711,950
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`Exhibit 1129 Reserved
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`Exhibit 1130 Janeway et al., Immunobiology 626-627 (5th ed. 2001)
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`Exhibit 1131 Reserved
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`Exhibit 1132 Reserved
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`Exhibit 1133 Reserved
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`Exhibit 1134 Reserved
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`Exhibit 1135 Reserved
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`Exhibit 1136 September 5, 2013 Teva’s Response to Office Action (U.S. Patent
`No. 8,597,649 prosecution history)
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`Exhibit 1137 Reserved
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Description
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`Exhibit
`Exhibit 1138 Reserved
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`Exhibit 1139 Reserved
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`Exhibit 1140 Reserved
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`Exhibit 1141 Reserved
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`Exhibit 1142 Reserved
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`Exhibit 1143 June 28, 2013 Amendment (U.S. Patent No. 8,586,045 prosecution
`history)
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`Exhibit 1144 Reserved
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`Exhibit 1145 Reserved
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`Exhibit 1146 August 31, 2015 Application Data Sheet (U.S. Patent No.
`9,266,951 prosecution history)
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`Exhibit 1147 March 24, 2017 Corrected Application Data Sheet (U.S. Patent No.
`9,266,951 prosecution history)
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`Exhibit 1148 November 5, 2015 Office Action (U.S. Patent No. 9,266,951
`prosecution history)
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`Exhibit 1149 November 17, 2005 Teva’s Response to Office Action (U.S. Patent
`No. 9,266,951 prosecution history)
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`Exhibit 1150 November 17, 2005 Terminal Disclaimers (U.S. Patent No.
`9,266,951 prosecution history)
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`Exhibit 1151 September 4, 2015 Information Disclosure Statement (U.S. Patent
`No. 9,266,951 prosecution history)
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`Exhibit 1152 October 8, 2015 Information Disclosure Statement (U.S. Patent No.
`9,266,951 prosecution history)
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`Exhibit 1153 November 17, 2015 Information Disclosure Statement (U.S. Patent
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`Exhibit
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`Description
`No. 9,266,951 prosecution history)
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`Exhibit 1154 November 30, 2015 Information Disclosure Statement (U.S. Patent
`No. 9,266,951 prosecution history)
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`Exhibit 1155 Reserved
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`Date: August 8, 2018
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`Respectfully submitted,
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`
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`By: /William B. Raich/
`William B. Raich (Reg. No. 54,386)
`Erin M. Sommers (Reg. No. 60,974)
`Pier D. DeRoo (Reg. No. 69,340)
`Yieyie Yang (Reg. No. 71,923)
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`Telephone: 202-408-4000
`Facsimile: 202-408-4400
`
`Sanjay M. Jivraj (Reg. No. 61,806)
`Mark J. Stewart (Reg. No. 43,936)
`Eli Lilly and Company Lilly Corporate
`Center
`Indianapolis, IN 46285
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`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned certifies
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`that on August 8, 2018, a copy of the foregoing Petitioner’s Exhibit List as of
`
`August 8, 2018 and Exhibits 1001, 1004-1005, 1019-1036, 1038-1052, 1055-
`
`1077, 1079, 1081-1082, 1089-1091, 1095-1098, 1101, 1127-1128, 1130, 1136,
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`1143, 1146-1154 were served by Priority Mail Express on the correspondence
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`address of record indicated in the Patent Office’s public PAIR system for U.S.
`
`Patent No. 9,266,951:
`
`FISH & RICHARDSON P.C. (BO)
`P.O. Box 1022
`Minneapolis, MN 55440-1022
`
`A courtesy copy of the foregoing was also served by FedEx on the attorney
`
`
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`for assignee Teva Pharmaceuticals International GmbH indicated in Patent Office’s
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`public PAIR system for U.S. Patent No. 9,266,951:
`
`Todd E. Garcia, Ph.D.
`FISH & RICHARDSON P.C.
`One Marina Park Drive
`Boston, MA 02210-1878
`
`
`Date: August 8, 2018
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`By: /William Esper/
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`