`
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Exhibit
`Exhibit 1001 U.S. Patent No. 9,266,951
`
`Description
`
`Exhibit 1002 Reserved
`
`Exhibit 1003 Reserved
`
`Exhibit 1004 Declaration of Andrew Charles, M.D. (U.S. Patent No. 9,266,951)
`
`Exhibit 1005 Declaration of Alain P. Vasserot (U.S. Patent No. 9,266,951)
`
`Exhibit 1006 Reserved
`
`Exhibit 1007 Reserved
`
`Exhibit 1008 Reserved
`
`Exhibit 1009 Reserved
`
`Exhibit 1010 Reserved
`
`Exhibit 1011 Reserved
`
`Exhibit 1012 Reserved
`
`Exhibit 1013 Reserved
`
`Exhibit 1014 Reserved
`
`Exhibit 1015 Reserved
`
`Exhibit 1016 Reserved
`
`Exhibit 1017 Reserved
`
`Exhibit 1018 Reserved
`
`Exhibit 1019 Teva’s U.S. Provisional Application No. 60/736,623
`
`Exhibit 1020 Teva’s PCT Application No. WO 2007/054809
`
`1
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`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
`
`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
`
`Exhibit 1023 Queen et al., U.S. Patent No. 6,180,370
`
`Exhibit 1024 Doods et al., “Pharmacological Profile of BIBN4096BS, the First
`Selective Small Molecule CGRP Antagonist,” Br. J. Pharmacol.
`(2000) 129: 420-423
`
`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
`
`Exhibit 1026 Sveinsson, International Publication No. WO 2004/014351
`
`Exhibit 1027 Salmon et al., U.S. Patent Application Publication No. US
`2002/0162125
`
`Exhibit 1028 De Lacharriere et al., U.S. Patent No. 6,344,438
`
`Exhibit 1029 Olesen et al., “S26 CGRP Antagonism as a New Therapeutic
`Principle in Acute Migraine,” Neuropeptides (2004) 38: 110-131
`
`Exhibit 1030 Arndt et al., “CGRP Antagonism — A Valid New Concept for the
`Treatment of Migraine Pain,” Neuropeptides (2004) 38: 110-131
`
`Exhibit 1031 Arulmani et al., “Calcitonin Gene-related Peptide and Its Role in
`Migraine Pathophysiology,” Eur. J. Pharmacol. (2004) 143: 315-
`330
`
`2
`
`
`
`
`
`
`
`
`
`
`
`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
`
`Exhibit 1033 Wong et al., “Monoclonal Antibody to Rat α-CGRP: Production,
`Characterization, and in vivo Immunoneutralization Activity,”
`Hybridoma (1993) 12: 93-106
`
`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
`
`Exhibit 1035 Edvinsson and Hargreaves, The Headaches 289-299 (3rd ed. 2006)
`
`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
`
`Exhibit 1037 Reserved
`
`Exhibit 1038 Mason et al., “Release of the Predicted Calcitonin Gene-Related
`Peptide from Cultured Rat Trigeminal Ganglion Cells,” Nature
`(1984) 308: 653-655
`
`Exhibit 1039 Brain et al., “Calcitonin Gene-Related Peptide is a Potent
`Vasodilator,” Nature (1985) 313: 54-56
`
`Exhibit 1040 Arulmozhi et al., “Migraine: Current Concepts and Emerging
`Therapies,” Vascular Pharmacol. (2005) 43: 176-187
`
`Exhibit 1041 Durham, “CGRP-Receptor Antagonists - A Fresh Approach to
`Migraine Therapy?” N. Engl. Med. (2004) 250(11): 1073-1075
`
`3
`
`
`
`
`
`
`Exhibit
`Exhibit 1042
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`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
`
`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
`
`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
`
`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
`
`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
`
`Exhibit 1047 Lassen et al., “CGRP May Play a Causative Role in Migraine,”
`Cephalagia (2002) 22: 54-61
`
`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
`
`Exhibit 1049 Dockray et al., “Immunoneutralization Studies with Calcitonin
`Gene-Related Peptide,” Annals of New York Academy of Sciences
`(1992) 258-267
`
`4
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`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)
`
`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
`
`Exhibit 1053 Reserved
`
`Exhibit 1054 Reserved
`
`Exhibit 1055 Andrew et al., “Monoclonal Antibodies Distinguishing α and β
`Forms of Calcitonin Gene-Related Peptide,” J. Immunol. Methods
`(1990) 154: 87-94
`
`Exhibit 1056 Reichert, “Monoclonal Antibody Successes in the Clinic,” Nat
`Biotechnol (2005) 23: 1073-1078
`
`Exhibit 1057 Projan et al., “Small Molecules for Small Minds? The Case for
`Biologic Pharmaceuticals,” Expert Opin Biol Ther (2004) 4: 1345-
`1350
`
`Exhibit 1058 Janeway et al., Immunobiology 93-122 (5th ed. 2001)
`
`Exhibit 1059 Janeway et al., Immunobiology 123-154 (5th ed. 2001)
`
`Exhibit 1060 Janeway et al., Immunobiology 341-380 (5th ed. 2001)
`
`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
`
`5
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`Exhibit
`Exhibit 1062 Kipriyanov and Le Gall, “Generation and Production of Engineered
`Antibodies,” Mol. Biotechnol. (2004) 26: 39-60
`
`Exhibit 1063 Elgert, Immunology: Understanding the Immune System 58-78 (1st
`ed. 1996)
`
`Exhibit 1064 Wright and Morrison, “Effect of Glycosylation on Antibody
`Function: Implications for Genetic Engineering,” Trends
`Biotechnol. (1997) 15: 26-32
`
`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
`
`Exhibit 1066 Presta, “Selection, Design, and Engineering of Therapeutic
`Antibodies,” J. Allergy. Clin. Immunol. (2005) 116: 731-736
`
`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
`
`Exhibit 1068 Maynard and Georgiou, “Antibody Engineering,” Annu. Rev.
`Biomed. Eng. (2000) 2: 339-376
`
`Exhibit 1069 Chester and Hawkins, “Clinical Issues in Antibody Design,”
`Trends Biotechnol. (1995) 13: 294-300
`
`Exhibit 1070 Kim et al., “Antibody Engineering for the Development of
`Therapeutic Antibodies,” Mol. Cells (2005) 20: 17-29
`
`Exhibit 1071 Gavilondo and Larrick, “Antibody Engineering at the Millennium,”
`BioTechniques (2000) 29: 128-145
`
`Exhibit 1072 Khazaeli et al., “Human Immune Response to Monoclonal
`Antibodies,” J. Immunother. (1994) 15: 42-52
`
`6
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`Exhibit
`Exhibit 1073 Carter, “Improving the Efficacy of Antibody-Based Cancer
`Therapies,” Nature Revs. Cancer (2001) 1: 118-129
`
`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
`
`Exhibit 1075 Queen et al., “A Humanized Antibody that Binds to the Interleukin
`2 Receptor,” Proc. Natl. Acad. Sci. USA (1989) 86: 10029-10033
`
`Exhibit 1076 Friend et al., “Phase I Study of an Engineered Aglycosylated
`Humanized CD3 Antibody in Renal Transplant Rejection,”
`Transplantation (1999) 68: 1632-1637
`
`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
`
`Exhibit 1078 Reserved
`
`Exhibit 1079 Huse et al., International Publication No. WO 2001/27160
`
`Exhibit 1080 Reserved
`
`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
`
`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
`
`Exhibit 1083 Reserved
`
`Exhibit 1084 Reserved
`
`Exhibit 1085 Reserved
`
`7
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`
`
`
`
`Exhibit
`Exhibit 1086 Reserved
`
`Exhibit 1087 Reserved
`
`Exhibit 1088 Reserved
`
`Exhibit 1089 Goadsby et al., “Migraine — Current Understanding and
`Treatment,” N. Engl. J. Med. (2002) 346: 257-270
`
`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
`
`Exhibit 1091 Purves et al., Neuroscience 763-773 (3rd ed. 2004)
`
`Exhibit 1092 Reserved
`
`Exhibit 1093 Reserved
`
`Exhibit 1094 Reserved
`
`Exhibit 1095 Conner et al., “Interaction of Calcitonin-Gene-Related Peptide with
`Its Receptors,” Biochemistry Society Transactions (2002) 30(4):
`451-455
`
`Exhibit 1096 Wimalawansa, “Calcitonin Gene-Related Peptide and Its
`Receptors: Molecular Genetics, Physiology, Pathophysiology, and
`Therapeutic Potentials,” Endocrine Revs. (1996) 17(5): 533-585
`
`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
`
`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
`
`8
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`
`
`
`
`Exhibit
`Exhibit 1099 Reserved
`
`Exhibit 1100 Reserved
`
`Exhibit 1101 Jones et al., “Replacing the Complementarity-Determining Regions
`in a Human Antibody with Those from a Mouse,” Nature (1986)
`321: 522-525
`
`Exhibit 1102 Reserved
`
`Exhibit 1103 Reserved
`
`Exhibit 1104 Reserved
`
`Exhibit 1105 Reserved
`
`Exhibit 1106 Reserved
`
`Exhibit 1107 Reserved
`
`Exhibit 1108 Reserved
`
`Exhibit 1109 Reserved
`
`Exhibit 1110 Reserved
`
`Exhibit 1111 Reserved
`
`Exhibit 1112 Reserved
`
`Exhibit 1113 Reserved
`
`Exhibit 1114 Reserved
`
`Exhibit 1115 Reserved
`
`Exhibit 1116 Reserved
`
`Exhibit 1117 Reserved
`
`9
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`
`
`
`
`Exhibit
`Exhibit 1118 Reserved
`
`Exhibit 1119 Reserved
`
`Exhibit 1120 Reserved
`
`Exhibit 1121 Reserved
`
`Exhibit 1122 Reserved
`
`Exhibit 1123 Reserved
`
`Exhibit 1124 Reserved
`
`Exhibit 1125 Reserved
`
`Exhibit 1126 Reserved
`
`Exhibit 1127 Lilly’s U.S. Provisional Application No. 60/753,004
`
`Exhibit 1128 U.S. Provisional Application No. 60/711,950
`
`Exhibit 1129 Reserved
`
`Exhibit 1130 Janeway et al., Immunobiology 626-627 (5th ed. 2001)
`
`Exhibit 1131 Reserved
`
`Exhibit 1132 Reserved
`
`Exhibit 1133 Reserved
`
`Exhibit 1134 Reserved
`
`Exhibit 1135 Reserved
`
`Exhibit 1136 September 5, 2013 Teva’s Response to Office Action (U.S. Patent
`No. 8,597,649 prosecution history)
`
`Exhibit 1137 Reserved
`
`10
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Description
`
`
`
`
`Exhibit
`Exhibit 1138 Reserved
`
`Exhibit 1139 Reserved
`
`Exhibit 1140 Reserved
`
`Exhibit 1141 Reserved
`
`Exhibit 1142 Reserved
`
`Exhibit 1143 June 28, 2013 Amendment (U.S. Patent No. 8,586,045 prosecution
`history)
`
`Exhibit 1144 Reserved
`
`Exhibit 1145 Reserved
`
`Exhibit 1146 August 31, 2015 Application Data Sheet (U.S. Patent No.
`9,266,951 prosecution history)
`
`Exhibit 1147 March 24, 2017 Corrected Application Data Sheet (U.S. Patent No.
`9,266,951 prosecution history)
`
`Exhibit 1148 November 5, 2015 Office Action (U.S. Patent No. 9,266,951
`prosecution history)
`
`Exhibit 1149 November 17, 2005 Teva’s Response to Office Action (U.S. Patent
`No. 9,266,951 prosecution history)
`
`Exhibit 1150 November 17, 2005 Terminal Disclaimers (U.S. Patent No.
`9,266,951 prosecution history)
`
`Exhibit 1151 September 4, 2015 Information Disclosure Statement (U.S. Patent
`No. 9,266,951 prosecution history)
`
`Exhibit 1152 October 8, 2015 Information Disclosure Statement (U.S. Patent No.
`9,266,951 prosecution history)
`
`Exhibit 1153 November 17, 2015 Information Disclosure Statement (U.S. Patent
`
`11
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`Exhibit
`
`Description
`No. 9,266,951 prosecution history)
`
`Exhibit 1154 November 30, 2015 Information Disclosure Statement (U.S. Patent
`No. 9,266,951 prosecution history)
`
`Exhibit 1155 Reserved
`
`
`
`
`
`
`
`
`Date: August 8, 2018
`
`
`
`Respectfully submitted,
`
`
`
`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
`
`12
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Exhibit List
`U.S. Patent No. 9,266,951
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned certifies
`
`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,
`
`1143, 1146-1154 were served by Priority Mail Express on the correspondence
`
`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
`
`
`
`for assignee Teva Pharmaceuticals International GmbH indicated in Patent Office’s
`
`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
`
`
`
`
`
`
`
`
`
`By: /William Esper/
`William Esper
`Litigation Legal Assistant
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
