`
`
`
`
`IN THE 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.
`
`_____________________
`
`Case IPR2018-01423
`U.S. Patent No. 9,266,951
`_____________________
`
`TEVA PHARMACEUTICALS INTERNATIONAL GMBH’S
`EXHIBIT LIST
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`

`

`Case IPR2018-01423
`Patent No. 9,266,951
`
` Exhibit #
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`Description
`Edvinsson, L., “Calcitonin Gene-Related Peptide (CGRP) in
`Cerebrovascular Disease,” TheScientificWorldJOURNAL, 2: 1484–90
`(2002)
`Hasbak, P., et al., “Investigation of CGRP Receptors and Peptide
`Pharmacology in Human Coronary Arteries. Characterization with a
`Nonpeptide Antagonist,” The Journal Of Pharmacology And
`Experimental Therapeutics, 304:326–33 (2003)
`Brain, S. and Grant, A., “Vascular Actions of Calcitonin Gene-Related
`Peptide and Adrenomedullin,” Physiol Rev., 84: 903-34 (2004)
`Chiba, T., et al., “Calcitonin gene-related peptide receptor antagonist
`human CGRP-(8-37),” Am. J. Physiol.: Endocrin. & Metab.
`256:E331-35 (1989)
`File History for U.S. Patent No. 8,597,649 B2
`Gegg, Jr., C., et al., “CGRP Peptide Antagonists And
`Conjugates,” U.S. Patent No. 8,168,592 B2 (filed October 19, 2006;
`issued May 1, 2012)
`Escott, K. and Brain, S., “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. 110: 772-76
`(1993)
`Rist, B., et al., “CGRP 27-37 analogues with high affinity to the CGRP1
`receptor show antagonistic properties in a rat blood flow assay,” Regul.
`Pept. 79:153-58 (1999)
`Edvinsson, L., "Blockade of CGRP Receptors in the Intracranial
`Vasculature: A New Target in the Treatment of Headache,"
`Cephalalgia, 24:611-22 (2004)
`Goadsby, P., “Calcitonin Gene-Related Peptide Antagonists as
`Treatments of Migraine and Other Primary Headaches,” Drugs, 65:
`2557-67 (2005)
`Supowit, S., et al., “Calcitonin Gene-Related Peptide Protects Against
`Hypertension-Induced Heart and Kidney Damage,” Hypertension,
`45:109-14 (2005)
`Aiyar, N., et al., “Pharmacology of SB-273779, a Nonpeptide
`Calcitonin Gene-Related Peptide 1 Receptor Antagonist,” The Journal
`Of Pharmacology And Experimental Therapeutics, 296:768–75 (2001)
`
`- 2 -
`
`

`

`Case IPR2018-01423
`Patent No. 9,266,951
`
` Exhibit #
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`Description
`Rudolf, K., et al., “Modified Aminoacids, Pharmaceuticals Containing
`These Compounds and Method For Their Production,” U.S. Patent
`Application Publication No. 2003/0069231 A1 (filed April 10, 2002;
`published April 10, 2003)
`Patchett, A., et al., “Benzimidazolinyl Piperidines As CGRP Ligands,”
`U.S. Patent No. 6,552,043 B1 (filed September 22, 1999; issued April
`22, 2003)
`Zimmer, O., et al., “Substituted Cyclopentene Compounds,” U.S.
`Patent No. 7,109,214 B2 (filed November 19, 2004; issued September
`19, 2006)
`Chaturvedula, P., et al., “Constrained Compounds As CGRP-Receptor
`Antagonists,” U.S. Patent No. 7,384,930 B2 (filed October 11, 2005;
`issued June 10, 2008)
`Rudolf, K., et al., “Modified Aminoacids, Pharmaceuticals Containing
`These Compounds And Method For Their Production,” U.S. Patent No.
`6,344,449 B1 (filed September 8, 1997; issued February 5, 2002)
`Paone, D., et al., “CGRP Receptor Antagonists,” U.S. Patent No.
`7,772,224 B2 (filed April 3, 2009; issued August 10, 2010)
`Petersen, K., et al., “The CGRP-antagonist, BIBN4096BS does not
`affect cerebral or systemic haemodynamics in healthy volunteers,”
`Cephalalgia, 25, 139–47 (2004)
`Leahy, D., et al., “Process For The Preparation Of Cycloheptapyridine
`CGRP Receptor Antagonists,” U.S. Patent No. 8,669,368 B2 (filed
`September 19, 2011; issued March 11, 2014)
`Clinical Trials for BIBN4096BS, downloaded from
`https://clinicaltrials.gov/ct2/results?cond=&term=bibn4096bs&cntry=
`&state=&city=&dist (last accessed November 5, 2018)
`Clinical Trials for MK-0974, downloaded from
`https://clinicaltrials.gov/ct2/results?cond=&term=mk-0974&cntry=&st
`ate=&city=&dist (last accessed on November 15, 2018)
`Clinical Trials for BMS-927711, downloaded from
`https://clinicaltrials.gov/ct2/results?cond=&term=BMS-927711&cntry
`=&state=&city=&dist (last accessed on November 5, 2018)
`Zeller, J., et al., “Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide And Methods Using Same,” U.S. Patent No.
`8,007,794 B2 (filed November 2, 2006; issued August 30, 2011)
`
`- 3 -
`
`

`

`Case IPR2018-01423
`Patent No. 9,266,951
`
` Exhibit #
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
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`2031
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`2032
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`2033
`2034
`2035
`2036
`2037
`2038
`2039
`2040
`2041
`2042
`2043
`2044
`
`Description
`Zeller, J., et al., “Methods of Using Anti-CGRP Antagonist
`Antibodies,” U.S. Patent No. 8,586,045 B2 (filed July 11, 2011; issued
`November 19, 2013)
`Zeller, J., et al., "Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide and Methods Using Same," U.S. Patent No.
`9,340,614 B2 (filed August 31, 2015; issued May 17, 2016)
`Zeller, J., et al., "Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide and Methods Using Same," U.S. Patent No.
`8,597,649 B2 (filed April 25, 2013; issued December 3, 2013)
`Zeller, J., et al., "Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide and Methods Using Same," U.S. Patent No.
`9,346,881 B2 (filed August 31, 2015; issued May 24, 2016)
`Zeller, J., et al., "Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide," U.S. Patent No. 9,890,210 B2 (filed May 5,
`2017; issued February 13, 2018)
`Zeller, J., et al., "Antagonist Antibodies Directed Against Calcitonin
`Gene-Related Peptide," U.S. Patent No. 9,890,211 B2 (filed May 5,
`2017; issued February 13, 2018)
`Zeller, J., et al., "Methods for Treating Headache Using Antagonist
`Antibodies Directed Against Calcitonin Gene-Related Peptide," U.S.
`Patent No. 9,884,907 B2 (filed May 5, 2017; issued February 6, 2018)
`Zeller, J., et al., "Methods for Treating Headache Using Antagonist
`Antibodies Directed Against Calcitonin Gene-Related Peptide," U.S.
`Patent No. 9,884,908 B2 (filed May 5, 2017; issued February 6, 2018)
`File History for U.S. Patent No. 8,007,794 B2
`File History for U.S. Patent No. 8,586,045 B2
`File History for U.S. Patent No. 8,734,802 B1
`File History for U.S. Patent No. 9,115,194 B2
`File History for U.S. Patent No. 9,328,168 B2
`File History for U.S. Patent No. 9,346,881 B2
`File History for U.S. Patent No. 9,266,951 B2
`File History for U.S. Patent No. 9,340,614 B2
`File History for U.S. Patent No. 9,365,648 B1
`File History for U.S. Patent No. 9,890,211 B2
`File History for U.S. Patent No. 9,890,210 B2
`File History for U.S. Patent No. 9,884,907 B2
`
`- 4 -
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`

`

`Case IPR2018-01423
`Patent No. 9,266,951
`
` Exhibit #
`2045
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`
`
`Description
`File History for U.S. Patent No. 9,884,908 B2
`Clinical Trials for BHV-3000, downloaded from
`https://clinicaltrials.gov/ct2/results?cond=&term=bhv-3000&cntry=&s
`tate=&city=&dist (last accessed on November 5, 2018)
`Alberts, B., et al., Molecular Biology of the Cell, p. G-34, 4th ed.,
`Garland Science, Taylor & Francis Group, New York (2002)
`John H. Byrne, Essential Medical Physiology, Chapter 6:
`Neuromuscular and Synaptic Transmission, pp. 97-122, (Leonard R.
`Johnson, ed.), 3rd Ed., Elsevier Academic Press, Amsterdam (2003)
`Pisegna, J., et al., “Cloning And Characterization Of
`Calcitonin Gene Related Peptide Receptors,” U.S. Patent Application
`Publication No. 2004/0110170 A1 (filed May 16, 2003; published June
`10, 2004)
`Petition for Inter Partes Review of U.S. Patent No. 8,597,649, filed
`August 8, 2018 (IPR2018-01427)
`Knight, D., et al., “Pharmacodynamic enhancement of the anti-platelet
`antibody Fab abciximab by site-specific pegylation,” Platelets 15:
`409–418 (2004)
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
` Deborah Sterling, Ph.D.
`Date: November 21, 2018
` Lead Attorney for Patent Owner
`
`
`
`
`
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
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`

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`
`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`I certify that the above-captioned “Teva Pharmaceuticals International
`
`GmbH’s Exhibit List” and Exhibits 2001 – 2051, were served in their entirety on
`
`November 21, 2018, upon the following parties via electronic mail:
`
`William B. Raich
`Erin M. Sommers
`Pier D. DeRoo
`Yieyie Yang
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`william.raich@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`yieyie.yang@finnegan.com
`
`
`
`
`
`
`
`
`
`
`Sanjay M. Jivraj
`Mark J. Stewart
`Eli Lilly and Company
`Lilly Corporate Center Patent Dept.
`Indianapolis, IN 46285
`jivraj_sanjay@lilly.com
`stewart_mark@lilly.com
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`
` Deborah Sterling, Ph.D.
`Date: November 21, 2018
` Lead Attorney for Patent Owner
`
`
`
`
`
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`(202) 371-2600
`
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