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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PHIGENIX, INC.
`Petitioner
`v.
`IMMUNOGEN, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR2014-00676
`U.S. Patent No. 8,337,856
`_____________________
`
`IMMUNOGEN, INC.'S EXHIBIT LIST
`
`
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`
`
`
`
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`ImmunoGen
`Exhibit #
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`IMMUNOGEN INC.'S EXHIBIT LIST
`IPR2014-00676
`
`
`Description
`
`Hamel, E., "Natural Products Which Interact with Tublin in the
`Vinca Domain: Maytansine, Rhizoxin, Phomopsin A, Dolastatins
`10 and 15 and Halichondrin B," Pharmacy Therapy 55:31-51
`(1992)
`Maytansine, Annual Report to the Food and Drug Administration;
`Investigational Drug Branch Cancer Therapy Evaluation
`Program Division of Cancer Treatment National Cancer Institute,
`1-21 (1984)
`Cabanillas, F., et al., "Results of a Phase II Study of Maytansine
`in Patients with Breast Carcinoma and Melanoma," Cancer
`Treatment Reports 63: 507-509 (1979)
`Rosenthal, S., et al., "Phase II Study of Maytansine in Patients
`with Advanced Lymphomas: An Eastern Cooperative Oncology
`Group Pilot Study," Cancer Treatment Reports 64: 1115-1117
`(1980)
`Ravry, M., et al., "Phase II Evaluation of Maytansine (NSC
`153858) in Advanced Cancer," American Journal of Clinical
`Oncology: Cancer Clinical Trials 8: 148-150 (1985)
`Blättler, W., et al., "Immunoconjugates," in Cancer Therapeutics:
`Experimental and Clinical Agents, Chapter 17, pp. 371-394
`(1996)
`Dubowchik, G. and Walker, M.A., "Receptor-Mediated and
`Enzyme-Dependent Targeting of Cytotoxic Anticancer Drugs,"
`Pharmacology & Therapeutics 83: 67-123 (1999)
`Cheson, B., et al., "2011 Top Game Changers in Oncology," pp.
`1-9 (2011) available at www.medscape.com at
`http://www.medscape.com/viewarticle/754136_print (last
`accessed July 30, 2014)
`
`
`
`1
`
`
`
`ImmunoGen
`Exhibit #
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`IMMUNOGEN INC.'S EXHIBIT LIST
`IPR2014-00676
`
`
`Description
`
`Wildiers, H., et al., "Late Breaking Abstract: T-DM1 for HER2-
`positive metastatic breast cancer (MBC): Primary result from
`TH3RESA, a phase 3 study of T-DM1 vs treatment of physician's
`choice," European Cancer Congress 2013, pp. 1-2, available at
`http://eccamsterdam2013.ecco-org.eu/Scientific-
`Programme/Abstract-search.aspx?abstractid=8879 (last accessed
`July 28, 2014)
`Tolcher, A., et al., "Randomized Phase II Study of BR96-
`Doxorubicin Conjugate in Patients With Metastatic Breast
`Cancer," Journal of Clinical Oncology 17: 478-484 (1999)
`Elias, D., et al., "Monoclonal Antibody KS1/4-Methotrexate
`Immunoconjugate Studies in Non-Small Cell Lung Carcinoma,"
`American Journal of Respiratory and Critical Care Medicine
`150: 1114-1122 (1994)
`Krop, I., et al., "Trastuzumab emtansine versus treatment of
`physician’s choice for pretreated HER2-positive advanced breast
`cancer (TH3RESA): a randomised, open-label, phase 3 trial,"
`Lancet Oncology 15: 689-699 (2014)
`Figueroa-Magalhães, M. and Stearns, V., "T-DM1 adds to the
`Armamentarium for Targeting Advanced HER2-Positive Breast
`Cancer," Community Oncology 10: 69-73 (2013)
`Interview Summary dated September 14, 2009 from the File
`History of U.S. Patent No. 8,337,856, p. 1.
`Cao, Y., et al., "Construction and Characterization of Novel,
`Completely Human Serine Protease Therapeutics Targeting
`Her2/neu," Molecular Cancer Therapeutics 12: 979-991 (2013)
`Cao, Y., and Rosenblum, M.G., "Design, Development, and
`Characterization of Recombinant Immunotoxins Targeting
`HER2/neu," in Antibody-Drug Conjugates and Immunotoxins:
`From Pre-Clinical Development to Therapeutic Applications,
`Chapter 18, pp. 319-348 (2013)
`
`
`
`2
`
`
`
`ImmunoGen
`Exhibit #
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`IMMUNOGEN INC.'S EXHIBIT LIST
`IPR2014-00676
`
`
`Description
`
`Engert, A. et al., "The Emerging Role of Ricin in A-Chain
`Immunotoxins in Leukemia and Lymphoma" in Clinical
`Applications of Immunotoxins by Frankel, A.E., (Ed.), pp. 1-23
`(1998)
`Roth, B., et al., "Clinical Cancer Advances 2012: Annual Report
`on Progress Against Cancer From the American Society of
`Clinical Oncology," Journal of Clinical Oncology 31: 131-161,
`2063 (2013)
`Gochenauer, G., "Roche/Genentech's "Magic Bullet" in HER2+
`Breast Cancer," available at
`http://www.kantarhealth.com/blog/oncology/gordon-
`gochenauer/2012/06/03/Roche_Genentech_Magic_Bullet_in_HE
`R2_Breast_Cancer (last accessed July 30, 2014) pp. 1-2 (2012)
`Miller, K., et al., "T-DM1: Golden Age in HER2+ Breast
`Cancer?" pp. 1-6 (2012)( available at www.medscape.com at
`http://www.medscape.com/viewarticle/765248 (last accessed July
`30, 2014)
`"FDA Approves New Late-Stage Breast Cancer Drug Kadcyla,"
`pp. 1-4 (2013) available at
`http://www.cbsnews.com/news/fda-approves-new-late-stage-
`breast-cancer-drug-kadcyla/ (last accessed July 28, 2014)
`"Breast Cancer Drug Targets Tumor Cells, Spares Healthy Ones,"
`pp. 1-2 (2013) available at
`http://abc7.com/archive/9003043/ (last accessed July 28, 2014)
`Helwick, C., "Refining Current Treatments and Looking Ahead in
`HER2-positive Breast Cancer," Best of ASCO Supplement 3:1-2
`(2012)
`
`
`
`3
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`
`
`IMMUNOGEN INC.'S EXHIBIT LIST
`IPR2014-00676
`
`
`Description
`
`Herper, M., "A Triumph In Breast Cancer--And Another
`Expensive Drug," pp. 1-3 (2013) available at
`http://www.forbes.com at
`http://www.forbes.com/sites/matthewherper/2013/02/22/a-
`triumph-in-breast-cancer-and-another-expensive-drug/ (last
`accessed July 28, 2014)
`Kadcyla™ Prescribing Information, pp. 1-21(2013)
`Hurvitz, S., et al., "Phase II Randomized Study of Trastuzumab
`Emtansine Versus Trastuzumab Plus Docetaxel in Patients with
`Human Epidermal Growth Factor Receptor 2-Positive Metastatic
`Breast Cancer," Journal of Clinical Oncology 31: 1157-1163,
`2977 (2013)
`Nandini, D., et al., "T-DM1: A Giant Step Forwards in HER2
`Therapeutics," Cancer Therapy 9: 45-54 (2013)
`September 17, 2010 Office Communication from the File History
`of U.S. Patent No. 8,337,856, pp. 1-2.
`
`ImmunoGen
`Exhibit #
`2024
`
`2025
`2026
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`2027
`
`2028
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`
`Respectfully Submitted,
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Date: July 30, 2014
`
`
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`
`
`1100 New York Avenue, N.W.
`Washington, D.C.20005-3934
`(202) 371-260
`
`
`/Eldora L. Ellison/
`
` Eldora L. Ellison, Ph.D.
`Registration No. 39,967
` Lead Counsel for Patent Owner ImmunoGen,
`
`Inc.
`
`4
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`
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`CERTIFICATION OF SERVICE (37.C.F.R. §§ 42.6(e), 42.105(a))
`
`
`
`The undersigned hereby certifies that the above-captioned Exhibit List and
`
`Exhibits 2001 - 2028 were served in their entirety on July 30, 2014, upon the
`
`following parties via electronic mail:
`
`
`
`
`Ping Wang
`ANDREWS KURTH, LLP
`
`
`1350 I Street NW, Suite 1100
`
`Washington, DC 20005
`
`
`Tel: (202) 662-3042
`
`
`Fax: (202) 662-3729
`
`PingWang@andrewskurth.com
`
`
`
`
`
`
`
`
`
`Gregory Porter
`ANDREWS KURTH, LLP
`600 Travis, Suite 4200
`Houston, TX 77002
`Tel: (713) 220-4621
`Fax: (713) 220-4257
`GregPorter@andrewskurth.com
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: July 30, 2014
`
`
`
` /Eldora L. Ellison/
` Eldora L. Ellison (Reg. No. 39,967)
`Lead Attorney for Patent Owner ImmunoGen,
`Inc.
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
`
`
`
`
`
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