`Patent Owner’s Updated Exhibit List
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`FRESENIUS KABI USA, LLC
`Petitioner,
`
`v.
`
`CEPHALON, INC.
`Patent Owner.
`
`_____________
`
`Case IPR2016-00098
`Patent No. 8,791,270 B2
`
`_____________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`TREANDA® Prescribing Information
`
`“Treanda New Drug Application for the Treatment of
`Chronic Lymphocytic Leukemia Granted Priority
`Review Status by FDA,” Drugs.com (December 3,
`2007)
`Kanti R. Rai, et al., “Fludarabine Compared with
`Chlorambucil as Primary Therapy for Chronic
`Lymphocytic Leukemia,” 343(24) New Eng. J. Med.
`1752 (December 14, 2000)
`M. J. Keating, et al., “Long-Term Follow-up of
`Patients with Chronic Lymphocytic Leukemia (CLL)
`Receiving Fludarabine Regimens as Initial Therapy,”
`92 Blood 1165 (August 15, 1998)
`Guillaume Dighiero, et al., “Chlorambucil in Indolent
`Chronic Lymphocytic Leukemia,” 338 New Eng. J.
`Med. 1506 (May 21, 1998)
`The French Cooperative Group on Chronic
`Lymphocytic Leukemia, “Comparison of Fludarabine,
`Cyclophosphamide / Doxorubicin / Prednisone, and
`Cyclophosphamide / Doxorubicin / Vincristine /
`Prednisone in Advanced Forms of Chronic
`Lymphocytic Leukemia: Preliminary Results of a
`Controlled Clinical Trial,” 20 Seminarsin Oncology 21
`(October 1993)
`Suzanne Demko, et al., “FDA Drug Approval
`Summary: Alemtuzumab as Single-Agent Treatment
`for B-Cell Chronic Lymphocytic Leukemia,” 13 The
`Oncologist 167 (2008)
`A. J. Davies, et al., “Tositumomab and Iodine I 131
`Tositumomab for Recurrent Indolent and Transformed
`B-Cell Non-Hodgkin’s Lymphoma,” 22 J. Clin. Oncol.
`1469 (April 15, 2004)
`
`
`
`EXHIBIT
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`DESCRIPTION
`
`Samuel A. Jacobs, et al., “Phase II Trial of Short-
`Course CHOP-R Followed by 90Y-ibritumomab
`Tiuexetan and Extended Rituximab in Previously
`Untreated Follicular Lymphoma,” 14(21) Clin. Cancer
`Res. 7088 (November, 1, 2008)
`Richard I. Fisher, et al., “Comparison of a Standard
`Regimen (CHOP) with Three Intensive Chemotherapy
`Regimens for Advanced Non-Hodgkin’s Lymphoma,”
`328(14) New Eng. J. Med. 1002 (April 8, 1993)
`Peter McLaughlin, et al., “Fludarabine, Mitoxantrone,
`and Dexamethasone: An Effective New Regimen for
`Indolent Lymphoma,” 14 J. Clin. Oncol. 1262 (April
`1996)
`File History of U.S. Patent No. 8,609,863
`
`“FDA Approves Treanda,” Drugs.com (March 20,
`2008)
`“Cephalon Receives FDA Approval for Treanda to
`Treat Patients with Relapsed Indolent Non-Hodgkin’s
`Lymphoma,” Drugs.com (October 31, 2008)
`Brad S. Kahl, et al., “Bendamustine Is Effective
`Therapy in Patients with Rituximab-Refractory,
`Indolent B-cell Non-Hodgkin Lymphoma: Results
`From a Multicenter Study,” Cancer 106 (January 1,
`2010)
`K. Sue Robinson, et al., “Phase II Multicenter Study of
`Bendamustine Plus Rituximab in Patients with
`Relapsed Indolent B-Cell and Mantle Cell Non-
`Hodgkin’s Lymphoma,” 26 J. Clin. Oncol. 4473
`(September 20, 2008)
`Wolfgang U. Knauf, et al., “Phase III Randomized
`Study of Bendamustine Compared with Chlorambucil
`in Previously Untreated Patients with Chronic
`Lymphocytic Leukemia,” 27 J. Clin. Oncol. 4278
`(September 10, 2009)
`
`2
`
`
`
`EXHIBIT
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`DESCRIPTION
`
`Wolfgang U. Knauf, et al., “Bendamustine Compared
`with Chlorambucil in Previously Untreated Patients
`with Chronic Lymphocytic Leukaemia: Updated
`Results of a Randomized Phase III Trial,” 159 Brit. J.
`Hematology 67 (August 4, 2012)
`Norbert Niederle, et al., “Bendamustine Compared to
`Fludarabine as Second-Line Treatment in Chronic
`Lymphocytic Leukemia,” 92 Ann. Hematology 653
`(January 23, 2013)
`Teva Pharmaceutical Industries Limited, Form 20-F,
`2014
`Teva Pharmaceutical Industries Limited, Form 20-F,
`2011
`Cephalon, Inc., Form 10-K, 2010
`
`Cephalon, Inc., Form 10-K, 2009
`
`Cephalon, Inc., Form 10-K, 2008
`
`Alternate Copy of Birgit Maas et al., Stability of
`Bendamustine Hydrochloride in Infusions, 49
`PHARMAZIE 775 (1994) produced in Fresenius Kabi
`USA, LLC v. Cephalon, Inc., IPR2016-00111, Ex.
`1009 (PTAB Nov. 2, 2015)
`Alternate Copy of Birgit Maas et al., Stability of
`Bendamustine Hydrochloride in Infusions, 49
`PHARMAZIE 775 (1994) produced in, Agila
`Specialties Inc. v. Cephalon, Inc., IPR2015-00503, Ex.
`1010 (PTAB Dec. 24, 2014)
`
`Thissen Laboratories, Batch 02K27 Certificate of
`Analysis
`Thissen Laboratories, Batch 03C08 Certificate of
`Analysis
`Thissen Laboratories, Batch 03H08 Certificate of
`Analysis
`
`3
`
`
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`EXHIBIT
`
`DESCRIPTION
`
`2030
`
`2031
`
`2032
`
`Thissen Laboratories, Batch 03H07 Certificate of
`Analysis
`Cephalon, Inc.’s Preliminary Patent Owner Response
`Pursuant to 37 C.F.R. § 42.107, IPR2016-00026,
`Paper 12 (PTAB Jan. 20, 2016)
`CONFIDENTIAL – Agreement between the Parties
`
`4
`
`
`
`Dated: July 26, 2016
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`Respectfully submitted,
`
`KAYE SCHOLER LLP
`
`/s/ Soumitra Deka
`Soumitra (Sam) Deka
`(No. 70,252)
`soumitra.deka@kayescholer.com
`Two Palo Alto Square
`3000 El Camino Real, Suite 400
`Palo Alto, CA 94306
`Tel: (212) 836-8000
`Fax: (212) 836-8689
`
`Attorneys for Patent Owner
`
`5
`
`
`
`IPR2016-00098 (Paper No. 19)
`Patent Owner’s Updated Exhibit List
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that the foregoing PATENT OWNER’S
`
`UPDATED EXHIBIT LIST was served electronically via e-mail on this 26th day
`
`of July 2016, and directed to:
`
`Counsel for Petitioner
`
`Lawrence Sung
`Neal Seth
`WILEY REIN LLP
`nseth@wileyrein.com
`lsung@wileyrein.com
`
`WILEY REIN LLP
`ATTN: Patent Administration
`1776 K Street NW
`Washington, DC 20006
`
`Dated: July 26, 2016
`
`KAYE SCHOLER LLP
`
`By
`
`/Soumitra Deka #70,252
`Soumitra (Sam) Deka
`Two Palo Alto Sq.
`3000 El Camino Real
`Palo Alto, CA 94306
`
`6