`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`Filed on behalf of: Breckenridge Pharmaceutical, Inc.
`
`By: Daniel R. Evans
`Registration No. 55,868
`MERCHANT & GOULD P.C.
`191 Peachtree Street, NE
`Suite 3800
`Atlanta, GA 30303
`Main Telephone: 404.954.5100
`Main Facsimile: 612.332.9081
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE
`
`PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGEG PHARMACEUTICAL, INC.
`
`Petitioner, v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION
`
`Patent Owner.
`
`Case: IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`DATED MARCH 16, 2018
`
`
`
`
`
`
`
`
`
`
`Exhibit
`Number
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`
`
`
`
`Exhibit Description
`
`U.S. Patent No. 8,410,131 ("the '131 patent")
`
`PCT Published Application No. WO 01/51049 A1, O-
`Methylated Rapamycin Derivatives for Alleviation and
`Inhibition of Lymphoproliferative Disorders, to Wasik
`et al. ("Wasik")
`
`PCT Published Application No. WO 00/33878 A2,
`Macrolides, to Navarro et al. ("Navarro")
`
`Crowe et al., Absorption and Intestinal Metabolism of
`SDZ-RAD and Rapamycin in Rats, Drug Metab. Disp.
`(1999), 27(5): 627-632 ("Crowe")
`
`Luan et al., Sirolimus Prevents Tumor Progression:
`mTOR Targeting for the Inhibition of Neoplastic
`Progression, Am. J. Transplant. (2001) 1 Suppl 1, 243
`(Abstr. No. 428) ("Luan")
`Hidalgo et al., The Rapamycin-sensitive Signal
`Transduction Pathway as a Target for Cancer
`Therapy, Oncogene (2000) 19(56): 6680-6686
`("Hidalgo")
`
`Alexandre et al., CCI-779, A new Rapamycin Analog,
`Has Antitumor Activity at Doses Including Only Mild
`Cutaneous Effects and Mucositis: Early Results of an
`Ongoing Phase I Study, Clin. Cancer Res. Suppl.
`(1999) 5: 3730s, Abstr. No. 7 (AACR-NCI-EORTC
`International Conference, November 16-19, 1999 held
`in Washington, DC) ("Alexandre")
`Schuler et al., SDZ RAD, A New Rapamycin
`Derivative, Transplantation (1997) 64(1): 36-42
`("Schuler")
`
`
`
`
`
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`
`Neumayer et al., Entry-into-human Study with the
`Novel Immunosuppressant SDZ RAD in Stable Renal
`Transplant Patients, Br. J. Clin. Pharmacol. (1999)
`48(5): 694-703 ("Neumayer")
`Declaration of Allan J. Pantuck, M.D. in Support of
`Petition for Inter Partes Review of U.S. Patent No.
`8,410,131
`
`RAPAMUNE® (sirolimus) Oral Solution
`RAPAMUNE® Approval Letter and approved labeling
`Great Britain patent application (GB 0104072.4, "GB
`'072" or "the '072 priority application")
`
`Great Britain patent application (GB0124957.2, "GB
`'957" or "the '957 priority application")
`
`International Patent Application No. PCT/EP02/01714
`("the '714 PCT Application")
`
`IPR Final Rules
`
`Dancey, J. E., Rapamycin-Sensitive Signal-
`Transduction Pathways: Protein Translation Control
`of Cell Proliferation, ASCO Educational Book (2000)
`68-75 ("Dancey")
`Sorbera et al, SDZ-RAD, Drugs of the Future (1999)
`24(1): 22-29 ("Sorbera")
`
`U.S. Patent No. 5,362,718, to Skotnicki et al.
`("Skotnichi '718")
`
`U.S. Patent No. 5,665,772 to Cottens et al. ("Cottens
`'772 patent")
`
`Sedrani et al., Chemical Modification of Rapamycin:
`The Discovery of SDZ RAD, Transplantation
`Proc.(1998) 30(5): 2192-2194 ("Sedrani")
`
`
`
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`PCT Published Application No. WO 97/47317 A1,
`Combination of a Somatostatin Analogue and a
`Rapamycin, to G. Weckbecker ("Weckbecker")
`U.S. Patent No. 6,331,547, Water Soluble SDZ RAD
`Esters, which issued to Zhu et al. on December 18,
`2001 from U.S. Provisional Patent Application No.
`60/183,035 filed on August 18, 1999 to Zhu ("Zhu
`'547 patent")
`U.S. Patent Application Publication No.
`2002/0183239 A1, Antineoplastic Combinations,
`which published on December 5, 2002 from an
`application filed on April 6, 2001, to Gibbons
`("Gibbons US '239")
`U.S. Patent Application Publication No.
`2003/0008923 A1, Antineoplastic Combinations,
`which published on January 9, 2003 from an
`application filed on June 1, 2001 to Dukart ("Dukart
`US '923")
`Flowcharts for 35 U.S.C. § 102(e) Dates ("102(e)
`Date Flowchart")
`Published Application No. WO 94/09010 A1, O-
`Alkylated Rapamycin Derivatives and their use,
`particularly as immunosuppressants, to Cottens et al.
`("Cottens WO '010")
`Selected portions of Prosecution History Documents
`("May 10, 2010 Amendment re. Cottens WO '010")
`Curriculum Vitae of Allan J. Pantuck, M.D.
`
`2015 Orange Book,"35th Edition (2015) with respect
`to AFINITOR® ("2015 Orange Book ")
`Alexandre, Raymond, et al., La rapamycine et le
`CCI- 779, Bull. Cancer (1999) 86(10): 808-811
`("Alexandre" and Raymond")
`
`
`
`
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`Boni et al., Pharmacokinetics of escalating doses of
`CCI-779 in Combination with 5-Fluorouracil and
`Leucovorin in Patients with Advanced Solid Tumors,
`Eur. J. Cancer (2001) 37(Suppl. 6): S68 (Abstr. No.
`242) (The 11th ECCO October 21-25, 2001 meeting
`held in Lisbon, Portugal) ("Boni")
`Dinney et al., Biology of Metastasis: Studies in Renal
`Cancer (17-24), in Principles and Practice of
`Genitourinary Oncology (Raghavan et al. eds., 1997)
`("Dinney")
`
`Shi et al., Rapamycin enhances Apoptosis and
`Increases Sensitivity to Cisplatin in Vitro, Cancer
`Research (1995) 55(9): 1982-1988 ("Shi")
`
`Fosså et al., Survival of Patients with Advanced
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`Chemotherapy, Brit. J. Cancer (1996) 74: 1655-1659
`("Fosså")
`
`Motzer et al., Survival and Prognostic Stratification of
`670 Patients with Advanced Renal Cell Carcinoma, J.
`Clin. Oncol. (1999) 17(8): 2530-2540 ("Motzer et al.")
`
`PCT Published Application No. WO 02/40000 A2, Use
`of CCI-779 as an Antineoplastic Agent, to Dukart et al.
`("Dukart WO '000")
`
`PCT Published Application No. WO 02/080975 A1,
`Antineoplastic Combinations such as Rapamycin
`together with Gemcitabine or Fluorouracil, to Gibbons
`et al. ("Gibbons WO '975")
`
`PCT Published Application No. WO 02/098416 A2,
`Antineoplastic Combinations, to Dukart et al. ("Dukart
`WO '416")
`U.S. Patent Application Publication No. 2002/0091137
`A1, Use of CCI-779 as an Antineoplastic Agent, which
`published on July 11, 2002, to Dukart ("Dukart '137")
`
`
`
`
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`U.S. Patent No. 7,781,446, Use of CCI-779 as an
`Antineoplastic Agent, which issued to Dukart et al. on
`August 24, 2010 ("Dukart '446"), and which claims
`priority to U.S. Provisional Patent Application No.
`60/249,077 ("Dukart")
`Perez-Atayde et al., Spectrum of Tumor Angiogenesis
`in the Bone Marrow of Children with Acute
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`150(3): 815-821 ("Perez-Atayde")
`
`True et al., Pathology of Renal Cancers (799-811), in
`Principles and Practice of Genitourinary Oncology
`(Raghavan et al. eds., 1997) ("True")
`
`Jennings et al., Renal, Perirenal and Ureteral
`Neoplasms (643-694), In Adult and Pediatric Urology;
`Third Edition. (Gillenwater et al. eds., 3rd ed. 1996,
`Volume 1), Grayhack, Howards, and Duckett Eds.
`Mosby-Year Book, Inc. 1996 ("Jennings")
`Robert R. Bahnson, Renal and Urinary Tract
`Neoplasia (371-379), In Primer on Kidney Diseases
`(Greenberg, A. et al. eds., 2nd ed. 1998) ("Bahnson")
`
`Vézina et al., Rapamycin (AY-22,989), A New
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`Sehgal et al., Rapamycin (AY-22,989), a New
`Antifungal Antibiotic II. Fermentation, Isolation, and
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`Antifungal Antibiotic III. In Vitro and In Vivo
`Evaluation, J. Antibiotics (1978) 31(6): 539-545
`("Baker")
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`U.S. Patent No. 3,929,992 to Sehgal ("Sehgal '992
`patent")
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`
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`1049
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`1050
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`1051
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`1052
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`U.S. Patent No. 8,410,131
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`Martel et al. Inhibition of the Immune Response by
`Rapamycin, a New Antifungal Antibiotic, Can. J.
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`Eng et al., Activity of Rapamycin (AY-22,989) against
`Transplanted Tumors, J. Antibiotics (1984) 37(10):
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`U.S. Patent No. 5,066,493 to Sehgal et al. ("Sehgal
`'493 patent")
`
`U.S. Patent No. 5,206,018 to Sehgal et al. ("Sehgal
`'018 patent")
`Calne et al., Rapamycin for Immunosuppression in
`Organ Allografting, Lancet (1989) 2(8656): 227
`("Calne")
`Morris et al., Identification of a New Pharmacological
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`Transplantation Reviews (1992) 6(1): 39-87 ("Morris
`1992")
`Van Duyne et al., Atomic Structure of the Rapamycin
`Human Immunophilin FKBP-12 Complex, J. Am.
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`
`Choi et al., Structure of the FKBP12-Rapamycin
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`Human FRAP, Science (1996) 273(5272): 239-242
`("Choi")
`Rapamune prescribing information as of August 2000
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`Garber, K., Rapamycin's Resurrection: A New Way to
`Target the Cancer Cell Cycle, J Natl Cancer Inst.
`(2001) 93(2): 1517-1519 ("Garber")
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`1061
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`1062
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`1063
`
`1064
`
`1065
`
`1066
`
`1067
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`1068
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`1069
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`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`Breitenbach et al., Rapamycin Inhibits Tumor Growth
`and Metastasis in Mice by Antiangiogenesis, Am. J.
`Transplant. (2001) 1 Suppl 1, 250 (Abstr. No. 459)
`("Breitenbach")
`Guba et al, Rapamycin inhibits Tumor Growth and
`Metastasis by Antiangiogenesis, Chirugicshes Forum
`2001 für experimentelle und klinsche Forschung
`(2001) 30: 37-39 ("Guba")
`
`Hosoi et al., Studies on the Mechanism of Resistance to
`Rapamycin in Human Cancer Cells, Mol. Pharmacol.,
`(1998) 54 815-824 ("Hosoi")
`
`Zhang et al., Differences in Phosphorylation of the IL-
`2R Associated JAK/STAT Proteins between HTLV-I
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`and Uncultured Leukemic Cells from Patients with
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`(1999) 23(4): 373-384 ("Zhang")
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`("Merck Index")
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`U.S. Patent No. 5,260,300 to Hu ("Hu '300 patent")
`
`U.S. Patent No. 5,221,670 to Caufield ("Caufield '670
`patent")
`U.S. Patent No. 5,434,260 to Skotnicki et al. ("Skotnicki
`'260 patent")
`Freireich et al., Quantitative Comparison of Toxicity of
`Anticancer Agents in Mouse, Rat, Hamster, Dog,
`Monkey, and Man, Cancer Chemotherapy Reports
`(1966) 50(4): 219-244 ("Freireich")
`PRNewswire, August 30, 2000 press release, Novartis
`Announces Positive Trial Results for Two Novel
`Transplantation Drugs ("Press Release")
`
`
`
`
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`1076
`
`1077
`
`1078
`
`1079
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`AFINITOR® approval letter and prescribing
`information, as of March 30, 2009 ("AFINITOR® Mar
`30, 2009 approval")
`AFINITOR® prescribing information, as of June 14,
`2016 ("AFINITOR® Jun 14, 2016 prescribing
`information")
`ZORTRESS® approval letter and prescribing
`information, as of April 20, 2010 ("ZORTRESS®
`approval")
`U.S. Patent No. 7,297,703 to Navarro et al. ("Navarro
`'703 patent")
`International Nonproprietary Names of Pharmaceutical
`Substances (INN), WHO Drug Information, (2000)
`14(3): 183-209 ("Everolimus INN")
`Majewski et al., The Immunosuppresive Macrolide
`RAD inhibits Growth of Human Epstein-Barr Virus-
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`Potential Approach to Prevention and Treatment of
`Postrransplant Lymphoproliferative Disorders, Proc.
`Natl. Acad. Sci. (2000) 97(8): 4285-4290 ("Majewski")
`Huang et al., Mechanisms of Resistance to Rapamycin,
`Drug Resistance Updates, (2001) 4: 378-392 ("Huang")
`
`Beuvink et al., Antitumor Activity of RAD001, an
`Orally Active Rapamycin Derivative, Proc. Amer.
`Assoc. Cancer Res. (2001) 42, 366, Abstr. No. 1972
`("Beuvink")
`
`International Nonproprietary Names of Pharmaceutical
`Substances (INN), WHO Drug Information, (2005)
`19(3): 243-270 ("Temsirolimus INN")
`
`Wall Street Journal, Drug Progress on Hard-to-Treat
`Cancers is Cited, by Robert Langreth and Michael
`Waldholz in the November 17, 1999 edition
`("Langreth")
`
`
`
`
`
`1080
`
`1081
`
`1082
`
`1083
`
`1084
`
`1085
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`Hidalgo et al., A Phase I and Pharmacological Study of
`CCI-779, a Rapamycin Ester Cell Cycle Inhibitor,
`Ann. Oncol. (2000) 11 (Suppl. 4) 133, Abstr. No. 606O
`(25th ESMO Congress, October 13-17, 2000 held in
`Hamburg, DE) ("Hidalgo ESMO Abstract")
`
`December 1, 2000 issue of The Lancet Oncology, CCI-
`779: A New Targeted Anticancer Agent, by Ezzie
`Hutchinson ("Hutchinson")
`
`Hidalgo et al., Phase I and Pharmacological Study of
`CCI-779, a Cell Cycle Inhibitor, Clinical Cancer
`Research (2000), Supplement 6: 4548s-4549s, Abstr.
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`2000 meeting held in Amsterdam, NL) ("Hidalgo NCI
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`
`Gibbons et al., The Effect of CCI-779, a Novel
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`In Vivo, Proc. Amer. Assoc. Cancer Res. (1999) 40:
`301, Abstr. No. 2000 ("Gibbons Abstract")
`
`
`
`
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
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`growth of Human Medulloblastoma Xenographs, Proc.
`Amer. Assoc. Cancer Res. (1999) 40: 603a, Abstr. No.
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`1999 held in Philadelphia, PA) ("Geoerger Abstract")
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`Analog CCI-779 in Human Primitive Neuroectodermal
`Tumor/Medulloblastoma Models as Single Agent and in
`Combination Chemotherapy, Cancer Res. (2001) 61(4):
`1527-1532 ("Geoerger")
`TORISEL® approval letter and prescribing information,
`as of May 30, 2007 ("TORISEL® Approval")
`
`1089
`
`TORISEL® prescribing information, as of July 27, 2016
`
`1090
`
`1091
`
`1092
`
`1093
`
`Cowan et al., Sirolimus: Mammalian Target of
`Rapamycin Inhibitor to Prevent Kidney Rejection,
`Nephrol. Nursing Journal (2000) 27(6): 623-625
`("Cowan")
`Serkova et al., Tissue Distribution and Clinical
`Monitoring of the Novel Macrolide Immunosuppressant
`SDZ-RAD and its Metabolites in Monkey Lung
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`("Serkova")
`U.S. Patent No. 6,432,973, to Zhu et al. ("Zhu '973
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`
`Neshat et al., Enhanced Sensitivity of PTEN-deficient
`Tumors to Inhibition of FRAP/mTOR, Proc. Natl. Acad.
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`
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`1094
`
`1095
`
`1096
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`1097
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`1098
`
`1099
`
`1100
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`1101
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`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`Podsypanina et al., An Inhibitor of mTOR reduces
`Neoplasia and Normalizes p70/S6 Kinase Activity in
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`Increased Growth Inhibition Sensitivity to a TOR
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`Phosphoinositide 3-Kinase / AKT Pathway, Proc. Natl.
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`(885-896) in Principles and Practice of Genitourinary
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`
`
`
`
`
`1102
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`1103
`
`1104
`
`1105
`
`1106
`
`1107
`
`1108
`
`1109
`
`1110
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`NEXAVAR® approval letter and prescribing
`information as of December 1, 2005 ("NEXAVAR®
`approval letter")
`SUTENT® approval letter and prescribing information
`as of January 26, 2006 ("SUTENT® approval letter")
`Quinn et al., Renal-Cell Cancer ― Targeting an
`Immune Checkpoint or Multiple Kinases, New England
`J. Med. (2015) 373(19): 1872-1874 ("Quinn")
`
`Choueiri et al., Cabozantinib versus Everolimus in
`Advanced Renal-Cell Carcinoma, New England
`Journal Med. (2015) 373(19): 1814-1823 ("Choueiri")
`
`R. J. Motzer, B. Escudier et al., Nivolumab versus
`Everolimus in Advanced Renal-Cell Carcinoma, New
`England Journal Med. (2015) 373(19): 1803-1813
`("Escudier")
`AFINITOR® approval letter and prescribing
`information, as of April 26, 2012 ("AFINITOR® Apr
`26, 2012 approval")
`
`Kenerson et al., Activated Mammalian Target of
`Rapamycin Pathway in the Pathogenesis of Tuberous
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`(2002) 62(2): 5645-5650 ("Kenerson")
`Bissler et al., Sirolimus for Angiomyolipoma in
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`306(3): F279-F283 ("Henske")
`
`
`
`
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`1111
`
`1112
`
`1113
`
`1114
`
`1115
`
`1116
`
`1117
`
`1118
`
`1119
`
`1120
`
`Kingswood et al., Review of the Tuberous Sclerosis
`Renal Guidelines from the 2012 Consensus
`Conference: Current Data and Future Study,
`Nephron. Clin. Pract. (2016) 134(2) ("Kingswood")
`
`Declaration of Daniel R. Evans dated January 18,
`2018
`
`Morel, Inhibitors of mTOR and FTY 720, Special
`Transcript 2001 ("Morel")
`
`Program Book for Joint American Transplant
`Meeting, May 11-16, 2001 ("Transplant 2001
`Program Book")
`Luan et al., Sirolimus Prevents Tumor Progressions:
`mTOR Targeting for the Inhibition of Neapolastic
`Progression, American Journal of Transplantation,
`Sup. 1, Vol.1, Abstract 428, Chicago, May 11-16,
`2001 ("Luan Abstract")
`ISO 26324, Information and documentation – Digital
`object identifier system, 1st Ed. 2012-05-01 ("ISO
`26324")
`The DOI Foundation and Wiley Online Library
`webpages
`
`Declaration of Terrence L. Stokke dated January 18,
`2018
`
`Declaration of Fu L. Luan, M.D., dated January 19,
`2018
`
`List of exhibits with paragraph citations to Dr.
`Pantuck's Declaration
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2017-01592
`U.S. Patent No. 8,410,131
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Petitioner’s Updated
`
`
`
`
`
`Exhibit Dated March 16, 2018, and Exhibit 1120 were served in their entirety on
`
`March 16, 2018, upon the following parties via email:
`
`Nicholas N. Kallas
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-2100
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`By: /Daniel R. Evans/
`Daniel R. Evans, Registration No. 55,868
`MERCHANT & GOULD P.C.
`191 Peachtree Street, NE, Suite 3800
`Atlanta, GA 30303
`Main Telephone: 404.954.5100
`Main Facsimile: 612.332.9081
`
`Counsel for Petitioner Breckenridge
`Pharmaceutical, Inc.
`
`
`
`
`Dated: March 16, 2018
`
`
`
`
`
`
`
`
`
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