Paper No. 71
`
`Filed: February 24, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002371
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST AS OF FEBRUARY 24, 2017
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`1 Cases IPR2016-01190, IPR2016-01335 and IPR2016-01341 have been joined
`with the instant proceeding.
`
`
`
`Filed: February 24, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and
`WOCKHARDT BIO AG,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002371
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST AS OF FEBRUARY 24, 2017
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`1 Cases IPR2016-01190, IPR2016-01335 and IPR2016-01341 have been joined
`with the instant proceeding.
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST
`(Updated February 24, 2017)
`
`
`Description
`Exhibit No.
`Exhibit 1001 U.S. Patent No. 7,772,209 to Clet Niyikiza, filed on July 11, 2007,
`and issued on Aug. 10, 2010 (“the ’209 patent”)
`Exhibit 1002 U.S. Patent No. 7,772,209 Prosecution History (“’209 prosecution
`history”)
`Exhibit 1003 U.S. Patent No. 5,344,932 to Edward C Taylor, issued on Sep. 6,
`1994 (“Taylor”)
`Exhibit 1004 Claim Chart for Niyikiza ’209 Petition (Attachment 2 to Bleyer
`Declaration)
`Exhibit 1005 Worzalla et al., “Role of Folic Acid in Modulating the Toxicity
`and Efficacy of the Multitargeted Antifolate, LY231514.”
`Anticancer Research 18:3235-3240 (1998) (“Worzalla”)
`Exhibit 1006 U.S. Patent No. 4,140,707 to Cleare et al., issued on Feb. 20, 1979
`(“Cleare”)
`Exhibit 1007 Tsao CS, “Influence of Cobalamin on the Survival of Mice
`Bearing Ascites Tumor.” Pathobiology 1993;61:104-108 (“Tsao”)
`Exhibit 1008 Niyikiza et al., “MTA (LY231514): Relationship of vitamin
`metabolite profile, drug exposure, and other patient characteristics
`to toxicity.” Annals of Oncology, Vol. 9, Suppl. 4, 1998, Abstract
`609P, pg. 126 (“Niyikiza”)
`Exhibit 1009 U.S. Patent No. 5,217,974 (“the ’974 Patent”)
`Exhibit 1010 European Patent Application No. 0,595,005 A1 (“EP 005”)
`Exhibit 1011 Rusthoven et al., “Multitargeted Antifolate LY231514 as First-
`Line Chemotherapy for Patients with Advanced Non-Small-Cell
`Lung Cancer: A Phase II Study.” Journal of Clinical Oncology,
`Vol. 17, No. 4, (April 1999), pp. 1194-1199 (“Rusthoven”)
`Exhibit 1012 Refsum H & Ueland PM, “Clinical significance of
`pharmacological modulation of homocysteine metabolism.” Trends
`in Pharmacol. Sci., Vol. 11, No. 10, 1990, pp. 411-416 (“Refsum”)
`Exhibit 1013 Calvert AH & Walling JM, “Clinical studies with MTA.” British
`Journal of Cancer (1998) 78 (Suppl. 3), 35-40 (“Clavert 1998”)
`
`
`
`1
`
`
`
`Description
`Exhibit No.
`Exhibit 1014 Calvert H, “An Overview of Folate Metabolism: Features
`Relevant to the Action and Toxicities of Antifolate Anticancer
`Agents,” Seminars in Oncology, Vol. 26, No. 2, Suppl 6 (April),
`1999, pp.3-10 (“Calvert 1999”)
`Exhibit 1015 O’Dwyer et al., “Overview of Phase II Trials of MTA in Solid
`Tumors.” Seminars in Oncology, Vol. 26, No. 2, Suppl 6 (April),
`1999, pp. 99-104 (“O’Dwyer”)
`Exhibit 1016 Zervos et al., “Functional folate status as a prognostic indicator of
`toxicity in clinical trials of the multitargeted antifolate LY231514.”
`Proceedings of ASCO, Vol. 16, 1997, pg. 256a (“Zervos”)
`Exhibit 1017 Allen et al., “Diagnosis of Cobalamin Deficiency I: Usefulness
`of Serum Methylmalonic Acid and Total Homocysteine
`Concentrations.” American Journal of Hematology, 34, 1990,
`90-98 (“Allen”)
`Exhibit 1018 Savage et al., “Sensitivity of Serum Methylmalonic Acid and Total
`Homocysteine Determinations for Diagnosing Cobalamin and
`Folate Deficiencies. The American Journal of Medicine, 96: 1994,
`239-246 (“Savage”)
`Exhibit 1019 Brönstrup et al., “Effects of folic acid and combinations of folic
`acid and vitamin B-12 on plasma homocysteine concentrations in
`healthy, young women.” Am. J. Clin. Nutr. Vol. 68, 1998, 1104-10
`(“Bronstrup”)
`Exhibit 1020 Carrasco et al., “Acute megaloblastic anemia: homocysteine
`levels are useful for diagnosis and follow-up.” Haematologica,
`Vol. 84(8), August 1999, 767-768 (“Carrasco”)
`Exhibit 1021 Thödtmann et al., “Phase I study of different sequences of MTA
`(LY231514) in combination with cisplatin in patients with solid
`tumours.” Annals of Oncology, Vol. 9, Suppl. 4, 1998, Abstract
`618P, pg. 129 (“Thodtmann”)
`Exhibit 1022 Hammond et al., “A Phase I and pharmacokinetic (PK) study of
`the multitargeted antifolate (MTA, LY231514) with folic acid
`(FA).” Annals of Oncology, Vol. 9, Suppl. 4, 1998, Abstract 620P,
`pg. 129 (“Hammond”)
`
`
`
`2
`
`
`
`Description
`Exhibit No.
`Exhibit 1023 Morgan et al., “The Effect of Folic Acid Supplementation on the
`Toxicity of Low-Dose Methotrexate in Patients with Rheumatoid
`Arthritis.” Arthritis and Rheumatism, Vol. 33, No. 1, January
`1990, pp. 9-18 (“Morgan”) (Ex. 1023)
`Exhibit 1024 Curriculum Vitae of W. Archie Bleyer, M.D., FRCP[Glasg]
`(Attachment 1 to Bleyer Declaration)
`Exhibit 1025 Declaration of W. Archie Bleyer, M.D., FRCP[Glasg]
`Exhibit 1026 Eli Lilly and Company v. Teva Parental Medicines, Inc., et al.,
`INSD-1:10-cv-01376 Markman Order (June 20, 2012) (“Teva”)
`Exhibit 1027 Eli Lilly and Company v. Teva Parental Medicines, Inc., et al.,
`INSD-1:10-cv-01376 Joint Claim Construction Brief (April 19,
`2012) (“Teva Claim Construction”)
`Exhibit 1028 Eli Lilly and Company v. Teva Parental Medicines, Inc., et al.,
`INSD-1:10-cv-01376 Decision (March 31, 2014) (“Teva
`Decision”)
`Exhibit 1029 Curriculum Vitae of Scott Bennett, Ph.D.
`Exhibit 1030 Declaration of Scott Bennett, Ph.D.
`Exhibit 1031 Copy of Niyikiza from Oxford University Press Journals
`Exhibit 1032 University of Illinois at Urbana-Champaign Library directory entry
`for Annals of Oncology
`Exhibit 1033 Statewide Illinois Library Catalog record for Annals of Oncology
`Exhibit 1034 Copy of Niyikiza from the University of Wisconsin Library
`Exhibit 1035 Online copy of Carrasco from the Highwire Press
`Exhibit 1036 University of Illinois at Urbana-Champaign Library directory entry
`for Haematologica
`Exhibit 1037 Statewide Illinois Library Catalog record for Haematologica
`Exhibit 1038 Copy of Carrasco from the University of Michigan Taubman
`Medical Library
`Exhibit 1039 Web of Science entry for Carrasco
`Exhibit 1040 Declaration of Mieke K. Malmberg
`Exhibit 1041 Declaration of Paul J. Skiermont
`
`
`
`3
`
`
`
`Description
`Exhibit No.
`Exhibit 1042 Transcript of October 31, 2016 Telephone Hearing
`Exhibit 1043 Tashjian, AH J, and BA Chabner. “Commentary on Clinical Safety
`of Recombinant Human Parathyroid Hormone 1-34 in the
`Treatment of Osteoporosis in Men and Postmenopausal Women.”
`Journal of Bone and Mineral Research : the Official Journal of the
`American Society for Bone and Mineral Research. 17.7 (2002):
`1151-61. Print. (Previously introduced as Ex. 1043 in Dr.
`Chabner’s deposition.)
`Exhibit 1044 Tefferi, A, H Kantarjian, S V. Rajkumar, L H. Baker, J L.
`Abkowitz, J W. Adamson, R H. Advani, J Allison, K H. Antman,
`and R C. Bast. “In Support of a Patient-Driven Initiative and
`Petition to Lower the High Price of Cancer Drugs.” Mayo Clinic
`Proceedings. 90.8 (2015): 996-1000. Print. (Previously introduced
`as Ex. 1044 in Dr. Chabner’s deposition.)
`Exhibit 1045 Singh, H, D L. Longo, and B A. Chabner. “Improving Prospects
`for Targeting Ras.” Journal of Clinical Oncology. 33.31 (2015):
`3650-3659. Print. (Previously introduced as Ex. 1045 in Dr.
`Chabner’s deposition.)
`Information for Contributors,
`theoncologist.alphamedpress.org/site/miscllnfoForContributors.xht
`mi#_Toc374525716 (viewed on 11/15/2016). (Previously
`introduced as Ex. 1046 in Dr. Chabner’s deposition.)
`Exhibit 1047 Hanauske, AR, V Chen, P Paoletti, and C Niyikiza. “Pemetrexed
`Disodium: a Novel Antifolate Clinically Active against Multiple
`Solid Tumors.” The Oncologist. 6.4 (2001): 363-73. Print.
`(Previously introduced as Ex. 1047 in Dr. Chabner’s deposition.)
`Exhibit 1048 Chabner BA., hand drawn sketch. (Previously introduced as Ex.
`1048 in Dr. Chabner’s deposition.)
`Exhibit 1049 Mason, Joel B, and Joshua W. Miller. “The Effects of Vitamins
`B12, B6, and Folate on Blood Homocysteine Levels.” Annals of
`the New York Academy of Sciences. 669.1 (1992): 197-203. Print.
`(Previously introduced as Ex. 1049 in Dr. Chabner’s deposition.)
`
`Exhibit 1046
`
`
`
`4
`
`
`
`Description
`Exhibit No.
`Exhibit 1050 Deposition transcript of Bruce A. Chabner, M.D., November 10,
`2016, Sandoz, Inv. et al. v. Eli Lilly & Company, Case No.
`IPR2016-00318 (PTAB) (Previously introduced as Ex. 1050 in Dr.
`Chabner’s deposition.)
`Exhibit 1051 Trial transcript Volume VI and VII, August 26, 2013 and August
`27, 2013, Eli Lilly and Company v. Teva Parenteral Medicines,
`Inc., et al., Case No. 1:10-cv-01376 (S.D. Ind.) (Previously
`introduced as Ex. 1051 in Dr. Chabner’s deposition.)
`Exhibit 1052 Deposition transcript of Bruce A. Chabner, M.D., April 23, 2013,
`Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et al.,
`Case No. 1:10-cv-01376 (S.D. Ind.) (Previously introduced as Ex.
`1052 in Dr. Chabner’s deposition.)
`Exhibit 1053 Relevant excerpts from Physicians' Desk Reference for
`Nonprescription Drugs and Dietary Supplements. Montvale, NJ:
`Medical Economics Co, 1999. Print. (Previously introduced as Ex.
`1053 in Dr. Zeisel’s deposition.)
`Exhibit 1054 Lindenbaum, J, EB Healton, DG Savage, JC Brust, TJ Garrett, ER
`Podell, PD Marcell, SP Stabler, and RH Allen. “Neuropsychiatric
`Disorders Caused by Cobalamin Deficiency in the Absence of
`Anemia or Macrocytosis.” The New England Journal of Medicine.
`318.26 (1988): 1720-8. Print. (Previously introduced as Ex. 1054
`in Dr. Zeisel’s deposition.)
`Exhibit 1055 Deposition transcript of Steven Zeisel, M.D., April 17, 2013, Eli
`Lilly and Company v. Teva Parenteral Medicines, Inc., et al., Case
`No. 1:10-cv-01376 (S.D. Ind.) (Previously introduced as Ex. 1055
`in Dr. Zeisel’s deposition.)
`Exhibit 1056 Trial transcript Volume VIII, August 28, 2013, Eli Lilly and
`Company v. Teva Parenteral Medicines, Inc., et al., Case No.
`1:10-cv-01376 (S.D. Ind.) (Previously introduced as Ex. 1056 in
`Dr. Zeisel’s deposition.)
`Exhibit 1057 FDA meeting transcript, July 27, 2001. (Previously introduced as
`Ex. 1042 in Dr. Chabner’s deposition.)
`
`
`
`5
`
`
`
`Description
`Exhibit No.
`Exhibit 1058 Barber MD, Ross JA, Voss AC, Tisdale MJ, Fearon KC., “The
`effect of an oral nutritional supplement enriched with fish oil on
`weight-loss in patients with pancreatic cancer.” Br J Cancer. 1999
`Sep;81(1):80-6.
`Exhibit 1059 Bodian, Martin. “Neuroblastoma: an Evaluation of Its Natural
`History and the Effects of Therapy, with Particular Reference to
`Treatment by Massive Doses of Vitamin B12.” Archives of
`Disease in Childhood. 38 (1963): 606-19.
`Exhibit 1060 Bodian, Martin. “Neuroblastoma.” Pediatric Clinics of North
`America. 6.2 (1959):449-472.
`Exhibit 1061 Cubeddu, LX, IS Hoffmann, NT Fuenmayor, and AL Finn.
`“Efficacy of Ondansetron (gr 38032f) and the Role of Serotonin in
`Cisplatin-Induced Nausea and Vomiting.” The New England
`Journal of Medicine. 322.12 (1990): 810-6.
`Exhibit 1062 Dietary Reference Intakes for Thiamin, Riboflavin, Niacin,
`Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and
`Choline. Washington, D.C: National Academy Press, 1998.
`Exhibit 1063 Brattström, L. “Vitamins As Homocysteine-Lowering Agents.”
`The Journal of Nutrition. 126.4 (1996). Print. (Previously
`introduced as Trial Exhibit TX 1050 in Eli Lilly and Company v.
`Teva Parenteral Medicines, Inc., et al., Case No. 1:10-cv-01376
`(S.D. Ind.))
`Exhibit 1064 Halpern, R M, Halpern, B C, Clark, B R, Ashe, H, Hardy, D N,
`Jenkinson, P Y, Chou, S C, and Smith, R A. “New approach to
`antifolate treatment of certain cancers as demonstrated in tissue
`culture.” Proceedings of the National Academy of Sciences of the
`United States of America. 72.10 (1975) 4018-4022. Print.
`(Previously introduced as Trial Exhibit TX 1336 in Eli Lilly and
`Company v. Teva Parenteral Medicines, Inc., et al., Case No.
`1:10-cv-01376 (S.D. Ind.))
`
`
`
`6
`
`
`
`Description
`Exhibit No.
`Exhibit 1065 Naurath, HJ, E Joosten, R Riezler, SP Stabler, RH Allen, and J
`Lindenbaum. “Effects of Vitamin B12, Folate, and Vitamin B6
`Supplements in Elderly People with Normal Serum Vitamin
`Concentrations.” Lancet (London, England). 346.8967 (1995): 85-
`9. Print. (Previously introduced as Trial Exhibit TX 1448 in Eli
`Lilly and Company v. Teva Parenteral Medicines, Inc., et al., Case
`No. 1:10-cv-01376 (S.D. Ind.))
`Exhibit 1066 Farber, S, EC Cutler, JW Hawkins, JH Harrison, EC Peirce, and
`GG Lenz. “The Action of Pteroylglutamic Conjugates on Man.”
`Science (New York, N.Y.). 106.2764 (1947): 619-21.
`Exhibit 1067 Horns, JW. “Rationale for Vitamin-B12 Treatment of
`Retinoblastoma.” American Journal of Ophthalmology. 61.5
`(1966): 910-1.
`Exhibit 1068 Dose-Response Information to Support Drug Registration. The
`International Council for Harmonisation of Technical
`Requirements for Pharmaceuticals for Human Use (ICH), 1994.
`Exhibit 1069 Kirkemo, AK, ME Burt, and MF Brennan. “Serum Vitamin Level
`Maintenance in Cancer Patients on Total Parenteral Nutrition.”
`The American Journal of Clinical Nutrition. 35.5 (1982): 1003-9.
`Exhibit 1070 Lindenbaum, John, David G. Savage, Sally P. Stabler, and Robert
`H. Allen. “Diagnosis of Cobalamin Deficiency: Ii. Relative
`Sensitivities of Serum Cobalamin, Methylmalonic Acid, and Total
`Homocysteine Concentrations.” American Journal of Hematology.
`34.2 (1990): 99-107.
`Exhibit 1071 Lockwood, K, S Moesgaard, T Hanioka, and K Folkers. “Apparent
`Partial Remission of Breast Cancer in 'high Risk' Patients
`Supplemented with Nutritional Antioxidants, Essential Fatty Acids
`and Coenzyme Q10.” Molecular Aspects of Medicine. 15 (1994):
`231-40.
`Exhibit 1072 Nilsson-Ehle, H. “Age-related Changes in Cobalamin (vitamin
`B12) Handling. Implications for Therapy.” Drugs & Aging. 12.4
`(1998): 277-92. Print. (Previously introduced as Trial Exhibit TX
`95 in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., et
`al., Case No. 1:10-cv-01376 (S.D. Ind.))
`
`
`
`7
`
`
`
`Description
`Exhibit No.
`Exhibit 1073 Priestman, Terry J. Cancer Chemotherapy: An Introduction.
`Chapter 5 - The Management of the Side Effects of
`Cytotoxic Drugs. London: Springer-Verlag, 1989.
`Exhibit 1074 Vu, Thu, Jyoti Amin, Mercedita Ramos, Victoria Flener, Lori
`Vanyo, and Glenn Tisman. “New Assay for the Rapid
`Determination of Plasma Holotranscobalamin II Levels:
`Preliminary Evaluation in Cancer Patients.” American Journal of
`Hematology. 42.2 (1993): 202-211.
`Exhibit 1075 Deposition transcript of Bruce A. Chabner, M.D., November 16,
`2016
`Exhibit 1076 Deposition transcript of Steven Zeisel, M.D., November 22, 2016
`Exhibit 1077 Supplemental Declaration of W. Archie Bleyer, M.D.,
`FRCP[Glasg]
`Exhibit 1078 Declaration of Joel Bernard Mason, B.S., M.D.
`Exhibit 1079 Curriculum Vitae of Joel Bernard Mason, B.S., M.D.
`Exhibit 1080 Declaration of David W. Feigal, Jr., M.D., M.P.H.
`Exhibit 1081 Curriculum Vitae of David W. Feigal, Jr., M.D., M.P.H.
`Exhibit 1082 Takimoto, Chris H. “New Antifolates: Pharmacology and Clinical
`Applications.” The Oncologist. 1 (1996):68-81.
`Exhibit 1083 McLean, A, and I Chanarin. “Urinary Excretion of 5-Methyl-
`Tetrahydrofolate in Man.” Blood. 27.3 (1966):386-8.
`Exhibit 1084 B A Chabner, C J Allegra, G A Curt, N J Clendeninn, J Baram, S
`Koizumi, J C Drake, and J Jolivet. “Polyglutamation of
`methotrexate. Is methotrexate a prodrug?.” J Clin Invest. 76.3
`(1985):907-912.
`Exhibit 1085 Habeck, LL, LG Mendelsohn, C Shih, EC Taylor, PD Colman, LS
`Gossett, TA Leitner, RM Schultz, SL Andis, and RG Moran.
`“Substrate Specificity of Mammalian Folylpolyglutamate
`Synthetase for 5,10-Dideazatetrahydrofolate Analogs.” Molecular
`Pharmacology. 48.2 (1995): 326-33.
`
`
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`8
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`
`
`Description
`Exhibit No.
`Exhibit 1086 Li, KM, LP Rivory, and SJ Clarke. “Pemetrexed Pharmacokinetics
`and Pharmacodynamics in a Phase I/ii Study of Doublet
`Chemotherapy with Vinorelbine: Implications for Further
`Optimisation of Pemetrexed Schedules.” British Journal of
`Cancer. 97.8 (2007): 1071-6.
`Exhibit 1087 Kuzminski, AM, Giacco E. J. Del, RH Allen, SP Stabler, and J
`Lindenbaum. “Effective Treatment of Cobalamin Deficiency with
`Oral Cobalamin.” Blood. 92.4 (1998): 1191-8.
`Exhibit 1088 Herbert, V. “Staging Vitamin B-12 (cobalamin) Status in
`Vegetarians.” The American Journal of Clinical Nutrition. 59.5
`(1994).
`Exhibit 1089 Markle HV. “Cobalamin.” Crit Rev Clin Lab Sci. 33.4 (1996):
`Abstract.
`Exhibit 1090 Gleeson, MH, and PS Graves. “Complications of Dietary
`Deficiency of Vitamin B12 in Young Caucasians.” Postgraduate
`Medical Journal. 50.585 (1974): 462-64.
`Exhibit 1091 Mann, NJ, D Li, AJ Sinclair, NP Dudman, XW Guo, GR Elsworth,
`AK Wilson, and FD Kelly. “The Effect of Diet on Plasma
`Homocysteine Concentrations in Healthy Male Subjects.”
`European Journal of Clinical Nutrition. 53.11 (1999): 895-9.
`Exhibit 1092 Carmel, R. “Cobalamin, the Stomach, and Aging.” The American
`Journal of Clinical Nutrition. 66.4 (1997): 750-9. Print.
`Exhibit 1093 Krasinski, Stephen D, Robert M. Russell, I M. Samloff, Robert A.
`Jacob, Gerard E. Dallal, Robert B. McGandy, and Stuart C. Hartz.
`“Fundic Atrophic Gastritis in an Elderly Population: Effect on
`Hemoglobin and Several Serum Nutritional Indicators.” Journal of
`the American Geriatrics Society. 34.11 (1986): 800-806.
`Exhibit 1094 Lindenbaum, J, IH Rosenberg, PW Wilson, SP Stabler, and RH
`Allen. “Prevalence of Cobalamin Deficiency in the Framingham
`Elderly Population.” The American Journal of Clinical Nutrition.
`60.1 (1994): 2-11.
`Exhibit 1095 MacLean, LD, BM Rhode, and HM Shizgal. “Nutrition Following
`Gastric Operations for Morbid Obesity.” Annals of Surgery. 198.3
`(1983): 347-55.
`
`
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`9
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`
`
`Description
`Exhibit No.
`Exhibit 1096
`Joel Bernard Mason, B.S., M.D. Materials Considered.
`Exhibit 1097 Barker, L R, John R. Burton, and Philip D. Zieve. Principles of
`Ambulatory Medicine. Baltimore: Williams & Wilkins, 1995.
`Exhibit 1098 Clarke, M.D R, and M.R.C.P J. Armitage. “Vitamin Supplements
`and Cardiovascular Risk: Review of the Randomized Trials of
`Homocysteine-Lowering Vitamin Supplements.” Seminars in
`Thrombosis and Hemostasis. 26.3 (2000).
`Exhibit 1099 Brönstrup, Dominique, Dominique Hages, and Dominique
`Pietrzik. “Lowering of Homocysteine Concentrations in Elderly
`Men and Women.” International Journal for Vitamin and
`Nutrition Research. 69.3 (1999): 187-193.
`Exhibit 1100 Herbert V. “Vitamin 8-12 and folic acid supplementation.” The
`American Journal of Clinical Nutrition. 66.6 (1997):1479
`Exhibit 1101 Physicians' Desk Reference: PDR, 1998. Montvale, NJ: Medical
`Economics Co, 1998.
`Exhibit 1102 Boushey, CJ, SA Beresford, GS Omenn, and AG Motulsky. “A
`Quantitative Assessment of Plasma Homocysteine As a Risk
`Factor for Vascular Disease. Probable Benefits of Increasing Folic
`Acid Intakes.” Jama. 274.13 (1995): 1049-57.
`Exhibit 1103 Saltzman, JR, JA Kemp, BB Golner, MC Pedrosa, GE Dallal, and
`RM Russell. “Effect of Hypochlorhydria Due to Omeprazole
`Treatment or Atrophic Gastritis on Protein-Bound Vitamin B12
`Absorption.” Journal of the American College of Nutrition. 13.6
`(1994):584-91.
`Exhibit 1104 U.S. Patent No. 5,563,126 to Allen et al., filed on December 29,
`1992, and issued on October 8, 1996 (“the ’126 patent”)
`Exhibit 1105 Reserved
`Exhibit 1106 CURTIN, M. “Neuroblastoma in Infancy Ireland with Vitamin B
`12.” Journal of the Irish Medical Association. 53 (1963):11-2.
`Exhibit 1107 Murray, Michael T. Encyclopedia of Nutritional Supplements: The
`Essential Guide for Improving Your Health Naturally. Rocklin,
`Calif: Prima Pub, 1996.
`Exhibit 1108 Declaration of Sarah E. Spires (NOT FILED)
`
`
`
`10
`
`
`
`Description
`Exhibit No.
`Exhibit 1109 Errata sheet for the November 10, 2016 deposition of Bruce
`Chabner, M.D.; Sandoz Inc., et al. v. Eli Lilly and Company,
`IPR2016-00318 (PTAB) (NOT FILED)
`Exhibit 1110 British Journal of Cancer Table of Contents (NOT FILED)
`Exhibit 1111 Errata sheet for the November 22, 2016 deposition of Steven H.
`Zeisel, M.D., Ph.D. (NOT FILED)
`Exhibit 1112 European Journal of Clinical Nutrition Table of Contents (NOT
`FILED)
`International Journal for Vitamin and Nutrition Research Table of
`Contents (NOT FILED)
`Exhibit 1114 The American Journal of Clinical Nutrition Table of Contents
`(NOT FILED)
`Exhibit 1115 Ambulatory Medicine, Chapter 50 (1995) (NOT FILED)
`Exhibit 1116 Transcript of February 22, 2017 Telephone Hearing
`
`Exhibit 1113
`
`
`
`
`
`11
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`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice
`requested)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`
`Mieke K. Malmberg (pro hac vice
`requested)
`SKIERMONT DERBY LLP
`800 Wilshire Boulevard
`Los Angeles, CA 90017
`P: 213-788-4500/F: 213-788-4545
`Back-Up Counsel for Petitioner
`
`
`
`12
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`February 24, 2017
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
`
`Current Exhibit List as of February 24, 2017 Pursuant to 37 C.F.R. § 42.63(e), by
`
`electronic means on February 24, 2017 at the following addresses of record:
`
`Dov P. Grossman (Reg. No. 72,525)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
`Lead Counsel for Patent Owner
`
`Adam L. Perlman (pro hac vice)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5244
`Facsimile: 202-434-5029
`aperlman@wc.com
`Back-Up Counsel for Patent Owner
`
`John C. Demeter (Reg. No. 30,167)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`Demeter_john_c@lilly.com
`Back-Up Counsel for Patent Owner
`
`David M. Krinsky (Reg. No. 72,339)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
`Back-Up Counsel for Patent Owner
`
`James P. Leeds (Reg. No. 35,241)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
`Back-Up Counsel for Patent Owner
`
`John D. Polivick (Reg. No. 57,926)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`jpolivick@rmmslegal.com
`Lead Counsel for Petitioner Apotex
`
`
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`Deanne M. Mazzochi (Reg. No. 50,158)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`dmazzochi@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Patrick C. Kilgore (Reg. No. 69,131)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`pkilgore@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Gary J. Speier (Reg. No. 45,458)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`gspeier@carlsoncaspers.com
`Lead Counsel for Petitioner Teva
`
`Mark D. Schuman (Reg. No. 31,197)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`mschuman@carlsoncaspers.com
`Back-Up Counsel for Petitioner Teva
`
`Cynthia Lambert Hardman
`(Reg. No. 45,458)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`chardman@goodwinprocter.com
`Back-Up Counsel for Petitioner Teva
`
`Patrick A. Doody
`(Reg. No. 35,002)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7538
`Fax: 703-770-7901
`patrick.doody@pillsburylaw.com
`Lead Counsel for Wockhardt Bio AG
`
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`Bryan P. Collins
`(Reg. No. 43,560)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7755
`Fax: 703-770-7901
`bryan.collins@pillsburylaw.com
`Back-Up Counsel for Wockhardt Bio AG
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`
`Lead Counsel for Petitioner
`
`Dated: February 24, 2017
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