`Patent 7,772,209
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NEPTUNE GENERICS, LLC,
`Petitioner,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-00240
`Patent No. 7,772,209
`__________________
`
`
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`
`DESCRIPTION
`Lilly Eli & Co. Form 10-k Annual Report filed February 19, 2016 for the
`Period Ending December 31, 2015
`Alimta Prescribing Information revised September 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Defendants’ Opening Post-Trial Brief Regarding the
`Invalidity of U.S. Patent No. 7,772,209, dated October 11, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Plaintiff Eli Lilly and Company’s Post-Trial Brief,
`dated November 22, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Defendants’ Trial Brief Regarding the Invalidity of
`U.S. Patent No. 7,772,209, dated June 14, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Joint Trial Exhibit List, dated August 18, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Official Reporter’s Transcript of Bench Trial
`Volume VI, dated August 26, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines et al., United States Court
`of Appeals for the Federal Circuit Case 15-2067, Notice of Docketing,
`dated September 25, 2015
`Eli Lilly and Co. v. Teva Parenteral Medicines et al., United States Court
`of Appeals for the Federal Circuit Case 15-2067, Order on Motion to
`Modify Briefing Schedule, dated November 5, 2015
`
`United States Court of Appeals for the Federal Circuit Internal Operating
`Procedures
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Official Reporter’s Transcript of Bench Trial
`Volume VII, dated August 27, 2013
`
`EXHIBIT
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`Exhibit Number Not Used
`
`
`
`2
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`2013
`
`Exhibit Number Not Used
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Exhibit Number Not Used
`
`
`Niyikiza, et al., LY231514 (MTA): Relationship of vitamin metabolite
`profile to toxicity, AMERICAN SOCIETY OF CLINICAL ONCOLOGY, 17:
`558a, Abstract 2139 (1998) (“Niyikiza II”)
`
`The New Shorter Oxford English Dictionary on Historical Principles
`[excerpt] Vol. 2, pg. 2123 (1993)
` Random House Unabridged Dictionary [excerpt], 2nd Ed., pg. 1421
`(1993)
`
`Affidavit of Adam L. Perlman In Support of Motion for Pro Hac Vice
`Admission Pursuant to 37 C.F.R. § 42.10(c)
`
`Transcript of July 22, 2016 Teleconference with the Board
`
`PDR 53rd (1999)
`
`ABPI COMPENDIUM OF DATA SHEET AND SUMMARIES OF PRODUCT
`CHARACTERISTICS 1998-99:1542-45 (1998) (“ABPI Compendium of
`Data Sheets”)
`
`
`Rinaldi, et al., A phase I evaluation of LY231514, a novel multitargeted
`antifolate, administered every 21 days, AMERICAN SOCIETY OF CLINICAL
`ONCOLOGY, 15: 489, Abstract 1559 (1996) (“Rinaldi I”)
`
`
`Declaration of W. Archie Bleyer, M.D., FRCP [GLASG] (IPR2016-
`00237 Proceeding)
`
`
`
`
`3
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Declaration of W. Archie Bleyer, M.D., FRCP [GLASG] (IPR2016-
`00240 Proceeding)
`
`PDR 52nd (1998)
`
`Deposition Transcript of Ron D. Schiff, M.D. (August 25, 2016) [Not
`Filed]
`
`Deposition Transcript of W. Archie Bleyer, M.D., FRCP [GLASG]
`Part 1 (August 30, 2016)
`
`
`Deposition Transcript of W. Archie Bleyer, M.D., FRCP [GLASG]
`Part 2 (August 31, 2016)
`
`Exhibit Number Not Used
`
`Rinaldi, Overview of Phase I Trials of Multitargeted Antifolate (MTA, LY
`231514), SEMINARS IN ONCOLOGY, 26 (2:6): 82-88 (1999) (Stamped
`Univ. Wisconsin Health Sciences Library) (“Rinaldi II”)
`
`
`Laohavinij, et al., A Phase I clinical study of the antipurine antifolate
`lometrexol (DDATHF) given with oral folic acid, INVESTIGATIONAL NEW
`DRUGS, 14: 325-335 (1996) (“Laohavinij”)
`
`
`VIDAL LE DICTIONNAIRE, 21, 30 & 1985-1986 (1998) [w/
`Translation] (“Vidal 1998”)
`
`
`Quinn et al., Evaluation of Homocysteine and Excitatory Amino Acid
`Neurotransmitters in the CSF of Children Who Received Methotrexate
`for the Treatment of Cancer, JOURNAL OF CLINICAL ONCOLOGY, 15:
`2800-2806 (1997) (“Quinn”)
`
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`
`
`4
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Calvert, MTA: Summary and Conclusions, SEMINARS IN ONCOLOGY,
`26(2:6): 105-108 (1999) (Stamped Univ. of Wisconsin Health Sciences
`Library) (“Calvert II”)
`
`
`Hammond, et al., A phase I and pharmacokinetic (PK) study of the
`multitargeted antifol (MTA) LY231514 folic acid, AMERICAN SOCIETY OF
`CLINICAL ONCOLOGY, 17: 225a, Abstract 866 (1998) (“Hammond II”)
`
`Exhibit Number Not Used
`
`Dierkes, et al., Supplementation With Vitamin B12 Decreases
`Homocysteine and Methylmalontc, / Acid But Also Serum Folate in
`Patients With End-Stage Renal Disease, METABOLISM, 48(5): 631-635
`(1999) (Stamped Univ. of Wisconsin Health Sciences Library)
`(“Dierkes”)
`
`
`Gulati, et al., Posttranscriptional Regulation of Mammalian Methionine
`Synthase by B 12, BIOCHEMICAL AND BIOPHYSICAL RESEARCH
`COMMUNICATIONS, 259: 436-442 (1999) (“Gulati”)
`
`Exhibit Number Not Used
`
`Smith, et al., Enhanced Antitumor Activity for the Thymidylate Synthase
`Inhibitor 1843U89 through Decreased Host Toxicity with Oral Folic
`Acid, CANCER RESEARCH, 55:6117-6125 (1995) (“Smith & Amyx”)
`
`
` P. Sofyina, et al., Possibility to Increase the Antitumor Effect of Folic
`Acid Antagonist with the Help of Methylcobalamine Analogs, SCIENTIFIC
`CENTER ONCOLOGY, 1:72-78 (1979) (“Sofyina”) (Lilly Translation)
`
`
` Z
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`
`
`5
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Farber, et al., Temporary Remissions in Acute Leukemia in Children
`Produced by Folic Acid Antagonist, 4-Aminopteroyl-Glutamic Acid
`(Aminopterin), THE NEW ENGLAND JOURNAL OF MEDICINE, 238(23): 787-
`793 (1948) (“Farber”)
`
`
`Mendelsohn, et al., Preclinical and Clinical Evaluation of the
`Glycinamide Ribonucleotide Formyltransferase Inhibitors Lometrexol
`and LY309887, ANTIFOLATE DRUGS IN CANCER THERAPY, Jackman (Ed),
`261-280 (1999) (“Mendelsohn”)
`
`
`Boritzki, et al., AG2034 A GAR.FT Inhibitor with Selective Cytotoxicity
`to Cells that Lack a GI Checkpoint, ANTIFOLATE DRUGS IN CANCER
`THERAPY, Jackman (Ed), 281-292 (19 ) (“Boritzki”)
`
`
`Halford, et al., A Phase I and pharmacokinetic study of LY309887 given
`every 3 weeks with folic acid supplementation, AMERICAN SOCIETY OF
`CLINICAL ONCOLOGY, 18: 170a, Abstract 652 1999) (Stamped Univ. of
`Minn. Bio-Medical Library) (“Halford”)
`
`
`Bailey, et al., Oral Jolie acid improves lometrexol toxicity profile: A
`phase I Study, EUROPEAN JOURNAL OF CANCER, 31A(suppl 5): Sl93-Sl94,
`Abstract 931 (1995) (“Bailey”)
`
`
`Synold, et al., Cellular but not plasma pharmacokinetics of lometrexol
`correlate with the occurrence of cumulative hematological toxicity,
`CLINICAL CANCER RESEARCH, 4: 2349-2355 (1998) (“Synold”)
`
`
`Wedge, et al., Clinical pharmacokinetics of the antipurine antifolate
`(6R)-5, 1 O-dideaza-5, 6, 7, 8-tetrahydrofolic acid (Lometrexol)
`administered with an oral Jolie acid supplement, CLINICAL CANCER
`RESEARCH, 1: 1479-1486 (1995) (“Wedge”)
`
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`
`
`6
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Young, et al., Improved clinical tolerance of /ometrexol with oral Jolie
`acid, AMERICAN ASSOCIATION FOR CANCER RESEARCH, 33: 406, Abst.
`2422 (1992) (“Young”)
`
`
`AMERICAN SOCIETY OF CLINICAL ONCOLOGY Thirty Fifth Annual
`Meeting Program Volume 17, dated May 16-19, 1998 (Stamped Univ. of
`Minn. Bio-Medical Library) (“1998 ASCO Abstracts”)
`
`
`AMERICAN SOCIETY OF CLINICAL ONCOLOGY Thirty Fifth Annual
`Meeting Program Volume 18, dated May 15-18, 1999 (Stamped Univ. of
`Minn. Bio-Medical Library) (“1999 ASCO Abstracts”)
`
`
`Graul, Pemetrexed Disodium, DRUGS OF THE FUTURE, 23(5): 498-507
`(1998) (“Graul”)
`
`
`D. D. Von Hoff and J. Turner, Response rates, duration of response, and
`dose response effects of phase I studies of antineoplastics,
`INVESTIGATIONAL NEW DRUGS, 9:115-122 (1991) (“Von Hoff”)
`
`
`E. Chu and C. J. Allegra, Antifolates, in CANCER CHEMOTHERAPY AND
`BIOTHERAPY: PRINCIPLES AND PRACTICE (Bruce A. Chabner & D. L.
`Longo eds., 1996) (“Chu”)
`
`
`Arsenyan, et al., Influence of Methylcobalamin on the Antineoplastic
`Activity of Methotrexate, PHARMACEUTICAL CHEMISTRY JOURNAL,
`12(10): 1299-1303 (1978) (“Arsenyan”)
`
`
`Barak, et al., Vitamin B 12 as a Possible Adjunct in Prevention of
`Methotrexate Hepatotoxicity, BIOCHEMICAL ARCHIVES, 1: 139-142
`(1985) (“Barak I”)
`
`
`7
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Barak, et al,.Methotrexate Hepatotoxicity, JOURNAL OF THE AMERICAN
`COLLEGE OF NUTRITION, 3 :93-96 (1984) (“Barak II”)
`
`
`G. R. McLean et al., Cobalamin Analogues Modulate the Growth of
`Leukemia Cells in Vitro, CANCER RESARCH, 57: 4015-4022 (1997)
`(“McLean”)
`
`
`VIDAL LE DICTIONNAIRE, 2052 (1999) [w/ Translation] (“Vidal
`1999”)
`
`
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY,
`19th ed., 47-48 (1995) (“Remington’s”)
`
`Sandoz Petition for Inter Partes Review [Not Filed]
`
`J.D. Kinloch, Maintenance Treatment of Pernicious Anaemia by Massive
`Parenteral Doses of Vitamin B12 at Intervals of Twelve Weeks, BRITISH
`MEDICAL JOURNAL, 1:99-100 (1960) (“Kinloch”)
`
`
`Zervos, et al. Functional Folate Status as a Prognostic Indicator of
`Toxicity in Clinical Trials of the Multitargeted antifolate LY231514,
`EUROPEAN JOURNAL OF CANCER, 33(Suppl. 8): SI 8 (1997)
`(“Zervos II”)
`
`
`Exhibit Number Not Used
`
`L. Brattström, Vitamins as Homocysteine-Lowering Agents, JOURNAL
`NUTRITION, 126: 1276S-1280S (1996) (“Brattström”)
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`
`
`8
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Ubbink, et al., Vitamin Requirements for the Treatment of
`Hyperhomocysteinemia in Human, THE JOURNAL OF NUTRITION, 124(1):
`1927-1933 (1994) ("Ubbink I")
`
`
`Ubbink, The role of vitamins in the pathogenesis and treatment of
`hyperhomocyst(e)inaemia, JOURNAL OF INHERITED METABOLIC DISEASE,
`20: 316-325 (1997) (“Ubbink II”)
`
`Exhibit Number Not Used
`
`Naurath, et al., Effects of vitamin B 12, folate, and vitamin B6
`supplements in elderly people with normal serum vitamin concentrations,
`THE LANCET, 346: 85-89 (1995) (“Naurath”)
`
`
`Clarke, et al., Lowering blood homocysteine withfolic acid based
`supplements: meta-analysis of randomized trials, BRITISH MEDICAL
`JOURNAL, 316: 894-898 (1998) (“Clarke”)
`
`
`den Heijer, et al., Vitamin Supplementation Reduces Blood
`Homocysteine Levels, ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR
`BIOLOGY, 18: 356-361 (1998) (“den Heijer”)
`
`U.S. Patent No. 5,217,974 [Not Filed]
`
`Jackman and Calvert, Folate-based thymidylate synthase inhibitors as
`anticancer drugs, ANNALS OF ONCOLOGY, 6: 871-881 (1995)
`(“Jackman”)
`
`
`P. G. Johnston et al., "Antimetabolites," CANCER CHEMOTHERAPY AND
`BIOLOGICAL RESPONSE MODIFIERS ANNUAL 17 (Pinedo, et al., eds.)
`Chapter 1: 1-39 (1997) (“Johnston”)
`
`
`9
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Shih, et al., LY23 J 514, a Pyrrolo(2, 3-d)pyrimidine-based Antifolate
`That Inhibits Multiple Folate-requiring Enzymes, CANCER RESEARCH,
`57: 1116-1123 (1997) (“Shih”)
`
`
`J. L. Grem, et al., Antimetabolites, CANCER CHEMOTHERAPY AND
`BIOLOGICAL RESPONSE MODIFIERS ANNUAL 18 (Pinedo, et al., eds.)
`Chapter 1: 1-38 (1999) (“Grem”)
`
`
`G. R. Westerhof, et al., Carrier- and Receptor-Mediated Transport of
`Folate Antagonists Targeting Folate-Dependent Enzymes: Correlates of
`Molecular-Structure and Biological Activity, AMERICAN SOCIETY
`PHARMACOLOGY EXPERIMENTAL THERAPEUTICS, 48:459-471 (1995)
`(“Westerhof”)
`
`
`Shih, et al., Multiple folate enzyme inhibition: Mechanism of a novel
`pyrrolopyrimidin -based antifolate LY231514 (MTA), ADVANCES IN
`ENZYME REGULATION, 38: 135-152 (1998) (“Shih 1998”)
`
`
`G. Tisman, et al., Overcoming Colon Cancer Resistance to Hepatic
`Artery Infusional 5FUdR Chemotherapy with Folinic Acid, CLINICAL
`RESEARCH, 33(2): 459A (1985) (“Tisman”)
`
`
`V. Herbert, The Role of Vitamin B12 and Folate in Carcinogenesis,
`ADVANCES EXPERIMENTAL MEDICAL BIOLOGY, 206: 293-311 (1986)
`(“Herbert”)
`
`
`DIETARY REFERENCE INTAKES FOR THIAMIN, RIBOFLAVIN, NIACIN,
`VITAMIN B6, FOLATE, VITAMIN B 12, PANTOTHENIC ACID, BIOTIN, AND
`CHOLINE, National Academy Press, 196-352 (1998) (“DRI”)
`
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`
`
`10
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Omenn, et al., Preventing Coronary Heart Disease: B Vitamins and
`Homocysteine, CIRCULATION, 97: 421-424 (1998) (“Omenn”)
`
`
`Grindey, et al., Reversal of the toxicity but not the antitumor activity of
`Lometrexol by folic acid, American Association for Cancer Research, 32:
`324, Abstract 1921 (1991) (“Grindey”)
`
`Exhibit Number Not Used
`
`S. L. Morgan, et al., Supplementation with Folic Acid during
`Methotrexate Therapy for Rheumatoid Arthritis, ANNALS OF INTERNAL
`MEDICINE, 121: 833-841 (1994) ("Morgan 1994”)
`
`
`van Ede, et al., Methotrexate in Rheumatoid Arthritis: An Update With
`Focus on Mechanisms Involved in Toxicity, SEMINARS IN ARTHRITIS AND
`RHEUMATISM, 27(5): 277-292 ( 1998) (“van Ede”)
`
`
`Shiroky, The Use of Folates Concomitantly with Low-Dose Pulse
`Methotrexate, RHEUMATIC DISEASE CLINICS OF NORTH AMERICA, 23( 4):
`969-980 (1997) (“Shiroky”)
`
`E. Beutler and J. K. Weick, Blood and Neoplastic Disorders, in
`CURRENT CLINICAL PRACTICE (Messerli, ed., 1987), Ch. 1: 291-302
`
`J. Tamura, et al., Immunomodulation by Vitamin B12: Augmentation of
`CD8+ T Lymphocytes and Natural Killer (NK) Cell Activity in Vitamin
`B12-Deficient Patients by Methyl-B12 Treatment, CLINICAL
`EXPERIMENTAL IMMUNOLOGY, 116:28-32 (1999) (“Tamura”)
`
`
`D. Wray, et al., Recurrent Aphthae: Treatment with Vitamin B12, Folic
`Acid, and Iron, BRITISH MEDICAL JOURNAL, 2:490-493 (1975) (“Wray”)
`
`
`11
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Burton, By Learning From Failures, Lilly Keeps Drug Pipeline Full, THE
`WALL STREET JOURNAL ONLINE, (April 21, 2004) (“The Wall Street
`Journal”)
`
`Declaration of Ron D. Schiff, M.D., Ph.D. [Not Filed]
`
`Combs, Gerald R., THE VITAMINS: FUNDAMENTAL ASPECTS IN
`NUTRITION AND HEALTH (2d ed. 1998) (Chapter 16)
`
`
`Stabler, et al., Elevation of Total Homocysteine in the Serum of Patients
`with Cobalamin or Folate Deficiency Detected by Capillary Gas
`Chromatography—Mass Spectrometry, JOURNAL OF CLINICAL
`INVESTIGATION, 81(2): 466-74 (1988) (“Stabler”)
`
`
`Yap, et al., Homocystinuria due to cystathionine β-synthase deficiency in
`Ireland: 25 years’ experience of a newborn screened and treated
`population with reference to clinical outcome and biochemical control,
`JOURNAL OF INHERITED METABOLIC DISEASE, 21:738-747 (1998) (“Yap
`1998”)
`
`
`Mudd, et al., The Natural History of Homocystinura Due to Cystationine
`β-Synthase Deficiency, AM. J. HUM. GENET. 37:1-31 (1985) (“Mudd
`1985”)
`
`
`Wendel, et al., Betaine in the treatment of homocystinuria due to 5,10-
`methylenetetrahydrofolate reductase deficiency, EUROPEAN JOURNAL OF
`PEDIATRICS, 142(2): 147-150 (1984) (“Wendel”)
`
`
`Letter to FDA regarding Briefing document for End-of-Phase II Meeting
`dated 7/29/1998 [TX-2083]
`
`
`12
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Letter to FDA regarding End of Phase II Meeting dated September 8,
`1998
`
`
`LY231514 (MTA) End of Phase 2 Meeting with the FDA Clinical Issues
`– Friday, September 25, 1998 at FDA [TX-326]
`
`
`Letter from Lilly to FDA re IND 40,061 – LY231514 Serial No. 137
`End-of-Phase 2 Meeting Minutes Compound LY231514 (MTA<
`Multitargeted Antifolate), dated November 18, 1998 [TX-392]
`
`
`Letter from Lilly to FDA re IND 40,061 – MTA (LY231514) Serial No.
`194 Letter to Investigate Regarding Patients with High Baseline
`Homocysteine Levels, dated November 24, 1999 [TX-394]
`
`
`Letter from Lilly to FDA re IND 40,061 – MTA (LY231514) Serial No.
`195 Supplementation with Folic Acid and Vitamin B12 to Reduce
`Toxicity in Patients Receiving LY231514, dated December 3, 1999 [TX-
`330]
`
`
`Fax from the FDA to Lilly referring to November 8 and December 3,
`1999 LY231514 (MTA) submissions, dated December 21, 1999 [TX-
`1463]
`
`
`Letter to FDA regarding response to 12/21/99 fax dated December 22,
`1999 [TX-2262]
`
`Fax from FDA regarding JMCH(c) dated January 6, 2000 [TX-2100]
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`
`
`13
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`
`Letter from Lilly to FDA re LY231514 (MTA, MultiTargeted
`Antifolate); IND # 40,061 Serial No. 207 Briefing Document for March
`1 meeting to Discuss Vitamin Supplementation in the Ongoing
`Mesothelioma Registration Trial, dated February 16, 2000 [TX-913]
`
`FDA Meeting Minutes dated March 1, 2000 [TX-2102]
`
`Letter from Lilly to FDA re Meeting Minutes (MTA, MultiTargeted
`Antifolate); IND 40,061 – LY231514 Serial No. 216 Meeting Minutes
`from the March 1, 2000 Meeting to Discuss Vitamin Supplementation
`Instituted in the Ongoing Mesothelioma Registration Trial, dated March
`20, 2000 [TX-337]
`
`
`Niyikiza et al., Homocysteine and Methylmalonic Acid: Markers to
`Predict and Avoid Toxicity from Pemetrexed Therapy 1, MOLECULAR
`CANCER THERAPEUTICS, 1:545-552 (2002)
`
`Core Team Meeting Minutes (July 17, 1997) [TX-64]
`
`Lilly Minutes of the Antifolate Advisory Panel Meeting, Washington,
`DC (October 28 and 29, 1997) [TX-312]
`
`Antifolate Advisory Panel Meeting Minutes (March 16, 1998) [TX-74]
`
`Z.P. Sofyina, et al., Possibility to Increase the Antitumor Effect of Folic
`Acid Antagonist with the Help of Methylcobalamine Analogs, SCIENTIFIC
`CENTER ONCOLOGY, 1:72-78 (1979) (“Sofyina”) (w/ Translation)
`
`
`Exhibit Number Not Used
`
`Excerpts from Trial Testimony of Dr. Clet Niyikiza in Eli Lilly & Co. v.
`Teva Parenteral Medicines, Inc. et al., No. 10-cv-0136-TWP-DKL (S.D.
`Ind.), dated August 22, 2013
`
`14
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
` 2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`2117
`
`Declaration of David M. Krinsky
`
`2118
`
`Declaration of Steven H. Zeisel, M.D., Ph.D.
`
`2119
`
`Zeisel CV
`
`2120
`
`Declaration of Bruce A Chabner, M.D.
`
`2121
`
`2122
`
`2123
`
`Chabner CV
`
`Broxson, et al., Changes in Plasma Methionine and Total Homocysteine
`Levels in patients Receiving Methotrexate Infusions, CANCER RESEARCH,
`49:5879-5883 (1989)
`
`Declaration of Gregory T. Brophy, Ph.D.
`
`
`
`Respectfully submitted,
`
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for
`Patent Owner
`
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`202-434-5812 (Telephone)
`202-434-5029 (Facsimile)
`dgrossman@wc.com
`
`
`
`
`
`
`
`
`
`Date: September 30, 2016
`
`
`
`
`
`15
`
`
`
`Case IPR2016-00240
`Patent 7,772,209
`
`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the document above was served on
`
`
`
`
`
`this 30th day of September, 2016, on the Petitioner by delivering a copy via
`
`electronic mail to the following individuals at the email addresses below:
`
`/Dov P. Grossman/
`Dov P. Grossman
`Attorney for Patent Owner
`Registration No. 72,525
`Lead Counsel for Patent Owner
`
`
`Sarah E. Spires
`Reg. No. 61,501
`240Neptune@skiermontderby.com
`
`Dr. Parvathi Kota
`Reg. No. 65,122
`240Neptune@skiermontderby.com
`
`Skiermont Derby LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`
`
`
`
`
`16
`
`Date: September 30, 2016