UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
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`Petitioner
`
`v .
`
`ELI LILLY AND COMPANY,
`
`Patent Owner
`
`
`
`
`U.S. Patent 7,772,209
`Issue Date: Aug. 10, 2010
`Title: Antifolate Combination Therapies
`
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`Inter Partes Review No. 2016-00318
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`PETITIONER SANDOZ INC.’S
`CURRENT EXHIBIT LIST UNDER 37 C.F.R. § 42.63(e)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`
`Petitioner
`
`v .
`
`ELI LILLY AND COMPANY,
`
`Patent Owner
`
`
`
`
`U.S. Patent 7,772,209
`Issue Date: Aug. 10, 2010
`Title: Antifolate Combination Therapies
`
`
`
`
`
`
`Inter Partes Review No. 2016-00318
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`PETITIONER SANDOZ INC.’S
`CURRENT EXHIBIT LIST UNDER 37 C.F.R. § 42.63(e)
`
`
`
`Exhibit
`No.
`
`Exhibit
`1001:
`
`Exhibit
`1002:
`
`Exhibit
`1003:
`
`Exhibit
`1004:
`
`Exhibit
`1005:
`
`Exhibit
`1006:
`
`EXHIBIT LIST
`
`Description
`
`Referred To In
`The Petition As
`
`U.S. Patent No. 7,772,209
`
`“’209 patent”
`
`File History of U.S. Patent Application
`No. 11/776,329, which issued as U.S. Patent
`No. 7,772,209 on August 10, 2010
`
`“’209 file history”
`
`Findings Of Fact And Conclusions Of Law
`Following Bench Trial August 19, 2013, in
`Eli Lilly & Co. v. Teva Parenteral
`Medicines, Inc., Case No. 1:10-cv-1376,
`Dkt. 336 (S.D. Ind. March 31, 2014)
`
`“Teva Decision”
`
`Declaration of Ron D. Schiff, M.D., Ph.D.
`
`“Schiff Decl.”
`
`U.S. Patent No. 5,217,974
`
`“’974 patent”
`
`C. Niyikiza, et al., MTA (LY231514):
`Relationship of vitamin metabolite profile,
`drug exposure, and other patient
`characteristics to toxicity, Annals Oncology 9
`(Suppl. 4): 125-140, Abstract 609P, (1998)
`
`“Niyikiza I”
`
`Exhibit
`1007:
`
`Hilary Calvert, An Overview of Folate
`Metabolism: Features Relevant to the Action
`and Toxicities of Antifolate Anticancer
`Agents, Seminars Oncology, 26: 3-10 (1999)
`
`“Calvert”
`
`Exhibit
`1008:
`
`Textbook of Small Animal Medicine (John K.
`Dunn ed. 1999)
`
`“Animal Medicine”
`
`Exhibit
`1009:
`
`Sidney Farber, et al., Temporary Remissions in
`acute leukemia in children produced by folic
`
`“Farber”
`
`
`
`1
`
`
`
`Exhibit
`No.
`
`Description
`
`Referred To In
`The Petition As
`
`acid antagonist, 4-aminopteroylglutamic acid
`(aminopterin), New Eng. J. Med., 238(23):
`787-793
`
`Exhibit
`1010:
`
`Sarah L. Morgan, et al., Supplementation with
`Folic Acid during Methotrexate Therapy for
`Rheumatoid Arthritis, Annals Internal Med.,
`121: 833-841 (1994)
`
`“Morgan”
`
`Exhibit
`1011:
`
`G.B. Grindey, et al., Reversal of the toxicity but
`not the antitumor activity of Lometrexol by folic
`acid, Am. Ass’n Cancer Res., 32: 324, Abstract
`1921 (1991)
`
`“Grindey”
`
`Exhibit
`1012:
`
`Laurane G. Mendelsohn, et al., Preclinical and
`Clinical Evaluation of the Glycinamide
`Ribonucleotide Formyltransferase Inhibitors
`Lometrexol and LY309887, in Anticancer Drug
`Dev. Guide: Antifolate Drugs Cancer Therapy,
`(Ann L. Jackman, ed.) Ch. 12: 261-80 (1999)
`
`“Mendelsohn”
`
`Exhibit
`1013
`
`John F. Worzalla, et al., Role of Folic Acid in
`Modulating the Toxicity and Efficacy of the
`Multitargeted Antifolate, LY231514, Anticancer
`Res., 18: 3235-3240 (1998)
`
`“Worzalla”
`
`Exhibit
`1014
`
`L. Hammond, et al., A Phase I and
`Pharmacokinetic (PK) Study of the
`Multitargeted Antifol (MTA) LY231514 with
`Folic Acid, Proc. Am. Soc’y Clinical
`Oncology, 17: Abstract 866 (1998)
`
`“Hammond II”
`
`Exhibit
`1015
`
`L. Hammond, et al., A phase I and
`pharmacokinetic (PK) study of the multitargeted
`antifolate (MTA, LY231514) with folic acid
`(FA), Annals Oncology, 9: 129, Abstract 620P
`(1998)
`
`“Hammond I”
`
`
`
`2
`
`
`
`Exhibit
`No.
`
`Exhibit
`1016
`
`Exhibit
`1017
`
`Exhibit
`1018
`
`Exhibit
`1019
`
`Description
`
`C. Niyikiza, et al., LY231514 (MTA):
`Relationship of vitamin metabolite profile to
`toxicity, Proc. Am. Ass’n Cancer Res., 17: 558a,
`Abstract 2139 (1998)
`
`R. Thödtmann, et al., Preliminary Results of a
`Phase I Study with MTA (LY231415) in
`Combination with Cisplatin in Patients with
`Solid Tumors, Seminars Oncology, 26 (2, Suppl.
`6): 89-93 (1999)
`
`Referred To In
`The Petition As
`
`“Niyikiza II”
`
`“Thödtmann I”
`
`U.S. Patent No. 5,563,126
`
`“’126 patent”
`
`Ernest Beutler & James K. Weick, Blood and
`Neoplastic Disorders, in Current Clinical
`Practice (Messerli, ed., 1987), Ch. 1: 291-302
`
`“Beutler”
`
`Exhibit
`1020
`
`Lars Brattström, Vitamins as Homocysteine-
`Lowering Agents, J. Nutrition, 126: 1276S-
`1280S (1996)
`
`“Brattström”
`
`Exhibit
`1021
`
`Chuan Shih, et al., LY231514, a Pyrrolo[2,3-
`d]pyrimidine-based Antifolate That Inhibits
`Multiple Folate-requiring Enzymes, Cancer
`Res., 57, 1116- 1123 (1997)
`
`“Shih”
`
`Exhibit
`1022
`
`G. Robbin Westerhof, et al., Carrier- and
`Receptor-Mediated Transport of Folate
`Antagonists Targeting Folate-Dependent
`Enzymes: Correlates of Molecular-Structure
`and Biological Activity, Am. Soc’y
`Pharmacology Experimental Therapeutics, 48:
`459-471 (1995)
`
`“Westerhof”
`
`Exhibit
`1023
`
`F. G. Arsenyan, et al., Influence of
`Methylcobalamin on the Antineoplastic Activity
`of Methotrexate, Pharmaceutical Chemistry J.,
`
`“Arsenyan”
`
`
`
`3
`
`
`
`Exhibit
`No.
`
`Description
`
`Referred To In
`The Petition As
`
`12(10): 1299-1303 (1978)
`
`Exhibit
`1024
`
`File History of U.S. Patent Application
`No. 11/288,807, Abandoned
`
`“’807 File History”
`
`Exhibit
`1025
`
`U.S. Food & Drug Administration, Approved
`Drug Products with Therapeutic Equivalents
`Evaluations (30th ed. 2010)
`
`“Orange Book
`Listing for
`Alimta®”
`
`Exhibit
`1026
`
`Z.P. Sofyina, et al., Possibility to Increase the
`Antitumor Effect of Folic Acid Antagonist with
`the Help of Methylcobalamine Analogs, Sci.
`Center Oncology 1:72-78 (1979)
`
`Exhibit
`1027
`
`Victor Herbert, The Role of Vitamin B12 and
`Folate in Carcinogenesis, Advances
`Experimental Med. Biology, 206: 293-311
`(1986)
`
`“Sofyina”
`
`“Herbert”
`
`Exhibit
`1028
`
`Glenn Tisman, et al., Overcoming Colon Cancer
`Resistance to Hepatic Artery Infusional 5FUdR
`Chemotherapy with Folinic Acid, Clinical Res.,
`33(2): 459A (1985)
`
`“Tisman”
`
`Exhibit
`1029
`
`J.D. Kinloch, Maintenance Treatment of
`Pernicious Anaemia by Massive Parenteral
`Doses of Vitamin B12 at Intervals of Twelve
`Weeks, Brit. Med. J., 1:99-100 (1960)
`
`“Kinloch”
`
`Exhibit
`1030
`
`D. Wray, et al., Recurrent Aphthae: Treatment
`with Vitamin B12, Folic Acid, and Iron, Brit.
`Med. J., 2:490-93 (1975)
`
`“Wray”
`
`Exhibit
`1031
`
`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, Clin. Experimental Immunology,
`
`“Tamura”
`
`
`
`4
`
`
`
`Exhibit
`No.
`
`Description
`
`Referred To In
`The Petition As
`
`116:28-32 (1999)
`
`Exhibit
`1032
`
`Carrasco et al., Acute Megaloblastic Anemia:
`Homocysteine Levels Are Useful for Diagnosis
`and Follow-Up, Haematologica, 84: 767- 768
`(1999)
`
`“Carrasco”
`
`Exhibit
`1033
`
`Exhibit
`1034
`
`Exhibit
`1035
`
`Exhibit
`1036
`
`European Patent Application No. 0 595 005
`
`“EP005”
`
`U.S. Patent No. 5,344,932
`
`“’932 patent”
`
`Amended Joint Claim Construction Statement
`in Eli Lilly & Co. v. Teva Parenteral
`Medicines, Inc. et al., No. 1:10-cv-1376 (S.D.
`Ind.), filed April 19, 2012 (Dkt. 110)
`
`“Joint Claim
`Construction
`Statement”
`
`Excerpts from transcript of the trial on
`invalidity held between August 19 and August
`29, 2013 in Eli Lilly & Co. v. Teva Parenteral
`Medicines, Inc., Case No. 1:10-cv-1376 (S.D.
`Ind.)
`
`“Teva Litigation
`Trial Tr.”
`
`Exhibit
`1037
`
`E. Bajetta et al., Phase II study of pemetrexed
`disodium (Alimta®) administered with oral
`folic acid in patients with advanced gastric
`cancer, Annals of Oncology 14:1543-48
`(2003).
`
`“Bajetta”
`
`Exhibit
`1038
`
`Letter dated February 4, 2004 from Robert
`Temple to John Worzalla concerning NDA 21-
`462
`
`“Alimta®
`Approval Letter”
`
`Exhibit
`1039
`
`Johan B. Ubbink et al., Vitamin Requirements
`for the Treatment of Hyperhomocysteinemia in
`Humans, J. Nutrition 124:1927-1933 (1994)
`
`“Ubbink I”
`
`Exhibit Anja Brönstrup et al., Effects of folic acid and
`
`“Brönstrup”
`
`
`
`5
`
`
`
`Exhibit
`No.
`
`1040
`
`Description
`
`Referred To In
`The Petition As
`
`combinations of folic acid on plasma
`homocysteine concentrations in healthy, young
`women, Am. J. Clin. Nutr. 1998:68:1104-10
`(1998)
`
`Exhibit
`1041
`
`J. B. Ubbink, The role of vitamins in the
`pathogenesis and treatment of
`hyperhomocyst(e)inaemia, J. Inherited
`Metabolic Disease, 20:316-25 (1997)
`
`“Ubbink II”
`
`Exhibit
`1042
`
`S. Sörenson et al., A systematic overview of
`chemotherapy effects in non-small cell lung
`cancer, Acta Oncologica 40(2-3):327-29 (2001)
`
`“Sörenson”
`
`Exhibit
`1043
`
`R. Thödtmann et al., Phase I study of different
`sequences of MTA (LY231514) in combinaition
`with cisplatin in patients with solid tumours,
`Annals Oncology, 9: 129, 618P (Abstract)
`(1998)
`
`“Thödtmann II”
`
`Exhibit
`1044
`
`Complaint filed in Eli Lilly & Co. v. Teva
`Parenteral Medicines, Inc., No. 1:08-cv-335 (D.
`Del.) on June 5, 2008
`
`“Delaware Teva
`Litigation
`Complaint”
`
`Exhibit
`1045
`
`Calvert, MTA: Summary and Conclusions,
`Seminars in Oncology, 26 (2, Suppl. 6): 105-08
`(1999)
`
`“MTA: Summary
`& Conclusions”
`
`Exhibit
`1046
`
`Center for Drug Evaluation and Research,
`Product Development under the Animal Rule:
`Guidance for the Industry (October 2015)
`
`“FDA Animal
`Rule Guidance”
`
`Exhibit
`1047
`
`A.H. Calvert & J.M. Walling, Clinical Studies
`with MTA, British J. Cancer (1998) 78 (Suppl.
`3): 35-40
`
`“Calvert &
`Walling”
`
`Exhibit
`1048
`
`Center for Drug Evaluation and Research,
`Guidance for Industry: Single Dose Acute
`Toxicity Testing for Pharmaceuticals (August
`
`“FDA Single Dose
`Guidance”
`
`
`
`6
`
`
`
`Exhibit
`No.
`
`1996)
`
`Description
`
`Referred To In
`The Petition As
`
`Exhibit
`1049
`
`Center for Drug Evaluation and Research, E6
`Good Clinical Practice: Consolidated Guidance
`(April 1996)
`
`“FDA E6
`Guidance”
`
`Exhibit
`1050
`
`Robert H. Allen et al., Diagnosis of Cobalamin
`Deficiency I: Usefulness of Serum
`Methylmalonic Acid and Total Homocysteine
`Concentrations, Am. J. Hematology 34:90-98
`(1990)
`
`Allen
`
`Exhibit
`1051
`
`Eli Lilly & Company, Alimta® Labeling
`(Revised Sept. 2013)
`
`“Alimta Labeling”
`
`Exhibit
`1052
`
`Rusthoven et al., Multitargeted Antifolate
`LY231514 as First-Line Chemotherapy for
`Patients with Advanced Non-Small-Cell Lung
`Cancer: A Phase II Study, J. Clin. Oncology, 17
`(4) 1194-99 (April 1999)
`
`“Rusthoven”
`
`Exhibit
`1053
`
`Return of Service, Eli Lilly & Co. v. Sandoz
`Inc., Case No. 1:14-cv-2008 (S.D. Ind. Dec. 29,
`2014)
`
`“Return of
`Service”
`
`Exhibit
`1054
`
`FDA, Electronic Orange Book: Approved Drug
`Products and Therapeutic Equivalence
`Evaluations Entry for Alimta®, available at
`http://www.accessdata.fda.gov/scripts/cder/ob/d
`ocs/patexclnew.cfm?Appl_No=021462&Produc
`t_No=001&table1=OB_Rx (last accessed Dec.
`14, 2015)
`
`“2015 Alimta®
`Orange Book
`Listing”
`
`Exhibit
`1055
`
`Declaration of L. Lydigsen in support of
`Motion to Admit Pro Hac Vice As Backup
`Counsel
`
`“Lydigsen
`Declaration”
`
`
`
`
`
`7
`
`
`
`
`
`Respectfully submitted,
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`8
`
`Dated: February 25, 2016
`
`
`
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`
`
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`
`
`
`
`
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`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing Petitioner Sandoz
`Inc.’s Current Exhibit List Under 37 C.F.R. § 42.63(e) were served on February
`25, 2016 via electronic mail to the following individuals at the email addresses
`below.
`
`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
`
`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
`
`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
`
`Dated: February 25, 2016
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
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