`
`Filed: November 9, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP.,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`
`PETITIONERS,
`
`V.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002371
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST AS OF NOVEMBER 9, 2016
`PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`1 Cases IPR2016-01190 and IPR2016-01341 have been joined with the instant
`proceeding.
`
`
`
`PETITIONER’S CURRENT EXHIBIT LIST
`(Updated November 9, 2016)
`
`
`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
`
`
`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
`
`
`
`4
`
`November 9, 2016
`
`
`
`
`
`
`
`
`
`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 November 9, 2016 Pursuant to 37 C.F.R. § 42.63(e), by
`
`electronic means on November 9, 2016 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
`
`
`
`
`
`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
`
`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
`
`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`
`Lead Counsel for Petitioner
`
`
`
`
`
`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
`
`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
`
`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
`
`Dated: November 9, 2016