`
`
`
` Case IPR2016-00318
`Patent 7,772,209
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD., MYLAN LABORATORIES
`LIMITED, TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG
`Petitioners,
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-003181
`Patent No. 7,772,209
`__________________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
`
`with the instant proceeding.
`
`
`
`
`
`Case IPR2016-00318
`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’s Post-Trial Brief, dated November 22,
`2013
`Exhibit Number Not Used
`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
`Exhibit Number Not Used
`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
`Exhibit Number Not Used
`
`United States Court of Appeals for the Federal Circuit Internal Operating
`Procedures
`Exhibit Number Not Used
`
`Exhibit Number Not Used
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Defendants’ Reply Post-Trial Brief Regarding the
`Invalidity of U.S. Patent No. 7,772,209, dated December 17, 2013
`Eli Lilly and Co. v. Teva Parenteral Medicines Inc. et al., Civil Action
`No. 1:10-cv-01376, Entry on Claim Construction, dated June 20, 2012
`Eli Lilly and Co. v. Teva Parenteral Medicines et al., United States Court
`of Appeals for the Federal Circuit Case 15-2067 Docket, dated March
`16, 2016
`
`2
`
`
`
`
`EXHIBIT
`
`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`2011
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`2012
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`2013
`
`2014
`
`2015
`
`
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`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)
`
`
`
`EXHIBIT
`
`2016
`
`2017
`
`2018
`
`2019
`
`Transcript of July 22, 2016 Teleconference with the Board
`
`2020
`
`PDR 53rd (1999)
`
`2021
`
`2022
`
`2023
`
`2024
`
`
`ABPI COMPENDIUM OF DATA SHEET AND SUMMARIES OF PRODUCT
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`Declaration of W. Archie Bleyer, M.D., FRCP [GLASG] (IPR2016-
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`
`
`Declaration of W. Archie Bleyer, M.D., FRCP [GLASG] (IPR2016-
`00240 Proceeding) [Not Filed]
`
`
`2025
`
`PDR 52nd (1998)
`
`2026
`
`Schiff Deposition Transcript
`
`
`
`3
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`
`
`
`EXHIBIT
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`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
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`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
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`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”)
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`AMERICAN SOCIETY OF CLINICAL ONCOLOGY Thirty Fifth Annual
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`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
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`AMERICAN SOCIETY OF CLINICAL ONCOLOGY Thirty Fifth Annual
`Meeting Program Volume 18, dated May 15-18, 1999 (Stamped Univ. of
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`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`
`
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`
`
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY,
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`2067
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`
`
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`
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`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
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`Clarke, et al., Lowering blood homocysteine withfolic acid based
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`den Heijer, et al., Vitamin Supplementation Reduces Blood
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`Patent 7,772,209
`
`DESCRIPTION
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`
`J. L. Grem, et al., Antimetabolites, CANCER CHEMOTHERAPY AND
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`
`DESCRIPTION
`
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`van Ede, et al., Methotrexate in Rheumatoid Arthritis: An Update With
`Focus on Mechanisms Involved in Toxicity, SEMINARS IN ARTHRITIS AND
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`WALL STREET JOURNAL ONLINE, (April 21, 2004) (“The Wall Street
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`
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`
`
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`Patent 7,772,209
`
`DESCRIPTION
`
`
`Yap, et al., Homocystinuria due to cystathionine β-synthase deficiency in
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`
`
`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]
`
`
`
`
`EXHIBIT
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`
`
`12
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`
`
`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]
`
`
`
`
`EXHIBIT
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`Fax from FDA regarding JMCH(c) dated January 6, 2000 [TX-2100]
`
`2107
`
`
`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]
`
`
`2108
`
`FDA Meeting Minutes dated March 1, 2000 [TX-2102]
`
`
`
`13
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`
`
`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)
`
`
`
`
`EXHIBIT
`
`2109
`
`2110
`
`2111
`
`Core Team Meeting Minutes (July 17, 1997) [TX-64]
`
`2112
`
`
`Lilly Minutes of the Antifolate Advisory Panel Meeting, Washington,
`DC (October 28 and 29, 1997) [TX-312]
`
`
`2113
`
`Antifolate Advisory Panel Meeting Minutes (March 16, 1998) [TX-74]
`
`2114
`
`Exhibit Number Not Used
`
`2115
`
`2116
`
`
`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
`
`
`2117
`
`Declaration of David M. Krinsky
`
`2118
`
`Declaration of Steven H. Zeisel, M.D., Ph.D.
`
`
`
`14
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`
`
`
`EXHIBIT
`
`2119
`
`Zeisel CV
`
`2120
`
`Declaration of Bruce A Chabner, M.D.
`
`2121
`
`Chabner CV
`
`2122
`
`Broxson, et al., Changes in Plasma Methionine and Total Homocysteine
`Levels in patients Receiving Methotrexate Infusions, CANCER RESEARCH,
`49:5879-5883 (1989)
`
`
`2123
`
`Declaration of Gregory T. Brophy, Ph.D.
`
`VIDAL LE DICTIONNAIRE, 21, 30 & 1985-1986 (1998) [w/
`Translation] (“Vidal 1998”) [Not Filed]
`
`Declaration of David M. Krinsky (with Exhibit A, 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 and 23, 2013)
`[Not Filed]
`
`Deposition Transcript of Ron D. Schiff, M.D. (August 25, 2016) [Not
`Filed]
`Letter to FDA regarding End of Phase II Meeting dated September 8,
`1998 [Not Filed]
`Minutes for the End of Phase II Meetings held on September 23, 1998 to
`discuss LY231514 with FDA [Not Filed]
`
`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 (1999) (“Boritzki II”) [Not Filed]
`
`15
`
`2124
`
`2125
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`Case IPR2016-00318
`Patent 7,772,209
`
`DESCRIPTION
`Mason et al., A Temporal Association between Folic Acid Fortification
`and an Increase in Colorectal Cancer Rates May Be Illuminating
`Important Biological Principles: A Hypothesis, CANCER EPIDEMIOL.
`BIOMARKERS PREV., 16(7):1325-1329 (2007) [Not Filed]
`
`
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`EXHIBIT
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`2130
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`2131
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`Transcript of January 25, 2017 Teleconference with the Board
`
`2132
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`Ross Deposition Transcript (January 20, 2017)
`
`2133
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`Feigal Deposition Transcript (February 8, 2017) [Not Filed]
`
`2134
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`Mason Deposition Transcript (January 25, 2017) [Not Filed]
`
`2135
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`Bleyer Deposition Transcript (January 31, 2017) [Not Filed]
`
`2136
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`Schiff Deposition Transcript (January 27, 2017)
`
`2137
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`Stover Deposition Transcript (February 10, 2017)
`
`
`
`Respectfully submitted,
`
`
`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Back-up Counsel for
`Patent Owner
`
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`
`
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`
`
`Date: February 14, 2017
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`16
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`Case IPR2016-00318
`Patent 7,772,209
`
`Washington, D.C. 20005
`202-434-5338 (Telephone)
`202-480-8302 (Facsimile)
`dkrinsky@wc.com
`
`
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`
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`17
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`Case IPR2016-00318
`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 14th day of February, 2017, on the Petitioner by delivering a copy via
`
`electronic mail to the following individuals at the email addresses below:
`
`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
`
`Joshua H. James
`Reg. No. 72,568
`jjames@brinksgilson.com
`
`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
`
`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
`
`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
`
`Counsel for Sandoz Inc.
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
`
`
`
`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
`
`
`
`
`
`
`
`
`
`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
`
`18
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`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`
`Patrick C. Kilgore
`Reg. No. 69,131
`pkilgore@rmmslegal.com
`
`
`
`
`
`
`
`
`
`
`19
`
`
`William A. Rakoczy
`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
`
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
`
`Attorneys for Apotex Inc. and Apotex
`Corp.
`
`Thomas J. Parker
`Reg. No. 42,062
`thomas.parker@alston.com
`
`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`P: 212-210-9529/F: 212-210-9444
`
`Counsel for Mylan Laboratories
`Limited
`
`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5135/F: 917-591-6921
`
`Counsel for Glenmark
`Pharmaceuticals Inc., USA, Glenmark
`
`
`
`
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`
`
`
`
`
`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
`
`
`
`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
`
`
`20
`
`Holding SA, and Glenmark
`Pharmaceuticals Ltd.
`
`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5290/F: 917-332-3063
`
`Counsel for Emcure Pharmaceuticals
`Ltd., Heritage Pharma Labs Inc., and
`Heritage Pharmaceuticals Inc.
`
`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
`
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
`
`Counsel for Wockhardt Bio AG
`
`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
`
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
`
`
`
`
`
`
`
`Case IPR2016-00318
`Patent 7,772,209
`
`/David M. Krinsky/
`David M. Krinsky
`Attorney for Patent Owner
`Registration No. 72,339
`Back-up Counsel for Patent
`Owner
`
`
`
`
`
`
`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
`
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Fresenius Kabi USA,
`LLC
`
`
`
`
`
`Date: February 14, 2017
`
`
`
`21
`
`
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