Case 1:10-cv-01376-TWP-DKL Document 302 Filed 08/18/13 Page 1 of 3 PageID #: 5989
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`
`Plaintiff,
`
`v.
`
`)
`ELI LILLY AND COMPANY,
`
`)
`
`
`)
`
`
` )
`
` ) Civil Action No. 1:10-cv-01376-TWP-DKL
`
` )
`
`
`
` )
`TEVA PARENTERAL MEDICINES, INC.,
` )
`APP PHARMACEUTICALS, LLC,
` )
`PLIVA HRVATSKA D.O.O.,
`TEVA PHARMACEUTICALS USA, INC., and )
`BARR LABORATORIES, INC.,
` )
`
` )
`
` )
`
` )
`
`Defendants.
`
`
`
`
`
`
`
`JOINT TRIAL EXHIBIT LIST
`
`For the Court’s convenience, the parties hereby submit a joint trial exhibit list,
`
`attached hereto as Exhibit A. This joint trial exhibit list is filed without prejudice to any
`
`objections previously exchanged by the parties.
`
`
`
`
`
`Dated: August 18, 2013
`
`/s/ Megan A. Hughes
`Jan M. Carroll
`BARNES & THORNBURG LLP
`11 South Meridian Street
`Indianapolis, IN 46204
`(317) 236-1313
`Fax: (317) 231-7433
`Email: jan.carroll@btlaw.com
`
`Bruce R. Genderson
`Adam L. Perlman
`Ellen E. Oberwetter
`Dov P. Grossman
`David M. Krinsky
`
`
`
`
`
` Respectfully submitted,
`
`/s/ Michael B. Cottler (with permission)
`David O. Tittle
`Kandi Kilkelly Hidde
`BINGHAM MCHALE LLP
`10 West Market Street
`Market Tower, Suite 2700
`Indianapolis, IN 46204
`(317) 635-8900
`Fax: (317) 236-9907
`Email: dtittle@bgdlegal.com
`Email: khidde@bgdlegal.com
`
`Daryl L. Wiesen
`Elaine Herrmann Blais
`1
`
`Lilly Ex. 2006 pg. 1
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302 Filed 08/18/13 Page 2 of 3 PageID #: 5990
`
`
`Megan A. Hughes
`Andrew V. Trask
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street N.W.
`Washington, DC 20005
`(202) 434-5000
`Fax: (202) 434-5029
`Email: bgenderson@wc.com
`Email: aperlman@wc.com
`Email: eoberwetter@wc.com
`Email: dgrossman@wc.com
`Email: dkrinsky@wc.com
`Email: mhughes@wc.com
`Email: atrask@wc.com
`
`Attorneys for Plaintiff Eli Lilly
`and Company
`
`
`
`
`
`Emily L. Rapalino
`GOODWIN PROCTER LLP
`53 State Street
`Boston, MA 02109
`Tel: (617) 570-1000
`dwiesen@goodwinprocter.com
`eblais@goodwinprocter.com
`erapalino@goodwinprocter.com
`
`
`Michael B. Cottler
`Brian J. Prew
`Natasha E. Daughtrey
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`Tel: (212) 813-8800
`mcottler@goodwinprocter.com
`bprew@goodwinprocter.com
`ndaughtrey@goodwinprocter.com
`
`Attorneys for Defendants
`
`2
`
`Lilly Ex. 2006 pg. 2
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302 Filed 08/18/13 Page 3 of 3 PageID #: 5991
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on August 18, 2013, I caused a copy of the foregoing
`
`Joint Trial Exhibit List to be served electronically via operation of the Court’s CM/ECF
`
`system upon the following:
`
`David O. Tittle
`Kandi K. Hidde
`BINGHAM GREENEBAUM DOLL LLP
`dtittle@bgdlegal.com
`khidde@ bgdlegal.com
`
`Daryl L. Wiesen
`Emily L. Rapalino
`Michael B. Cottler
`Brian J. Prew
`Natasha E. Daughtrey
`GOODWIN PROCTER LLP
`dwiesen@goodwinprocter.com
`erapalino@goodwinprocter.com
`mcottler@goodwinprocter.com
`bprew@goodwinprocter.com
`ndaughtrey@goodwinprocter.com
`
`Attorneys for Defendants Teva Parenteral
`Medicines, Inc., APP Pharmaceuticals, LLC,
`Pliva Hrvatska d.o.o., Teva Pharmaceuticals
`USA, Inc., and Barr Laboratories, Inc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` /s/ Megan A. Hughes
`Megan A. Hughes
`
`3
`
`
`
`
`
`
`
`
`
`Lilly Ex. 2006 pg. 3
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 1 of 43 PageID #: 5992
`
`
`
`Exhibit A
`
`Lilly Ex. 2006 pg. 4
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Exhibit 
`Number
`1
`
`Date
`
`7/11/2007
`
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`
`13
`
`14
`15
`16
`
`17
`
`18
`20
`
`21
`
`22
`
`26
`27
`
`00/00/1995
`00/00/1996
`00/00/1997
`00/00/1998
`00/00/1999
`00/00/2000
`00/00/2001
`00/00/2001
`00/00/2002
`00/00/2003-
`00/00/2006
`00/00/2007-
`00/00/2008
`00/00/0000
`12/29/1992
`00/00/1993
`
`7/27/1995
`
`8/7/2000
`09/00/1997
`
`7/28/1997
`
`10/30/1997
`
`11/4/1997
`09/001997
`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 2 of 43 PageID #: 5993
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`Certified United States Patent Number 7,772,209
`
`AV01075423-1075433
`
`Defendants' Deposition Exhibit 35
`Defendants' Deposition Exhibit 82
`Defendants' Deposition Exhibit 104
`Plaintiffs' Deposition Exhibit 2
`Defendants' Deposition Grabowski Exhibit 1
`
`Defendants' Deposition Exhibit 3
`Defendants' Deposition Exhibit 4
`Defendants' Deposition Exhibit 5
`Defendants' Deposition Exhibit 6
`Defendants' Deposition Exhibit 7
`Defendants' Deposition Exhibit 8
`Defendants' Deposition Exhibit 9
`Defendants' Deposition Exhibit 10
`Defendants' Deposition Exhibit 11
`Defendants' Deposition Exhibit 12
`
`Defendants' Deposition Exhibit 13
`
`Defendants' Deposition Exhibit 14
`Defendants' Deposition Exhibit 15
`Defendants' Deposition Exhibit 16
`
`Defendants' Deposition Exhibit 18
`Defendants' Deposition Exhibit Zeisel 5
`Defendants' Deposition Exhibit 20
`Defendants' Deposition Exhibit 37
`
`Defendants' Deposition Exhibit 21
`Defendants' Deposition Exhibit 65
`Defendants' Deposition Exhibit 22
`Defendants' Deposition Exhibit 70
`Defendants' Deposition Exhibit 26
`Defendants' Deposition Exhibit 27
`
`AV00991578-991586
`
`Defendants' Deposition Exhibit 17
`
`Metabolite Laboratory Record: Sample # 2 Assays
`Metabolite Laboratory Record: Sample # 687 Assays
`Metabolite Laboratory Record: Sample # 393 Assays
`Metabolite Laboratory Record: Sample # 334 Assays
`Metabolite Laboratory Record: Sample # 1243 Assays
`Metabolite Laboratory Record: Sample # 2943 Assays
`Metabolite Laboratory Record: Sample # 555 Assays
`Metabolite Laboratory Record: Sample # 2330 Assays
`Metabolite Laboratory Record: Sample # 1616 Assays
`Metabolite Laboratory Record: Sample # 1889 Assays
`
`Metabolite Laboratory Record: Sample # 405 Assays
`
`Curriculum Vitae of Robert Allen
`United States Patent Number 5,563,126
`Jooseten, et al. "Metabolic evidence that deficiencies of vitamin B-12
`(cobalamin), folate, and vitamin B-6 occur commonly in elderly people,"
`American Journal of Clinical Nutrition, 58: 469-476 (1993)
`Blanket Laboratory Services Agreement between Metabolite Laboratories,
`Inc. and Eli Lilly Company (1995)
`Lilly Letter Agreement with Robert Allen, dated August 7, 2000
`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): S18 (1997) ("Zervos")
`
`DPEM2_0001423-1448
`
`AV01074071-1074074
`DPEM2_0001644
`
`Handwritten Meeting Notes, dated July 28, 1997
`
`AV00008264-8267
`
`Lilly Antifolate Advisory Board Meeting Agenda
`(October 27 – 30, 1997)
`Letter from Allen to Walling, dated November 4, 1997
`Markus, et al. "A Common Polymorphism in the Methylenetetrahydrofolate
`Reductase Gene, Homocysteine, and Ischemis Cerebrovasculae Disease,"
`STROKE , 28(9): 1739-1743 (September 1997)
`
`AV00438779
`
`AV00398988
`AV00398989-398993
`
`1 of 42
`
`Lilly Ex. 2006 pg. 5
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 3 of 43 PageID #: 5994
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`Exhibit 
`Number
`29
`
`Date
`
`00/00/1998
`
`Niyikiza, et al. "MTA (LY231514): Relationship of vitamin metabolite profile,
`drug exposure, and other patient characteristics to toxicity," Annals of
`Oncology , Abstract 609P, 9(Suppl 4): 125-140 (1998) (“Niyikiza I”)
`
` DPEM2_0000769-784
`
`34
`
`36
`40
`
`41
`
`42
`
`43
`
`44
`
`45
`
`46
`
`47
`
`48
`
`49
`
`50
`
`51
`
`52
`
`9/19/2012
`
`05/00/2012
`6/20/1996
`
`10/10/1995
`
`11/9/1995
`
`4/29/1996
`
`5/24/1996
`
`7/30/1996
`
`8/24/1996
`
`9/22/1997
`
`9/25/1996
`
`10/11/1996
`
`12/13/1996
`
`1/20/1997
`
`1/21/1997
`
`Defendants’ Joint Notice of Deposition of Donald Thornton, dated
`September 19, 2012
`ALIMTA® Label, revised 05/2012
`LY231514 Protocol H3E-MC-JMAS
`Phase 1 Trial of LY231514 with Folic Acid Supplementation in Patients with
`Locally Advanced or Metastatic Cancer
`(Protocol Approved by Lilly: June 20, 1996)
`Project Team Meeting Minutes – October 10, 1995
` LY309887 (GARFT Inhibitor) / Lometrexol
`Project Team Status Report (95-02)
`LY231514 – Multitargeted Antifolate (H3E)
`November 9, 1995
`LY309887 Investigators’ Meeting – Brief Summary
`(April 29, 1996)
`Project Team Meeting – May 24, 1996
`LY309887 (GARFT Inhibitor)
`Minutes from the May 23, 1996 (GARFT Inhibitor) Project Team Meeting
`
`MTA (LY231514) – Strategic Planning Meeting
`(July 30, 1996) [DRAFT]
`MTA Core Team Meeting
`(August 24, 1996)
`Minutes of the Antifolate Advisory Board Panel
`(September 22, 1997)
`MTA Core Team Meeting Minutes
`(September 25, 1996)
` GARFT Inhibitor (LY309887) Project Team Meeting Minutes (October 11,
`1996)
`Lilly Global Development Plan
`LY231514
`Multitargeted Antifolate (MTA)
`MTA Core/ProjectTeam Minutes
`(January 14, 1997)
`MTA Project Team Meeting Minutes
`(January 21, 1997)
`
`Defendants' Deposition Exhibit 29
`Defendants' Deposition Exhibit 39
`Plaintiff's Deposition Exhibit 1015
`
`Defendants' Deposition Exhibit 34
`
`Defendants' Deposition Exhibit 36
`Defendants' Deposition Exhibit 40
`
`ELAP00004264-4312
`
`AV00399050-399053
`
`Defendants' Deposition Exhibit 41
`
`AV00568942–568961
`
`Defendants' Deposition Exhibit 42
`
`AV00399029-399030
`
`Defendants' Deposition Exhibit 43
`
`AV00399234-399236
`
`Defendants' Deposition Exhibit 44
`
`AV00008592-8594
`
`Defendants' Deposition Exhibit 45
`
`AV00008856-8857
`
`Defendants' Deposition Exhibit 46
`
`AV00008872-8879
`
`Defendants' Deposition Exhibit 47
`
`AV00008842-8844
`
`Defendants' Deposition Exhibit 48
`
`AV00568245-568246
`
`Defendants' Deposition Exhibit 49
`
`AV00731901-731991
`
`Defendants' Deposition Exhibit 50
`
`AV00484561-484562
`
`Defendants' Deposition Exhibit 51
`
`AV00008838-8839
`
`Defendants' Deposition Exhibit 52
`
`2 of 42
`
`Lilly Ex. 2006 pg. 6
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Exhibit 
`Number
`53
`
`54
`
`55
`56
`
`57
`
`58
`
`59
`
`60
`
`61
`
`62
`
`63
`
`64
`
`66
`
`67
`
`68
`
`71
`
`72
`
`73
`
`74
`
`75
`
`Date
`
`2/4/1997
`
`2/10/1997
`
`2/10/1997
`2/10/1997
`
`2/18/1997
`
`3/2/1997
`
`3/11/1997
`
`4/2/1997
`
`4/8/1997
`
`4/18/1997
`
`7/8/1997
`
`7/17/1997
`
`8/26/1997
`
`9/11/1997
`
`9/13/1997
`
`10/29/1997
`
`12/2/1997
`
`2/3/1998
`
`3/16/1998
`
`12/3/1999
`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 4 of 43 PageID #: 5995
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`MTA Core/Project Team Minutes
`(February 4, 1997)
`Email from Walling to Arnett, et al. re Multivariate Analysis: MTA. Action
`points for completion within 4 weeks, dated February 10, 1997
`Handwritten Notes, dated February 10, 1997
`Minutes from February 10 MTA PPT Meeting
`(February 10, 1997)
`MTA Core Team Minutes
`(February 18, 1997)
`Email from Walling re Notes from Meeting with Dan Von Hoff – 25 Feb
`1997
`Email from Hamburger to Chick et al. re FDA Clinical issues, dated March
`11, 1997 (with Handwritten Note: “MTA Core team”)
`Antifolate Advisory Panel Meeting Minutes
`(April 2, 1997)
`Minutes of MTA Core Team Meeting
`(April 8, 1997)
`MTA Clinical Strategy Meeting Minutes
`(April 18, 1997)
`MTA Product Team Meeting Minutes
`(July 8, 1997)
`Core Team Meeting Minutes
`(July 17, 1997)
`Core Team Meeting Minutes
`(August 26, 1997)
`Core Team Meeting Minutes
`(September 11, 1997)
`MTA Investigators' Meeting Minutes (September 13, 1997)
`
`Handwritten - Investigators’ Meeting Minutes
`(October 29, 1997)
`Core Team meeting Minutes
`(December 2, 1997)
`MTA Product Team Meeting Minutes
`(February 3, 1998)
`Antifolate Advisory Panel Meeting Minutes
`(March 16, 1998)
`LY231514 (MTA) Safety Analysis
`(December 3, 1999)
`
`AV00399198-399199
`
`Defendants' Deposition Exhibit 53
`
`AV00008657
`
`Defendants' Deposition Exhibit 54
`
`AV00008658-8659
`AV00367301-367302
`
`Defendants' Deposition Exhibit 55
`Defendants' Deposition Exhibit 56
`
`AV00484556-484560
`
`Defendants' Deposition Exhibit 57
`
`AV00008650-8651
`
`Defendants' Deposition Exhibit 58
`
`AV00367315-367318
`
`Defendants' Deposition Exhibit 59
`
`AV00008825-8829
`
`Defendants' Deposition Exhibit 60
`
`AV00484522-484523
`
`Defendants' Deposition Exhibit 61
`
`AV00008652-8656
`
`Defendants' Deposition Exhibit 62
`
`AV00008805-8810
`
`Defendants' Deposition Exhibit 63
`
`AV00365851
`
`Defendants' Deposition Exhibit 64
`
`AV00365849-365850
`
`Defendants' Deposition Exhibit 66
`
`AV00399460
`
`Defendants' Deposition Exhibit 67
`
`AV00008690-8695
`
`AV00008249-8263
`
`Defendants' Deposition Exhibit 68
`Defendants' Deposition Exhibit 84
`Defendants' Deposition Exhibit 71
`
`AV00008802-8803
`
`Defendants' Deposition Exhibit 72
`
`AV00001057-1068
`
`Defendants' Deposition Exhibit 73
`
`AV00008671-8681
`
`Defendants' Deposition Exhibit 74
`
`ELAP00012824-12843
`
`Defendants' Deposition Exhibit 75
`Defendants' Deposition Exhibit 375
`
`3 of 42
`
`Lilly Ex. 2006 pg. 7
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 5 of 43 PageID #: 5996
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Exhibit 
`Number
`76
`
`Date
`
`2/16/2000
`
`77
`
`09/00/1997
`
`78
`
`04/00/1999
`
`79
`
`80
`
`81
`83
`
`85
`
`86
`
`87
`
`88
`
`90
`
`91
`
`2001
`
`2002
`
`6/15/2001
`6/12/2000
`
`10/14/1998
`
`10/20/1998
`
`11/20/1998
`
`12/3/1998
`
`2/17/1999
`
`3/8/1999
`
`Description
`
`Briefing Document
`(February 16, 2000)
`
`Rusthoven, et al. "Phase II Trial of the multi-targeted antifolate LY231514
`(MTA) as first-line therapy for patients with advanced non-small cell lung
`cancer," NSCLC Abstract 1045, The European Cancer Conference 9,
`33(Suppl 8): S231 (1997)
`Rusthoven, et al. "Multitargeted Antifolate LY231514 as a First-Line
`Chemotherapy for Patients With Advanced Non-Small-Cell Lung Cancer: A
`Phase II Study," Journal of Clinical Oncology,17(4): 1194-1199 (1999)
`
`Bunn et al., Vitamin B12 and Folate Reduce Toxicity of Alimta (Pemetrexed
`Disodium, LY231514, MTA), a Novel Antifolate/Antimetabolite,
`PROCEEDINGS OF THE ASCO (20), Poster 300 ("Bunn")
`
`Niyikiza, et al., Homocysteine Methylmalonic Acid Markers to Predict and
`Avoid Toxicity from Pemetrexed Therapy, MOLECULAR CANCER
`THERAPEUTICS 1: 545-552 ("Niyikiza 2002")
`United States Patent Number 7,053,065
`Data Analysis Presentation:
`Interim Efficacy & Safety Results from the Single-blind Randomized Phase
`3 Trial of MTA plus Cisplatin versus Cisplatin in Patients
` with Malignant Pleural Mesothelioma
`Protocol H3E-MC-JMCH
`MTA PFT Meeting Minutes
`(October 14, 1998)
`
`MTA Core Team Minutes
`(dated October 20, 1998)
`MTA Product Team Meeting Agenda
`(November 20, 1998)
`MTA Core Team Minutes
`(December 3, 1998)
`Minutes of Meeting with Paul Bunn and Karen Kelly, dated February 17,
`1999
`Minutes
`Business Planning Meeting (7-year Plan)
`March 8, 1999
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`ELAP00013763-13793
`
`Defendants' Deposition Exhibit 76
`Defendants' Deposition Exhibit 89
`Defendants' Deposition Exhibit 507
`Defendants' Deposition Exhibit 1308
`Defendants' Deposition Exhibit 77
`
`DPEM2_0001185-1190
`
`Defendants' Deposition Exhibit 78
`Defendants' Deposition Exhibit 906
`
`AV01191546
`
`Defendants' Exhibit 79
`
`AV01067620 - AV01067627
`
`Defendants' Exhibit 80; Deposition Exhibit
`1019
`
`AV00978357-978447
`
`Defendants' Deposition Exhibit 81
`Defendants' Deposition Exhibit 83
`Defendants' Deposition Exhibit 202
`
`AV00367215-367218
`
`AV00399373
`
`AV00731007
`
`Defendants' Deposition Exhibit 85
`Defendants' Deposition Exhibit 207
`Defendants' Deposition Exhibit 319
`Defendants' Deposition Exhibit 86
`Defendants' Deposition Exhibit 208
`Defendants' Deposition Exhibit 87
`
`AV00399382-399383
`
`Defendants' Deposition Exhibit 88
`
`AV00833602-833605
`
`AV00008516-8539
`
`Defendants' Deposition Exhibit 90
`Defendants' Deposition Exhibit 110
`Defendants' Deposition Exhibit 91
`Defendants' Deposition Exhibit 328
`
`4 of 42
`
`Lilly Ex. 2006 pg. 8
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 6 of 43 PageID #: 5997
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Date
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`5/26/1999
`
`Email from Rusthoven to Robb re JMAS Study, dated May 26, 1999
`
`AV00007871-7872
`
`AV01075637
`
`AV01075493-1075506
`
`AV00009229
`AV00009228
`AV00009216-9217
`
`AV00009218-9219
`
`AV00573722
`
`AV00573723 -573730
`
`AV00691747
`AV00691748-691749
`ELAP00013337-13430
`
`AV00735034-735154
`
`Defendants' Deposition Exhibit 92
`Defendants' Deposition Exhibit 111
`Defendants' Deposition Exhibit 93
`
`Defendants' Deposition Exhibit 94
`Defendants' Deposition Exhibit 203
`Defendants' Deposition Exhibit 95
`Defendants' Deposition Exhibit 96
`Defendants' Deposition Exhibit 97
`
`Defendants' Deposition Exhibit 98
`Defendants' Deposition Exhibit 118
`Defendants' Deposition Exhibit 99
`Defendants' Deposition Exhibit 119
`Defendants' Deposition Exhibit 100
`Defendants' Deposition Exhibit 120
`Defendants' Deposition Exhibit 101
`Defendants' Deposition Exhibit 102
`Defendants' Deposition Exhibit 103
`Defendants' Deposition Exhibit 204
`
`Defendants' Deposition Exhibit 105
`Defendants' Deposition Exhibit 106
`
`AV00568344-568346
`
`AV00008871-8873
`
`Defendants' Deposition Exhibit 107
`Defendants' Deposition Exhibit 301
`Defendants' Deposition Exhibit 108
`
`AV00008613-8617
`
`Defendants' Deposition Exhibit 109
`
`AV00833453-833460
`
`Defendants' Deposition Exhibit 112
`
`AV00833641
`
`Defendants' Deposition Exhibit 113
`
`AV00008049-8052
`
`Defendants' Deposition Exhibit 114
`
`AV01075639-1075641
`
`Defendants' Deposition Exhibit 115
`
`5 of 42
`
`Exhibit 
`Number
`92
`
`93
`
`94
`
`95
`96
`97
`
`98
`
`99
`
`100
`
`101
`102
`103
`
`105
`106
`
`107
`
`108
`
`109
`
`112
`
`113
`
`114
`
`115
`
`12/15/1999
`
`3/1/2000
`
`9/8/2000
`9/14/2000
`9/18/2000
`
`6/12/2001
`
`7/13/2001
`
`00/00/0000
`
`7/26/2001
`00/00/0000
`12/10/1999
`
`10/9/2012
`6/8/1994
`
`7/8/1994
`
`2/21/1996
`
`5/6/1996
`
`6/25/1999
`
`9/19/1999
`
`11/29/1999
`
`12/14/1999
`
`Email from Rusthoven to Gilliard re Updated Alimta Safety
`Communication, dated December 15, 1999
`Notes for March 1, 2000 FDA Meeting entitled: “Efficacy Issues” (with
`Handwritten note: “for FDA Mtg 3/1/00”)
`Email from Robb to Fennig re JMAS, dated September 8, 2000
`Email from Robb to Hananuske re JMAS, dated September 14, 2000
`Email from Rusthoven to Marchesani re Article on “sublingual form of
`cobalamin (vitamin B12)…good option for deficient patients who cannot
`tolerate injections.” dated September 18, 2000
`Email Rusthoven exchange to Paolo/Brian/Clet, dated June 12, 2001
`
`Email from Stuglik to Derbyshire, et al. re Submission issues list, dated
`July 13, 2001
`Spreadsheet attachment to July 13, 2001 Stuglik email
`
`Email from Rusthoven to Worzalla, dated July 26, 2001
`FDA Communication attachment to July 26, 2001 Rusthoven email
`Single-blind Randomized Phase 3 Trial of MTA plus Cisplatin versus
`Cisplatin in Patients with Malignant Pleural Meothelioma
`Protocol H3E-MC-JMCH(c)
`Deposition Notice of Brian Stuglik
`Project Team Approval Committee – Compound 309887: An antifolate
`inhibitor of GAR formyl transferase for Cancer Therapy – Cancer Strategy
`Group, dated June 8, 1994
`LY309887 Project Team Meeting Notes
`(July 8, 1994)
`MTA Project Team Meeting Minutes
`(February 21, 1996)
`Strategy Planning Session – MTA (LY231514)
`(May 6, 1996)
`Minutes of Meeting Between FDA and Lilly to Discuss LY231514 for
`Mesothelioma (June 25, 1999)
`Email from Stuglik to Niyikiza re JMAS folic acid non-compliance issue,
`dated September 19, 1999
`Email from Rusthoven to Stuglik re URGENT! ALIMTA Safety Information,
`dated November 29, 1999
`Email from Stuglik to Layman re Please Read: Update ALIMTA Safety
`Communication, dated December 14, 1999
`
`Lilly Ex. 2006 pg. 9
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Exhibit 
`Number
`116
`
`Date
`
`12/20/1999
`
`117
`200
`
`201
`
`205
`
`209
`
`300
`302
`
`303
`
`5/30/2000
`6/30/2000
`
`7/11/2007
`
`9/12/2000
`
`10/29/1998
`
`10/18/2012
`12/19/1994
`
`3/9/1995
`
`304
`
`3/26/1996
`
`305
`
`306
`
`307
`
`308
`
`309
`
`310
`
`311
`
`312
`
`7/25/1996
`
`7/3/1997
`
`7/27/1997
`
`7/29/1997
`
`8/3/1997
`
`8/5/1997
`
`10/26/1997
`
`10/28/1997
`10/29/1997
`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 7 of 43 PageID #: 5998
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`Email from Lassus to Cuypers, et al. re Homocysteine and folate, dated
`December 20, 1999
`MTA / FDA Meeting Minutes, dated May 30, 2000
`Provisional Application Number 60/215,310
`
`AV01243525-1243527
`
`Defendants' Deposition Exhibit 116
`
`AV00833267-833270
`AV01192219-1192242
`
`Defendants' Deposition Exhibit 117
`Defendants' Deposition Exhibit 200
`
`Certified File History of United States Patent Number 7,772,209
`(11/776,329)
`Lilly Oncology Satellite Symposium “Novel Agents for the Treatment of
`Lung Cancer” September 12, 2000
`Email from Seitz to Paoletti re Vitamin Discussion and MTA Strategy
`(Handwritten Notes: Vitamin Supplementation in MTA Studies)
`Jackie Walling LinkedIn Profile
`Project Team Meeting Minutes of December 19, 1994
`[with handwritten markups/notes]
`Project Team Meeting Minutes - LY309887/LY309887 (GARFT
`Inhibitor/Lometrexol) Discussion from the March 9, 1995
`LY309887/LY309887 (GARFT Inhibitor/Lometrexol) Project Team meeting
`
`Protocol H3E-MC-JMAD( c ) A Phase 2 Trial of LY231514
`Administered Intravenously Every 21 Days in Patients with Pancreatic
`Cancer
`(Amendment (c) Approved by Lilly, March 26, 1996)
` Project Team Meeting Minutes - GARFT (LY309887)
`(July 25, 1996)
`MTA Core Team Minutes
`(July 3, 1997)
`LY309887 Telephone conference call 22/7/97
`Preliminary MVA data
`(July 27, 1997)
`Core Team Minutes
`(July 29, 1997)
`Minutes of the GARFT (LY309887) August 3, 1997 Project Team Meeting
`Notes
`Email from Walling re Subacute Combined Degeneration of the cord
`symptoms, dated August 5, 1997
`Email from Walling to Eklov re JQAE one more question, dated October
`26, 1997
`Lilly Minutes of the Antifolate Advisory Panel Meeting, Washington, DC
`(October 28 and 29, 1997)
`
`AV00000001-905
`
`Defendants' Deposition Exhibit 201
`
`AV01140662-1140688
`
`Defendants' Deposition Exhibit 205
`
`AV00833729-833730
`
`Defendants' Deposition Exhibit 209
`
`AV00399055-399057
`
`Defendants' Deposition Exhibit 300
`Defendants' Deposition Exhibit 302
`
`AV00734367-734370
`
`Defendants' Deposition Exhibit 303
`
`AV00711793-711844
`
`Defendants' Deposition Exhibit 304
`
`AV00399046-399047
`
`Defendants' Deposition Exhibit 305
`
`AV00569043
`
`Defendants' Deposition Exhibit 306
`
`AV00726336-726337
`
`Defendants' Deposition Exhibit 307
`
`AV00569058
`
`Defendants' Deposition Exhibit 308
`
`AV00568193-568195
`
`Defendants' Deposition Exhibit 309
`
`AV00072155-72156
`
`Defendants' Deposition Exhibit 310
`
`AV00083352
`
`Defendants' Deposition Exhibit 311
`
`AV00008682-8689
`
`Defendants' Deposition Exhibit 23
`Defendants' Deposition Exhibit 69
`Defendants' Deposition Exhibit 312
`
`6 of 42
`
`Lilly Ex. 2006 pg. 10
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Exhibit 
`Number
`313
`
`314
`
`315
`
`316
`
`Date
`
`10/29/1997
`
`10/30/1997
`
`11/4/1997
`
`10/22/2012
`
`317
`
`7/28/1998
`
`320
`
`321
`
`322
`
`324
`
`325
`
`326
`
`3/00/1999
`
`10/18/1999
`
`00/00/0000
`
`7/30/1998
`7/31/1998
`8/4/1998
`
`9/25/1998
`
`327
`
`2/12/1999
`
`329
`
`330
`
`331
`
`332
`
`12/1/1999
`
`12/3/1999
`
`1/12/2000
`
`12/22/1999
`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 8 of 43 PageID #: 5999
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`LY309887 Antifolate Advisory Board Meeting Minutes
`(October 29, 1997)
`LY309887 Investigators’ Meeting Minutes, Washington, DC
`(October 30, 1997)
`LY309887 Program Team Meeting Minutes
`(November 4, 1997)
`Subpoena to Testify to Jacqueline M. Walling
`in re Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., et al. 10-cv-1376-
`TWP-DML
`July 28, 1998
`MTA (LY231514)
`FDA Briefing Document
`Lilly Oncology: Lometrexol Outpartnering
`Eli Lilly March 1999
`Letter form Lilly to Tularik re Lometrexol documents, dated October 18,
`1999
`Exhibit B – Product Data Package, attachment to Lilly October 18, 1999
`Letter
`MTA Core Team Meeting Minutes
`(July 30 and 31, 1998)
`MTA Core Team Meeting Minutes
`(August 4, 1998)
`LY231514 (MTA) End of Phase 2 Meeting with the FDA Clinical Issues –
`Friday, September 25, 1998 at FDA
`
`Letter from Lilly to FDA re IND 40,061 – MTA (LY231514) Serial No. 150
`PROTOCOL AMENDMENT(S):Change in Protocol H3E-MC-JMCH(a),
`dated February 12, 1999
`Email from Worzalla to Ruighaver re Safety FDA Dec 01.doc, dated
`December 1, 1999
` 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
`Email from Worzalla to Hanauske re Response to FDA regarding vitamins,
`dated January 12, 2000
`Letter from Lilly to FDA re IND 40,061 – MTA (LY231514) Serial No. 200
`Protocol Amendment, dated December 22, 1999
`
`AV00008123-8127
`
`AV00008134-8137
`
`AV00725671-725675
`
`Defendants' Deposition Exhibit 24
`Defendants' Deposition Exhibit 313
`Defendants' Deposition Exhibit 25
`Defendants' Deposition Exhibit 314
`Defendants' Deposition Exhibit 315
`
`Defendants' Deposition Exhibit 316
`
`AV00366660-366756
`
`Defendants' Deposition Exhibit 317
`Defendants' Deposition Exhibit 323
`
`AV01232795 -1232801
`
`Defendants' Deposition Exhibit 320
`
`AV00018868
`
`Defendants' Deposition Exhibit 321
`
`AV00018869-18870
`
`Defendants' Deposition Exhibit 322
`
`AV00008746-8747
`
`Defendants' Deposition Exhibit 324
`
`AV00008734-8735
`
`Defendants' Deposition Exhibit 325
`
`ELAP00008716-8723
`
`ELAP00009005-9180
`
`Defendants' Deposition Exhibit 326
`Defendants' Deposition Exhibit 318
`[AV00833405-833412]
`Defendants' Deposition Exhibit 327
`
`AV00000936-937
`
`Defendants' Deposition Exhibit 329
`
`ELAP00199791-199818
`
`AV01075646-1075647
`
`Defendants' Deposition Exhibit 206
`Defendants' Deposition Exhibit 330
`Defendants' Deposition Exhibit 1307
`Defendants' Deposition Exhibit 331
`
`ELAP00013311-13430
`
`Defendants' Deposition Exhibit 332
`
`7 of 42
`
`Lilly Ex. 2006 pg. 11
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 9 of 43 PageID #: 6000
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`Letter from Lilly to FDA re IND 40,061 – LY231514 (MTA, MultiTargeted
`Antifolate) Serial No. 203 Formal Type A Meeting Request to Discuss
`Changes of Vitamin Supplementation Instituted for the Ongoing
`Mesothelioma Registration Trial, dated January 25, 2000
`Email from Stuglik to Brophy, et al. re FDA Q&A.doc, dated February 28,
`2000 attaching Efficiacy Issues document
`Letter from Lilly to FDA re LY231514 (ALIMTA™, MultiTargeted Antifolate);
`IND 40,061 Serial No. 323 Safety Update – Impact of Folic Acid and
`Vitamin B12 Supplementation on Safety of LY231514, dated June 4, 2001
`
`Letter from Lilly to FDA re IND 40,061, MTA (LY231514); Serial No. 291
`Protocol H3E-MC-JMCH(f), dated February 6, 2001
`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
`
`ELAP00013452-13462
`
`Defendants' Deposition Exhibit 333
`
`AV00008057-8071
`
`Defendants' Deposition Exhibit 334
`
`ELAP00227144-227159
`
`Defendants' Deposition Exhibit 335
`DX 97 (Peme 1st Lit)
`
`ELAP00018335-18449
`
`Defendants' Deposition Exhibit 336
`
`ELAP00014729-14742
`
`Defendants' Deposition Exhibit 337
`
`Exhibit 
`Number
`333
`
`Date
`
`1/25/2000
`
`2/28/2000
`
`6/4/2001
`
`2/6/2001
`
`3/20/2000
`
`334
`
`335
`
`336
`
`337
`
`338
`
`339
`
`340
`341
`
`342
`
`343
`
`344
`
`345
`
`3/21/2006
`
`1/20/2003
`
`00/00/0000
`00/00/0000
`
`9/2/1994
`
`Email from Worzalla to Chapman re 1999-12-03 IND SN195
`Supplementation and Safety Analysis.pdf, dated March 21, 2006
`Integrated Summary of Efficacy Pemetrexed (LY231514) in the Treatment
`of Malignant Pleural Mesothelioma
`Date report Approved by Lilly medical: January 20. 2003
`In Vivo Antitumor Activity by John Worzalla
`Delayed Cumulative Toxicity and Human Folate Status by Laura
`Mendelsohn
`LY309887 Project Team Meeting Notes
`(September 2, 1994)
`03/00/1996 Worzalla, et al. "Elevation of homocysteine in plasma of mice as a marker
`of dietary folic acid status," Proceedings of the American Association for
`Cancer Research, April 20-24, 1996, Washington, DC, Abstract 2618, 37:
`384 (March 1996)
`Subpoena to Testify to John Worzalla
`in re Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., et al. 10-cv-1376-
`TWP-DML
`Subpoena to Testify to F. Andrew Dorr
`in re Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., et al. 10-cv-1376-
`TWP-DML
`
`11/6/2012
`
`11/6/2012
`
`AV00068389-68392
`
`Defendants' Deposition Exhibit 338
`
`ELAP00301473-301638
`
`Defendants' Deposition Exhibit 339
`
`AV00103061-103080
`AV00103081-103092
`
`AV00083207-83208
`
`Defendants' Deposition Exhibit 340
`Defendants' Deposition Exhibit 341
`
`Defendants' Deposition Exhibit 342
`Defendants' Deposition Exhibit 352
`Defendants' Deposition Exhibit 19
`Defendants' Deposition Exhibit 343
`
`Defendants' Deposition Exhibit 344
`
`Defendants' Deposition Exhibit 345
`
`8 of 42
`
`Lilly Ex. 2006 pg. 12
`Sandoz v. Lilly IPR2016-00318
`
`

`
`Exhibit 
`Number
`346
`
`Date
`
`05/17/1997-
`05/20/1997
`
`347
`
`5/31/1995
`
`Case 1:10-cv-01376-TWP-DKL Document 302-1 Filed 08/18/13 Page 10 of 43 PageID #:
`IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
` 6001
`Eli Lilly Co. v. Teva Parenterals, et al.
`Civil Action No. 1:10‐cv‐01376‐TWP‐DKL
`Joint Trial Exhibit List
`
`Description
`
`Bates Range(s)
`
`Deposition Exhibit Number(s)
`
`Introduced
`
`Admitted
`
`Walling, et al, "Dose escalation methodology in phase I clinical trials: a
`comparison of the modified continual reassessment method (MCRM) and a
`traditional method. Experience with the multitargeted antifolate (MTA),"
`Abstract 733, American Society of Clinical Oncology , 16: 209a, May 17-20,
`1997 (1997)
`Thymidylate Synthase Inhibitor (LY231514) TSI
`Protocol H3E-MC-JMAC
`A Phase 2 Trial of LY213514 (Thymidylate Synthase Inhibitor)
`Administered Intravenously Every 21 Days in Patients with Metastatic
`Colorectal Cancer
`Protocol Approved by Lilly May 31, 1995
`Annual Report – Annual Review Period Ending September 24, 1994
`PTAC Compound 309887 cover page
`Andrew Dorr’s Clinical Plan Presentation from PTAC
`Andrew Dorr’s Clinical Plan Presentation from PTAC
`(continued)
`Global Plans Approval Committee – Executive Summary – GARFT Inhibitor
`(LY309887) [DRAFT 2] dated September 15, 1994
`Global Plans Approval Committee – Executive Summary – GARFT Inhibitor
`(LY309887) dated September 15, 1994
`Global Plans Approval Committee Meeting Minutes (September 15, 1994)
`
`Defendants' Deposition Exhibit 346
`
`ELAP00003391-3443
`
`Defendants' Deposition Exhibit 347
`
`ELAP00002957-3084
`AV00735033
`AV00735155-735174
`AV00735175-735193
`
`Defendants' Deposition Exhibit 348
`Defendants' Deposition Exhibit 349
`Defendants' Deposition Exhibit 350
`Defendants' Deposition Exhibit 351
`
`AV00735219-735230
`
`Defendants' Deposition Exhibit 353
`
`AV00568849-568860
`
`Defendants' Deposition Exhibit 354
`
`AV00725034-725037
`
`Defendants' Deposition Exhibit 355
`
`Phase I Protocol for LY309887
`LY309887
`Protocol B3C-MC-JQAC(a)
`Phase 1 Clinical and Pharmacokinetic Evaluation of LY309887
`Administered Weekly in Patients with Metastatic Cancer
`(Protocol Approved by Lilly November 14, 1995)
`Project Team Status Report (93-1)
`LY264618 – Lometrexol (F2A)
`(January 25, 1993)
`Folic Acid Team Meetings (June 2, 1993)
`Agreement between Eli Lilly and the Division of Cancer Treatment, NCI for
`the Clinical Development of Lometrexol
`[Executed version]
`Provisional Application Number 60/235,859
`
`AV00009254-9587
`AV00012006-12058
`
`Defendants' Deposition Exhibit 357
`Defendants' Deposition Exhibit 358
`
`AV00908643-908648
`
`Defendants' Deposition