Case 1:05-cv SLR Document Filed 05/13/2008 Page 1 of 15 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
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1 Case 1:05-cv SLR Document Filed 05/13/2008 Page 1 of 15 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE TEVA PHARMACEUTICALS USA, INC., TEVA PHARMACEUTICAL INDUSTRIES LTD., and NOVOPHARM, LTD., v. Counterclaim Plaintiffs, ABBOTT LABORATORIES, FOURNIER INDUSTRIE ET SANTÉ, and LABORATOIRES FOURNIER S.A., Counterclaim Defendants. IMPAX LABORATORIES, INC., v. Counterclaim Plaintiff, ABBOTT LABORATORIES, FOURNIER INDUSTRIE ET SANTÉ, and LABORATOIRES FOURNIER S.A., Counterclaim Defendants. IN RE TRICOR DIRECT PURCHASER ANTITRUST LITIGATION THIS DOCUMENT RELATES TO: ALL ACTIONS IN RE TRICOR INDIRECT PURCHASER ANTITRUST LITIGATION THIS DOCUMENT RELATES TO: ALL ACTIONS C.A. No (SLR CONSOLIDATED C.A. No (SLR CONSOLIDATED C.A. No (SLR CONSOLIDATED C.A. No (SLR CONSOLIDATED DEFENDANTS JOINT APPENDIX IN SUPPORT OF SUMMARY JUDGMENT MOTIONS VOLUME III OF III
2 Case 1:05-cv SLR Document Filed 05/13/2008 Page 2 of 15 MORRIS, NICHOLS, ARSHT & TUNNELL LLP Mary B. Graham (#2256 James W. Parrett, Jr. (# North Market Street P.O. Box 1347 Wilmington, DE ( mgraham@mnat.com jparrett@mnat.com OF COUNSEL: William F. Cavanaugh, Jr. Thomas W. Pippert Chad J. Peterman Alexis Deise PATTERSON, BELKNAP, WEBB & TYLER LLP 1133 Avenue of the Americas New York, NY ( Attorneys for Defendant Abbott Laboratories Dated: May 5, 2008 RICHARDS, LAYTON & FINGER, P.A. Frederick L. Cottrell, III (#2555 Anne Shea Gaza (#4093 One Rodney Square P.O. Box 551 Wilmington, DE ( cottrell@rlf.com gaza@rlf.com OF COUNSEL: William Baer James Cooper Anne P. Davis ARNOLD & PORTER LLP th Street, N.W. Washington, DC ( Timothy C. Bickham STEPTOE & JOHNSON LLP 1330 Connecticut Avenue, N.W. Washington, DC ( Attorneys for Fournier Industrie Et Santé and Laboratoires Fournier, S.A.
3 Case 1:05-cv SLR Document Filed 05/13/2008 Page 3 of 15 DEFENDANTS JOINT APPENDIX TABLE OF CONTENTS DOCUMENT DESCRIPTION APPENDIX PAGES DEPOSITION TRANSCRIPTS/EXHIBITS Dr. Loyd V. Allen Deposition Transcript, December 12, 2001 DJA-1 to DJA-4 Pierre Diebolt Deposition Transcript, June 8, 2004 Edward Grieff Deposition Transcript, June 25, 2004 Dr. Gordon Amidon Deposition Transcript, November 18, 2004 Dr. Loyd V. Allen Deposition Transcript, November 23, 2004 James McNeil Deposition Transcript, December 22, 2004 Philippe Reginault Deposition Transcript, October 24, 2006 Philippe Reginault Deposition Exhibit 1, October 24, 2006 Philippe Reginault Deposition Exhibit 4, October 24, 2006 Philippe Reginault Deposition Exhibit 8, October 24, 2006 Philippe Reginault Deposition Exhibit 25, October 24, 2006 Pascale Blouquin, Deposition Transcript, November 30, 2006 Dr. Peter Jones Deposition Transcript, November 28, 2007 Keith B. Leffler Deposition Transcript, December 7, 2007 Dr. Sander J. Robins Deposition Transcript, December 19, 2007 Iain Cockburn Deposition Transcript, January 9, 2008 Dr. Loyd V. Allen Deposition Transcript, January 10, 2008 Dr. Stephen P. Schondelmeyer Deposition Transcript, January 24, 2008 DJA-5 to DJA DJA to DJA DJA-8 to DJA-9 DJA-10 to DJA-12 DJA to DJA DJA-13 to DJA-22 DJA-23 to DJA-28 DJA-29 to DJA-32 DJA-33 to DJA-46 DJA-47 to DJA-52 DJA DJA-53 to DJA-57 DJA-58 to DJA-80 DJA-81 to DJA-97 DJA-98 to DJA-106 DJA-107 to DJA-108 DJA-109 to DJA-118
4 Case 1:05-cv SLR Document Filed 05/13/2008 Page 4 of 15 DOCUMENT DESCRIPTION Dr. Gordon Amidon Deposition Transcript, January 29, 2008 Charles L. King III Deposition Transcript, January 29, 2008 Arthur Schwartzbard Deposition Transcript, February 12, 2008 Dr. Hal J. Singer Deposition Transcript, February 21, 2008 Dr. Richard Grimm Deposition Transcript, March 4, 2008 Dr. Rodolfo Soto Deposition Transcript, March 12, 2008 Dr. Jeffrey J. Leitzinger Deposition Transcript, March 13, 2008 APPENDIX PAGES DJA-119 to DJA-126 DJA-127 to DJA-136 DJA-137 to DJA-148 DJA-149 to DJA-158 DJA-159 to DJA-168 DJA-169 to DJA-196 DJA-197 to DJA Marketing Plan (Abbott_Tricor Abbott_Tricor DISCOVERY DOCUMENTS Pharmaceutical Products Division Cardiology Franchise Summary 2004 Plan (Abbott_Tricor Abbott_Tricor TriCor 2003 Marketing Plan (Abbott_Tricor , Abbott_Tricor , Abbott_Tricor TriCor 03 Plan (Abbott_Tricor Abbott_Tricor Strategic Marketing Plan (Abbott_Tricor Abbott_Tricor Section VI Bioavailability/Bioequivalence (Continued IABII IABII Data Summary; In-Process Control in Manufacturing the Biobatch of Fenofibrate Tablets, 100 mg (Lot #R02015 (IABII Section VII Components and Composition (Continued IABII In-Process Control in Manufacturing the Biobatch of Fenofibrate Tablets, 54 mg IABII DJA-213 to DJA-268 DJA-269 to DJA-275 DJA-276 to DJA-278 DJA-279 to DJA-363 DJA-364 to DJA-401 DJA-402 to DJA-404 DJA-405 DJA-406 DJA
5 Case 1:05-cv SLR Document Filed 05/13/2008 Page 5 of 15 Teva ANDA Application excerpt DOCUMENT DESCRIPTION Lofibra Marketing Communications Plan Teva (Teva- TriCor Teva-TriCor Convention Report (Teva-TriCor Teva-TriCor46653 Lofibra Training Manual (Teva-TriCor083807, Teva- TriCor Teva-TriCor APPENDIX PAGES DJA-408 to DJA-409 DJA-410 to DJA-434 DJA-435 to DJA-436 DJA-437 to DJA-465 REPORTS AND DECLARATIONS Expert Statement of Dr. Arthur H. Goldberg in Rebuttal to the Expert Report of Dr. Loyd V. Allen, Jr., October 31, 2001 Expert Report of Dr. Arthur H. Goldberg, February 15, 2002 Expert Report of Dr. Loyd V. Allen, Jr., August 26, 2004 Expert Report of Dr. Stephen R. Byrn, August 27, 2004 DJA-466 to DJA-471 DJA-472 to DJA-475 DJA-476 to DJA-480 DJA-481 to DJA-578 Rebuttal Expert Report of Dr. Gordon Amidon, October 15, 2004 DJA-579 to DJA- 617 Expert Report of Dr. Robert O. Williams III, October 15, 2004 Declaration of Dr. Robert O. Williams III, January 18, 2005 Supplemental Expert Report of Dr. Stephen R. Byrn, May 27, 2005 Declaration of Michael A. Jones, August 16, 2006 Expert Report of Dr. Edmund Elder, December 14, 2006 Expert Report of Professor Iain M. Cockburn, December 15, 2006 Expert Report of Gerhard Levy Relating to the Antitrust Case Expert Report of Dr. Gregory K. Leonard, December 15, 2006 Expert Report of Richard H. Grimm, M.D., M.P.H., P.H.D. on behalf of End Payor Plaintiffs and Pacificare, December 15, 2006 DJA-618 to DJA-651 DJA-652 to DJA-656 DJA-657 to DJA-667 DJA-668 to DJA-681 DJA-682 to DJA-684 DJA-685 to DJA-731 DJA-732 to DJA-733 DJA-734 to DJA-738 DJA-739 to DJA
6 Case 1:05-cv SLR Document Filed 05/13/2008 Page 6 of 15 DOCUMENT DESCRIPTION Expert Report of Jeffrey J. Leitzinger, PH.D, December 15, 2006 Expert Report of Keith B. Leffler in In Re Tricor Direct Purchaser Antitrust Litigation, December 15, 2006 Declaration of Charles King III Concerning Liability and Product Market Definition, December 15, 2006 Declaration of Charles King III Concerning Damages, December 15, Physicians Desk Reference (60 th ed Zetia Expert Report of Gerhard Levy Relating to the Antitrust Case, December 15, 2006 Expert Report of Stephen W. Schondelmeyer, Pharm.D., PH.D., December 15, 2006 Expert Report of Dr. Arthur Schawrtzbard, M.D., F.A.C.C., January 16, 2007 Expert Report of Dr. Peter Howard Jones, April 17, 2007 Expert Report of Dr. Gordon Amidon, April 18, 2007 Expert Report of Dr. Stephen R. Byrn, April 18, 2007 Expert Report of Dr. Arthur H. Goldberg, April 18, 2007 Expert Report of Dr. James McGinty, April 18, 2007 Expert Report of Dr. Robert O. Williams, III, April 18, 2007 Expert Report of Richard J. Gilbert, PH.D, June 29, 2007 Expert Report of Margaret E. Guerin-Calvert, June 29, 2007 Expert Report of Richard J. Gilbert, PH.D, June 29, 2007 Expert Report of Sander J. Robins, M.D., July 13, 2007 Expert Report of Rodolfo Soto, M.D., July 20, 2007 APPENDIX PAGES DJA-748 to DJA-774 DJA-775 to DJA-793 DJA-794 to DJA-814 DJA-815 to DJA-820 DJA-821 to DJA-824 DJA-825 to DJA-842 DJA-843 to DJA-846 DJA-847 to DJA-859 DJA-860 to DJA-875 DJA-877 to DJA-907 DJA-908 to DJA-926 DJA-927 to DJA-942 DJA-943 to DJA-953 DJA-954 to DJA-990 DJA-991 to DJA-1006 DJA-1007 to DJA-1036 DJA-1037 to DJA-1046 DJA-1047 to DJA
7 Case 1:05-cv SLR Document Filed 05/13/2008 Page 7 of 15 DOCUMENT DESCRIPTION Reply Expert Report of Stanley A. Kaplan, Ph.D., August 10, 2007 Surrebuttal of Charles King III Concerning Liability and Product Market Definition, October 5, 2007 Rebuttal Expert Report of Professor Iain M. Cockburn, October 8, 2007 Rebuttal Expert Report of Jeffrey J. Leitzinger, PH.D., October 8, 2007 Expert Report of Keith B. Leffler, October, 8, 2007 Supplemental Expert Report of Richard J. Gilbert, PH.D, March 28, 2008 APPENDIX PAGES DJA-1051 to DJA-1053 DJA-1054 to DJA-1067 DJA-1068 to DJA-1087 DJA-1088 to DJA-1094 DJA-1095 to DJA-1105 DJA-1106 to DJA-1118 LEGAL FILINGS Defendant s Memorandum of Law in Support of Motion for Partial Summary Judgment of Non-Infringement, US Dist. Court for the N. District of Illinois Eastern Division, April 23, 2002 Declaration of Philippe Reginault, Deposition Exhibit 25 Declaration of Charles King III, Concerning Damages, December 15, 2006 Declaration of Charles King III, Concerning Liability and Product Market Definition, December 15, 2006 DJA-1119 to DJA-1122 DJA-1123 to DJA-1128 DJA-1129 to DJA-1134 DJA-1135 to DJA-1155 MISCELLANEOUS Webster s Third New International Dictionary of the English Language Unabridged IMS Business Watch Article 1999 In Review May 2000 ATP III Executive Summary May 2001 DJA-1156 to DJA-1157 DJA-1158 to DJA-1168 DJA-1169 to DJA Physicians Desk Reference (56 th ed DJA-1209 to DJA Physicians Desk Reference (56 th ed DJA-1210 to DJA
8 Case 1:05-cv SLR Document Filed 05/13/2008 Page 8 of 15 DOCUMENT DESCRIPTION Teva Internal Document re Formula Comparison, June 14, 2002 Kurt Nielsen Letter, August 21, 2002 Charles Wolfe Letter, December 9, 2002 Mark Shaw Letter, January 28, 2003 Declaration of Philippe Reginault, June 13, 2003 Kurt Nielsen Letter, July 16, 2003 Mark Shaw Letter, August 8, 2003 Mark Shaw Letter, November 28, 2003 Kurt Nielsen Letter, December 12, 2003 Blouquin Declaration, February 17, 2005 APPENDIX PAGES DJA-1215 to DJA-1238 DJA-1239 to DJA-1247 DJA-1248 to DJA-1264 DJA-1265 to DJA-1279 DJA-1280 to DJA-1285 DJA-1286 to DJA-1293 DJA-1294 to DJA-1300 DJA-1301 to DJA-1320 DJA-1321 to DJA-1329 DJA-1330 to DJA Physicians Desk Reference (60 th ed Crestor DJA-1335 to DJA Physicians Desk Reference (60 th ed Pravachol DJA-1341 to DJA Physicians Desk Reference (60 th ed Advicor DJA-1347 to DJA Physicians Desk Reference (60 th ed Niaspan DJA-1353 to DJA Physicians Desk Reference (60 th ed Zocor DJA-1358 to DJA Physicians Desk Reference (60 th ed Vytorin DJA-1365 to DJA Physicians Desk Reference (60 th ed Zetia DJA-1370 to DJA Physicians Desk Reference (60 th ed Lipitor DJA-1377 to DJA Physicians Desk Reference (60 th ed Lescol DJA-1381 to DJA Physicians Desk Reference (60 th ed Omacor DJA-1386 to DJA
9 Case 1:05-cv SLR Document Filed 05/13/2008 Page 9 of 15 Tricor Label 48 mg and 145 mg DOCUMENT DESCRIPTION APPENDIX PAGES DJA to DJA Standards of Medical Care in Diabetes DJA-1388 to DJA Washington Manual of Medical Therapeutics - WMMT - Dyslipidemia DJA-1478 to DJA-1489 United States Patent 4,895,726 United States Patent 6,074,670 United States Patent 6,277,405 United States Patent 6,589,522 United States Patent 6,652,881 PATENTS DJA-1490 to DJA-1494 DJA-1495 to DJA-1503 DJA-1504 to DJA-1512 DJA-1513 to DJA-1521 DJA-1522 to DJA
10 Case 1:05-cv SLR Document Filed 05/13/2008 Page 10 of 15 REDACTED IN ITS ENTIRETY
11 DJA-1156
12 DJA-1157
13 Case 1:05-cv SLR Document Filed 05/13/2008 Page 13 of 15 DJA-1158
14 Case 1:05-cv SLR Document Filed 05/13/2008 Page 14 of 15 DJA-1159
15 Case 1:05-cv SLR Document Filed 05/13/2008 Page 15 of 15 DJA-1160
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An ANDA Update. June 2004 Bulletin 04-50
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