Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 603

NOTICE by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc. of Filing with the Clerk's Office Exhibit to Declaration of Keith E. Toms [DN 593] In Support of Defendants' Opposition to Amgen's Motion for Summary Judgment of Infringement of '422 Claim 1, '933 Claim 3, and '698 Claim 6 (Huston, Julia)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 603

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, vs. F. HOFFMANN-LA ROCHE LTD; ROCHE DIAGNOSTICS GmbH; and HOFFMANN-LA ROCHE INC. Defendants. ) ) ) ) ) ) ) ) ) ) ) ) )

CIVIL ACTION No.: 05-CV-12237WGY

NOTICE OF FILING WITH CLERK'S OFFICE OF EXHIBITS TO DECLARATION OF KEITH E. TOMS IN SUPPORT OF DEFENDANTS' OPPOSITION TO AMGEN'S MOTION FOR SUMMARY JUDGMENT OF INFRINGEMENT OF '422 CLAIM 1, '933 CLAIM 3, AND '698 CLAIM 6 Pursuant to CMF/ECF Administrative Procedures Rule M(6) notice is hereby given that the exhibits listed below have been manually filed with the Court and are available in paper form only. The original documents are maintained in the case file in the Clerk's Office. Exhibit 1 Exhibit 2 Exhibit 3 Exhibit 4 Exhibit 5 Exhibit 6 Exhibit 7 Exhibit 8 Exhibit 9 '178 File History, Application Claims at 49, 97, 101, 102. '178 File History, Paper 11, 6/2/89 Amendment at 3-4. '178 File History, Paper 13, 6/20/89 Office Action at 3, 5. '178 File History, Paper 15, 7/11/89 Amendment at 1, 3-4. '178 File History, Paper 17, 12/1/89 Examiner Interview Summary Record. '178 File History, Paper 19, 1/10/90 Amendment at 1, 5, 6. '178 File History, Paper 32, 4/21/99 Examiner Interview Summary. '197 File History, Paper 35, Terminal Disclaimer. '178 File History, Paper 4, 6/2/86 Office Action at 3-5.

Dockets.Justia.com

Exhibit 10 Exhibit 11 Exhibit 12 Exhibit 13 Exhibit 14 Exhibit 15 Exhibit 16 Exhibit 17 Exhibit 18 Exhibit 19 Exhibit 20 Exhibit 21 Exhibit 22 Exhibit 23 Exhibit 24 Exhibit 25 Exhibit 26 Exhibit 27 Exhibit 28 Exhibit 29 Exhibit 30 Exhibit 31 Exhibit 32 Exhibit 33

'178 File History, Paper 6, 12/1/88 Amendment and Reply at 3, 8-9. '178 File History, Paper 9, 2/10/89 Office Action. '179 File History, Paper 1. '179 File History, Paper 14, 9/27/88 Reply. '179 File History, Paper 29, 9/1/93 Office Action at 9-10. '179 File History, Paper 33, 1/3/94 Amendment and Response at 2 , 5, 11. '179 File History, Paper 8, 5/24/88 Second Preliminary Amendment at 3-4, 6-10, 15-19. '197 File History, Paper 2, 11/6/90 Preliminary Amendment at 8. '197 File History, Paper 20, 6/1/94 Office Action at 3, 4. '197 File History, Paper 26, 3/31/95 Letter. '197 File History, Paper 33, 4/28/99 Amendment at 3-4. '197 File History, Paper 4, 4/6/92 Office Action at 2. '381 File History, Paper 1, Application. '381 File History, Paper 3a, 6/6/95 Continuing Application Transmittal. '381 File History, Paper 7, 12/11/96 Interview Summary. '381 File History, Paper 8, 12/20/96 Terminal Disclaimer;. '381 File History, Paper 9, 12/20/96 Second Preliminary Amendment at 7-8, 10. '398 patent File History, Response to Final Office Action and Amendment (6/24/02) at 5. '741 File History, Application Claims at 102. '741 File history, Paper 1, 11/6/90 Application. '741 File History, Paper 2, 11/6/90 Preliminary Amendment at 2, 4, 5, 6 and 8. '741 File History, Paper 4, 4/6/92 Office Action. '774 File History, Paper 45, 6/7/95 Preliminary Amendment at 2. '774 File History, Paper 50, 12/20/95 Second Preliminary Amendment at 2.

2

Exhibit 34 Exhibit 35 Exhibit 36 Exhibit 37

'874 File History, Paper 37, 6/13/94 Preliminary Amendment. '197 File History, Paper 23, 12/1/94 Request for Reconsideration. '197 File History, Paper 25, 3/3/95 Amendment and Declaration of Richard D. Cummings, Ph.D. 12/20/99 Expert Statement of Harvey F. Lodish, Ph.D., at paragraph 124.

Exhibit 38 is intentionally omitted. Exhibit 39 is intentionally omitted. Exhibit 40 4,703,008.

Exhibit 41 is intentionally omitted. Exhibit 42 Exhibit 43 Exhibit 44 Exhibit 45 Exhibit 46 Exhibit 47 Exhibit 48 Exhibit 49 Exhibit 50 Exhibit 51 Exhibit 52 Exhibit 53 5,153,265. 5,441,868. 5,547,933. 5,618,698. 5,856,298. 5,955,422. 5/11/07 Cords Report ¶¶ 24-33. 6,399,333. 6,471,500. 6,583,272. 6,586,398. 7,217,689.

Exhibit 54 is intentionally omitted. Exhibit 55 is intentionally omitted. Exhibit 56 Exhibit 57 Exhibit 58 Abuchowski et al. (1977) at 3579. Alberts (1983) at 92. AM 44 0004799-834 at 809. 3

Exhibit 59 Exhibit 60 Exhibit 61 Exhibit 62 Exhibit 63 Exhibit 64 Exhibit 65

AM 44 0197792. AM 44 0445251-5274 at 61. AM44 0003879. AM44 0004809. AM44 004799-AM44 0004834: "How Do Physical Changes in ESPs Affect Biological Activity". AM44 0156801-0156884 at 811. AM44 0230737-67 at 745.

Exhibit 66 is intentionally omitted. Exhibit 67 Exhibit 68 Exhibit 69 Exhibit 70 AM44 0825645. AM44 0897376-82. AM44 1591670-1679. AM67 01078325-330 at 327.

Exhibit 71 is intentionally omitted. Exhibit 72 Exhibit 73 Exhibit 74 Exhibit 75 Exhibit 76 Exhibit 77 Exhibit 78 Exhibit 79 Exhibit 80 Exhibit 81 Amgen I at 91. Amgen Inc.'s Response to Defendants' Claim Construction Brief filed 3/19/07 323. AM-ITC 00974613 (Amgen Patent Tree). Amgen Supplemental Response to Rogg. 8, 2/10/07. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 339 F. Supp. 2d 202, 283-303 (D. Mass. 2004). Amgen's Epogen Label. Amgen's Supp. Response to Rogg 8, dated 2/9/07 at 26. AM-ITC 00052992-95. AM-ITC 00102090-105. AM-ITC 00595293.

4

Exhibit 82 Exhibit 83 Exhibit 84 Exhibit 85 Exhibit 86 Exhibit 87 Exhibit 88 Exhibit 89 Exhibit 90 Exhibit 91 Exhibit 92 Exhibit 93 Exhibit 94

AM-ITC 00596039-042. AM-ITC 00941090-1099, at 1094. AM-ITC-00087147-7158. AM-ITC-00900034-39. AM-ITC-00903447-56. AM-ITC-00929860-862. AM-ITC-01072476-2501. AM-ITC 00592757. Banga (2006) at 205. Beauchamp et al. (1983) at 31. Benet Report I ¶¶ 30-32. Benet Tr. 197:7-15, 246:11-13. Boone Tr. (3/30/07) 28:11-22 , 31:5-12, 46:20-22, 93:1-10, 94:21-95:4, 96:12-21 24:22-26:1, 31:6-11, 46:20-22, 76:6 - 77:16, 92:24 - 93:3, 94:14 - 96:24, 159:1624. Bradshaw Expert Report 6/1/07 ¶¶ 17, 20. Bradshaw Tr. pp. 272:20-277:18, 76:2-10, 16:1-25. Cheetham et al. (1998) at 861.

Exhibit 95 Exhibit 96 Exhibit 97

Exhibit 98 is intentionally omitted. Exhibit 99 Exhibit 100 Exhibit 101 Exhibit 102 Exhibit 103 Exhibit 104 Cram & Cram, "The Essence of Organic Chemistry" 273 (Addison-Wesley Publishing Co. 1978)). Declaration of Thomas Wayne Strickland (11/30/88 ¶¶ 5, 6, 11). Delgado (1992) at 274, 276. Delivery of Protein and Peptide Drugs in Cancer (2006) Chapter 4 pp. 76-77. Delorme et al. (1992). Elliot Tr., 3/29/07, pp. 198:12-199:11.

5

Exhibit 105 is intentionally omitted. Exhibit 106 Exhibit 107 Exhibit 108 Exhibit 109 Exhibit 110 Elliott Depo. Tr. (5/20/98) Ortho Biotech v. Kirin-Amgen, 70:22-72:15, 141:6141:9). Elliott et al., Mapping of the Active Site of Recombinant Human Erythorpoietin, Blood, Vol. 89, No. 2, pp. 493-502 (1997)). Elliott Ortho Tr. 10/15/98 at 3354:22-3355:17, 3421:8-3424:20, 3636:1-10. Elliott Tr. (3/29/07) 13:5-16; 23:16-19; 24:13-15; 24:23-25:2, 201:25-202:22, 216:16-220:12, 229:4-232:21, 237:13-241:24. Elliott, S.G., New Molecules and Formulations of Recombinant Human Erythropoietin, in ERYTHROPOIETINS AND ERYTHROPOIESIS 241-58 (G. Molineux et al., eds. 2003)). EPOGEN Label issued 03/09/07 p. 25.

Exhibit 111

Exhibit 112 is intentionally omitted. Exhibit 113 Exhibit 114 Exhibit 115 Exhibit 116 Exhibit 117 Exhibit 118 Exhibit 119 Exhibit 120 Exhibit 121 Exhibit 122 Exhibit 123 Exhibit 124 Exhibit 125 Exhibit 31 to its "Memorandum In Support of Amgen Inc.'s Motion for Summary Judgment Of Infringement of `422 Claim 1, `933 Claim 3, And `698 Claim 6.". File History of U.S. Pat. No. 4,703,008, AM-ITC-00873591. Genentech, Inc., v. Boehringer Mannheim Gmbh, 47 F.Supp.2d 91, 95 (D. Mass. 1999. Goldwasser et al. (1974) at 4202-4206. Goldwasser Tr. 2/14/07, pp. 177:18-178:11). Gross & Lodish (2006) Entire Article. Gutfreund (1955). Halstenson Clin. Pharmacol. Ther. 50: 702-712 (1991). Harris & Chess (2003) at 215, 220. Harris (2001), 542-549). Haselbeck Dep. Tr. 128-129. Heatherington in ERYTHROPOIETINS AND ERYTHROPOIESIS AT 87 (G. Molineaux et al., eds. 2003)0. . http://www.amgen.com/patients/prca.html.

6

Exhibit 126 Exhibit 127 Exhibit 128 Exhibit 129 Exhibit 130 Exhibit 131 Exhibit 132 Exhibit 133 Exhibit 134 Exhibit 135 Exhibit 136 Exhibit 137 Exhibit 138 Exhibit 139 Exhibit 140 Exhibit 141 Exhibit 142 Exhibit 143 Exhibit 144 Exhibit 145 Exhibit 146 Exhibit 147 Exhibit 148

Hynes, Adherence to Guidelines for ESRD Anemia Management 2006. ITC-R-BLA-00005515. ITC-R-BLA 00000091. ITC-R-BLA- 00004032, 4035 . ITC-R-BLA- 00004271-4275. ITC-R-BLA- 00004301-4306. ITC-R-BLA- 00005580. ITC-R-BLA 00007306-00007318. AM-ITC 00899473. ITC-R-BLA-00004178. ITC-R-BLA-00000001-22. ITC-R-BLA-00000066 (draft package insert). ITC-R-BLA-00000212. ITC-R-BLA-00000217. ITC-R-BLA-00000248. ITC-R-BLA-00000250. ITC-R-BLA-00000261. ITC-R-BLA-00000309. ITC-R-BLA-00000313-327. ITC-R-BLA-00000322-325. ITC-R-BLA-00000502-506, 511-513. ITC-R-BLA-00002808. ITC-R-BLA-00003366.

Exhibit 149 is intentionally omitted. Exhibit 150 ITC-R-BLA-00003417.

7

Exhibit 151 Exhibit 152 Exhibit 153 Exhibit 154 Exhibit 155 Exhibit 156 Exhibit 157 Exhibit 158 Exhibit 159 Exhibit 160 Exhibit 161 Exhibit 162 Exhibit 163 Exhibit 164 Exhibit 165 Exhibit 166 Exhibit 167 Exhibit 168 Exhibit 169 Exhibit 170 Exhibit 171 Exhibit 172 Exhibit 173 Exhibit 174 Exhibit 175

ITC-R-BLA-00003428-29. ITC-R-BLA-00004027. ITC-R-BLA-00004028. ITC-R-BLA-00004029. ITC-R-BLA-00004031. ITC-R-BLA-00004032. ITC-R-BLA-00004035. ITC-R-BLA-00004043. ITC-R-BLA-00004046-4051. ITC-R-BLA-00004059. ITC-R-BLA-00004126. ITC-R-BLA-00004178. ITC-R-BLA-00004233. ITC-R-BLA-00004241-4268. ITC-R-BLA-00004247-4256. ITC-R-BLA-00004257-4268. ITC-R-BLA-00004271-4275. ITC-R-BLA-00004296-4316. ITC-R-BLA-00004299-300. ITC-R-BLA-00004307-4312. ITC-R-BLA-00004659. ITC-R-BLA-00004660. ITC-R-BLA-00004661. ITC-R-BLA-00004663-4. ITC-R-BLA-00004667.

8

Exhibit 176 Exhibit 177 Exhibit 178 Exhibit 179 Exhibit 180

ITC-R-BLA-00004680. ITC-R-BLA-00004682-4704. ITC-R-BLA-00004716. ITC-R-BLA-00004722. ITC-R-BLA-00004723.

Exhibit 181 is intentionally omitted. Exhibit 182 is intentionally omitted. Exhibit 183 Exhibit 184 Exhibit 185 Exhibit 186 Exhibit 187 Exhibit 188 Exhibit 189 ITC-R-BLA-00005616-32. ITC-R-BLA-00005656-74. ITC-R-BLA-00005770-73. ITC-R-BLA-00007081-7124. ITC-R-BLA-00007125-7158 Entire Doc. ITC-R-BLA-00007159-7206. ITC-R-BLA-00007243-255.

Exhibit 190 is intentionally omitted. Exhibit 191 Exhibit 192 Exhibit 193 Exhibit 194 Exhibit 195 Exhibit 196 Exhibit 197 Exhibit 198 Exhibit 199 ITC-R-BLA-00007256-70. ITC-R-BLA-00007267. ITC-R-BLA-00007271-90. ITC-R-BLA-00007281-3, Figures 1 and 2. ITC-R-BLA-00007291-7305. ITC-R-BLA-00007310-18 at 15-18, figs. 1 and 2, table 1. ITC-R-BLA-00007319- 753 at 325, Fig.1, Tables 1 and 2; 326-327, Fig. 2, Tables 3 and 4. ITC-R-BLA-00007469-7506 at 7486, 7490. ITC-R-BLA-00019402-84.

Exhibit 200 is intentionally omitted. 9

Exhibit 201 is intentionally omitted. Exhibit 202 Exhibit 203 Exhibit 204 Exhibit 205 Exhibit 206 Exhibit 207 Exhibit 208 Exhibit 209 ITC-RBLA-00022202-00022327. ITC-R-BLA-0005775-81. ITC-R-BLA-00066252-66426 at 282. ITC-R-BLA-00075601-802. ITC-R-BLA-00084420-84557. ITC-R-BLA-00109530-675. ITC-R-BLA-00115298-421. ITC-R-BLA-00140975-41134.

Exhibit 210 is intentionally omitted. Exhibit 211 Exhibit 212 Exhibit 213 Exhibit 214 Exhibit 215 Exhibit 216 Exhibit 217 Exhibit 218 Exhibit 219 Exhibit 220 Exhibit 221 ITC-R-IND-00064970-981 at 971. Jacobs 1985. Jarsch (3/27/07) Tr. at 56:8-17. Jorgensen and Tirado-Rives Molecular Modeling of Organic and Biomolecular Systems Using BOSS and MCPRO, Comput. Chem. 2005, 26, 1689-1700. Karp (2002) at 52-53, 55-62. Katre (1993) at 93, 95, 98, 103. Kinstler et al. (2002) at 478. Klibanov 5/11/07 Expert Report ¶ 116. Klibanov Tr. 5/23/07. 153:18-154:13. Kozlowski and Harris (2001) at 219-20. Krantz and Goldwasser, Specific Binding of Erythropoietin to spleen cells infected with the anemia strain of Friend virus, Proc. Natl. Acad. Sci , 81: 7574-7578 (1984). Kynclova (1996) at 644. Lai 1986.

Exhibit 222 Exhibit 223

10

Exhibit 224 Exhibit 225 Exhibit 226 Exhibit 227 Exhibit 228 Exhibit 229 Exhibit 230 Exhibit 231 Exhibit 232 Exhibit 233 Exhibit 234 Exhibit 235

Lin et al., "Cloning and expression of the human erythropoietin gene," PNAS, 82 7580-7584 (1985). Lin Tr. (3/28/07) 91:4-122:25, 304:12-305:5. Lin Tr. 6/7/00 at 965:8-14. Lodish 4/6/07 Expert Report ¶¶ 24, 31-33, 92, 94-95, 139, 141, 172, 182, 183, 187-89, 192. Lodish Dep. Tr., J&J Arb., Jul. 30, 1998 at 110-111. Macdougall & Eckardt, "Novel strategies for stimulating erythropoiesis and potential new treatments for anaemia," Lancet, 2006, 368:947-953). MacDougall (2005) at 436, 439. Macdougall Clin J. Am Soc. Nephrol. 1: 1211-1215 (2006). Macdougall J. Am Soc Nephrol 10: 2392-2395 (1999). Markman Tr. Mattison (2001) at 66-67. Mayeux, P. et al., The Erythropoietin Receptor of Rat Erythroid Progenitor Cells; Characterization and Affinity Cross Linkage, J. Bio. Chem., Vol. 262, No. 29, pp. 13985-13990 (1987)). Molineux (2002) at 13-15. Molineux Depo. Tr., 3/28/07 at 44-45, 47-48. Molineux in "Erythropoietins and Erythropoiesis, Molecular, Cellular, Preclinical and Clinical Biology" at 8, fig. 2). Molineux Tr. (3/28/07) 43:19-50:6, 72:1- 72:20. Molineux, Anti-Cancer Drugs (2003) at 259-260. Molineux, Pharmacotherapy (2003) at 5S. Morrison & Boyd (1983) at 2-3, 79, 157. MPEP §2173.05(p) (8th ed. Rev. 5, Aug. 2006). MPEP §706.03(e) (5th ed. Rev. 6, Oct. 1987).

Exhibit 236 Exhibit 237 Exhibit 238 Exhibit 239 Exhibit 240 Exhibit 241 Exhibit 242 Exhibit 243 Exhibit 244

Exhibit 245 is intentionally omitted.

11

Exhibit 246 Exhibit 247 Exhibit 248 Exhibit 249 Exhibit 250 Exhibit 251 Exhibit 252 Exhibit 253 Exhibit 254 Exhibit 255 Exhibit 256 Exhibit 257 Exhibit 258 Exhibit 259 Exhibit 260 Exhibit 261 Exhibit 262

Ossulund (2003) at 32-33. R001507222-225. R001564952-981 at 960. R001572230. R004792356. R004961456. R005310871. R005312429-2430. R005312436. R005312471. R005312683-774. R008890740-755. R-10-002641295. R11-000165902. R11-000636121-129. Rawn BIOCHEMISTRY (1989) at 106). Recny et al., "Structural Characterization of Natural Human Urinary and Recombinant DNA-derived Erythropoietin," J. Biol. Chem., 262(35) 1715617163 (1987) at 17161. Roberts et al. (2002) at 462, 474. Schneider, Homodimerization, 1997;. Stewart (1959). Storring et al., (1998) 100: 79-89. Strickland Tr. (3/9/07). Stryer (1988) at 4.

Exhibit 263 Exhibit 264 Exhibit 265 Exhibit 266 Exhibit 267 Exhibit 268

Exhibit 269 is intentionally omitted.

12

Exhibit 270

Syed (1998) at 515.

Exhibit 271 is intentionally omitted. Exhibit 272 Exhibit 273 Exhibit 274 Exhibit 275 Exhibit 276 Exhibit 277 Exhibit 278 Exhibit 279 Exhibit 280 Torchilin 4/6/07 Expert Report ¶¶ 61, 86-88,110. Torchilin 6/1/07 Expert Report ¶¶ 14, 30, 41, 51). Torchilin Dep. Tr. 06/18/07 at . U.S.S.N. 06/866,459. U.S.S.N. 07/632,070, Paper No. 15, dated December 2, 1991, p.13. U.S.S.N. 07/983,620, Paper No. 27, dated August 13, 1996, p. 8. U.S.S.N. 08/413,803, Paper No. 12, dated December 10, 1996, p. 14. U.S.S.N. 08/479,892, "Brief for Party Elliott" dated February 11, 2004. USSN 06/866,459, Paper No. 5, dated 8/3/87, pp. 4-7, 9, 10.

Exhibit 281 is intentionally omitted. Exhibit 282 Exhibit 283 Exhibit 284 Varki I at para. 86, 89, 92. Veronese (1985) at 142. Veronese et al. (1983) at 757.

Exhibit 285 I TC-R-BLA-00004026. Exhibit 286 Exhibit 287 Exhibit 288 Exhibit 289 Exhibit 290 Exhibit 291 Bailon & Berthold, "Polyethylene glycol-conjugated pharmaceutical proteins," PSTT 1(8): 352-356 (1998). Meister (ed). Biochemistry of the Amino Acids Volume 1. CKD Best Practice September/October 2004. Morgan Stanley Equity Research -AMGEN: Some Setbacks For Competitors In EU, February 23, 2006. Pollack, A., "Rivals Laying Siege to Amgen's Near Monopoly in Anemia Drugs," The New York Times, Dec. 23, 2005. Memo in Support of Roche's Motion for Summary Judgment of NonInfringement of Claim 1 of Patent No. 5,955,422.

13

Exhibit 292

Memo in Support of Roche's Motion for Summary Judgment of NonInfringement that Claims of the `933 Are Invalid for Indefiniteness and Lack of Written Description. Torchilin II expert report ¶ 66. the Widness and Veng-Pedersen Report. the Supplemental Expert Report of Harvey F. Lodish

Exhibit 293 Exhibit 294 Exhibit 295

Dated: June 29, 2007 Boston, Massachusetts

Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By its attorneys, /s/ Julia Huston_____________ Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO# 551926) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. [phone] [e-mail] Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Christopher T. Jagoe (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. [phone]

14

CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non-registered participants on the above date.

/s/ Julia Huston Julia Huston
03099/00501 696668.1

15