throbber
Arnold B. Calmann (abc@saiber.com)
`Jeffrey Soos (js@saiber.com)
`Katherine A. Escanlar (kae@saiber.com)
`SAIBER LLC
`One Gateway Center, 10th Floor, Suite 1000
`Newark, New Jersey 07102
`Telephone: (973) 622-3333
`
`Douglas H. Carsten (dcarsten@wsgr.com)
`Elham Firouzi Steiner (esteiner@wsgr.com)
`Arthur P. Dykhuis (adykhuis@wsgr.com)
`Nathaniel R. Scharn (nscharn@wsgr.com)
`Alina L. Litoshyk (alitoshyk@wsgr.com)
`James P.H. Stephens (jstephens@wsgr.com)
`Michael Taylor Dimler (tdimler@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI P.C.
`12235 El Camino Real
`San Diego, California 92130
`Telephone: (858) 350-2300
`
`Attorneys for Defendants Mylan GmbH, Biocon Ltd., Biocon
`Research Ltd., Biocon Sdn. Bhd., and Biocon S.A.
`
`IN THE UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH, and
`SANOFI WINTHROP INDUSTRIE,
`
`
`
`C.A. No. 17-cv-09105-SRC-CLW
`
`Plaintiffs,
`
`v.
`
`
`
`MYLAN N.V., MYLAN GMBH, MYLAN INC.,
`and MYLAN PHARMACEUTICALS INC.,
`
`Defendants.
`
`MYLAN GMBH AND BIOCON’S PRELIMINARY CLAIM CONSTRUCTIONS AND
`SUPPORTING EVIDENCE PURSUANT TO L. PAT. R. 4.2
`
`Pursuant to the Court’s December 19, 2017 Scheduling Order (D.I. 23), Local Patent
`
`Rule 4.2, and agreement of the parties, based on the evidence available to it at this time,
`
`1
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 1 of 153
`
`

`

`Defendants Biocon Ltd., Biocon Research Ltd., Biocon Sdn. Bhd., and Biocon S.A. (collectively
`
`“Biocon”) and Mylan GmbH (with Biocon, “Defendants”) provide the following preliminary
`
`proposed constructions of each term identified by the parties in the above-captioned case for
`
`claim construction. Biocon and Mylan GmbH further identify references from the patent
`
`specifications and prosecution histories of U.S. Patent Nos. 7,476,652 (“’652 patent”), 7,713,930
`
`(“’930 patent”), 8,603,044 (“’044 patent”), 8,679,069 (“’069 patent”), 8,992,486 (“’486 patent”),
`
`9,526,844 (“’844 patent”), and 9,604,008 (“’008 patent”) (collectively, “Asserted Patents”) in
`
`support of their preliminary proposed constructions, as well as supporting extrinsic evidence,
`
`pursuant to Local Patent Rule 4.2(b).
`
`The proposed constructions and supporting evidence, listed in Exhibits A-G, are
`
`preliminary and subject to revision or supplementation as discovery proceeds. Biocon and
`
`Mylan GmbH reserve the right to rely on additional intrinsic and extrinsic evidence, including
`
`expert testimony, to rebut any evidence relied upon by Plaintiffs in support of their proposed
`
`claim constructions, pursuant to Local Patent Rule 4.2(c). Furthermore, Biocon and Mylan
`
`GmbH reserve the right to amend or supplement these preliminary proposed constructions and
`
`supporting evidence in connection with the Joint Claim Construction and Prehearing Statement
`
`required by Local Patent Rule 4.3.
`
`Biocon and Mylan GmbH reserve the right to supplement or change their proposed
`
`constructions for the listed claim terms, or to add or remove proposed terms for construction,
`
`based on Plaintiffs’ proposed constructions, any modification or amendments to Plaintiffs’
`
`Infringement or Responses to Invalidity Contentions, or based on any additional evidence that
`
`Biocon and Mylan GmbH may discover in this action.
`
`
`
`
`
`2
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 2 of 153
`
`

`

`Dated: September 5, 2018
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
` /s/ Nathaniel R. Scharn
`Nathaniel R. Scharn
`Douglas H. Carsten
`Elham Firouzi Steiner
`Arthur P. Dykhuis
`Alina L. Litoshyk
`James P.H. Stephens
`Michael Taylor Dimler
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego, California 92130
`(858) 350-2300
`
`
`
`Arnold B. Calmann
`Katherine A. Escanlar
`SAIBER LLC
`One Gateway Center
`10th Floor, Suite 100
`Newark, New Jersey 07102
`(973) 622-3333
`abc@saiber.com
`kae@saiber.com
`
`Attorneys for Defendants Mylan GmbH,
`Biocon Ltd., Biocon Research Ltd., Biocon
`Sdn. Bhd., and Biocon S.A.
`
`3
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 3 of 153
`
`

`

`
`
`Exhibit A
`
`
`
`4
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 4 of 153
`
`

`

`U.S. Patent No. 7,476,652
`
`Claim Term
`
`Defendants’ Construction
`
`“polysorbate”
`(claims 7, 24)
`
`Plain and ordinary meaning, which
`the person of ordinary skill in the
`art would understand to be “a series
`of partial fatty acid esters of
`sorbitol and its anhydrides
`copolymerized with approximately
`20, 5, or 4 moles of ethylene oxide
`for each mole of sorbitol and its
`anhydrides.” No construction
`necessary.
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`Intrinsic Evidence
`
`Claims
`
`’652 patent, claims 1, 2, 7, 8, 23 24
`
`
`Specification
`
`’652 patent, at 3:50-56
`
`’652 patent, at examples 1-3 (5:17-10:67)
`
`
`Prosecution History
`U.S. Application No. 11/089,777
` March 25, 2005 Transmittal of New Application, at
`16-19
` October 3, 2006 Non-Final Rejection, at 3-7; March
`21, 2007 Response, at 5-10
`
`
`Defendants reserve the right to rely on any portion of the
`’652 patent specification and prosecution history.
`
`Related Patents
`’930 patent, at 3:27-30; examples 1-3 (5:25-11:47)
`
`Extrinsic Evidence
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT (Dkt. 95, at Exhibit 1; Dkt. 149,
`at 20-24; Dkt. 236, at 2-3) and references cited therein.
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`
`5
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 5 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`1:14-cv-00113-RGA-MPT, N. Lill Depo. Tr. (Jan. 28,
`2015, SANOFI3_90285986-6099). Defendants may rely on
`all mentions of the terms “polysorbate,” “polysorbates,”
`“tween,” and “tweens” in the deposition transcripts of N.
`Lill, as well as the surrounding disclosure. For example:
` N. Lill (Jan. 28, 2015), “polysorbate”:
`o 23:11; 23:12, 18, 24; 24:4; 24:19; 70:12, 13,
`25; 71:6, 11, 18, 24; 72:7, 13, 14, 21; 73:14,
`18, 22; 74:13; 75:5; 96:15; 106:20; 106:24;
`107:5; 107:23; 108:12, 19; 109:9; 109:20;
`110:20; 111:20 112:3, 7; 113:23; 114:5, 6,
`17; 114:18; 115:10; 116:3, 11, 18, 22; 117:5;
`118:6, 17; 124:13; 125:13, 19; 125:22;
`126:6, 14; 126:18, 20; 127:10; 127:12, 20;
`133:17; 133:18; 134:20; 135:11; 137:7, 10;
`137:15, 16; 138:5, 6; 138:14, 15; 139:4, 6;
`139:7, 17; 142:7, 12; 142:20; 143:4, 12, 18;
`143:22; 149:20, 22, 24; 150:6, 12, 18, 22;
`152:3, 8, 12; 155:11; 155:15, 21, 25; 156:10,
`24, 25; 157:12; 158:10, 17; 159:12; 160:2;
`165:5; 166:14, 18; 167:6, 6, 23; 168:3;
`168:13, 19; 169:25; 170:9, 16; 171:3, 4;
`171:17, 20, 24; 172:12; 173:9, 22; 174:7;
`178:18; 179:2, 8, 21; 180:4; 180:15; 181:17,
`19; 182:4, 20; 183:4, 6; 183:15; 184:5;
`185:3; 186:2; 188:8; 189:20, 22; 190:14;
`191:24; 192:9, 9, 13; 192:21; 193:19, 21;
`194:15; 199:10, 16; 199:20; 200:15, 20;
`201:4, 16, 18, 25; 202:6; 202:20; 203:3, 4, 5;
`203:6, 16, 22, 23, 25; 204:5, 6, 9, 17, 25;
`205:9, 18, 25; 211:14; 211:15, 22; 212:2;
`
`6
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 6 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`213:2, 5; 224:10, 15; 225:23, 23; 226:10;
`226:10, 13, 18; 226:21, 24; 227:3; 227:13,
`22, 23; 228:7; 231:16, 20; 232:4, 17; 233:14;
`233:22; 234:6; 239:9.
` N. Lill (Jan. 28, 2015), “polysorbates”:
`o 107:23; 142:20; 143:22; 201:16, 18; 211:14
` N. Lill (Jan. 28, 2015), “tween”:
`o 70:19; 71:22; 88:5, 7, 21, 22; 88:24; 89:4, 5;
`89:14; 90:21; 91:2; 91:5, 9, 14, 15, 19;
`91:20; 92:15; 94:19; 95:9; 98:22; 99:11, 20,
`25; 100:4, 7, 10, 13, 16; 100:18, 21, 24;
`101:4, 18; 102:9, 17; 103:6, 9, 15, 25; 104:6,
`22; 116:11; 128:10; 132:5; 192:5; 212:18;
`212:19; 213:9, 10; 214:14
` N. Lill (Jan. 28, 2015), “tweens”:
`o 133:5
`
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. 2:17-cv-05914-SRC-CLW (Dkt. 53, at 1) and
`references cited therein.
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. 1:16-cv-00812-RGA-MPT, N. Lill Depo. Tr.
`(Nov. 30, 2017, SANOFI5_00003495-877). Defendants
`may rely on all mentions of the terms “polysorbate,”
`“polysorbates,” and “tween” in the deposition transcripts of
`N. Lill, as well as the surrounding disclosure. For example:
` N. Lill (Nov. 30, 2017), “polysorbate”:
`o 36:14; 37:3; 38:18, 25; 39:5, 12; 40:1; 58:1;
`68:21; 69:4; 89:9; 93:12, 18; 94:2, 3, 7;
`94:17, 20; 100:21; 100:22; 101:4, 5; 102:6;
`
`7
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 7 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`108:21, 22; 111:5; 115:6; 120:11, 12, 17;
`120:24; 124:10; 124:11, 14, 25; 125:17;
`127:13; 128:11, 15, 16; 130:6, 22; 133:3;
`140:4, 8, 17; 140:18, 20; 141:21; 142:5, 10,
`25; 144:11; 148:6, 12; 148:17, 22; 152:18;
`153:22; 156:17; 159:7, 19; 160:16; 160:21;
`161:5, 10; 161:17, 20; 162:8; 162:13, 19;
`163:4; 163:16, 21; 164:5, 6; 164:20, 21;
`165:10; 165:18; 166:8, 21; 166:22; 167:14;
`168:17, 21; 169:14; 169:17, 23, 25; 170:5,
`20; 171:1, 3; 173:15; 176:4; 176:10, 20;
`177:8; 177:24; 178:8, 17; 179:13; 180:2, 6,
`24; 181:1, 25; 182:8, 11; 182:15, 20; 183:18;
`183:24; 184:6, 19; 185:8, 20, 22; 186:6;
`186:10, 16; 187:4, 8; 189:11; 190:1, 20;
`190:20; 193:4, 20; 194:17, 18, 25; 195:7, 20;
`196:15; 197:2, 11; 198:5; 199:6, 18, 23;
`200:13, 23; 201:10; 201:21; 202:14; 203:11;
`204:1, 5, 6; 204:16, 21; 205:1, 9; 205:19, 20;
`206:5; 206:13; 206:22; 207:7, 11; 210:25;
`212:15; 212:21; 213:12; 213:13, 17, 18;
`214:1; 215:5, 8, 13; 215:17, 22; 216:3, 5;
`216:22; 217:2, 12; 217:19, 23; 220:7;
`221:23; 230:4; 235:8, 10, 15, 25; 242:7;
`244:20; 245:21; 246:6, 19; 246:23; 247:14;
`247:17; 248:7; 248:10; 249:14; 250:14;
`279:20; 280:14; 281:5, 19; 281:20, 23;
`282:10; 283:8, 18; 297:23; 298:3, 18, 21;
`299:19, 21; 300:4; 301:10, 17; 302:21;
`304:8, 24; 305:19; 306:7, 17; 307:4; 309:2;
`312:2; 317:1; 321:21; 322:12, 13; 322:24;
`
`8
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 8 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`“polysorbate 20”
`(claims 1, 2, 8, 23)
`
`Plain and ordinary meaning, which
`the person of ordinary skill in the
`art would understand to be “a
`laurate ester of sorbitol and its
`anhydrides copolymerized with
`approximately 20 moles of ethylene
`oxide for each mole of sorbitol and
`sorbitol anhydrides.” No
`construction necessary.
`
`9
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`323:5, 7, 14; 323:15; 324:7, 16.
` N. Lill (Nov. 30, 2017), “polysorbates”:
`o 187:4, 8; 206:5; 247:17; 248:10
` N. Lill (Nov. 30, 2017), “tween”:
`o 120:15, 16; 122:14; 123:10; 124:6; 126:3;
`169:1; 221:15; 232:6; 286:23; 287:23; 288:3,
`6, 10, 12; 296:11, 23; 297:3
`
`
`Handbook of Pharmaceutical Excipients 2d ed. 376, 375-
`378 (1994) (MYL_IG00428435-54).
`
`Defendants may rely upon expert testimony concerning the
`meaning of this term to a person of ordinary skill in the art
`in light of the disclosures of the ’652 patent. Defendants’
`expert(s) may also rebut arguments presented by Plaintiffs’
`expert(s).
`
`Defendants also reserve the right to rely on the disclosures
`identified in Exhibit B relating to the term “polysorbate.”
`
`Defendants reserve the right to rely upon any intrinsic or
`extrinsic evidence cited by Plaintiffs.
`Intrinsic Evidence
`
`Claims
`
`’652 patent, claims 1, 2, 8, 23
`
`
`Specification
`
`’652 patent, at 3:50-56
`
`’652 patent, at examples 1-3 (5:17-10:67)
`
`
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 9 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`Prosecution History
`U.S. Application No. 11/089,777
` March 25, 2005 Transmittal of New Application, at
`16-19
` October 3, 2006 Non-Final Rejection, at 3-7; March
`21, 2007 Response, at 5-10
` April 15, 2008, at 2-3; July 15, 2008 Response, at 7-
`8
`
`
`Defendants reserve the right to rely on any portion of the
`’652 patent specification and prosecution history.
`
`Related Patents
`’930 patent, at 3:27-30; examples 1-3 (5:25-11:47)
`
`Extrinsic Evidence
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT (Dkt. 95, at Exhibit 1; Dkt. 149,
`at 24-30; Dkt. 236, at 3-5) and references cited therein.
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT, N. Lill Depo. Tr. (Jan. 28,
`2015, SANOFI3_90285986-6099). Defendants may rely on
`all mentions of the terms “polysorbate,” “polysorbates,”
`“tween,” and “tweens” in the deposition transcripts of N.
`Lill, as well as the surrounding disclosure. For example:
` N. Lill (Jan. 28, 2015), “polysorbate”:
`o 23:11; 23:12, 18, 24; 24:4; 24:19; 70:12, 13,
`25; 71:6, 11, 18, 24; 72:7, 13, 14, 21; 73:14,
`18, 22; 74:13; 75:5; 96:15; 106:20; 106:24;
`
`10
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 10 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`107:5; 107:23; 108:12, 19; 109:9; 109:20;
`110:20; 111:20 112:3, 7; 113:23; 114:5, 6,
`17; 114:18; 115:10; 116:3, 11, 18, 22; 117:5;
`118:6, 17; 124:13; 125:13, 19; 125:22;
`126:6, 14; 126:18, 20; 127:10; 127:12, 20;
`133:17; 133:18; 134:20; 135:11; 137:7, 10;
`137:15, 16; 138:5, 6; 138:14, 15; 139:4, 6;
`139:7, 17; 142:7, 12; 142:20; 143:4, 12, 18;
`143:22; 149:20, 22, 24; 150:6, 12, 18, 22;
`152:3, 8, 12; 155:11; 155:15, 21, 25; 156:10,
`24, 25; 157:12; 158:10, 17; 159:12; 160:2;
`165:5; 166:14, 18; 167:6, 6, 23; 168:3;
`168:13, 19; 169:25; 170:9, 16; 171:3, 4;
`171:17, 20, 24; 172:12; 173:9, 22; 174:7;
`178:18; 179:2, 8, 21; 180:4; 180:15; 181:17,
`19; 182:4, 20; 183:4, 6; 183:15; 184:5;
`185:3; 186:2; 188:8; 189:20, 22; 190:14;
`191:24; 192:9, 9, 13; 192:21; 193:19, 21;
`194:15; 199:10, 16; 199:20; 200:15, 20;
`201:4, 16, 18, 25; 202:6; 202:20; 203:3, 4, 5;
`203:6, 16, 22, 23, 25; 204:5, 6, 9, 17, 25;
`205:9, 18, 25; 211:14; 211:15, 22; 212:2;
`213:2, 5; 224:10, 15; 225:23, 23; 226:10;
`226:10, 13, 18; 226:21, 24; 227:3; 227:13,
`22, 23; 228:7; 231:16, 20; 232:4, 17; 233:14;
`233:22; 234:6; 239:9.
` N. Lill (Jan. 28, 2015), “polysorbates”:
`o 107:23; 142:20; 143:22; 201:16, 18; 211:14
` N. Lill (Jan. 28, 2015), “tween”:
`o 70:19; 71:22; 88:5, 7, 21, 22; 88:24; 89:4, 5;
`89:14; 90:21; 91:2; 91:5, 9, 14, 15, 19;
`
`11
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 11 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`91:20; 92:15; 94:19; 95:9; 98:22; 99:11, 20,
`25; 100:4, 7, 10, 13, 16; 100:18, 21, 24;
`101:4, 18; 102:9, 17; 103:6, 9, 15, 25; 104:6,
`22; 116:11; 128:10; 132:5; 192:5; 212:18;
`212:19; 213:9, 10; 214:14
` N. Lill (Jan. 28, 2015), “tweens”:
`o 133:5
`
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. 2:17-cv-05914-SRC-CLW (Dkt. 53, at 1-2) and
`references cited therein.
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. Case No. 1:16-cv-00812-RGA-MPT, N. Lill
`Depo. Tr. (Nov. 30, 2017, SANOFI5_00003495-877).
`Defendants may rely on all mentions of the terms
`“polysorbate,” “polysorbates,” and “tween” in the
`deposition transcripts of N. Lill, as well as the surrounding
`disclosure. For example:
` N. Lill (Nov. 30, 2017), “polysorbate”:
`o 36:14; 37:3; 38:18, 25; 39:5, 12; 40:1; 58:1;
`68:21; 69:4; 89:9; 93:12, 18; 94:2, 3, 7;
`94:17, 20; 100:21; 100:22; 101:4, 5; 102:6;
`108:21, 22; 111:5; 115:6; 120:11, 12, 17;
`120:24; 124:10; 124:11, 14, 25; 125:17;
`127:13; 128:11, 15, 16; 130:6, 22; 133:3;
`140:4, 8, 17; 140:18, 20; 141:21; 142:5, 10,
`25; 144:11; 148:6, 12; 148:17, 22; 152:18;
`153:22; 156:17; 159:7, 19; 160:16; 160:21;
`161:5, 10; 161:17, 20; 162:8; 162:13, 19;
`163:4; 163:16, 21; 164:5, 6; 164:20, 21;
`
`12
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 12 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`165:10; 165:18; 166:8, 21; 166:22; 167:14;
`168:17, 21; 169:14; 169:17, 23, 25; 170:5,
`20; 171:1, 3; 173:15; 176:4; 176:10, 20;
`177:8; 177:24; 178:8, 17; 179:13; 180:2, 6,
`24; 181:1, 25; 182:8, 11; 182:15, 20; 183:18;
`183:24; 184:6, 19; 185:8, 20, 22; 186:6;
`186:10, 16; 187:4, 8; 189:11; 190:1, 20;
`190:20; 193:4, 20; 194:17, 18, 25; 195:7, 20;
`196:15; 197:2, 11; 198:5; 199:6, 18, 23;
`200:13, 23; 201:10; 201:21; 202:14; 203:11;
`204:1, 5, 6; 204:16, 21; 205:1, 9; 205:19, 20;
`206:5; 206:13; 206:22; 207:7, 11; 210:25;
`212:15; 212:21; 213:12; 213:13, 17, 18;
`214:1; 215:5, 8, 13; 215:17, 22; 216:3, 5;
`216:22; 217:2, 12; 217:19, 23; 220:7;
`221:23; 230:4; 235:8, 10, 15, 25; 242:7;
`244:20; 245:21; 246:6, 19; 246:23; 247:14;
`247:17; 248:7; 248:10; 249:14; 250:14;
`279:20; 280:14; 281:5, 19; 281:20, 23;
`282:10; 283:8, 18; 297:23; 298:3, 18, 21;
`299:19, 21; 300:4; 301:10, 17; 302:21;
`304:8, 24; 305:19; 306:7, 17; 307:4; 309:2;
`312:2; 317:1; 321:21; 322:12, 13; 322:24;
`323:5, 7, 14; 323:15; 324:7, 16.
` N. Lill (Nov. 30, 2017), “polysorbates”:
`o 187:4, 8; 206:5; 247:17; 248:10
` N. Lill (Nov. 30, 2017), “tween”:
`o 120:15, 16; 122:14; 123:10; 124:6; 126:3;
`169:1; 221:15; 232:6; 286:23; 287:23; 288:3,
`6, 10, 12; 296:11, 23; 297:3
`
`
`
`13
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 13 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`“polysorbate 80”
`(claim 1)
`
`Plain and ordinary meaning, which
`the person of ordinary skill in the
`art would understand to be “an
`oleate ester of sorbitol and its
`anhydrides copolymerized with
`approximately 20 moles of ethylene
`oxide for each mole of sorbitol and
`sorbitol anhydrides.” No
`construction necessary.
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`Handbook of Pharmaceutical Excipients 2d ed. 376, 375-
`378 (1994) (MYL_IG00428435-54).
`
`Defendants may rely upon expert testimony concerning the
`meaning of this term to a person of ordinary skill in the art
`in light of the disclosures of the ’652 patent. Defendants’
`expert(s) may also rebut arguments presented by Plaintiffs’
`expert(s).
`
`Defendants reserve the right to rely upon any intrinsic or
`extrinsic evidence cited by Plaintiffs.
`Intrinsic Evidence
`
`Claims
`
`’652 patent, claim 1
`
`
`Specification
`
`’652 patent, at 3:50-56
`
`’652 patent, at examples 1-3 (5:17-10:67)
`
`
`Prosecution History
`U.S. Application No. 11/089,777
` March 25, 2005 Transmittal of New Application, at
`16-19
` October 3, 2006 Non-Final Rejection, at 3-7; March
`21, 2007 Response, at 5-10
` April 15, 2008, at 2-3; July 15, 2008 Response, at 7-
`8
`
`
`Defendants reserve the right to rely on any portion of the
`’652 patent specification and prosecution history.
`
`14
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 14 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`
`
`Extrinsic Evidence
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT (Dkt. 95, at Exhibit 1; Dkt. 149,
`at 24-30; Dkt. 236, at 5-6) and references cited therein.
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT, N. Lill Depo. Tr. (Jan. 28,
`2015, SANOFI3_90285986-6099). Defendants may rely on
`all mentions of the terms “polysorbate,” “polysorbates,”
`“tween,” and “tweens” in the deposition transcripts of N.
`Lill, as well as the surrounding disclosure. For example:
` N. Lill (Jan. 28, 2015), “polysorbate”:
`o 23:11; 23:12, 18, 24; 24:4; 24:19; 70:12, 13,
`25; 71:6, 11, 18, 24; 72:7, 13, 14, 21; 73:14,
`18, 22; 74:13; 75:5; 96:15; 106:20; 106:24;
`107:5; 107:23; 108:12, 19; 109:9; 109:20;
`110:20; 111:20 112:3, 7; 113:23; 114:5, 6,
`17; 114:18; 115:10; 116:3, 11, 18, 22; 117:5;
`118:6, 17; 124:13; 125:13, 19; 125:22;
`126:6, 14; 126:18, 20; 127:10; 127:12, 20;
`133:17; 133:18; 134:20; 135:11; 137:7, 10;
`137:15, 16; 138:5, 6; 138:14, 15; 139:4, 6;
`139:7, 17; 142:7, 12; 142:20; 143:4, 12, 18;
`143:22; 149:20, 22, 24; 150:6, 12, 18, 22;
`152:3, 8, 12; 155:11; 155:15, 21, 25; 156:10,
`24, 25; 157:12; 158:10, 17; 159:12; 160:2;
`165:5; 166:14, 18; 167:6, 6, 23; 168:3;
`168:13, 19; 169:25; 170:9, 16; 171:3, 4;
`171:17, 20, 24; 172:12; 173:9, 22; 174:7;
`
`15
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 15 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`178:18; 179:2, 8, 21; 180:4; 180:15; 181:17,
`19; 182:4, 20; 183:4, 6; 183:15; 184:5;
`185:3; 186:2; 188:8; 189:20, 22; 190:14;
`191:24; 192:9, 9, 13; 192:21; 193:19, 21;
`194:15; 199:10, 16; 199:20; 200:15, 20;
`201:4, 16, 18, 25; 202:6; 202:20; 203:3, 4, 5;
`203:6, 16, 22, 23, 25; 204:5, 6, 9, 17, 25;
`205:9, 18, 25; 211:14; 211:15, 22; 212:2;
`213:2, 5; 224:10, 15; 225:23, 23; 226:10;
`226:10, 13, 18; 226:21, 24; 227:3; 227:13,
`22, 23; 228:7; 231:16, 20; 232:4, 17; 233:14;
`233:22; 234:6; 239:9.
` N. Lill (Jan. 28, 2015), “polysorbates”:
`o 107:23; 142:20; 143:22; 201:16, 18; 211:14
` N. Lill (Jan. 28, 2015), “tween”:
`o 70:19; 71:22; 88:5, 7, 21, 22; 88:24; 89:4, 5;
`89:14; 90:21; 91:2; 91:5, 9, 14, 15, 19;
`91:20; 92:15; 94:19; 95:9; 98:22; 99:11, 20,
`25; 100:4, 7, 10, 13, 16; 100:18, 21, 24;
`101:4, 18; 102:9, 17; 103:6, 9, 15, 25; 104:6,
`22; 116:11; 128:10; 132:5; 192:5; 212:18;
`212:19; 213:9, 10; 214:14
` N. Lill (Jan. 28, 2015), “tweens”:
`o 133:5
`
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. 2:17-cv-05914-SRC-CLW (Dkt. 53, at 1-2) and
`references cited therein.
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. Case No. 1:16-cv-00812-RGA-MPT, N. Lill
`
`16
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 16 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`Depo. Tr. (Nov. 30, 2017, SANOFI5_00003495-877).
`Defendants may rely on all mentions of the terms
`“polysorbate,” “polysorbates,” and “tween” in the
`deposition transcripts of N. Lill, as well as the surrounding
`disclosure. For example:
` N. Lill (Nov. 30, 2017), “polysorbate”:
`o 36:14; 37:3; 38:18, 25; 39:5, 12; 40:1; 58:1;
`68:21; 69:4; 89:9; 93:12, 18; 94:2, 3, 7;
`94:17, 20; 100:21; 100:22; 101:4, 5; 102:6;
`108:21, 22; 111:5; 115:6; 120:11, 12, 17;
`120:24; 124:10; 124:11, 14, 25; 125:17;
`127:13; 128:11, 15, 16; 130:6, 22; 133:3;
`140:4, 8, 17; 140:18, 20; 141:21; 142:5, 10,
`25; 144:11; 148:6, 12; 148:17, 22; 152:18;
`153:22; 156:17; 159:7, 19; 160:16; 160:21;
`161:5, 10; 161:17, 20; 162:8; 162:13, 19;
`163:4; 163:16, 21; 164:5, 6; 164:20, 21;
`165:10; 165:18; 166:8, 21; 166:22; 167:14;
`168:17, 21; 169:14; 169:17, 23, 25; 170:5,
`20; 171:1, 3; 173:15; 176:4; 176:10, 20;
`177:8; 177:24; 178:8, 17; 179:13; 180:2, 6,
`24; 181:1, 25; 182:8, 11; 182:15, 20; 183:18;
`183:24; 184:6, 19; 185:8, 20, 22; 186:6;
`186:10, 16; 187:4, 8; 189:11; 190:1, 20;
`190:20; 193:4, 20; 194:17, 18, 25; 195:7, 20;
`196:15; 197:2, 11; 198:5; 199:6, 18, 23;
`200:13, 23; 201:10; 201:21; 202:14; 203:11;
`204:1, 5, 6; 204:16, 21; 205:1, 9; 205:19, 20;
`206:5; 206:13; 206:22; 207:7, 11; 210:25;
`212:15; 212:21; 213:12; 213:13, 17, 18;
`214:1; 215:5, 8, 13; 215:17, 22; 216:3, 5;
`
`17
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 17 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`“at least one chemical entity
`chosen from”
`(claims 1, 7, 24)
`
`Plain and ordinary meaning, which
`the person of ordinary skill in the
`art would understand to be “one or
`
`18
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`216:22; 217:2, 12; 217:19, 23; 220:7;
`221:23; 230:4; 235:8, 10, 15, 25; 242:7;
`244:20; 245:21; 246:6, 19; 246:23; 247:14;
`247:17; 248:7; 248:10; 249:14; 250:14;
`279:20; 280:14; 281:5, 19; 281:20, 23;
`282:10; 283:8, 18; 297:23; 298:3, 18, 21;
`299:19, 21; 300:4; 301:10, 17; 302:21;
`304:8, 24; 305:19; 306:7, 17; 307:4; 309:2;
`312:2; 317:1; 321:21; 322:12, 13; 322:24;
`323:5, 7, 14; 323:15; 324:7, 16.
` N. Lill (Nov. 30, 2017), “polysorbates”:
`o 187:4, 8; 206:5; 247:17; 248:10
` N. Lill (Nov. 30, 2017), “tween”:
`o 120:15, 16; 122:14; 123:10; 124:6; 126:3;
`169:1; 221:15; 232:6; 286:23; 287:23; 288:3,
`6, 10, 12; 296:11, 23; 297:3
`
`
`Handbook of Pharmaceutical Excipients 2d ed. 376, 375-
`378 (1994) (MYL_IG00428435-54).
`
`Defendants may rely upon expert testimony concerning the
`meaning of this term to a person of ordinary skill in the art
`in light of the disclosures of the ’652 patent. Defendants’
`expert(s) may also rebut arguments presented by Plaintiffs’
`expert(s).
`
`Defendants reserve the right to rely upon any intrinsic or
`extrinsic evidence cited by Plaintiffs.
`Intrinsic Evidence
`
`Claims
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 18 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`more chemical entities (as
`construed) selected to be included
`in the pharmaceutical formulation
`from.” No construction necessary
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`’652 patent, claims 1, 7, 24
`
`
`
`
`Specification
`
`’652 patent, at 1:11-15
`
`’652 patent, at 4:18-27
`
`
`Prosecution History
`U.S. Application No. 11/089,777
` March 19, 2007 Request for Continued
`Examination, at 9-12
` March 21, 2007 Response to October 3, 2006 Non-
`Final Rejection, at 2
` April 25, 2007 Final Rejection, at 2-3; July 25, 2007
`Response, at 7-8
` August 8, 2007 Non-Final Rejection, at 2-3;
`November 8, 2007Response, at 2-3
`
`
`Defendants reserve the right to rely on any portion of the
`’652 patent specification and prosecution history.
`
`Extrinsic Evidence
`
`Oxford English Reference Dictionary (2003), 258-59
`
`Random House Webster’s Unabridged Dictionary (2001),
`pg. 365, 367.
`
`Webster’s Third New International Dictionary of the
`English Language (2002), pg. 397, 399
`
`Sanofi-Aventis US LLC et al v. Eli Lilly & Co., Case No.
`
`19
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 19 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`1:14-cv-00113-RGA-MPT (Dkt. 95, at Exhibit 1; Dkt. 149,
`at 8-13; Dkt. 192, at 4-5) and references cited therein.
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT, N. Lill Depo. Tr. (Jan. 28,
`2015, SANOFI3_90285986-6099). Defendants may rely on
`all mentions of the term “excipients” in the deposition
`transcripts of N. Lill, as well as the surrounding disclosure.
`For example:
` N. Lill (Jan. 28, 2015), “excipient”
`o 74:22; 85:4; 138:6,21,25; 155:24; 156:17; 188:9;
`198:24; 24:14; 53:23; 64:7,16,23; 65:8; 70:11
`73:15; 79:2; 112:4; 150:6; 150:25; 151:9,11;
`152:18; 153:3,14; 156:23; 198:19; 199:5
`
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. 1:16-cv-00812-RGA-MPT (Dkt. 86, at Exhibit 1;
`Dkt. 124, at 3-20; Dkt. 192, at 3-6) and references cited
`therein.
`
`Sanofi-Aventis US LLC et al v. Merck Sharp & Dohme Co.,
`Case No. Case No. 1:16-cv-00812-RGA-MPT, N. Lill
`Depo. Tr. (Nov. 30, 2017, SANOFI5_00003495-877).
`Defendants may rely on all mentions of the term
`“excipient” in the deposition transcripts of N. Lill, as well
`as the surrounding disclosure. For example:
` N. Lill (Nov. 30, 2017), “excipient”:
`o 203:20; 204:15,17; 249:13; 39:6; 57:18,21,24;
`204:18; 219:11
`
`
`Defendants may rely upon expert testimony concerning the
`
`20
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 20 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`“the polysorbate is present in
`an effective amount to avoid
`turbidity”
`(claim 8)
`
`Plain and ordinary meaning, which
`the person of ordinary skill in the
`art would understand to be “the
`amount of polysorbate chosen
`prevents cloudiness.” No
`construction necessary.
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`meaning of this term to a person of ordinary skill in the art
`in light of the disclosures of the ’652 patent. Defendants’
`expert(s) may also rebut arguments presented by Plaintiffs’
`expert(s).
`
`Defendants also reserve the right to rely on the disclosures
`identified in Exhibit B relating to the term “at least one
`chemical entity chosen from.”
`
`Defendants reserve the right to rely upon any intrinsic or
`extrinsic evidence cited by Plaintiffs.
`Intrinsic Evidence
`
`Claims
`
`’652 patent, claim 8
`
`
`Specification
`
`’652 patent, at 2:66-3:7
`
`’652 patent, at 3:32-37
`
`’652 patent, at examples 1-3 (5:17-10:67)
`
`
`Prosecution History
`U.S. Application No. 11/089,777
` March 21, 2007 Response to October 3, 2006 Non-
`Final Rejection, at 3
`
`
`Defendants reserve the right to rely on any portion of the
`’652 patent specification and prosecution history.
`
`Related Patents
`’930 patent, at 3:4-12; examples 1-3 (5:25-11:47)
`
`21
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 21 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`
`
`Extrinsic Evidence
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT (Dkt. 95, at Exhibit 1; Dkt. 149,
`at 30-32; Dkt. 192, at 8) and references cited therein.
`
`Sanofi-Aventis US LLC et al. v. Eli Lilly & Co., Case No.
`1:14-cv-00113-RGA-MPT, N. Lill Depo. Tr. (Jan. 28,
`2015, SANOFI3_90285986-6099). Defendants may rely on
`all mentions of the terms “turbid,” “turbidity,” “stability,”
`“stabilize,” stabilized,” “stabilizer,” “stabilizes,”
`“stabilizing,” “stable,” “particle,” “particles,” “fibril,”
`“fibrillation,” “fibrils,” “micelle,” “micelles,” “effective,”
`“amount,” “amounts,” “prevent,” “prevented,”
`“preventing,” “avoid,” “avoided,” “reduced,” “reduction,”
`“precipitate,” and “shelf” in the deposition transcripts of N.
`Lill, as well as the surrounding disclosure. For example:
` N. Lill (Jan. 28, 2015), “turbid”:
`o 101:20; 104:18; 191:22
` N. Lill (Jan. 28, 2015), “turbidity”:
`o 65:17; 66:9, 14, 21, 24; 67:3, 7, 12, 13, 14;
`67:17, 21, 25; 68:7; 68:20; 70:6, 21; 71:8;
`72:9, 22; 73:4; 73:5; 74:16; 75:8; 80:23;
`81:9, 10; 82:14, 20; 83:2, 8; 83:15, 22; 84:3,
`10; 84:21; 87:17, 24; 94:20; 95:10; 96:9;
`96:17; 100:21; 101:4; 103:16; 104:3, 8, 24;
`129:15; 129:15, 22; 130:11; 130:18; 144:14,
`18; 145:3, 19, 22; 146:12, 18, 24; 147:4, 19;
`149:7; 163:8; 173:23; 177:10; 183:19; 184:3;
`191:4, 8, 15; 200:9; 209:4, 7, 10; 209:19;
`
`22
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 22 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
`213:18, 23; 214:7, 20, 24; 215:4; 224:16, 19;
`231:17; 231:20; 232:4, 7, 19
` N. Lill (Jan. 28, 2015), “stability”:
`o 65:24; 66:3; 66:18; 74:23; 116:10,18; 117:5;
`118:17; 130:3; 132:3; 133:13; 137:12;
`165:25; 166:9; 172:20; 173:7, 9, 11, 15, 16;
`173:17, 25; 174:4; 174:10; 182:25; 199:14;
`204:11, 19; 205:2, 11; 206:2; 208:12, 15;
`209:14; 210:11, 13, 15;
` N. Lill (Jan. 28, 2015), “stabilize”:
`o 49:11; 70:16, 20; 71:7, 12; 71:19; 75:7;
`106:24; 107:23; 108:12, 19; 109:10, 20;
`110:20; 111:20; 112:7; 113:23; 114:5, 7, 17;
`114:19; 115:10; 118:6; 124:13; 125:13, 20,
`23; 126:17, 20; 127:11; 127:12; 128:10;
`133:6; 134:20; 137:17; 149:21; 183:6;
`206:22; 209:25; 210:4; 211:11; 218:7, 12;
`223:11, 23; 224:15; 224:19; 225:3, 12;
`227:6, 14, 24; 228:9
` N. Lill (Jan. 28, 2015), “stabilized”:
`o 206:9; 210:18
` N. Lill (Jan. 28, 2015), “stabilizer”:
`o 161:25
` N. Lill (Jan. 28, 2015), “stabilizes”:
`o 137:21; 203:16
` N. Lill (Jan. 28, 2015), “stabilizing”:
`o 71:9; 135:11; 166:15, 19; 168:4, 13, 20;
`170:2; 170:10; 197:7, 14; 197:17, 21; 198:7;
`198:14 225:15
` N. Lill (Jan. 28, 2015), “stable”:
`o 114:12, 15; 174:8; 190:23
`
`23
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1028, p. 23 of 153
`
`

`

`Claim Term
`
`Defendants’ Construction
`
`Evidence Identified to Potentially Be Used in Support of
`Defendants’ Construction
` N. Lill (Jan. 28, 2015), “particle”:
`o 91:21; 92:5; 102:11, 19; 170:18; 227:25;
`228:9
` N. Lill (Jan. 28, 2015), “particles”:
`o 55:4, 5, 8; 72:22; 73:13, 19, 24; 92:17, 21;
`94:7, 23; 95:6; 1

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