`
`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`
`
`
`
`
`Filed on behalf of Patent Owner Genentech, Inc. by:
`
`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
`
`Andrew J. Danford (Pro Hac Vice)
`
`WILMER CUTLER PICKERING
`
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`PFIZER, INC. AND
`SAMSUNG BIOEPIS CO., LTD.;
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014891
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`1 Case IPR2017-02140 has been joined with this proceeding.
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Genentech, Inc.
`
`(“Genentech”) presents the following objections to evidence served with Petitioner
`
`Pfizer, Inc. and Samsung Bioepis Co., Ltd.’s (collectively, “Petitioners”) Reply
`
`(Paper 56).
`
`I.
`
`Exhibits 1693-1696 and 1706-1711
`Genentech objects to Exhibits 1693-1696 and 1706-1711for the following
`
`reasons.
`
`A. Exhibit 1693
`Genentech objects to Exhibit 1693 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1693 on the grounds
`
`that it is irrelevant because it is not part of the instituted grounds, and because
`
`Petitioners’ use of the exhibit is misleading, confusing, and unfairly prejudicial.
`
`See Fed. R. Evid. 401, 402, 403. Genentech further objects to Exhibit 1693 as
`
`inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`B.
`Exhibit 1694
`Genentech objects to Exhibit 1694 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1694 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not prior art, not part of
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`1
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`the instituted grounds, not probative of the state of the art at the time of the
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`invention, and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1694 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`C. Exhibit 1695
`Genentech objects to Exhibit 1695 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1195 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not part of the instituted
`
`grounds and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1695 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`D. Exhibit 1696
`Genentech objects to Exhibit 1696 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1695 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not part of the instituted
`
`grounds and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1695 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
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`2
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`E.
`Exhibit 1706
`Genentech objects to Exhibit 1706 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1706 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not prior art, not part of
`
`the instituted grounds, not probative of the state of the art at the time of the
`
`invention, and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1706 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`F.
`Exhibit 1707
`Genentech objects to Exhibit 1707 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1707 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not part of the instituted
`
`grounds and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1707 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`G. Exhibit 1708
`Genentech objects to Exhibit 1708 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`3
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`
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1708 on the grounds
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`
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`that it is irrelevant to the instituted ground of obviousness because it is not part of
`
`the instituted ground and because Petitioners’ use of the exhibit is misleading,
`
`confusing, and unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech
`
`further objects to Exhibit 1708 as inadmissible hearsay. See Fed. R. Evid. 801,
`
`802.
`
`H. Exhibit 1709
`Genentech objects to Exhibit 1709 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1709 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not part of the instituted
`
`grounds and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1709 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`I.
`Exhibit 1710
`Genentech objects to Exhibit 1710 as a new exhibit that was not included in
`
`the Petition or the instituted ground, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1710 on the grounds
`
`that it is irrelevant to the instituted grounds because it not part of the instituted
`
`grounds and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`4
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`
`
`
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`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`
`
`Exhibit 1710 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`J.
`Exhibit 1711
`Genentech objects to Exhibit 1711 as a new exhibit that was not included in
`
`the Petition or the instituted grounds, or any submission by Patent Owner. See 37
`
`C.F.R. § 42.23(b). Genentech objects to the use of Exhibit 1711 on the grounds
`
`that it is irrelevant to the instituted grounds because it is not prior art, not part of
`
`the instituted grounds, not probative of the state of the art at the time of the
`
`invention, and because Petitioners’ use of the exhibit is misleading, confusing, and
`
`unfairly prejudicial. See Fed. R. Evid. 401, 402, 403. Genentech further objects to
`
`Exhibit 1711 as inadmissible hearsay. See Fed. R. Evid. 801, 802.
`
`II. Deposition Transcript of Ian Wilson, D. Phil. (Exhibit 1697)
`Genentech objects to excerpts of Deposition Transcript of Ian Wilson,
`
`D. Phil. (Exhibit 1697) cited within the Reply to the extent that they are
`
`mischaracterized or taken out of context, including 19:7-23:15, 19:7-21:8, 24:11-
`
`28:8, 33:18-36:3, 51:3-53:13, 54:6-13, 55:19-56:17, 61:4-16, 75:5-77:13, 77:17-
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`81:21, 84:11-15, 91:3-13, 92:3-14, 93:4-12, 97:19-101:18, 101:19-103:5, 103:12-
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`25; 104:12-105:5, 112:12-21, 137:21-138:20, 143:1-144:24, 146:9-176:14, 162:7-
`
`168:10, 176:25-178:23, 183:14-184:4, 184:16-185:7, 187:21-193:6, 212:8-217:22,
`
`218:3-224:13, 225:17-229:24, 236:7-238:5, 244:9-245:15, 245:22-246:19, 252:12-
`
`5
`
`
`
`
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`254:21, 255:20-257:3, 258:3-263:21; 264:9-267:18, 267:24-268:12, and 280:24-
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`
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`284:15, as being misleading, confusing, unfairly prejudicial, and irrelevant. See
`
`Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to Exhibit 1697 to the extent testimony was elicited from
`
`questions outside the scope of the witness’s direct testimony, as such testimony is
`
`both not relevant and prejudicial to Genentech, as well as in violation of Fed. R.
`
`Evid. 611(b) and 37 C.F.R. § 42.53(d)(5)(ii).
`
`III. Deposition Transcript of Paul J. Carter, Ph.D. (Exhibit 1698)
`Genentech objects to excerpts from the Deposition Transcript of Paul J.
`
`Carter, Ph.D. (Exhibit 1698) cited within the Reply to the extent that they are
`
`mischaracterized or taken out of context, including 22:13-24:7, 24:13-26:15, 27:7-
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`28:20, 29:17-32:15, 32:25-39:15, 37:19-39:15, 50:17-51:11, 56:20-61:24, 61:25-
`
`70:4, 83:7-18, 89:18-94:7, 92:18-94:7, 110:6-129:8, 112:7-112:19, 114:9-129:8,
`
`141:12-145:13,169:14-173:14, 174:9-13; and 175:3-10, as being misleading,
`
`confusing, unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to Exhibit 1698 the extent testimony was elicited from
`
`questions outside the scope of the witness’s direct testimony, as such testimony is
`
`both not relevant and prejudicial to Genentech, as well as in violation of Fed. R.
`
`Evid. 611(b) and 37 C.F.R. § 42.53(d)(5)(ii).
`
`6
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`
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`IV. Deposition Transcript of Leonard George Presta, Ph.D. (Exhibit 1699)
`Genentech objects to excerpts of Deposition Transcript of Leonard George
`
`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`Presta, Ph.D. (Exhibit 1699) cited within the Reply to the extent that they are
`
`mischaracterized or taken out of context, including 22:18-23, 23:19-25:23, 26:7-
`
`27:13, 27:14-28:13, 29:25-36:2, 30:5-13, 30:14-32:9, 33:7-34:9, 41:10-44:4, 57:1-
`
`58:6, 63:12-64:10, 65:1-67:5, 65:13-67:5, 67:6-70:3, 70:11-25, 71:8-23, 72:9-21,
`
`75:17-76:18, 76:19-80:13, 84:3-85:2, 86:20-87:7, 90:1-102:25, 92:9-93:9; 96:14-
`
`97:13, 98:25-99:5, 99:6-20, 101:24-102:9, 109:24-112:21, 110:21-111:22, 115:1-
`
`116:17, 115:7-17, 117:10-125:15, 131:10-141:22, 131:10-136:14, 137:24-141:22,
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`156:24-159:10, 156:25-157:8, 157:10-17, 157:19-22, 159:22-163:1, 165:17-169:9,
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`178:24-179:6, 179:14-180:15, 180:16-181:24, as being misleading, confusing,
`
`unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to Exhibit 1699 to the extent testimony was elicited from
`
`questions outside the scope of the witness’s direct testimony, as such testimony is
`
`both not relevant and prejudicial to Genentech, as well as in violation of Fed. R.
`
`Evid. 611(b) and 37 C.F.R. § 42.53(d)(5)(ii).
`
`V. Deposition Transcript of Irene Loeffler (Exhibit 1700)
`Genentech objects to excerpts of Deposition Transcript of Irene Loeffler
`
`(Exhibit 1700) cited within the Reply to the extent that they are mischaracterized
`
`or taken out of context, including 15:1-12, 18:2-20:6, 21:1-22:7, 23:18-27:24,
`
`7
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`
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`28:2-38:11, 38:20-39:2, 41:18-42:4, and 46:14-50:3 as being misleading,
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`
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
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`confusing, unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to Exhibit 1700 to the extent testimony was elicited from
`
`questions outside the scope of the witness’s direct testimony, as such testimony is
`
`both not relevant and prejudicial to Genentech, as well as in violation of Fed. R.
`
`Evid. 611(b) and 37 C.F.R. § 42.53(d)(5)(ii).
`
`VI. Deposition Transcript of John Ridgway Brady (Exhibit 1701)
`Genentech objects to excerpts of Deposition Transcript of John Ridgway
`
`Brady (Exhibit 1701) cited within the Reply to the extent that they are
`
`mischaracterized or taken out of context, including 9:1-12:12, as being misleading,
`
`confusing, unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to Exhibit 1201 to the extent testimony was elicited from
`
`questions outside the scope of the witness’s direct testimony, as such testimony is
`
`both not relevant and prejudicial to Genentech, as well as in violation of Fed. R.
`
`Evid. 611(b) and 37 C.F.R. § 42.53(d)(5)(ii).
`
`VII. Reply Declaration of Jefferson Foote, Ph.D. (Exhibit 1702)
`Genentech objects to Exhibit 1702 to the extent it includes arguments that
`
`were not made in the Petition and are therefore improper to raise for the first time
`
`in Petitioner’s reply, including in, but not limited to, paragraphs 5, 7, 9, 12, 41-45,
`
`8
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`
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`
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`61, 79, 87-88, 92, 105, 119, 160-163, and 187 of Exhibit 1202. See 37 C.F.R. §
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
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`
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`42.23(b).
`
`Genentech further objects to paragraphs 3-21, 27, 29-34, 36, 41-44, 47-57,
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`60-67, 68-93, 95-96, 99, and 101-191 as not based on sufficient facts or data, the
`
`product of reliable principles and methods, and/or a reliable application of the
`
`principles and methods to the facts, see Fed. R. Evid. 702, 703, 705, 403; 77 Fed.
`
`Reg. at 48,763; 37 C.F.R. § 42.65, and as being misleading and/or confusing. See
`
`Fed. R. Evid. 403.
`
`Genentech objects to excerpts from the Deposition Transcript of Ian Wilson,
`
`D. Phil. (Exhibit 1697) cited within the Foote Reply Declaration (Ex. 1702) to the
`
`extent that they are mischaracterized or taken out of context, including 19:7-23:15,
`
`19:7-21:9, 19:7-25:6, 24:11-28:8, 29:4-31:4, 33:18-36:7, 47:13-22, 51:3-53:13,
`
`54:6-13, 55:19-56:17, 57:6-60:10, 61:4-16, 61:17-64:11, 67:14–68:23, 69:16-70:2,
`
`75:5-77:13, 84:11-15, 91:3-13, 92:3-14, 93:4-12 97:19-101:18, 101:19-103:5,
`
`103:12-25, 104:12-105:5, 111:25-112:21, 112:12-21, 137:21-138:20, 143:1-
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`144:24, 146:9-176:14, 176:25-178:23, 183:14-184:4 , 187:21-193:6, 212:8-217:22,
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`218:3-224:13, 225:17-229:24, 231:10-232:14, 233:3-234:2; 234:14-17 236:7-
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`238:5, 239:11-18, 242:4-244:7, 244:9-245:15, 244:9-245:16, 245:22-246:19,
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`252:12-254:21, 255:20-257:3, 258:3-263:21, 264:9-267:18, 267:24-268:12,
`
`9
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`
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`280:24-284:15, 286:10-288:19, and 289:2-292:20, as being misleading, confusing,
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
`
`
`
`unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to excerpts to the Deposition Transcript of Paul J. Carter,
`
`Ph.D. (Exhibit 1698) cited within the Foote Reply Declaration (Ex. 1702) to the
`
`extent that they are mischaracterized or taken out of context, including 22:13-24:7,
`
`24:13-26:15, 27:7-28:20, 29:17-32:15, 32:25-39:15, 37:19-39:15, 43:11-18; 47:14-
`
`49:11, 47:15-48:21, 56:20-61:24, 61:25-70:4, 89:18-94:7, 92:14-94:7, 110:6-129:8,
`
`112:7-19, 113:20-114:20, 114:9-129:8, 125:15-129:1, 125:22-129:8, 129:3-8,
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`167:2-169:13, 169:14-173:14, 174:9-13; and 175:3-10 as being misleading,
`
`confusing, unfairly prejudicial, and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to excerpts to the Deposition Transcript of Leonard
`
`George Presta, Ph.D. (Exhibit 1699) cited within the Foote Reply Declaration (Ex.
`
`1702) to the extent that they are mischaracterized or taken out of context, including
`
`14:22-21:18, 22:18-23, 23:19-25:23, 27:14-28:13, 29:25-30:13, 30:5-32:20, 30:5-
`
`13, 30:14-32:9, 33:7-34:9, 34:21-36:2, 35:22-36:1, 41:10-44:4, 49:5-50:19, 57:1-
`
`58:6, 63:12-64:10; 65:1-67:5, 65:13-67:5, 67:6-70:3, 70:11-25, 71:8-23, 72:9-21,
`
`75:17-76:18, 76:19-80:13, 84:3-85:2, 85:3-91:7, 86:10-88:24, 88:25-91:7, 90:1-
`
`102:25, 92:9-93:9, 96:14-97:13, 98:25-99:5, 98:25-99:20, 99:6-20, 100:11-102:19,
`
`101:17-21, 101:24-102:19, 101:24-102:9, 109:24-112:21, 110:21-111:22, 115:1-
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`116:17, 115:7-17, 117:10-125:15, 119:15-121:4, 123:11-25, 131:10-141:22,
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`10
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`
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`131:10-136:14, 137:24-141:22, 156:24-159:10, 156:25-157:8, 157:9-159:10,
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
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`
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`157:10-17, 157:10-158:18, 159:22-163:1, 165:17-169:9, 178:24-179:6, 179:14-
`
`180:15, and 180:16-181:24 as being misleading, confusing, unfairly prejudicial,
`
`and irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`Genentech objects to excerpts to the Deposition Transcript of John Ridgway
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`Brady (Exhibit 1701) cited within the Foote Reply Declaration (Ex. 1702) to the
`
`extent that they are mischaracterized or taken out of context, including 25:15-
`
`31:17, and 32:12-23, as being misleading, confusing, unfairly prejudicial, and
`
`irrelevant. See Fed. R. Evid. 401, 402, 403.
`
`
`
`Date: June 4, 2018
`
`
`
`Respectfully submitted,
`
`
`
`/David L. Cavanaugh/
`By:
`David L. Cavanaugh
`Reg. No. 36,476
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`202-663-6025
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
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`CERTIFICATE OF SERVICE
`
`I hereby certify that, on June 4, 2018, I caused a true and correct copy
`of the following materials:
`
` Patent Owner’s Objections to Evidence
`
`to be served via electronic mail on the following attorneys of record:
`
`Amanda Hollis
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`300 North LaSalle, Chicago, IL 60654
`
`Stefan M. Miller, Ph.D.
`stefan.miller@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Karen Younkins
`karen.younkins@kirkland.com
`333 South Hope Street, Los Angeles, CA 90071
`
`Benjamin A. Lasky
`benjamin.lasky@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Sarah K. Tsou
`sarah.tsou@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Mark C. McLennan
`mark.mclennan@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Christopher J. Citro
`christopher.citro@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`
`12
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`IPR2017-01489
` Patent Owner’s Objections to Evidence
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`Pfizer_Genentech_IPRs@kirkland.com
`
`Dimitrios T. Drivas
`White & Case LLP
`ddrivas@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Scott T. Weingaertner
`White & Case LLP
`scott.weingaertner@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Amit H. Thakore
`White & Case LLP
`athakore@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`Eric Majchrzak
`White & Case LLP
`eric.majchrzak@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`
`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
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`
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