Paper No. ____
`Date Filed: August 10, 2017
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`Case IPR2016-01479
`Patent No. 9,006,224
`
`PATENT OWNER’S OBJECTIONS UNDER
`37 C.F.R. § 42.64 TO EVIDENCE SUBMITTED BY PAR
`PHARMACEUTICAL, INC. WITH ITS REPLY
`
`
`Date Filed: August 10, 2017
`
`Filed On Behalf Of:
`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`Case IPR2016-01479
`Patent No. 9,006,224
`
`PATENT OWNER’S OBJECTIONS UNDER
`37 C.F.R. § 42.64 TO EVIDENCE SUBMITTED BY PAR
`PHARMACEUTICAL, INC. WITH ITS REPLY
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis AG (“Novartis”)
`
`objects to the admissibility of the following exhibits filed by Petitioner Par
`
`Pharmaceutical, Inc. (“Par”) with its Reply (Paper 21) on the grounds set forth
`
`below.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence, a
`
`reference to “C.F.R.” means the Code of Federal Regulations, and “the ’224
`
`Patent” means U.S. Patent No. 9,006,224. All objections under F.R.E. 802
`
`(hearsay) apply to the extent Par relies on the exhibits identified in connection with
`
`that objection for the truth of the matters asserted therein. Novartis’s objections to
`
`Par’s exhibits are without prejudice to Novartis’s reliance on or discussion of those
`
`exhibits in Novartis’s papers in this proceeding.
`
`Novartis’s objections are as follows:
`
`Exhibits 1071, 1072, 1073, 1075, 1076, 1077, 1078, 1079, 1081, 1082, 1083,
`1085, 1089, 1090, 1091, 1092, 1095, 1096, 1097, 1098, 1100, 1101, 1102, 1104,
`1106, 1107, 1108, 1109, 1111, 1112, 1114, 1115, 1116, 1118, 1120, 1121, 1122,
`1123, And 1124
`
`Novartis objects to Exhibits 1071, 1072, 1073, 1075, 1076, 1077, 1078,
`
`1079, 1081, 1082, 1083, 1085, 1089, 1090, 1091, 1092, 1095, 1096, 1097, 1098,
`
`1100, 1101, 1102, 1104, 1106, 1107, 1108, 1109, 1111, 1112, 1114, 1115, 1116,
`
`1118, 1120, 1121, 1122, 1123, and 1124 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`1
`
`
`
`Novartis also objects to Exhibit 1121 under F.R.E. 402 (relevance), F.R.E.
`
`403 (confusing, waste of time), F.R.E. 702 (improper expert testimony), and F.R.E.
`
`703 (bases of an expert opinion), because it is not relevant to any issue in this IPR
`
`proceeding, and is not the type of document upon which a person of ordinary skill
`
`in the art at the time of invention would rely. Novartis further objects to Exhibit
`
`1121 under F.R.E. 106 (completeness).
`
`Novartis also objects to Exhibits 1075, 1097, 1100, 1104, and 1108 under
`
`F.R.E. 901(authentication). Par has not provided any information that these
`
`exhibits are authentic or that the exhibits are self-authenticating under F.R.E. 902.
`
`Novartis also objects to Exhibits 1076, 1077, 1079, 1089, 1095, 1102, 1106,
`
`1107, 1109, 1111, 1114, and 1120 under 37 C.F.R. §§ 42.22(a)(2), 42.23, and
`
`42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402 (relevance), F.R.E. 403
`
`(confusing, waste of time), F.R.E. 702 (improper expert testimony), and F.R.E. 703
`
`(bases for expert opinion), as these exhibits were not published until after the
`
`November 21, 2005 priority date of the ’224 Patent and these exhibits are not the
`
`type of documents upon which a person of ordinary skill in the art at the time of
`
`invention would rely.
`
`Novartis also objects to Exhibits 1071 and 1108 under 37 C.F.R. §§
`
`42.22(a)(2), 42.23, 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert
`
`2
`
`
`
`testimony), and F.R.E. 703 (bases for expert opinion), as Par has presented no
`
`evidence that these exhibits were published before the November 21, 2005 priority
`
`date of the ’224 Patent and these exhibits are not the type of documents upon
`
`which a person of ordinary skill in the art at the time of invention would rely.
`
`Novartis also objects to Exhibits 1075, 1097, 1100, and 1104 under 37
`
`C.F.R. §§ 42.22(a)(2), 42.23, and 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b),
`
`F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E. 702
`
`(improper expert testimony), and F.R.E. 703 (bases for expert opinion), as these
`
`are stamped with dates after the November 21, 2005 priority date of the ’224
`
`Patent, Par has presented no evidence that these exhibits were publicly available
`
`prior to November 21, 2005, and these exhibits are not the type of documents upon
`
`which a person of ordinary skill in the art at the time of invention would rely.
`
`Novartis also objects to Exhibits 1066, 1067, 1068, 1069,1 1071, 1072, 1073,
`
`1075, 1077, 1078, 1079, 1081, 1082, 1083, 1085, 1089, 1090, 1091, 1092, 1097,
`
`1098, 1100, 1101, 1102, 1104, 1106, 1107, 1108, 1109, 1111, 1112, 1114, 1116,
`
`1118, 1120, 1121, and 1122 under 37 C.F.R. §§ 42.22(a)(2), 42.23, and 42.24(c)(1)
`
`as these documents are not cited in the Reply or Par’s previously filed Petition, and
`
`1 Novartis maintains the objections to Exhibits 1066, 1067, 1068, and 1069 that it
`
`raised during the July 12, 2017 Deposition of Matthew H. Kulke, M.D.
`
`3
`
`
`
`therefore any attempt by Par to rely on these Exhibits to establish unpatentability
`
`(either directly by citing these Exhibits, or indirectly by citing paragraphs of Par’s
`
`expert declaration that discuss these Exhibits) will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Novartis also objects to Exhibits 1066, 1067, 1068, 1069, 1071, 1072, 1073,
`
`1075, 1077, 1078, 1079, 1081, 1082, 1083, 1085, 1089, 1090, 1091, 1092, 1097,
`
`1098, 1100, 1101, 1102, 1104, 1106, 1107, 1108, 1109, 1111, 1112, 1114, 1116,
`
`1118, 1120, 1121, and 1122 under 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§
`
`42.22(a)(2), 42.104(b) and 42.105 as these documents are not cited in the Reply or
`
`Par’s previously filed Petition, and therefore any attempt by Par to later rely on
`
`these Exhibits to establish unpatentability is improper and untimely.
`
`Novartis also objects to Exhibits 1066, 1068, 1071, 1072, 1073, 1075, 1076,
`
`1078, 1079, 1081, 1085, 1089, 1090, 1091, 1092, 1095, 1096, 1097, 1098, 1100,
`
`1101, 1104, 1106, 1111, 1112, 1115, 1116, 1118, 1120, 1121, 1122, 1123, and
`
`1124 as improper and untimely to the extent they are cited in support of Par’s
`
`prima facie case as they should have been included in the evidence served with
`
`Par’s Petition as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b), and 42.105.
`
`4
`
`
`
`Exhibit 1119
`
`Novartis objects to Exhibit 1119 under F.R.E. 802 (hearsay), F.R.E. 702
`
`(improper expert testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R.
`
`§ 42.65 as Dr. Ratain’s scientific, technical, or other specialized knowledge will
`
`not help the trier of fact to understand the evidence or to determine a fact in issue,
`
`the testimony is not based on sufficient facts or data, is not the product of reliable
`
`principles and methods, and the principles and methods have not been reliably
`
`applied to the facts of the case. In particular, the challenged claims concern the
`
`treatment of pancreatic neuroendocrine tumors (PNETs) (see, e.g., Ex. 1003 ¶¶ 20,
`
`25), and Dr. Ratain admitted that he did not have special expertise in PNETs. See
`
`Ex. 2024, Ratain Trial Tr. I at 995.
`
`Novartis also objects to Exhibit 1119 under 35 U.S.C. § 312(a)(3), 37 C.F.R.
`
`§§ 42.65 and 42.104(b)(5), F.R.E. 702 (improper expert testimony), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time) for failing to identify with
`
`particularity the underlying facts and data on which the opinion is based; Exhibit
`
`1119 ¶¶ 9, 10, 11, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 27, 29, 31, 32, 33, 34, 35,
`
`36, 37, 38, 39, 40, 41, 44, 46, 47, 49, 51, 52, 56, 57, 58, 61, 62, 63, 67, 68, 69, 71,
`
`74, 77, 80, 81, 83, 85, 86, 88, and 89 fail to cite any support at all, include
`
`statements that do not cite any support, or include statements that are not supported
`
`by the cite(s) provided; and Exhibit 1119 ¶¶ 37, 38, 39, 55, 56, and 61 cite to entire
`
`5
`
`
`
`articles, book chapters or other references without identifying which aspects of
`
`those references are relied upon.
`
`Novartis also objects to Exhibit 1119 ¶¶ 17, 18, 19, 20, 21, 22, 23, 24, 25,
`
`26, 48, 53, 54, 55, 56, 57, and 72 under F.R.E. 402 (relevance) and F.R.E. 403
`
`(confusing, waste of time), as these paragraphs are not cited in Par’s Reply.
`
`Novartis also objects to Exhibit 1119 ¶¶ 8, 11, 12, 13, 16, 19, 32, 36, 38, 39,
`
`41, 44, 47, 52, 70, 71, 76, 80, 85, 87, and 91 under F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance) and
`
`F.R.E. 403 (confusing, waste of time); these paragraphs include expert opinion
`
`based on documents that are inadmissible under at least 37 C.F.R. §§ 42.22(a)(2),
`
`42.23, and 42.104(b)(2) and (b)(5), F.R.E. 802 (hearsay), F.R.E. 402 (relevance),
`
`F.R.E. 403 (confusing, waste of time, needlessly presenting cumulative evidence),
`
`F.R.E. 702 (improper expert testimony), F.R.E. 703 (bases of an expert opinion),
`
`and F.R.E. 901 (authentication), as not relevant to any issue in this IPR proceeding
`
`and not the type of document upon which a person of ordinary skill in the art at the
`
`time of invention would rely.
`
`Novartis also objects to 1119 ¶¶ 13, 14, 15, 16, and 59 under F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time), as they are not relevant to
`
`any issue in this IPR proceeding.
`
`6
`
`
`
`Novartis also objects to Exhibit 1119 ¶ 59 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.23, and 42.104(b)(2) and (b)(5), 35 U.S.C. § 311(b), F.R.E. 702 (improper
`
`expert testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402 (relevance),
`
`and F.R.E. 403 (confusing, waste of time), as this paragraph relies on the
`
`disclosures of the ’224 Patent, which is not prior art nor are the disclosures in the
`
`’224 Patent an admission of the disclosures of the prior art.
`
`Novartis also objects to Exhibit 1119 ¶¶ 7, 8, 12, 45, 52, 60, 66, 71, 72, 77,
`
`80, 82, 91, and 92 under F.R.E. 106 (completeness) because these paragraphs cite
`
`only portions of testimony from Ex. 1070, and omit portions of answers or follow
`
`up questions that in fairness ought to be considered in connection with Exhibit
`
`1070, including for ¶¶ 7-8, Dep. Tr. 46:17-47:5, 49:12-50:4, 50:19-51:7, and
`
`172:7-21; for ¶ 12, Dep. Tr. 46:17-47:5 and 49:12-50:4; for ¶ 45, Dep. Tr. 62:21-
`
`63:14, 65:15-66:7, 67:17-68:20, and 69:19-70:2; for ¶ 60, Dep. Tr. 120:15-16 and
`
`120:24-121:9; for ¶ 66, Dep. Tr. 134:8-18; for ¶ 71, Dep. Tr. 74:22-75:5, 75:25-
`
`76:14, and 77:2-14; for ¶ 72, Dep. Tr. 139:7-18; for ¶ 77, Dep. Tr. 85:20-25, 86:9-
`
`18, and 87:2-88:20; for ¶ 80, Dep. Tr. 160:11-161:10; for ¶ 82, Dep. Tr. 167:14-
`
`169:25; for ¶ 91, Dep. Tr. 85:20-25, 86:9-18, and 87:2-88:20; for ¶ 92, Dep. Tr.
`
`85:20-25. Novartis further objects to Exhibit 1119 ¶¶ 52, 66, 71, 72, and 92 under
`
`F.R.E. 106 (completeness) because these paragraphs quote only portions of
`
`7
`
`
`
`testimony from Ex. 1070, and omit portions of answers or follow up questions that
`
`in fairness ought to be considered in connection with Exhibit 1070.
`
`Novartis also objects to Exhibit 1119 ¶¶ 70 and 91 under F.R.E. 106
`
`(completeness) because these paragraphs cite only portions of testimony from Ex.
`
`1095, and omit portions of answers or follow up questions that in fairness ought to
`
`be considered in connection with Exhibit 1095, including for ¶ 70, Trial Tr. 790:7-
`
`791:5; for ¶ 91, Trial Tr. 791:21-792:15. Novartis further objects to Exhibit 1119
`
`¶¶ 32 and 91 under F.R.E. 106 (completeness) because these paragraphs quote only
`
`portions of testimony from Ex. 1095, and omit portions of answers or follow up
`
`questions that in fairness ought to be considered in connection with Exhibit 1095.
`
`Novartis also objects to Exhibit 1119 ¶¶ 13, 14, 15, 16, 37, 44, 46, 49, 52,
`
`62, 80, 85, 86 and 91 under F.R.E. 602 (lack of personal knowledge), F.R.E. 702
`
`(improper expert testimony), F.R.E. 703 (bases of an expert opinion), F.R.E. 402
`
`(relevance) and F.R.E. 403 (confusing, waste of time), as the declarant is testifying
`
`regarding factual matters for which he does not have personal knowledge.
`
`Novartis also objects to Exhibit 1119 ¶¶ 8, 12, 13, 16, 19, 23, 31, 32, 33, 34,
`
`37, 38, 39, 44, 46, 47, 49, 50, 51, 52, 58, 59, 61, 62, 64, 67, 69, 70, and 71 as
`
`improper and untimely as these paragraphs cite exhibits (Exs. 1066, 1068, 1071,
`
`1072, 1073, 1075, 1078, 1079, 1081, 1085, 1089, 1090, 1091, 1092, 1095, 1097,
`
`1098, 1100, 1101, 1104, 1106, 1111, 1112, 1115, 1116, 1118, 1120, 1121, 1123,
`
`8
`
`
`
`and 1124) and make arguments in support of Par’s prima facie case based on those
`
`exhibits that should have been included in the evidence served with Par’s Petition
`
`as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and
`
`42.105.
`
`Novartis also objects to Exhibit 1119 ¶¶ 21, 22, 23, 27, 29, 31, 32, 35, 36,
`
`40, 41, 49, 50, 51, 59, 62, 64, 67, and 71 as improper and untimely as these
`
`paragraphs make arguments in support of Petitioners’ prima facie case that should
`
`have been included in the evidence served with Par’s Petition as required by 35
`
`U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and 42.105.
`
`Dated: August 10, 2017
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`9
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Objections Under 37
`
`C.F.R. § 42.64 To Evidence Submitted By Par Pharmaceutical, Inc. With Its Reply
`
`was served on August 10, 2017 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Jonathan M. Strang (jonathan.strang@lw.com)
`
`Brenda L. Danek (brenda.danek@lw.com)
`
`Dated: August 10, 2017
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`1
`
`
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