`Date Filed: December 12, 2016
`
`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.,
`BRECKENRIDGE PHARMACEUTICAL, INC., AND
`ROXANE LABORATORIES, INC.
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`
`Case IPR2016-000841
`U.S. Patent 5,665,772
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PETITIONERS WITH THEIR REPLY
`
`
`1 Breckenridge Pharmaceutical, Inc. was joined as a party to this proceeding via a
`Motion for Joinder in IPR2016-01023; Roxane Laboratories, Inc. was joined as a
`party via a Motion for Joinder in IPR2016-01102.
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis AG (“Novartis”)
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`objects to the admissibility of the following exhibits filed with Petitioners’ Par
`
`Pharmaceutical, Inc., Breckenridge Pharmaceutical, Inc., and Roxane Laboratories,
`
`Inc. (“Petitioners”) Reply 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 “’772 Patent”
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`means U.S. Patent No. 5,665,772. All objections under F.R.E. 802 (hearsay) apply
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`to the extent Petitioners rely on the exhibits identified in connection with that
`
`objection for the truth of the matters asserted therein.
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`Novartis’s objections are as follows:
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`Exhibits 1034, 1036 – 1043, 1047 – 1057, 1062 – 1063, 1065 – 1070, 1074, 1077
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`– 1083, 1085 – 1086, 1088, 1092 – 1093, 1097 – 1100, 1102 – 1106, 1108 – 1110,
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`1113, 1117, and 1120 – 1121
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`Novartis objects to Exhibits 1034, 1036 – 1043, 1047 – 1057, 1062 – 1063,
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`1065 – 1070, 1074, 1077 – 1083, 1085 – 1086, 1088, 1092 – 1093, 1097 – 1100,
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`1102 – 1106, 1108 – 1110, 1113, 1117, and 1120 – 1121 under F.R.E. 802
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`(hearsay), F.R.E. 402 (relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis further objects to Exhibits 1047 – 1050, 1055 – 1057, 1065 – 1069,
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`1074, 1077 – 1083, 1085 – 1086, 1088, 1092 – 1093, 1097 – 1100, 1102 – 1106,
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`1108 – 1110, and 1120 under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.104(b)(2) and
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`1
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`
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`(b)(5), and 42.105, as these documents were not published until after the October
`
`9, 1992 priority date of the ’772 Patent and these documents are not the types of
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`documents upon which a person of ordinary skill in the art at the time of invention
`
`would rely.
`
`Novartis further objects to Exhibits 1036 – 1043, 1047 – 1057, 1062 – 1063,
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`1065 – 1070, 1074, 1077 – 1083, 1085 – 1086, 1088, 1092 – 1093, 1097 – 1100,
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`1102 – 1106, 1108 – 1110, 1113, 1117, and 1120 – 1121 under 37 C.F.R.
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`§§ 42.22(a)(2), 42.23, and 42.24(c)(1) as these documents are not cited in
`
`Petitioners’ Reply, and therefore any attempt by Petitioners to rely on these
`
`Exhibits to establish unpatentability (either directly by citing these Exhibits, or
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`indirectly by citing paragraphs of their expert declarations that discuss these
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`Exhibits) will constitute an improper incorporation by reference under 37 C.F.R.
`
`§ 42.6(a)(3).
`
`Novartis further objects to Exhibits 1038 – 1040, 1043, 1047, 1049 – 1050,
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`1055 – 1057, 1062, 1065 – 1066, 1070, 1092, 1104, 1109 – 1110, 1113, and 1121
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`under 37 C.F.R. §§ 42.104(b)(5) and 42.23 as Petitioners have failed to identify
`
`which aspects of the documents are relied upon.
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`2
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`
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`Novartis further objects to Exhibits 1034,2 1036, 1037, 1062 – 1063, 1065 –
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`1070, 1102 – 1106, 1113, 1117, 1120, and 1121 as improper and untimely as they
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`should have been included in the evidence served with Petitioners’ Petitions as
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`required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and
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`42.105.
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`Novartis further objects to Exhibit 1121 as improperly labeled and produced
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`under 37 C.F.R § 42.63 and F.R.E. 1003 (duplicates), as the copy provided appears
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`to have alterations that do not appear in the original document and certain portions
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`of the document are not legible.
`
`Exhibit 1044, 1046, and 1061
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`Novartis objects to Exhibits 1044, 1046, and 1061 under F.R.E. 802
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`(hearsay), F.R.E. 402 (relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis further objects to Exhibits 1044, 1046 and 1061 under 37 C.F.R.
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`§§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105, as these
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`documents were not published until after the October 9, 1992 priority date of the
`
`’772 Patent, these documents are not the types of documents upon which a person
`
`of ordinary skill in the art at the time of invention would rely, and these documents
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`2 Novartis maintains the objections to Exhibit 1034 that it raised during the
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`November 14, 2016 Deposition of Alexander M. Klibanov.
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`3
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`
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`are not cited in Petitioners’ Reply, and therefore any attempt by Petitioners to rely
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`on these Exhibits (either directly by citing these Exhibits, or indirectly by citing
`
`paragraphs of their expert declarations that discuss these Exhibits) to establish
`
`unpatentability will constitute an improper incorporation by reference under 37
`
`C.F.R. § 42.6(a)(3).
`
`Exhibits 1045 and 1091
`
`Novartis objects to Exhibits 1045 and 1091 under F.R.E. 802 (hearsay),
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`F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time). Novartis further
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`objects to Exhibits 1045 and 1091 under 37 C.F.R. §§ 42.22(a)(2), 42.23,
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`42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105, as these documents were not
`
`published until after the October 9, 1992 priority date of the ’772 Patent, these
`
`documents are not the types of documents upon which a person of ordinary skill in
`
`the art at the time of invention would rely, and these documents are not cited in
`
`Petitioners’ Reply, and therefore any attempt by Petitioners to rely on these
`
`Exhibits to establish unpatentability (either directly by citing these Exhibits, or
`
`indirectly by citing paragraphs of their expert declarations that discuss these
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`Exhibits) will constitute an improper incorporation by reference under 37 C.F.R.
`
`§ 42.6(a)(3).
`
`Novartis further objects to Exhibits 1045 and 1091 under F.R.E. 901
`
`(authentication). No information about the source of Exhibit 1045 has been
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`4
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`
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`provided. The web address listed on Petitioners’ exhibit list in connection with
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`Exhibit 1091 links to a page that is different from this document, and no further
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`information about the source of this document has been provided.
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`Exhibits 1075 – 1076, 1087, 1089 – 1090, and 1111 – 1112
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`Novartis objects to Exhibits 1075 – 1076, 1087, 1089 – 1090, and 1111 –
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`1112 under F.R.E. 802 (hearsay), F.R.E. 402 (relevance), and F.R.E. 403
`
`(confusing, waste of time). Novartis further objects to Exhibits 1075 – 1076, 1087,
`
`1089 – 1090, and 1111 – 1112 under 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and
`
`(b)(5), and 42.105, as these documents were not published until after the October
`
`9, 1992 priority date of the ’772 Patent and these documents are not the types of
`
`documents upon which a person of ordinary skill in the art at the time of invention
`
`would rely.
`
`Novartis further objects to Exhibits 1075 – 1076, 1089 – 1090, and 1111 –
`
`1112 under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5),
`
`and 42.105, as these documents are not cited in Petitioners’ Reply, and therefore
`
`any attempt by Petitioners to rely on these Exhibits to establish unpatentability
`
`(either directly by citing these Exhibits, or indirectly by citing paragraphs of their
`
`expert declarations that discuss these Exhibits) will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`5
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`Novartis further objects to Exhibits 1087, 1089 – 1090, and 1111 – 1112
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`under 37 C.F.R. §§ 42.104(b)(5) and 42.23 as Petitioners have failed to identify
`
`which aspects of the documents are relied upon.
`
`Novartis further objects to Exhibits 1075 – 1076, 1087, 1089 – 1090, and
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`1111 – 1112 under F.R.E. 901 (authentication). No information about the source
`
`of these documents has been provided.
`
`Exhibit 1058
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`Novartis objects to Exhibit 1058 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time). Novartis further objects
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`under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and
`
`42.105, as this document was not published until after the October 9, 1992 priority
`
`date of the ’772 Patent, this document is not the type of document upon which a
`
`person of ordinary skill in the art at the time of invention would rely, and this
`
`document is not cited in Petitioners’ Reply, and therefore any attempt by
`
`Petitioners to rely on this Exhibit to establish unpatentability (either directly by
`
`citing this Exhibit, or indirectly by citing paragraphs of their expert declarations
`
`that discuss this Exhibit) will constitute an improper incorporation by reference
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`under 37 C.F.R. § 42.6(a)(3).
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`6
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`
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`Novartis further objects to Exhibit 1058 under F.R.E. 106 (completeness), as
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`the document is incomplete because it includes only a select portion of a larger
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`document that in fairness ought to be considered in connection with Exhibit 1058.
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`Exhibit 1059
`
`Novartis objects to Exhibit 1059 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), F.R.E. 403 (confusing, waste of time). Novartis further objects under
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`37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105,
`
`as this document was not published until after the October 9, 1992 priority date of
`
`the ’772 Patent, this document is not the type of document upon which a person of
`
`ordinary skill in the art at the time of invention would rely, and this document is
`
`not cited in Petitioners’ Reply, and therefore any attempt by Petitioners to rely on
`
`this Exhibit to establish unpatentability (either directly by citing this Exhibit, or
`
`indirectly by citing paragraphs of their expert declarations that discuss this Exhibit)
`
`will constitute an improper incorporation by reference under 37 C.F.R.
`
`§ 42.6(a)(3).
`
`Novartis further objects to Exhibit 1059 under F.R.E. 901 (authentication).
`
`This exhibit appears to have been printed from the Internet; however the web
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`address listed on Petitioners’ exhibit list in connection with this exhibit does not
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`link to any active page, and no further information about the source of the
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`document has been provided.
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`7
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`Exhibit 1060
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`Novartis objects to Exhibit 1060 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), and F.R.E. 403 (confusing, waste of time). Novartis further objects
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`under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and
`
`42.105, as this document is not dated and this document is not cited in Petitioners’
`
`Reply, and therefore any attempt by Petitioners to rely on this Exhibit to establish
`
`unpatentability (either directly by citing this Exhibit, or indirectly by citing
`
`paragraphs of their expert declarations that discuss this Exhibit) will constitute an
`
`improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Novartis further objects to Exhibit 1060 under F.R.E. 901 (authentication).
`
`This exhibit appears to have been printed from the Internet; however the web
`
`address listed on Petitioners’ exhibit list in connection with this exhibit does not
`
`link to any active page, and no further information about the source of the
`
`document has been provided.
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`Exhibit 1064
`
`Novartis objects to Exhibit 1064 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
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`Exhibits 1071, 1094, and 1116
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`Novartis objects to Exhibits 1071, 1094, and 1116 under F.R.E. 802
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`(hearsay), F.R.E. 402 (relevance), and F.R.E. 403 (confusing, waste of time).
`
`8
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`
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`Novartis further objects under 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5),
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`and 42.105, as these documents were not published until after the October 9, 1992
`
`priority date of the ’772 Patent, these documents are not the types of documents
`
`upon which a person of ordinary skill in the art at the time of invention would rely,
`
`and these documents are not relevant to any issue in this IPR proceeding.
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`Novartis further objects to Exhibits 1071 and 1094 under 37 C.F.R.
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`§§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105, as these
`
`documents were not cited in Petitioners’ Reply, and therefore any attempt by
`
`Petitioners to rely on these Exhibits to establish unpatentability (either directly by
`
`citing these Exhibits, or indirectly by citing paragraphs of their expert declarations
`
`that discuss these Exhibits) will constitute an improper incorporation by reference
`
`under 37 C.F.R. § 42.6(a)(3).
`
`Exhibit 1072
`
`Novartis objects to Exhibit 1072 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time). Novartis further objects
`
`under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and
`
`42.105, as this document is not dated and this document was not cited in
`
`Petitioners’ Reply, and therefore any attempt by Petitioners to rely on this Exhibit
`
`to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`9
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`citing paragraphs of their expert declarations that discuss this Exhibit) will
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`constitute an improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
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`Exhibit 1073
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`Novartis objects to Exhibit 1073 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), and F.R.E. 403 (confusing, waste of time). Novartis further objects
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`under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and
`
`42.105, as this document is not dated and this document was not cited in
`
`Petitioners’ Reply, and therefore any attempt by Petitioners to rely on this Exhibit
`
`to establish unpatentability (either directly by citing this Exhibit, or indirectly by
`
`citing paragraphs of their expert declarations that discuss this Exhibit) will
`
`constitute an improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Exhibit 1084
`
`Novartis objects to Exhibit 1084 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time). Novartis further objects under
`
`37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105,
`
`as this document is not dated until after the October 9, 1992 priority date of the
`
`’772 Patent, this document is not the type of document upon which a person of
`
`ordinary skill in the art at the time of invention would rely, and this document was
`
`not cited in Petitioners’ Reply, and therefore any attempt by Petitioners to rely on
`
`this Exhibit to establish unpatentability (either directly by citing this Exhibit, or
`
`10
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`
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`indirectly by citing paragraphs of their expert declarations that discuss this Exhibit)
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`will constitute an improper incorporation by reference under 37 C.F.R.
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`§ 42.6(a)(3).
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`Exhibits 1095 and 1096
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`Novartis objects to Exhibits 1095 and 1096 under F.R.E. 802 (hearsay),
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`F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time). Novartis further
`
`objects under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5),
`
`and 42.105, as these documents are not dated and were not retrieved from the
`
`Internet until after the October 9, 1992 priority date of the ’772 Patent, these
`
`documents are not the types of documents upon which a person of ordinary skill in
`
`the art at the time of invention would rely, and these documents were not cited in
`
`Petitioners’ Reply, and therefore any attempt by Petitioners to rely on these
`
`Exhibits to establish unpatentability (either directly by citing these Exhibits, or
`
`indirectly by citing paragraphs of their expert declarations that discuss these
`
`Exhibits) will constitute an improper incorporation by reference under 37 C.F.R.
`
`§ 42.6(a)(3).
`
`Novartis further objects to Exhibit 1096 under 37 C.F.R. §§ 42.104(b)(5)
`
`and 42.23 as Petitioners have failed to identify which aspects of the document are
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`11
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`relied upon.
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`Exhibit 1101
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`Novartis objects to Exhibit 1101under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), and F.R.E. 403 (confusing, waste of time). Novartis further objects
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`under 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and
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`42.105, as this document was not published until after the October 9, 1992 priority
`
`date of the ’772 Patent, this document is not the type of document upon which a
`
`person of ordinary skill in the art at the time of invention would rely, this
`
`document was not cited in Petitioners’ Reply, and therefore any attempt by
`
`Petitioners to rely on this Exhibit to establish unpatentability (either directly by
`
`citing this Exhibit, or indirectly by citing paragraphs of their expert declarations
`
`that discuss this Exhibit) will constitute an improper incorporation by reference
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`under 37 C.F.R. § 42.6(a)(3), and Petitioners have failed to identify which aspects
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`of the document are relied upon.
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`Exhibit 1107
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`Novartis objects to Exhibit 1107 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), F.R.E. 403 (confusing, waste of time). Novartis further objects under
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`37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105,
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`as this document is dated after and was not retrieved until after the October 9, 1992
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`priority date of the ’772 Patent, this document is not the type of document upon
`
`which a person of ordinary skill in the art at the time of invention would rely, this
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`12
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`
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`document was not cited in Petitioners’ Reply, and therefore any attempt by
`
`Petitioners to rely on this Exhibit to establish unpatentability (either directly by
`
`citing this Exhibit, or indirectly by citing paragraphs of their expert declarations
`
`that discuss this Exhibit) will constitute an improper incorporation by reference
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`under 37 C.F.R. § 42.6(a)(3), and Petitioners have failed to identify which aspects
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`of the document are relied upon.
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`Exhibit 1118
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`Novartis objects to Exhibit 1118 under F.R.E. 802 (hearsay), F.R.E. 702
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`(improper expert testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R.
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`§ 42.65 as 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.
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`Novartis objects to Exhibit 1118 under 35 U.S.C. § 312(a)(3), 37 C.F.R.
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`§§ 42.65 and 42.104(b)(5), F.R.E. 702 (improper expert testimony), F.R.E. 402
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`(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
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`1118 ¶¶ 7-8, 10-17, 19-21, 23-24, 26-29, 31-35, 38-39, 42-45, 50-51, 53-54, 57-58,
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`61-63, 66-68, 70-71, 76-77, 79-82, 86-87, 89-96, 99, 101-108, and 110-111 fail to
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`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; Exhibit 1118 ¶¶ 5, 9-12,
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`13
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`15, 17-18, 20-23, 25-27, 29, 31, 33-34, 39, 41, 44, 47, 50-51, 55-57, 63, 65, 73, 78,
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`107, and 110 cite to prior expert testimony without identifying any underlying
`
`support; and Exhibit 1118 ¶¶ 8-9, 33, and 42 cite to entire articles, book chapters or
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`other references without identifying which aspects of those references are relied
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`upon.
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`Novartis also objects to Exhibit 1118 ¶¶ 1-12, 14, 16, 24, 30-31, 36, 45-46,
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`59-63, 79-81, and 111 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time) and 37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5),
`
`and 42.105 as these paragraphs are not cited in Petitioners’ Reply, and therefore
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`any attempt by Petitioners to rely on these paragraphs or the arguments therein to
`
`establish unpatentability will constitute an improper incorporation by reference
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`under 37 C.F.R. § 42.6(a)(3).
`
`Novartis also objects to Exhibit 1118 ¶¶ 9, 17-18, 26, 33, 42, 82, 96-99,
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`and 110 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 F.R.E. 802 (hearsay), F.R.E. 402 (relevance), F.R.E. 403 (confusing,
`
`waste of time), F.R.E. 702 (improper expert testimony), F.R.E. 703 (bases of an
`
`expert opinion), as not relevant to any issue in this IPR proceeding and not the type
`
`14
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`of document upon which a person of ordinary skill in the art at the time of
`
`invention would rely.
`
`Novartis also objects to Exhibit 1118 ¶¶ 5-7, 10-11, 16-20, 63, 78, 107, and
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`111 under 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). The
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`declarant is not stated to have expertise with respect to pharmacology,
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`immunosuppression, or transplant rejection.
`
`Novartis further objects to Exhibit 1118 ¶¶ 77 and 91 under F.R.E. 106
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`(completeness) because these paragraphs cite and quote only portions of testimony
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`from Ex. 1114, and omit portions of answers or follow up questions that in fairness
`
`ought to be considered in connection with Exhibit 1114 , including for ¶ 77, Dep.
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`Tr. 52:23-57:5; and for ¶ 91, Dep. Tr. 47:15-48:22.
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`Novartis further objects to Exhibit 1118 ¶¶ 8, 29, 56, 62, 74, 83, and 82
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`under F.R.E. 106 (completeness) because these paragraphs quote only portions of
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`testimony from Exhibits 2092 and/or Exhibits 2093, and omit portions of
`
`testimony set forth in the cited paragraphs of the declarations of Dr. Klibanov
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`and/or Dr. Roush that in fairness ought to be considered in connection with
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`Exhibits 2092 and 2093.
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`Novartis further objects to Exhibit 1118 ¶ 38 under F.R.E. 106
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`(completeness) because it cites only portions of testimony from Ex. 1115, and
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`15
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`omits related questions that in fairness ought to be considered in connection with
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`Exhibit 1115, including Dep. Tr. 7-14.
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`Novartis further objects to Exhibit 1118 ¶¶ 9, 26, 29, 33, 38, 42, 43, 53, 56,
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`and 97-99 as improper and untimely as these paragraphs cite exhibits (Ex. 1034,
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`1117,1121, 2075, and 2111) and make arguments in support of Petitioners’ prima
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`facie lead compound case based on those exhibits that should have been included
`
`in the evidence served with Petitioners’ Petitions as required by 35 U.S.C.
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`§ 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and 42.105.
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`Novartis further objects to Exhibit 1118 ¶¶ 8-11, 13-17, 20, 23, 25- 27, 29,
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`32, 33, 38, 42, 43, 53, 62, 78, 79, 82, 86, 87, 89-99, 101-105, 107, 108, and 110 as
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`improper and untimely as these paragraphs make arguments in support of
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`Petitioners’ prima facie lead compound case that should have been included in the
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`evidence served with Petitioners’ Petitions as required by 35 U.S.C. § 312(a)(3)
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`and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and 42.105.
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`Novartis also objects to Exhibit 1118 ¶¶ 8, 9, 25, 26 and 33 under F.R.E. 702
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`(improper expert testimony), F.R.E. 703 (bases of an expert opinion), F.R.E. 402
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`(relevance) and F.R.E. 403 (confusing, waste of time). The declarant is not stated
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`to have personal knowledge of, or expertise with respect to, the work done by the
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`’772 patent inventors, the National Cancer Institute or any entity involved in the
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`“Development of rapamycin.”
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`16
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`Exhibit 1119
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`Novartis objects to Exhibit 1119 under F.R.E. 802 (hearsay), F.R.E. 702
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`(improper expert testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R.
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`§ 42.65 as the testimony is not based on sufficient facts or data, is not the product
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`of reliable principles and methods, and the principles and methods have not been
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`reliably applied to the facts of the case.
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`Novartis objects to Exhibit 1119 under 35 U.S.C. § 312(a)(3), 37 C.F.R.
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`§§ 42.65 and 42.104(b)(5), F.R.E. 702 (improper expert testimony), F.R.E. 402
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`(relevance), and F.R.E. 403 (confusing, waste of time) for failing to identify with
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`particularity the underlying facts and data on which the opinion is based; Exhibit
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`1119 ¶¶ 29-30, 32, 35-41, 43-49, 52-55, 57, 59, 61, 63-66, 68-69, 72-79, 82-90, 92-
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`95, 97, 99-101, 103-107, and 109-112 fail to cite any support at all, include
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`statements that do not cite any support, or include statements that are not supported
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`by the cite(s) provided; and Exhibit 1119 ¶¶ 37, 40, 46, 49-50, 56, 58, 61-62, 75,
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`86-87, 91, 100, 102, 107, and 111 cite to entire articles, book chapters or other
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`references without identifying which aspects of those references are relied upon.
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`Patent Owners also object to Exhibit 1119 under F.R.E. 402 (relevance),
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`F.R.E. 403 (confusing, waste of time), F.R.E. 702 (improper expert testimony), and
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`F.R.E. 703 (bases for expert opinion); Exhibit 1119 ¶¶ 41, 46, 49-50, 52, 54, 58,
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`17
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`
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`60, 67-68, 70-71, 74-76, 85-92, 94, 96-107, and 111 include expert opinion based
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`on documents that are not prior art.
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`Novartis also objects to Exhibit 1119 ¶¶ 1-31, 37-42, and 44 under F.R.E.
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`402 (relevance), F.R.E. 403 (confusing, waste of time) and 37 C.F.R.
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`§§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105 as these
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`paragraphs are not cited in Petitioners’ Reply, and therefore any attempt by
`
`Petitioners to rely on these paragraphs or the arguments therein to establish
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`unpatentability will constitute an improper incorporation by reference under 37
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`C.F.R. § 42.6(a)(3).
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`Novartis also objects to Exhibit 1119 ¶¶ 32, 34, 36-41, 43, 46-47, 49-50, 52,
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`54, 56-58, 60-61, 67-68, 70-71, 74-76, 85-94, 96-107, and 111 under F.R.E. 702
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`(improper expert testimony), F.R.E. 703 (bases for expert opinion), F.R.E. 402
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`(relevance) and F.R.E. 403 (confusing, waste of time); these paragraphs include
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`expert opinion based on documents that are inadmissible under at least F.R.E. 802
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`(hearsay), F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of time), F.R.E.
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`702 (improper expert testimony), F.R.E. 703 (bases of an expert opinion), as not
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`relevant to any issue in this IPR proceeding and not the type of document upon
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`which a person of ordinary skill in the art at the time of invention would rely.
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`Novartis also objects to Exhibit 1119 ¶¶ 29, 38, 42, 47-49, and 60 under
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`F.R.E. 702 (improper expert testimony), F.R.E. 703 (bases of an expert opinion),
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`18
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`
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`F.R.E. 402 (relevance) and F.R.E. 403 (confusing, waste of time). The declarant is
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`not stated to have expertise with respect to medicinal chemistry and/or
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`immunology and/or transplantation.
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`Novartis also objects to Exhibit 1119 ¶ 61 under F.R.E. 702 (improper
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`expert testimony), F.R.E. 703 (bases of an expert opinion), F.R.E. 402 (relevance)
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`and F.R.E. 403 (confusing, waste of time). The declarant is not stated to have
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`expertise with respect to Wyeth’s clinical development plans.
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`Novartis also objects to Exhibit 1119 ¶¶ 46, 52, 61, 70, 73, and 75 under
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`F.R.E. 602 (lack of personal knowledge), F.R.E. 702 (improper expert testimony),
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`F.R.E. 703 (bases of an expert opinion), F.R.E. 402 (relevance) and F.R.E. 403
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`(confusing, waste of time), as the declarant is testifying regarding factual matters
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`for which he does not have personal knowledge.
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`Novartis further objects to Exhibit 1119 ¶¶ 28, 35-36, 38, and 41-42, under
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`F.R.E. 106 (completeness) because these paragraphs cite and quote only portions
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`of testimony from Ex. 1115, and omit a portion of an answer and related questions
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`and answers that in fairness ought to be considered in connection with Exhibit
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`1115, including for ¶ 28, Dep. Tr. 18:18-19:18; for ¶ 35, Dep. Tr. 68:20-69:7; for
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`¶ 36, Dep. Tr. 78:12-82:12, 89:19-92:4; for ¶ 38, Dep. Tr. 120:12-20; for ¶ 41,
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`Dep. Tr. 130:4-131:21; and for ¶ 42, Dep. Tr. 120:2-20.
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`19
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`Novartis further objects to Exhibit 1119 ¶ 67 under F.R.E. 106
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`(completeness) because this paragraph cites only portions of testimony from Ex.
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`1071, and omits related trial testimony that in fairness ought to be considered in
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`connection with Exhibit 1071, including Trial Tr. 565:23-566:15.
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`Novartis further objects to Exhibit 1119 ¶ 99 under F.R.E. 106
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`(completeness) because this paragraph cites only portions of testimony from Ex.
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`1094, and omits related trial testimony that in fairness ought to be considered in
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`connection with Exhibit 1094, including Trial. Tr. 632:24-633:8, 635:14-18.
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`Novartis further objects to Exhibit 1119 as improper and untimely; Exhibit
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`1119 ¶¶ 32-36, 43, 57 and 101-106 are improper and untimely as these paragraphs
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`make arguments relied on by Petitioners’ in support of Petitioners’ prima facie
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`reasonable expectation of success case and/or cite exhibits that should have been
`
`included in the evidence served with Petitioners’ Petitions as required by 35 U.S.C.
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`§ 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.104(b) and 42.105.
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`Exhibit 1122
`
`Novartis objects to Exhibit 1122 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), F.R.E. 403 (confusing, waste of time). Novartis further objects under
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`37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105,
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`as this document is not dated until after the October 9, 1992 priority date of the
`
`’772 Patent, this document is not the type of document upon which a person of
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`20
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`
`
`ordinary skill in the art at the time of invention would rely, and this document was
`
`not cited in Petitioners’ Reply, and therefore any attempt by Petitioners to rely on
`
`this Exhibit to establish unpatentability (either directly by citing this Exhibit, or
`
`indirectly by citing paragraphs of their expert declarations that discuss this Exhibit)
`
`will constitute an improper incorporation by reference under 37 C.F.R.
`
`§ 42.6(a)(3).
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`Novartis objects to Exhibit 1122 under F.R.E. 901 (authentication). No
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`information about the source of this document is provided.
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`Exhibit 1123
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`Novartis objects to Exhibit 1123 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), F.R.E. 403 (confusing, waste of time). Novartis further objects under
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`37 C.F.R. §§ 42.22(a)(2), 42.23, 42.24(c)(1), 42.104(b)(2) and (b)(5), and 42.105,
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`as this document was not published until after the October 9, 1992 priority date of
`
`the ’772 Patent, this document is not the type of document upon which a person of
`
`ordinary skill in the art at the time of invention would rely, and this document was
`
`not cited in Petitioners’ Reply, and therefore any attempt by Petitioners to rely on
`
`this Exhibit to establish unpatentability (either directly by citing this Exhibit, or
`
`indirectly by citing paragraphs of their expert declarations that discuss this Exhibit)
`
`will constitute an improper incorporation by reference under 37 C.F.R.
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`21
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`§ 42.6(a)(3).
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`
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`In addition, Novartis objects to each of Exhibits 1034-1123 to the extent
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`Petitioners rely on them to establish any claim element or any aspect of the Federal
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`Circuit’s lead compound analysis, as none of Exhibits 1034-1123 are references
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`upon which trial was instituted under Ground 1 or Ground 2. Novartis similarly
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`objects to Petitioners’ reliance on any 2000-series exhibit (or any other Exhibit that
`
`is not a reference in Ground 1 or 2) for the same reasons.
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`Respectfully submitted,
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`/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
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`Dated: December 12, 2016
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`22
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`CERTIFICATE OF SERVICE
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`I certify that a copy of the foregoing Patent Owner’s Objections Under 37
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`C.F.R. § 42.64 To Evidence Submitted By Petitioners With Their Reply was
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`served on December 12, 2016 by causing it to be sent by email to counsel for
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`Petitioners at the following email addresses:
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`Daniel G. Brown (daniel.brown@lw.com)
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`Robert Steinberg (bob.steinberg@lw.com)
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`Brenda L. Danek (brenda.danek@lw.com)
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`Jonathan M. Strang (jonathan.strang@lw.com)
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`Matthew L. Fedowitz (mfedowitz@merchantgould.com)
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`B. Jefferson Boggs (jboggs@merchantgould.com)
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`Daniel R. Evans (devans@merchantgould.com)
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`Keith A. Zullow (kzullow@goodwinlaw.com)
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`Marta Delsignore (mdelsignore@goodwinprocter.com)
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`/Nicholas N. Kallas/
`Nicholas N. Kall