`
`Filed On Behalf Of:
`Novartis Pharmaceuticals Corporation
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`
`
`
`
`Paper No. ____
`Date Filed: January 18, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`
`
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`
`
`
`Case IPR2017-01592
`
`Patent No. 8,410,131
`
`
`
`
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY BRECKENRIDGE PHARMACEUTICAL,
`INC. WITH ITS PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis Pharmaceuticals
`
`Corporation (“Novartis”) objects to the admissibility of the following exhibits filed
`
`prior to institution of the trial by Petitioner Breckenridge Pharmaceutical, Inc.
`
`(“Breckenridge”) 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 ’131
`
`Patent” means U.S. Patent No. 8,410,131. All objections under F.R.E. 802
`
`(hearsay) and 37 C.F.R § 42.61(c) (hearsay) apply to the extent Breckenridge relies
`
`on the exhibits identified in connection with that objection for the truth of the
`
`matters asserted therein. Novartis’s objections to Breckenridge’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 1001, 1012 – 1014
`
`
`
`Novartis objects to Exhibits 1001, and 1012 – 1014 under F.R.E. 802
`
`(hearsay) and 37 C.F.R § 42.61(c) (hearsay).
`
`Novartis objects to Exhibits 1001, and 1012 – 1014 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. 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 the disclosures of these
`
`
`
`
`
`1
`
`
`
`
`
`documents are not prior art under 35 U.S.C. § 102 nor admissions of the
`
`disclosures of the prior art and these documents are not the type of documents
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Novartis further objects to Exhibit 1014 under 37 C.F.R. § 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`Exhibits 1002 – 1009, 1016 – 1021, 1026, 1029 – 1039, 1041 – 1057, 1059 –
`
`1069, 1073, 1075 – 1077, 1079 – 1087, 1090, 1091, 1093 – 1101, 1104 – 1106,
`
`1108 – 1111
`
`Novartis objects to Exhibits 1002 – 1009, 1016 – 1021, 1026, 1029 – 1039,
`
`1041 – 1057, 1059 – 1069, 1073, 1075 – 1077, 1079 – 1087, 1090, 1091, 1093 –
`
`1101, 1104 – 1106, and 1108 – 1111 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis objects to Exhibits 1002, 1003, 1018, 1019, 1021, 1026, 1036 -
`
`1039, 1048, 1051, 1052, 1065, 1066, 1067, and 1073 under 37 C.F.R § 42.61(c)
`
`(hearsay).
`
`Novartis further objects to Exhibits 1002 – 1005, 1008, 1009, 1017, 1020,
`
`1045 – 1049, 1053, 1054 – 1057, 1060, 1063, 1065, 1069, 1075, 1090, and 1091
`
`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 for expert opinion) as they are
`
`not relevant to any issue in this IPR proceeding, and are not the type of documents
`
`
`
`
`
`2
`
`
`
`
`
`upon which a person of ordinary skill in the art at the time of invention would rely
`
`because they relate to the field of immunosuppression and/or transplantation and/or
`
`are in a separate field of endeavor and/or are not pertinent to the entire problem
`
`solved by the ’131 Patent.
`
`Novartis further objects to Exhibits 1005, 1029, 1060, 1069, 1085, and 1086
`
`under F.R.E. 901 (authentication). Breckenridge has not provided sufficient
`
`evidence that these exhibits are authentic or that the exhibits are self-authenticating
`
`under F.R.E. 902.
`
`Novartis further objects to Exhibits 1018, 1019, 1029 – 1039, 1041 – 1057,
`
`1059 – 1069, 1073, 1075 – 1077, 1079 – 1087, 1090, 1091, 1093 – 1101, 1104 –
`
`1106, and 1108 – 1111 under 37 C.F.R. § 42.104(b)(5) (failure to identify specific
`
`portions of evidence).
`
`Novartis further objects to Exhibits 1002, 1005, 1023, 1024, 1029, 1036 –
`
`1039, 1064, 1073, 1093, 1094, 1104 – 1106, and 1108 – 1111 under 37 C.F.R. §§
`
`42.22(a)(2), 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 documents were not published until
`
`after the February 19, 2001 priority date of the ’131 Patent, the October 17, 2001
`
`priority date of the ’131 Patent, or the February 18, 2002 application date of the
`
`
`
`
`
`3
`
`
`
`
`
`’131 Patent, and are not the type of documents upon which a person of ordinary
`
`skill in the art at the time of invention would rely.
`
`Novartis further objects to Exhibits 1031, 1059, 1061, 1077, and 1095 –
`
`1096 under 37 C.F.R. §§ 42.22(a)(2), 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
`
`documents are stamped with dates after the February 19, 2001 priority date of the
`
`’131 Patent, the October 17, 2001 priority date of the ’131 Patent, or the February
`
`18, 2002 application date of the ’131 Patent, were not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
`
`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
`
`Patent, and 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 1060, 1069, 1076, 1085, 1086, and 1098
`
`under 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 42.105, 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
`
`Breckenridge has not provided evidence to prove that these documents were
`
`published before the February 19, 2001 priority date of the ’131 Patent, the
`
`October 17, 2001 priority date of the ’131 Patent, or the February 18, 2002
`
`
`
`
`
`4
`
`
`
`
`
`application date of the ’131 Patent, and these exhibits 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 Exhibit 1005 under 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, 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 Breckenridge has not provided evidence to
`
`prove that this document was published before the October 17, 2001 priority date
`
`of the ’131 Patent or the February 18, 2002 application date of the ’131 Patent and
`
`this exhibit 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 Exhibits 1029 – 1039, 1041 – 1057, 1059 – 1069,
`
`1073, 1075 – 1077, 1079 – 1087, 1090, 1091, 1093 – 1101, 1104 – 1106, and 1108
`
`– 1111 under 35 U.S.C. § 312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b),
`
`and 42.105 as these documents are not cited in the Petition, and therefore any
`
`attempt by Breckenridge to rely on these Exhibits to establish unpatentability
`
`(either directly by citing these Exhibits, or indirectly by citing paragraphs of
`
`Breckenridge’s expert declaration that discuss these Exhibits) is improper and
`
`untimely and will constitute an improper incorporation by reference under 37
`
`C.F.R. § 42.6(a)(3).
`
`
`
`
`
`5
`
`
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`
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`Exhibits 1022 – 1024, 1040, 1092
`
`Novartis objects to Exhibits 1022 – 1024, 1040, and 1092 under F.R.E. 802
`
`(hearsay), F.R.E. 402 (relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis objects to Exhibits 1022 – 1024, 1040, and 1092 under 37 C.F.R §
`
`42.61(c) (hearsay).
`
`Novartis further objects to Exhibits 1022 – 1024, 1040, and 1092 under 37
`
`C.F.R. §§ 42.6(a)(3) (combined documents), 42.63 (form of evidence) as these
`
`exhibits appear to be compilations of more than one document.
`
`Novartis further objects to Exhibits 1022 – 1024, 1040, and 1092 under
`
`F.R.E. 901(authentication). Breckenridge has not provided sufficient evidence that
`
`some or all documents comprising these exhibits are authentic or that the exhibits
`
`are self-authenticating under F.R.E. 902.
`
`Novartis further objects to Exhibits 1022, 1040, and 1092 under 37 C.F.R. §
`
`42.104(b)(5) (failure to identify specific portions of evidence).
`
`Novartis further objects to Exhibits 1022 – 1024, 1040, and 1092 under 37
`
`C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 42.105, 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
`
`Breckenridge has provided no evidence that some or all documents comprising
`
`these exhibits were published before the February 19, 2001 priority date of the
`
`
`
`
`
`6
`
`
`
`
`
`’131 Patent, the October 17, 2001 priority date of the ’131 Patent, or the February
`
`18, 2002 application date of the ’131 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 further objects to Exhibits 1040 and 1092 under 35 U.S.C. §
`
`312(a)(3), 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as these
`
`documents are not cited in the Petition, and therefore any attempt by Breckenridge
`
`to rely on these Exhibits to establish unpatentability (either directly by citing these
`
`Exhibits, or indirectly by citing paragraphs of Breckenridge’s expert declaration
`
`that discuss these Exhibits) is improper and untimely and will constitute an
`
`improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Exhibit 1010
`
`Novartis objects to Exhibit 1010 under 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 for expert opinion), and 37 C.F.R. § 42.65 as Dr.
`
`Pantuck’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.
`
`
`
`
`
`7
`
`
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`
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`Novartis objects to Exhibit 1010 under 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 for expert opinion), and 37 C.F.R. § 42.65 as Dr.
`
`Pantuck’s testimony is not based on an analysis of the prior art as a whole.
`
`Novartis objects to Exhibit 1010 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
`
`1010 ¶¶ 29, 30, 41, 59, 60-65, 70, 71, 73, 75-79, 81-85, 87, 89-94, 96, 97, 99-102,
`
`105, 114-116, 119, 120-122, 124, 125, 127-129, 130, 131, 133-140, 142, 144-150,
`
`156-159, 162-164, 168, 169, 171-179, 183-187, 189-193, 194, 196-198, 200, 202-
`
`203, 207, 209, 211, 214-217, 219, 223-226, 228-233, 235-237, 239, 243-248, 249-
`
`255, 257, 261, 263-280, and 284-308 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 1010 ¶¶ 95-98, 100-102, 106, 107, 114, 116-
`
`118, 121-123, 140-142, 155, and 186 cite to entire articles, book chapters or other
`
`references without identifying which aspects of those references are relied upon.
`
`Novartis also objects to Exhibit 1010 under F.R.E. 402 (relevance), F.R.E.
`
`403 (confusing, waste of time), 35 U.S.C. § 312(a)(3), and 37 C.F.R. §§
`
`42.22(a)(2), 42.24(a), 42.104(b), and 42.105; Exhibit 1010 ¶¶ 1-18, 21-23, 25, 27-
`
`
`
`
`
`8
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`
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`30, 66-67, 139, 148, 236-238, and 309 are not cited in Breckenridge’s Petition; and
`
`Exhibit 1010 ¶¶ 20, 24, 26, 31-65, 68, 69, 71-73, 76, 77, 79, 81-84, 87, 88, 91, 92,
`
`94-132, 134, 136-138, 140-147, 151-157, 159-161, 164-166, 168-172, 174-176,
`
`179-188, 190-192, 195-216, 219-222, 225, 226, 228-233, 235, 244, 246, 247, 280,
`
`284, 290, 294-296, 306, and 308 are not specifically identified or discussed in
`
`detail in whole or in part in Breckenridge’s Petition. Any attempt by Breckenridge
`
`to rely on these paragraphs to establish unpatentability is improper and untimely
`
`and will constitute an improper incorporation by reference under 37 C.F.R. §
`
`42.6(a)(3) or attempt to circumvent the word count limits for petitions under 37
`
`C.F.R. § 42.24(a).
`
`Novartis also objects to Exhibit 1010 ¶¶ 23-65, 68-93, 95-142, 144-147,
`
`149-233, 235, 237-280, and 284-307 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),
`
`42.61(c) (hearsay), 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
`
`for expert opinion), and F.R.E. 901 (authentication), documents that are stamped
`
`with dates after the February 19, 2001 priority date of the ’131 Patent, the October
`
`
`
`
`
`9
`
`
`
`
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`17, 2001 priority date of the ’131 Patent, or the February 18, 2002 application date
`
`of the ’131 Patent, documents that were not published until after the February 19,
`
`2001 priority date of the ’131 Patent, the October 17, 2001 priority date of the ’131
`
`Patent, or the February 18, 2002 application date of the ’131 Patent, and/or
`
`documents for which Breckenridge has not provided evidence to prove were
`
`published before the February 19, 2001 priority date of the ’131 Patent, the
`
`October 17, 2001 priority date of the ’131 Patent, or the February 18, 2002
`
`application date of the ’131 Patent 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 further objects to Exhibit 1010 ¶¶ 46-65, 217, and 247 under F.R.E.
`
`106 (completeness) as these paragraphs include expert opinion based on
`
`documents that are incomplete under at least under F.R.E. 106 (completeness).
`
`Novartis also objects to Exhibit 1010 ¶¶ 137, 138, 168, 214, 233, 244, and
`
`300 under 37 C.F.R. §§ 42.22(a)(2), 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 these
`
`paragraphs rely on the disclosures of the ’131 Patent, which is not prior art under
`
`35 U.S.C. § 102 nor are the disclosures in the ’131 Patent an admission of the
`
`disclosures of the prior art.
`
`
`
`
`
`10
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`
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`Novartis also objects to Exhibit 1010 ¶¶ 60, 95-99, 100-102, 104, 106, 108,
`
`109, 111, 120, 149-171, 190-224, 226, 228, 231-233, 237, 243-264, 266-272, 274-
`
`280, 291-294, 296-297, and 299-307 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) as they are not relevant to any issue in this
`
`IPR proceeding because they relate to the field of immunosuppression and/or
`
`transplantation and/or are in a separate field of endeavor and/or are not pertinent to
`
`the entire problem solved by the ’131 Patent.
`
`Novartis also objects to Exhibit 1010 ¶¶ 60, 95-99, 100-102, 104, 106, 108,
`
`109, 111, 119, 120, 142, 149-171, 185, 190-224, 226, 228, 231-233, 237, 243-264,
`
`266-272, 274-280, 291-294, and 296-307 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). The declarant is not stated to have expertise
`
`with respect to organic chemistry, medicinal chemistry, immunosuppression,
`
`transplantation, tuberous sclerosis complex, or related fields.
`
`Exhibits 1011, 1058, 1070 – 1072, 1088, 1089, 1102, 1103, 1107
`
`Novartis objects to Exhibits 1011, 1058, 1070 – 1072, 1088, 1089, 1102,
`
`1103, and 1107 under F.R.E. 802 (hearsay), F.R.E. 402 (relevance), and F.R.E. 403
`
`(confusing, waste of time).
`
`
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`
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`11
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`
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`Novartis further objects to Exhibits 1011, 1058, 1070 – 1072, 1088, 1089,
`
`1102, 1103, and 1107 under F.R.E. 901(authentication). No information about the
`
`sources of Exhibits 1011, 1058, 1070 – 1072, 1088, 1089, 1102, 1103, and 1107
`
`has been provided.
`
`Novartis further objects to Exhibits 1011, 1058, 1070 – 1072, 1088, 1089,
`
`1102, 1103, and 1107 under 37 C.F.R. § 42.104(b)(5) (failure to identify specific
`
`portions of evidence).
`
`Novartis further objects to Exhibits 1070 – 1072, 1088, 1089, 1102, 1103,
`
`and 1107 under 37 C.F.R. §§ 42.22(a)(2), 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
`
`documents were not published until after the February 19, 2001 priority date of the
`
`’131 Patent, the October 17, 2001 priority date of the ’131 Patent, or the February
`
`18, 2002 application date of the ’131 Patent, and 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 1011 and 1058 under 37 C.F.R. §§
`
`42.22(a)(2), 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 Breckenridge has not provided evidence to
`
`prove that these documents were published on or before the February 19, 2001
`
`
`
`
`
`12
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`
`
`
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`priority date of the ’131 Patent, the October 17, 2001 priority date of the ’131
`
`Patent, or the February 18, 2002 application date of the ’131 Patent, and these
`
`exhibits 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 1058, 1070 – 1072, 1088, 1089, 1102,
`
`1103, and 1107 under 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2),
`
`42.24(a), 42.104(b), and 42.105 as these documents are not cited in the Petition,
`
`and therefore any attempt by Breckenridge to rely on these Exhibits to establish
`
`unpatentability (either directly by citing these Exhibits, or indirectly by citing
`
`paragraphs of Breckenridge’s expert declaration that discuss these Exhibits) is
`
`improper and untimely and will constitute an improper incorporation by reference
`
`under 37 C.F.R. § 42.6(a)(3).
`
`Exhibit 1025
`
`Novartis objects to Exhibit 1025 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis further objects to Exhibit 1025 under F.R.E. 901(authentication).
`
`No information about the source of Exhibit 1025 has been provided.
`
`Novartis further objects to Exhibit 1025 under 37 C.F.R. §§ 42.22(a)(2),
`
`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
`
`
`
`
`
`13
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`
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`
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`(bases for expert opinion) as this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
`
`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
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`Patent, 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 1025 under 37 C.F.R. § 42.24(a) as
`
`circumventing the word count limits for petitions.
`
`Exhibit 1027
`
`Novartis objects to Exhibit 1027 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis further objects to Exhibit 1027 under F.R.E. 106 (completeness).
`
`Novartis further objects to Exhibit 1027 under 37 C.F.R. §§ 42.22(a)(2),
`
`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 this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
`
`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
`
`Patent, and is not the type of document upon which a person of ordinary skill in the
`
`art at the time of invention would rely.
`
`
`
`
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`14
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`
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`Exhibit 1028
`
`Novartis objects to Exhibit 1028 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Novartis further objects to Exhibit 1028 under 37 C.F.R. § 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`Novartis further objects to Exhibit 1028 under 37 C.F.R. §§ 42.22(a)(2),
`
`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 this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
`
`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
`
`Patent, 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 1028 under 35 U.S.C. § 312(a)(3) and 37
`
`C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as this document is not
`
`cited in the Petition, and therefore any attempt by Breckenridge to rely on this
`
`Exhibit to establish unpatentability (either directly by citing this Exhibit, or
`
`indirectly by citing paragraphs of Breckenridge’s expert declaration that discuss
`
`this Exhibit) is improper and untimely and will constitute an improper
`
`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`
`
`
`
`15
`
`
`
`
`
`Exhibits 1074, 1078
`
`Novartis objects to Exhibits 1074 and 1078 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 1074 and 1078 under 37 C.F.R. §
`
`42.104(b)(5) (failure to identify specific portions of evidence).
`
`Novartis further objects to Exhibits 1074 and 1078 under 35 U.S.C. §
`
`312(a)(3) and 37 C.F.R. §§ 42.22(a)(2), 42.24(a), 42.104(b), and 42.105 as these
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`documents are not cited in the Petition, and therefore any attempt by Breckenridge
`
`to rely on these Exhibits to establish unpatentability (either directly by citing these
`
`Exhibits, or indirectly by citing paragraphs of Breckenridge’s expert declaration
`
`that discuss these Exhibits) is improper and untimely and will constitute an
`
`improper incorporation by reference under 37 C.F.R. § 42.6(a)(3).
`
`Novartis further objects to Exhibits 1074 and 1078 under F.R.E. 901
`
`(authentication). No information about the sources of Exhibits 1074 and 1078 has
`
`been provided.
`
`Novartis further objects to Exhibit 1078 under 37 C.F.R. §§ 42.22(a)(2),
`
`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 this document was not published until after the
`
`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
`
`
`
`
`
`16
`
`
`
`
`
`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
`
`Patent, 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 also objects under F.R.E. 402, F.R.E. 403, 35 U.S.C. § 312(a)(3),
`
`and 37 C.F.R. § 42.104(b) to any evidence that does not appear in instituted
`
`Grounds 1, 2, 3, 4, or 5 and that Breckenridge relies upon to establish any element
`
`of their prima facie case against claims 1-3 and 5-9 of the ’131 Patent (other than
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`evidence used for the limited purposes of describing the state of the art or
`
`reinforcing the meaning of a prior art reference that appears in Grounds 1, 2, 3, 4,
`
`or 5). See In re NuVasive, 841 F.3d 966, 972-73 (Fed. Cir. 2016) (Board abused its
`
`discretion by relying on portion of prior art reference that was first identified by
`
`petitioner in its reply; that portion of the reference did not merely describe the state
`
`of the art, but instead was the sole prior art disclosure of disputed claim elements
`
`relied upon by the Board); Genzyme Therapeutic Prods. Limited Partnership v.
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`Biomarin Pharms. Inc., 825 F.3d 1360, 1368 (Fed. Cir. 2016) (parties should move
`
`to exclude a reference not cited in instituted grounds).
`
`
`
`Dated: January 18, 2018
`
`
`
`
`
`
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 31,530
`Lead Counsel for Patent Owner
`
`17
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`
`
`
`
`
`
`
`
`
`
`
`
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`18
`
`
`
`
`
`
`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 Breckenridge Pharmaceutical, Inc. With
`
`Its Petition For Inter Partes Review was served on January 18, 2018 by causing it
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`to be sent by email to counsel for Petitioner at the following email addresses:
`
`
`
`Daniel R. Evans (devans@merchantgould.com)
`
`Jeffrey D. Blake (jblake@merchantgould.com)
`
`Melissa M. Hayworth (mhayworth@merchantgould.com)
`
`
`
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`Dated: January 18, 2018
`
`
`
`
`
`
`
`/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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`
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`1
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