`
`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 25, 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.
`
`
`
`
`
`
`
`In its January 3, 2018 decision instituting inter partes review in this
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`proceeding (Paper 12, “Institution Decision”), the Board authorized Petitioner
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`Breckenridge Pharmaceutical, Inc. (“Breckenridge”) “to file one or more
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`declarations explaining the relevance of the documents appended to the Luan
`
`abstract….” Institution Decision at 22-23 (discussing Exhibit 1005, Luan). On
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`January 18, 2018, Breckenridge filed Exhibits 1112 – 1118. In its January 23,
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`2018 Order Regarding the Conduct of the Proceeding Under 37 C.F.R. § 42.5
`
`(Paper 16, “Order”), the Board authorized Breckenridge to file a Declaration of Fu
`
`L. Luan, M.D. on the basis of Breckenridge’s representation to the Board that “the
`
`proposed ‘declaration specifically addresses the publication date issue of the Luan
`
`Abstract.’” Order at 2. On January 23, 2018, Breckenridge filed Exhibit 1119.
`
`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
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`on January 18, 2018 and January 23, 2018 by Breckenridge on the grounds set
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`forth below.
`
`In this paper, a reference to “F.R.E.” means the Federal Rules of Evidence, a
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`reference to “C.F.R.” means the Code of Federal Regulations, and “the ’131
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`Patent” means U.S. Patent No. 8,410,131. All objections under F.R.E. 802
`
`(hearsay) apply to the extent Breckenridge relies on the exhibits identified in
`
`connection with that objection for the truth of the matters asserted therein.
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`1
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`Novartis’s objections to Breckenridge’s exhibits are without prejudice to
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`Novartis’s reliance on or discussion of those exhibits in Novartis’s papers in this
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`proceeding.
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`Novartis’s objections are as follows:
`
`Exhibit 1112
`
`
`
`Novartis objects to Exhibit 1112 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and F.R.E. 701 (improper
`
`testimony by lay witness), as Dr. Evans’s testimony is not rationally based on his
`
`perceptions and not helpful to clearly understanding his testimony or determining a
`
`fact in issue in this proceeding.
`
`Novartis also objects to Exhibit 1112 under F.R.E. 402 (relevance), F.R.E.
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`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 1112 was not cited in
`
`Breckenridge’s Petition. Any attempt by Breckenridge to rely on this document to
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`establish unpatentability is improper and untimely and will constitute an improper
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`incorporation by reference under 37 C.F.R. § 42.6(a)(3) or attempt to circumvent
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`the word count limits for petitions under 37 C.F.R. § 42.24(a).
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`Novartis further objects to Exhibit 1112 as improper and untimely to the
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`extent this document is cited in support of Breckenridge’s prima facie case as this
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`document should have been included in the evidence served with Breckenridge’s
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`2
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`
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`Petition as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2),
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`42.104(b), and 42.105.
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`Novartis also objects to Exhibit 1112 ¶¶ 2-7 and 9-12 under F.R.E. 701
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`(improper testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403
`
`(confusing, waste of time); these paragraphs include statements based on
`
`documents that are inadmissible under at least 37 C.F.R. §§ 42.22(a)(2),
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`42.104(b)(2) and (b)(5), F.R.E. 802 (hearsay), F.R.E. 402 (relevance), F.R.E. 403
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`(confusing, waste of time, needlessly presenting cumulative evidence), F.R.E. 701
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`(improper testimony by lay witness), and F.R.E. 901 (authentication), documents
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`that are stamped with dates after the February 19, 2001 priority date of the ’131
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`Patent, the October 17, 2001 priority date of the ’131 Patent, or the February 18,
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`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
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`priority date of the ’131 Patent, or the February 18, 2002 application date of the
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`’131 Patent, and/or documents for which Breckenridge has not provided evidence
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`to prove were published before the February 19, 2001 priority date of the ’131
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`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.
`
`
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`3
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`
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`Novartis also objects to Exhibit 1112 ¶ 5 under F.R.E. 701 (improper
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`testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing,
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`waste of time), as the declarant has provided no information to support his
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`testimony that Exhibit 1114 was located “[f]rom online research” or is “available
`
`online.” Exhibit 1112 ¶ 5.
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`Novartis also objects to Exhibit 1112 ¶¶ 3-7, 9, and 10 under 37 C.F.R.
`
`§ 42.123 and as beyond the scope of the Board’s order in its Institution Decision,
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`as these paragraphs do not “explain[] the relevance of the documents appended to
`
`the Luan abstract” and/or rely on documents that are not “declarations explaining
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`the relevance of the documents appended to the Luan abstract.”
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`Novartis also objects to Exhibit 1112 ¶¶ 2-12 under F.R.E. 701 (improper
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`testimony by lay witness), 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
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`they relate to the field of immunosuppression and/or transplantation and/or are in a
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`separate field of endeavor and/or are not pertinent to the entire problem solved by
`
`the ’131 Patent.
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`Novartis also objects to Exhibit 1112 ¶¶ 4, 5, and 10 under F.R.E. 701
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`(improper testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403
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`(confusing, waste of time). The declarant is not stated to have expertise with
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`respect to renal cell carcinoma, transplantation, library science, or related fields
`
`
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`
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`4
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`and has provided no evidence of his alleged “experience attending conferences.”
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`Exhibit 1112 ¶ 5.
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`Novartis also objects to Exhibit 1112 ¶¶ 3-7 and 9-12 under F.R.E. 602 (lack
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`of personal knowledge), F.R.E. 701 (improper testimony by lay witness), F.R.E.
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`402 (relevance), and F.R.E. 403 (confusing, waste of time), as the declarant is
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`testifying regarding factual matters for which he does not have personal
`
`knowledge.
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`Novartis also objects to Exhibit 1112 ¶¶ 2-4 under F.R.E. 701 (improper
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`testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing,
`
`waste of time), as the declarant is testifying regarding issues of law, which is not
`
`helpful to clearly understanding the declarant’s testimony or to determining a fact
`
`in issue. Further, any attempt by Breckenridge to rely on the declarant’s testimony
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`regarding any issue of law to establish unpatentability will constitute an attempt to
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`circumvent the word count limits for petitions under 37 C.F.R. § 42.24(a).
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`Exhibits 1113 – 1117
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`Novartis objects to Exhibits 1113 - 1117 under F.R.E. 802 (hearsay), F.R.E.
`
`402 (relevance), and F.R.E. 403 (confusing, waste of time).
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`Novartis further objects to Exhibits 1113 – 1117 under 37 C.F.R. § 42.123
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`and as beyond the scope of the Board’s order in its Institution Decision, as these
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`5
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`documents are not “declarations explaining the relevance of the documents
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`appended to the Luan abstract.”
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`Novartis further objects to Exhibits 1113 – 1117 under F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and F.R.E. 701 (improper
`
`testimony by lay witness), as they are not relevant to any issue in this IPR
`
`proceeding, and are not the type of documents 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.
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`Novartis further objects to Exhibit 1114 under F.R.E. 901 (authentication).
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`Breckenridge has not provided sufficient evidence that this exhibit is authentic or
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`that this exhibit is self-authenticating under F.R.E. 902.
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`Novartis further objects to Exhibits 1113 – 1117 under 37 C.F.R. §
`
`42.104(b)(5) (failure to identify specific portions of evidence).
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`Novartis further objects to Exhibits 1116 and 1117 under 37 C.F.R. §§
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`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), and F.R.E. 701 (improper testimony by lay
`
`witness), as these documents were not published until after the February 19, 2001
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`priority date of the ’131 Patent, the October 17, 2001 priority date of the ’131
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`Patent, or the February 18, 2002 application date of the ’131 Patent, and are not the
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`6
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`types of documents upon which a person of ordinary skill in the art at the time of
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`invention would rely.
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`Novartis further objects to Exhibits 1113 and 1115 under 37 C.F.R. §§
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`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), and F.R.E. 701 (improper testimony by lay
`
`witness), as these documents are stamped with dates after the February 19, 2001
`
`priority date of the ’131 Patent or the October 17, 2001 priority date of the ’131
`
`Patent, were not published until after the February 19, 2001 priority date of the
`
`’131 Patent or the October 17, 2001 priority 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.
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`Novartis further objects to Exhibit 1114 under 37 C.F.R. §§ 42.22(a)(2),
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`42.104(b)(2) and (b)(5), and 42.105, 35 U.S.C. § 311(b), F.R.E. 402 (relevance),
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`F.R.E. 403 (confusing, waste of time), and F.R.E. 701 (improper testimony by lay
`
`witness), as Breckenridge has not provided evidence to prove that this document
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`was published before the February 19, 2001 priority date of the ’131 Patent, the
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`October 17, 2001 priority date of the ’131 Patent, or the February 18, 2002
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`application date of the ’131 Patent, and this exhibit is not the type of document
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`upon which a person of ordinary skill in the art at the time of invention would rely.
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`7
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`Novartis further objects to Exhibits 1113 – 1117 under 35 U.S.C. §
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`312(a)(3), 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
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`to rely on these Exhibits to establish unpatentability (either directly by citing these
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`Exhibits, or indirectly by citing paragraphs of Breckenridge’s declarations that
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`discuss these Exhibits) is improper and untimely and will constitute an improper
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`incorporation by reference under 37 C.F.R. § 42.6(a)(3).
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`Novartis further objects to Exhibits 1113 – 1117 as improper and untimely
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`to the extent they are cited in support of Breckenridge’s prima facie case as they
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`should have been included in the evidence served with Breckenridge’s Petition 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.
`
`Exhibit 1118
`
`Novartis objects to Exhibit 1118 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and F.R.E. 701 (improper
`
`testimony by lay witness), as Mr. Stokke’s testimony is not rationally based on his
`
`perceptions and not helpful to clearly understanding his testimony or determining a
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`fact in issue in this proceeding.
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`Novartis also objects to Exhibit 1118 under F.R.E. 402 (relevance), F.R.E.
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`403 (confusing, waste of time), 35 U.S.C. § 312(a)(3), and 37 C.F.R. §§
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`
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`
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`8
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`
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`42.22(a)(2), 42.24(a), 42.104(b), and 42.105; Exhibit 1118 was not cited in
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`Breckenridge’s Petition. Any attempt by Breckenridge to rely on this document to
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`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 further objects to Exhibit 1118 as improper and untimely to the
`
`extent this document is cited in support of Breckenridge’s prima facie case as this
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`document should have been included in the evidence served with Breckenridge’s
`
`Petition as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2),
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`42.104(b), and 42.105.
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`Novartis also objects to Exhibit 1118 ¶¶ 3-9 under F.R.E. 701 (improper
`
`testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing,
`
`waste of time); these paragraphs include statements based on documents that are
`
`inadmissible under at least 37 C.F.R. §§ 42.22(a)(2), 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. 701 (improper testimony by lay
`
`witness), and F.R.E. 901 (authentication), 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
`
`
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`
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`9
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`
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`Patent, as not relevant to any issue in this IPR proceeding and not the type of
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`document upon which a person of ordinary skill in the art at the time of invention
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`would rely.
`
`Novartis also objects to Exhibit 1118 ¶¶ 3-9 under F.R.E. 701 (improper
`
`testimony by lay witness), 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 1118 ¶¶ 5-7 under F.R.E. 602 (lack of
`
`personal knowledge), F.R.E. 701 (improper testimony by lay witness), 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 1118 ¶ 6 under F.R.E. 701 (improper
`
`testimony by lay witness), F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste of
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`time), and F.R.E. 106 (completeness), as the declarant is testifying regarding one
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`or more document(s) that are not in evidence in this proceeding that in fairness
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`ought to be considered in connection with Exhibits 1005 and/or 1118.
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`10
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`Ex. 1119
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`Novartis objects to Exhibit 1119 under F.R.E. 802 (hearsay), F.R.E. 402
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`(relevance), F.R.E. 403 (confusing, waste of time), and F.R.E. 701 (improper
`
`testimony by lay witness), as Dr. Luan’s testimony is not rationally based on his
`
`perceptions and not helpful to clearly understanding his testimony or determining a
`
`fact in issue in this proceeding.
`
`Novartis also objects to Exhibit 1119 under F.R.E. 402 (relevance), F.R.E.
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`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 1119 was not cited in
`
`Breckenridge’s Petition. Any attempt by Breckenridge to rely on this document 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 further objects to Exhibit 1119 as improper and untimely to the
`
`extent this document is cited in support of Breckenridge’s prima facie case as this
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`document should have been included in the evidence served with Breckenridge’s
`
`Petition as required by 35 U.S.C. § 312(a)(3) and 37 C.F.R. §§ 42.22(a)(2),
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`42.104(b), and 42.105.
`
`Novartis also objects to Exhibit 1119 under 37 C.F.R. § 42.5(c)(3) and as
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`beyond the scope of the Board’s order in its Institution Decision, as Breckenridge
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`11
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`filed Exhibit 1119 on January 23, 2018, after the January 18, 2018 deadline set by
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`the Board (Institution Decision at 23), even though Breckenridge failed to show
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`good cause for the late action or that consideration of Exhibit 1119 on the merits
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`would be in the interests of justice.
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`Novartis also objects to Exhibit 1119 to the extent that the Board’s Order
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`deprives Novartis of any property interest and/or Novartis is adversely affected by
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`the Board’s Order without providing Novartis an opportunity to be heard. Novartis
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`indicated in its January 22, 2018 email to the Board (Ex. 3002 at 1) that it opposed
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`Breckenridge’s request to file Exhibit 1119 after the deadline, but did not include
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`substantive arguments in support of its opposition because such arguments are
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`prohibited in an email by Board Technical Issue No. 2. The Board did not give
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`Novartis any opportunity to provide substantive arguments regarding its opposition
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`to Breckenridge’s request to file Exhibit 1119.
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`Novartis also objects to Exhibit 1119 ¶¶ 3-7 under F.R.E. 701 (improper
`
`testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing,
`
`waste of time); these paragraphs include statements based on documents that are
`
`inadmissible under at least 37 C.F.R. §§ 42.22(a)(2), 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. 701 (improper testimony by lay
`
`witness), and F.R.E. 901 (authentication), and/or documents for which
`
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`12
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`Breckenridge has not provided evidence to prove were published before the
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`February 19, 2001 priority date of the ’131 Patent, the October 17, 2001 priority
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`date of the ’131 Patent, or the February 18, 2002 application date of the ’131
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`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 also objects to Exhibit 1119 ¶¶ 3, 4, 6, and 7 under 37 C.F.R.
`
`§ 42.123 and as beyond the scope of the Board’s orders in its Institution Decision
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`and Order, as these paragraphs do not “explain[] the relevance of the documents
`
`appended to the Luan abstract” and/or rely on documents that are not “declarations
`
`explaining the relevance of the documents appended to the Luan abstract.”
`
`Novartis also objects to Exhibit 1119 ¶¶ 1-7 under F.R.E. 701 (improper
`
`testimony by lay witness), 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.
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`Novartis also objects to Exhibit 1119 ¶¶ 3 and 5-7 under F.R.E. 602 (lack of
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`personal knowledge), F.R.E. 701 (improper testimony by lay witness), F.R.E. 402
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`(relevance), and F.R.E. 403 (confusing, waste of time), as the declarant is
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`13
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`testifying regarding factual matters for which he does not have personal knowledge
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`and/or has not testified that he has personal knowledge of such factual matters.
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`Novartis also objects to Exhibit 1119 ¶ 7 under F.R.E. 701 (improper
`
`testimony by lay witness), F.R.E. 402 (relevance), and F.R.E. 403 (confusing,
`
`waste of time), as the declarant is testifying regarding issues of law, which is not
`
`helpful to clearly understanding the declarant’s testimony or to determining a fact
`
`in issue. Further, any attempt by Breckenridge to rely on the declarant’s testimony
`
`regarding any issue of law establish unpatentability will constitute an attempt to
`
`circumvent the word count limits for petitions under 37 C.F.R. § 42.24(a).
`
`*
`
`*
`
`*
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`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
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`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
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`reinforcing the meaning of a prior art reference that appears in Grounds 1, 2, 3, 4,
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`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
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`of the art, but instead was the sole prior art disclosure of disputed claim elements
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`14
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`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
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`to exclude a reference not cited in instituted grounds).
`
`
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`Dated: January 25, 2018
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`
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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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`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 Breckenridge Pharmaceutical, Inc. was
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`served on January 25, 2018 by causing it to be sent by email to counsel for
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`Petitioner at the following email addresses:
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`Daniel R. Evans (devans@merchantgould.com)
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`Jeffrey D. Blake (jblake@merchantgould.com)
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`Melissa M. Hayworth (mhayworth@merchantgould.com)
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`Dated: January 25, 2018
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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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`1
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