`Novartis AG
`
`By:
`Nicholas N. Kallas
`NKallas@fchs.com
`ZortressAfinitorIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PAR PHARMACEUTICAL INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG,
`Patent Owner
`
`Case IPR2016-00084
`U.S. Patent 5,665,772
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`EVIDENCE SUBMITTED BY PAR PHARMACEUTICAL INC.
`WITH ITS PETITION FOR INTER PARTES REVIEW
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Novartis AG (“Novartis”)
`
`objects to the admissibility of the following exhibits filed prior to institution of the
`
`trial by Petitioner Par Pharmaceutical Inc. (“Par”) 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”
`
`means U.S. Patent No. 5,665,772. All objections under F.R.E. 802 (hearsay) apply
`
`to the extent Par relies on the exhibits identified in connection with that objection
`
`for the truth of the matters asserted therein.
`
`Novartis’s objections are as follows:
`
`Exhibit 1001
`
`Novartis objects to Exhibit 1001 under F.R.E. 802 (hearsay), 37 C.F.R §
`
`42.61(c) (hearsay), and F.R.E. 106 (completeness), as the document is incomplete
`
`because it does not contain the Certificates of Correction dated June 2, 2015 or
`
`February 9, 2016.
`
`Exhibit 1002
`
`Novartis objects to Exhibit 1002 under F.R.E. 802 (hearsay), 37 C.F.R §
`
`42.61(c) (hearsay), and F.R.E. 106 (completeness), as the document is incomplete
`
`because it does not contain the Certificate of Correction dated February 9, 2016.
`
`1
`
`
`
`Exhibit 1003
`
`Novartis objects to Exhibit 1003 under F.R.E. 802 (hearsay), F.R.E. 702
`
`(improper expert testimony), F.R.E. 703 (bases for expert opinion), and 37 C.F.R.
`
`§ 42.65 as 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.
`
`Novartis objects to Exhibit 1003 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
`
`1003 ¶¶ 21, 40-43, 53, 54, 55, 57, 58, 61, 63, 69, 71, 74, 75, 76, 78, 79, 83, 85, 86,
`
`87, 100, 103, 105, 107, 108, 109, 110, 111, 113, 114, 115, 116, 117, 118, 119, 120,
`
`122, 127, 128, 134, 139, 140, 142, 146, 149, 150, 151, 152, 165, 168, 169, 174,
`
`179, 182, 198, and 200 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 1003 ¶¶ 56, 57, 77, 89, 108, 115, 125, 129, 141, and 179 cite
`
`to entire articles, book chapters or other references without identifying which
`
`aspects of those references are relied upon. Novartis also objects to Exhibit 1003
`
`¶¶ 107-111, 114-120, 174-79, and 182 under F.R.E. 702 and 37 C.F.R. § 42.65 as
`
`those paragraphs rely on software without identifying, disclosing, or providing the
`2
`
`
`
`underlying data and software used; without providing or disclosing how the
`
`software and underlying data was used to generate the opinions provided in these
`
`paragraphs; without providing or disclosing how the underlying data was obtained
`
`or generated; or without identifying whether the software used was publicly
`
`available as of the priority date of the ’772 Patent.
`
`Novartis also objects to Exhibit 1003 ¶¶ 10, 11, 14, 20, 31, 40, 41, 42, 43,
`
`48, 56, 57, 58, 75, 78, 83, 85, 86, 87, 89, 99, 115, 116, 117, 118, 119, 129, 136,
`
`139, 140, 142, 149, 153, 174, and 182 under F.R.E. 402 (relevance) and F.R.E. 403
`
`(confusing, waste of time), as these paragraphs are not cited in Par’s Petition.
`
`Novartis also objects to Exhibit 1003 ¶¶ 113-120 and 173-204 under FRE 402
`
`(relevance) and FRE 403 (confusing, waste of time) as these paragraphs are cited
`
`in Par’s Petition only with respect to grounds for which inter partes review was not
`
`authorized.
`
`Novartis also objects to Exhibit 1003 ¶¶ 10, 11, 19, 40, 41, 42, 43, 53, 54,
`
`56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82,
`
`83, 84, 86, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 102, 103, 104, 105,
`
`106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121,
`
`122, 123, 125, 126, 128, 129, 132, 133, 134, 135, 138, 139, 141, 143, 144, 146,
`
`147, 148, 149, 153, 156, 166, 167, 168, 169, 170, 171, 174, 175, 176, 177, 179,
`
`180, 182, 183, 185, 198, 199, 200, 201, 202, and 203 under F.R.E. 702 (improper
`3
`
`
`
`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, needlessly presenting
`
`cumulative evidence), 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 of document upon which a person of ordinary skill in the art at the time of
`
`invention would rely.
`
`Novartis also objects to Exhibit 1003 ¶¶ 53, 54, 57, 64, 65, 68, 72, 73, 74,
`
`75, 76, 89, 92, 97, 98, 99, 100, 125, 126, 131, 132, 133, 134, 138, 139, 140, 146,
`
`150, 153, 156, 165, 166, 167, 169, 170, 171, 180, 183, 197, 198, 199, 201, 202,
`
`and 203 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 declarant is not stated to have expertise with respect to pharmacology,
`
`immunosuppression, or transplant rejection.
`
`Novartis also objects to Exhibit 1003 ¶¶ 40-43 under F.R.E. 602 (lack of
`
`personal knowledge), F.R.E. 702 (improper expert testimony), F.R.E. 703 (bases of
`
`an expert opinion), F.R.E. 402 (relevance) and F.R.E. 403 (confusing, waste of
`
`time), as the declarant is testifying regarding factual matters for which he does not
`
`have personal knowledge.
`
`4
`
`
`
`Exhibit 1004
`
`Novartis objects to Exhibit 1004 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Exhibit 1005
`
`Novartis objects to Exhibit 1005 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and 37 C.F.R. §§ 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`Exhibit 1006
`
`Novartis objects to Exhibit 1006 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and 37 C.F.R. §§ 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`Exhibit 1007
`
`Novartis objects to Exhibit 1007 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1007 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), F.R.E. 702 (improper expert testimony), and F.R.E. 703 (bases of an
`
`expert opinion), because it is not relevant to any issue in this IPR proceeding, and
`
`is not the type of document upon which a person of ordinary skill in the art at the
`
`time of invention would rely.
`
`5
`
`
`
`Exhibit 1008
`
`Novartis objects to Exhibit 1008 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1003 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), and F.R.E. 106 (completeness), as the document is incomplete and
`
`includes only a select portion of a larger document that in fairness ought to be
`
`considered in connection with Exhibit 1008.
`
`Exhibit 1009
`
`Novartis objects to Exhibit 1009 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and 37 C.F.R. §§ 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`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), and 37 C.F.R. §§ 42.104(b)(5)
`
`(failure to identify specific portions of evidence).
`
`Exhibit 1011
`
`Novartis objects to Exhibit 1011 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), F.R.E. 403 (confusing, waste of time), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`and Par has failed to identify which aspects of the document are relied upon.
`
`6
`
`
`
`Exhibit 1012
`
`Novartis objects to Exhibit 1012 under F.R.E. 802 (hearsay), F.R.E. 402
`
`(relevance), and F.R.E. 403 (confusing, waste of time).
`
`Exhibit 1013
`
`Novartis objects to Exhibit 1013 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1013 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), F.R.E. 702 (improper expert testimony), and F.R.E. 703 (bases of an
`
`expert opinion), because it is not relevant to any issue in this IPR proceeding, and
`
`is not the type of document upon which a person of ordinary skill in the art at the
`
`time of invention would rely.
`
`Exhibit 1014
`
`Novartis objects to Exhibit 1014 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1014 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), F.R.E. 702 (improper expert testimony), and F.R.E. 703 (bases of an
`
`expert opinion), as the document was not published until December 1992, after the
`
`October 9, 1992 priority date of the ’772 Patent, it is not relevant to any issue in
`
`this IPR proceeding, and is not the type of document upon which a person of
`
`ordinary skill in the art at the time of invention would rely.
`
`7
`
`
`
`Exhibit 1015
`
`Novartis objects to Exhibit 1015 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1015 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), F.R.E. 702 (improper expert testimony), and F.R.E. 703 (bases of an
`
`expert opinion), because it is not relevant to any issue in this IPR proceeding, and
`
`is not the type of document upon which a person of ordinary skill in the art at the
`
`time of invention would rely.
`
`Novartis also objects to Exhibit 1015 under F.R.E. 106 (completeness), as
`
`the document is incomplete and includes only a select portion of a larger document
`
`that in fairness ought to be considered in connection with Exhibit 1015. Novartis
`
`also objects to Exhibit 1015 as improperly labeled and produced under 37 C.F.R §
`
`42.63, as the copy provided appears to have markings that do not appear in the
`
`original document.
`
`Exhibit 1016
`
`Novartis objects to Exhibit 1016 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1016 under 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), and 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 42.105, as the
`
`document is not cited in Par’s Petition, Par has failed to identify which aspects of
`
`the document are relied upon, it is not relevant to any issue in this IPR proceeding,
`8
`
`
`
`and it is not the type of document upon which a person of ordinary skill in the art
`
`at the time of invention would rely.
`
`Exhibit 1017
`
`Novartis objects to Exhibit 1017 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1017 under 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), and 37 C.F.R. §§ 42.22(a)(2), 42.104(b)(2) and (b)(5), and 42.105, as the
`
`document is not cited in Par’s Petition, Par has failed to identify which aspects of
`
`the document are relied upon, it is not relevant to any issue in this IPR proceeding,
`
`and it is not the type of document upon which a person of ordinary skill in the art
`
`at the time of invention would rely.
`
`Exhibit 1018
`
`Novartis objects to Exhibit 1018 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1018 under F.R.E. 402 (relevance) F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document was not published until
`
`November 1993, after the October 9, 1992 priority date of the ’772 Patent, the
`
`document is not cited in Par’s Petition, Par has failed to identify which aspects of
`
`the document are relied upon, it is not relevant to any issue in this IPR proceeding,
`9
`
`
`
`and it is not the type of document upon which a person of ordinary skill in the art
`
`at the time of invention would rely.
`
`Exhibit 1019
`
`Novartis objects to Exhibit 1019 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1019 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document was not published until 1998,
`
`after the October 9, 1992 priority date of the ’772 Patent, the document is not cited
`
`in Par’s Petition, Par has failed to identify which aspects of the document are relied
`
`upon, it is not relevant to any issue in this IPR proceeding, and it is not the type of
`
`document upon which a person of ordinary skill in the art at the time of invention
`
`would rely.
`
`Exhibit 1020
`
`Novartis objects to Exhibit 1020 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1020 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document was not published until 1999,
`
`after the October 9, 1992 priority date of the ’772 Patent, the document is not cited
`10
`
`
`
`in Par’s Petition, Par has failed to identify which aspects of the document are relied
`
`upon, it is not relevant to any issue in this IPR proceeding, and it is not the type of
`
`document upon which a person of ordinary skill in the art at the time of invention
`
`would rely.
`
`Exhibit 1021
`
`Novartis objects to Exhibit 1021 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1021 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Exhibit 1022
`
`Novartis objects to Exhibit 1022 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1022 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`11
`
`
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Exhibit 1023
`
`Novartis objects to Exhibit 1023 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1023 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Exhibit 1024
`
`Novartis objects to Exhibit 1024 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1024 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. § 42.104(b)(5),
`
`as Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`12
`
`
`
`Exhibit 1025
`
`Novartis objects to Exhibit 1025 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1025 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Exhibit 1026
`
`Novartis objects to Exhibit 1026 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1026 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`13
`
`
`
`Exhibit 1027
`
`Novartis objects to Exhibit 1027 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1027 under F.R.E. 402 (relevance) F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`Exhibit 1028
`
`Novartis objects to Exhibit 1028 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1028 under F.R.E. 402 (relevance) F.R.E. 403 (confusing, waste
`
`of time, needlessly presenting cumulative evidence), F.R.E. 702 (improper expert
`
`testimony), F.R.E. 703 (bases of an expert opinion), and 37 C.F.R. §§ 42.22(a)(2),
`
`42.104(b)(2) and (b)(5), and 42.105, as the document is not cited in Par’s Petition,
`
`Par has failed to identify which aspects of the document are relied upon, it is not
`
`relevant to any issue in this IPR proceeding, and it is not the type of document
`
`upon which a person of ordinary skill in the art at the time of invention would rely.
`
`14
`
`
`
`Exhibit 1029
`
`Novartis objects to Exhibit 1029 under F.R.E. 802 (hearsay). Novartis also
`
`objects to Exhibit 1029 under F.R.E. 402 (relevance), F.R.E. 403 (confusing, waste
`
`of time), and 37 C.F.R. § 42.104(b)(5), as Par has failed to identify which aspects
`
`of the document are relied upon.
`
`Dated: May 13, 2016
`
`Respectfully submitted,
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 32,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`15
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Objections Under 37
`
`C.F.R. § 42.64 To Evidence Submitted By Par Pharmaceutical Inc. With Its
`
`Petition For Inter Partes Review was served on May 13, 2016 by causing it to be
`
`sent by email to counsel for Par at the following email addresses:
`
`Daniel G. Brown (daniel.brown@lw.com)
`
`Robert Steinberg (bob.steinberg@lw.com)
`
`Dated: May 13, 2016
`
`/Nicholas N. Kallas/
`Nicholas N. Kallas
`Registration No. 32,530
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`16