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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`APOTEX INC. and APOTEX CORP.,
`Petitioners,
` v.
`NOVARTIS AG,
`Patent Owner.
`______________________
`Case IPR2017-00854
`U.S. Patent No. 9,187,405
`______________________
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64(B)(1) TO
`EXHIBITS SUBMITTED IN THE PRE-TRIAL PHASE FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 9,187,405
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Novartis AG (“Patent Owner”) objects
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`to the admissibility of the below-referenced exhibits submitted by Petitioners Apotex
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`Inc. and Apotex Corp. (“Petitioners”) in their Petition for Inter Partes Review of
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`U.S. Patent No. 9,187,405.
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`Patent Owner’s objections to the admissibility of exhibits submitted with the
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`Petition are made in accordance with the Federal Rules of Evidence (“FRE”). Patent
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`Owner’s objections are also made pursuant to the Code of Federal Regulations
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`(“C.F.R.”) governing this proceeding, including without limitation 37 C.F.R. §§
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`42.61-42.65 and § 42.6(a)(3).
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`Patent Owner notes that Argentum Pharmaceuticals LLC (“Argentum”) has
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`filed an unopposed motion to join this IPR. Argentum Pharm. LLC v. Novartis A.G.,
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`Case IPR2017-01550 (Mot. Join June 9, 2017) (Paper 3). Argentum’s exhibits are
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`identical to those filed by Petitioners, except for the addition of one exhibit, Exhibit
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`1041. As of today, the Board has not yet ruled on the motion for joinder submitted
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`by Argentum. In the event the Board grants the motion for joinder, the objections
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`below apply equally to Argentum and additionally, Patent Owner has included
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`herein its objections to Argentum’s additional exhibit.
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`I.
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`OBJECTIONS TO PETITIONER’S EXHIBITS
`A. Exhibit 1002
`Patent Owner objects to the admissibility of Exhibit 1002, particularly those
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`portions related to references and pieces of art that post-date the filing of the ‘405
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`patent (e.g. Ex. 1002 ¶¶ 99–100, 144–46, 148), which lack relevance to any issue
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`in this case. FRE 402.
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`In addition, Patent Owner objects that at least part of Exhibit 1002 is beyond
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`the declarant’s “knowledge, skill, experience, training or education” and “based on
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`insufficient facts or data,” and is therefore improper expert evidence (e.g. id. ¶¶
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`113, 116–19, 139–40, 148). Exhibit 1002 is also based on legally erroneous claim
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`construction, including without limitation erroneous interpretations of “a subject in
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`need” and recited “A method for . . .” preambles (e.g. id. ¶¶43–47). FRE 702, 703.
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`Furthermore, Patent Owner objects to the admissibility of Exhibit 1002 to
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`the extent it was not cited in the Petition, as uncited evidence may not be
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`incorporated by reference (e.g. id. ¶¶ 5–14, 16–18, 22–26, 31–38, 42, 48, 73, 89,
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`93, 96, 99, 101–103, 130). 37 C.F.R. §42.6(a)(3).
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`B.
`Exhibit 1003
`Patent Owner objects to the admissibility of Exhibit 1003 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1003 because it lacks
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`relevance to any issue in this case. FRE 402.
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`C. Exhibit 1004
`Patent Owner objects to the admissibility of Exhibit 1004 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`D. Exhibit 1005
`Patent Owner objects to the admissibility of Exhibit 1005 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`E.
`Exhibit 1006
`Patent Owner objects to the admissibility of Exhibit 1006 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`F.
`Exhibit 1007
`Patent Owner objects to the admissibility of Exhibit 1007 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`G. Exhibit 1008
`Patent Owner objects to the admissibility of Exhibit 1008 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`H. Exhibit 1009
`Patent Owner objects to the admissibility of Exhibit 1009 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`I.
`Exhibit 1010
`Patent Owner objects to the admissibility of Exhibit 1010 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`J.
`Exhibit 1011
`Patent Owner objects to the admissibility of Exhibit 1011 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`K. Exhibit 1012
`Patent Owner objects to the admissibility of Exhibit 1012 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`L.
`Exhibit 1013
`Patent Owner objects to the admissibility of Exhibit 1013 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1013 because it lacks
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`relevance to any issue in this case. FRE 402.
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`M. Exhibit 1014
`Patent Owner objects to the admissibility of Exhibit 1014 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`N. Exhibit 1015
`Patent Owner objects to the admissibility of Exhibit 1015 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1015 because it lacks
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`relevance to any issue in this case. FRE 402.
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`O. Exhibit 1016
`Patent Owner objects to the admissibility of Exhibit 1016 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`P.
`Exhibit 1017
`Patent Owner objects to the admissibility of Exhibit 1017 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Q. Exhibit 1018
`Patent Owner objects to the admissibility of Exhibit 1018 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`R. Exhibit 1019
`Patent Owner objects to the admissibility of Exhibit 1019 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`S.
`Exhibit 1020
`Patent Owner objects to the admissibility of Exhibit 1020 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`T.
`Exhibit 1021
`Patent Owner objects to the admissibility of Exhibit 1021 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1021. FRE 901, 902.
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`Exhibit 1021 is incomplete, and Patent Owner objects to the extent that
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`portions excluded by excerpt “in fairness ought to be considered at the same time.”
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`FRE 106.
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`U. Exhibit 1022
`Patent Owner objects to the admissibility of Exhibit 1022 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`V. Exhibit 1023
`Patent Owner objects to the admissibility of Exhibit 1023 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1023. FRE 901, 902.
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`Exhibit 1023 is incomplete, and Patent Owner objects to the extent that
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`portions excluded by excerpt “in fairness ought to be considered at the same time.”
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`FRE 106.
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`W. Exhibit 1024
`Patent Owner objects to the admissibility of Exhibit 1024 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`X. Exhibit 1025
`Patent Owner objects to the admissibility of Exhibit 1025 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Y. Exhibit 1026
`Patent Owner objects to the admissibility of Exhibit 1026 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Z.
`Exhibit 1027
`Patent Owner objects to the admissibility of Exhibit 1027 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`AA. Exhibit 1028
`Patent Owner objects to the admissibility of Exhibit 1028 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`BB. Exhibit 1029
`Patent Owner objects to the admissibility of Exhibit 1029 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`CC. Exhibit 1030
`Patent Owner objects to the admissibility of Exhibit 1030 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`DD. Exhibit 1031
`Patent Owner objects to the admissibility of Exhibit 1031 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`EE. Exhibit 1032
`Patent Owner objects to the admissibility of Exhibit 1032 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1032 because it lacks
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`relevance to any issue in this case. FRE 402.
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`Any probative value of Exhibit 1032 is outweighed by the dangers of
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`prejudice to Patent Owner and waste of time. FRE 403.
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`FF. Exhibit 1033
`Patent Owner objects to the admissibility of Exhibit 1033 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1033. FRE 901, 902.
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`Exhibit 1033 is incomplete, and Patent Owner objects to the extent that
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`portions excluded by excerpt “in fairness ought to be considered at the same time.”
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`FRE 106.
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`GG. Exhibit 1034
`Patent Owner objects to the admissibility of Exhibit 1034 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1034. FRE 901, 902.
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`Exhibit 1034 is incomplete, and Patent Owner objects to the extent that
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`portions excluded by excerpt “in fairness ought to be considered at the same time.”
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`FRE 106.
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`HH. Exhibit 1035
`Patent Owner objects to the admissibility of Exhibit 1035 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1035 because it lacks
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`relevance to any issue in this case. FRE 402.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1035. FRE 901, 902.
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`II. Exhibit 1036
`Patent Owner objects to the admissibility of Exhibit 1036 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1036 because it lacks
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`relevance to any issue in this case. FRE 402.
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`In addition, Patent Owner objects that Petitioner has not proffered evidence
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`authenticating Exhibit 1036. FRE 901, 902.
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`JJ. Exhibit 1037
`Patent Owner objects to the admissibility of Exhibit 1037 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1037 because it lacks
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`relevance to any issue in this case. FRE 402.
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`KK. Exhibit 1038
`Patent Owner objects to the admissibility of Exhibit 1038 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1038 because it lacks
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`relevance to any issue in this case. FRE 402.
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`LL. Exhibit 1039
`Patent Owner objects to the admissibility of Exhibit 1039 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Furthermore, Patent Owner objects to the admissibility of Exhibit 1039
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`because it was not cited in Petitioner’s Petition for Inter Partes Review, and
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`uncited evidence may not be incorporated by reference. 37 C.F.R. 42.6(a)(3).
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`MM. Exhibit 1040
`Patent Owner objects to the admissibility of Exhibit 1040 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`NN. Exhibit 1041
`Patent Owner objects to the admissibility of Exhibit 1041 because it contains
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`inadmissible hearsay to the extent its contents are offered for the truth of any matter
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`asserted therein. FRE 802.
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`Patent Owner also objects to the admissibility of Exhibit 1041 because it lacks
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`relevance to any issue in this case. FRE 402.
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`Any probative value of Exhibit 1041 is outweighed by the dangers of
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`prejudice to Patent Owner and waste of time. FRE 403.
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`
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`Dated: August 1, 2017
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`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
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`12
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 4.26, I hereby certify that on August 1, 2017, a true
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`and accurate copy of PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. §
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`42.64(B)(1) TO EXHIBITS SUBMITTED IN THE PRE-TRIAL PHASE FOR
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`INTER PARTES REVIEW OF U.S. PATENT NO. 9,187,405 was served via
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`electronic mail by agreement of the parties, on the following counsel of record for
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`Petitioner and Argentum:
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`For Petitioner:
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`For Argentum:
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`Dated: August 1, 2017
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`
`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad. A. Mills: jmills@wsgr.com
`
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
`
`
`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyelling@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`
`
`
`
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