Paper No. ____
`Date Filed: May 29, 2015
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-005491 (U.S. Patent No. 6,316,023)
`Inter Partes Review No. 2014-005502 (U.S. Patent No. 6,335,031)3
`
`PATENT OWNERS’ OBJECTIONS TO
`PETITIONERS’ DEMONSTRATIVE EXHIBITS
`
`1 Case IPR2015-00265 has been joined with this proceeding.
`2 Case IPR2015-00268 has been joined with this proceeding.
`3 Patent Owners attest that the word-for-word identical paper is filed in each
`proceeding identified in the heading.
`
`
`Date Filed: May 29, 2015
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-005491 (U.S. Patent No. 6,316,023)
`Inter Partes Review No. 2014-005502 (U.S. Patent No. 6,335,031)3
`
`PATENT OWNERS’ OBJECTIONS TO
`PETITIONERS’ DEMONSTRATIVE EXHIBITS
`
`1 Case IPR2015-00265 has been joined with this proceeding.
`2 Case IPR2015-00268 has been joined with this proceeding.
`3 Patent Owners attest that the word-for-word identical paper is filed in each
`proceeding identified in the heading.
`
`
`
`As authorized by the Board’s Order for a Consolidated Oral Hearing (Paper
`
`56) and pursuant to 37 C.F.R. § 42.70(a), Patent Owners object to Petitioners’
`
`demonstrative exhibits on the grounds set forth below.
`
`In the Order for a Consolidated Oral Hearing (Paper 56), the Board directed
`
`the parties to “St. Jude Medical, Cardiology Division, Inc. v. The Board of Regents
`
`of the University of Michigan, IPR2013-00041 (PTAB January 27, 2014) (Paper
`
`65), for guidance regarding the appropriate content of demonstrative exhibits.” St.
`
`Jude Medical states that “[a]rguments that have not been made previously cannot
`
`be made at the trial hearing, and thus, cannot be in a demonstrative exhibit.” St.
`
`Jude Med., IPR2013-00041, Paper 65 at 3; see also 77 Fed. Reg. 48,756, 48,768
`
`(Aug. 14, 2012) (“No new evidence or arguments may be presented at the oral
`
`argument.”).4 Demonstrative exhibits further cannot “rely on evidence that,
`
`although it is in the record, was never specifically discussed in any paper before
`
`4 The Office Patent Trial Practice Guide further states that a response to
`
`observations on cross-examination “is not an opportunity to raise new issues.” 77
`
`Fed. Reg. at 48,768. Thus, to the extent Petitioners have raised new issues in
`
`response to Patent Owners’ observations on cross-examination not raised in the
`
`Petition for Inter Partes Review (Paper 1) (“Petition”) or Petitioner’s Reply (Paper
`
`31) (“Reply”), Petitioners should not be permitted to raise those issues at the oral
`
`argument.
`
`1
`
`
`
`the Board.” St. Jude Med., IPR2013-00041, Paper 65 at 2-3. Demonstrative
`
`exhibits thus should identify “how [] arguments were previously presented to the
`
`Board.” Id. at 4. Because as set forth below, Petitioners’ demonstrative exhibit
`
`slides 7, 8, 13, 17, 19, 28, 30, 32, 34-36, 39, 40, 43, 44, 46, 47, 53 and 55 fail to
`
`comply with these rules, the Board should exercise its discretion not to allow
`
`presentation of such demonstrative exhibits. See CBS Interactive Inc. v. Helferich
`
`Patent Licensing, LLC, IPR2013-00033, Paper 118 at 5 (PTAB Oct. 23, 2013) (“In
`
`light of the number of the non-compliant slides involved, and the inefficiencies of
`
`sorting through all of the slides, one by one, the Board exercised discretion to not
`
`allow presentation of any [slides].”).
`
`I.
`
`Petitioners’ Demonstrative Exhibits
`Improperly Include New Evidence And New Arguments
`
`Slide 7: Petitioners improperly cite Ex. 1011 ¶ 11 and Ex. 1031 ¶¶ 13-14 not
`
`previously cited or discussed in the Petition or Reply as support for Slide 7 and
`
`thus Slide 7 improperly raises new evidence.
`
`Slide 8: Petitioners improperly cite Ex. 1032 ¶¶ 37-40 and 60-64 not
`
`previously cited or discussed in the Petition or Reply as support for Slide 8 and
`
`improperly raise a new argument based on Ebert in the third bullet not previously
`
`made in the Petition or Reply and thus Slide 8 improperly raises new evidence and
`
`new argument.
`
`2
`
`
`
`Slide 13: Petitioners improperly reproduce an excerpt from Ex. 1038, an
`
`exhibit not previously cited or discussed in the Petition or Reply, and improperly
`
`cite Ex. 1031 ¶ 14 and Ex. 1038 at 6 as support for Slide 13 and thus Slide 13
`
`improperly raises new evidence and new argument.
`
`Slide 17: Petitioners improperly cite Ex. 1011 ¶ 47 not previously cited or
`
`discussed in the Petition or Reply as support for Slide 17 and thus Slide 17
`
`improperly raises new evidence.
`
`Slide 19: Petitioners improperly cite Ex. 1032 ¶ 21 not previously cited or
`
`discussed in the Petition or Reply as support for Slide 19 and thus Slide 19
`
`improperly raises new evidence.
`
`Slide 28: Petitioners improperly raise a new argument in the third bullet not
`
`previously made in the Petition or Reply that a POSA’s “reasonable expectation is
`
`confirmed by structurally similar compounds” because in their papers, Petitioners
`
`previously have only relied on one compound, nicotine, that is allegedly
`
`structurally similar to rivastigmine.
`
`Slide 30: Petitioners improperly cite Ex. 1010 ¶¶ 33-35 not previously cited
`
`or discussed in the Petition or Reply as support for Slide 30 and thus Slide 30
`
`improperly raises new evidence.
`
`3
`
`
`
`Slide 32: Petitioners improperly cite Ex. 1025 at 180:13-183:6 and Ex. 1026
`
`at 513:1-516:14 not previously cited or discussed in the Petition or Reply as
`
`support for Slide 32 and thus Slide 32 improperly raises new evidence.
`
`Slide 34: Petitioners improperly cite Ex. 1031 ¶ 40 not previously cited or
`
`discussed in the Petition or Reply as support for Slide 34 and thus Slide 34
`
`improperly raises new evidence.
`
`Slide 35: Petitioners improperly raise a new argument in the fifth bullet of
`
`Slide 35 not previously made in the Petition or Reply.
`
`Slide 36: Petitioners improperly cite Ex. 1031 ¶¶ 40 and 50-53 not
`
`previously cited or discussed in the Petition or Reply as support for Slide 36 and
`
`improperly raise new arguments in the first and third bullets not previously made
`
`in the Petition or Reply and thus Slide 36 improperly raises new evidence and new
`
`argument.
`
`Slide 39: Petitioners improperly reproduce an excerpt from Ex. 2046, an
`
`exhibit not previously cited or discussed in the Petition or Reply, in Slide 39, and
`
`thus Slide 39 improperly raises new evidence and any argument Petitioners intend
`
`to make concerning Ex. 2046 improperly raises a new argument.
`
`Slide 40: Petitioners improperly cite Ex. 2046, an exhibit not previously
`
`cited or discussed in the Petition or Reply, in Slide 40, and thus Slide 40
`
`4
`
`
`
`improperly raises new evidence and any argument Petitioners intend to make
`
`concerning Ex. 2046 improperly raises a new argument.
`
`Slide 43: Petitioners improperly cite Ex. 1010 ¶¶ 37 and 39 not previously
`
`cited or discussed in the Petition or Reply as support for Slide 43 and improperly
`
`raise a new argument in the third bullet not previously made in the Petition or
`
`Reply that Ebert discloses “[a]ntioxidant use is a solution to oxidative degradation
`
`in a transdermal patch” because Petitioners previously argued only that Ebert
`
`teaches that “oxidation during manufacturing may be further reduced by adding
`
`an antioxidant” (Paper 1 at 15-16 (emphasis added)), and thus Slide 43 improperly
`
`raises new evidence and new argument.
`
`Slide 44: Petitioners improperly raise new arguments in both bullets in Slide
`
`44 not previously made in the Petition or Reply.
`
`Slide 46: Petitioners improperly cite Ex. 1010 ¶ 41, Ex. 1031 ¶ 79, and Ex.
`
`1025 at 160:8-166:1, 189:12-193:1 and 198:14-199:18 not previously cited or
`
`discussed in the Petition or Reply as support for Slide 46 and thus Slide 46
`
`improperly raises new evidence.
`
`Slide 47: Petitioners improperly cite Ex. 1025 at 199:19-200:10 not
`
`previously cited or discussed in the Petition or Reply as support for Slide 47 and
`
`thus Slide 47 improperly raises new evidence.
`
`5
`
`
`
`Slide 53: Petitioners improperly cite Ex. 1010 ¶ 35, Ex. 1011 ¶ 51, and Ex.
`
`1031 ¶¶ 40 and 88 not previously cited or discussed in the Petition or Reply as
`
`support for Slide 53 and thus Slide 53 improperly raises new evidence.
`
`Slide 55: Petitioners improperly cite Ex. 1031 ¶ 46, Ex. 2026, Ex. 2027 and
`
`Ex. 2036 not previously cited or discussed in the Petition or Reply as support for
`
`Slide 55 and improperly raise a new argument in the second bullet and the
`
`subsequent sub-bullets not previously made in the Petition or Reply, and thus Slide
`
`55 improperly raises new evidence and new argument.
`
`Dated: May 29, 2015
`
`Respectfully submitted,
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNERS’ OBJECTIONS
`
`TO PETITIONERS’ DEMONSTRATIVE EXHIBITS was served on May 29,
`
`2015 by causing it to be sent by email to counsel for Petitioners at the following
`
`email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Joseph M. Reisman (BoxMylan2@knobbe.com)
`
`Jay R. Deshmukh (BoxMylan2@knobbe.com)
`
`William R. Zimmerman (BoxMylan@knobbe.com)
`
`Dated: May 29, 2015
`
`/s/ Raymond R. Mandra
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`7
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