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