`
`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. 2014-005501
`
`U.S. Patent 6,335,031
`
`PATENT OWNERS’ REQUEST FOR
`ORAL ARGUMENT PURSUANT TO 37 C.F.R. § 42.70(a)
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`
`
`Pursuant to the October 14, 2014 Scheduling Order (Paper 11) in this
`
`proceeding and 37 C.F.R. § 42.70(a), Patent Owners Novartis AG and LTS
`
`Lohmann Therapie-Systeme AG request that the Patent Trial and Appeal Board
`
`hear oral argument on the issues set forth below.
`
`There are currently two pending IPR proceedings between the parties, both
`
`of which are scheduled for oral argument on June 2, 2015. The two proceedings
`
`are:
`
`-
`
`-
`
`IPR2014-005492 (U.S. Patent No. 6,316,023); and
`
`IPR2014-005503 (U.S. Patent No. 6,335,031).
`
`The two patents are within the same patent family. Due to related issues in these
`
`cases, Patent Owners respectfully request that the Board allow for a single oral
`
`argument for the two above-cited cases. If the Board permits such consolidation
`
`for the purpose of oral argument, Patent Owners respectfully request 60 minutes of
`
`argument time.
`
`Pursuant to 37 C.F.R. § 42.70(a), Patent Owners specify the following issues
`
`to be argued in regards to the two cases, without intent to waive consideration of
`
`any issue not requested:
`
`(1) Petitioners’ failure to meet their burden of establishing obviousness of
`
`2 Case IPR2015-00265 has been joined with this proceeding.
`3 Case IPR2015-00268 has been joined with this proceeding.
`1
`
`
`
`the claims under any of the instituted Grounds, particularly where:
`
`(a) None of Enz, the Handbook, Rosin, Elmalem, Ebert, or Sasaki,
`
`alone or in combination, taught or reasonably suggested to the POSA that
`
`rivastigmine oxidatively degrades under pharmaceutically relevant
`
`conditions,
`
`(b) A POSA would not reasonably have predicted from rivastigmine’s
`
`structure that rivastigmine would oxidatively degrade under
`
`pharmaceutically relevant conditions, and
`
`(c) Thus, the problem of rivastigmine’s oxidative degradation under
`
`pharmaceutically relevant conditions was unknown as of 1998 and
`
`(d) There was no motivation for a POSA to combine rivastigmine
`
`with an antioxidant in a pharmaceutical composition because the art as of
`
`1998 taught a POSA not to include an antioxidant in a pharmaceutical
`
`formulation unless one was required.
`
`(2) The absence of expert testimony or references supporting many of the
`
`arguments advanced in Petitioners’ Reply (Paper 31) and Reply Declarations (Exs.
`
`1031-1032).
`
`(3) The relevance of any art dated after the January 1998 priority date of
`
`claims 1-3, 7, and 15-18 of the ’031 Patent.
`
`2
`
`
`
`(4) Any other issues raised by Petitioners in a request for oral argument (if
`
`any), in a motion to exclude (if any), or in any other motion or paper filed by
`
`Petitioner before oral argument.
`
`(5) Any other issues that the Board deems necessary for issuing a final
`
`written decision.
`
`Petitioners request the ability to use audio-visual equipment to display
`
`demonstrative exhibits, including the use of a projector and screen for PowerPoint
`
`display.
`
`Dated: April 28, 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
`Tel. 212-218-2100
`
`3
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNERS’ REQUEST FOR
`
`ORAL ARGUMENT PURSUANT TO 37 C.F.R. § 42.70(a) was served on April
`
`28, 2015 by causing them 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: April 28, 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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