Paper No. ___
`Date Filed: March 31, 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.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`Inter Partes Review No.: 2014-00550
`U.S. Patent No. 6,335,031
`
`PATENT OWNERS’ UNOPPOSED MOTION FOR ENTRY OF
`STIPULATED PROTECTIVE ORDER AND TO SEAL EXHIBITS 1033-
`1036 AND PORTIONS OF PETITIONER’S REPLY PETITION AND
`EXHIBIT 1031
`
`
`Date Filed: March 31, 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.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`_________________________________
`
`Inter Partes Review No.: 2014-00550
`U.S. Patent No. 6,335,031
`
`PATENT OWNERS’ UNOPPOSED MOTION FOR ENTRY OF
`STIPULATED PROTECTIVE ORDER AND TO SEAL EXHIBITS 1033-
`1036 AND PORTIONS OF PETITIONER’S REPLY PETITION AND
`EXHIBIT 1031
`
`
`
`Pursuant to the Office Patent Trial Practice Guide (Federal Register, Vol. 77,
`
`No. 157, Aug. 14, 2012) and 37 C.F.R. § 42.54, Patent Owners, Novartis AG and
`
`LTS Lohmann Therapie-Systeme AG, respectfully submit this motion for entry of
`
`a stipulated protective order and to seal Exhibits 1033, 1034, 1035, and 1036,
`
`which contain Patent Owners’ confidential information. In addition, Patent
`
`Owners move to seal the portions of Petitioner’s Reply Petition and accompanying
`
`declaration of Agis Kydonieus, Ph.D. (Exhibit 1031) containing substantive
`
`reference to the above exhibits.
`
`On February 18, 2015, Petitioner provided Patent Owners with a detailed
`
`description of four confidential documents that are subject to the protections of the
`
`Stipulated Protective Order entered in the concurrent district court litigation,
`
`Novartis Pharm. Corp. et al. v. Noven Pharmaceuticals, Inc., D. Del. No. 13-CV-
`
`527 (RGA), which Petitioner stated that it intended to use in its Reply Petition. On
`
`February 20, 2015, Patent Owners notified Petitioner that they consented to
`
`Petitioner’s use of the cited materials in the manner described provided that the
`
`parties agree to the entry of a protective order in this proceeding. Thereafter, the
`
`parties conferred on scope of a protective order. By email dated March 13, 2015,
`
`Petitioner confirmed that it would not object to Patent Owners’ motion for entry of
`
`the stipulated Protective Order or to Patent Owners’ motion to seal.
`
`1
`
`
`
`I.
`
`Motion For Entry Of A Stipulated Protective Order
`
`Patent Owners move for entry of a Stipulated Protective Order, which is a
`
`slightly amended version of the Default Protective Order provided in Appendix B
`
`of the Trial Practice Guide, 77 FED. REG. 48756, 48771 (Aug. 14, 2012). A
`
`redlined version of the Default Protective Order showing where modifications have
`
`been made is attached hereto as Exhibit 2055. Patent Owners certify pursuant to
`
`37 C.F.R. § 42.54 that they have conferred with Petitioner and have reached
`
`agreement regarding the scope of the proposed Stipulated Protective Order.
`
`Attached as Exhibit 2056 is a signed Stipulated Protective Order to which the
`
`parties agree to be bound in this matter.
`
`In particular, provision 2(A) of the Default Protective Order has been
`
`removed, as no individual natural person is either a Patent Owner or Petitioner in
`
`this proceeding. Also, to avoid the possibility of disclosure of designated
`
`protective order material to employees of the non-designating party, the parties
`
`have agreed to remove provision 2(A). Further, the parties have agreed to identify
`
`by name specific in-house counsel in provision 2(C). This last modification is
`
`consistent with paragraph 6 of the Stipulated Protective Order entered by the
`
`district court in the concurrent litigation. For the Board’s reference, attached as
`
`Exhibit 2057 is the Stipulated Protective Order entered in the district court
`
`proceeding.
`
`2
`
`
`
`II. Motion to Seal
`
`The Patent Trial Practice Guide provides that “[t]he rules aim to strike a
`
`balance between the public’s interest in maintaining a complete and
`
`understandable file history and the parties’ interest in protecting truly sensitive
`
`information.” 77 FED. REG. 48756, 48760 (Aug. 14, 2012). “The rules identify
`
`confidential information in a manner consistent with Federal Rule of Civil
`
`Procedure 26(c)(1)(G), which provides for protective orders for trade secret or
`
`other confidential research, development, or commercial information.” Id.
`
`Patent Owners identify Exhibits 1033, 1034, 1035, and 1036 as containing
`
`sensitive confidential research and development information, including Patent
`
`Owners’ proprietary, internal test methods and test data for rivastigmine
`
`transdermal formulations. Although the documents at issue contain some subject
`
`matter that is similar to that contained in Exhibits 2015, 2032 and 2053, the
`
`substance is in fact different and unlike those documents, the exhibits at issue here
`
`were not entered as trial exhibits in the trial of Novartis Pharm. Corp. et al. v.
`
`Watson Labs., Inc. et al., D. Del. No. 11-CV-1077 (consolidated) (RGA).
`
`Accordingly, Exhibits 1033, 1034, 1035, and 1036 have not previously been
`
`published or made public. Efforts to maintain the confidentiality of this
`
`information have been undertaken by the parties in the concurrent district court
`
`proceeding. As summarized below, Exhibits 1033, 1034, 1035, and 1036 contain
`
`3
`
`
`
`Patent Owners’ sensitive confidential information that Patent Owners maintain an
`
`interest in protecting:
`
`Exhibit
`
`Summary of Contents
`
`1033
`
`Internal Novartis
`
`Good Cause for Filing
`Under Seal
`Contains sensitive
`
`memorandum written by
`
`business and technical
`
`Dr. Tiemessen.
`
`research and development
`
`information, including
`
`test methods and data, and
`
`has been marked
`
`“Confidential” in the
`
`concurrent district court
`
`litigation.
`
`1034
`
`Internal Novartis e-mail
`
`Contains sensitive
`
`communication from Dr.
`
`research and development
`
`Tiemessen to O. Garinot.
`
`information and has been
`
`marked “Confidential” in
`
`the concurrent district
`
`court litigation.
`
`1035
`
`Meeting minutes of the
`
`Contains sensitive
`
`LTS-Sandoz (Novartis)
`
`business and technical
`
`4
`
`
`
`working group.
`
`research and development
`
`information, including
`
`test methods and data, and
`
`has been marked
`
`“Confidential” in the
`
`concurrent district court
`
`litigation.
`
`1036
`
`Excerpts of the
`
`Discusses and contains
`
`confidential transcript of
`
`sensitive research and
`
`the October 17-18, 2012
`
`development information
`
`deposition of Dr.
`
`and has been marked
`
`Henricus L.G.M.
`
`“Confidential” in the
`
`Tiemessen.
`
`concurrent district court
`
`litigation.
`
`In addition, Patent Owners move to seal the portions of Petitioner’s Reply
`
`Petition and accompanying declaration of Agis Kydonieus, Ph.D. (Exhibit 1031)
`
`containing substantive reference to the above exhibits. Consistent with this
`
`motion, Petitioner has confirmed that it will file sealed versions of its Reply
`
`Petition and Exhibit 1031 as well as public versions redacting substantive reference
`
`to Exhibits 1033, 1034, 1035, and 1036.
`
`5
`
`
`
`For the foregoing reasons good cause exists for sealing Exhibits 1033, 1034,
`
`1035, 1036 and for sealing those portions of Petitioner’s Reply Petition and the
`
`declaration of Agis Kydonieus, Ph.D. (Exhibit 1031) that substantively refer to the
`
`above-listed exhibits.
`
`Dated: March 31, 2015
`
`Respectfully submitted,
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA,
`HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNERS’ UNOPPOSED
`
`MOTION FOR ENTRY OF STIPULATED PROTECTIVE ORDER AND
`
`TO SEAL EXHIBITS 1033-1036 AND PORTIONS OF PETITIONER’S
`
`REPLY PETITION AND EXHIBIT 1031 was served on March 31, 2015 by
`
`causing it to be sent by email to counsel for Petitioner at the following email
`
`addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Dated: March 31, 2015
`
`/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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