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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
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`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`Case IPR2023-00049
`U.S. Patent 7,713,947
`
`PATENT OWNER’S MOTION TO SEAL AND FOR ENTRY OF
`DEFAULT PROTECTIVE ORDER
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`
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
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`
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`I.
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`INTRODUCTION
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`Under 37 C.F.R. §§ 42.54 and 42.14, Patent Owner, Merck Serono SA,
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`hereby moves to seal Exhibits 2039, 2048, 2049, and 2050 submitted with the
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`Patent Owner’s Response. Good cause to seal these documents exists
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`because they include highly confidential, competitively sensitive information
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`of Patent Owner, which Patent Owner designated as “PROTECTIVE
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`ORDER MATERIAL.” Patent Owner further moves for entry of the Board’s
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`Default Protective Order. Petitioner, TWi Pharmaceuticals, Inc., has
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`consented to the Board’s Default Protective Order with respect to information
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`for which good cause to seal is established, but has not taken a position
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`regarding Patent Owner’s Motion to Seal.
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`II. AUTHORIZATION FOR THIS MOTION
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`Prior Board authorization is not required for “motions where it is
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`impractical for a party to seek prior Board authorization.” Consolidated Trial
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`Practice Guide (Nov. 20, 2019) (the “Consolidated Trial Practice Guide”), p.
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`37. “Motions where it is not practical to seek prior Board authorization
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`include motions to seal. . . .” Id.
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`III. CERTIFICATION OF CONFERENCE
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`Under 37 C.F.R. § 42.54, Patent Owner, through the undersigned,
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
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`hereby certifies that it corresponded with Petitioner through counsel on
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`February 29 and March 8, 2024 in good faith regarding this motion.
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`Petitioner agreed to entry of the Board’s Default Protective Order for
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`information which Patent Owner establishes good cause to seal, but has not
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`taken a position as to whether any particular exhibits should be sealed.
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`IV. GOOD CAUSE EXISTS FOR SEALING EXHIBITS 2039, 2048,
`2049, AND 2050
`The Board may issue protective orders for good cause to protect a
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`party from disclosing confidential information. Consolidated Trial Practice
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`Guide, pp. 19-20; 37 C.F.R. § 42.54. In deciding whether to grant a motion
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`to seal, the Board must find “good cause,” and must “strike a balance
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`between the public’s interest in maintaining a complete and understandable
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`file history and the parties’ interest in protecting truly sensitive information.”
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`Garmin International, Inc. et al. v. Cuozzo Speed Technologies LLC,
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`IPR2012-00001, Paper 36 at 4 (P.T.A.B. April 5, 2013). “Confidential
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`Information” is identified in a manner consistent with Fed. R. Civ. P.
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`26(c)(1)(G), “which provides for protective orders for trade secret or other
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`confidential research, development, or commercial information.” Id.
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`Good cause for sealing material can be established by demonstrating
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`that the balance of the following considerations favors sealing the material:
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`
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`whether (1) the information sought to be sealed is truly confidential, (2) a
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`concrete harm would result upon public disclosure, (3) there exists a genuine
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`need to rely in the trial on the specific information sought to be sealed, and
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`(4), on balance, an interest in maintaining confidentiality outweighs the
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`strong public interest in having an open record. See Argentum Pharms. LLC
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`v. Alcon Research, Ltd., IPR2017-01053, Paper 27 at 4 (P.T.A.B. January 19,
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`2018).
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`Exhibits 2039 (“Deposition Transcript of Nicholas Bodor, February 15,
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`2024”), 2048 (the “IVAX-Serono Agreement”), 2049 (“December 17, 2003,
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`Briefing Document”), and 2050 (“August 27, 2003, Meeting Minutes”) contain
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`confidential research, development, or business information designated as
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`“PROTECTIVE ORDER MATERIAL” under the Default Protective Order
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`that was agreed-upon by the parties. Patent Owner moved to seal three of the
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`same exhibits—Exhibits 2048, 2049, and 2050—unopposed in IPR2023-
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`00480 and -00481. The balance of the Argentum factors favors sealing
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`Exhibits 2039, 2048, 2049, and 2050.
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`a. Exhibits 2039, 2048, 2049, and 2050 Contain Confidential
`Information
`The information Patent Owner seeks to seal in Exhibits 2039, 2048,
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`2049, and 2050 is “truly confidential.” See Fed. R. Civ. P. 26(c)(1)(G).
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`
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`Exhibits 2039, 2048, 2049, and 2050 contain confidential technical
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`information regarding drug development and/or financial and business
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`information of Patent Owner and non-parties to this proceeding. The
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`information contained in Exhibits 2039, 2048, 2049, and 2050 is subject to
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`non-party confidentiality obligations (e.g., with development partners and
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`Patent Owner’s affiliate) or would cause competitive business harm to Patent
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`Owner if publicly disclosed.
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`First, the Deposition Transcript of Nicholas Bodor, February 15, 2024
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`is a true and correct copy of the deposition of Dr. Nicholas Bodor in
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`IPR2023-00480 and -00481, which took place on February 15, 2024. This
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`transcript contains Patent Owner’s and non-party Ares Trading S.A. and
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`IVAX’s highly confidential information relating to drug development
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`research Dr. Bodor performed that is not relevant to any issue in dispute in
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`this proceeding. See Ex. 2039. Patent Owner submits a public, redacted
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`version of the transcript as Exhibit 2041 and requests sealing of Exhibit 2039,
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`the full, unredacted transcript containing this confidential information. To
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`the best of its knowledge, Patent Owner has not made, and does not intend to
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`make, this research publicly available. IVAX (now Teva) does not oppose
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`making this full transcript available in this proceeding, subject to this motion
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`to seal and treatment of the transcript under the Board’s Default Protective
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`Order.
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`Second, the IVAX-Serono Agreement (EX 2048) is a true and
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`redacted1 copy of the highly confidential joint development and license
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`agreement between Ares Trading S.A., an affiliate of Patent Owner, and
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`IVAX International GmBH (“IVAX”)2 dated October 16, 2002. The IVAX-
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`Serono Agreement contains Patent Owner’s and non-party Ares Trading S.A.
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`and IVAX’s highly confidential commercial terms concerning the joint
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`research and development obligations for investigational cladribine oral
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`formulations, dosing regimens, and clinical studies that have not been made
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`publicly available. See Ex. 2048. Moreover, the IVAX-Serono Agreement
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`contains confidentiality provisions requiring Ares Trading S.A. and its
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`affiliate, Patent Owner, to maintain the confidentiality of the agreement
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`1 Ex. 2048 contains minimal redactions of specific monetary values which are
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`highly sensitive to Patent Owner, its non-party affiliate Ares Trading S.A., and
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`non-party IVAX, which are not relevant to any issue in dispute in this
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`proceeding.
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`2 In January 2006, IVAX became part of Teva Pharmaceutical Industries Ltd.
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`(“Teva”) through the acquisition of IVAX Corporation by Teva. References to
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`IVAX also refer to Teva as its successor.
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`- 6 -
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`terms. To the best of its knowledge, Patent Owner has not made, and does
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`not intend to make, the contents of the IVAX-Serono Agreement publicly
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`available. IVAX (now Teva) does not oppose making the IVAX-Serono
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`Agreement available in this proceeding, subject to this motion to seal and
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`treatment of the agreement under the Board’s Default Protective Order.
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`Third, the December 17, 2003, Briefing Document (Ex. 2049) is a true
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`and correct copy of an email communication and attachment sent from
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`Serono to IVAX and Serono personnel on December 17, 2003 and concerns
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`the subject matter of the IVAX-Serono Agreement. The communication
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`contains a highly confidential draft “Briefing Document” concerning
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`Serono’s development plan for an oral cladribine drug product, including
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`Patent Owner’s confidential technical data, research data, and prospective
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`research and clinical development plans. See Ex. 2049.
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`Fourth, the August 27, 2003, Meeting Minutes (Ex. 2050) is a true and
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`redacted3 copy of confidential meeting minutes between IVAX’s and
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`Serono’s drug development teams held on August 27, 2003, concerning the
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`3 Ex. 2050 contains minimal redactions to protect privileged discussions with
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`IVAX’s counsel presented earlier at the meeting under common-interest privilege
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`between IVAX and Patent Owner.
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`
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`subject matter of the IVAX-Serono Agreement. The August 27, 2003,
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`Meeting Minutes includes highly confidential information related to the
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`ongoing development of the joint research efforts of Ares Trading S.A. and
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`IVAX, including technical data reports and prospective research and clinical
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`development plans. See Ex. 2050.
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`The contents of Exhibits 2039, 2048, 2049, and 2050 constitute “trade
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`secret or other confidential research, development, or commercial
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`information” under Fed. R. Civ. P. 26(c)(1)(G) and 37 C.F.R. § 42.54(a) and
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`should be subject to the protection of the Board’s Default Protective Order.
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`b. Public Disclosure of Exhibits 2039, 2048, 2049, and 2050
`Would Result in Concrete Harm to Patent Owner and Non-
`Parties
`Patent Owner would suffer several concrete harms from the public
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`disclosure of Exhibits 2039, 2048, 2049, and 2050. Exhibits 2039, 2048,
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`2049, and 2050 detail Patent Owner’s drug development activities, business
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`strategies, drug commercialization strategy, and commercial and financial
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`provisions, including a roadmap of how to replicate Patent Owner’s
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`confidential and valuable drug product development and business model.
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`Accordingly, public access to this information risks unfair competitive and
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`commercial disadvantage to Patent Owner and non-party Ares Trading S.A.
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`and IVAX. Moreover, Patent Owner is subject to contractual obligations of
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`confidentiality concerning Exhibits 2039, 2048, 2049, and 2050 and public
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`disclosure of the contents of these exhibits conflict with Patent Owner’s
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`obligations.
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`c. There is a Genuine Need for Exhibits 2039, 2048, 2049, and
`2050 in This Proceeding
`There exists a genuine need to rely on Exhibits 2039, 2048, 2049, and
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`2050 in the trial. Confidential information in Exhibits 2039, 2048, 2049, and
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`2050 are pertinent to the disputed issue of whether the asserted invalidating
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`art is prior art under Pre-AIA 35 U.S.C. §102. This confidential information
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`is not available from any non-confidential sources and supports Patent
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`Owner’s argument that disclosures of a dosing regimen in the asserted Bodor
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`reference is not “by another” as required by § 102(a) and (e).
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`d. Maintaining Confidentiality of Exhibits 2039, 2048, 2049,
`and 2050 Outweighs the Public Interest in an Open Record
`Although the public has an interest in the Patent Office maintaining a
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`complete and comprehensive file history, the public interest would not be
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`harmed by sealing Exhibits 2039, 2048, 2049, and 2050 and the need for
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`confidentiality outweighs any risk of such harm. The contents of Exhibits
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`2039, 2048, 2049, and 2050 concern the intimate details and communications
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`of IVAX and Serono’s joint development and research efforts, and if publicly
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`disclosed, risk significant competitive harm to Patent Owner and non-party
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
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`Ares Trading S.A. and IVAX (now Teva). In contrast, sealing Exhibits 2039,
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`2048, 2049, and 2050 deprives the public of only the confidential and
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`granular business and research dealings of Patent Owner and non-parties that
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`are routinely maintained confidential in inter partes review proceedings and
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`district court litigation. For example, the Board has previously held that
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`confidential information in a license and collaboration agreement, like the
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`one submitted here, should remain under seal. See, e.g., Westinghouse Air
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`Brake Technologies Corporation v. Siemens Mobility, Inc., IPR2017-01669,
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`Paper 60 (P.T.A.B. January 8, 2019). Furthermore, the public’s interest in an
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`open record may still be served as the general fact of the collaboration
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`between IVAX and Serono was publicly announced and reflected in exhibits
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`contemporaneously filed herewith. Moreover, the public will have access to
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`Ex. 2041, which is the redacted version of Ex. 2039 and which includes all
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`the information from Ex. 2039 that is relevant to the issues in dispute in this
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`proceeding. On balance, the preceding factors weigh in favor of sealing
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`Exhibits 2039, 2048, 2049, and 2050.
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`For the foregoing reasons, Patent Owner respectfully requests the
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`Board seal Exhibits 2039, 2048, 2049, and 2050.
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`V. MOTION FOR ENTRY OF THE DEFAULT PROTECTIVE
`ORDER
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`
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`Pursuant to 37 C.F.R. § 42.54, Patent Owner respectfully requests
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`entry of the Board’s Default Protective Order as set forth in Appendix B of
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`the Consolidated Trial Practice Guide. The parties have conferred and agreed
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`to entry of the Default Protective Order for exhibits for which good cause to
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`seal is shown.
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`VI. CONCLUSION
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`For the foregoing reasons, Patent Owner respectfully requests that the
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`Board grant this Motion to Seal and enter the Default Protective Order.
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`Dated: March 12, 2024
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`Respectfully Submitted,
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`/Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`Counsel for Patent Owner
`Wilmer Cutler Pickering Hale and Dorr
`LLP
`60 State Street
`Boston, MA 02109
`Tel. (617) 526-6567
`E-mail: emily.whelan@wilmerhale.com
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`IPR2023-00049
`Motion to Seal and For Entry of Default Protective Order
`
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`CERTIFICATE OF SERVICE
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` hereby certify that on March 13, 2024, I caused a true and correct copy of
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` I
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`the below documents:
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`• Patent Owner’s Motion to Seal and for Entry of Default Protective
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`Order
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`• Exhibit No. 2039
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`• Exhibit No. 2048
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`• Exhibit No. 2049
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`• Exhibit No. 2050
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`to be served via e-mail, as consented to by Petitioner, to:
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`
`
`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@huschblackwell.com
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`
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`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: (212) 295-6470
`E-mail: cindy.kan@wilmerhale.com
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`- 12 -
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