`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`Case IPR2023-00481
`U.S. Patent 8,377,903
`
`PATENT OWNER’S UNOPPOSED MOTION TO SEAL AND FOR ENTRY
`OF DEFAULT PROTECTIVE ORDER
`
`
`
`1
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`
`
`I.
`
`INTRODUCTION
`
`Under 37 C.F.R. §§ 42.54 and 42.14, Patent Owner, Merck Serono SA,
`
`hereby moves to seal Exhibits 2048, 2049, and 2050 submitted with the
`
`Patent Owner’s Response on December 21, 2023. Good cause to seal these
`
`documents exists because they include highly confidential, competitively
`
`sensitive information of Patent Owner, which Patent Owner designated as
`
`“PROTECTIVE ORDER MATERIAL.” Patent Owner further moves for
`
`entry of the Board’s Default Protective Order. Petitioner, Hopewell Pharma,
`
`Ventures, Inc., does not oppose Patent Owner’s Motion to Seal and has
`
`consented to the Board’s Default Protective Order.
`
`II. AUTHORIZATION FOR THIS MOTION
`
`Prior Board authorization is not required for “motions where it is
`
`impractical for a party to seek prior Board authorization.” Consolidated Trial
`
`Practice Guide (Nov. 20, 2019) (the “Consolidated Trial Practice Guide”), p.
`
`37. “Motions where it is not practical to seek prior Board authorization
`
`include motions to seal. . . .” Id.
`
`III. CERTIFICATION OF CONFERENCE
`
`Under 37 C.F.R. § 42.54, Patent Owner, through the undersigned,
`
`hereby certifies that it has conferred with Petitioner through counsel on
`
`
`
`- 2 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`November 22 and 27, 2023 and December 19, 2023 in good faith regarding
`
`this motion. Petitioner does not oppose Patent Owner’s Motion to Seal and
`
`has agreed to entry of the Default Protective Order.
`
`IV. GOOD CAUSE EXISTS FOR SEALING EXHIBITS 2048, 2049,
`AND 2050
`The Board may issue protective orders for good cause to protect a
`
`party from disclosing confidential information. Consolidated Trial Practice
`
`Guide, pp. 19-20; 37 C.F.R. § 42.54. In deciding whether to grant a motion
`
`to seal, the Board must find “good cause,” and must “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.”
`
`Garmin International, Inc. et al. v. Cuozzo Speed Technologies LLC,
`
`IPR2012-00001, Paper 36 at 4 (P.T.A.B. April 5, 2013). “Confidential
`
`Information” is identified in a manner consistent with Fed. R. Civ. P.
`
`26(c)(1)(G), “which provides for protective orders for trade secret or other
`
`confidential research, development, or commercial information.” Id.
`
`Good cause for sealing material can be established by demonstrating
`
`that the balance of the following considerations favors sealing the material:
`
`whether (1) the information sought to be sealed is truly confidential, (2) a
`
`concrete harm would result upon public disclosure, (3) there exists a genuine
`
`
`
`- 3 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`need to rely in the trial on the specific information sought to be sealed, and
`
`(4), on balance, an interest in maintaining confidentiality outweighs the
`
`strong public interest in having an open record. See Argentum Pharms. LLC
`
`v. Alcon Research, Ltd., IPR2017-01053, Paper 27 at 4 (P.T.A.B. January 19,
`
`2018).
`
`Exhibits 2048 (the “IVAX-Serono Agreement”), 2049 (“December 17,
`
`2003, Briefing Document”), and 2050 (“August 27, 2003, Meeting Minutes”)
`
`contain confidential
`
`research, development, or business
`
`information
`
`designated as “PROTECTIVE ORDER MATERIAL” under the Default
`
`Protective Order that was agreed-upon by the parties. The balance of the
`
`Argentum factors favors sealing Exhibits 2048, 2049, and 2050.
`
`a. Exhibits 2048, 2049, and 2050 Contain Confidential
`Information
`The information Patent Owner seeks to seal in Exhibits 2048, 2049,
`
`and 2050 is “truly confidential.” See Fed. R. Civ. P. 26(c)(1)(G). Exhibits
`
`2048, 2049, and 2050 contain confidential technical information regarding
`
`drug development and/or financial and business information of Patent Owner
`
`and non-parties to this proceeding. The information contained in Exhibits
`
`2048, 2049, and 2050 is subject to non-party confidentiality obligations (e.g.,
`
`with development partners and Patent Owner’s affiliate) or would cause
`
`
`
`- 4 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`competitive business harm to Patent Owner if publicly disclosed.
`
`First, the IVAX-Serono Agreement (EX 2048) is a true and redacted1
`
`copy of the highly confidential joint development and license agreement
`
`between Ares Trading S.A., an affiliate of Patent Owner, and IVAX
`
`International GmBH (“IVAX”)2 dated October 16, 2002. The IVAX-Serono
`
`Agreement contains Patent Owner’s and non-party Ares Trading S.A. and
`
`IVAX’s highly confidential commercial terms concerning the joint research
`
`and development obligations for investigational cladribine oral formulations,
`
`dosing regimens, and clinical studies that have not been made publicly
`
`available. See Ex. 2048. Moreover, the IVAX-Serono Agreement contains
`
`confidentiality provisions requiring Ares Trading S.A. and its affiliate, Patent
`
`Owner, to maintain the confidentiality of the agreement terms. To the best of
`
`
`1 Ex. 2048 contains minimal redactions of specific monetary values which are
`
`highly sensitive to Patent Owner, its non-party affiliate Ares Trading S.A., and
`
`non-party IVAX, which are not relevant to any issue in dispute in this
`
`proceeding.
`
`2 In January 2006, IVAX became part of Teva Pharmaceutical Industries Ltd.
`
`(“Teva”) through the acquisition of IVAX Corporation by Teva. References to
`
`IVAX also refer to Teva as its successor.
`
`
`
`- 5 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`its knowledge, Patent Owner has not made, and does not intend to make, the
`
`contents of the IVAX-Serono Agreement publicly available. IVAX (now
`
`Teva) does not oppose making the IVAX-Serono Agreement available in this
`
`proceeding, subject to this motion to seal and treatment of the agreement
`
`under the Board’s Default Protective Order.
`
`Second, the December 17, 2003, Briefing Document (Ex. 2049) is a
`
`true and correct copy of an email communication and attachment sent from
`
`Serono to IVAX and Serono personnel on December 17, 2003 and concerns
`
`the subject matter of the IVAX-Serono Agreement. The communication
`
`contains a highly confidential draft “Briefing Document” concerning
`
`Serono’s development plan for an oral cladribine drug product, including
`
`Patent Owner’s confidential technical data, research data, and prospective
`
`research and clinical development plans. See Ex. 2049.
`
`Third, the August 27, 2003, Meeting Minutes (Ex. 2050) is a true and
`
`correct copy of confidential meeting minutes between IVAX’s and Serono’s
`
`drug development teams held on August 27, 2003, concerning the subject
`
`matter of the IVAX-Serono Agreement. The August 27, 2003, Meeting
`
`Minutes includes highly confidential information related to the ongoing
`
`development of the joint research efforts of Ares Trading S.A. and IVAX,
`
`including technical data reports and prospective research and clinical
`- 6 -
`
`
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`development plans. See Ex. 2050.
`
`The contents of Exhibits 2048, 2049, and 2050 constitute “trade secret
`
`or other confidential research, development, or commercial information”
`
`under Fed. R. Civ. P. 26(c)(1)(G) and 37 C.F.R. § 42.54(a) and should be
`
`subject to the protection of the Board’s Default Protective Order.
`
`b. Public Disclosure of Exhibits 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
`
`disclosure of Exhibits 2048, 2049, and 2050. Exhibits 2048, 2049, and 2050
`
`detail Patent Owner’s drug development activities, business strategies, drug
`
`commercialization strategy, and commercial and financial provisions,
`
`including a roadmap of how to replicate Patent Owner’s confidential and
`
`valuable drug product development and business model. Accordingly, public
`
`access to this information risks unfair competitive and commercial
`
`disadvantage to Patent Owner and non-party Ares Trading S.A. and IVAX.
`
`Moreover, Patent Owner is subject to contractual obligations of
`
`confidentiality concerning Exhibits 2048, 2049, and 2050 and public
`
`disclosure of the contents of these exhibits conflict with Patent Owner’s
`
`obligations.
`
`c. There is a Genuine Need for Exhibits 2048, 2049, and 2050 in
`This Proceeding
`
`
`
`- 7 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`There exists a genuine need to rely on Exhibits 2048, 2049, and 2050
`
`in the trial. Confidential information in Exhibits 2048, 2049, and 2050 are
`
`pertinent to the disputed issue of whether the asserted invalidating art is prior
`
`art under Pre-AIA 35 U.S.C. §102. This confidential information is not
`
`available from any non-confidential sources and supports Patent Owner’s
`
`argument that disclosures of a dosing regimen in the asserted Bodor reference
`
`is not “by another” as required by § 102(a) and (e).
`
`d. Maintaining Confidentiality of Exhibits 2048, 2049, and 2050
`Outweighs the Public Interest in an Open Record
`Although the public has an interest in the Patent Office maintaining a
`
`complete and comprehensive file history, the public interest would not be
`
`harmed by sealing Exhibits 2048, 2049, and 2050 and the need for
`
`confidentiality outweighs any risk of such harm. The contents of Exhibits
`
`2048, 2049, and 2050 concern the intimate details and communications of
`
`IVAX and Serono’s joint development and research efforts, and if publicly
`
`disclosed, risk significant competitive harm to Patent Owner and non-party
`
`Ares Trading S.A. and IVAX (now Teva). In contrast, sealing Exhibits 2048,
`
`2049, and 2050 deprives the public of only the confidential and granular
`
`business and research dealings of Patent Owner and non-parties that are
`
`routinely maintained confidential in inter partes review proceedings and
`
`
`
`- 8 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`district court litigation. For example, the Board has previously held that
`
`confidential information in a license and collaboration agreement, like the
`
`one submitted here, should remain under seal. See, e.g., Westinghouse Air
`
`Brake Technologies Corporation v. Siemens Mobility, Inc., IPR2017-01669,
`
`Paper 60 (P.T.A.B. January 8, 2019). Furthermore, the public’s interest in an
`
`open record may still be served as the general fact of the collaboration
`
`between IVAX and Serono was publicly announced and reflected in exhibits
`
`contemporaneously filed herewith. On balance, the preceding factors weigh
`
`in favor of sealing Exhibits 2048, 2049, and 2050.
`
`For the foregoing reasons, Patent Owner respectfully requests the
`
`Board seal Exhibits 2048, 2049, and 2050.
`
`V. MOTION FOR ENTRY OF THE DEFAULT PROTECTIVE
`ORDER
`Pursuant to 37 C.F.R. § 42.54, Patent Owner respectfully requests
`
`entry of the Board’s Default Protective Order as set forth in Appendix B of
`
`the Consolidated Trial Practice Guide. The parties have conferred and agreed
`
`to entry of the Default Protective Order.
`
`VI. CONCLUSION
`
`For the foregoing reasons, Patent Owner respectfully requests that the
`
`Board grant this Motion to Seal and enter the Default Protective Order.
`
`
`
`- 9 -
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`Dated: December 21, 2023
`
`
`Respectfully Submitted,
`
`/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
`
`
`
`
`
`
`- 10 -
`
`
`
`
`
`
`
`
`
`
`
`IPR2023-00481
`Motion to Seal and For Entry of Default Protective Order
`
`
`CERTIFICATE OF SERVICE
`
` hereby certify that on December 21, 2023, I caused a true and correct copy
`
` I
`
`of the below documents:
`
` Patent Owner’s Unopposed Motion to Seal and for Entry of Default
`
`Protective Order
`
` Exhibit No. 2048
`
` Exhibit No. 2049
`
` Exhibit No. 2050
`
`to be served via e-mail, as consented to by Petitioner, to:
`
`eellison-PTAB@sternekessler.com
`opartington-PTAB@sternekessler.com
`cvira-PTAB@sternekessler.com
`jcrozendaal-PTAB@sternekessler.com
`PTAB@sternekessler.com
`
`
`
`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
`
`
`
`- 11 -
`
`
`
`
`
`