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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL
`BOARD
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`
`Case IPR2023-00480
`U.S. Patent 7,713,947
`
`PATENT OWNER’S UNOPPOSED MOTION TO SEAL
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`1
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`I.
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`INTRODUCTION
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`
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`IPR2023-00480
`Motion to Seal
`
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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 Patent Owner’s Demonstrative Exhibits, Paper 56,
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`submitted on June 20, 2024. Good cause to seal Patent Owner’s
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`Demonstratives exists because they include excerpts of documents containing
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`highly confidential, competitively sensitive information of Patent Owner,
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`which Patent Owner designated as “PROTECTIVE ORDER MATERIAL.”
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`Patent Owner previously moved for entry of the Board’s Default Protective
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`Order with Petitioner’s consent. Paper 19. Patent Owner and Petitioner
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`previously moved to seal documents that are excerpted in Patent Owner’s
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`Demonstrative Exhibits. Papers 19, 42.
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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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`hereby certifies that it has conferred with Petitioner through counsel on June
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`IPR2023-00480
`Motion to Seal
`
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`20, 2024 in good faith regarding this motion. Petitioner does not oppose
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`Patent Owner’s Motion to Seal.
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`IV. GOOD CAUSE EXISTS FOR SEALING PATENT OWNER’S
`DEMONSTRATIVE EXHIBITS
`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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`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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`IPR2023-00480
`Motion to Seal
`
`
`(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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`Patent Owner’s Demonstrative Exhibits, Paper 56, contain confidential
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`research, development, or business information designated as “PROTECTIVE
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`ORDER MATERIAL” under the Default Protective Order that was agreed-
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`upon by the parties. Specifically, it contains confidential excerpts of Exhibits
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`1063, 2049, and 2050, which Patent Owner and Petitioner previously moved
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`to seal. Papers 19, 42. The balance of the Argentum factors favors sealing
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`Patent Owner’s Demonstrative Exhibits.
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`a. Patent Owner’s Demonstrative Exhibits Contain
`Confidential Information
`The information Patent Owner seeks to seal in Patent Owner’s
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`Demonstrative Exhibits is “truly confidential.” See Fed. R. Civ. P.
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`26(c)(1)(G). Patent Owner’s Demonstrative Exhibits contain confidential
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`technical information regarding drug development of Patent Owner and non-
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`parties to this proceeding. The information contained in Patent Owner’s
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`Demonstrative Exhibits is subject to non-party confidentiality obligations
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`(e.g., with development partners and Patent Owner’s affiliate) or would cause
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`IPR2023-00480
`Motion to Seal
`
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`competitive business harm to Patent Owner if publicly disclosed.
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`First, Patent Owner’s Demonstrative Exhibits include excerpts of the
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`December 17, 2003, Briefing Document (Ex. 2049), which is a true and
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`correct copy of an email communication and attachment sent from Serono to
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`IVAX and Serono personnel on December 17, 2003 and concerns the subject
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`matter of the IVAX-Serono Agreement, Ex. 2048. 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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`Second, Patent Owner’s Demonstrative Exhibits include excerpts of
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`the August 27, 2003, Meeting Minutes (Ex. 2050), which is a true and correct
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`copy of confidential meeting minutes between IVAX’s and Serono’s drug
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`development teams held on August 27, 2003, concerning the subject matter
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`of the IVAX-Serono Agreement, Ex. 2048. The August 27, 2003, Meeting
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`Minutes includes highly confidential information related to the ongoing
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`development of the joint research efforts of Ares Trading S.A. and IVAX,
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`including technical data reports and prospective research and clinical
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`development plans. See Ex. 2050.
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`- 5 -
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`Third, Patent Owner’s Demonstrative Exhibits include excerpts of the
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`IPR2023-00480
`Motion to Seal
`
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`Deposition Transcript of Dr. Munafo (Exhibit 1063), which includes
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`quotations, paraphrasing, and characterization of confidential portions of
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`Exhibits 2048, 2049, and 2050, all of which Patent Owner previously moved
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`to seal, as well as testimony concerning the joint research and development
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`obligations for investigational cladribine oral formulations, dosing regimens,
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`and clinical studies and Serono’s development plan for an oral cladribine
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`drug product, including Patent Owner’s confidential technical data, research
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`data, and prospective research and clinical development plans, none of which
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`been made publicly available. See Ex. 1063.
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`The excerpts of Exhibits 1063, 2049, and 2050 included in Patent
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`Owner’s Demonstrative Exhibits include confidential information relating to
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`Serono’s development plan for an oral cladribine drug product, including
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`Patent Owner’s confidential prospective research and clinical development
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`plans, which have not been made publicly available. See Paper 56.
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`Therefore, the contents of Patent Owner’s Demonstrative Exhibits
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`constitute “trade secret or other confidential research, development, or
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`commercial information” under Fed. R. Civ. P. 26(c)(1)(G) and 37 C.F.R. §
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`42.54(a) and should be subject to the protection of the Board’s Default
`
`Protective Order. Patent Owner and Petitioner previously moved to seal,
`- 6 -
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`
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`among other exhibits, Exhibits 1063, 2049, and 2050. Papers 19, 42.
`
`IPR2023-00480
`Motion to Seal
`
`
`b. Public Disclosure of Patent Owner’s Demonstrative Exhibits
`Would Result In Concrete Harm to Patent Owner and Non-
`Parties
`Patent Owner would suffer several concrete harms from the public
`
`disclosure of Patent Owner’s Demonstrative Exhibits. Patent Owner’s
`
`Demonstrative Exhibits include excerpts that detail Patent Owner’s
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`confidential drug development activities. Accordingly, public access to this
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`information risks unfair competitive disadvantage to Patent Owner and non-
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`parties Ares Trading S.A. and IVAX. Moreover, Patent Owner is subject to
`
`contractual obligations of confidentiality concerning Exhibits 2048, 2049,
`
`and 2050 and the exhibits and papers quoting or excerpting them, including
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`Patent Owner’s Demonstrative Exhibits. Public disclosure of the contents of
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`Patent Owner’s Demonstrative Exhibits would conflict with Patent Owner’s
`
`obligations.
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`c. There is a Genuine Need for Exhibits 1063, 2049, and 2050 in
`This Proceeding
`There exists a genuine need to rely on Exhibits 1063, 2049, and 2050
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`in the trial. Confidential information in Exhibits 1063, 2049, and 2050 are
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`pertinent to the disputed issue of whether the asserted invalidating art is prior
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`art under Pre-AIA 35 U.S.C. §102. This confidential information is not
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`available from any non-confidential sources and supports Patent Owner’s
`- 7 -
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`argument that disclosures of a dosing regimen in the asserted Bodor reference
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`IPR2023-00480
`Motion to Seal
`
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`is not “by another” as required by § 102(a) and (e). Patent Owner Owner’s
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`Demonstratives include confidential excerpts of 1063, 2049, and 2050 to
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`illustrate for the Board some of the portions of Exhibits 1063, 2049, and 2050
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`that are genuinely needed in the trial.
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`d. Maintaining Confidentiality of Patent Owner’s
`Demonstrative Exhibits 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 Patent Owner’s Demonstrative Exhibits and the need for
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`confidentiality outweighs any risk of such harm. The excerpts of Exhibits
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`1063, 2049, and 2050 included in Patent Owner’s Demonstrative Exhibits
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`concern the details of IVAX and Serono’s joint development and research
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`efforts, and if publicly disclosed, risk competitive harm to Patent Owner and
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`non-parties Ares Trading S.A. and IVAX (now Teva). In contrast, sealing
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`Patent Owner’s Demonstrative Exhibits deprives the public of only
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`confidential details of Patent Owner and non-parties that are routinely
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`maintained confidential in inter partes review proceedings and district court
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`litigation. For example, the Board has previously held that confidential
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`information in a license and collaboration agreement, like the one referenced
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`- 8 -
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`here, should remain under seal. See, e.g., Westinghouse Air Brake
`
`IPR2023-00480
`Motion to Seal
`
`
`Technologies Corporation v. Siemens Mobility, Inc., IPR2017-01669, Paper
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`60 (P.T.A.B. January 8, 2019). On balance, the preceding factors weigh in
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`favor of sealing Patent Owner’s Demonstrative Exhibits.
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`For the foregoing reasons, Patent Owner respectfully requests the
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`Board seal Patent Owner’s Demonstrative Exhibits. The parties are awaiting
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`the Board’s guidance regarding treatment of confidential information at the
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`oral hearing. See Paper 50, 3-4. Patent Owner will, at the Board’s request,
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`submit a redacted version of Patent Owner’s Demonstrative Exhibits.
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`V. PROTECTIVE ORDER
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`Patent Owner filed an Unopposed Motion for Entry of Default
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`Protective Order on December 21, 2023. Paper 19.
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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 Patent Owner’s Demonstrative Exhibits.
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`Dated: June 20, 2024
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`
`Respectfully Submitted,
`
`/Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`- 9 -
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`
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`IPR2023-00480
`Motion to Seal
`
`
`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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`- 10 -
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`CERTIFICATE OF SERVICE
`
`IPR2023-00480
`Motion to Seal
`
`
` hereby certify that on June 20, 2024, I caused a true and correct copy of the
`
` I
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`below documents:
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` Patent Owner’s Unopposed Motion to Seal Patent Owner’s
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`Demonstrative Exhibits and
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` Patent Owner’s Demonstrative Exhibits
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`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
`cdashe-PTAB@sternekessler.com
`pkhanduri-PTAB@sternekessler.com
`tliu-PTAB@sternekessler.com
`mbond-PTAB@sternekessler.com
`PTAB@sternekessler.com
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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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