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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_________________________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
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`Case IPR2023-00884
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`U.S. Patent No. 11,253,572
`_________________________
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`PETITIONER’S MOTION TO SEAL
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`Pursuant to 37 C.F.R. §§ 42.14 and 42.54 and the Patent Trial and Appeal
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`Board Consolidated Trial Practice Guide November 2019, Petitioner Samsung
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`Bioepis Co., Ltd. (“Petitioner” or “Samsung ”) respectfully submits this Motion to
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`Seal concurrently with Petitioner’s Reply to Patent Owner Preliminary Response
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`(“Reply”). Specifically, based on Patent Owner’s representations that a number of
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`its exhibits are confidential (See, Paper 7, Patent Owner’s Motion to File
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`Confidential Documents Under Seal), Samsung seeks to seal portions of its Reply
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`disclosing and analyzing the substance of those exhibits submitted by Patent Owner.
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`I.
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`GOOD CAUSE EXISTS TO SEAL
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`The standard governing the Board’s determination of whether to grant a
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`motion to seal is “good cause.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 36 at 4 (April 5, 2013) (quoting 37 C.F.R. § 42.54). The
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`Board aims to “strike a balance between the public’s interest in maintaining a
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`complete and understandable file history and the parties’ interest in protecting truly
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`sensitive information.” Id.
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`The portions of the Reply Petitioner seeks to file under seal discuss Patent
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`Owner’s exhibits that, according to Patent Owner, allegedly contain confidential
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`business information that would cause competitive harm to Patent Owner were it to
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`be disclosed publicly. Paper 7, 2-7. Based on Patent Owner’s representations, “good
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`cause” exists to maintain the portions of the Reply discussing Patent Owner’s
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`1
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`allegedly confidential exhibits under seal and available only to the parties and Board.
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`Pursuant to Paragraph 5(A)(ii) of the Board’s default protective order (Ex. 2059), a
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`redacted copy of Petitioner’s Reply is being filed publicly.
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`A. Petitioner’s Reply Discusses Exhibits Patent Owner Has Designated
`Confidential
`Certain portions of Petitioner’s Reply discuss the substance of Exhibits 2015,
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`2018, 2019, 2039, 2040, and 2043, previously submitted by the Patent Owner under
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`seal in this proceeding. See, Reply, 4-10; Paper 7. According to Patent Owner,
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`Exhibits 2015, 2019, and 2043 are Patent Owner’s internal summaries of its DA
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`VINCI and VIEW clinical trial results; Exhibit 2018 is a detailed report of Patent
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`Owner’s DA VINCI clinical trial results; and Exhibits 2039-2040 are Patent
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`Owner’s internal memoranda, notes, and other planning documents from 2008
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`related to Patent Owner’s development of aflibercept, and in particular to the design
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`of aflibercept clinical trials. Id., 2-7.
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`In its motion to seal, Patent Owner argues that these documents include non-
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`public confidential internal memoranda, notes, and other planning documents
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`concerning Patent Owner’s design of aflibercept clinical trials as well as Patent
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`Owner’s strategic decision making in the development of Eylea®, including its
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`commercial and regulatory strategies. Id.1 According to Patent Owner, public
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`release of the details in these exhibits could cause competitive harm to Patent Owner
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`by giving its competitors knowledge of its clinical research operations. Id. For
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`purposes of the instant Motion to Seal only, Petitioner does not object to the
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`confidentiality of Patent Owner’s exhibits referenced in the Reply. On that basis,
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`the Board should grant this Motion to Seal.
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`II. CERTIFICATION
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`Pursuant to 37 CFR § 42.54, Petitioner certifies that it has conferred with
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`Patent Owner regarding this motion to seal. Patent Owner does not object to the
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`motion.
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`1 Patent Owner further notes that in the district court litigation between Patent
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`Owner and Mylan, Patent Owner produced these documents with a designation of
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`“CONFIDENTIAL” as defined by the protective order in that case.
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`3
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`DATED: September 18, 2023
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`Respectfully submitted,
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
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`Attorneys for Petitioner Samsung Bioepis
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`4
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`CERTIFICATE OF SERVICE
`In accordance with 37 C.F.R. § 42.6(e), I hereby certify that on September 18,
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`2023, true and correct copies of Petitioner’s Motion to Seal was served via electronic
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`mail to Patent Owner at the following email addresses of record:
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`Brausa, Adam R. ABrausa@mofo.com
`Davis, Kira A KiraDavis@mofo.com
`Weires, Rebecca RWeires@mofo.com
`Durie, Daralyn J. DDurie@mofo.com
`Regeneron-MoFo-IPR Regeneron-MoFo-IPR@mofo.com
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`DATED: September 18, 2023
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`Respectfully submitted,
`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
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`5
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