Trials@uspto.gov
`571.272.7822
`
` Paper 25
`
`
` Date: January 8, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ORDER
`
`Granting Parties Motions to File Documents Under Seal and
`for Protective Order
`U.S.C. § 316; 37 C.F.R. §§ 42.14, 42.54
`
`
`
`
`____________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00884
`Patent 11,253,572 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`571.272.7822
`
` Paper 25
`
`
` Date: January 8, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ORDER
`
`Granting Parties Motions to File Documents Under Seal and
`for Protective Order
`U.S.C. § 316; 37 C.F.R. §§ 42.14, 42.54
`
`
`
`
`____________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00884
`Patent 11,253,572 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`
`
`
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`INTRODUCTION
`
`I.
`On August 25, 2023, Patent Owner filed a Motion to File
`Confidential Documents under Seal (Paper 7, “Patent Owner’s Motion to
`Seal”) and a Motion for Protective Order (Paper 8). Patent Owner’s Motion
`to Seal seeks to seal the following exhibits filed with Patent Owner’s
`Preliminary Response: Exhibits 2001, 2013, 2015, 2018, 2019, 2036, 2037,
`2038, 2039, 2040, 2041, 2043, and 2048. Paper 7 at 1. The Motion for
`Protective Order seeks entry of the Board’s Default Protective Order
`(submitted as Ex. 2059). Paper 8 at 1. On September 18, 2023, Petitioner
`filed a Motion to Seal as well, seeking to seal portions of its Reply that
`disclose, analyze, and discuss Exhibits 2015, 2018, 2019, 2019, 2039, 2040,
`and 2043. Paper 11.
`For the reasons below, the Motions are granted, and the Protective
`Order is entered.
`
`II. MOTIONS TO SEAL
`
`Under 37 C.F.R. § 42.14, the default rule is that all papers filed in
`such proceedings are available to the public. Only “confidential
`information” is subject to protection against public disclosure. 35 U.S.C.
`§ 326(a)(7); 37 C.F.R. § 42.55. The Board also observes a strong policy in
`favor of making all information filed in inter partes review proceedings
`open to the public. See Argentum Pharms. LLC v. Alcon Research, Ltd.,
`IPR2017-01053, Paper 27, 3–4 (PTAB Jan. 19, 2018) (informative).
`“Redactions to documents filed in [a] proceeding should be limited to the
`minimum amount necessary to protect confidential information, and the
`thrust of the underlying argument or evidence must be clearly discernible
`from the redacted versions.” CTPG 91. The moving party bears the burden
`of showing that the relief requested should be granted. 37 C.F.R. § 42.20(c).
`
`2
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`The standard for granting a party’s requested relief is “good cause.” Id.
`§ 42.54(a).
`PATENT OWNER’S MOTION TO SEAL
`A.
`Patent Owner’s Motion to Seal seeks to seal Exhibits 2001, 2013,
`2015, 2018, 2019, 2036, 2037, 2038, 2039, 2040, 2041, 2043, and 2048.
`Paper 7 at 1–7. For reasons that follow, we determine that the Motion to
`Seal demonstrates “good cause” for sealing these Exhibits. 37 C.F.R.
`§ 42.54(a). As noted, Petitioner does not oppose the Motion. Accordingly,
`the Motion is granted.
`Exhibit 2001
`1.
`Patent Owner states that “Dr. Richard Manning relies on a range of
`confidential information in his declaration,” Exhibit 2001, “including:
`(1) “Confidential financial information drawn from
`Patent Owner’s internal business records”;
`(2) “Confidential marketing plans and information
`prepared and compiled by Patent Owner”;
`(3) “Confidential market metrics and projections . . .
`compiled and provided by third party data provider[s] Vestrum
`Health . . . and IQVIA”; and
`(4) “Confidential information obtained from the
`American Society of Retina Specialists (ASRS).”
`Paper 7 at 2–4.
`
`Patent Owner asserts that the “confidential financial information” “is
`not publicly available,” “is completely sensitive,” and “[i]ts inclusion in the
`public docket would cause commercial harm to Patent Owner.” Id. at 3.
`Patent Owner asserts that the “confidential marketing plans and information”
`“is not publicly, and public release of this information could benefit Patent
`Owner’s competitors and thereby cause competitive harm to Patent Owner.”
`Id. Patent Owner asserts that the “confidential market metrics and
`
`3
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`projections” contain information that is not publicly available and would
`cause competitive harm to Patent Owner, Vestrum, and IQVIA if disclosed
`on the public docket. Id. at 3–4. And, Patent Owner asserts that the
`“confidential information obtained from . . . ASRS” are documents that
`“include restrictions on their publication,” and the information “is not
`publicly available and may cause competitive harm to ASRS if disclosed on
`the public docket.” Id. at 4. Patent Owner also states that it “moves to seal
`the specific portions of Dr. Manning’s declaration that reveal this
`confidential information,” and “[p]ursuant to Paragraph 5(A)(ii) of the
`Board’s default protective order, Ex.2059, a redacted copy of Dr. Manning’s
`declaration is being filed publicly with the same exhibit number.” Id. (citing
`Ex. 2059).
`
`Exhibits 2013, 2036, 2037, 2038, 2039, 2040, and 2041
`2.
` Patent Owner asserts that “Exhibits 2013, 2036, 2039, 2040, and
`2041 are Patent Owner’s internal memoranda, notes, and other planning
`documents . . . related to Regeneron’s development of aflibercept, and in
`particular to the design of aflibercept clinical trials,” which “reveal
`non-public aspects of Patent Owner’s strategic decision making in the
`development of Eylea®, including its commercial and regulatory strategies,”
`where “[p]ublic release of these details could cause competitive harm to
`Patent Owner by giving its competitors knowledge of its clinical research
`operations.” Paper 7 at 5. Patent Owner similarly asserts that “Exhibits
`2037 and 2038 are Patent Owner’s internal summaries of the status of
`planned, ongoing, and completed clinical trials and planned regulatory
`submissions,” which “reveal non-public details of Patent Owner’s clinical
`development for Eylea® and aspects of Patent Owner’s regulatory and
`
`4
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`commercial strategies,” where “[p]ublic release of these details could cause
`competitive harm to Patent Owner by giving its competitors knowledge of
`its clinical research operations.” Id.
`Exhibits 2015, 2019, and 2043
`3.
`Patent Owner asserts that “Exhibits 2015, 2019, and 2043 are Patent
`Owner’s internal summaries of its DA VINCI and VIEW clinical trial
`results,” which “reveal non-public data and data analysis,” where “[p]ublic
`release of these details could cause competitive harm to Patent Owner.”
`Paper 7 at 6. According to Patent Owner, “these exhibits report patient-level
`demographic information as well as details of these patients’ adverse events
`and treatment outcomes,” the disclosure of which “would compromise the
`confidentiality of the clinical trial subjects.” Id. Patent Owner states that it
`“moves to seal the specific portions of these exhibits that reveal unpublished
`data and data analysis,” and that “a redacted copy of these exhibits is being
`filed publicly with the same exhibit number.” Id.
`Exhibits 2018 and 2048
`4.
`Patent Owner asserts that “Exhibit 2018 is a detailed report of Patent
`Owner’s DA VINCI clinical trial results,” which “reveals non-public details
`of the protocol, results, and data analysis,” the public release of which
`“could cause competitive harm to Patent Owner.” According to Patent
`Owner, “these exhibits report patient-level demographic information as well
`as details of these patients’ adverse events and treatment,” the disclosure of
`which “would compromise the confidentiality of the clinical trial subjects.”
`Paper 7 at 6–7. Patent Owner also asserts that “Exhibit 2048 is a detailed
`clinical trial protocol for the DA VINCI trial,” which “reveals non-public
`details about Patent Owner’s clinical trial protocol, data analysis, and the
`product used in the clinical trial, and it implicates Patent Owner’s
`
`5
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`commercial and regulatory strategies,” where “[p]ublic release of these
`details could cause competitive harm to Patent Owner by giving its
`competitors knowledge of its clinical research operations.” Id. at 7.
`Summary
`5.
`It appears that Patent Owner has identified portions of Exhibits 2001,
`
`2013, 2015, 2018, 2019, 2036, 2037, 2038, 2039, 2040, 2041, 2043, and
`2048 that include confidential information, and that a business harm might
`result upon their public disclosure. Thus, we find there is “good cause” for
`sealing Exhibits 2001, 2013, 2015, 2018, 2019, 2036, 2037, 2038, 2039,
`2040, 2041, 2043, and 2048.
`PETITIONER’S MOTION TO SEAL
`B.
`
`Petitioner’s Motion to Seal “seeks to seal portions of its [Preliminary]
`Reply disclosing and analyzing the substance of those exhibits submitted by
`Patent Owner” as confidential in its motion to seal. Paper 11 at 1. Petitioner
`explains that “[c]ertain portions of [its] Reply discuss the substance of
`Exhibits 2015, 2018, 2019, 2039, 2040, and 2043,” which include internal
`summaries of clinical trial results, memoranda, notes, and planning
`documents Patent Owner asserts to be confidential. Id. at 2–3 (citing Paper
`7 at 2–7; Paper 10 at 4–10).
`Petitioner asserts that good cause exists to seal because “[t]he
`
`portions of the Reply Petitioner seeks to file under seal discuss Patent
`Owner’s exhibits that, according to Patent Owner, allegedly contain
`confidential business information that would cause competitive harm to
`Patent Owner were it to be disclosed publicly.” Id. at 1 (citing Paper 7 at 2–
`7).
`It appears Petitioner has identified portions of its Preliminary Reply
`
`that include confidential information, and that a business harm might result
`
`6
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`upon their public disclosure. Thus, we find there is “good cause” for sealing
`Paper 10.
`
`III. MOTION FOR PROTECTIVE ORDER
`
`The Board may, for good cause, issue an order to protect a party or
`person from disclosing confidential information. 37 C.F.R. § 42.54(a). A
`protective order is not entered by default, but must be proposed by one or
`more parties and must be approved and entered by the Board. PTAB
`Consolidated Trial Practice Guide 19–20, 107 (Nov. 2019) (“CTPG”).1 The
`CTPG sets forth specific guidelines on proposing a protective order and
`provides a Default Protective Order. See id. at 19–20, 107–122.
`Consistent with our requirements, Patent Owner “moves for entry of
`the Board’s Default Protective Order, as set forth in the Office Trial Practice
`Guide Update (November 2019) and filed concurrently as Ex.2059.” Paper
`8 at 1; Ex. 2059. Patent Owner states that good cause exists “because for its
`. . . Preliminary Response, Patent Owner submits and relies on non-public
`confidential research, development, and commercial information that it
`seeks to maintain as confidential.” Id. Patent Owner also states that
`“Petitioner does not object to the motion.” Id.
`Petitioner does not oppose Patent Owner’s Motion for entry of our
`Default Protective Order, and, as discussed, the Motions to Seal demonstrate
`“good cause” for sealing the subject Exhibits and Paper. See Paper 8; Paper
`11; see also discussion infra. Accordingly, we grant Patent Owner’s Motion
`for Protective Order, and enter the Default Protective Order (Ex. 2059). See
`CTPG 117–122; see also id. at 107–116 (providing guidance on the
`procedures for filing of motions to seal and the entry of protective orders).
`
`
`1 Available at http://www.uspto.gov/TrialPracticeGuideConsolidated.
`
`7
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that Patent Owner’s Motion to File Confidential
`
`Documents Under Seal is granted and Exhibits 2001, 2013, 2015, 2018,
`2019, 2036, 2037, 2038, 2039, 2040, 2041, 2043, and 2048 will be
`maintained as sealed;
`
`FURTHER ORDERED that Petitioner’s Motion to Seal is granted
`and Petitioner’s Reply (Paper 10) will be maintained as sealed; and
`
`FURTHER ORDERED that Patent Owner’s Motion for Protective
`Order is granted and the default Protective Order (Ex. 2059) is entered in
`this proceeding.
`
`
`
`
`
`8
`
`
`
`IPR2023-00884
`Patent 11,253,572 B2
`For PETITIONER:
`
`Raymond Nimrod
`Matthew Traupman
`Landon Smith
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`
`For PATENT OWNER:
`
`Adam Brausa
`Rebecca Weires
`MORRISON & FOERSTER LLP
`abrausa@mofo.com
`rweires@mofo.com
`
`9
`
`
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