`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: October 28, 2021
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`_____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`______________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Denying Patent Owner’s Motion to Seal
`37 C.F.R. §§ 42.14 and 42.54
`
`
`
`
`
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`IPR2021-00816
`Patent 9,220,631 B2
`
`Introduction
`
`Patent Owner filed a Motion to Seal Exhibits 2002, 2063, 2064, and
`2066–2088. Paper 10, 2 (“Mot.”). Petitioner has not filed any opposition to
`the Motion, and the period for doing so has expired. See 37 C.F.R.
`§ 42.25(a)(1). Patent Owner also filed an unopposed Motion to enter a
`Modified Default Protective Order (Ex. 2091). Paper 9. For the reasons set
`forth below, Patent Owner’s Motions are denied without prejudice subject to
`the conditions explained in this Order.
`
`
`Motion to Seal
`“There is a strong public policy for making all information filed in a
`
`quasi-judicial administrative proceeding open to the public.” Garmin Int’l v.
`Cuozzo Speed Techs., LLC, IPR2012–00001, slip op. at 1–2 (PTAB Mar. 14,
`2013) (Paper 34). The record for an inter partes review shall be made
`available to the public, except as otherwise ordered, and a document filed
`with a motion to seal shall be treated as sealed until the motion is decided.
`35 U.S.C. § 326(a)(1); 37 C.F.R. § 42.14. The standard for granting a
`motion to seal is “good cause.” 37 C.F.R. § 42.54; see also Argentum
`Pharms. LLC v. Alcon Res., Ltd., IPR2017-01053, Paper 27 at 3–4 (PTAB
`Jan. 19, 2018) (Informative) (describing the “good cause” standard). The
`moving party bears the burden of showing that the relief requested should be
`granted. 37 C.F.R. § 42.20(c). That includes showing that the information
`is truly confidential, and that such confidentiality outweighs the strong
`public interest in having an open record. See Argentum, Paper 27 at 3–4
`(“[A] movant to seal must demonstrate adequately that (1) the information
`sought to be sealed is truly confidential, (2) a concrete harm would result
`
`
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`2
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`IPR2021-00816
`Patent 9,220,631 B2
`upon public disclosure, (3) there exists a genuine 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.”).
`Patent Owner seeks to seal Exhibits 2002, 2063, 1 2064, and 2066–
`2088, which Patent Owner avers contain “non-public and proprietary”
`information related to “confidential research and development” of the
`subject matter of the patent at issue. Mot. 3. Patent Owner states that “the
`information sought to be sealed by this motion has not been published or
`otherwise made public.” Id. In addition, Patent Owner states that the
`exhibits contain confidential information of a third party. Id.; id. at 4.
`Patent Owner states that “[t]he proprietary information contained in
`Exhibits 2002, 2063–2064, and 2066–2088 is not essential to an
`understanding of the accompanying Patent Owners’ Preliminary Response
`and does not impede the public’s understanding of the file history.” Id. at 4.
`Patent Owner further asserts “[t]he public’s interest in accessing this
`information for the purposes of the patentability of the challenged claims in
`this proceeding is outweighed by Patent Owners’ interest in maintaining its
`proprietary research and development information as confidential.” Id.
`
`
`1 Patent Owner named almost all of its approximately 100 exhibits by the
`exhibit number without giving each a descriptive (non-argumentative) name.
`Although our rules do not address naming exhibits, having a unique name
`for each exhibit aids in our (and the public’s) review of the evidence
`submitted and allows more efficient use of the Board’s time.
`3
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`IPR2021-00816
`Patent 9,220,631 B2
`
`Exhibit 2002
`Exhibit 2002 is a declaration of named inventor Marie Picci. Id. at 3.
`Patent Owner filed a corresponding redacted public version of Exhibit 2002.
`Id. The Motion avers that the redacted information pertains to confidential
`research and development as well as the confidential information of a third
`party. Id.
`However, the Motion does not explain what information is Patent
`Owner’s versus what information is third party information, and the Motion
`further fails to explain why the third party information is confidential such
`that it should not be subject to public disclosure. In addition, the Motion is
`silent as to why public disclosure of the information is harmful to Patent
`Owner/third party or why the information sought to be sealed is needed at
`trial.
`As such, the Motion fails to demonstrate that the third party
`information sought to be sealed is truly confidential, that a concrete harm
`would result upon public disclosure, and that there exists a genuine need to
`rely in the trial on the specific information sought to be sealed. Accordingly,
`Patent Owner has not established that its interest in maintaining
`confidentiality of information in Exhibit 2002 outweighs the strong public
`interest in having an open record.
`Exhibits 2063 and 2064
`Exhibits 2063 and 2064 are Patent Owner’s internal PowerPoint
`Presentation and technical report, respectively, authored by a named
`inventor. Id. The Motion avers that the exhibits contain information
`pertaining to confidential research development and the confidential
`information of third parties.
`
`
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`4
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`IPR2021-00816
`Patent 9,220,631 B2
`We point out that the exhibits sought to be sealed include redacted
`portions with no explanation as to the reason(s) for the redactions. See
`Exs. 2063, 2064. In addition, Patent Owner did not file corresponding
`redacted public versions of these exhibits, and the Motion is silent on that
`point, providing no reason why the exhibits should be sealed in their
`entirety. The Motion also fails to identify which portions are Patent
`Owner’s information and which are third party information. As such, the
`public’s interest in maintaining an open record, that is both complete and
`understandable, is negatively impacted.
`The Motion is also silent as to how these Exhibits relate to any
`disputed issue of fact or why they are necessary to a specific position taken
`by a party in this proceeding.
`Furthermore, the Motion fails to describe any harm that will result in
`the event of public disclosure. Rather than averring that public disclosure of
`Exhibits 2063 and 2064 will result in concrete injury, the Motion merely
`states Patent Owner has an “interest in maintaining its proprietary research
`and development information as confidential.” Id. at 4. The Motion is silent
`as to any harm that would result due to public disclosure of its proprietary
`research and development information or third party information.
`With respect to Exhibits 2063 and 2064, Patent Owner did not
`1) provide appropriately redacted public versions of the exhibits, 2) identify
`sufficiently a reason why the information sought to be sealed is necessary in
`this trial, and 3) identify any concrete harm that would result as a result of
`public disclosure. As a result, the Motion fails to balance the public’s
`interest in maintaining a complete and understandable record against the
`
`
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`5
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`IPR2021-00816
`Patent 9,220,631 B2
`need to rely on the information at trial and the harm that might result from
`that information’s public disclosure.
`Exhibits 2066–2088
`Exhibits 2066–2088 are Patent Owner’s team Meeting Minutes. Id.
`The Motion avers that the exhibits contain information pertaining to
`confidential research development and the confidential information of third
`parties.
`For reasons similar to those already discussed above, the Motion fails
`to demonstrate good cause for sealing Exhibits 2066–2088. The Exhibits
`sought to be sealed include unexplained redacted portions. See Exs. 2066–
`2088. In addition, Patent Owner did not file corresponding redacted public
`versions of these Exhibits, and the Motion does not provide a reason why the
`Exhibits should be sealed in their entirety. The Motion also does not
`indicate what information is third party information and why the third party
`information is confidential such that it should not be subject to public
`disclosure. As such, the public’s interest in maintaining an open (complete
`and understandable) record is negatively impacted.
`Further, Patent Owner did not specify either the need to rely on the
`information sought to be sealed or the harm (to either Patent Owner or the
`third party) that would result from the information’s public disclosure.
`As such, with respect to Exhibits 2066–2088, the Motion fails to
`balance the public’s interest in maintaining a complete and understandable
`record against the need to rely on the information at trial and the harm that
`might result from that information’s public disclosure.
`
`
`
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`6
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`IPR2021-00816
`Patent 9,220,631 B2
`
`Conclusion
`In reviewing the Motion as well as Exhibits 2002, 2063, 2064, and
`2066–2088, we are not persuaded of good cause to seal these exhibits. We
`deny without prejudice Patent Owner’s Motion to Seal Exhibits 2002, 2063,
`2064, and 2066–2088.
`The Exhibits sought to be sealed in the Motion, however, shall
`continue to be provisionally sealed until such time as the Board resolves a
`second motion to seal, a request to unseal, or until the Exhibits are expunged
`pursuant to the guidance in this Order. See 37 C.F.R. § 42.14 (discussing
`Board’s authority to provisionally seal information).
`Patent Owner is hereby authorized to file a Second Motion to Seal for
`Exhibits 2022, 2063, 2064, and 2066–2088, in which Patent Owner must
`indicate what information is third party information and why that
`information is confidential. The Second Motion to Seal also must explain
`sufficiently the need to rely in the trial on the information sought to be
`sealed as well as explain what concrete harm would result upon public
`disclosure of the information.
`Regarding Exhibits 2063, 2064, and 2066–2088, Patent Owner may
`either refile the Exhibits sought to be sealed without redactions or provide
`sufficient explanation for the presence of redactions in the Exhibits sought to
`be sealed. Also, Patent Owner should file public versions of these Exhibits
`with narrowly tailored redactions; alternatively, if Patent Owner wishes to
`seal the Exhibits in their entirety, the Motion must explain sufficiently why
`all the information in each Exhibit, including, e.g., titles and dates, should
`not be subject to public disclosure.
`
`
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`7
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`IPR2021-00816
`Patent 9,220,631 B2
`
`
`Modified Default Protective Order
`Our rules provide for entry of a protective order when necessary to
`protect confidential information filed in a proceeding. See 37 C.F.R.
`§§ 42.14, 42.54. As explained above, the Motion does not demonstrate good
`cause for sealing any of the Exhibits that are the subject of the Motion.
`The Modified Default Protective Order (Paper 9) does not suffer from
`the same deficiencies and the proposed changes to our default order seem
`reasonable. Accordingly, we grant the Motion to enter the Modified Default
`Protective Order (Paper 9).
`
`
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`8
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`IPR2021-00816
`Patent 9,220,631 B2
`
`Order
`
`Accordingly, it is:
`ORDERED that Patent Owner’s Motion to Seal (Paper 10) is denied
`without prejudice;
`FURTHER ORDERED that Patent Owner’s Motion to enter the
`Modified Default Protective Order (Paper 9) is granted;
`FURTHER ORDERED that Patent Owner is authorized to file, within
`fifteen (15) business days of entry of this Order, a Second Motion to Seal
`subject to the conditions set forth in this Order for the purpose of requesting
`to seal Exhibits 2002, 2063, 2064, and 2066–2088;
`FURTHER ORDERED that Exhibits 2002, 2063, 2064, and 2066–
`2088 will remain provisionally sealed;
`FURTHER ORDERED that, in the event Patent Owner fails to file a
`timely Second Motion to Seal with respect to any of Exhibits 2002, 2063,
`2064, and 2066–2088, then the exhibits shall be expunged from the record;
`FURTHER ORDERED that, to the extent any argument or evidence
`relies on an expunged exhibit, that argument or evidence shall be accorded
`no weight in any final written decision entered in this proceeding; and
`FURTHER ORDERED that no other briefing is authorized at this
`
`time.
`
`
`
`
`
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`
`
`9
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`For PETITIONER:
`Elizabeth Weiswasser
`Anish Desai
`Brian Ferguson
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`brian.ferguson@weil.com
`christopher.pepe@weil.com
`
`For PATENT OWNER:
`Elizabeth Holland
`William James
`Linnea Cipriano
`Joshua Weinger
`GOODWIN PROCTER LLP
`eholland@goodwinprocter.com
`wjames@goodwinlaw.com
`lcipriano@goodwinlaw.com
`jweinger@goodwinprocter.com
`
`
`
`
`
`10
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`