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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NEUROCRINE BIOSCIENCES, INC.
`Petitioner
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`v.
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`SPRUCE BIOSCIENCES, INC.
`Patent Owner
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`Case PGR2021-00088
`U.S. Patent 10,849,908
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`PETITIONER’S MOTION TO SEAL
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
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`I. Introduction
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`Pursuant to 37 CFR § 42.54, Petitioner, Neurocrine Biosciences, Inc.
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`respectfully submits this Motion to Seal Exhibits 1005 and 1009, as well as the
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`Petition for Post Grant Review. Below, Petitioner explains that Good Cause exists
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`for placing these exhibits and the Petition for Post Grant Review under seal.
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`II. Applicable Legal Principles for Sealing Confidential Information
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`There is a strong public policy for making all information filed in a quasi-
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`judicial administrative proceeding open to the public, especially in an inter partes
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`review which determines the patentability of claims in a patent and therefore
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`affects the rights of the public. St. Jude Medical, Cardiology Division, Inc. v.
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`Volcano Corp., IPR2013-00258, Decision to Revised Motion to Seal 37 C.F.R. §§
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`42.14 and 42.54, Paper 28 at 2. Under 35 U.S.C. § 316(a)(1), the default rule is
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`that all papers filed in an inter partes review are open and available for access by
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`the public; and a party may file a concurrent motion to seal and the information at
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`issue is sealed pending the outcome of the motion. Id.
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`It is, however, only “confidential information” that is protected from
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`disclosure. 35 U.S.C. § 316(a)(7) (“The Director shall prescribe regulations -- …
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`providing for protective orders governing the exchange and submission of
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`confidential information”). Id. In that regard, the Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012), provides:
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
`The rules aim to 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.
`* * *
`identify confidential
`rules
`Information: The
`Confidential
`information in a manner consistent with Federal Rule of Civil
`Procedure 26(c)(1)(G), which provides for protective orders for
`trade secret or other confidential research, development, or
`commercial information. § 42.54.
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`The standard for granting a motion to seal is “for good cause.” 37 C.F.R. §
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`42.54. Patent Owner, as the moving party, has the burden of proof in showing
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`entitlement to the requested relief. Id.
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`III. Good Cause Exists for Sealing Exhibits 1005 and 1009, and the Petition
`for Post Grant Review.
`Exhibit 1009: Exhibit 1009 is a manuscript that describes Petitioner’s
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`Phase II clinical study related to the use of crinecerfont to treat CAH. It was
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`submitted confidentially for review to The Lancet scientific journal on April 30,
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`2021, and has not been published. The manuscript contains clinical study
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`protocols and results that are proprietary to Neurocrine. Disclosing those protocols
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`and results to the public while the manuscript is undergoing peer review could
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`damage Neurocrine.
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`Exhibit 1005: Exhibit 1005 includes portions that refer to and discuss
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`Exhibit 1009.
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
`Petition for Post Grant Review: The Petition for Post Grant Review
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`includes portions that refer to and discuss Exhibit 1009.
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`IV. Certification of Non-Publication
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`On behalf of Petitioner, undersigned counsel certifies that as of this date, the
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`information sought to be sealed has not been published or otherwise made public.
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`Further, the confidentiality of this information has been consistently maintained by
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`the Petitioner during this proceeding, and any related proceedings.
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`V. Proposed Protective Order
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`The Protective Order attached hereto as Appendix A corresponds to the
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`default protective order set forth in the Office Patent Trial Practice Guide.
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`Petitioner and Patent Owner have agreed to use the attached protective order to
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`govern the handling of confidential information in this proceeding. Per agreement
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`of the parties, confidential information will be designated “PGR Protective Order
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`Material.” Accordingly, Petitioner respectfully requests entry of the Proposed
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`Protective Order.
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`VI. Confidential and Non-Confidential Versions
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` Submitted herewith are non-confidential versions of the Petition for Post Grant
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`review and Exhibit 1005. Confidential versions are being filed concurrently.
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`VII. Conclusion
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
`For the above reasons, Petitioner, Neurocrine Biosciences Inc., respectfully
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`requests Exhibit 1009, and the unredacted Petition for Post Grant Review and
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`Exhibit 1005, to be treated as confidential information and be placed under seal.
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`Date: /May 28, 2021/
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`Fish & Richardson P.C.
`Telephone: (612) 335-5070
`Facsimile: (877) 769-7945
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` Respectfully submitted,
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` /Dorothy P. Whelan/
` Dorothy P. Whelan
` Reg. No. 33,814
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4), the undersigned certifies that on May 28,
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`2021, a complete and entire copy of this Petitioner’s Motion to Seal was provided
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`by Federal Express, to the Patent Owner, by serving the correspondence addresses
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`of record as follows:
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`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO CA 94304-1050
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`/Diana Bradley/
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`Diana Bradley
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(858) 678-5667
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
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`APPENDIX A
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`6
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NEUROCRINE BIOSCIENCES, INC.
`Petitioner
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`v.
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`SPRUCE BIOSCIENCES, INC.
`Patent Owner
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`Case PGR2021-00088
`U.S. Patent 10,849,908
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`PROTECTIVE ORDER
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`This standing protective order governs the treatment and filing of
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`confidential information, including documents and testimony.
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`1. Confidential information shall be clearly marked ‘‘PROTECTIVE
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`ORDER MATERIAL.’’
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
`2. Access to confidential information is limited to the following individuals
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`who have executed the acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the proceeding
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`and other persons who are named parties to the proceeding.
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`(B) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(C) Experts. Retained experts of a party in the proceeding who further
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`certify in the Acknowledgement that they are not a competitor to any party, or a
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`consultant for, or employed by, such a competitor with respect to the subject matter
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`of the proceeding.
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`(D) In-house counsel. In-house counsel of a party.
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`(E) Other Employees of a Party. Employees, consultants or other persons
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`performing work for a party, other than in-house counsel and in-house counsel’s
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`support staff, who sign the Acknowledgement shall be extended access to
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`confidential information only upon agreement of the parties or by order of the
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`Board upon a motion brought by the party seeking to disclose confidential
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`information to that person. The party opposing disclosure to that person shall have
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`the burden of proving that such person should be restricted from access to
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`confidential information.
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`Attorney Docket No.: 47291-0002PS1
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`(F) The Office. Employees and representatives of the Office who have a need
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`for access to the confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and representatives
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`shall include the Director, members of the Board and their clerical staff, other
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`support personnel, court reporters, and other persons acting on behalf of the Office.
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`(G) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are reasonably
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`necessary to assist those persons in the proceeding shall not be required to sign an
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`Acknowledgement, but shall be informed of the terms and requirements of the
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`Protective Order by the person they are supporting who receives confidential
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`information.
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`3. Persons receiving confidential information shall use reasonable efforts to
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`maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons not
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`authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of the
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`information, which efforts shall be no less rigorous than those the recipient uses to
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`maintain the confidentiality of information not received from the disclosing party;
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`(C) Ensuring that support personnel of the recipient who have access to the
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`confidential information understand and abide by the obligation to maintain the
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`confidentiality of information received that is designated as confidential; and
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`(D) Limiting the copying of confidential information to a reasonable number
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`of copies needed for conduct of the proceeding and maintaining a record of the
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`locations of such copies.
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`4. Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`(A) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the Board under seal,
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`together with a non-confidential description of the nature of the confidential
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`information that is under seal and the reasons why the information is confidential
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`and should not be made available to the public. The submission shall be treated as
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`confidential and remain under seal, unless, upon motion of a party and after a
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`hearing on the issue, or sua sponte, the Board determines that the documents or
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`information do not to qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the information
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`submitted to the Board, the submitting party shall file confidential and non-
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`confidential versions of its submission, together with a Motion to Seal the
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`confidential version setting forth the reasons why the information redacted from
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`Attorney Docket No.: 47291-0002PS1
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`the non-confidential version is confidential and should not be made available to the
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`public. The nonconfidential version of the submission shall clearly indicate the
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`locations of information that has been redacted. The confidential version of the
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`submission shall be filed under seal. The redacted information shall remain under
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`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte,
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`the Board determines that some or all of the redacted information does not qualify
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`for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties. Information
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`designated as confidential that is disclosed to another party during discovery or
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`other proceedings before the Board shall be clearly marked as “PROTECTIVE
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`ORDER MATERIAL” and shall be produced in a manner that maintains its
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`confidentiality.
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`(j) Standard Acknowledgement of Protective Order. The following form may
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`be used to acknowledge a protective order and gain access to information covered
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`by the protective order:
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`11
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NEUROCRINE BIOSCIENCES, INC.
`Petitioner
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`v.
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`SPRUCE BIOSCIENCES, INC.
`Patent Owner
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`
` I
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` _____________________________, affirm that I have read the Protective
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`Order; that I will abide by its terms; that I will use the confidential information
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`only in connection with this proceeding and for no other purpose; that I will only
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`allow access to support staff who are reasonably necessary to assist me in this
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`Case PGR2021-00088
`U.S. Patent 10,849,908
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`Standard Acknowledgment for Access to
`Protective Order Material
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`Attorney Docket No.: 47291-0002PS1
`Case No.: PGR2021-00088
`proceeding; that prior to any disclosure to such support staff I informed or will
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`inform them of the requirements of the Protective Order; that I am personally
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`responsible for the requirements of the terms of the Protective Order and I agree to
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`submit to the jurisdiction of the Office and the United States District Court for the
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`Eastern District of Virginia for purposes of enforcing the terms of the Protective
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`Order and providing remedies for its breach.
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`Signed ____________________________________________
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