`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-00881
`Patent 9,254,338 B2
`____________
`
`PATENT OWNER’S UNOPPOSED MOTION FOR ENTRY OF
`DEFAULT PROTECTIVE ORDER PURSUANT TO 37 C.F.R. § 42.54
`
`
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`IPR2021-00881
`Patent 9,254,338 B2
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`I.
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`MOTION FOR ENTRY OF DEFAULT PROTECTIVE ORDER
`Patent Owner Regeneron Pharmaceuticals, Inc. moves for entry of the Default
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`Protective Order found in Appendix B of the PTAB Consolidated Trial Practice
`
`Guide
`
`(November
`
`2019),
`
`available
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`at
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`https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf, which is appended
`
`hereto as Addendum A.
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`“[P]rotective orders may be issued for good cause by the Board to protect a
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`party from disclosing confidential information. 37 C.F.R. § 42.54.” PTAB
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`Consolidated Trial Practice Guide (November 2019) at 20. “Confidential
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`information [includes] trade secret or other confidential research, development, or
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`commercial information.” Id. at 19. Good cause exists here because Patent Owner
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`intends to submit non-public confidential research, development and commercial
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`information with its forthcoming Patent Owner’s Response that it seeks to maintain
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`as confidential.
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`II.
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`CERTIFICATE OF CONFERENCE
`Pursuant to 37 C.F.R. § 42.54, Patent Owner certifies that it has conferred
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`with Petitioner regarding this motion and Petitioner has indicated that it does not
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`object to the entry of the default protective order. Consequently, Patent Owner
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`respectfully requests that the Board’s default protective order be entered in this
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`proceeding.
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`IPR2021-00881
`Patent 9,254,338 B2
`
`Dated: February 3, 2022
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`Respectfully Submitted,
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
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`IPR2021-00881
`Patent 9,254,338 B2
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`ADDENDUM A
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`
`____________
`
`Case IPR2021-00881
`Patent 9,254,338 B2
`____________
`
`DEFAULT PROTECTIVE ORDER
`
`This protective order governs the treatment and filing of confidential
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`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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`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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`IPR2021-00881
`Patent 9,254,338 B2
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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,
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`or a consultant for, or employed by, such a competitor with respect to the
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`subject matter of the proceeding.
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`(D) In-house counsel. In-house counsel of a party.
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`(E) Support Personnel. Administrative assistants, clerical staff, court
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`reporters another support personnel of the foregoing persons who are
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`reasonably necessary to assist those persons in the proceeding shall not be
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`required to sign an Acknowledgement, but shall be informed of the terms
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`and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`(F) The Office. Employees and representatives of the United States Patent
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`and Trademark Office who have a need for access to the confidential
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`information shall have such access without the requirement to sign an
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`Acknowledgement. Such employees and representatives shall include the
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`Director, members of the Board and their clerical staff, other support
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`personnel, court reporters, and other persons acting on behalf of the Office.
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`3. Employees (e.g., corporate officers), consultants, or other persons
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`IPR2021-00881
`Patent 9,254,338 B2
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`performing work for a party, other than those persons identified above in (d)(2)(A)–
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`(E), shall be extended access to confidential information only upon agreement of
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`the parties or by order of the Board upon a motion brought by the party seeking to
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`disclose confidential information to that person and after signing the
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`Acknowledgment. The party opposing disclosure to that person shall have the
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`burden of proving that such person should be restricted from access to confidential
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`information.
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`4. 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
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`uses to maintain the confidentiality of information not received from the
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`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
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`the confidentiality of information received that is designated as confidential;
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`and
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`(D) Limiting the copying of confidential information to a reasonable
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`IPR2021-00881
`Patent 9,254,338 B2
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`number of copies needed for conduct of the proceeding and maintaining a
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`record of the locations of such copies.
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`5. 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 along with a
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`Motion to Seal. The Motion to Seal should provide a non-confidential
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`description of the nature of the confidential information that is under seal,
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`and set forth the reasons why the information is confidential and should not
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`be made available to the public. A party may challenge the confidentiality
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`of the information by opposing the Motion to Seal. The documents or
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`information shall remain under seal unless the Board determines that some or
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`all of it does not 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
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`from the non-confidential version is confidential and should not be made
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`available to the public. A party may challenge the confidentiality of the
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`information by opposing the Motion to Seal. The non-confidential version of
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`IPR2021-00881
`Patent 9,254,338 B2
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`the submission shall clearly indicate the locations of information that has
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`been redacted. The confidential version of the submission shall be filed
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`under seal. The redacted information shall remain under seal unless the
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`Board determines that some or all of the redacted information does not
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`qualify for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties.
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`Documents(including deposition transcripts) and other information
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`designated as confidential that are disclosed to another party during
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`discovery or other proceedings before the Board shall be clearly marked as
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`“PROTECTIVE ORDER MATERIAL” and shall be produced in a manner
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`that maintains its confidentiality.
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`6. Within 60 days after the final disposition of this action, including the
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`exhaustion of all appeals and motions, each party receiving confidential
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`information must return, or certify the destruction of, all copies of the confidential
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`information to the producing party.
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`(k) Standard Acknowledgement of Protective Order. The following form may be
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`used to acknowledge a protective order and gain access to information covered by
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`the protective order:
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`IPR2021-00881
`Patent 9,254,338 B2
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`v.
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner
`____________
`
`Case IPR2021-00881
`Patent 9,254,338 B2
`____________
`
`Standard Acknowledgment for Access to Protective Order Material
`
`I
`
`, affirm that I have
`
`read the Protective Order; that I will abide by its terms; that I will use the
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`confidential information only in connection with this proceeding and for no other
`
`purpose; that I will only allow access to support staff who are reasonably necessary
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`to assist me in this proceeding; that prior to any disclosure to such support staff I
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`informed or will inform them of the requirements of the Protective Order; that I am
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`personally responsible for the requirements of the terms of the Protective Order
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`and I agree to submit to the jurisdiction of the Office and the United States District
`
`Court for the Eastern District of Virginia for purposes of enforcing the terms of the
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`Protective Order and providing remedies for its breach.
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`[Signature]
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`IPR2021-00881
`Patent 9,254,338 B2
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e)(4)(i) et seq. and 42.105(b), the undersigned
`
`Certifies that on February 3, 2022, a true and entire copy of this UNOPPOSED
`
`MOTION FOR ENTRY OF DEFAULT PROTECTIVE ORDER, and all
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`supporting exhibits, were served via e-mail to the Petitioner at the following email
`
`addresses:
`
`MYL_REG_IPR@rmmslegal.com
`paul@ rmmslegal.com
`wrakoczy@ rmmslegal.com
`hsalmen@ rmmslegal.com
`nmclaughlin@rmmslegal.com
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`