UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`
` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`
`Inter Partes Review No. IPR2023-008841
`
`
`MOTION FOR AMENDED PROTECTIVE ORDER
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`1 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`
` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`
`Inter Partes Review No. IPR2023-008841
`
`
`MOTION FOR AMENDED PROTECTIVE ORDER
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`1 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
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`IPR2023-00884
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`
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`Patent Owner Regeneron Pharmaceuticals, Inc. moves for entry of the
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`Amended Protective Order, filed concurrently as Ex. 2245. The amended
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`protective order includes an “Outside Counsel Only” tier for highly confidential
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`information. Good cause exists to so amend the protective order because
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`Regeneron will be producing highly confidential documents related to its recent
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`strategic decision-making and its proprietary manufacturing process.
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`I.
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`PROCEDURAL BACKGROUND
`Regeneron is litigating the ’572 and other patents in the Northern District of
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`West Virginia in several actions, including in Regeneron Pharmaceuticals, Inc. v.
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`Mylan Pharmaceuticals Inc., No. 1:22-cv-00061-TSK (N.D. W.Va.) (“Mylan
`
`Litigation”). A trial was held in that case in June 2023.
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`In the present IPR, Petitioner Samsung Bioepis Co., Ltd requested additional
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`discovery of deposition and trial exhibits from the Mylan Litigation. Ex.1070,
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`11-12. Many of the requested materials were produced in the Mylan Litigation
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`subject to the protective order in that litigation. Some were designated “Outside
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`Counsel’s Eyes Only.” When Regeneron noted this fact, Samsung “agree[d] that
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`documents produced on an Outside Counsel’s Only basis in the Mylan Litigation
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`can be designated as Outside Counsel’s Eye[]s Only in this IPR.” Ex.1070, 8.
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`The Board granted Samsung’s motion for additional discovery on May 23,
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`2024. Paper 58. The Board ordered Regeneron to produce the requested documents
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`1
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`IPR2023-00884
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`by May 31, 2024 and invited the parties to request a modified protective order if
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`necessary. Paper 58 at 10-11.
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`II. GOOD CAUSE EXISTS TO AMEND THE PROTECTIVE ORDER
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`The Board may issue a protective order “for good cause” in order “to protect
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`a party from disclosing confidential information.” 37 C.F.R. § 42.54. The
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`protective order may require “that a trade secret or other confidential research,
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`development, or commercial information not be revealed or be revealed only in a
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`specified way.” 37 C.F.R. § 42.54(a)(7).
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`Good cause exists to amend the protective order. The additional discovery
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`Regeneron will serve encompasses highly confidential information. Regeneron
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`does not believe that the Board’s default protective order, which currently governs
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`this IPR, offers an adequate level of protection for these materials. For example,
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`Regeneron will produce the following:
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` A 2018 internal PowerPoint presentation describing the potential
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`commercial effects of biosimilar competition and Regeneron’s strategic
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`responses to such competition, as well as deposition testimony about the
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`same.
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` Interrogatory responses describing Regeneron’s manufacturing processes.
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`Regeneron developed new manufacturing processes within the last ten
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`years, aspects of which are Regeneron’s trade secrets.
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`2
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`IPR2023-00884
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`
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`Some of the requested documents were produced subject to “Outside Counsel’s
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`Eyes Only” protective order provisions in the Mylan Litigation. Regeneron would
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`be harmed if its competitors obtained this information and intentionally or
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`inadvertently misused or disclosed it. The default protective order does not restrict
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`the party itself from accessing confidential information, which creates a risk of
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`widespread distribution within the company, and in turn a risk of disclosure or
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`misuse of Regeneron’s confidential information.
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`The Regeneron and Samsung have agreed to a protective order that
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`addresses Regeneron’s concern. Ex.2045; Appendix A (redline comparison to
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`default protective order). The proposed protective order includes heightened
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`“Outside Counsel Only” protections for highly confidential information.
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`III. CERTIFICATION
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`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
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`Petitioners regarding this motion for a protective order. Samsung does not object
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`to the motion. Petitioners Celltrion Inc. and Biocon Biologics Inc. have not
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`responded with their position.
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`3
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`IPR2023-00884
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`
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`Dated: 5/31/2024
`
`Respectfully submitted,
`
`By: /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`
`Counsel for Patent Owner
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`4
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`IPR2023-00884
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached MOTION FOR AMENDED
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`PROTECTIVE ORDER was served as of the below date via email on the
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`Petitioner (by agreement) at the following correspondence address:
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Richard W. Erwine (Reg. No 41,737)
`Matthew A. Traupman (Reg. No. 50,832)
`Laura Fairneny (pro hac vice granted)
`Elliot Choi (pro hac vice granted)
`Zachariah Summers (pro hac vice granted)
`Sarah Cork (pro hac vice to be applied for)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`Email: raynimrod@quinnemanuel.com Email:
`richarderwine@quinnemanuel.com Email:
`matthewtraupman@quinnemanuel.com Email:
`laurafairneny@quinnemanuel.com Email:
`elliotchoi@quinnemanuel.com
`Email: zachsummers@quinnemanuel.com
`Email: landonsmith@quinnemanuel.com
`Email: qe-samsungbioepis@quinnemanuel.com
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy (pro hac vice to be filed)
`Deanne M. Mazzochi (Reg. No. 50,158) Heinz
`J. Salmen (pro hac vice to be filed) Eric R.
`Hunt (pro hac vice to be filed)
`Neil B. McLaughlin (Reg. No. 70,810) Lauren
`M. Lesko (pro hac vice to be filed)
`
`5
`
`
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`IPR2023-00884
`
`
`
`
`
`L. Scott Beall (Reg. No. 52,601)
`Thomas H. Ehrich (Reg. No. 67,122)
`Steven J. Birkos (Reg. No. 65,300)
`Jake R. Ritthamel (pro hac vice to be filed)
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone: (312) 527-2157
`Facsimile: (312) 843-6260
`MYL_REG_IPR@rmmslegal.com
`
`Lora Green (Reg. No. 43,541)
`Yahn-Lin Chu (Reg. No. 75,946)
`Robert Cerwinski (to be admitted pro hac vice, pending)
`Aviv Zalcenstein (to be admitted pro hac vice, pending)
`Brigid Morris (to be admitted pro hac vice, pending)
`Gemini Law LLP
`40 W 24th Street, Suite 6N
`New York, NY 10010
`Tel.: 917-915-8832
`Email: lgreen@geminilaw.com
`Email: fchu@geminilaw.com
`Email: rcerwinski@geminilaw.com
`Email: azalcenstein@geminilaw.com
`Email: bmorris@geminilaw.com
`
`
`Dated: 5/31/2024
`
`
`
` /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
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`6
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`Appendix A
`Appendix A
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`Inter Partes Review No. IPR2023-008841
`
`____________________________________________________________
`
`AMENDED PROTECTIVE ORDE
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`1 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
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`1
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`
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`DEFAULT AMENDED PROTECTIVE ORDER
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`This protective order governs the treatment and filing of confidential information,
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`
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`including documents and testimony.
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`1. Confidential information shall be clearly marked “PROTECTIVE
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`ORDER MATERIAL.” or “PROTECTIVE ORDER MATERIAL – OUTSIDE
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`COUNSEL ONLY.”
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`
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`2. Access to confidential information marked “PROTECTIVE ORDER
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`MATERIAL” is limited to the following individuals who have executed the
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`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,
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`or a consultant for, or employed by, such a competitor with respect to the
`
`subject matter of the proceeding.
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`(D) In-house counsel. In-house counsel of a party.
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`2
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`
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`(E) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other 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. Access to confidential information marked “PROTECTIVE ORDER
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`MATERIAL – OUTSIDE COUNSEL ONLY” is limited to the following
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`individuals who have executed the acknowledgment appended to this order:
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`(A) Party Representatives. Representatives of record for a party, who have
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`appeared in the proceeding (IPR2023-00884) as of May 31, 2024, who are
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`not also in-house counsel for a party.
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`3
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`(B) Experts. Retained experts of a party in the proceeding who (1) are not
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`current employees of a party, (2) at the time of retention, are not anticipated
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`to become officers, directors, or employees of a Party, and (3) are not a
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`competitor to any party, or a consultant for, or employed by, such a
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`competitor with respect to the subject matter of the proceeding.
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`(C) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other 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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`(D) 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
`
`Acknowledgement. Such employees and representatives shall include the
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`Director, members of the Board and their clerical staff, other support
`
`personnel, court reporters, and other persons acting on behalf of the Office.
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`For clarity, the omission of in-house counsel from this list of individuals is
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`intended to preclude in-house counsel for the non-disclosing party from accessing
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`the disclosing party’s confidential information; it is not intended to preclude in-
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`4
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`house counsel for a disclosing party from accessing the disclosing party’s own
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`confidential information. The “PROTECTIVE ORDER MATERIAL – OUTSIDE
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`COUNSEL ONLY” designation shall be applied only to confidential information
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`that has not been made publicly available and that is competitively sensitive—i.e.,
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`if disclosed, could reasonably be used to inform or guide business decisions that
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`would compete with or otherwise harm the designating party.
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`
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`4. Employees (e.g., corporate officers), consultants, or other persons
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`performing work for a party, other than those persons identified above in
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`(d)(Paragraphs 2)((A)–(E) and 3(A)-(C), shall be extended access to confidential
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`information only upon agreement of the parties or by order of the Board upon a
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`motion brought by the party seeking to disclose confidential information to that
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`person and after signing the Acknowledgment. The party opposing disclosure to
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`that person shall have the burden of proving that such person should be restricted
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`from access to confidential information.
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`
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`45. 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
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`not authorized to receive the information shall not have access;
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`5
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of
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`the information, which efforts shall be no less rigorous than those the
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`recipient uses to maintain the confidentiality of information not received
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`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
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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 number
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`of copies needed for conduct of the proceeding and maintaining a record of
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`the locations of such copies.
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`
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`56. 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 of
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`6
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`
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`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
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`or 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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`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. Documents
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`(including deposition transcripts) and other information designated as
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`confidential that are disclosed to another party during discovery or other
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`proceedings before the Board shall be clearly marked as “PROTECTIVE
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`ORDER MATERIAL” or “PROTECTIVE ORDER MATERIAL –
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`7
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`OUTSIDE COUNSEL ONLY” and shall be produced in a manner that
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`maintains its confidentiality.
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`67. 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 across to information covered by
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`the protective order:
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`8
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`_______________
`
`Inter Partes Review No. IPR2023-008842
`
`____________________________________________________________
`
`Standard Acknowledgement 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 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 to assist me in this proceeding; that prior to any disclosure to
`such support staff I informed or will inform them of the requirements of the Protective Order;
`that I am personally responsible for the requirements of the terms of the Protective Order 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 Protective Order and
`providing remedies for its breach.
`
`
`
`___________________________________
`[signature]
`
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`2 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
`
`9
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`
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