`
`
`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 ORDER
`
`
`1 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 1
`Samsung et al. v. Regeneron IPR2023-00884
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`AMENDED PROTECTIVE ORDER
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`This protective order governs the treatment and filing of confidential information,
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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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`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
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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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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 2
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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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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 3
`Samsung et al. v. Regeneron IPR2023-00884
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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
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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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`(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
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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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`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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`3
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 4
`Samsung et al. v. Regeneron IPR2023-00884
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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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`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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`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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`5. 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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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 5
`Samsung et al. v. Regeneron IPR2023-00884
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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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`6. 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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`5
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 6
`Samsung et al. v. Regeneron IPR2023-00884
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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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`6
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 7
`Samsung et al. v. Regeneron IPR2023-00884
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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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`7. 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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`7
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 8
`Samsung et al. v. Regeneron IPR2023-00884
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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
`
`____________________________________________________________
`
`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]
`
`2 IPR2024-00260 and IPR2024-00298 are joined with this proceeding.
`
`8
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`Regeneron Pharmaceuticals, Inc. Exhibit 2245 Page 9
`Samsung et al. v. Regeneron IPR2023-00884
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`