UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`v.
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`
`Case IPR2021-00816
`Patent 9,220,631
`
`
`SECOND MODIFIED DEFAULT PROTECTIVE ORDER
`
`
`
`Novartis Exhibit 2324.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`v.
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`
`Case IPR2021-00816
`Patent 9,220,631
`
`
`SECOND MODIFIED DEFAULT PROTECTIVE ORDER
`
`
`
`Novartis Exhibit 2324.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`SECOND MODIFIED DEFAULT PROTECTIVE ORDER
`
`This protective order governs the treatment and filing of confidential and
`
`Outside Counsel Only information, including documents and testimony.
`
`1.
`
`Confidential information shall be clearly marked “CONTAINS
`
`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE
`
`ORDER.”
`
`2.
`
`Access to confidential information is limited to the following
`
`individuals who have executed the acknowledgment appended to this order:
`
`(A) Party Representatives. Representatives of record for a party in the
`
`proceeding.
`
`(B) Experts. Retained experts of a party in the proceeding who further
`
`certify in the Acknowledgement that they are not a competitor to any
`
`party, or a consultant for, or employed by, such a competitor with
`
`respect to the subject matter of the proceeding.
`
`(C)
`
`In-house counsel. Two in-house counsel representatives of a party.
`
`(D) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who
`
`are reasonably necessary to assist those persons in the proceeding
`
`shall not be required to sign an Acknowledgement, but shall be
`
`
`
`2
`
`Novartis Exhibit 2324.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`informed of the terms and requirements of the Protective Order by the
`
`person they are supporting who receives confidential information.
`
`(E) The Office. Employees and representatives of the United States
`
`Patent and Trademark Office who have a need for access to the
`
`confidential information shall have such access without the
`
`requirement to sign an Acknowledgement. Such employees and
`
`representatives shall include the Director, members of the Board and
`
`their clerical staff, other support personnel, court reporters, and other
`
`persons acting on behalf of the Office.
`
`3.
`
`Outside Counsel Only information shall be clearly marked
`
`“CONTAINS OUTSIDE COUNSEL ONLY INFORMATION, SUBJECT TO
`
`PROTECTIVE ORDER.” Outside Counsel Only information includes
`
`documents produced by Third Parties in Certain Pre-Filled Syringes for
`
`Intravitreal Injection & Components Thereof, ITC Investigation No. 337-TA-
`
`1207 (“the ITC Investigation”), deposition transcripts of Third Party
`
`witnesses in the ITC Investigation and exhibits thereto, and declarations of
`
`Third Party witnesses in the ITC Investigation.
`
`4.
`
`Access to Outside Counsel Only information is limited to the
`
`following individuals who have executed the acknowledgement appended to
`
`this order:
`
`
`
`3
`
`Novartis Exhibit 2324.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
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`
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`(A) Party Representatives. Representatives of record for a party in
`
`the proceeding, excluding any in-house counsel who are of record.
`
`(B) Experts. Retained experts of a party in the proceeding who
`
`further certify in the Acknowledgement that they are not a
`
`competitor to any party, or a consultant for, or employed by, such
`
`a competitor with respect to the subject matter of the proceeding.
`
`(C) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons
`
`who are reasonably necessary to assist those persons in the
`
`proceeding shall not be required to sign an Acknowledgement, but
`
`shall be informed of the terms and requirements of the Protective
`
`Order by the person they are supporting who receives Outside
`
`Counsel Only information.
`
`(D) The Office. Employees and representatives of the United States
`
`Patent and Trademark Office who have a need for access to the
`
`confidential information shall have such access without the
`
`requirement to sign an Acknowledgement. Such employees and
`
`representatives shall include the Director, members of the Board
`
`and their clerical staff, other support personnel, court reporters,
`
`and other persons acting on behalf of the Office.
`
`4
`
`Novartis Exhibit 2324.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`5.
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`3. Employees (e.g., corporate officers), consultants, or other persons
`
`performing work for a party, other than those persons identified above in 2(A)–(D)
`
`or 4(A)- (C), shall be extended access to confidential and Outside Counsel Only
`
`information, respectively, only upon agreement of the parties (including
`
`agreement by any Third Party in the case of Outside Counsel Only
`
`Information) or by order of the Board upon a motion brought by the party seeking
`
`to disclose confidential information to that person and after signing the
`
`Acknowledgment. The party opposing disclosure to that person shall have the
`
`burden of proving that such person should be restricted from access to confidential
`
`or Outside Counsel Only information.
`
`6.
`
`4. Persons receiving confidential or Outside Counsel Only
`
`information shall use reasonable efforts to maintain the confidentiality of the
`
`information, including:
`
`(A) Maintaining such information in a secure location to which persons
`
`not authorized to receive the information shall not have access;
`
`(B) Otherwise using reasonable efforts to maintain the confidentiality of
`
`the information, which efforts shall be no less rigorous than those the
`
`recipient uses to maintain the confidentiality of information not
`
`received from the disclosing party;
`
`
`
`5
`
`Novartis Exhibit 2324.005
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`(C) Ensuring that support personnel of the recipient who have access to
`
`the confidential information understand and abide by the obligation to
`
`maintain the confidentiality of information received that is designated
`
`as confidential; and
`
`(D) Limiting the copying of confidential or Outside Counsel Only
`
`information to a reasonable number of copies needed for conduct of
`
`the proceeding and maintaining a record of the locations of such
`
`copies.
`
`7.
`
`5. Persons receiving confidential or Outside Counsel Only
`
`information shall use the following procedures to maintain the confidentiality of
`
`the information:
`
`(A) Documents and Information Filed With the Board.
`
`(i) A party may file documents or information with the Board
`
`along with a Motion to Seal. The Motion to Seal should provide a
`
`non-confidential description of the nature of the confidential
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`information that is under seal, and set forth the reasons why the
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`information is confidential and should not be made available to the
`
`public. A party may challenge the confidentiality of the information
`
`by opposing the Motion to Seal. The documents or information shall
`
`
`
`6
`
`Novartis Exhibit 2324.006
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`
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`remain under seal unless the Board determines that some 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
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`information submitted to the Board, the submitting party shall file
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`confidential and non-confidential versions of its submission, together
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`with a Motion to Seal the confidential or Outside Counsel Only
`
`version setting forth the reasons why the information redacted from
`
`the non-confidential version is confidential or designated Outside
`
`Counsel Only and should not be made available to the public. A
`
`party may challenge the confidentiality of the information by
`
`opposing the Motion to Seal. The non-confidential version of the
`
`submission shall clearly indicate the locations of information that has
`
`been redacted. The confidential or Outside Counsel Only version of
`
`the submission shall be filed under seal. The redacted information
`
`shall remain under seal unless the Board determines that some or all
`
`of the redacted information does not qualify for confidential or
`
`Outside Counsel Only treatment.
`
`(B) Documents and Information Exchanged Among the Parties.
`
`Documents (including deposition transcripts) and other information
`
`designated as confidential that are disclosed to another party during
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`7
`
`Novartis Exhibit 2324.007
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
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`discovery or other proceedings before the Board shall be clearly
`
`marked as “CONTAINS CONFIDENTIAL BUSINESS
`
`INFORMATION, SUBJECT TO PROTECTIVE ORDER” and shall
`
`be produced in a manner that maintains its confidentiality.
`
`Documents (including deposition transcripts) and other
`
`information designated as Outside Counsel Only that are
`
`disclosed to another party during discovery or other proceedings
`
`before the Board shall be clearly marked as “OUTSIDE
`
`COUNSEL ONLY, SUBJECT TO PROTECTIVE ORDER” and
`
`shall be produced in a manner that maintains its confidentiality.
`
`8.
`
`6. Within 60 days after the final disposition of this action, including
`
`the exhaustion of all appeals and motions, each party receiving confidential
`
`information must return, or certify the destruction of, all copies of the confidential
`
`information to the producing party.
`
`
`
`
`
`
`
`8
`
`Novartis Exhibit 2324.008
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`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
`
`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.
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`
`
`Date:
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`
`
`
`
`
`
`
`9
`-
`
`Novartis Exhibit 2324.009
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Summary report:
`Litera Compare for Word 11.0.0.61 Document comparison done on
`1/18/2022 3:58:39 PM
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`Style name: Default Style
`Intelligent Table Comparison: Inactive
`Original filename: Ex. 2091.docx
`Modified filename: 2022.01.18_IPR2021-00816 Second Modified Protective
`Order.DOCX
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`Novartis Exhibit 2324.0010
`Regeneron v. Novartis, IPR2021-00816
`
`
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