`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`
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`REGENERON PHARMACEUTICALS, INC.,
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`CELLTRION INC.,
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`
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`Plaintiff,
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`v.
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`Defendant.
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`
`
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`Judge Thomas S. Kleeh
`
`No. 1:23-cv-89-TSK
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`
`
`REGENERON PHARMACEUTICALS, INC.’S AMENDED OBJECTIONS AND
`RESPONSES TO CELLTRION INC.’S FIRST SET OF REQUESTS FOR THE
`PRODUCTION OF DOCUMENTS AND THINGS TO REGENERON (NOS. 1–32)
`
`Pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure and Rule 34.01 of
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`the Local Rules of Civil Procedure, Plaintiff Regeneron Pharmaceuticals, Inc. (“Plaintiff” and/or
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`“Regeneron”), by and through its counsel, hereby submits the following amended objections and
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`responses to Defendant Celltrion Inc.’s (“Defendant” and/or “Celltrion”) Requests for the
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`Production of Documents and Things to Regeneron (Nos. 1–32) (“Requests”).
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`These objections and responses are based on information currently available and without
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`prejudice to Regeneron’s right to produce evidence of any subsequently discovered fact or
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`information, to add, modify, or otherwise change, amend, or supplement its responses as
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`appropriate, or to correct any inadvertent errors, mistakes, or omissions.
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`GENERAL OBJECTIONS
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`1.
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`Regeneron incorporates by reference these General Objections into each and
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`every specific response below. A specific response may repeat a General Objection for emphasis
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`or for other reasons. The omission of any General Objection in any specific response to a
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 2 of 35 PageID #: 16034
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`Request is not intended to be and should not be construed as a waiver or limitation of any
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`General Objection to that response.
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`2.
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`Regeneron objects to the Instructions and Definitions to the extent that they
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`seek to impose on Regeneron any requirement or discovery obligation greater or different than
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`those imposed by the Court, the Federal Rules of Civil Procedure, or the Local Rules of the
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`United States District Court for the Northern District of West Virginia (collectively, the
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`“Rules”).
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`3.
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`Regeneron objects to each Request to the extent that it seeks information
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`(including electronically stored information) or documents that are already in the possession,
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`custody, or control of Defendant or counsel for Defendant, or to the extent that it seeks
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`information or documents that are in the public domain and would be no more burdensome for
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`Defendant to obtain than for Regeneron to obtain. Unless otherwise specifically indicated
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`below, Regeneron will not produce any such information or documents.
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`4.
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`Regeneron objects to each Request to the extent that it seeks any document or
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`electronically stored information that is not within the possession, custody, or control of
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`Regeneron.
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`5.
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`Regeneron objects to producing documents in response to any Requests or any
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`parts of Requests relating to patents not currently at issue in the litigation, as set forth in the
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`Court’s Scheduling Order of January 9, 2024 (ECF No. 61). Regeneron only will produce
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`documents in response to Requests or parts of Requests to the extent they relate to the PI Patents
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`currently at issue in this initial phase of the litigation.
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`6.
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`Regeneron objects to each Request to the extent that it seeks “each” or “any”
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`or “all” documents and electronically stored information responsive to the Request. Such
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`2
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 3 of 35 PageID #: 16035
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`demands are unduly burdensome and overly broad, and they seek documents and electronically
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`stored information that are not relevant to the claims or defenses of any party nor proportional to
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`the needs of the case. Regeneron will consider as responsive to any Request that seeks
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`documents or things “concerning,” “reflecting,” “regarding,” or “relating” (or similar language)
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`to a designated subject only those documents or things that discuss the subject on their face.
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`7.
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`In furnishing these objections and responses to these Requests and in
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`producing documents and electronically stored information in response to these Requests,
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`Regeneron does not admit or concede the relevance, materiality, authenticity, or admissibility in
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`evidence of any such Request, document, or electronically stored information. All objections to
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`the use, at trial or otherwise, of any document produced or information provided in response to
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`the Requests are hereby expressly reserved.
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`8.
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`Regeneron’s statements that it will produce documents in response to a
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`particular Request do not mean that it has any such documents, and its response should not be
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`construed in such a manner.
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`9.
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`Regeneron objects to each Request to the extent that it uses language
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`incorporating or calling for a legal conclusion or making an erroneous statement of law. By
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`incorporating the need to make a legal conclusion or erroneous statement of law, such Requests
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`are vague and ambiguous. Such Requests also intrude upon the attorney work product protection
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`by seeking an identification of the information that counsel believes satisfies the legal
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`contention. Regeneron’s responses herein shall be as to matters of fact only, and shall not be
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`construed as stating or implying any conclusions of law concerning the matters referenced in any
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`Request or concerning any matter relevant to this litigation.
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`10.
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`Regeneron objects to each Request to the extent that it prematurely seeks
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`3
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 4 of 35 PageID #: 16036
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`production of information to be provided during later expert discovery. Regeneron will not
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`prematurely produce documents or information that are to be provided during later expert
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`discovery.
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`11.
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`Regeneron objects to each Request to the extent that it calls for the production
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`of documents or disclosure of electronically stored information protected by any privilege,
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`including, without limitation, the attorney-client privilege, the work product doctrine, the
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`common interest privilege, or any other available and valid grounds for withholding documents
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`and electronically stored information from production. Regeneron will not produce such
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`privileged documents or information—all Requests have been read to exclude the discovery
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`and/or production of such privileged information and documents, and any indication by
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`Regeneron that it will produce documents or electronically stored information, including in these
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`responses, shall be read to exclude the production of such privileged documents and information.
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`Regeneron objects to any Request that it log communications with litigation counsel retained to
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`handle patent litigation and inter partes review and post-grant review proceedings, including
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`counsel at Williams & Connolly, Arnold & Porter, Carey Douglas Kessler & Ruby PLLC,
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`Kellogg, Hansen, Todd, Figel & Frederick: P.L.L.C., Weil, Gotshal & Manges LLP, Morrison
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`Foerster, and Bienert Katzman Littrell Williams LLP. Regeneron objects to Defendant’s
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`Instruction No. 7 regarding the logging of withheld documents as imposing on Regeneron a
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`burden of production greater than that provided in the Rules (in accordance with Fed. R. Civ. P.
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`26(b)(5)). Regeneron will not produce any privilege logs at this time. It is willing to meet and
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`confer with Celltrion regarding the production and form of any logs at an appropriate time.
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`12.
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`Regeneron objects to each Request to the extent that it seeks information or
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`documents containing private, confidential, secret, trade secret, proprietary, and/or sensitive
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`4
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 5 of 35 PageID #: 16037
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`business information of Regeneron, its employees, and/or third parties (hereinafter referred to as
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`“Confidential Information”). Regeneron will only disclose Confidential Information, including
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`trade secret, proprietary, personal, commercially sensitive, third-party confidential, or other
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`confidential information, that is responsive, relevant, and not otherwise protected, with the
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`understanding that these documents should be treated on an Outside Counsel’s Eyes Only basis
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`until entry of a protective order in this case, at which time they may be treated according to the
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`protective order and consistent with their confidentiality branding . Regeneron may withhold
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`information or documents on this basis, and Regeneron may redact Confidential Information
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`from documents that it has otherwise agreed to produce. For example, Regeneron will exclude
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`personnel file materials such as evaluations and reviews because those documents lack relevance
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`and reflect sensitive, personal information. Regeneron may, for its sole convenience, produce
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`documents and/or information in response to a Request without agreeing that other, similar
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`documents or information in its possession, custody, or control are responsive and without
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`waiving any objections it may have to the production of such documents or information.
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`13.
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`Regeneron may, in response to particular Requests, refer to or produce
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`documents from custodians or non-custodial sources located outside the United States. Foreign
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`privacy laws, over which Regeneron has no control, may have a substantial impact on the nature
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`and extent of information or documents that Regeneron can disclose or produce from such
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`sources. Regeneron objects to the Requests to the extent that they call for production of
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`information from any jurisdiction outside that United States that (i) pertains to a specific
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`individual that can be linked to that individual; or (ii) is reasonably believed by Regeneron to
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`contain information about or pertaining to a specific individual that can be linked to that
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`individual and that reveals race, ethnic origin, sexual orientation, political opinions, religious or
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`5
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 6 of 35 PageID #: 16038
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`philosophical beliefs, trade union or political party membership or that concerns an individual’s
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`health. Regeneron is withholding such documents or information on this basis and will redact
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`such information from any documents that it produces in this action.
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`14.
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`Regeneron will withhold and redact Confidential Information from documents
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`and electronically stored information that it produces, to the extent that such Confidential
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`Information is not relevant to any claim or defense in this action. The Confidential Information
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`that Regeneron will withhold and/or redact may include, but is not limited to, Confidential
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`Information pertaining to individual patients involved in clinical trials; clinical trial
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`investigators’ personal information; the personal information of Regeneron’s employees; the
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`configuration of Regeneron’s information technology systems; Regeneron drugs not investigated
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`or developed as part of the development of Eylea®; and proprietary manufacturing information to
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`the extent not relevant to Regeneron’s claims. All of Regeneron’s responses should be read to
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`exclude the production of such documents and information.
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`15.
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`Regeneron objects to producing in response to each Request for Board of
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`Director minutes, presentations, and related documents, because the burden of reviewing and
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`producing such material is disproportionate to the needs of the case and such documents contain
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`highly commercially sensitive information.
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`16.
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`Regeneron objects to each Request to the extent that it seeks the production of
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`publicly available documents or electronically stored information gathered by counsel in
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`connection with litigation involving the PI Patents or Eylea®.
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`17.
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`Regeneron objects to each Request to the extent that it is not limited to a
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`particular time period.
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`18.
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`Regeneron objects to each Request to the extent that it seeks production of
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`6
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 7 of 35 PageID #: 16039
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`documents and electronically stored information relating to Regeneron’s aflibercept products in
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`countries other than the United States—including but not limited to documents and electronically
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`stored information relating to foreign counterparts to the PI Patents (including any foreign
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`litigation or patent office proceedings involving such patents), foreign regulatory documents, and
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`foreign sales and marketing information—on the grounds that such requests are overly broad,
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`unduly burdensome, and seek information not relevant to any party’s claim or defense nor
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`proportional to the needs of the case in accordance with Federal Rule of Civil Procedure
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`26(b)(1). Regeneron will not produce such documents and electronically stored information, and
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`Regeneron’s responses should be read to exclude the production of such documents and
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`electronically stored information.
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`19.
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`Regeneron objects to each Request to the extent that it calls for production of
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`documents or electronically stored information based on a subjective conclusion or
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`determination about what the document or information shows, means, supports, or contradicts.
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`Regeneron objects to each Request incorporating or calling for a subjective judgment that
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`information “supports” a particular issue or “refutes” a particular issue. Such Requests are
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`necessarily vague and ambiguous and may intrude upon the attorney work product protection by
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`seeking an identification of the information that counsel considers to support or refute a
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`particular position.
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`20.
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`Regeneron objects to Defendant’s definition of “Plaintiffs” as overly broad.
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`Regeneron will construe the Requests to require production of such documents or electronically
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`stored information to the extent that they are in Regeneron’s possession, custody, or control.
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`Regeneron will interpret all references to “Plaintiffs” to mean Regeneron Pharmaceuticals, Inc.
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`21.
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`Regeneron objects to Defendant’s Instruction No. 5 regarding the production
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`7
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 8 of 35 PageID #: 16040
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`of documents, including the requirement that Regeneron produce information such as “the
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`company, division, department, and/or individual from whose files the document is being
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`produced,” as imposing on Regeneron a burden of production greater than that provided in the
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`Rules. Regeneron will not be providing the information requested in Defendant’s Instruction No.
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`5.
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`22.
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`Regeneron’s responses herein are based on facts presently known to
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`Regeneron and represent a diligent and good faith effort to respond to the Requests based on the
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`claims and defenses currently at issue in the litigation. Further, Regeneron’s discovery and
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`investigation into the matters specified are ongoing. Accordingly, Regeneron reserves the right
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`to supplement, alter, or change its responses and objections and to produce additional responsive
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`information or documents, if any, that Regeneron has in its possession, custody, or control at the
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`time the Requests were propounded. Regeneron also reserves the right, at trial or during other
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`proceedings, to rely on documents, evidence, and other matters in addition to the documents or
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`information produced in response to these Requests, whether or not such documents, evidence,
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`or other matters are newly discovered or are now in existence but have not been identified or
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`produced despite diligent and good-faith efforts.
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`DEFINITIONS
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`1.
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`2.
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`3.
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`4.
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`“Furfine Patent” means U.S. Patent No. 11,084,865 (the ’865 patent).
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`“Cook Patent” means U.S. Patent No. 11,793,926 (“the ’926 patent”).
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`“PI Patents” means the Furfine and Cook Patents.
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`“Furfine Research & Development Documents” means non-privileged
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`documents that discuss or reflect the research and development of the formulations described or
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`claimed in the Furfine Patent, including related to the formulation of Eylea®.
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`8
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 9 of 35 PageID #: 16041
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`5.
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`“Cook Research & Development Documents” means non-privileged
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`documents that discuss or reflect the research and development of the subject matter described or
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`claimed in the Cook Patent.
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`6.
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`“PI Patents Research & Development Documents” means the Furfine Research
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`& Development Documents and the Cook Research & Development Documents.
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`7.
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`“Patent and Prosecution Documents” means a certified copy of each one of the
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`PI Patents and the file history of each one of the PI Patents.
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`8.
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`“Regulatory Documents” means copies of Modules 1–4 of Regeneron’s BLA
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`No. 125387 for Eylea®.
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`9.
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` “Marketing Documents” means non-privileged documents and
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`communications constituting a representative set of patient-facing and healthcare provider-facing
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`marketing materials for Eylea® identified through a reasonable search, including submissions to
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`the Office of Prescription Drug Promotion.
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`10.
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`“Financial Documents” means non-privileged documents and communications
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`sufficient to show Regeneron’s actual and forecasted sales, revenue, profit, and costs for Eylea®
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`from the period beginning January 1, 2020, and to the extent maintained in the ordinary course of
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`business.
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`11.
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`“Regeneron’s Aflibercept Biosimilar Litigation Productions” means documents
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`produced by Regeneron in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et
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`al., Civil Action No. 1:22-cv-00061-TSK (N.D. W. Va.), Regeneron Pharmaceuticals, Inc. v.
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`Samsung Bioepis, Co., Ltd., Civil Action No. 1:23-cv-00094-TSK (N.D. W. Va.), Regeneron
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`Pharmaceuticals, Inc. v. Samsung Bioepis Co., Ltd., Civil Action No. 1:23-cv-00106-TSK (N.D.
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`W. Va.), Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc., Civil Action No. 1:23-cv-00089-
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`
`
`9
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`
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 10 of 35 PageID #: 16042
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`TSK (N.D. W. Va.), Regeneron Pharmaceuticals, Inc. v. Formycon AG, Civil Action No. 1:23-
`
`cv-00097-TSK (N.D. W. Va.), and Regeneron Pharmaceuticals, Inc. v. Amgen, Inc., Civil
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`Action No. 2:24-cv-00264 (C.D. Cal.) excluding (1) documents that implicate third party
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`confidentiality obligations for which relevant permissions to re-produce have not yet been
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`obtained, (2) documents produced in connection with Regeneron’s expert reports regarding
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`infringement by Mylan, and (3) documents produced in response to Mylan’s Requests for
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`Production Nos. 144-151. Regeneron’s Aflibercept Biosimilar Litigation Productions include
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`the Furfine Research & Development Documents, the Regulatory Documents, the Marketing
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`Documents, and the Financial Documents.
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`12.
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`“Mylan Litigation Written Discovery” means the interrogatories and
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`responses, requests for admission and responses, and statements pursuant to 42 U.S.C.
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`§ 262(l)(3)(B) and 42 U.S.C. § 262(l)(3)(C) served in Regeneron Pharmaceuticals, Inc. v. Mylan
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`Pharmaceuticals Inc., et al., Civil Action No. 1:22-cv-00061-TSK-JPM (N.D. W. Va.) relating
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`to the PI Patents.
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`13.
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`“Mylan Litigation Trial Demonstratives” means the trial demonstratives used
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`by the parties during opening statements, closing arguments, and direct examinations in the 2023
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`trial in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al., Civil Action No.
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`1:22-cv-00061-TSK-JPM (N.D. W. Va.) to the extent those demonstratives relate to the PI
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`Patents.
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`14.
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`“Mylan Litigation Deposition Materials” means transcripts of and exhibits
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`from depositions in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al., Civil
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`Action No. 1:22-cv-00061-TSK-JPM (N.D. W. Va.) of Regeneron employees or experts and
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`relating to the PI Patents.
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`10
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 11 of 35 PageID #: 16043
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`15.
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`“Regeneron PI Commercial Materials” means non-privileged documents
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`sufficient to show Regeneron’s present aflibercept market research in the United States,
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`Regeneron’s aflibercept sales between 2020 and 2023 in the United States, Regeneron’s present
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`United States aflibercept sales forecasting, Eylea and Eylea HD’s present market share in the
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`United States, Regeneron’s present United States aflibercept market share forecasting,
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`Regeneron’s present aflibercept biosimilar competitive planning, Regeneron’s present aflibercept
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`pricing in the United States, and Regeneron’s present aflibercept pricing and contracting
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`planning for the United States market.
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`16.
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`“PI Patent PTO Materials” means non-public filings, deposition transcripts,
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`and deposition exhibits from inter partes review, post-grant review, or re-examination
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`proceedings concerning the PI Patents.
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`17.
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`“Mylan Litigation Expert Reports” means the expert reports served in
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`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., et al., Civil Action No. 1:22-
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`cv-00061-TSK-JPM (N.D. W. Va.) relating to the PI Patents and excluding reports relating
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`solely to the commercial success of the inventions claimed in such patents.
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`11
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 12 of 35 PageID #: 16044
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`SPECIFIC OBJECTIONS AND RESPONSES TO REQUESTS FOR PRODUCTION
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`
`REQUEST NO. 1
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`All documents and things produced by Regeneron in the Mylan Litigation, the Formycon
`Litigation, Amgen Litigation, and the Samsung Litigations.
`RESPONSE TO REQUEST NO. 1:
`
`Regeneron incorporates each of its General Objections as if fully set forth herein.
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`Regeneron objects to this Request on the ground that it seeks documents or things not relevant to
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`any party’s claim or defense and is unduly burdensome, overly broad, and not proportionate to
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`the needs of the case, including because it seeks materials unrelated to the PI Patents or other
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`subjects at issue in the preliminary injunction phase of the present litigation.
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`Subject to the foregoing general and specific objections Regeneron will produce
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`Regeneron’s Aflibercept Biosimilar Litigation Productions.
`
`REQUEST NO. 2
`All documents and things that relate to, support, refute, contradict, or concern
`Regeneron’s contention that Regeneron would experience economic or irreparable harm if the
`Court were to deny a preliminary injunction preventing Celltrion from making, using, offering to
`sell, or selling the Celltrion Product upon approval.
`RESPONSE TO REQUEST NO. 2:
`
`Regeneron incorporates each of its General Objections as if fully set forth herein.
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`Regeneron objects to this Request to the extent that it seeks documents and things protected by
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`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
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`other applicable privilege.
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`Subject to the foregoing general and specific objections Regeneron will produce
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`Regeneron PI Commercial Materials as well as Regeneron’s Aflibercept Biosimilar Litigation
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`Productions, which include the Financial Documents and Marketing Documents; and any non-
`
`
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`12
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 13 of 35 PageID #: 16045
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`public documents or things cited in any briefing or fact witness or expert declarations submitted
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`in support of Regeneron’s motion for preliminary injunction in this matter.
`
`REQUEST NO. 3
`All documents and things concerning the bases of Regeneron’s contention(s) that
`Celltrion infringes or will infringe the Identified Patents, including without limitation, any
`opinions or analyses that compare the Celltrion Product to any claim of the Identified Patents,
`and all documents and things which support, refute, or contradict Regeneron’s contention that
`Celltrion infringes or will infringe the Identified Patents.
`RESPONSE TO REQUEST NO. 3:
`
`Regeneron incorporates each of its General Objections as if fully set forth herein.
`
`Regeneron objects to this Request to the extent that it seeks documents and things protected by
`
`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
`
`other applicable privilege. Regeneron objects to this Request on the grounds that it is overly
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`broad, unduly burdensome, and not proportional to the needs of the case. Regeneron further objects
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`to this Request as premature to the extent it seeks an expert determination or information more
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`appropriately sought through expert discovery.
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`Subject to the foregoing general and specific objections, Regeneron will produce any
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`non-public documents or things not already in Defendant’s possession, custody or control and
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`that are cited in any briefing or fact witness or expert declarations submitted in support of
`
`Regeneron’s motion for preliminary injunction in this matter, including non-public documents or
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`things cited in any briefing or fact witness or expert declarations submitted in support of
`
`Regeneron ’s allegations that the PI Patents are infringed or will be infringed by Celltrion.
`
`REQUEST NO. 4
`All documents and things concerning, or produced by Regeneron, in any prior U.S.
`federal litigation, proceedings before the United States Patent and Trademark Office, any foreign
`litigation, or any proceedings before any foreign patent office or other administrative entity,
`relating to any of the Identified Patents, or aflibercept, including all correspondence, pleadings,
`
`
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`13
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 14 of 35 PageID #: 16046
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`demonstratives, reports, expert reports, validity or invalidity opinions, including opinions of
`counsel regarding the validity or invalidity of the Identified Patents; expert opinions, discovery
`responses, prior art identified by any party, documents concerning validity, including validity
`and invalidity contentions, transcripts, and all documents produced by Regeneron in those
`litigations, including without limitation: the unredacted decision in the Mylan Litigation,
`demonstratives relied upon by Regeneron in the Mylan Litigation, the final pretrial Order and
`pre- and post-trial briefing in the Mylan Litigation, the 3(B) and 3(C) contentions from the
`Mylan Litigation, interrogatory or RFA responses served by Regeneron in the Mylan Litigation,
`and any prior art relied upon by Mylan or Regeneron in the Mylan Litigation.
`RESPONSE TO REQUEST NO. 4:
`
`Regeneron incorporates each of its General Objections as if fully set forth herein.
`
`Regeneron objects to this Request to the extent that it seeks documents and things protected by
`
`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
`
`other applicable privilege. Regeneron objects to this Request on the ground that it seeks
`
`documents or things not relevant to any party’s claim or defense and is unduly burdensome,
`
`overly broad, and not proportionate to the needs of the case, including because it seeks
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`information, documents, and things unrelated to the PI Patents or other subjects at issue in the
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`preliminary injunction phase of the present litigation. Regeneron further objects to this request
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`as unduly burdensome because it seeks documents from “any prior U.S. federal litigation,
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`proceedings before the United States Patent and Trademark Office, any foreign litigation, or any
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`proceedings before any foreign patent office or other administrative entity,” and it seeks
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`documents containing third-party confidential information.
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`Subject to the foregoing general and specific objections, Regeneron will produce
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`Regeneron’s Aflibercept Biosimilar Litigation Productions; Mylan Litigation Expert Reports,
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`subject to confirmation by Mylan that these materials do not contain Mylan confidential
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`information or as redacted by Mylan to remove Mylan confidential information; Mylan
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`Litigation Deposition Materials, subject to confirmation by Mylan that these materials do not
`
`contain Mylan confidential information or as redacted by Mylan to remove Mylan confidential
`
`
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`14
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 15 of 35 PageID #: 16047
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`information; and Mylan Litigation Trial Demonstratives, subject to confirmation by Mylan that
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`these materials do not contain Mylan confidential information or as redacted by Mylan to remove
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`Mylan confidential information.
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`REQUEST NO. 5
`All records concerning the alleged invention of the subject matter described or covered
`by the Identified Patents including, without limitation, laboratory notebooks, invention
`disclosure forms, and invention records.
`RESPONSE TO REQUEST NO. 5:
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`Regeneron incorporates each of its General Objections as if fully set forth herein.
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`Regeneron objects to this Request to the extent that it seeks documents and things protected by
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`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
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`other applicable privilege. Regeneron objects to this Request on the ground that it seeks
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`documents or things not relevant to any party’s claim or defense and is unduly burdensome,
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`overly broad, and not proportionate to the needs of the case, including to the extent it requests
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`documents “concerning the alleged invention of the subject matter described or covered by the
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`Identified Patents including, without limitation, laboratory notebooks, invention disclosure
`
`forms, and invention records” from an unlimited number of sources and not limited to a
`
`particular time period.
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`Subject to the foregoing general and specific objections, Regeneron will produce
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`Regeneron’s Aflibercept Biosimilar Litigation Productions and Cook Research & Development
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`Documents.
`
`REQUEST NO. 6
`All documents and opinions on which Regeneron or its experts intend to rely in in a
`motion for a preliminary injunction.
`RESPONSE TO REQUEST NO. 6:
`
`
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`15
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 16 of 35 PageID #: 16048
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`Regeneron incorporates each of its General Objections as if fully set forth herein.
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`Regeneron objects to this Request to the extent that it seeks documents and things protected by
`
`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
`
`other applicable privilege. Regeneron further objects this this request as vague in so far as it
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`seeks documents that “Regeneron or its experts intend to rely in in a motion for a preliminary
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`injunction.”
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`Subject to the foregoing general and specific objections, Regeneron will produce any
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`non-public documents or things not already in Defendant’s possession, custody or control and
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`that are cited in any briefing or fact witness or expert declarations submitted in support of
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`Regeneron’s motion for preliminary injunction in this matter.
`
`REQUEST NO. 7
`All documents and things that Regeneron contends support its position that the asserted
`claims of the Identified Patents are not invalid for the reasons provided in Celltrion’s 3(B)
`contentions.
`RESPONSE TO REQUEST NO. 7:
`
`Regeneron incorporates each of its General Objections as if fully set forth herein.
`
`Regeneron objects to this Request to the extent that it seeks documents and things protected by
`
`the attorney-client privilege, the work-product doctrine, the common-interest privilege, or any
`
`other applicable privilege. Regeneron objects to this Request on the ground that it seeks
`
`documents or things not relevant to any party’s claim or defense and is unduly burdensome,
`
`overly broad, and not proportionate to the needs of the case, including because it seeks “[a]ll
`
`documents” relating to the subject matter of this Request.
`
`Subject to the foregoing general and specific objections, Regeneron will produce any
`
`non-public documents or things not already in Defendant’s possession, custody or control and
`
`
`
`16
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`Case 1:23-cv-00089-TSK Document 122-2 Filed 03/04/24 Page 17 of 35 PageID #: 16049
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`that are cited in any briefing or fact witness or expert declarations submitted in support of
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`Regeneron’s motion for preliminary injunction in this matter, including non-public documents or
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`things cited in any briefing or fact witness or expert declarations submitted in support of
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`Regeneron’s asserted claims that the PI Patents are not invalid.
`
`REQUEST NO. 8
`All documents and things that comprise Regeneron’s BLA No. 125387 and BLA No.
`761355, including any amendments.
`RESPONSE TO REQUEST NO. 8:
`
`Regeneron incorporates each of its General Objection