Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 1 of 10 PageID #: 16107
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`Case No. 1:23-cv-89 (TSK)
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`REGENERON PHARMACEUTICALS, INC.,
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`CELLTRION, INC.,
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`Plaintiff,
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`v.
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`Defendant.
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`REGENERON’S MEMORANDUM IN OPPOSITION TO DEFENDANTS’
`EMERGENCY MOTION TO COMPEL
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`Regeneron hereby responds to Defendant Celltrion, Inc.’s Emergency Motion to Compel,
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`filed on March 4, 2024. Celltrion seeks to compel production of materials from Regeneron
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`Pharms., Inc. v. Mylan Pharms. Inc. and Biocon Biologics Inc., No. 1:22-cv-00061, (the “Mylan
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`Action”), for purposes of the parties’ preliminary injunction proceedings.
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`I.
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`Regeneron Does Not Oppose Production Consistent With Its Obligations Under the
`Mylan Protective Order
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`As Regeneron has repeatedly informed Celltrion, Regeneron is more than willing to
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`produce the Mylan Litigation Materials1 but cannot do so absent one of two things: (1) an Order
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`1 The Mylan Litigation Materials include “Mylan Litigation Written Discovery” (the
`interrogatories and responses, requests for admission and responses, and statements pursuant to
`42 U.S.C. § 262(l)(3)(B) and 42 U.S.C. § 262(l)(3)(C) served in the Mylan action relating to the
`PI Patents), Celltrion Ex. 2 (Regeneron Responses and Objections “R&O”) at Definition No. 12;
`“Mylan Litigation Trial Demonstratives” (the trial demonstratives used by the parties during
`opening statements, closing arguments, and direct examinations in the 2023 trial in the Mylan
`action to the extent those demonstratives relate to the PI Patents), id. at Definition No. 13;
`“Mylan Litigation Deposition Materials” (transcripts of and exhibits from depositions in the
`Mylan action of Regeneron employees or experts and relating to the PI Patents), id. at Definition
`No. 14; and “Mylan Litigation Expert Reports” (the expert reports served in the Mylan action
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`1
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 2 of 10 PageID #: 16108
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`of this Court, or (2) Mylan’s consent. Upon receiving Celltrion’s requests for documents,
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`Regeneron promptly sought the latter. Ex. A at 7-10 (January 27, 2024 email from Regeneron
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`counsel to Mylan counsel notifying them of Celltrion’s document requests); id. at 3-4 (February
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`21, 2024 follow-up email). Mylan promptly, and adamantly, refused. Id. at 2-3 (February 22,
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`2024 email from Mylan counsel to Regeneron) (“Biocon and Mylan do not consent to
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`Regeneron producing any of the documents identified in your list below.” (emphasis in
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`original)). Regeneron informed Celltrion of Mylan’s position and the fact that Mylan
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`represented that it was continuing to evaluate the documents implicated by Celltrion’s request.
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`Id. at 2-3 (February 22, 2024 email); Celltrion Ex. 4 at 2.
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`To be clear, Regeneron does not oppose an Order directing it to produce the Mylan
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`Litigation Materials; as Celltrion knows, it is Mylan that does not consent. As Mylan is the
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`company that has opposed the production of the requested materials, fairness would dictate that
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`it has an opportunity to be heard in connection with Celltrion’s motion. Yet Mylan (to
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`Regeneron’s knowledge) was not served with the motion and does not possess an unredacted
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`version of the motion, which was filed only under seal. Regeneron provided Mylan with notice
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`of the motion and a copy of the redacted version filed on the public docket.
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`To the extent that Mylan consents to the production of the requested materials upon
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`receiving Celltrion’s motion, or the Court hears Mylan’s objections and rejects them, Regeneron
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`will produce the requested materials consistent with the Protective Order in the Mylan Action.
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`Accordingly, Regeneron has attached a proposed Order that would obligate it to produce the
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`Mylan Litigation Materials one week from entry of the Order—thereby allowing Mylan (if the
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`relating to the PI Patents and excluding reports relating solely to the commercial success of the
`inventions claimed in such patents), id. at Definition No. 17.
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`2
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 3 of 10 PageID #: 16109
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`Order issues) an opportunity to redact the materials as it deems appropriate. At the ordered time,
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`Regeneron will produce the Mylan Litigation Materials either as redacted by Mylan (if Mylan
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`has provided redacted copies), or in unredacted form (if Mylan has not) on an Outside-Counsel
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`Eye’s Only Basis (or at whatever designation the Court deems appropriate).
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`II.
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`Regeneron Diligently Sought Mylan’s Cooperation
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`Although Regeneron (unlike Mylan) does not oppose production of the materials at issue,
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`Celltrion’s aspersions improperly cast upon Regeneron and its counsel cannot go unanswered.
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`Contrary to Celltrion’s characterization, Regeneron did not simply “throw up its hands and
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`default to inaction” or “fail[] to take any effort” with regard to producing the Mylan Litigation
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`Materials. See Celltrion Motion at 2, 10. To the contrary, it has sought diligently Mylan’s
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`consent to produce materials that are not publicly available.
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`First, some background: Even before Regeneron’s litigation with Celltrion commenced,
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`and dating back to August 2023, Regeneron has sought Mylan’s cooperation in improving the
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`public accessibility of the docket in the Mylan Action, consistent with the Court’s May 31, 2023
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`Order Granting Amgen’s Motion to Intervene in the Mylan Action. See Mylan Action Dkt. No.
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`608. Celltrion likewise moved to intervene in the Mylan Action on August 10, 2023, and
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`conferred with Regeneron to that end on August 22, 2023 regarding the sealed filings that
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`Celltrion sought and the extent to which those documents differed from those sought by Amgen.
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`See Mylan Action Dkt. No. 636. Ultimately, Celltrion agreed that Regeneron and Mylan should
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`“diligently address Amgen’s request” and “notify Celltrion upon completion so it may begin its
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`independent review and supplementation.” See id. Regeneron’s coordination led to a joint
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`proposal to unseal hundreds of filings, see Mylan Action Dkt. Nos. 608, 639-1, 675, and a joint
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`effort to create redacted copies of relevant filings that could not be unsealed in their entirety, see
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`Ex. B (Email chain between Regeneron’s counsel and Mylan’s counsel).
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`Then, after litigation and formal discovery with Celltrion commenced, Regeneron
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`promptly notified Mylan of Celltrion’s requests for additional Mylan information. In particular,
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`Regeneron asked Mylan for two things on January 27, 2024: (1) redacted copies removing
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`Mylan’s confidential information from a list of documents over which Regeneron expected
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`Mylan to make claims of confidentiality, and (2) confirmation that the documents on a second
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`list did not contain Mylan confidential information and so could be produced imminently in their
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`current form. Ex. A at 7-10 (January 27, 2024 email from T. Gregory). On February 7, 2024,
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`Regeneron followed up on this request. Id. at 7. Mylan responded that it would review the
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`materials and would follow up once that review was complete. Id. at 6 (Feb. 11 email from L.
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`Lesko.). Ten days later, Regeneron followed up on its requests, narrowed the list of documents
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`for Mylan to review and notified Mylan that it would produce those documents it did not believe
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`contained Mylan confidential information as early as February 23, 2024. Id. at 3-6 (Feb. 21,
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`2024 email from T. Gregory). Mylan’s response was adamant: “Biocon and Mylan do not
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`consent to Regeneron producing any of the documents identified.” Id. at 3 (Email from L. Lesko
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`on Feb. 22) (original emphasis). Mylan asserted that, because “Regeneron is seeking to produce
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`documents that implicate Biocon/Mylan Confidential Information to direct competitors,” Mylan
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`would “require a reasonable amount of time to carefully review [the] voluminous requests in
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`order to ensure that [Mylan’s] information is properly maintained as confidential.” Id. Hearing
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`nothing further, Regeneron sent another email to Mylan days later, on February 27, 2024, asking
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`for a time estimate for Mylan to complete its review. Id. at 2 (February 27, 2024 email from T.
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`Gregory). More than two weeks later, at 10:19 PM last night (March 5, 2024), counsel for
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`Mylan emailed Regeneron to confirm that a subset of the documents identified by Regeneron did
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`not contain Mylan confidential information and could be produced. Id. at 1 (March 5, 2024
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`4
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 5 of 10 PageID #: 16111
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`email from L. Lesko). Regeneron will produce those documents to Celltrion promptly, but
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`Mylan still has not consented to the production of the remaining Mylan Litigation Materials. See
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`Id. It is Regeneron’s understanding, conveyed repeatedly to Celltrion, that Mylan continues to
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`oppose the production of the remaining materials. However, to Regeneron’s knowledge, Mylan
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`has not received an unredacted version of Celltrion’s motion and therefore has not been afforded
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`an opportunity to oppose it. Regeneron shares Celltrion’s frustration and thus seeks an Order
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`permitting it to produce the remaining materials in a manner consistent with the Mylan
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`Protective Order.2 Ex. C at ¶ 30 (providing that if Mylan “takes steps to prevent disclosure” of
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`information after being notified of a request for production, Regeneron “shall not produce” the
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`information “before a determination by a court of appropriate jurisdiction unless [Regeneron] has
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`obtained [Mylan’s] permission.”).
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`III. Regeneron Cannot Identify Documents Mylan Considers Public
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`Celltrion asserts that “[t]o the extent that the Mylan materials reference publicly available
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`documents, Regeneron confidential information only, or documents shown in open court,
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`Regeneron should be compelled to produce those documents.” Celltrion Motion at 7.
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`Unfortunately, as it has done throughout litigation, Mylan has asserted claims of confidentiality
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`even over documents and portions of documents shown in open court. As this Court is aware,
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`Mylan has a pending motion for sanctions against Regeneron with respect to inadvertent
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`disclosures of information that was shown in open court but that Mylan claims is confidential.
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`Mylan Action Dkt. No. 658. In view of this history, Regeneron is not in a position to share
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`documents that Mylan has deemed confidential and as to which Mylan has affirmatively refused
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`2 To simplify the discovery issues before the court, Regeneron no longer objects to producing the
`trial exhibits in the Mylan Action. However, these exhibits may contain Mylan confidential
`information and so they cannot be produced absent Mylan’s consent or a court order.
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`5
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 6 of 10 PageID #: 16112
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`to grant consent to produce, even as to confidentiality designations that appear to be indefensible
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`on their face.
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`Celltrion asserts that “[t]o the extent that the Mylan materials reference publicly available
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`documents, Regeneron confidential information only, or documents shown in open court,
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`Regeneron should be compelled to produce those documents.” Celltrion Motion at 7.
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`Unfortunately, as it has done throughout litigation, Mylan has asserted claims of confidentiality
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`even over documents and portions of documents shown in open court. As this Court is aware,
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`Mylan has a pending motion for sanctions against Regeneron with respect to inadvertent
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`disclosures of information that was shown in open court but that Mylan claims is confidential.
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`Mylan Action Dkt. No. 658. In view of this history, Regeneron is not in a position to share
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`documents that Mylan has deemed confidential and as to which Mylan has affirmatively refused
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`to grant consent to produce, even as to confidentiality designations that appear to be indefensible
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`on their face.
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`IV. Regeneron is Not Hiding Behind “Boilerplate” Objections
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`In light of the foregoing, Celltrion’s suggestion that Regeneron seeks to withhold the
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`Mylan Litigation Materials on the basis of “boilerplate” objections is completely baseless.
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`Regeneron actively has been taking steps to produce the Mylan Litigation Materials, so long as it
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`may produce them consistent with the Mylan Protective Order. Regeneron already has agreed to
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`provide the documents subject to Celltrion’s motion as soon as it is ordered to do so. The
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`General Objections, which, for the record, overlap heavily with Celltrion’s own twenty-one
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`prefatory objections in its responses to Regeneron’s Requests for Production therefore present no
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`obstacle to the production of the Mylan Litigation Materials. For clarity: Regeneron stands
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`6
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 7 of 10 PageID #: 16113
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`ready to produce the Mylan Litigation Materials upon consent by Mylan or an Order of the
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`Court, in a manner consistent with its obligations under the Mylan Protective Order.3
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`V.
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`Conclusion
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`For the foregoing reasons, Regeneron respectfully requests that, if the Court deems it
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`appropriate upon hearing Mylan’s objections, the Court enter the proposed order submitted
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`herewith.
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`3 Contrary to Celltrion’s assertions, Regeneron never conceded that its objections were “mere
`boilerplate,” and Regeneron maintains that its objections contain sufficient detail to allow the
`Court to evaluate the merits of its objections. See Celltrion Ex. 4 at 2-3. Additionally, during the
`parties’ Meet and Confer, Regeneron indicated that it was not sure with which objections
`Celltrion took issue and counsel for Celltrion did not provide any additional clarity.
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`7
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 8 of 10 PageID #: 16114
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` CAREY DOUGLAS KESSLER & RUBY, PLLC
`
`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`Raymond S. Franks II (WVSB No. 6523)
`707 Virginia Street East
`901 Chase Tower (25301)
`P.O. Box 913
`Charleston, West Virginia 25323
`(304) 345-1234
`sruby@cdkrlaw.com
`drpogue@cdkrlaw.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`Date: March 6, 2024
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`Of Counsel:
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`David I. Berl (admitted PHV)
`Ellen E. Oberwetter (admitted PHV)
`Thomas S. Fletcher (admitted PHV)
`Andrew V. Trask (admitted PHV)
`Teagan J. Gregory (admitted PHV)
`Shaun P. Mahaffy (admitted PHV)
`Kathryn S. Kayali (admitted PHV)
`Arthur J. Argall III (admitted PHV)
`Adam Pan (admitted PHV)
`Rebecca A. Carter (admitted PHV)
`Haylee N. Bernal Anderson (admitted PHV)
`Renee M. Griffin (admitted PHV)
`Jennalee Beazley* (admitted PHV)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, SW
`Washington, DC 20024
`(202) 434-5000
`dberl@wc.com
`eoberwetter@wc.com
`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@wc.com
`rebeccacarter@wc.com
`handerson@wc.com
`rgriffin@wc.com
`jbeazley@wc.com
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`*Admitted only in Pennsylvania; practice
`supervised by D.C. Bar members
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`Case 1:23-cv-00089-TSK-JPM Document 128 Filed 03/06/24 Page 9 of 10 PageID #: 16115
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`Elizabeth Stotland Weiswasser (admitted PHV)
`Anish R. Desai (admitted PHV)
`WEIL, GOTSHAL & MANGES
`767 Fifth Avenue
`New York, NY 10153
`Elizabeth.Weiswasser@weil.com
`Anish.Desai@weil.com
`
`Christopher M. Pepe (admitted PHV)
`WEIL, GOTSHAL & MANGES
`2001 M Street, NW
`Suite 600
`Washington, DC 20036
`Christopher.Pepe@weil.com
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`Andrew E. Goldsmith (admitted PHV)
`Evan T. Leo (admitted PHV)
`Jacob E. Hartman (admitted PHV)
`Mary Charlotte Y. Carroll (admitted PHV)
`Sven E. Henningson (admitted PHV)
`KELLOGG, HANSEN, TODD, FIGEL &
` FREDERICK, P.L.L.C.
`1615 M Street, N.W., Suite 400
`Washington, D.C. 20036
`TEL: (202) 326-7900
`agoldsmith@kellogghansen.com
`eleo@kellogghansen.com
`jhartman@kellogghansen.com
`mcarroll@kellogghansen.com
`shenningson@kellogghansen.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`CERTIFICATE OF SERVICE
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`I hereby certify that on March 6, 2024, I electronically transmitted the foregoing with the
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`Court. Counsel of record for all parties will be served by electronic mail.
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`/s/ Steven R. Ruby
`Steven R. Ruby
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`10
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