Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 1 of 8 PageID #: 2713
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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. 1:24-md-3103-TSK
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`IN RE: AFLIBERCEPT PATENT LITIGATION
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`THIS DOCUMENT RELATES TO ALL CASES
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`PLAINTIFF REGENERON PHARMACEUTICAL INC.’S RESPONSE TO
`DEFENDANT AMGEN INC.’S MOTION REQUIRING FILING AND SERVING OF
`REDACTED VERSIONS OF SEALED FILINGS
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) hereby responds to the motion filed by
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`Defendant Amgen Inc. (“Amgen”) seeking entry of an order requiring all parties to this multi-district
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`litigation (MDL) to file and serve redacted copies of all documents docketed under seal after June 11,
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`2024. (ECF No. 164.) Regeneron understands that Defendants Mylan Pharmaceuticals Inc., Biocon
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`Biologics Inc., Samsung Bioepis Co., Ltd., Celltrion, Inc., and Formycon AG do not oppose Amgen’s
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`motion. Regeneron likewise does not oppose entry of an order setting forth a process by which parties to
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`this MDL must provide redacted copies to each other and to the public—to the contrary, Regeneron
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`welcomes such a proposal. Regeneron opposes Amgen’s motion only for two reasons: (1) Amgen’s
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`proposed order omits certain logistical details—namely, a date certain by which Defendants must identify
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`their confidential information in a document before Regeneron is obligated to produce that document to
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`another party; and (2) Amgen’s proposed order does not address important categories of additional
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`documents—namely, deposition transcripts and sealed papers dated before June 11, 2024. Regeneron
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`briefly explains these concerns below, and attaches hereto as Exhibit 1 a redline showing its requested
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`changes to Amgen’s proposed order. Regeneron made similar suggestions before Amgen filed its motion;
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`Amgen ignored Regeneron’s concerns and filed its motion without responding to Regeneron’s proposal.
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`I.
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`Regeneron Needs Redacted Copies from Defendants Before it Produces Them
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`Amgen’s proposed order sets forth procedures by which:
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`1
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 2 of 8 PageID #: 2714
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`(1) Papers filed under seal in a single member case are to be served on all parties to the MDL in a
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`form that redacts all Defendants’ confidential information (ECF No. 164-2, ¶ 2);
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`(2) Papers filed under seal are to be filed on the public docket in a form redacting all parties’
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`confidential information (ECF No. 164-2, ¶ 3);
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`(3) Orders, memoranda, opinions or other documents entered by the Court under seal are to be
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`filed on the public docket in a form redacting all parties’ confidential information; and (ECF No. 164-2,
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`¶ 4);
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`(4) Orders, memoranda, opinions or other documents entered by the Court under seal in a single
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`member case are to be served on all parties to the MDL in a form that redacts all Defendant confidential
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`information, but not Regeneron information (ECF No. 164-2, ¶ 5).
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`These are salutary goals. Regeneron would like to effectuate them, but must be sure it can meet
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`its obligations under both Amgen’s proposal and the protective orders in force in each member case. In
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`particular, Regeneron depends on Defendants to identify what information they consider confidential in a
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`given document. Defendants must do this for any document—whether filed by a Defendant or filed by
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`Regeneron or entered by the Court—before Regeneron can serve that document on another party.
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`Amgen’s proposed order states only that “is the responsibility of the Defendant whose confidential
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`information is at issue to timely provide redactions to the Party that is required by this Order to file or
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`serve a redacted copy that does not contain any Defendant’s confidential information.” ECF No. 164-2 at
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`¶ 6. Regeneron is concerned that this vague “timeliness” requirement will not allow it to meet the
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`deadlines specified in Amgen’s proposal.
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`In particular, paragraphs two and five of Amgen’s proposed order require Regeneron to serve on
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`all parties to the MDL a copy of any paper Regeneron files under seal (ECF No. 164-2 at ¶ 2) and any
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`order or other document entered by the Court under seal (ECF No. 164-2 at ¶ 5) in a form that redacts the
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`applicable Defendant’s confidential information. After receiving from the Defendant a copy of the
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`document identifying all confidential information it believes should be redacted, Regeneron will need to
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`load the redacted copy into its document system, identify the appropriate confidentiality designation
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`2
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 3 of 8 PageID #: 2715
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`depending on the presence of Regeneron’s information (a decision that differs by Defendant), and then
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`brand multiple versions of the document bearing the appropriate Bates number and confidentiality
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`designation for each Defendant. As a practical matter, that process typically takes days, not hours. Thus,
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`Regeneron respectfully requests the following adjustments to Amgen’s proposal:
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`• Paragraph 6 of Amgen’s proposed order be changed to require that all redactions be provided
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`to the party whose obligation it is to serve or file a redacted pleading within three (3) business
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`days of any request;
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`• Paragraph 5 of Amgen’s proposed order be changed to require Regeneron to serve non-public
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`copies of sealed court orders seven (7) calendar days—rather than three (3) business days—
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`after docketing. This change will permit Regeneron enough time to process any redacted
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`copies of documents received from Defendants three business days after the Order’s entry
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`(pursuant to revised Paragraph 6).
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`II.
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`Past Filings and Deposition Transcripts
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`Amgen’s proposed order applies only to docket entries dated after June 11, 2024, and therefore
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`ignores all documents filed or served before that date. That omission means the public remains without
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`access to the vast majority of docket entries in the ongoing injunctive proceedings, and leaves the
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`parties—especially Regeneron—unclear as to what information may or may not safely be referenced in
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`subsequent filings. This issue may arise in the ongoing injunction briefing or future motions for
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`intervention, and will certainly arise during future proceedings at trial.
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`For a time, Amgen also sought access to past pleadings and supporting materials. Recently,
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`however, Defendants provided redacted copies of certain select documents requested by Amgen. Amgen
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`now has what it believes it needs, but the public and Regeneron do not. Defendants largely have refused
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`to provide redacted copies of any additional briefs, declarations, or deposition transcripts, frustrating the
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`public’s right of access and Regeneron’s ability to reference information appropriately in subsequent
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`filings. Unfortunately, it appears an Order of this Court is necessary to remedy this problem, and to
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`ensure that documents initially designated non-confidential remain so.
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`3
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 4 of 8 PageID #: 2716
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`For example, Regeneron first requested confirmation that certain portions of the transcript of Dr.
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`Boyle (an expert retained by Defendants Samsung Bioepis Co. Ltd. and Formycon AG), and Dr. Forrest
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`(an expert retained by Defendant Formycon) more than two months ago, on April 6, 2024. See Ex. 2 at 5
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`(Formycon); Ex. 3 at 4-5 (Samsung). Regeneron has reiterated its request multiple times in the
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`intervening eleven weeks, and has limited its request to confirmation that certain page and line numbers
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`of the relevant transcripts do not contain Defendants’ confidential information. Ex. 2 at 1-2 (Formycon);
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`Ex. 3 at 1-3 (Samsung). There can be no meaningful dispute that the identified questions and answers are
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`not confidential—Formycon and Samsung have not suggested otherwise, and instead assert that they have
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`no obligation to respond to Regeneron’s request.
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`Indeed, in the rare instances in which Defendants do comply with Regeneron’s request to provide
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`redacted versions of documents, they have not always honored their own redactions. For example,
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`Formycon filed a declaration of its expert Dr. Boyle on March 21, 2024. Regeneron thereafter requested
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`that Formycon provide a copy of Dr. Boyle’s declaration that redacted all of Formycon’s confidential
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`information, and Formycon did so on March 27, 2024. Ex. 4 at 1. Regeneron sought to use that “public”
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`version of Dr. Boyle’s declaration during its deposition of Dr. Boyle in the Samsung case, so that it could
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`simplify its deposition and appropriately adduce non-confidential testimony common to both cases.
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`However, when Regeneron marked the exhibit, Samsung’s counsel stopped the deposition and enlisted
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`the assistance of Formycon’s counsel, who (blaming a paralegal) promptly decided that the redacted copy
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`of Dr. Boyle’s declaration was confidential after all. Months later, Formycon still has not provided a
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`replacement (and permanently non-confidential) version of Dr. Boyle’s declaration. Ex. 5 at 1-3.
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`The stipulated protective orders in each case prohibit Regeneron from using one Defendant’s
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`confidential information in the case against a second Defendant. The protective orders do not, however,
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`restrict the flow or use of non-confidential information. Defendants’ papers, declarations, and deposition
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`transcripts reflect numerous non-confidential statements about common issues across the MDL—for
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`example, claim construction—that will continue to be litigated in these and other cases. The public is
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`entitled to access those statements, and Regeneron should be entitled to reference them freely.
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`4
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 5 of 8 PageID #: 2717
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`Now that all parties are united under a single MDL caption and therefore have the opportunity to
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`be heard in these proceedings, Regeneron respectfully requests that the Court order each Defendant to
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`serve Regeneron with redacted copies of all sealed filings and deposition transcripts applicable to their
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`respective cases, removing all Defendant confidential information. Regeneron will then produce those
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`redacted copies to all parties, consistent with various outstanding discovery requests. After adding
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`redactions to protect its own confidential information, Regeneron will facilitate the public docketing of
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`any document previously filed under seal. Recognizing that Defendants Mylan and Biocon are already
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`engaged with Regeneron in facilitating public access to documents filed before injunctive proceedings
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`began in that case, Regeneron proposes that process continue.
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`III.
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`Conclusion
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`Regeneron respectfully requests that the Court enter its proposed order, submitted herewith.
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`Alterations to the proposed order requested by Amgen are shown in redline in Exhibit 1.
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`Date: June 26, 2024
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`Respectfully Submitted:
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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)
`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
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
`David R. Pogue (WVSB No. 10806)
`Raymond S. Franks II (WVSB No. 6523)
`CAREY DOUGLAS KESSLER & RUBY,
`PLLC
`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
`rfranks@cdkrlaw.com
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`Attorneys for Plaintiff Regeneron
`Pharmaceuticals, Inc.
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`5
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 6 of 8 PageID #: 2718
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`tfletcher@wc.com
`atrask@wc.com
`tgregory@wc.com
`smahaffy@wc.com
`kkayali@wc.com
`aargall@wc.com
`apan@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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`Elizabeth Stotland Weiswasser (admitted
`PHV)
`Anish R. Desai (admitted PHV)
`Natalie C. Kennedy (admitted PHV)
`Jennifer Brooks Crozier (admitted PHV)
`Tom Yu (admitted PHV)
`Yi Zhang (admitted PHV)
`Kathryn Leicht (admitted PHV)
`Rocco Recce (admitted PHV)
`Zhen Lin (admitted PHV)
`WEIL, GOTSHAL & MANGES
`767 Fifth Avenue
`New York, NY 10153
`Elizabeth.Weiswasser@weil.com
`Anish.Desai@weil.com
`Natalie.Kennedy@weil.com
`Jennifer.Crozier@weil.com
`Tom.Yu@weil.com
`Yi.Zhang@weil.com
`Kathryn.Leicht@weil.com
`Rocco.Recce@weil.com
`Zhen.Lin@weil.com
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`Christopher M. Pepe (admitted PHV)
`Priyata Y. Patel (admitted PHV)
`Matthew Sieger (admitted PHV)
`WEIL, GOTSHAL & MANGES
`2001 M Street, NW
`Suite 600
`Washington, DC 20036
`Christopher.Pepe@weil.com
`Priyata.Patel@weil.com
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`6
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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 7 of 8 PageID #: 2719
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`Matthew.Seiger@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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`Case 1:24-cv-00053-TSK Document 18 Filed 06/26/24 Page 8 of 8 PageID #: 2720
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`CERTIFICATE OF SERVICE
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`The undersigned counsel hereby certifies that on the 26th day of June 2024, service of the
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`foregoing document was made to counsel of record by CM/ECF filing.
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`/s/ Steven R. Ruby
`Steven R. Ruby (WVSB No. 10752)
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`8
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