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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 1 of 15 PageID #:
`47440
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
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`Plaintiff,
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC., and
`BIOCON BIOLOGICS INC.,
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`
`
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`Defendants.
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`
`
`
`
`
`
`MEMORANDUM OF LAW IN SUPPORT OF
`NONPARTY CELLTRION INC.’S MOTION TO INTERVENE
`FOR THE LIMITED PURPOSE OF
`ASSERTING THE PUBLIC INTEREST IN ACCESS TO JUDICIAL RECORDS
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`Non-party Celltrion, Inc. (“Celltrion”) is a company that, like the defendant Mylan, has filed a
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`Biologics License Application (“BLA”) with the U.S. Food & Drug Administration (“FDA”) seeking approval of
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`a biosimilar to plaintiff Regeneron’s EYLEA product. Celltrion seeks to intervene in this action pursuant to
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`Fed. R. Civ. P. 24(b) for the limited purpose of seeking the redaction and/or unsealing of docket
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`entries (or portions thereof) that are currently unavailable to the public, in accordance with the public’s
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`First Amendment and common law rights.
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`The Court has granted similar relief to non-party Amgen, Inc. (“Amgen”), which filed a pre-
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`trial motion to intervene in this action to seek the redaction and unsealing of various pre-trial
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`pleadings. See ECF No. 485, 486. In granting Amgen’s motion, the Court directed Amgen and the
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`parties to “meet and confer after the bench trial takes place” to “determine which documents on the
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`docket can be unsealed and/or redacted.” ECF No. 516. The Court directed the parties to “submit a
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`filing with the Court on or before August 25, 2023, indicating which documents can be unsealed
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`and/or redacted.” Id.
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`1
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 2 of 15 PageID #:
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`The bench trial is now complete. In this motion, Celltrion seeks the same relief granted to
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`Amgen in order to protect Celltrion’s interest should Amgen decline to press forward with the August
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`25, 2023 filing or otherwise fail to obtain the unsealing or redaction of materials on the docket.
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`Celltrion also seeks to ensure that the parties and intervenors meet and confer to determine which of
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`the sealed portions of the trial transcript and post-trial docket entries, including the parties’ post-trial
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`briefing concerning infringement and the parties’ closing argument demonstratives, can be redacted
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`to remove commercially-sensitive information and then unsealed.
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`In support of this Motion, Celltrion states as follows:
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`INTRODUCTION
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`I.
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`The Parties
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`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) is the reference product sponsor of
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`EYLEA, a biologic product that contains aflibercept as its active ingredient and which is approved
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`by the FDA for the treatment of certain eye diseases. Defendant Mylan Pharmaceuticals Inc.
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`(“Mylan”) is seeking FDA approval under the Biologics Price Competition and Innovation Act
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`(“BPCIA”), 42 U.S.C. §§ 262(k)-(l), to commercialize “M710,” a proposed biosimilar of EYLEA.
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`Regeneron initiated this action (“Action”) seeking a judgment of patent infringement against Mylan
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`to prevent M710 from coming to market and competing with EYLEA. A 10-day bench trial was held
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`from June 12, 2023 to June 23, 2023. Closing arguments were held on August 3, 2023.
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`II.
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`The Movant
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`Celltrion is a biopharmaceutical company organized and existing under the laws of Korea,
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`with its principal place of business at 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of
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`Korea. Celltrion has devoted considerable effort to developing its own proposed biosimilar of
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`EYLEA, which is currently designated “CT-P42.” On June 29, 2023, Celltrion filed with the FDA a
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`BLA for CT-P42 that references EYLEA. At some point in the future, Regeneron may threaten or
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`file a patent infringement suit against Celltrion asserting some or all of the patents asserted against
`2
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`Mylan, to delay CT-P42 from coming to market and competing with EYLEA.
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`III.
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`Non-Party Amgen’s Motion to Intervene
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`On May 23, 2023, non-party Amgen, Inc. submitted a “Motion to Intervene for the Limited
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`Purpose of Asserting the Public Interest in Access to Judicial Records” (ECF No. 485). Amgen
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`argued that the public’s right of access to judicial proceedings supported permissive intervention
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`under Fed. R. Civ. P. 24(b). On May 31, 2023, Judge Kleeh granted Amgen’s motion for good cause.
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`See ECF No. 516. The parties and Amgen were ordered to meet and confer after the bench trial takes
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`place, but on or before August 18, 2023, to determine which documents on the docket can be unsealed
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`and/or redacted. The parties and Amgen were ordered to submit a filing with the Court on or before
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`August 25, 2023, indicating which documents can be unsealed and/or redacted. Id.
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`IV.
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`The Parties’ Sealing Practices
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`Amgen’s memorandum in support of its motion to intervene provides a detailed description
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`of the documents that the parties filed under seal prior to trial, as well as the Court’s Orders and
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`docket entries concerning the sealing of those documents. ECF No. 486, Section III, 2-3. Celltrion
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`incorporates that description by reference herein.1 In addition to the documents identified in Amgen’s
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`memorandum, much of the trial and post-trial record remains under seal.
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`At the start of trial, Mylan made a motion to seal the courtroom for “limited portions of the
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`trial proceedings” and “corresponding exhibits and portions of the trial transcript.” ECF No. 526, 1.
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`Mylan made clear that the information it sought to shield from public disclosure was very limited,
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`and included only
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`those portions of the trial that involve disclosure or discussion of (1) both the
`specific excipients or other constituents of the [Mylan YESALFI] product and the
`relative proportions and/or the specific amounts of each such constituent or
`excipient; (2) portions of Biocon’s [BLA] containing other competitively sensitive
`research and development and/or product details; and (3) specific clinical trial data
`beyond that in the label, including individual patient data submitted to the [FDA].”
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`1 Celltrion notes that since Amgen’s motion was filed, additional docket entries are missing from
`the docket sheet. See, e.g., ECF Nos. 487-489, 491-501, 503-510, 539, 542, and 543.
`3
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 4 of 15 PageID #:
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`Id. Mylan also promised to “provide a proposed redacted version of any relevant transcript volumes,
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`for public filing, to further narrow the scope of information that is not publicly available.” Id. at 4.
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`
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`The Court did seal the courtroom for certain portions of the trial (see, e.g., ECF No. 558 (Trial
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`Tr. Day 1), 4, 10-20; ECF No. 560 (Trial Tr. Day 3), 581-711); ECF No. 564 (Trial Tr. Day 6), 1384-
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`1416, 1451-80); ECF 566 (Trial Tr. Day 7), 1527-33, 1544-50; ECF 569 (Trial Tr. Day 9), 2121-22);
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`see also ECF Nos. 557, 561, 565, 567, 570), however, Mylan has, to date, not proposed any redacted
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`transcript volumes.
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`
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`Regeneron also proposed that its opening post-trial brief regarding infringement, which
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`presumably discloses or discusses information that falls into at least one of the three categories of
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`information Mylan regards as sensitive, be sealed in its entirety. See ECF No. 577. The Court granted
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`that motion, but again did not discuss or impose any requirement to redact those portions of the
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`briefing papers that disclosed or discussed the narrow categories of information that Mylan is
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`concerned about, so that the rest of the papers could be unsealed. ECF No. 580. Mylan also
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`apparently requested sealing of its reply to Regeneron’s post-trial brief concerning infringement, and
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`the Court apparently granted that motion, since the reply does not appear on the public docket. There
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`is no record of the Court requiring Mylan to file a redacted version of those reply papers.
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`Finally, during closing arguments, the Court again granted the parties’ request to exclude the
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`public from portions of the proceedings that risked disclosure of one or more of the three categories
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`of allegedly sensitive information. At the conclusion of the parties’ closing arguments, the Court also
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`required the parties to file the demonstratives used during their arguments under seal.2 No redacted
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`transcript has yet been proposed, and the Court did not discuss or impose a requirement on the parties
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`to prepare versions of the demonstratives with only information that falls into the three categories
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`2 The transcript of the closing arguments is not yet available to Celltrion, but counsel for Celltrion
`attended the closing arguments and thus has firsthand knowledge of the parties’ requests, and the
`Court’s Orders, regarding sealing.
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`4
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 5 of 15 PageID #:
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`redacted, so that the remainder could be unsealed.
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`ARGUMENT
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`I.
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`Celltrion’s Limited Intervention is Proper Under Fed. R. Civ. P. 24(b)
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`The Court should permit Celltrion to intervene in this action to assert the public’s right of
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`access to these judicial proceedings. Permissive intervention under Fed. R. Civ. P. 24(b) is the
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`appropriate method for a nonparty to assert the public’s right to access to judicial proceedings and
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`seek access to protected or sealed documents. See In re Grand Jury Subpoena, 836 F.2d 1468, 1470
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`(4th Cir. 1988); Kirby v. Res-Care, Inc., 596 F. Supp. 3d 588, 592 (S.D.W. Va. 2022)
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`(“[P]ermissive intervention is an appropriate method for a nonparty to seek access to protected or
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`sealed documents.”).
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`“It is well settled that the public and press have a qualified right of access to [judicial
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`documents and records] filed in civil and criminal proceedings.” Doe v. Public Citizen, 749 F.3d 246,
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`265 (4th Cir. 2014). Consistent with that well-settled principle, the Fourth Circuit has held that “the
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`press has standing to intervene in actions in which it is not otherwise a party to seek review of a
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`district court’s order sealing documents and court records.” Rosenfeld v. Montgomery Cty. Public
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`Schs., 25 F.App’x 123, 131 (4th Cir. 2011); see also Stone v. Univ of Md. Med. Sys. Corp., 855 F.2d
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`178, 180-181 (4th Cir. 1988); Virginia Dep’t of State Police v. Washington Post, 386 F.3d 567, 572
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`(4th Cir. 2004).
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`The public’s standing to intervene is no different than that of the media. Doe, 749 F.3d at 263
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`(“We see no reason why the standing of news media to seek appellate review of a district court’s
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`sealing order should differ from that of a member of the general public.”); see also In re Greensboro
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`News Co., 727 F.2d 1320, 1322 (4th Cir. 1984) (holding that the rights of access of the media “are co-
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`extensive with and do not exceed those rights of members of the public in general”). For the same
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`reasons, the interests of one member of the general public, such as nonparty Amgen’s, do not exceed
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`the rights of other members of the public, including Celltrion’s. Id. As explained by the Seventh
`5
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`Circuit, “every court of appeals to consider the matter has come to the conclusion that Rule 24 is
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`sufficiently broad-gauged to support a request for intervention for the purposes of challenging
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`confidential orders.” Jessup v. Luther, 227 F.3d 993, 997 (7th Cir. 2000); see also Phenix
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`Newspapers, Inc. v. U.S. Dist. Ct., 156 F.3d 940, 949 (9th Cir. 1998) (finding that it is well-established
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`that nonparties have standing to intervene to gain public access to sealed court documents). The First
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`Amendment’s protections to judicial documents would be meaningless without the ability for
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`nonparties to intervene to seek access to withheld documents. See CBS Inc. v. Young, 522 F.2d 234,
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`237-38 (6th Cir. 1975). Celltrion has standing to intervene as a member of the public.
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`Celltrion’s motion for limited intervention is timely and will not unduly delay or prejudice the
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`adjudication of the merits. Celltrion does not seek to adjust the case schedule or to participate in any
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`aspect of the Action. Because access to judicial proceedings remains relevant even after a case ends,
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`there is no particular time-limit for a party to intervene for the limited purpose of seeking access to
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`judicial proceedings. Courts in the Fourth Circuit have allowed intervention even after entry of final
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`judgment. See Kirby, 596 F. Supp. 3d at 592 (citing Rushford v. New Yorker Mag., Inc., 846 F.2d
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`249, 252 (4th Cir. 1988)). By seeking to litigate only an issue of access under the protective order,
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`Celltrion would not unduly delay or prejudice adjudication on the merits. See Kirby, 596 F. Supp. 3d
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`at 592.
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`II.
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`For these reasons, Celltrion should be permitted to intervene under Rule 24(b).
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`The Extensive Sealing in This Action Is Inconsistent with the Public’s Common Law and
`First Amendment Rights of Access to Courts
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`“It is clear that the courts of this country recognize a general right to inspect and copy public
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`records and documents, including judicial records and documents.” Nixon v. Warner Commc’ns, Inc.,
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`435 U.S. 589, 597 (1978). “[D]ocuments filed with the court are ‘judicial records’ if they play a role
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`in the adjudicative process, or adjudicate substantive rights.” In re Application of U.S. for an Order
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`Pursuant to 18 U.S.C. Section 2703(d), 707 F.3d 283, 290 (4th Cir. 2013). Stated differently,
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`6
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 7 of 15 PageID #:
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`documents filed with the objective of obtaining judicial action or relief constitute judicial records. Id.
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`at 291. Of course, judicial orders constitute judicial records. Id. at 290. Pursuant to Local Rule of
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`Civil Procedure 26.05(b), “[t]he rule requiring public inspection of Court documents is necessary to
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`allow interested parties to judge the Court’s work product in the cases assigned to it.” N.D. W.Va. LR
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`Civ. P. 26.05(b)(1); see also Columbus-America Discovery Group v. Atlantic Mut. Ins. Co., 203 F.3d
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`291, 303 (4th Cir. 2000) (publicity of courts records “is necessary in the long run so that the public
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`can judge the product of the courts in a given case.”).
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`This right of public access to documents or materials filed in a district court is derived from two
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`independent sources: the common law and the First Amendment. Virginia Dep’t of State Police, 386
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`F.3d at 575. “While the common law presumption in favor of access attaches to all ‘judicial records
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`and documents’, the First Amendment guarantee of access has been extended only to particular
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`judicial records and documents.” Stone, 855 F.2d at 180. The First Amendment right of access to
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`judicial records attaches if: “(1) ‘the place and process have historically been open to the press and
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`general public’ and (2) ‘public access plays a significant positive role in the functioning of the
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`particular process in question.’” Harper v. Elk Run Coal Co., 2012 WL 1999429, at *4 (S.D. W.Va.
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`June 12, 2012) (quoting Press-Enterprises Co. v. Superior Court, 478 U.S. 1, 8-9 (1986)). The Fourth
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`Circuit has specifically found that the public’s access to motions for summary judgment and
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`documents attached thereto is protected by the First Amendment. Rushford v. New Yorker
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`Magazine, Inc., 846 F.2d 249, 253 (4th Cir. 1988).
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`For judicial records that are subject to First Amendment protections, there is a higher bar for
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`restricting the public’s right of access. Virginia Dep’t of State Police, 386 F.3d at 575. A district
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`court may restrict the First Amendment right “‘only on the basis of a compelling governmental
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`interest, and only if the denial is narrowly tailored to serve that interest.’” Id. (quoting Stone, 855
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`F.2d at 180). The party seeking to restrict access to judicial records bears the substantial burden of
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`overcoming the First Amendment’s protections by presenting specific reasons in support of their
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 8 of 15 PageID #:
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`position. Conclusory assertions are insufficient to meet this burden. Virginia Dep’t of State Police,
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`386 F.3d at 575.
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`In addressing the common law right of access, District Judge Gina M. Groh explained:
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`The common law right of access applies to all judicial records that do not fall under
`the First Amendment’s protection. [Virginia Dep’t of State Police, 386 F.3d] at 576.
`The common law “presumption of access, however, can be rebutted if
`countervailing interests heavily outweigh the public interest in access, and [t]he
`party seeking to overcome the presumption bears the burden of showing some
`significant interest that outweighs the presumption.” Id. at 575 (quotation marks and
`citation omitted). The following factors are relevant to this balancing test: (1)
`“whether the records are sought for improper purposes, such as promoting public
`scandals or unfairly gaining a business advantage;” (2) “whether release would
`enhance the public’s understanding of an important historical event; and” (3)
`“whether the public already has access to the information contained in the records.””
`Id. (quotation marks and citation omitted). It is within the district court’s discretion
`to decide whether to restrict the common law right of access. See id. The court
`should, however, exercise this discretion in light of the case’s “relevant facts and
`circumstances.” Id. (quotation marks and citation omitted).
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`Patrick v. PHH Mortg. Corp., Case No. 3:12-CV-00039, ECF No. 210 at *3-4 (N.D. W.Va. Apr. 30,
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`2014).
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`Whether access to a judicial record is subject to the protections of the First Amendment or
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`simply the common law, said access “may be abrogated only in unusual circumstances.” Stone, 855
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`F.2d at 182; see also N.D. W.Va. LR Civ. P. 26.05(b) (stating that the rule requiring public access to
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`judicial records “may be abrogated only in exceptional circumstances”). A district court considering
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`a motion to seal must initially determine, as to each document, whether the judicial record is subject
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`to First Amendment or the common law protections. Stone, 855, F.2d at 181 (“The district court in
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`this case ordered sealed the entire record without indicating exactly what that record contained. On
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`remand, it must determine the source of the right of access with respect to each document sealed.
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`Only then can it accurately weigh the competing interests at stake.”). Once the district court has
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`ascertained the applicable standard to weigh competing interests, it must then weigh those interests in
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`accordance with the following procedures:
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`First, the district court must give the public adequate notice that the sealing of
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 9 of 15 PageID #:
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`documents may be ordered. In re Knight Publishing Co., 743 F.2d at 234. Second,
`the district court must provide interested persons “an opportunity to object to the
`request before the court ma[kes] its decision.” Id. at 235. Third, if the district court
`decides to close a hearing or seal documents, “it must state its reasons on the record,
`supported by specific findings.” Id. at 234. Finally, the court must state its reasons
`for rejecting alternatives to closure. Id. at 235.
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`Rushford, 846 F.2d at 253-254 (quoting In re Knight Publishing Co., 743 F.2d 231, 234-235 (4th
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`Cir. 1984)).
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`A.
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`The Public Was Not Given Adequate Notice Or A Sufficient Opportunity To
`Object
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`Before a judicial document is sealed, the public must be given notice and an opportunity to
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`object to its sealing. Media Gen. Operations, Inc. v. Buchanan, 417 F.3d 424, 429 (4th Cir. 2005).
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`The notice requirement may be met by placing a motion to seal on the docket sheet3; however,
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`notice must be given “reasonably in advance of deciding the issue.” Knight Publishing Co., 743 F.2d
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`at 235. In fact, the public has a First Amendment right to a civil action’s docket sheet. Doe, 749 F.3d
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`at 268-69.
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`In the instant action, as described in Amgen’s brief in support of its motion to intervene, no
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`notice was given as to most of the motions to seal that were filed with respect to the pre-trial pleadings,
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`see ECF No. 486 at Section II(A), 8-9 (hereby incorporated by reference), and many of the post-trial
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`pleadings. None of the parties’ motions to seal that correspond with ECF Nos. 584, 585, 586, 587 or
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`594 appear on the public docket, nor did the Court give a rationale for granting those motions in ECF
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`Nos. 588 and 596. The public also had no opportunity to respond to the Court’s Order sealing the
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`parties’ closing argument demonstratives in their entirety. While Regeneron did file a motion to seal
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`its opening post-trial brief that appeared on the public docket, see ECF No. 577-1, and the Court did
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`issue an Order granting that motion to seal that appeared on the public docket, see ECF No. 580, the
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`public has not had an adequate opportunity to respond the Court’s Order sealing the post-trial briefing
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`3 Patrick, Case No. 3:12-CV-00039, ECF No. 210 at *4.
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`in its entirety, as opposed to directing the parties to prepare a redacted version that could then be
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`unsealed.
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`As the public was not given proper notice of the numerous motions to seal, the necessary
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`procedural requirements were not met.
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`B.
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`The Public Has No Access To Orders Stating The Reasons For Sealing Various
`Judicial Records In This Matter
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`The procedure required in Knight Publishing dictates that the Court should provide reasons
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`for sealing any documents, including with specific supporting findings. Here, the public,
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`including Celltrion, cannot access most of the orders granting the various motions to seal or the facts
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`supporting the Court’s rulings. As such, Celltrion is precluded from analyzing the documents sealed
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`and the appropriateness of each determination.
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`C.
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`The Public Received No Explanation As To Why Alternatives To Sealing The
`Various Documents Were Rejected
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`Crucially, the Court has not provided any rationale for why redaction of those portions of the
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`sealed documents that actually disclose or discuss the allegedly-sensitive Mylan information, rather
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`than wholesale sealing of entire documents, is insufficient to protect Mylan’s interests. When a court
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`considers a motion to seal judicial records, “a judicial officer ‘must consider alternatives to sealing
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`the documents’ which may include giving the public access to some of the documents or releasing a
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`redacted version of the documents that are the subject of the [] motion to seal.” United States v.
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`Appelbaum, 707 F.3d 283, 294 (4th Cir. 2013) (quoting Media Gen. Operations, Inc., 417 F.3d at
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`429); see also Knight Publishing Co., 743 F.2d at 235 (holding that a district court must consider less
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`restrictive alternatives to sealing and, if it elects to seal the document, then it must provide the reasons
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`for rejecting such alternatives); N.D. W.Va. LR Civ. P. 26.05 (“Unless otherwise authorized by law, a
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`motion to seal . . . shall be accompanied by a memorandum which contains . . . the reasons why
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`sealing is necessary, including the reasons why alternatives to sealing, such as redaction, are
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`inadequate . . . .”). Again, as there are few orders to review, and those that are publicly available do
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 11 of 15 PageID #:
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`not discuss or consider the appropriateness of ordering the parties to prepare redacted versions of
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`sealed pleadings rather than sealing them in their entirety, the public does not know whether redaction
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`was considered and, if so, why that less restrictive alternative was rejected.
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`D. Mere Allegations That Documents Contain Sensitive Business Information Do
`Not Justify Wholesale Restriction Of Access
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`Celltrion recognizes that the public access to judicial records and proceedings is not absolute
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`and that an exception exists for commercially sensitive business information. Nixon v. Warner, 435
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`U.S. at 598. But a party seeking to restrict access to judicial records bears the burden of establishing
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`that the records do in fact contain commercially sensitive business information. If a party can make
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`that showing, “sealing should be limited to only those portions necessary to prevent the disclosure of
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`[sensitive business information].” Lifenet Health v. Lifecell Corp., No. 2:13-cv-486, 2015 WL
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`12516758, at *1 (E.D. Va. Jan. 9, 2015) (quoting Woven Elecs. Corp, v. Advance Group, Inc., 930
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`F.2d 913, 1991 WL 54118, at *6 (4th Cir. Apr. 15, 1991) (table disposition)). “Such a partial sealing
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`strikes an appropriate balance between the public’s right of access to judicial records and proceedings
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`and the parties’ legitimate interest in the protection of sensitive proprietary information.” Lifenet
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`Health, 2015 WL 12516758, at *2 (quoting Woven Elecs. Corp, 1991 WL 54118, at *6). Blanket
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`sealing of the record is not appropriate where, as here, much of the document being sealed is likely
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`to contain portions that can be published without harm to any of the litigants. Lifenet Health, 2015
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`U.S. Dist. LEXIS 181315, at *2-*3. Failure to narrowly tailor one’s motion to seal so that it solely
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`protects commercially sensitive business information should result in the denial of the motion to seal
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`or the granting of more narrowly-tailored relief, such as an order requiring the parties to prepare
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`redacted versions that can be unsealed. Id. at *3.
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`Like Amgen, Celltrion does not seek access to Regeneron’s or Mylan’s commercially
`
`sensitive business information. But the public record does not demonstrate that the restriction
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`imposed by the Court, i.e., sealing of the documents, was narrowly tailored so that only those portions
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`disclosing or discussing commercially sensitive business information is shielded from publication.
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`E.
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`A Protective Order Does Not Shield Parties From Complying With The Fourth
`Circuit’s Sealing Requirements
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`The Parties stipulated to a protective order that the Court entered on November 2, 2022. ECF
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`No. 91. Nonetheless, the Parties and Court are still obligated to comply with the Fourth Circuit’s
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`sealing requirements as set forth herein. In re C.R. Bard, Inc. Pelvic Repair System Prods. Liab.
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`Litig., Nos. 2:11–cv–00195, 2:11–cv–00012, 2:10–cv–01224, 2:11–cv–00114, MDL No. 2187, ECF
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`No. at *11 (S.D. W.Va. May 17, 2013) (holding that even when the parties agree to the proposed
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`redactions, the court is still required to assure that First Amendment protections to the right to access
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`are properly weighed and considered). That the parties have entered into a protective order and
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`redacted or sealed a document in accordance therewith thus does not relieve the parties or the Court
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`from complying with the process for sealing documents set forth in In re Knight Publishing Co.
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`F.
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`The Court Should At Least Unseal All Motions For Summary Judgment and
`Supporting Briefs and Exhibits; Claim Construction Briefs and Exhibits; and
`Any Other Dispositive Motions and Supporting Briefs and Exhibits
`
`Access to dispositive motions, including motions for summary judgment and related briefs and
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`documents attached thereto, are protected by the public’s First Amendment right to access judicial
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`records. Rushford, 846 F.2d at 253. Consequently, only a compelling government interest can warrant
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`sealing these materials, and even if warranted, sealing must be narrowly tailored to serve the
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`compelling interest. Virginia Dep’t of State Police, 386 F.3d at 575.
`
`Mylan filed a motion for summary judgment on April 20, 2023, with respect to four
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`Regeneron patents. See ECF No. 429. Although no motion to seal or order to seal can be found on the
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`docket sheet, the motion says that Mylan filed a supporting memorandum under seal. Id. Shortly after
`
`Mylan filed its motion, Regeneron stipulated to summary judgment against it for certain claims of
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`certain patents. See ECF No. 433. Mylan’s summary judgment brief and exhibits should be in the
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`public record to afford the public access to a motion that led to resolution of certain claims in the case.
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`Likewise, any briefs concerning claim construction should be in the public record to afford the
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`public access to the arguments the parties advanced concerning claim construction. The resolution
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`of claim construction issues also led, in part, to Regeneron’s agreement to stipulate to summary
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`judgment for certain claims. See ECF No. 433 (stipulating to summary judgment “under the Court’s
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`Claim Construction”).
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`Further, Mylan’s Answer, Defenses, and Counterclaims to Plaintiff’s Complaint includes
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`allegations that certain Regeneron patents are unenforceable due to Regeneron’s inequitable conduct
`
`during prosecution before the U.S. Patent Office. See ECF No. 47. On December 16, 2022,
`
`Regeneron filed a motion for judgment on the pleadings as to these inequitable conduct defenses and
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`counterclaims. See ECF No. 175. While the patent prosecution records are publicly available,
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`Mylan’s responsive brief and supporting exhibits were sealed in their entireties. See ECF No. 252.
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`These materials should be unsealed, or at least a redacted version should be filed, to afford the public
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`access to these potentially dispositive allegations.
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`G.
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`The Court Should Allow Celltrion to Meet and Confer With the Parties and Non-
`Party Amgen Regarding Unsealing of Documents
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`The Court should also allow Celltrion a “seat at the table” for the meet-and-confer between
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`the parties and non-party Amgen ordered by the Court in ECF No. 516. Celltrion likely has similar
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`interests as Amgen in unsealing as much of the pre- and post-trial record as possible. Allowing
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`Celltrion to participate in the meet-and-confer will not prejudice Amgen or any party, nor will it delay
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`the action in any respect. Should the parties require more time to redact the post-trial briefing, trial
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`transcripts and demonstratives than the August 25 deadline affords, Celltrion is agreeable to whatever
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`deadline the Court deems reasonable.
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`III.
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`Requested Actions
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`Celltrion respectfully requests that the Court take the following actions:
`
`i.
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`Grant Celltrion the same relief provided to Amgen in ECF No. 516.
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`ii.
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`Require the parties to prepare redacted versions of the pre-trial order, trial transcript,
`trial demonstratives, and post-trial briefing and supporting filings, with the redactions
`being narrowly tailored to obscure only those portions which disclose the information
`identified by Mylan in ECF No. 526 as “highly confidential and competitively
`sensitive details of [its] Yesafali product.”
`
`iii.
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`Unseal the redacted versions required in (ii).
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`For the aforesaid reasons, Celltrion, Inc. respectfully requests that the Court grant this
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`CONCLUSION
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`
`
`
`
`
`
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`Motion to Intervene and grant the relief requested above.
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`
`
`DATED: August 10, 2023
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`
`
`CELLTRION, INC.
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`
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`
`
`
`
`
`
`By:
`
`
`
`
`
`
` /s/Laura C. Davis
`Laura C. Davis, WV Bar #7801
`Manchin Ferretti, PLLC
`408 West King St.
`Martinsburg, WV 25401
`(304) 264-8505
`ldavis@wvjusticelawyers.com
`Counsel for Celltrion, Inc.
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`Case 1:22-cv-00061-TSK-JPM Document 605-1 Filed 08/10/23 Page 15 of 15 PageID #:
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`47454
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`Plaintiff,
`
`v.
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC., and
`BIOCON BIOLOGICS INC.,
`
`
`
`
`Defendants.
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
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`I hereby certify that on this 10th day of August, 2023, a copy of the foregoing pleading was
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`filed with the Clerk of the Court using the CM/ECF system. Notic