`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`Plaintiff,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`Defendant.
`
`MEMORANDUM OF LAW IN SUPPORT OF NONPARTY AMGEN INC.’S MOTION
`TO INTERVENE FOR THE LIMITED PURPOSE OF ASSERTING THE PUBLIC
`INTEREST IN ACCESS TO JUDICIAL RECORDS
`
`
`
`Nonparty Amgen Inc. (“Movant”), by and through its undersigned counsel, hereby submits
`
`this Memorandum in Support of its “Motion to Intervene for the Limited Purpose of Asserting the
`
`Public Interest in Access to Judicial Records,” and seeks to intervene in this action pursuant to
`
`Fed. R. Civ. P. 24(b) for the limited purpose of unsealing certain judicial records (or portions
`
`thereof) currently unavailable to the public, in accordance with the public’s First Amendment and
`
`common law rights. In support of this Motion, the Movant states as follows:
`
`INTRODUCTION
`
`The Parties
`
`Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) developed and sells Eylea®
`
`I.
`
`
`
`(aflibercept) – a treatment for certain eye diseases. Defendant Mylan Pharmaceuticals Inc.
`
`(“Mylan”) is seeking FDA approval under the Biologics Price Competition and Innovation Act
`
`(“BPCIA”), 42 U.S.C. §§ 262(k)-(l), to commercialize “M710,” a proposed biosimilar of Eylea.
`
`Regeneron initiated this action (“Action”) seeking a judgment of patent infringement against
`
`Mylan to prevent M710 from coming to market and competing with Eylea. On April 20, 2023, the
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 2 of 15 PageID #: 37635
`
`parties filed motions for summary judgment. A 10-day bench trial is scheduled to begin on June
`
`12, 2023.
`
`II.
`
`The Movant
`
`
`
`Movant, one of the world’s leading biopharmaceutical companies, is a corporation
`
`organized and existing under the laws of the State of Delaware, with its principal place of business
`
`at One Amgen Center Drive, Thousand Oaks, California 91320. Movant’s biosimilar business is
`
`committed to building on Amgen’s experience in the development, manufacture, and distribution
`
`of biological medicines.
`
`
`
`Movant has devoted considerable effort to developing a proposed biosimilar of Eylea,
`
`which is currently designated “ABP 938.” For example, Movant has completed the primary
`
`analysis of a randomized, double-blind, active controlled Phase III study evaluating the efficacy
`
`and safety of ABP 938 compared with Eylea. The final analysis is expected to be completed by
`
`June 2023.
`
`III. The Parties’ Sealing Practices
`
`During the course of the Action, the parties have filed numerous documents under seal.
`
`But, for the most part, the docket sheet does not list motions to seal with titles explaining what
`
`documents the party seeks to seal and the public cannot access the actual motions or pleadings:
`
`the motion and number where those pleadings or motions should be listed are absent from the
`
`docket sheet.1 For example, ECF Nos. 106, 119, 122, 133, 135, 146, 173, 174, 226, 228, 246, 261,
`
`286, 301, 305, 307, 309, 311, 313, 314, 322, 324, 335, 336, 337, 339, 342, 352, 353, 356, 357,
`
`360, 375, 377, 389, 391, 392, 403, 410, 430, 440, 441, 443, 445, 448, 449, 454, 455, 463, 466,
`
`467, 469, 470, 471, 472, 473, 474, 476, 477, 478, 479, 480 and 482 have been omitted from the
`
`
`1 The docket sheet for this Action is attached as Exhibit A.
`
`2
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 3 of 15 PageID #: 37636
`
`docket sheet. The only place some of these submissions can be found is in the descriptions of
`
`orders granting various motions to seal. See ECF at Nos. 132, 134, 136, 185, 186, 227, 251, 263,
`
`308, 310, 312, 334, 336, 338, 355, 359, 390, 405, 409, 411 and 464. Other orders state “SEALED,”
`
`but do not identify in the description what is being sealed or what motion is being granted. See
`
`ECF at Nos. 297, 298, 351, 361, 368, 376, 431, 442, 444, 462, 465 and 468. Moreover, each order
`
`granting the numerous motions to seal is itself sealed. Consequently, in general, no determination
`
`can be made as to what was sealed or the justification for sealing it.
`
`
`
`The docket sheet does identify a few documents that the parties requested to be sealed or
`
`that were sealed:
`
`• Regeneron requested that subpoenas to third-parties that supplied materials to Mylan be
`sealed. See ECF at Nos. 107, 120.
`• Mylan requested that its Opening Claim Construction Brief be sealed. See ECF at No. 123.
`• Mylan’s Responsive Claim Construction Brief, and the exhibits attached thereto, were
`sealed in their entireties. See ECF at No. 187.
`• Regeneron’s Responsive Claim Construction Brief, and the exhibits attached thereto, were
`sealed in their entireties. See ECF at No. 188.
`• Mylan’s Response in Opposition to Regeneron’s Motion for Judgment on the Pleadings as
`to Mylan’s Inequitable Conduct Defenses and Counterclaims and the exhibits attached
`thereto were sealed in their entireties. See ECF at No. 252.
`• Mylan’s Motion to Strike Plaintiff’s Unauthorized Reply Brief on Claim Construction
`Issues or, Alternatively, for Leave to File Response, and the exhibits attached thereto, were
`sealed in their entireties. See ECF at No. 264.
`• Regeneron’s Motion for Presumption Under 35 U.S.C. § 295 and the exhibits attached
`thereto, were sealed in their entireties. See ECF at No. 299.2
`• Mylan’s Memorandum in support of its motion for summary judgment, and the exhibits
`attached thereto, were sealed in their entireties. See ECF at No. 429.
`
`But no order justifying sealing these documents is available for review. Moreover, the parties have
`
`not filed redacted versions of these documents in the public record.
`
`
`2 On May 12, 2023, pursuant to Regeneron’s Motion (ECF 438), the Court denied Regeneron’s
`Motion for Presumption as moot. See ECF 456. Nonetheless, Regeneron’s Motion for
`Presumption and the exhibits attached thereto remain sealed.
`
`3
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 4 of 15 PageID #: 37637
`
`ARGUMENT
`
`I.
`
`
`
`Movant’s Limited Intervention is Proper Under Fed. R. Civ. P. 24(b)
`
`The Court should permit Movant to intervene in this action to assert the public’s right of
`
`access to these judicial proceedings. Permissive intervention under Fed. R. Civ. P. 24(b) is the
`
`appropriate method for a nonparty to assert the public’s right to access to judicial proceedings and
`
`seek access to protected or sealed documents. See In re Grand Jury Subpoena, 836 F.2d 1468,
`
`1470 (4th Cir. 1988); Kirby v. Res-Care, Inc., 596 F. Supp. 3d 588, 592 (S.D.W. Va. 2022)
`
`(“[P]ermissive intervention is an appropriate method for a nonparty to seek access to protected or
`
`sealed documents.”); see also Grove Fresh Distributors, Inc. v. Everfresh Juice Co., 24 F.3d 893,
`
`896 (7th Cir. 1994) (“[I]ntervention is the procedurally appropriate course for third-party
`
`challenges to protective orders.”).
`
`“It is well settled that the public and press have a qualified right of access to [judicial
`
`documents and records] filed in civil and criminal proceedings.” Doe v. Public Citizen, 749 F.3d
`
`246, 265 (4th Cir. 2014). Consistent with that well-settled principle, the Fourth Circuit has held
`
`that “the press has standing to intervene in actions in which it is not otherwise a party to seek
`
`review of a district court’s order sealing documents and court records.” Rosenfeld v. Montgomery
`
`Cty. Public Schs., 25 F.App’x 123, 131 (4th Cir. 2011); see also Stone v. Univ of Md. Med. Sys.
`
`Corp., 855 F.2d 178, 180-181 (4th Cir. 1988); Virginia Dep’t of State Police v. Washington Post,
`
`386 F.3d 567, 572 (4th Cir. 2004).
`
`The public’s standing to intervene is no different than that of the media. Doe, 749 F.3d at
`
`263 (“We see no reason why the standing of news media to seek appellate review of a district
`
`court’s sealing order should differ from that of a member of the general public.”); see also In re
`
`Greensboro News Co., 727 F.2d 1320, 1322 (4th Cir. 1984) (holding that the rights of access of the
`
`media “are co-extensive with and do not exceed those rights of members of the public in general”).
`
`4
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 5 of 15 PageID #: 37638
`
`As explained by the Seventh Circuit, “every court of appeals to consider the matter has come to
`
`the conclusion that Rule 24 is sufficiently broad-gauged to support a request for intervention for
`
`the purposes of challenging confidential orders.” Jessup v. Luther, 227 F.3d 993, 997 (7th Cir.
`
`2000); see also Phenix Newspapers, Inc. v. U.S. Dist. Ct., 156 F.3d 940, 949 (9th Cir. 1998)
`
`(finding that it is well-established that nonparties have standing to intervene to gain public access
`
`to sealed court documents). The First Amendment’s protections to judicial documents would be
`
`meaningless without the ability for nonparties to intervene to seek access to withheld documents.
`
`See CBS Inc. v. Young, 522 F.2d 234, 237-38 (6th Cir. 1975). Movant has standing to intervene as
`
`a member of the public.
`
`Movant’s motion for limited intervention is timely and will not unduly delay or prejudice
`
`the adjudication of the merits. Movant does not seek to adjust the case schedule or to participate
`
`in any aspect of the Action. Because access to judicial proceedings remains relevant even after a
`
`case ends, there is no particular time limit for a party to intervene for the limited purpose of seeking
`
`access to judicial proceedings. Courts, including the Third Circuit, “have allowed intervention by
`
`parties for the limited purpose of modifying a confidentiality or protective order even after the
`
`underlying dispute between the parties has been settled.” Pansy v. Borough of Stroudsburg, 23
`
`F.3d 772, 779 (3d Cir. 1994); Kirby, 596 F. Supp. at 592 (finding that intervention for the purpose
`
`of asserting the right of access “can be appropriate even after entry of a final judgment”). By
`
`seeking to litigate only an issue of access under the protective order, Movant would not disrupt
`
`this case on the merits. Pansy, 23 F.3d at 780.
`
`For these reasons, Movant should be permitted to intervene under Rule 24(b).
`
`5
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 6 of 15 PageID #: 37639
`
`II.
`
`The Extensive Sealing in This Action Is Inconsistent with the Public’s Common Law
`
`and First Amendment Rights of Access to Courts
`
`
`
`
`
`
`
`“It is clear that the courts of this country recognize a general right to inspect and copy
`
`public records and documents.” Nixon v. Warner Commc’ns, Inc., 435 U.S. 589, 597 (1978).
`
`“[D]ocuments filed with the court are ‘judicial records’ if they play a role in the adjudicative
`
`process, or adjudicate substantive rights.” In re Application of U.S. for an Order Pursuant to 18
`
`U.S.C. Section 2703(d), 707 F.3d 283, 290 (4th Cir. 2013). Stated differently, documents filed
`
`with the objective of obtaining judicial action or relief constitute judicial records. Id. at 291. Of
`
`course, judicial orders constitute judicial records. Id. at 290. Pursuant to Local Rule of Civil
`
`Procedure 26.05(b), “[t]he rule requiring public inspection of Court documents is necessary to
`
`allow interested parties to judge the Court’s work product in the cases assigned to it.” N.D. W.Va.
`
`LR Civ. P. 26.05(b); see also Columbus-America Discovery Group v. Atlantic Mut. Ins. Co., 203
`
`F.3d 291, 303 (4th Cir. 2000).
`
`
`
`This right of public access to documents or materials filed in a district court is derived from
`
`two independent sources: the common law and the First Amendment. Virginia Dep’t of State
`
`Police, 386 F.3d at 575. “While the common law presumption in favor of access attaches to all
`
`judicial records and documents, the First Amendment guarantee of access has been extended to
`
`particular judicial records and documents.” Stone, 855 F.2d at 180. The First Amendment right
`
`of access to judicial records attaches if: “(1) ‘the place and process have historically been open to
`
`the press and general public’ and (2) ‘public access plays a significant positive role in the
`
`functioning of the particular process in question.’” Harper v. Elk Run Coal Co., 2012 WL
`
`1999429, at *4 (S.D. W.Va. June 12, 2012) (quoting Press-Enterprises Co. v. Superior Court, 478
`
`U.S. 1, 8-9 (1986)). The Fourth Circuit has specifically found that the public’s access to motions
`
`6
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 7 of 15 PageID #: 37640
`
`for summary judgment and documents attached thereto is protected by the First Amendment.
`
`Rushford v. New Yorker Magazine, Inc., 846 F.2d 249, 253 (4th Cir. 1988).
`
`For judicial records that are subject to First Amendment protections, there is a higher bar
`
`for restricting the public’s right of access. Virginia Dep’t of State Police, 386 F.3d at 575. A
`
`district court may restrict the First Amendment right “‘only on the basis of a compelling
`
`governmental interest, and only if the denial is narrowly tailored to serve that interest.’” Id.
`
`(quoting Stone, 855 F.2d at 180). The party seeking to restrict access to judicial records bears the
`
`substantial burden of overcoming the First Amendment’s protections by presenting specific
`
`reasons in support of their position. Conclusory assertions are insufficient to meet this burden.
`
`Virginia Dep’t of State Police, 386 F.3d at 575.
`
`In addressing the common law right of access, District Judge Gina M. Groh explained:
`
`The common law right of access applies to all judicial records that
`do not fall under the First Amendment’s protection. Id. 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).
`
`
`Patrick v. PHH Mortg. Corp., 2014 U.S. Dist. LEXIS 190143 (N.D. W.Va. Apr. 30, 2014).
`
`
`7
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 8 of 15 PageID #: 37641
`
`
`
`Whether access to a judicial record is subject to the protections of the First Amendment or
`
`simply the common law, said access “may be abrogated only in unusual circumstances.” Stone,
`
`855 F.2d at 182; see also N.D. W.Va. LR Civ. P. 26.05(b) (stating that the rule requiring public
`
`access to judicial records “may be abrogated only in exceptional circumstances”). A district court
`
`considering a motion to seal must initially determine, as to each document, whether the judicial
`
`record is subject to First Amendment or the common law protections. Stone, 855, F.2d at 181
`
`(“The district court in this case ordered sealed the entire record without indicating exactly what
`
`that record contained. On remand, it must determine the source of the right of access with respect
`
`to each document sealed. Only then can it accurately weigh the competing interests at stake.”).
`
`Once the district court has ascertained the applicable standard to weigh competing interests, it must
`
`then weigh those interests in accordance with the following procedures:
`
`First, the district court must give the public adequate notice that the
`sealing of 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.
`
`
`Rushford, 846 F.2d at 253-254 (internal citations omitted) (quoting In re Knight Publishing Co.,
`
`743 F.2d 231, 234-235 (4th Cir. 1984)).
`
`A.
`
`The Public Was Not Given Adequate Notice Or An Opportunity To Object
`
`
`
`
`Before a document is sealed, the public must be given notice and an opportunity to object
`
`to the sealing of a judicial record. Media Gen. Operations, Inc. v. Buchanan, 417 S.E.2d 424, 429
`
`(4th Cir. 2005). The notice requirement may be met by placing a motion to seal on the docket
`
`8
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 9 of 15 PageID #: 37642
`
`sheet3; however, notice must be given “reasonably in advance of deciding the issue.” Knight
`
`Publishing Co., 743 S.E.2d at 235. In fact, the public has a First Amendment right to a civil
`
`action’s docket sheet. Doe, 749 F.3d at 270. In the instant action, no notice was given as to the
`
`various motions to seal filed. The motions are not identified on the docket sheet. In fact, not only
`
`is there no description of a motion to seal located on the docket sheet, the numbers under which
`
`the motions should be listed are omitted. See ECF at Nos. 106, 119, 122, 133, 135, 146, 173, 174,
`
`226, 228, 246, 261, 286, 301, 305, 307, 309, 311, 313, 314, 322, 324, 335, 336, 337, 339, 342,
`
`352, 353, 356, 357, 360, 375, 377, 389, 391, 392, 403, 410, 430, 440, 441, 443, 445, 448, 449,
`
`454, 455, 463, 466, 467, 469, 470, 471, 472, 473, 474, 476, 477, 478, 479, 480 and 482 . Some of
`
`the numbers for the unlisted motions can be found in the order granting the motion to seal;
`
`however, there is still no title given to the motion or description of what is being sealed. See ECF
`
`at Nos. 132, 134, 136, 185, 186, 227, 251, 263, 308, 310, 312, 334, 336, 338, 355, 359, 390, 405,
`
`409, 411 and 464. Of course, by the time an order granting the motion to seal appears on the
`
`docket, there is no opportunity to object before the issue is decided. Other motions to seal appear
`
`to have been granted without ever being identified beforehand. See ECF at Nos. 297, 298, 351,
`
`361, 368, 376, 431, 442, 444, 462, 465 and 468.
`
`
`
`As the public was not given proper notice of the numerous motions to seal, the necessary
`
`procedural requirements were not met.
`
`B.
`
`The Public Has No Access To Any Order Stating The Reasons For Sealing
`Judicial Records In This Matter
`
`
`The procedure required in Knight Publishing Co. dictates that the Court should provide
`
`
`
`reasons for sealing any documents, including with specific supporting findings. Here, the public,
`
`
`3 Patrick, 2014 U.S. Dist. LEXIS 190143, at *6.
`
`9
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 10 of 15 PageID #:
`37643
`
`including Movant, cannot access any of the orders granting the various motions to seal or the facts
`
`supporting the Court’s rulings. As such, Movant is precluded from analyzing the documents sealed
`
`and the appropriateness of each determination.
`
`C.
`
`The Public Received No Explanation As To Why Alternatives To Sealing The
`Various Documents Were Rejected
`
`When a court considers a motion to seal judicial records, “a judicial officer ‘must consider
`
`alternatives to sealing the documents’ which may include giving the public access to some of the
`
`documents or releasing a redacted version of the documents that are the subject of the
`
`government’s motion to seal.” United States v. Appelbaum, 707 F.3d 283, 294 (4th Cir. 2013)
`
`(quoting Media Gen. Operations, Inc., 417 F.3d at 429 (internal citation omitted)); see also Knight
`
`Publishing Co., 743 F.2d at 235 (holding that a district court must consider less restrictive
`
`alternatives to sealing and, if it elects to seal the document, then it must provide the reasons for
`
`rejecting such alternatives); N.D. W.Va. LR Civ. P. 26.05 (“Unless otherwise authorized by law, a
`
`motion to seal . . . shall be accompanied by a memorandum which contains . . . the reasons why
`
`sealing is necessary, including the reasons why alternatives to sealing, such as redaction, are
`
`inadequate . . . .”). Again, as there are no orders to review, the public does not know whether
`
`alternatives to sealing, such as redaction, were considered and, if so, why they were rejected.
`
`D. Mere Allegations That Documents Contain Sensitive Business Information Do
`Not Justify Wholesale Restriction Of Access
`
`
`Movant recognizes that the public access to judicial records and proceedings is not absolute
`
`and that an exception exists for commercially sensitive business information. Nixon v. Warner,
`
`435 U.S. at 598. But a party seeking to restrict access to judicial records bears the burden of
`
`establishing that the records do in fact contain commercially sensitive business information. If a
`
`party can make that showing, “sealing should be limited to only those portions necessary to prevent
`
`the disclosure of [sensitive business information].” Lifenet Health v. Lifecell Corp., 2015 U.S.
`
`10
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 11 of 15 PageID #:
`37644
`
`Dist. LEXIS 181315, at *4 (S.D. W.Va. Jan. 9, 2015) (quoting Woven Elecs. Corp, v. Advance
`
`Group, Inc., 1991 U.S. App. LEXIS 14345, at *6 (4th Cir. Apr. 15, 1991)). “Such a partial sealing
`
`strikes an appropriate balance between the public’s right of access to judicial records and
`
`proceedings and the parties’ legitimate interest in the protection of sensitive proprietary
`
`information.” Lifenet Health, 2015 U.S. Dist. LEXIS 181315, at *5 (quoting Woven Elecs. Corp,
`
`1991 U.S. App. LEXIS 14345, at *6). Blanket sealing of the record is not appropriate. Lifenet
`
`Health, 2015 U.S. Dist. LEXIS 181315, at *4. Failure to narrowly tailor one’s motion to seal so
`
`that it solely protects commercially sensitive business information should result in the denial of
`
`the motion to seal. Id. at *6.
`
`Movant assumes that Regeneron and Mylan will argue that at least some of the sealed
`
`documents contain commercially sensitive business information. To be clear, Movant does not
`
`seek access to Regeneron’s or Mylan’s commercially sensitive business information. But the
`
`public record does not demonstrate that the documents sealed by the Court at the request of
`
`Regeneron or Mylan contain commercially sensitive business information, or that the restriction
`
`imposed, i.e., sealing of the documents, was narrowly tailored so that only such information is
`
`protected.
`
`E.
`
`A Protective Order Does Not Shield Parties From Complying With The Fourth
`Circuit’s Sealing Requirements
`
`
`
`The Parties stipulated to a protective order that the Court entered on November 2, 2022.
`
`ECF at No. 91. Nonetheless, the Parties and Court are still obligated to comply with the Fourth
`
`Circuit’s sealing requirements as set forth herein. In re C.R. Bard, Inc. Pelevic Repair System
`
`Prods. Liab. Litig., 2013 U.S. LEXIS 70189, at *21 (S.D. W.Va. May 17, 2013) (holding that even
`
`when the parties agree to the proposed redactions, the court is still required to assure that First
`
`Amendment protections to the right to access are properly weighed and considered); see also Trs.
`
`11
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 12 of 15 PageID #:
`37645
`
`of Purdue Univ. v. Wolfspeed, Inc., 2023 U.S. Dist. LEXIS 60521, at *10 (M.D.N.C. Feb. 28, 2023).
`
`That the parties have entered into a protective order and redacted or sealed a document in
`
`accordance therewith thus does not relieve the parties or the Court from complying with the
`
`process for sealing documents set forth in In re Knight Publishing Co.
`
`F.
`
`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 documents attached thereto, are protected by the public’s First Amendment right to access
`
`judicial records. Rushford, 846 F.2d at 253. Consequently, only a compelling government interest
`
`can warrant sealing these materials, and even if warranted, sealing must be narrowly tailored to
`
`serve the 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
`
`Regeneron patents. See ECF at No. 429. Although no motion to seal or order to seal can be found
`
`on the 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 certain patents. See ECF at No. 433. Mylan’s summary judgment brief and
`
`exhibits should be in the public record to afford the public access to a motion that led to resolution
`
`of certain claims in the case.
`
`Likewise, any briefs concerning claim construction should be in the public record to afford
`
`the public access to the arguments the parties advanced concerning claim construction. The
`
`resolution of claim construction issues also led, in part, to Regeneron’s agreement to stipulate to
`
`summary judgment for certain claims. See ECF at No. 433 (stipulating to summary judgment
`
`“under the Court’s Claim Construction”).
`
`12
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 13 of 15 PageID #:
`37646
`
`Further, Mylan’s Answer, Defenses, and Counterclaims to Plaintiff’s Complaint includes
`
`allegations that certain Regeneron patents are unenforceable due to Regeneron’s inequitable
`
`conduct during prosecution before the U.S. Patent Office. See ECF at No. 47. On December 16,
`
`2022, Regeneron filed a motion for judgment on the pleadings as to these inequitable conduct
`
`defenses and counterclaims. See ECF at No. 175. While the patent prosecution records are
`
`publicly available, Mylan’s responsive brief and supporting exhibits were sealed in their entireties.
`
`See ECF at No. 252. These materials should be unsealed, or at least a redacted version should be
`
`filed, to afford the public access to these potentially dispositive allegations.
`
`III. Requested Actions
`
`
`
`
`
`Movant respectfully requests that the Court take the following actions:
`
`i.
`
`ii.
`
`iii.
`
`iv.
`
`
`
`
`
`v.
`
`vi.
`
`Order that all summary judgment, claim construction, and inequitable conduct motions,
`briefs, and exhibits be filed in the public record, or that the parties file redacted versions
`of all such materials with redactions limited to information for which a compelling
`interest warrants sealing.
`
`Add all previously filed motions to seal to the public docket sheet.
`
`Add all previously filed sealing orders to the public docket sheet.
`
`Review the current extent of sealing in light of the First Amendment and common law
`rights of the public. If the Court decides that the parties’ motions to seal do not satisfy
`the Fourth Circuit’s requirements for sealing, in whole or in part, the sealing requests
`should be denied, and the filings (or the appropriate portions thereof) should be made
`available to the public. If the Court decides that the parties’ motions to seal satisfy the
`Fourth Circuit’s requirements for sealing, in whole or in part, Movant respectfully
`requests that the Court provide public access to the reasons for sealing, including why
`alternatives to sealing, such as redaction, are inadequate.
`
`Require the parties to file motions to seal any additional filings that they seek to seal,
`in whole or in part.
`
`Ensure that the public has in-person and/or remote access to the trial in the Action, and
`any associated hearings, exhibits, and testimony, except to the extent a party establishes
`entitlement to seal portions to protect commercially sensitive business information.
`
`
`13
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 14 of 15 PageID #:
`37647
`
`CONCLUSION
`
`
`
`For the aforesaid reasons, Nonparty Amgen Inc., respectfully requests that the Court grant
`
`this Motion to Intervene and take the requested actions set forth above.
`
`DATED: May 23, 2023
`
`
`AMGEN INC.
`
`By: Hendrickson & Long, PLLC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ John H. Tinney___________
`John H. Tinney, Jr. (Bar No. 6970)
`John K. Cecil (Bar No. 9511)
`HENDRICKSON & LONG, PLLC
`214 Capital Street
`Charleston, West Virginia 25301
`(304) 346-5500
`jtinney@handl.com
`jcecil@handl.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 486 Filed 05/23/23 Page 15 of 15 PageID #:
`37648
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
`
`
`Plaintiff,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. 1:22-cv-00061-TSK
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`v.
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`Defendant.
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on this 23rd day of May, 2023, a copy of the foregoing pleading was
`
`filed with the Clerk of the Court using the CM/ECF system. Notice of this filing will be sent by
`
`operation of the Court’s electronic filing system to all parties registered to receive electronic
`
`notice.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ John H. Tinney___________
`John H. Tinney, Jr. (Bar No. 6970)
`John K. Cecil (Bar No. 9511)
`HENDRICKSON & LONG, PLLC
`214 Capital Street
`Charleston, West Virginia 25301
`(304) 346-5500
`jtinney@handl.com
`jcecil@handl.com
`
`15
`
`