Case 1:24-cv-00053-TSK Document 17-1 Filed 06/12/24 Page 1 of 8 PageID #: 2665
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`IN RE: AFLIBERCEPT PATENT LITIGATION
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`MDL No. 1:24-md-03103-TSK
`Hon. Thomas S. Kleeh
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`THIS DOCUMENT RELATES TO:
`ALL CASES
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`MEMORANDUM OF LAW IN SUPPORT OF DEFENDANT AMGEN INC.’S
`EXPEDITED MOTION REQUIRING FILING AND SERVING OF
`REDACTED VERSIONS OF SEALED FILINGS
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`Defendant Amgen Inc. (“Amgen”) submits this Memorandum in Support of its Expedited
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`Motion Requiring Filing and Serving of Redacted Versions of Sealed Filings. The requested relief
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`is set forth in the attached Proposed Order, which specifies a procedure for ensuring that all parties
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`to this Multidistrict Litigation (“MDL”) will have timely, equitable, and orderly access to judicial
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`materials, particularly on common issues. The other MDL Defendants have agreed to the Proposed
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`Order and indicated that they do not oppose Amgen’s motion.1 This request is now urgent due to
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`the Court’s issuance yesterday of a sealed injunction decision in one of these MDL cases (and the
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`expected issuance of more in other MDL cases) that could affect time sensitive proceedings.
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`Regeneron Pharmaceuticals, Inc. (“Regeneron”) has not consented to the Proposed Order.
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`However, Regeneron told this Court that allowing parties to consider this Court’s decisions across
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`the MDL would “serve interest of efficiency and consistency by ensuring that Regeneron’s Amgen
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`1 These other MDL defendants are Mylan Pharmaceuticals Inc. (“Mylan”), Biocon Biologics Inc.
`(“Biocon”), Celltrion, Inc. (“Celltrion”), Samsung Bioepis Co., Ltd. (“SB”), Formycon AG
`(“Formycon”), and Amgen Inc. (“Amgen”) (collectively, “MDL Defendants”).
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`motion comports with the Court’s earlier decisions,” otherwise “the parties would need to burden
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`the Court with supplemental briefing to account for the Court’s decisions in these other cases,
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`which may narrow or otherwise inform issues in the Amgen case.” Regeneron’s May 10, 2024
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`Submission at Ex. 4, pp. 2-3 (submitted via email).
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`With Amgen’s opposition to Regeneron’s preliminary injunction motion due in less than a
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`month (on July 3), and depositions scheduled as early as next week, an expedited briefing schedule
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`is needed such that any opposition to this motion should be due within three (3) business days.
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`I. Request to Enter the Attached Proposed Order
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`In its order creating this MDL proceeding and transferring Amgen’s case, the Judicial Panel
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`on Multidistrict Litigation (“JPML”) found that these actions “involve common questions of fact”
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`such that “centralization in the Northern District of West Virginia will serve the convenience of
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`the parties and witnesses and promote the just and efficient conduct of this litigation.” 1:24-md-
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`3403, ECF No. 1 at 1. The JPML further ordered centralization to “avoid the risk of duplicative
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`discovery and prevent inconsistent rulings as to claim construction, patent validity, and other
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`issues.” Id. at 2.
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`On June 11, 2024, this Court issued a sealed decision resolving Regeneron’s motion for a
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`permanent injunction against Mylan and Biocon. 1:24-md-3403, ECF No. 162. Only Regeneron
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`and Biocon can see the contents of this decision. Other decisions in other MDL cases are expected
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`to issue shortly that could affect the proceedings against Amgen.
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`In view of the importance and time sensitivity around providing access to judicial materials
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`within this MDL, the MDL Defendants made efforts to reach agreement on a procedure to facilitate
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`timely, equitable, and orderly access to judicial materials. That consensus procedure is set forth in
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`the attached Proposed Order. Amgen reached out to the MDL Defendants who each indicated that
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`they do not oppose the Proposed Order. Amgen reached out to the MDL Defendants who each
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`indicated that they do not oppose this motion. The only party to the MDL who has not consented
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`is Regeneron.
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`A. Access to Parties in the MDL
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`It is important for all parties in this MDL to receive access to versions of judicial materials
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`that appropriately redact and keep under seal confidential information. Such access is important to
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`further the JPML’s objective of minimizing the risk of “inconsistent rulings.” ECF No. 1 at 2.
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`On June 7, 2024, Regeneron filed its motion for a preliminary injunction against Amgen.
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`Amgen’s opposition is due in less than one month (on July 3). In the next three weeks, Amgen will
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`be deposing Regeneron’s witnesses Bernhardt Trout, Sean Sheridan, and Kevin Clark, whose prior
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`testimony is likely to have been considered, if not expressly addressed, by this Court. There could
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`be decisions by this Court related to claim construction and patent validity that may affect matters
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`in the Amgen proceeding. It is therefore important for Amgen to consider this Court’s decisions.
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`As Regeneron stated in its May 10 Position Statement, allowing parties to consider such decisions:
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`“[W]ill serve interest of efficiency and consistency by ensuring that Regeneron’s Amgen motion
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`comports with the Court’s earlier decisions. Otherwise, it is likely the parties would need to burden
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`the Court with supplemental briefing to account for the Court’s decisions in these other cases,
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`which may narrow or otherwise inform issues in the Amgen case.” Regeneron’s May 10, 2024
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`Submission at Ex. 4, pp. 2-3 (submitted via email).
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`As this Court recognized at the case management conference conducted on May 17, access
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`to sealed materials has been a “frustration” to date. 1:24-md-3403, ECF No. 111 at 19:23-25.
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`Ordering a formal procedure will minimize such frustrations by creating a process for ensuring
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`timely access to redacted filings to all parties in the MDL. The MDL Defendants have worked
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`together to settle on a proposed order to address this issue. All parties except Regeneron have
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`agreed to the attached Proposed Order as an appropriate procedure for ensuring timely access to
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`future sealed filings.
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`Specifically, the parties (including Regeneron) have exchanged correspondence since May
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`21, 2024 (shortly after the case management conference) regarding access to judicial records and
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`all parties to the MDL participated in several meet and confers in an effort to reach consensus on
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`these issues. Exs. 1 and 2 (email correspondence and proposed stipulation); see also Exs. 3 and 4
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`(email correspondence confirming meet and confers on May 28 and June 10). After remaining
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`silent for weeks, and only after all of the other MDL parties had already agreed to the Proposed
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`Order on June 4, 2024, did Regeneron raise its concerns during a meet and confer on June 10,
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`2024. Ex. 5, at 1. Last night, at 10:09 pm ET, Regeneron proposed a series of revisions to the
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`Proposed Order, several of which incorporate edits that certain parties had already rejected and
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`resolved not to include in the attached Proposed Order in the interest of compromise. Exs. 5 and
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`6, at 2-4. Due to the time sensitive nature of preliminary injunction proceedings, and the need to
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`make redacted versions of this Court’s orders available to all parties in the MDL, Amgen is forced
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`to bring an urgent motion to seek resolution on these access issues.
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`On the June 10, 2024 meet and confer, Regeneron voiced a concern that the Proposed Order
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`does not allow Regeneron to share one defendant’s confidential information with other defendants.
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`That should not prevent entry of the attached Proposed Order. This Court has acknowledged that
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`the defendants in this MDL are competitors and have a proprietary interest in not allowing their
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`respective confidential information to be shared with other defendants by Regeneron. Specifically,
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`during a case management conference related to the preliminary injunction proceedings, the Court
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`ruled that the defendants’ confidential information would be “siloed.” No. 1:23-cv-89, ECF 107 at
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`6-7 (N.D.W. Va. Feb. 15, 2024) (“I think the same concerns would overflow, in all candor, to the
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`anticipated preliminary injunction … supporting briefs should be filed with respect to each
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`separate civil action and defendant.… I think each matter should be siloed, again, out of abundance
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`of caution, to preserve any proprietary interests defendants may have in certain of these biosimilar
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`products.”). The Court’s siloing approach is consistent with the protective orders that Regeneron
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`already agreed to in each case. The Proposed Order preserves the Court’s case management order
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`while enabling access to non-confidential versions for all parties.
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`Because Regeneron is the only party to this MDL that already has access to all the sealed
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`filings, Regeneron may feel no individual need for the Proposed Order. However, basic notions of
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`fair play dictate that all the MDL Defendants should have equal access to decisions in this MDL.
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`A decision in one case may affect a decision in another case, and timely access so that the MDL
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`Defendants can consider redacted versions of those decisions is important to reduce the risk of
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`inconsistency.
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`There is good cause and an immediate need to enter the attached Proposed Order so that
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`redacted versions of Court decisions are made accessible to all MDL parties. This formal procedure
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`will facilitate timely, equitable, and ordered access to litigation materials in this MDL. Providing
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`a formal procedure will also minimize motions practice by creating a default for timely access.2
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`B. Public Access to Judicial Proceedings
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`This Proposed Order also addresses the need for public versions of Sealed Court Orders to
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`be filed on the public docket in view of the public’s right of access to judicial proceedings. Nixon
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`v. Warner Commc’ns, Inc., 435 U.S. 589, 597 (1978); see also In re Application of U.S. for an
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`Order Pursuant to 18 U.S.C. Section 2703(d), 707 F.3d 283, 290 (4th Cir. 2013). This is consistent
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`with Local Rule of Civil Procedure 26.05(b), which states: “The rule requiring public inspection
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`2 While much of the briefing is under seal, Formycon also filed a motion to compel documents
`produced in the Mylan litigation. 1:23-cv-97, ECF Nos. 131, 179, 180.
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`of Court documents is necessary to allow interested parties to judge the Court’s work product in
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`the cases assigned to it.” N.D.W. Va. LR Civ. P. 26.05(b). Entry of the Proposed Order will further
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`reduce the need for motions practice seeking access to redacted versions of these documents.3
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`II. Expedited Consideration Is Warranted
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`In view of the time sensitive nature of these injunction proceedings, expedited briefing on
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`this motion is respectfully requested such that any opposition is due in three (3) business days.
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`Date: June 12, 2024
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`Respectfully submitted,
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`AMGEN INC.
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`/s/Ashley Hardesty Odell_____________________
`Ashley Hardesty Odell [WVSB # 9380]
`ahardestyodell@bowlesrice.com
`Kaitlyn N. McKitrick [WVSB #12782]
`kmckitrick@bowlesrice.com
`Karly N. King [WVSB #14461]
`karly.king@bowlesrice.com
`BOWLES RICE LLP
`125 Granville Square
`Morgantown, West Virginia 26505
`(304) 285-2500 – Telephone
`(304) 285-2575 – Facsimile
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`John R. Labbe (PHV)
`Kevin M. Flowers (PHV)
`Thomas Burns (PHV)
`MARSHALL, GERSTEIN & BORUN LLP
`233 South Wacker Drive
`6300 Willis Tower
`Chicago, IL 60606
`(312) 474-6300
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`3 Celltrion and Amgen filed motions to intervene seeking public access to the Mylan litigation
`documents. 1:22-cv-61, ECF No. 516; 1:22-cv-61, ECF No. 605.
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`E. Anthony Figg (PHV)
`Joseph A. Hynds (PHV)
`Jennifer Nock (PHV)
`Brett A. Postal (PHV)
`ROTHWELL, FIGG, ERNST, & MANBECK, P.C.
`901 New York Avenue, NW
`Suite 900 East
`Washington, D.C. 20001
`(202) 783-6040
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`Wendy Whiteford (PHV)
`Eric Agovino (PHV)
`Chanson Chang (PHV)
`Pauline Pelletier (PHV)
`AMGEN INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320
`(805) 447-1000
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`Attorneys for Defendant Amgen Inc.
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`Case 1:24-cv-00053-TSK Document 17-1 Filed 06/12/24 Page 8 of 8 PageID #: 2672
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`CLARKSBURG DIVISION
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`IN RE: AFLIBERCEPT PATENT LITIGATION
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`MDL No. 1:24-md-03103-TSK
`Hon. Thomas S. Kleeh
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`CERTIFICATION OF GOOD FAITH CONFERENCE
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`Pursuant to L. R. Civ. P. 37.02(a)(3), the undersigned counsel hereby certifies that the
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`parties engaged in a good faith conference required under Fed. R. Civ. P. 37. Plaintiff Regeneron
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`Pharmaceuticals, Inc. (“Regeneron”), and Defendants Amgen Inc., Mylan Pharmaceuticals Inc.
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`and Biocon Biologics Inc., Samsung Bioepis Co., Ltd., Celltrion, Inc., Formycon AG, met and
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`conferred via telephone call on May 28, 2024, at 1:00 pm Eastern and June 10, 2024 at 11:30 am
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`Eastern. Counsel for each party participated in the meet and confer. Additionally, the parties have
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`exchanged several emails addressing the disputes raised in this Motion both before and after the
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`meet and confer. See, e.g., Ex. 3.
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`Date: June 12, 2024
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`_/s/Ashley Hardesty Odell____________________
`Ashley Hardesty Odell [WVSB #9380]
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