Case 1:23-cv-00089-TSK Document 100-6 Filed 02/14/24 Page 1 of 4 PageID #: 4248
`Case 1:23-cv-00089-TSK Document 100-6 Filed 02/14/24 Page 1of 4 PagelD #: 4248
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`EXHIBIT 6
`EXHIBIT 6
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`Case 1:23-cv-00089-TSK Document 100-6 Filed 02/14/24 Page 2 of 4 PageID #: 4249
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`Griffin, Renee
`
`From:
`Sent:
`To:
`
`Cc:
`Subject:
`
`Kayali, Kathryn
`Thursday, February 8, 2024 7:45 PM
`Zach Summers; Laura Fairneny; clt@simmermanlaw.com; fes@simmermanlaw.com;
`trey@simmermanlaw.com; Matthew Robson; Matthew Traupman; Ray Nimrod;
`skl@schraderlaw.com
`Eylea; Eylea Biosimilars; QE - Samsung Bioepis
`RE: MDL No. 3103: In re Aflibercept Patent Litigation
`
`Counsel:
`
`
`Needless to say, we disagree entirely with your posture and rhetoric below. Requesting permission to disclose
`information is not a “threat” nor does it in any way violate the BPCIA—to the contrary, such requests are explicitly
`contemplated by statute. While we thoroughly dispute that, for example, an assertion that a public document
`anticipates or renders obvious a public patent could possibly be confidential, we will abide by your refusal to permit the
`JPML to view materials relevant to its decision. Accordingly, we will not disclose the contents of Samsung Bioepis’s
`contentions in our MDL filings or otherwise attach excerpts of those contentions as exhibits. We will inform the JPML
`that we requested permission to do so and permission was denied. We trust this resolves your concerns.
`
`
`Best,
`
`
`Kat
`
`
`Kathryn S. Kayali
`Williams & Connolly LLP
`680 Maine Avenue S.W., Washington, DC 20024
`(P) 202-434-5644 | (F) 202-434-5029
`kkayali@wc.com | www.wc.com
`
`
`
`From: Zach Summers <zachsummers@quinnemanuel.com>
`Sent: Thursday, February 8, 2024 5:11 PM
`To: Laura Fairneny <laurafairneny@quinnemanuel.com>; Kayali, Kathryn <KKayali@wc.com>; clt@simmermanlaw.com;
`fes@simmermanlaw.com; trey@simmermanlaw.com; Matthew Robson <matthewrobson@quinnemanuel.com>;
`Matthew Traupman <matthewtraupman@quinnemanuel.com>; Ray Nimrod <raynimrod@quinnemanuel.com>;
`skl@schraderlaw.com
`Cc: Eylea <Eylea@wc.com>; Eylea Biosimilars <Eylea.Biosimilars@weil.com>; QE - Samsung Bioepis <qe-
`samsungbioepis@quinnemanuel.com>
`Subject: RE: MDL No. 3103: In re Aflibercept Patent Litigation
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`Counsel:
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`
`We have not received any response from you. Please confirm Regeneron and its counsel have immediately ceased their
`use of SB’s confidential information for the MDL or any other purpose not permitted by the statute. In particular, please
`confirm before 8 pm ET today that Regeneron withdraws its threat to use or reference the contents of SB’s 3B
`contentions in its MDL papers. If Regeneron does not do so, SB intends to seek a TRO from the Court tomorrow
`morning, pursuant to 42 U.S.C. § 262(l)(1)(H). That provision specifies that injunctive relief is appropriate and necessary
`for any violation or threatened violation of the confidentiality provisions of the BPCIA, which still govern that material
`here. See 42 U.S.C. § 262(l)(1)(H) (“[t]he disclosure of any confidential information in violation of this paragraph shall be
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`1
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`Case 1:23-cv-00089-TSK Document 100-6 Filed 02/14/24 Page 3 of 4 PageID #: 4250
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`deemed to cause the subsection (k) applicant to suffer irreparable harm for which there is no adequate legal remedy
`and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or
`threatened violation of this paragraph”).
`
`
`Best,
`Zach
`
`
`
`From: Laura Fairneny <laurafairneny@quinnemanuel.com>
`Sent: Wednesday, February 7, 2024 9:48 AM
`To: Kayali, Kathryn <KKayali@wc.com>; clt@simmermanlaw.com; fes@simmermanlaw.com; trey@simmermanlaw.com;
`Matthew Robson <matthewrobson@quinnemanuel.com>; Matthew Traupman
`<matthewtraupman@quinnemanuel.com>; Ray Nimrod <raynimrod@quinnemanuel.com>; Zach Summers
`<zachsummers@quinnemanuel.com>; skl@schraderlaw.com
`Cc: Eylea <Eylea@wc.com>; Eylea Biosimilars <Eylea.Biosimilars@weil.com>; QE - Samsung Bioepis <qe-
`samsungbioepis@quinnemanuel.com>
`Subject: RE: MDL No. 3103: In re Aflibercept Patent Litigation
`
`
`Counsel,
`
`
`Your email is deeply troubling. As your email notes, SB designated its 3B contentions as confidential pursuant to 42
`U.S.C. § 262(l)(1). Section 262(l)(1)(D) provides explicit limitations on the use of SB’s confidential
`information: “Confidential information shall be used for the sole and exclusive purpose of determining, with respect to
`each patent assigned to or exclusively licensed by the reference product sponsor, whether a claim of patent
`infringement could reasonably be asserted if the subsection (k) applicant engaged in the manufacture, use, offering for
`sale, sale, or importation into the United States of the biological product that is the subject of the application under
`subsection (k).” (emphases added). Plainly, Regeneron’s briefing in support of its motion to transfer and centralize its
`lawsuits against third parties Biocon, Mylan, Celltrion, Formycon and Amgen falls outside the scope of permissible uses
`of SB’s confidential information. Yet, your email demonstrates that Regeneron already has used SB’s confidential
`information for the impermissible purpose of preparing its reply brief. SB demands that Regeneron and its counsel
`immediately cease their use of SB’s confidential information for purposes not permitted by the statute. Any reference
`to the contents of SB’s 3B contentions in Regeneron’s brief before the JPML would constitute a breach of the statutory
`use limitations, and in particular your stated intention of attaching or quoting all or part of SB’s 3B contentions in
`connection with Regeneron’s upcoming reply brief would constitute an egregious violation of statute for which SB will
`seek immediate relief.
`
`
`Your email is the latest in a long and ongoing deliberate set of acts by Regeneron and its outside counsel of misusing
`confidential information produced by aflibercept biosimilar applicants. SB expects Regeneron to immediately take steps
`to ensure its full compliance with the relevant confidentiality provisions, and SB reserves its right to seek appropriate
`relief from Regeneron’s repeated and ongoing misuse of confidential information.
`
`
`Regards,
`Laura
`
`
`From: Kayali, Kathryn <KKayali@wc.com>
`Sent: Tuesday, February 6, 2024 11:49 PM
`To: clt@simmermanlaw.com; fes@simmermanlaw.com; trey@simmermanlaw.com; Laura Fairneny
`<laurafairneny@quinnemanuel.com>; Matthew Robson <matthewrobson@quinnemanuel.com>; Matthew Traupman
`<matthewtraupman@quinnemanuel.com>; Ray Nimrod <raynimrod@quinnemanuel.com>; Zach Summers
`<zachsummers@quinnemanuel.com>; skl@schraderlaw.com
`Cc: Eylea <Eylea@wc.com>; Eylea Biosimilars <Eylea.Biosimilars@weil.com>
`Subject: MDL No. 3103: In re Aflibercept Patent Litigation
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`2
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`Case 1:23-cv-00089-TSK Document 100-6 Filed 02/14/24 Page 4 of 4 PageID #: 4251
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`[EXTERNAL EMAIL from kkayali@wc.com]
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`Counsel,
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`In your MDL opposition brief, you stated that your defenses differ from the defenses raised by other Defendants
`(Amgen, Formycon, Celltrion, Mylan and/or Biocon). We therefore assume you reviewed the defenses asserted
`by other Defendants or otherwise conferred regarding their content. Please confirm that you therefore agree to
`Regeneron’s service of unredacted copies of excerpts of Samsung Bioepis’s contentions pursuant to 28 U.S.C. §
`262(l)(3)(B) (or information contained therein) on outside counsel for each of the other Defendants, which will
`be included as part of Regeneron’s JPML reply. Any such material will be filed under seal or redacted and not
`visible to the public. To the extent your position differs as to Samsung Bioepis’s infringement contentions and
`Samsung Bioepis’s invalidity contentions, please so specify. In the absence of agreement, we will need to serve
`outside counsel only with redacted copies of Regeneron’s reply.
`
`In the alternative, if your client does not consider its contentions to be confidential, please let us know so that
`we may dispense with the sealing process.
`
`
`Best,
`
`
`Kat
`
`
`Kathryn S. Kayali
`Williams & Connolly LLP
`680 Maine Avenue S.W., Washington, DC 20024
`(P) 202-434-5644 | (F) 202-434-5029
`kkayali@wc.com | www.wc.com
`
`
`
`
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`This message and any attachments are intended only for the addressee and may contain information that is privileged and
`confidential. If you have received this message in error, please do not read, use, copy, distribute, or disclose the contents of the
`message and any attachments. Instead, please delete the message and any attachments and notify the sender immediately. Thank
`you.
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