`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
`
`Case IPR2023-00884
`
`U.S. Patent No. 11,253,572
`_________________________
`
`JOINT SUMMARY OF RELATED PROCEEDINGS
`
`
`
`Pursuant to the Board’s April 18, 2024 email (Ex. 3002), the parties have
`
`prepared the following summary to update the Board on the related district court
`
`litigation, Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No.
`
`1:22-cv-00061 (ND WVa) (the “Mylan Litigation”).
`
`Joint Summary
`
`On December 27, 2023, the District Court in the Mylan Litigation issued a
`
`decision concerning the patentability of U.S. Patent No. 11,253,572 (the “’572
`
`patent”). Ex. 2093 (“Memorandum Opinion and Order”). In the Memorandum
`
`Opinion and Order, the District Court found “claim 6 of the ’572 patent is rendered
`
`obvious by the combination of Dixon and Hecht.” Id. at 236. The District Court
`
`also found “claim 25 of the ’572 patent [is] invalid as obvious in view of both the
`
`[U.S. Patent No. 7,303,747] alone, and the 9-14-2009 Press Release alone.”1 Id. at
`
`274.2
`
`1 “The Court also [found] that . . . claim 25 of the ’572 patent [is] invalid as
`
`obvious in view of both the ’747 patent, and the 9-14-2009 Press Release, either one
`
`in combination with Do 2009 and Lalwani 2009b.” Id. at 274.
`
`2 The Dixon, Hecht, and 9-14-2009 Press Release are also at issue in this
`
`proceeding. See Ex. 1009 (Dixon); Ex. 1016 (Hecht); Ex. 1005 (2009 Press Release).
`
`1
`
`
`
`On January 26, 2024, the parties to the Mylan Litigation appealed the
`
`Memorandum Opinion and Order, including the decision regarding the invalidity of
`
`the ’572 patent, to the Federal Circuit. See Federal Circuit Appeal Nos. 2024-1402,
`
`2024-1405. Before substantive briefing occurred, on April 12, 2024, both appeals
`
`were dismissed based on the parties’ agreement that the Federal Circuit lacked
`
`subject matter jurisdiction given that the District Court’s Memorandum Opinion and
`
`Order resolved fewer than all claims at issue. Regeneron Pharmaceuticals, Inc. v.
`
`Mylan Pharmaceuticals Inc and Biocon Biologics Inc., Appeal No. 24-1402, Dkt.
`
`No. 26 (Fed. Cir., Apr. 12, 2024). Consequently, at the moment, there are currently
`
`no pending appeals of the District Court’s Memorandum Opinion and Order.
`
`Currently pending before the District Court is Regeneron’s motion for permanent
`
`injunction, which does not involve the ‘572 patent, or any member of the ‘572 patent
`
`family. See Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc and
`
`Biocon Biologics Inc., Case No. 22-cv-61, Dkt. No. 708 (N.D.W. Va., Feb. 22,
`
`2024). Both the District Court’s decision regarding the invalidity of the ’572 patent
`
`and the District Court’s April 19, 2023 Order construing certain claim terms in the
`
`’572 patent will be subject to appeal upon entry of a final judgment from the District
`
`Court.
`
`2
`
`
`
`DATED: April 29, 2024
`
`Respectfully submitted,
`By /s/ Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel:
`(212) 849-7000
`Fax: (212) 849-7100
`
`Counsel for Petitioner Samsung Bioepis
`
`By /s/ Adam R. Brausa
`Adam R. Brausa (Reg. No. 60,287)
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, Calfiornia 94105
`Tel : (415) 268-6053
`ABrause@mofo.com
`
`Counsel for Patent Owner Regeneron
`
`3
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the Joint Summary of Related
`
`Proceedings was served on April 29, 2024, to Counsel for Patent Owner Regeneron
`
`via email to Regeneron-MoFo-IPR@mofo.com; Counsel for Biocon Biologics, Inc.
`
`at MYL_REG_IPR@rmmslegal.com; and Counsel
`
`for Celltrion,
`
`Inc. at
`
`lgreen@geminilaw.com,
`
`fchu@geminilaw.com,
`
`rcerwinski@geminilaw.com,
`
`azalcenstein@geminilaw.com, and bmorris@geminilaw.com.
`
`DATED: April 29, 2024
`
`Respectfully submitted,
`By /s/ Raymond N. Nimrod
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`
`4
`
`
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