`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION, INC.,
`and BIOCON BIOLOGICS INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
`
`Case IPR2023-008841
`
`
`
`U.S. Patent No. 11,253,572
`_________________________
`
`
`MOTION TO FILE CONFIDENTIAL DOCUMENTS UNDER
`SEAL PURSUANT TO 37 C.F.R. §§ 42.14
`
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
`
`
`
`
`
`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14, Petitioner Samsung
`
`Bioepis, Co., Ltd. moves to seal Exhibits 1080, 1082, and 1083, along with the
`
`specific portions of the Petitioner’s Reply that reveal confidential information in
`
`Exhibits 1080, 1082, 1083, 2067, 2069, and 2073. Pursuant to the Protective Order
`
`entered in this proceeding (Paper 25) and the Amended Protective Order which
`
`Petitioner and Patent Owner have agreed to abide by until entered (Paper 60),
`
`Petitioner must “maintain the confidentiality” of material that has been marked or
`
`designated as “Protective Material” in this proceeding. Accordingly, Petitioner
`
`moves to seal the following exhibits which Patent Owner has designated “Protective
`
`Material” and references of such confidential information in its Reply:
`
`Exhibit
`1080
`
`Description
`Deposition Transcript of George D. Yancopoulos, M.D., Ph.D. (April
`12, 2024) in IPR2023-00884
`
`Deposition Transcript of Karen Chu (April 11, 2024)
`
`RGN-EYLEA-MYLAN-00526220
`00526223
`
`to RGN-EYLEA-MYLAN-
`
`1082
`
`1083
`
`
`
`I.
`
`GOOD CAUSE EXISTS FOR SEALING
`
`The standard governing the Board’s determination of whether to grant a
`
`motion to seal is “good cause.” Arctic Cat, Inc. v. Polaris Indus. Inc., No. IPR2017-
`
`00433, 2018 WL 1145910, at *1 (P.T.A.B. Feb. 27, 2018) (quoting 37 C.F.R. §
`
`42.54). “The moving party bears the burden of showing that the relief requested
`
`
`
`
`
`
`
`should be granted, and establishing that information sought to be sealed is
`
`confidential information.” Askeladden LLC v. Verify Smart Corp., No. IPR2017-
`
`00726, 2017 WL 4763581, at *1 (P.T.A.B. Oct. 18, 2017).
`
`The documents, exhibits, and portions of the Reply that Petitioner seeks to file
`
`under seal, according to Patent Owner, contain confidential information of
`
`Regeneron. See Papers 34; 60. Based on Patent Owner’s representations, the “good
`
`cause” standard is met, as in each instance, the material is the confidential
`
`information of Patent Owner. See Id. Pursuant to Paragraph 5(A)(ii) of the Board’s
`
`default protective order, a redacted copy of the Petitioner’s Reply is being filed
`
`publicly.
`
`A. Documents to Be Sealed
`
`Exhibits 1080 and 1082 are the transcripts of Dr. Yancopoulos and Ms. Chu
`
`from this proceeding, IPR2023-00884. Dr. Yancopolos and Ms. Chu were both
`
`involved in the development of Eylea. Counsel for Patent Owner designated both
`
`transcripts as “Confidential Under the Protective Order.” Ex. 1080 at 254:8-12; Ex.
`
`1082 at 247:22-248:3. Petitioner understands these transcripts contain discussion
`
`related to Regeneron’s clinical development processes and strategic decision making
`
`and that Patent Owner considers this subject matter commercially sensitive
`
`information that would cause competitive harm if publicly disclosed. See Paper 34
`
`at 5-7.
`
`
`
`2
`
`
`
`
`
`Exhibit 1083 is email correspondence between George Yancopoulos and other
`
`Regeneron employees regarding the design of the studies for VEGF-Trap-Eye (i.e.,
`
`aflibercept). The exhibit was marked “Confidential Protective Order Material” by
`
`Patent Owner. Petitioner understands this material contains discussion related to
`
`Regeneron’s clinical development processes and strategic decision making and that
`
`Patent Owner considers such materials commercially sensitive information that
`
`would cause competitive harm if publicly disclosed. See Paper 34 at 5-7.
`
`Petitioner relies on and discusses the confidential contents of the above-
`
`mentioned exhibits within its Reply. Petitioner also relies on and discusses Patent
`
`Owner’s Exhibits 2067, 2069, and 2073, these Exhibits are the subject of Patent
`
`Owner’s pending Motion to Seal and marked “Confidential Material – Subject to
`
`Protective Order”. Paper 34. In this paper, Petitioner identifies Ex 2069 and Ex
`
`2073 as internal correspondence from 2006-2007 related to the development of
`
`aflibercept, and in particular to the design of aflibercept clinical trials. Id. at 5-6.
`
`Patent Owner states release of these details could cause competitive harm to Patent
`
`Owner. Id. Patent Owner identifies Exhibit 2073 as containing detailed internal
`
`results on Patent Owner’s CLEAR-IT-2 clinical trial. Id. at 6-7. Patent Owner states
`
`release of these details could cause competitive harm to Patent Owner. Id.
`
`
`
`3
`
`
`
`
`
`
`
`Accordingly, Petitioner moves to seal Exhibits 1080, 1082, and 1083, along
`
`with the specific portions of the Petitioner’s Reply that reveal confidential
`
`information in Exhibits 1080, 1082, 1083, 2067, 2069, and 2073.
`
`
`
`DATED: June 10, 2024
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By /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
`
`
`Attorneys for Petitioner Samsung Bioepis
`
`4
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Motion for Additional
`
`Discovery pursuant to 37 C.F.R. § 42.10(b) was served on June 10, 2024, to the
`
`following: Counsel for Petitioner 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: June 10, 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`By /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
`
`
`5
`
`
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