UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`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
`_________________________
`
`PETITIONER’S OBJECTIONS TO
`PATENT OWNER’S EXHIBITS
`
`
`
`_________________________
`
`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
`_________________________
`
`PETITIONER’S OBJECTIONS TO
`PATENT OWNER’S EXHIBITS
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Samsung Bioepis Co., Ltd.
`
`(“Petitioner”) submits the following objections to evidence submitted by Patent
`
`Owner Regeneron Pharmaceuticals, Inc. (“Patent Owner”). Petitioner’s objections
`
`apply equally to Patent Owner’s reliance on this evidence in any subsequently filed
`
`documents or further proceedings in this matter. These objections are timely, having
`
`been filed and served within ten business days of the institution of the trial.
`
`Notwithstanding these objections, Petitioner expressly reserves the right to rely on
`
`any evidence submitted by Patent Owner, including on the ground that such evidence
`
`constitutes a party admission.
`
`Exhibits 2001, 2003, 2026, 2028, 2031-2032, and 2034
`
`Objections
`
`Petitioner objects to these exhibits under FRE 401, 402 and 403. These
`
`exhibits are not relevant, and their probative value is substantially outweighed by
`
`the danger of confusion of the issues. Petitioner further objects to these exhibits for
`
`lack of foundation and lack of personal knowledge under FRE 602.
`
`Petitioner additionally objects to these exhibits under FRE 701, 702, and 703
`
`to the extent these exhibits include improper lay and/or expert testimony that fails to
`
`properly provide the requisite underlying facts, data, and other required disclosures.
`
`1
`
`
`
`Moreover, Petitioner objects to these exhibits as inadmissible hearsay and/or
`
`double-hearsay under FRE 801 and 802 that does not fall under any exceptions,
`
`including those of FRE 803, 804, 805, or 807, to the extent Patent Owner relies on
`
`these exhibits for the truth of the matter asserted. Petitioner further objects to the
`
`extent Patent Owner seeks to rely on declaration and trial testimony in a manner that
`
`circumvents Board rules regarding making the declarant available for cross-
`
`examination. Patent Trial and Appeal Board Consolidated Trial Practice Guide
`
`November 2019, 51 (“a party has the opportunity to cross-examine a witness
`
`providing declaration testimony submitted by another party, after institution, unless
`
`the Board orders otherwise. 37 C.F.R. § 42.51(b)(1)(ii).”)
`
`Exhibits 2004-2011, 2013, 2015, 2017-2025, 2035-2045, 2047-2048, and 2050-
`
`2054
`
`Petitioner objects to these exhibits as not properly authenticated under FRE
`
`901 because Patent Owner has not presented sufficient evidence to show that they
`
`are authentic or self-authenticating under FRE 902. Petitioner further objects to
`
`these exhibits for lack of foundation and lack of personal knowledge under FRE 602.
`
`To the extent Patent Owner relies on Exhibits 2005-2011, 2013, 2015, 2017-2019,
`
`2021-2025, 2035-2045, 2047-2048, and 2050-2054 for the truth of the matter
`
`asserted, Petitioner further objects to Exhibits 2005-2011, 2013, 2015, 2017-2019,
`
`2021-2025, 2035-2045, 2047-2048, and 2050-2054 as inadmissible hearsay and/or
`
`2
`
`
`
`inadmissible double hearsay under FRE 801 and 802 that does not fall under any
`
`exceptions, including those of FRE 803, 804, 805, or 807.
`
`Petitioner additionally objects to Exhibits 2005-2011, 2015, 2017-2019, 2024,
`
`2035, and 2039-2045 under FRE 401-403 because Exhibits 2005-2011, 2015, 2017-
`
`2019, 2024, 2035, and 2039-2045 are not relevant, are facially incomplete, and their
`
`probative value is substantially outweighed by the danger of confusion of the issues.
`
`Exhibits 2002, 2012, 2014, 2016, 2046, 2049, and 2055-2058
`
`Petitioner objects to these exhibits under FRE 401, 402 and 403. These
`
`exhibits are not relevant, including because these exhibits postdate the alleged
`
`priority date of U.S. Patent No. 11,253,572, and their probative value is substantially
`
`outweighed by the danger of confusion of the issues. Petitioner further objects to
`
`these exhibits as not properly authenticated under FRE 901 because Patent Owner
`
`has not presented sufficient evidence to show that they are authentic or self-
`
`authenticating under FRE 902. To the extent Patent Owner relies on Exhibits 2012,
`
`2014, 2016, 2046, 2049, and 2055-2058 for the truth of the matter asserted,
`
`Petitioner objects to Exhibits 2012, 2014, 2016, 2046, 2049, and 2055-2058 as
`
`inadmissible hearsay under FRE 801 and 802 that does not fall under any exceptions,
`
`including those of FRE 803, 804, 805, or 807.
`
`3
`
`
`
`DATED: December 4, 2023
`
`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
`In accordance with 37 C.F.R. § 42.6(e), I hereby certify that on December 4,
`
`2023, true and correct copies of the foregoing were served via electronic mail to
`
`Patent Owner at the following email addresses of record:
`
`Brausa, Adam R. ABrausa@mofo.com
`Davis, Kira A KiraDavis@mofo.com
`Weires, Rebecca RWeires@mofo.com
`Durie, Daralyn J. DDurie@mofo.com
`Regeneron-MoFo-IPR Regeneron-MoFo-IPR@mofo.com
`
`DATED: December 4, 2023
`
`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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