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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_________________________
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
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`Case IPR2023-00884
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`U.S. Patent No. 11,253,572
`_________________________
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`PETITIONER’S AMENDED MANDATORY NOTICES
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`Case IPR2023-00884
`U.S. Patent No. 11,253,572
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`Pursuant to 37 C.F.R. § 42.8, Petitioner Samsung Bioepis Co., Ltd.
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`(“Petitioner”) respectfully submits the following mandatory notices to notify the
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`Board of the addition of Zachariah Summers, Sarah M. Cork, and Elliot Choi from
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`Quinn Emanuel LLP as back-up counsel. A current listing of counsel is provided
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`below. Patent Owner also provides an update to the Related Matters.
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`A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
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`The real party-in-interest for Petitioner is Samsung Bioepis Co., Ltd.
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`B. Related Matters (37 C.F.R. § 42.8(b)(2)) (Amended)
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`Apotex filed an IPR Petition on September 9, 2022 asserting five grounds for
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`invalidating the non-DME claims of U.S. Patent No. 11,253,572 (“’572 patent”), all
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`of which recite “results limitations.” Ex.1008 (“Apotex Petition”). Grounds 1-4 of
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`Apotex’s petition were based on anticipation: (1) anticipation of claims 1-5, 8-11,
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`14, and 26- 30 based on Dixon; (2) anticipation of claims 1-5, 8-11, 14, and 26-30
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`based on a May 8, 2008 Regeneron Press Release; (3) anticipation of claims 1-5, 8-
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`11, 14, and 26-30 based on NCT-795 (i.e., VIEW 1 ClinicalTrials.gov entry); and
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`(4) anticipation of claims 1-5, 8-11, 14, and 26-30 based on NCT-377 (i.e., VIEW 2
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`ClinicalTrials.gov entry). Ex.1008, 12.
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`With respect to the “results limitations” in these claims, Apotex argued that
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`they (1) were not entitled to patentable weight (id., 17-20); or (2) were inherently
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`anticipated by practice of the claimed method (id., 35-68). Notably, Apotex did not
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`U.S. Patent No. 11,253,572
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`rely on obviousness to address the visual acuity limitations in any of the claims.
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`Apotex only asserted obviousness for claims 6, 7, 12, and 13 in its Ground 5. For
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`those claims, Apotex relied on any of the above anticipatory references in view of
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`Hecht. Ex.1008, 12. Apotex’s obviousness argument in Ground 5 was solely directed
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`to the “isotonic solution” limitation in dependent claims 6 and 12 and the “nonionic
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`surfactant” limitation in dependent claims 7 and 13—not the “results limitations.”
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`Ex.1008, 68-71. In its Institution Decision, the Board determined that the “results
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`limitations” were entitled to patentable weight. Ex.1004 (“Apotex ’572 ID”), 14-18.
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`The Board then went on to determine that the prior art did not inherently disclose
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`the “results limitations” for at least two reasons: (1) less than all of the patients in
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`the VIEW 1/2 trials achieved the claimed visual acuity limitations; and (2) the patient
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`population reported in the prior art as achieving the recited gains was not the same
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`as that described in the ’572 patent. Id, 30-36. It therefore denied institution. Id.
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`The ’572 patent is in the same family as U.S. Patent Nos. 9,254,338 (“’338 patent”),
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`9,669,069 (“’069 patent”), 10,130,681 (“’681 patent”), and 10,888,601 (“’601
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`patent”). Ex.1001.
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`In May 2021, Mylan Pharmaceuticals Inc. filed petitions requesting inter
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`partes review of the ’338 and ’069 patents. See IPR2021-00881 (“’338 IPR”) and
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`IPR2021-00880 (“’069 IPR”). The Board instituted review for the ’338 and ’069
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`patents and found all challenged claims of those patents unpatentable in Final
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`Written Decisions issued on November 9, 2022. See Ex.1011, ’338 IPR, Paper 94
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`(“’338 FWD”); ’069 IPR, Paper 89. Mylan filed a petition requesting IPR of the ’681
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`patent on July 1, 2022 (IPR2022-01225) (“Mylan ’681 IPR”). The Mylan ’681 IPR
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`was instituted on January 11, 2023. Ex.1012 (“’681 ID”). Petitioner filed a petition
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`against the ’681 patent on January 6, 2023 (IPR2023-00442) asserting different
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`grounds of invalidity than in the Mylan ’681 IPR. A decision on Petitioner’s petition
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`is pending. Mylan filed a petition requesting IPR of the non-DME claims of the ’601
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`patent on July 1, 2022. See IPR2022-01226 (“Mylan ’601 IPR”). The Mylan 601
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`IPR was instituted on January 11, 2023. Ex.1013 (’601 ID). Petitioner filed a
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`“copycat” IPR petition on February 10, 2023. See, Samsung Bioepis Co., Ltd. v.
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`Regeneron Pharmaceuticals, Inc., IPR2023-00566, Papers 2-3. The Board instituted
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`Petitioner’s IPR petition and granted its motion for joinder on March 22, 2023 in
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`IPR2023-00566. Id., Paper 10.
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`Petitioner filed a petition requesting IPR of the DME claims of the ’601 patent
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`on March 26, 2023. See Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals,
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`Inc., IPR2023-00739. A decision on Petitioner’s petition is pending.
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`Biocon Biologics Inc. filed a petition requesting IPR of the ’601 patent on
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`November 20, 2023 and filed a motion for joinder with the IPR2023-0079. See,
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`Biocon v. Regeneron Pharmaceuticals, Inc., IPR2024-00566, Papers 2-3.
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`Biocon Biologics Inc. filed a petition requesting IPR of the ’572 patent on
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`December 18, 2023 and filed a motion for joinder with the above-captioned IPR.
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`See, Biocon v. Regeneron Pharmaceuticals, Inc., IPR2024-00298, Papers 1-2.
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`Celltrion, Inc. filed a petition requesting IPR of the ’572 patent on December
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`14, 2023 and filed a motion for joinder with the above-captioned IPR. See, Celltrion
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`Inc. v. Regeneron Pharmaceuticals, Inc., IPR2024-00260, Papers 1-3.
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`To the best of Petitioner’s knowledge, the following are judicial or
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`administrative matters that potentially would affect, or be affected by, a decision in
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`this proceeding: Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis, Inc., No.
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`1:23-cv-00094 (N.D. W.Va.); Regeneron Pharmaceuticals, Inc. v. Samsung Bioepis,
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`Inc., No. 1:23-cv-00106 (N.D. W.Va.); Regeneron Pharmaceuticals, Inc. v.
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`Formycon, No. 1:23-cv-00097 (N.D. W.Va.); Regeneron Pharmaceuticals, Inc. v.
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`Mylan Pharmaceuticals Inc., No. 1:22-cv-00061 (N.D. W.Va.); and Regeneron
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`Pharmaceuticals, Inc. v. Celltrion, Inc., No. 1:23-CV-0089 (N.D. W.Va).
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`C. Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)-(4)) (Amended)
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`Petitioner hereby identifies its lead and backup counsel as follows:
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`Lead Counsel
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`Backup Counsel
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`Raymond N. Nimrod (Reg. No. 31,987)
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`
`Matthew A. Traupman (Reg. No. 50,832)
`Elliot Choi (pro hac vice to be applied
`for)
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
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`4
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`Case IPR2023-00884
`U.S. Patent No. 11,253,572
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`Fax: (212) 849-7100
`raynimrod@quinnemanuel.com
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`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`matthewtraupman@quinnemanuel.com
`elliotchoi@quinnemanuel.com
`
`Zachariah Summers (pro hac vice to be
`applied for)
`Sarah Cork (pro hac vice to be applied
`for)
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`865 S. Figueroa St., 10th Floor
`Los Angeles, California 90017
`General Tel: (213) 443-3000
`Fax: (213) 443-3100
`zachsummers@quinnemanuel.com
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`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`300 W. 6th Street
`Austin, TX 78701
`Tel: (737) 667-6100
`Fax: (737) 667-6110
`landonsmith@quinnemanuel.com
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`Pursuant to 37 C.F.R. § 42.10(b), a Power of Attorney has been filed herewith.
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`D.
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`Service Information (37 C.F.R. § 42.8(b)(4))
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`Please send all correspondence to the lead and backup counsel at the addresses
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`shown
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`above.
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`
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`Petitioner
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`consents
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`to
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`service
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`by
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`at
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`qe-samsungbioepis@quinnemanuel.com.
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`Case IPR2023-00884
`U.S. Patent No. 11,253,572
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`DATED: January 4, 2024 Respectfully submitted,
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`By /Raymond N. Nimrod/
`Raymond N. Nimrod (Reg. No. 31,987)
`raynimrod@quinnemanuel.com
`Matthew A. Traupman (Reg. No. 50,832)
`matthewtraupman@quinnemanuel.com
`Elliot Choi (admitted pro hac vice)
`elliotchoi@quinnemanuel.com
`QUINN EMANUEL URQUHART
`& SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
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`Zachariah Summers (admitted pro hac vice)
`Sarah Cork (admitted pro hac vice)
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`865 S. Figueroa St., 10th Floor
`Los Angeles, California 90017
`General Tel: (213) 443-3000
`Fax: (213) 443-3100
`zachsummers@quinnemanuel.com
`
`
`Landon Andrew Smith (Reg. No. 79,248)
`landonsmith@quinnemanuel.com
`QUINN EMANUEL URQUHART
` & SULLIVAN, LLP
`300 W. 6th Street
`Austin, TX 78701
`Tel: (737) 667-6100
`Fax: (737) 667-6110
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`Attorneys for Petitioner Samsung Bioepis
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`Case IPR2023-00884
`U.S. Patent No. 11,253,572
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Petitioner’s Power of Attorney
`Pursuant to 37 C.F.R. § 42.10(b) was served on January 4, 2024, to the following
`Counsel for Petitioner via email to Regeneron-MoFo-IPR@mofo.com.
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`DATED: January 4, 2024 Respectfully submitted,
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`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
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`7
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