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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., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`Patent No. 11,253,572
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`_______________
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`Inter Partes Review No. IPR2023-008841
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`____________________________________________________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE SUBMITTED WITH
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
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`IPR2023-00884
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`Patent Owner Regeneron Pharmaceuticals, Inc. hereby objects to the
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`following evidence that was submitted by Petitioner Samsung Bioepis Co., with
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`the Petitioner’s Reply to Patent Owner’s Response (Papers 63 and 64). These
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`objections are timely filed and served within five business days of service
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`Petitioner’s June 10, 2024 Reply. 37 C.F.R. § 42.64(b)(1)
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`A. Exhibit 1076 Deposition Transcript of Michael W. Stewart, M.D. (May
`30, 2024) in IPR2023-00884
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`Patent Owner objects to Exhibit 1076 for each of the reasons noted in the
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`objections made during the underlying deposition.
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`B. Exhibit 1077 Stewart MW, Rosenfeld PJ. Predicted biological activity of
`intravitreal VEGF Trap. Br J Ophthalmol. 2008 May;92(5):667-8
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`Patent Owner objects to Exhibit 1077 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`It is not clear where the exhibit came from or how it was compiled.
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`Patent Owner further objects to Exhibit 1077 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1077
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`IPR2023-00884
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`with its argument in the Petition. “Petitioner may not submit new evidence or
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`argument in reply that it could have presented earlier . . . .” U.S. Patent Trial and
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`Appeal Board, Consolidated Practice Guide 73 (Nov. 2019) (“Practice Guide”);
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`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70
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`(Fed. Cir. 2016) (precluding the introduction of new evidence to support a new
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`theory of invalidity); see also Ariosa Diagnostics v. Verinata Health, Inc.,
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`805 F.3d 1359, 1367 (Fed. Cir. 2015) (rejecting a reply even for reliance on new
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`portions of previously submitted prior art).
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`C. Exhibit 1078 Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS,
`Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab
`versus verteporfin for neovascular age-related macular degeneration. N
`Engl J Med. 2006 Oct 5;355(14):1432-44 (“ANCHOR Study”)
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`Patent Owner objects to Exhibit 1078 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents clinical results using a
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`different compound than the one in the claimed regimens, which is
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`substantially more prejudicial than probative.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`It is not clear where the exhibit came from or how it was compiled.
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`IPR2023-00884
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`Patent Owner further objects to Exhibit 1078 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1078
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`with its argument in the Petition. “Petitioner may not submit new evidence or
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`argument in reply that it could have presented earlier . . . .” Practice Guide at 73;
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`Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
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`D. Exhibit 1079 Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK,
`Chung CY, et al. Ranibizumab for neovascular age-related macular
`degeneration. New England Journal of Medicine 2006; 355(14):1419-31
`(“MARINA Study”)
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`Patent Owner objects to Exhibit 1079 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents clinical results using a
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`different compound than the one in the claimed regimens, which is
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`substantially more prejudicial than probative.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`It is not clear where the exhibit came from or how it was compiled.
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`Patent Owner further objects to Exhibit 1079 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1079
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`with its argument in the Petition. “Petitioner may not submit new evidence or
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`IPR2023-00884
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`argument in reply that it could have presented earlier . . . .” Practice Guide at 73;
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`Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
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`E. Exhibit 1080 Deposition Transcript of George D. Yancopoulos, M.D.,
`Ph.D. (April 12, 2024)
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`Patent Owner objects to Exhibit 1080 for each of the reasons noted in the
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`objections made during the underlying deposition.
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`F. Exhibit 1081 Samsung Bioepis Petition for IPR filed in Samsung Bioepis
`Co., Ltd. v. Regeneron Pharmaceuticals, Inc., PTAB-IPR2023-00739
`(Paper 1) (“Samsung 601 Petition”)
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`Patent Owner objects to Exhibit 1081 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder.
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`• FRE 611 and 37 CFR § 42.24 because Petitioner’s submission of an 83-
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`page petition from another proceeding violates the requirements of FRE
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`611 that the Board “exercise reasonable control over the mode and order
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`of . . . presenting evidence.” The exhibit contains attorney argument that
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`exceeds the scope of direct examination questioning. Likewise,
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`Petitioner’s submission of additional petitions in this proceeding flouts
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`the word limit established by 37 CFR § 42.24(c)(1). Patent Owner further
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`objects to Exhibit 1081 under FRE 403 because the consideration of the
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`83-page document, to the extent it has any probative value, is
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`substantially outweighed by the danger of unfair prejudice, confusing the
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`issues, wasting time, and needlessly presenting cumulative evidence.
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`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
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`unauthorized form and in a manner that is unfairly prejudicial to Patent
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`Owner.
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`Patent Owner further objects to Exhibit 1081 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised individual
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`arguments and evidence contained within Exhibit 1081 with its argument in the
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`Petition. “Petitioner may not submit new evidence or argument in reply that it
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`could have presented earlier . . . .” Practice Guide at 73; Intelligent Bio-Sys.,
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`821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
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`G. Exhibit 1082 Deposition Transcript of Karen Chu (April 11, 2024)
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`Patent Owner objects to Exhibit 1082 for each of the reasons noted in the
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`objections made during the underlying deposition.
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`H. Exhibit 1083 RGN-EYLEA-MYLAN-00526220 – RGN-EYLEA-
`MYLAN-00526223
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`Patent Owner objects to Exhibit 1083 under:
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`• FRE 901. Petitioner has not introduced evidence or testimony to properly
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`authenticate the exhibit.
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
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`unauthorized form and in a manner that is unfairly prejudicial to Patent
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`Owner.
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`I. Exhibit 1084 Deposition Transcript of Richard Manning, Ph.D. (March
`27, 2024) in Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals,
`Inc., PTAB-IPR2023-00739 and -00884
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`
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`Patent Owner objects to Exhibit 1084 for each of the reasons noted in the
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`objections made during the underlying deposition.
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`J. Exhibit 1085 (Deposition Transcript of Michael W. Stewart, M.D.
`(March 29, 2024) in Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., PTAB-IPR2023-00739)
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`Patent Owner objects to Exhibit 1085 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents a deposition from a
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`different proceeding with different arguments.
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`IPR2023-00884
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`• 37 CFR § 42.53. The rule requires that compelled testimony be submitted
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`in the form of a deposition transcript and that uncompelled testimony
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`must be submitted in the form of an affidavit. The rule further imposes
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`time limits of: “[s]even hours for cross-examination, four hours for
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`redirect examination, and two hours for re-cross examination.” Petitioner
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`has already exhausted its cross-examination allowance with the witness
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`at deposition, and thus Petitioner vastly exceeds its limit on allowable
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`testimonial time that it may present to the Board. Petitioner rejected
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`Patent Owner’s offer to consolidate the -00739 deposition with
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`the -00884 deposition, and using both depositions in this proceeding
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`unfairly prejudices Patent Owner. See 3/2/24 10:21 a.m. Z. Summers
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`Email to A. Brausa.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`Patent Owner further objects to Exhibit 1085 for each of the reasons noted in
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`the objections made during the underlying deposition.
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`K. Exhibit 1086 Memorandum Opinion and Order Following Bench Trial,
`Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 22-cv-00061-TSK
`(N.D.W. Va. January 31, 2024) (ECF No. 692) (REDACTED) (“Mylan
`Litigation”)
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`Patent Owner objects to Exhibit 1086 under:
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
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`unauthorized form and in a manner that is unfairly prejudicial to Patent
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`Owner.
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`L. Exhibit 1087 Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E,
`Sung J, Zimmer-Galler I, Do DV, Campochiaro PA. Vascular
`endothelial growth factor is a critical stimulus for diabetic macular
`edema. Am J. Ophthalmol. 2006 Dec;142(6):961-9
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`Patent Owner objects to Exhibit 1087 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents clinical results using a
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`different compound than the one in the claimed regimens, which is
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`substantially more prejudicial than probative.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
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`It is not clear where the exhibit came from or how it was compiled.
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`Patent Owner further objects to Exhibit 1087 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1087
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`with its argument in the Petition. “Petitioner may not submit new evidence or
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`argument in reply that it could have presented earlier . . . .” Practice Guide at 73;
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`Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
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`M. Exhibit 1088 Institution Decision issued in Samsung Bioepis Co., Ltd. v.
`Regeneron Pharmaceuticals, Inc., PTAB-IPR2023-00739 (Paper 9)
`(“’601 IPR ID”)
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`Patent Owner objects to Exhibit 1088 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents an opinion from a
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`different proceeding with different arguments.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• 37 CFR § 42.53, including to the extent Patent Owner is attempting to
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`introduce testimony in an unauthorized form and in a manner that is
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`unfairly prejudicial to Patent Owner.
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`N. Exhibit 1089 Declaration of Michael W. Stewart, M.D. submitted as
`Exhibit 2027 in Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals,
`Inc., PTAB-IPR2023-00739 (“Stewart ’601 IPR Decl.”)
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`Patent Owner objects to Exhibit 1089 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder. The exhibit presents a declaration from a
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`different proceeding with different arguments.
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`• 37 CFR § 42.53. First, the rule requires that compelled testimony be
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`submitted in the form of a deposition transcript and that uncompelled
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`testimony must be submitted in the form of an affidavit. Petitioner thus
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`improperly relies on Exhibit 1089 as uncompelled testimony from an
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`expert in the form of an expert declaration, which as explained below is
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`prejudicial to Patent Owner. Second, the rule imposes time limits of:
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`“[s]even hours for cross-examination, four hours for redirect
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`examination, and two hours for re-cross examination.” Petitioner has
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`already exhausted its cross-examination allowance with the witness at
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`deposition, and thus Petitioner vastly exceeds its limit on allowable
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`testimonial time that it may present to the Board.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`O. Exhibit 1091 RGN-EYLEA-MYLAN-00631182
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`Patent Owner objects to Exhibit 1091 under:
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder.
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
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`content without satisfying any of the hearsay exceptions.
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`• 37 CFR § 42.53, including to the extent Patent Owner is attempting to
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`introduce testimony in an unauthorized form and in a manner that is
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`unfairly prejudicial to Patent Owner.
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`P. Exhibit 1092 Responsive Expert Declaration of Dr. Edward Chaum,
`dated June 10, 2024 (“Chaum Resp. Decl.”)
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`Patent Owner objects to Exhibit 1092 under:
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`• FRE 402-403. The declaration is irrelevant, and its probative value is
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`substantially outweighed by the danger of confusion of the issues and
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`misleading the factfinder.
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`• FRE 106 and/or FRE 1006. The declaration relies on excerpts of
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`documents identified in these Objections. In fairness, the full document
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`ought to be considered at the same time. For example, at least Paragraphs
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`14, 19–27, 30, 32, 37–39, and 41–42 rely on incomplete evidence,
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`improperly summarize exhibits, and/or cherry-pick selective passages of
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`a reference, while ignoring other passages in the same reference.
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`• FRE 702, 703, and 705. The responsive declaration is not based on
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`sufficient facts or data, is not the product of reliable principles and
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`methods, and has not applied the proper principles to the facts of this
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`proceeding.
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`• FRE 901. The declaration relies on the unauthenticated evidence
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`identified in these Objections. For example, at least Paragraphs 14, 19-
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`27, 32, and 38–39 rely on Exhibit 2047, which is unauthenticated
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`evidence. Petitioner has not introduced corroborating evidence or
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`testimony to demonstrate Exhibit 2047’s authenticity, nor has it shown
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`that Exhibit 2047 was publicly available as of the priority date.
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`Patent Owner further objects to Exhibit 1092 as being improperly submitted
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`in Petitioner’s Reply for the first time. Petitioner could have raised the expert
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`testimony in Exhibit 1092 with its declaration in the Petition. “Petitioner may not
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`submit new evidence or argument in reply that it could have presented earlier . . . .”
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`Practice Guide at 73; Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa,
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`805 F.3d at 1367.
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`Q. Exhibit 2047 VEGF Trap-Eye in Wet AMD - CLEAR-IT 2: Summary
`of One- Year Key Results, Presented at 2008 Retina Society Meeting,
`Scottsdale, Arizona (Sep. 28, 2008)
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`Patent Owner objects to Exhibit 2047 under:
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`• FRE 402-403. As offered by Petitioner, the exhibit is irrelevant, and its
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`probative value on the issue as to which Petitioner seeks to use the
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`Exhibit is substantially outweighed by the danger of confusion of the
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`issues and misleading the factfinder. Patent Owner’s limited and
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`different use of this Exhibit in its Preliminary Response did not render
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`this Exhibit relevant and admissible for all purposes.
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`• FRE 802 and 805. As offered by the Petitioner, the exhibit is hearsay
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`because it is offered for the truth of its content without satisfying any of
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`the hearsay exceptions. The exhibit is further hearsay within hearsay to
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`the extent the presentation contains statements of others, without both
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`statements satisfying any of the hearsay objections.
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`• FRE 901. Petitioner has not demonstrated the authenticity or public
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`availability of the exhibit for the purpose of the exhibit as offered by
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`Petitioner. Petitioner has not provided corroborating evidence or
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`testimony to prove that Exhibit 2047 is what Petitioner purports it to be.
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`Patent Owner’s limited and different use of the Exhibit did not address
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`these issues.
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`• FRE 1002 and 1004. The exhibit is not an original version of the
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`underlying clinical study or any of the grounds, so it may not be used to
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`prove the contents of that clinical study or of an alleged prior art
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`reference.
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`• 37 C.F.R. § 42.120. The exhibit is inadmissible because it addresses
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`matters outside of the instituted grounds in this proceeding.
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`IPR2023-00884
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`Date: June 17, 2024
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`Respectfully Submitted,
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`By: /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`
`Counsel for Patent Owner
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`IPR2023-00884
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`
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached PATENT OWNER’S OBJECTIONS TO
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`EVIDENCE SUBMITTED WITH PETITIONER’S REPLY TO PATENT
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`OWNER’S RESPONSE was served as of the below date on the Petitioner via e-
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`mail (by agreement) to the following counsel of record:
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`Raymond N. Nimrod (Reg. No. 31,987)
`Richard W. Erwine (Reg. No 41,737)
`Matthew A. Traupman (Reg. No. 50,832)
`Laura Fairneny (pro hac vice granted)
`Elliot Choi (pro hac vice granted)
`Zachariah Summers (pro hac vice granted)
`Sarah Cork (pro hac vice granted)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`Email: raynimrod@quinnemanuel.com
`Email: richarderwine@quinnemanuel.com
`Email: matthewtraupman@quinnemanuel.com
`Email: laurafairneny@quinnemanuel.com
`Email: elliotchoi@quinnemanuel.com
`Email: zachsummers@quinnemanuel.com
`Email: landonsmith@quinnemanuel.com
`Email: qe-samsungbioepis@quinnemanuel.com
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy (pro hac vice to be filed)
`Deanne M. Mazzochi (Reg. No. 50,158)
`Heinz J. Salmen (pro hac vice to be filed)
`
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`IPR2023-00884
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`Eric R. Hunt (pro hac vice to be filed)
`Neil B. McLaughlin (Reg. No. 70,810)
`Lauren M. Lesko (pro hac vice to be filed)
`L. Scott Beall (Reg. No. 52,601)
`Thomas H. Ehrich (Reg. No. 67,122)
`Steven J. Birkos (Reg. No. 65,300)
`Jake R. Ritthamel (pro hac vice to be filed)
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone: (312) 527-2157
`Facsimile: (312) 843-6260
`Email: MYL_REG_IPR@rmmslegal.com
`
`Lora Green (Reg. No. 43,541)
`Yahn-Lin Chu (Reg. No. 75,946)
`Robert Cerwinski (to be admitted pro hac vice, pending)
`Aviv Zalcenstein (to be admitted pro hac vice, pending)
`Brigid Morris (to be admitted pro hac vice, pending)
`Gemini Law LLP
`40 W 24th Street, Suite 6N
`New York, NY 10010
`Tel.: 917-915-8832
`Email: lgreen@geminilaw.com
`Email: fchu@geminilaw.com
`Email: rcerwinski@geminilaw.com
`Email: azalcenstein@geminilaw.com
`Email: bmorris@geminilaw.com
`
`
`
`
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`Dated: June 17, 2024
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
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