`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2023-008841
`
`____________________________________________________________
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE SUBMITTED WITH
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`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
`
`following evidence that was submitted by Petitioner Samsung Bioepis Co., with
`
`the Petitioner’s Reply to Patent Owner’s Response (Papers 63 and 64). These
`
`objections are timely filed and served within five business days of service
`
`Petitioner’s June 10, 2024 Reply. 37 C.F.R. § 42.64(b)(1)
`
`A. Exhibit 1076 Deposition Transcript of Michael W. Stewart, M.D. (May
`30, 2024) in IPR2023-00884
`
`
`
`Patent Owner objects to Exhibit 1076 for each of the reasons noted in the
`
`objections made during the underlying deposition.
`
`B. Exhibit 1077 Stewart MW, Rosenfeld PJ. Predicted biological activity of
`intravitreal VEGF Trap. Br J Ophthalmol. 2008 May;92(5):667-8
`
`
`
`Patent Owner objects to Exhibit 1077 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
`
`It is not clear where the exhibit came from or how it was compiled.
`
`Patent Owner further objects to Exhibit 1077 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1077
`
`
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`1
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`IPR2023-00884
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`with its argument in the Petition. “Petitioner may not submit new evidence or
`
`argument in reply that it could have presented earlier . . . .” U.S. Patent Trial and
`
`Appeal Board, Consolidated Practice Guide 73 (Nov. 2019) (“Practice Guide”);
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70
`
`(Fed. Cir. 2016) (precluding the introduction of new evidence to support a new
`
`theory of invalidity); see also Ariosa Diagnostics v. Verinata Health, Inc.,
`
`805 F.3d 1359, 1367 (Fed. Cir. 2015) (rejecting a reply even for reliance on new
`
`portions of previously submitted prior art).
`
`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”)
`
`
`
`
`
`Patent Owner objects to Exhibit 1078 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder. The exhibit presents clinical results using a
`
`different compound than the one in the claimed regimens, which is
`
`substantially more prejudicial than probative.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
`
`It is not clear where the exhibit came from or how it was compiled.
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`2
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`IPR2023-00884
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`Patent Owner further objects to Exhibit 1078 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1078
`
`with its argument in the Petition. “Petitioner may not submit new evidence or
`
`argument in reply that it could have presented earlier . . . .” Practice Guide at 73;
`
`Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
`
`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”)
`
`
`
`Patent Owner objects to Exhibit 1079 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder. The exhibit presents clinical results using a
`
`different compound than the one in the claimed regimens, which is
`
`substantially more prejudicial than probative.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
`
`It is not clear where the exhibit came from or how it was compiled.
`
`Patent Owner further objects to Exhibit 1079 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1079
`
`with its argument in the Petition. “Petitioner may not submit new evidence or
`
`
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`3
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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.
`
`E. Exhibit 1080 Deposition Transcript of George D. Yancopoulos, M.D.,
`Ph.D. (April 12, 2024)
`
`
`
`Patent Owner objects to Exhibit 1080 for each of the reasons noted in the
`
`objections made during the underlying deposition.
`
`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”)
`
`
`
`
`
`Patent Owner objects to Exhibit 1081 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder.
`
`• FRE 611 and 37 CFR § 42.24 because Petitioner’s submission of an 83-
`
`page petition from another proceeding violates the requirements of FRE
`
`611 that the Board “exercise reasonable control over the mode and order
`
`of . . . presenting evidence.” The exhibit contains attorney argument that
`
`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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`4
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`IPR2023-00884
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`substantially outweighed by the danger of unfair prejudice, confusing the
`
`issues, wasting time, and needlessly presenting cumulative evidence.
`
`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
`
`unauthorized form and in a manner that is unfairly prejudicial to Patent
`
`Owner.
`
`Patent Owner further objects to Exhibit 1081 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised individual
`
`arguments and evidence contained within Exhibit 1081 with its argument in the
`
`Petition. “Petitioner may not submit new evidence or argument in reply that it
`
`could have presented earlier . . . .” Practice Guide at 73; Intelligent Bio-Sys.,
`
`821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
`
`G. Exhibit 1082 Deposition Transcript of Karen Chu (April 11, 2024)
`
`Patent Owner objects to Exhibit 1082 for each of the reasons noted in the
`
`objections made during the underlying deposition.
`
`H. Exhibit 1083 RGN-EYLEA-MYLAN-00526220 – RGN-EYLEA-
`MYLAN-00526223
`
`
`
`
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`Patent Owner objects to Exhibit 1083 under:
`
`• FRE 901. Petitioner has not introduced evidence or testimony to properly
`
`authenticate the exhibit.
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`5
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`IPR2023-00884
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`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
`
`unauthorized form and in a manner that is unfairly prejudicial to Patent
`
`Owner.
`
`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
`
`
`
`Patent Owner objects to Exhibit 1084 for each of the reasons noted in the
`
`objections made during the underlying deposition.
`
`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)
`
`Patent Owner objects to Exhibit 1085 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder. The exhibit presents a deposition from a
`
`different proceeding with different arguments.
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`6
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`IPR2023-00884
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`• 37 CFR § 42.53. The rule requires that compelled testimony be submitted
`
`in the form of a deposition transcript and that uncompelled testimony
`
`must be submitted in the form of an affidavit. The rule further imposes
`
`time limits of: “[s]even hours for cross-examination, four hours for
`
`redirect examination, and two hours for re-cross examination.” Petitioner
`
`has already exhausted its cross-examination allowance with the witness
`
`at deposition, and thus Petitioner vastly exceeds its limit on allowable
`
`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
`
`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
`
`Email to A. Brausa.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`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.
`
`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”)
`
`
`
`
`
`Patent Owner objects to Exhibit 1086 under:
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`7
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`IPR2023-00884
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• 37 CFR § 42.53. Patent Owner is attempting to introduce testimony in an
`
`unauthorized form and in a manner that is unfairly prejudicial to Patent
`
`Owner.
`
`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
`
`
`
`Patent Owner objects to Exhibit 1087 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder. The exhibit presents clinical results using a
`
`different compound than the one in the claimed regimens, which is
`
`substantially more prejudicial than probative.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• FRE 901. Petitioner has not demonstrated the authenticity of the exhibit.
`
`It is not clear where the exhibit came from or how it was compiled.
`
`Patent Owner further objects to Exhibit 1087 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised Exhibit 1087
`
`
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`8
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`IPR2023-00884
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`with its argument in the Petition. “Petitioner may not submit new evidence or
`
`argument in reply that it could have presented earlier . . . .” Practice Guide at 73;
`
`Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa, 805 F.3d at 1367.
`
`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:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder. The exhibit presents an opinion from a
`
`different proceeding with different arguments.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• 37 CFR § 42.53, including to the extent Patent Owner is attempting to
`
`introduce testimony in an unauthorized form and in a manner that is
`
`unfairly prejudicial to Patent Owner.
`
`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.”)
`
`Patent Owner objects to Exhibit 1089 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
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`9
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`IPR2023-00884
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`misleading the factfinder. The exhibit presents a declaration from a
`
`different proceeding with different arguments.
`
`• 37 CFR § 42.53. First, the rule requires that compelled testimony be
`
`submitted in the form of a deposition transcript and that uncompelled
`
`testimony must be submitted in the form of an affidavit. Petitioner thus
`
`improperly relies on Exhibit 1089 as uncompelled testimony from an
`
`expert in the form of an expert declaration, which as explained below is
`
`prejudicial to Patent Owner. Second, the rule imposes time limits of:
`
`“[s]even hours for cross-examination, four hours for redirect
`
`examination, and two hours for re-cross examination.” Petitioner has
`
`already exhausted its cross-examination allowance with the witness at
`
`deposition, and thus Petitioner vastly exceeds its limit on allowable
`
`testimonial time that it may present to the Board.
`
`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`O. Exhibit 1091 RGN-EYLEA-MYLAN-00631182
`
`Patent Owner objects to Exhibit 1091 under:
`
`• FRE 402-403. The exhibit is not relevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder.
`
`
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`10
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`IPR2023-00884
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`• FRE 802. The exhibit is hearsay because it is offered for the truth of its
`
`content without satisfying any of the hearsay exceptions.
`
`• 37 CFR § 42.53, including to the extent Patent Owner is attempting to
`
`introduce testimony in an unauthorized form and in a manner that is
`
`unfairly prejudicial to Patent Owner.
`
`P. Exhibit 1092 Responsive Expert Declaration of Dr. Edward Chaum,
`dated June 10, 2024 (“Chaum Resp. Decl.”)
`
`Patent Owner objects to Exhibit 1092 under:
`
`• FRE 402-403. The declaration is irrelevant, and its probative value is
`
`substantially outweighed by the danger of confusion of the issues and
`
`misleading the factfinder.
`
`• FRE 106 and/or FRE 1006. The declaration relies on excerpts of
`
`documents identified in these Objections. In fairness, the full document
`
`ought to be considered at the same time. For example, at least Paragraphs
`
`14, 19–27, 30, 32, 37–39, and 41–42 rely on incomplete evidence,
`
`improperly summarize exhibits, and/or cherry-pick selective passages of
`
`a reference, while ignoring other passages in the same reference.
`
`• FRE 702, 703, and 705. The responsive declaration is not based on
`
`sufficient facts or data, is not the product of reliable principles and
`
`11
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`IPR2023-00884
`
`methods, and has not applied the proper principles to the facts of this
`
`proceeding.
`
`• FRE 901. The declaration relies on the unauthenticated evidence
`
`identified in these Objections. For example, at least Paragraphs 14, 19-
`
`27, 32, and 38–39 rely on Exhibit 2047, which is unauthenticated
`
`evidence. Petitioner has not introduced corroborating evidence or
`
`testimony to demonstrate Exhibit 2047’s authenticity, nor has it shown
`
`that Exhibit 2047 was publicly available as of the priority date.
`
`Patent Owner further objects to Exhibit 1092 as being improperly submitted
`
`in Petitioner’s Reply for the first time. Petitioner could have raised the expert
`
`testimony in Exhibit 1092 with its declaration in the Petition. “Petitioner may not
`
`submit new evidence or argument in reply that it could have presented earlier . . . .”
`
`Practice Guide at 73; Intelligent Bio-Sys., 821 F.3d at 1369–70; see also Ariosa,
`
`805 F.3d at 1367.
`
`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)
`
`Patent Owner objects to Exhibit 2047 under:
`
`• FRE 402-403. As offered by Petitioner, the exhibit is irrelevant, and its
`
`probative value on the issue as to which Petitioner seeks to use the
`
`Exhibit is substantially outweighed by the danger of confusion of the
`
`12
`
`
`
`
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`
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`IPR2023-00884
`
`issues and misleading the factfinder. Patent Owner’s limited and
`
`different use of this Exhibit in its Preliminary Response did not render
`
`this Exhibit relevant and admissible for all purposes.
`
`• FRE 802 and 805. As offered by the Petitioner, the exhibit is hearsay
`
`because it is offered for the truth of its content without satisfying any of
`
`the hearsay exceptions. The exhibit is further hearsay within hearsay to
`
`the extent the presentation contains statements of others, without both
`
`statements satisfying any of the hearsay objections.
`
`• FRE 901. Petitioner has not demonstrated the authenticity or public
`
`availability of the exhibit for the purpose of the exhibit as offered by
`
`Petitioner. Petitioner has not provided corroborating evidence or
`
`testimony to prove that Exhibit 2047 is what Petitioner purports it to be.
`
`Patent Owner’s limited and different use of the Exhibit did not address
`
`these issues.
`
`• FRE 1002 and 1004. The exhibit is not an original version of the
`
`underlying clinical study or any of the grounds, so it may not be used to
`
`prove the contents of that clinical study or of an alleged prior art
`
`reference.
`
`• 37 C.F.R. § 42.120. The exhibit is inadmissible because it addresses
`
`matters outside of the instituted grounds in this proceeding.
`
`
`
`13
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`
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`IPR2023-00884
`
`Date: June 17, 2024
`
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`Respectfully Submitted,
`
`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
`
`14
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`
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`IPR2023-00884
`
`
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached PATENT OWNER’S OBJECTIONS TO
`
`EVIDENCE SUBMITTED WITH PETITIONER’S REPLY TO PATENT
`
`OWNER’S RESPONSE was served as of the below date on the Petitioner via e-
`
`mail (by agreement) to the following counsel of record:
`
`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)
`
`
`
`15
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`IPR2023-00884
`
`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
`
`
`
`
`
`Dated: June 17, 2024
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`
`
`
`
`16
`
`
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