Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 89
`Date: November 9, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`IPR2021-008801
`Patent 9,669,069 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L.C. MITCHELL, Administrative Patent Judges.
`NEW, Administrative Patent Judge
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Petitioner’s Motion to Exclude Evidence
`Denying in part and Dismissing in Part Patent Owner’s Motion to Exclude
`Evidence
`35 U.S.C. § 318(a), 37 C.F.R. § 42.64(c)
`
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding. See Papers 35 and 36.
`
`
`Tel: 571-272-7822
`
`Paper 89
`Date: November 9, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`IPR2021-008801
`Patent 9,669,069 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L.C. MITCHELL, Administrative Patent Judges.
`NEW, Administrative Patent Judge
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Petitioner’s Motion to Exclude Evidence
`Denying in part and Dismissing in Part Patent Owner’s Motion to Exclude
`Evidence
`35 U.S.C. § 318(a), 37 C.F.R. § 42.64(c)
`
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding. See Papers 35 and 36.
`
`
`
`IPR2021-00880
`Patent 9,669,069 B2
`
`
`
`I. INTRODUCTION
`We have jurisdiction to hear this inter partes review under 35 U.S.C.
`§ 6, and this Final Written Decision is issued pursuant to 35 U.S.C. § 318(a)
`and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that
`Mylan Pharmaceuticals Inc., Celltrion, Inc. and Apotex, Inc. (collectively
`“Petitioner”) have established by a preponderance of the evidence that
`claims 1 and 8–12 of Patent Owner Regeneron Pharmaceuticals, Inc.’s
`(“Patent Owner”) U.S. Patent No. 9,669,069 B2 (Ex. 1001, “’069 patent”)
`are unpatentable. We additionally deny Petitioner’s pending Motion to
`Exclude Evidence and deny in part and dismiss in part Patent Owner’s
`pending Motion to Exclude Evidence.
`
`A. Procedural History
`
`On May 5, 2021, Mylan Pharmaceuticals, Inc., the original Petitioner,
`filed a Petition (Paper 1, “Petition”) seeking inter partes review of claims 1
`and 8–12 of the ’069 patent. Patent Owner timely filed a Preliminary
`Response. (Paper 10). We authorized additional briefing (Papers 16 and 19)
`and pursuant to 35 U.S.C. § 314, on November 10, 2021, we instituted inter
`partes review of all of the challenged claims of the ’069 patent (Paper 21,
`“Institution Decision” or “Dec.”).
`
`2
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`After institution of trial, Patent Owner filed a corrected Response
`(Paper 39, “PO Resp.”), to which Petitioner filed a Reply2 (Paper 57, “Pet.
`Reply”), and Patent Owner, in turn, filed a Sur-Reply (Paper 68, “Sur-
`Reply”).
`On February 9, 2022, we instituted an inter partes review in IPR2022-
`00257 and granted the motion for joinder with IPR2021-00880, adding
`Celltrion, Inc. as a petitioner in the instant proceeding. Paper 35. On the
`same date, we also instituted an inter partes in IPR2022-00301 and likewise
`granted the motion for joinder with IPR2021-00880, adding Apotex, Inc. as
`a petitioner in the instant proceeding. Paper 36. We refer to Mylan
`Pharmaceuticals, Inc., Celltrion, Inc. and Apotex, Inc., collectively, as
`“Petitioner.”
`Oral argument was held on August 10, 2022. A transcript of the oral
`argument is included in the record. (Paper 88, “Hearing Trans.”).
`
`B. Related Proceedings
`Petitioner and Patent Owner identify Mylan Pharms. Inc. v.
`Regeneron Pharms., Inc., IPR2021-00881 (PTAB May 5, 2021) (the “-881
`IPR”) as a related matter. Pet. 4; Paper 5, 2. The -881 IPR challenges
`
`
`
`
`2 Petitioner filed a Reply containing confidential information (Paper 56),
`together with a redacted Reply (Paper 57). Although we have reviewed
`both briefs, in this Decision we quote or cite only to information presented
`in the redacted brief.
`
`3
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`claims of U.S. Patent No. 9,254,338 B2 (“the ’338 patent”). The parties
`further identify Chengdu Kanghong Biotechnol. Co. v. Regeneron Pharms.,
`Inc., PGR2021-00035 (PTAB Jan. 7, 2021) challenging the claims of U.S.
`Patent No. 10,828,345 B2 (“the ’345 patent”), which is related to the ’069
`patent and the ’338 patent. Pet. 5. This latter proceeding has been
`terminated. See Chengdu, PGR2021-00035, Paper 8.
`Petitioner also identifies additional patents and patent applications that
`claim priority to the ’069 patent, namely: U.S. Patent Nos. 10,130,681 B2,
`10,857,205 B2, 10,828,345 B2, and 10,888,601 B2, and U.S. Application
`Serial Nos. 17/072,417, 17/112,063, and 17/112,404. Pet. 5.
`
`Real Parties-in-Interest
`C.
`Petitioner states that Viatris Inc. and Mylan Inc. are parent companies
`
`of Petitioner Mylan Pharmaceuticals Inc. Paper 87, 1. Accordingly,
`Petitioner identifies Viatris Inc., Mylan Inc., and Mylan Pharmaceuticals
`Inc. as real parties-in-interest to the current Petition. Id. Petitioner also
`states that Momenta Pharmaceuticals, Inc. and Janssen Research &
`Development LLC are wholly-owned subsidiaries of Johnson & Johnson, a
`publicly held company. Id. Consequently, Petitioner also identifies
`Momenta Pharmaceuticals, Inc., Janssen Research & Development LLC,
`and Johnson & Johnson as real parties-in-interest to the current Petition. Id.
`
`Petitioner Celltrion, Inc. identifies itself, Celltrion Healthcare Co.
`Ltd., and Celltrion Healthcare U.S.A., Inc. as real parties-in-interest. See
`IPR2022-00257, Paper 2, 3. Petitioner Apotex, Inc. identifies itself, Apotex
`4
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`Corp., Apotex Pharmaceutical Holdings Inc., and Aposherm Delaware
`Holdings Corp. as real parties-in-interest. See IPR2022-00301, Paper 1, 3.
`Patent Owner identifies Regeneron Pharmaceuticals, Inc. as the real
`party-in-interest. Paper 5, 2.
`
`D.
`
`The Instituted Grounds of Unpatentability
`Petitioner contends that claims 1 and 8–12 of the ’069 patent are
`unpatentable, based upon the following grounds, all of which have been
`instituted in this proceeding:
`Ground
`Claim(s)
`Challenged
`1, 9–12
`1, 9–12
`1, 9–12
`1, 8–12
`
`I
`II
`III
`IV
`
`35 U.S.C. §
`
`Reference(s)/Basis
`
`102
`102
`102
`102 and/or
`103
`
`Dixon3
`Heier 20094
`Regeneron I5
`Dixon
`
`
`
`
`3J.A. Dixon et al., VEGF Trap-Eye for the Treatment of Neovascular Age-
`Related Macular Degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573–80 (2009) (“Dixon”) Ex. 1006.
`4 J.S. Heier, Intravitreal VEGF Trap for AMD: An Update, October 2009
`RETINA TODAY 44–45 (2009) (“Heier 2009”) Ex. 1020.
`5 Press Release, Bayer and Regeneron Extend Development Program for
`VEGF Trap-Eye to Include Central Retinal Vein Occlusion, April 30, 2009
`(“Regeneron I”) Ex. 1028.
`
`5
`
`
`
`
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`
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`35 U.S.C. §
`
`Reference(s)/Basis
`
`103
`
`Heier-2009 and
`Mitchell6 or Dixon, and
`optionally,
`Papadopolous7 or Dix8
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`Ground
`
`V
`
`Claim(s)
`Challenged
`1, 8–12
`
`
`Petitioner also relies upon the Declarations of Dr. Thomas A. Albini (the
`“Albini Declaration,” Ex. 1002, Ex. 1115 (confidential and public, redacted
`versions)) and Dr. Mary Gerritsen (the “Gerritsen Declaration,” Ex. 1003).
`Patent Owner relies upon Declarations by Lucian V. Del Priore (Ex. 2048),
`Dr. Alexander M. Klibanov (Ex. 2049), and Dr. David M. Brown
`(Ex. 2050). We have reviewed the credentials of Petitioners’ declarants,
`Drs. Albini and Gerritsen, and Patent Owner’s declarants, Drs. Del Priore,
`Klibanov, and Brown and consider each of them to be qualified to provide
`the opinions for which their testimony has been submitted.
`
`
`
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`
`
`6 P. Mitchell et al., Ranibizumab (Lucentis) in Neovascular Age-Related
`Macular Degeneration: Evidence from Clinical Trials, 94(2) Br. J.
`Ophthalmol. 2–13 (2010) Ex. 1030.
`7 Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopolous”)
`Ex. 1010.
`8 Dix et al., (US 2006/0217311 A1, May 20, 2008) (“Dix”) Ex. 1033.
`6
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`E.
`
`The ’069 Patent
`The ’069 patent is directed to methods for treating angiogenic eye
`disorders by sequentially administering multiple doses of a vascular
`epithelial growth factor (“VEGF”) antagonist to a patient. Ex. 1001, Abstr.
`These methods include the administration of multiple doses of a VEGF
`antagonist to a patient at a frequency of once every 8 or more weeks, and are
`useful for the treatment of angiogenic eye disorders such as, inter alia, age
`related macular degeneration. Id.
`In an exemplary embodiment, a single “initial dose” of VEGF
`antagonist (“VEGFT”) is administered at the beginning of the treatment
`regimen (i.e., at “week 0”), two “secondary doses” are administered at
`weeks 4 and 8, respectively, and at least six “tertiary doses” are administered
`once every 8 weeks thereafter, i.e., at weeks 16, 24, 32, 40, 48, 56, etc.).
`Ex. 1001 col. 2, ll. 56–62.
`
`F. Representative Claim
`Claim 1 is the sole independent claim of the ’069 patent, and recites:
`1. A method for treating an angiogenic eye disorder in a
`patient,
`said method
`comprising
`sequentially
`administering to the patient a single initial dose of a VEGF
`antagonist, followed by one or more secondary doses of
`the VEGF antagonist, followed by one or more tertiary
`doses of the VEGF antagonist;
`
`
`
`wherein each secondary dose is administered 2 to 4 weeks
`after the immediately preceding dose; and wherein
`each tertiary dose is administered on an as needed/
`7
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`pro re nata (PRN) basis, based on visual and/or
`anatomical outcomes as assessed by a physician or
`other qualified medical professional;
`
`
`wherein the VEGF antagonist is a receptor-based chimeric
`molecule comprising (1) a VEGFRl component
`comprising amino acids 27 to 129 of SEQ ID NO:2;
`(2) a VEGFR2 component comprising amino acids
`130–231 of SEQ
`ID NO:2; and
`(3) a
`multimerization component comprising amino
`acids 232–457 of SEQ ID NO:2.
`
`
`Ex. 1001, col. 21, ll. 42–60.
`
`Prosecution History of the ’069 Patent
`G.
`The ’069 patent issued from U.S. Application Ser. No. 14/972,560
`
`(the “’560 application”) filed on December 17, 2015, and claims the priority
`benefit of, inter alia, provisional Application Ser. No. Provisional
`application No. 61/432,245, which was filed on Jan. 13, 2011. Ex. 1001,
`code (60).
`The claims of the ’069 patent, including claims 1 and 8–12 were
`allowed on March 6, 2017, and the patent issued on June 6, 2017. Ex. 1017,
`162; Ex. 1001, code (45).
`
`
`II. ANALYSIS
`
`A. Petitioner’s Motion to Exclude
`
`Before turning to our analysis proper of the patentability of claims
`1 and 8–12 of the ’069 patent, we address the parties’ Motions to Exclude
`8
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`Evidence, turning first to Petitioner’s Motion to Exclude. (“Pet. Mot.
`Exclude”). Paper 76. Patent Owner has filed an Opposition to the Motion to
`Exclude (“PO Opp.,” Paper 79) and Petitioner has filed a Reply (“Pet. Reply
`MTE,” Paper 81).
`
`Specifically, Petitioner seeks to exclude Exhibits 2059, 2060, 2073,
`2096, and 2128, and portions of Exhibits 2048–50 (collectively, the
`“challenged Exhibits”). Pet. Mot. Exclude 1. Petitioner notes that it timely
`objected to these exhibits through written objections (Paper 40) and/or
`during deposition. Id. Petitioner asserts that, in response to Petitioner’s
`objections, Patent Owner served the declaration of Ms. Doris Weber
`(Ex. 2131), Patent Owner’s in-house, senior litigation support specialist, to
`authenticate Exhibits 2059–60, 2073, and 2128 as being “true and correct”
`copies. Id. at 2.
`
`Exclusion under Fed. R. Evid. 901
`1.
`Petitioner first argues that challenged Exhibits 2059, 2060, 2073,
`
`2096, and 2128 are not properly authenticated, as required by Federal Rule
`of Evidence 901. Pet. Mot. Exclude 1. Petitioner argues that Ms. Weber is
`not a custodian of these exhibits, and has no personal knowledge of the
`creation, authorship, maintenance, or modification of any of the exhibits or
`the underlying documents from which they were prepared. Id. at 2.
`Therefore, Petitioner asserts, Ms. Weber’s declaration does not “satisfy the
`requirement of authenticating or identifying an item of evidence under Fed.
`R. Evid. 901(a). Id. (citing Riverbed Tech., Inc v. Realtime Data LLC,
`9
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`IPR2016-00978, Paper 67 at 39–41 (PTAB Oct. 30, 2017); TRW Auto. U.S.
`LLC v. Magna Elecs., IPR2014-01348, Paper 25 at 5–12 (PTAB Jan. 15,
`2016). Petitioner argues that none of the Exhibits are self-authenticating
`under Fed. R. Evid. 902, and that Exhibits 2060 and 2128 are incomplete
`and/or excerpted versions of un-produced, allegedly confidential originals,
`which, Petitioner contends, casts further doubt on their authenticity and
`reliability. Id. at 3.
`
`Specifically, Petitioner contends, with respect to Exhibit 2060, that
`Ms. Weber could not authenticate the Exhibit, and that Patent Owner’s
`declarant, Dr. Del Priore testified that Exhibit 2060 fails to identify which
`clinical trial the data come from. Pet. Mot. Exclude 5 (citing Ex. 1111, 175–
`176). Petitioner notes that Dr. Del Priore also testified that he “[did not]
`know the source of the document” and refused to answer questions relating
`to Exhibit 2060 due to his lack of personal knowledge. Id. at 5–6 (citing
`Ex. 111, 175, 174–190).
`
`Concerning Exhibit 2073, Petitioner similarly argues that
`Ms. Weber’s declaration fails to authenticate Exhibit 2073, and that Patent
`Owner’s expert, Dr. Klibanov, was also unable to authenticate Exhibit 2073.
`Pet. Mot. Exclude 7. Petitioner also notes that, at deposition, Dr. Klibanov
`could not answer foundational questions about Exhibit 2073. Id. Petitioner
`asserts that Patent Owner has produced no credible evidence to support a
`finding that Exhibit 2073 is in fact what its expert claims it is. Id. at 8.
`
`Petitioner alleges that challenged Exhibit 2128, a confidential (filed
`under seal), non-public compilation of the VIEW protocol signature pages,
`10
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`should be excluded under Rule 901 because no witness with personal
`knowledge has authenticated it. Pet. Mot. Exclude 8. Nor, Petitioner
`contends, is there evidence that it is an accurate compilation of excerpts as
`they existed at the time of creation or regarding the maintenance of the
`documents in the 13–15 years since their alleged creation. Id. at 8–9 (citing
`Riverbed, IPR2016-00978, Paper 67 at 39–41; TRW, IPR2014-01348, Paper
`25 at 5–12).
`
`Petitioner argues that Exhibit 2096, a confidential (filed under seal),
`non-public document alleged to be a clinical study agreement between
`Vitreoretinal Consultants and Regeneron Pharmaceuticals, Inc., should be
`excluded under Rule 901. Pet. Mot. Exclude 10 (citing Ex. 1110, 59–62).
`Petitioner argues that Patent Owner’s declarant, Dr. Brown, admitted at his
`deposition that he did not sign the Exhibit 2096 agreement, nor could he
`answer foundational questions about it. Id. Consequently, Petitioner argues,
`Exhibit 2096 should be excluded as unauthenticated. Id.
`
`Patent Owner responds that, in her sworn declaration, Ms. Weber
`explained that she has personal knowledge of the facts recited therein, and
`that each of the Weber Exhibits is a true and correct copy of what it purports
`to be. PO Opp. 2 (citing Ex. 2131 ¶ 1). Patent Owner explains that, at
`Petitioner’s request, Ms. Weber appeared for deposition, where she testified
`as to the processes whereby she confirmed the authenticity of the Exhibits.
`Id. According to Patent Owner, Ms. Weber explained that she personally
`collected the documents addressed in her declaration from Regeneron
`systems, reviewed them, and confirmed that they are true and correct copies
`11
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`kept in accordance with Regeneron’s procedures. Id. (citing, e.g., Ex. 1150
`at 25–26, 29–30, 34, 41, 42–43).9 Patent Owner notes that, where possible,
`Ms. Weber also personally confirmed these details with individual
`custodians. Id. (citing, e.g., Ex. 1150, 35–37, 40, 44–45).
`Petitioner contends that Ms. Weber need not have personally authored
`or maintained the documents in order to serve as an authenticating witness.
`PO Opp. 3 (citing, e.g., Comcast Cable Comms., LLC v. Veveo, Inc.,
`IPR2019-002990, 2020 WL 4687062 at *28 (PTAB Aug. 12, 2020)).
`Furthermore, argues Patent Owner, Petitioner’s assertion that certain of the
`authenticated Weber Exhibits are “incomplete and/or excerpted versions of
`unproduced” originals is unsupported—and in some cases directly
`contradicted by the record. Id. (citing, e.g., IPR2021-00881, Ex. 1150, 32).
`
`Specifically, Patent Owner contends that Ms. Weber, who spoke with
`the custodian of Exhibit 2060 in preparation for her deposition, authenticated
`the Exhibit. PO Opp. 5 (citing IPR2021-00881, Ex. 1150 at 31–33. 35–37;
`see also Ex. 2131 ¶ 3). Petitioner contends that it is not necessary that its
`
`
`
`
`9 Petitioner deposed Ms. Weber in this proceeding, but only filed that
`deposition transcript in the parallel proceeding, Mylan Pharms. Inc. v.
`Regeneron Pharms., Inc., IPR2021-00881. Consequently, our citations to
`Ms. Weber’s deposition transcript reference Exhibit 1150 in IPR2021-
`00881.
`
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`declarant, Dr. Del Priore, separately authenticate, or have personal
`knowledge of, this Exhibit. Id.
`
`Similarly, Patent Owner contends that Exhibit 2073 was authenticated
`by Ms. Weber, and that Dr. Klibanov need not separately authenticate this
`document or have “firsthand knowledge” of the experiments it describes, to
`satisfy the requirements of Rule 901. PO Opp. 6 (citing Ex. 2131 ¶ 4;
`IPR2021-00881, Ex. 1150, 40–41).
`
`With respect to Exhibit 2128, Patent Owner contends that, in addition
`to the authentication by Ms. Weber, Patent Owner’s declarant Dr. Brown
`testified at deposition that: (1) he personally recognizes the Exhibit as an
`Investigator’s Agreement; (2) he was a principal investigator for the trial;
`(3) Exhibit 2128 is signed by Dr. Brown’s partner, who was the other
`principal investigator; and (4) Dr. Brown’s practice retains a copy of the
`agreement that is Exhibit 2128, which is stored at Iron Mountain. PO Opp. 7
`(citing Ex. 1110, 62–63). Patent Owner notes that Dr. Brown expressly
`confirmed that Exhibit 2128 “is our document, from my institution.” Id.
`(citing Ex. 1110, 63). Similarly, Patent Owner contends, Dr. Brown testified
`that Exhibit 2096 is a Clinical Study Agreement between Dr. Brown’s
`institution, Vitreoretinal Consultants of Houston, and Regeneron. Id. (citing
`Ex. 2050 ¶ 71). Patent Owner asserts that Dr. Brown further testified that he
`has personal knowledge of Exhibit 2096 (because he was the principal
`investigator in the associated clinical study), that his partner signed
`Exhibit 2096 (the Clinical Study Agreement), and that his practice
`maintained a copy of Exhibit 2096 at Iron Mountain in accordance with their
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`regular, FDA-mandated document retention policies. Id. at 9 (citing
`Ex. 1110, 59–62).
`
`Petitioner replies that the deposition testimony of Ms. Weber revealed
`authentication deficiencies. Pet. Reply MTE 1. By way of example,
`Petitioner points to Ms. Weber’s lack of personal knowledge concerning the
`author of Exhibit 2059 and the circumstances under which the document was
`signed. Id. at 1–3 (citing IPR2021-00881, Ex. 1150, 19–29). Furthermore,
`argues Petitioner, when asked what actions she took “to ensure that [the
`exhibits were] true and correct cop[ies],” Ms. Weber testified she “had no
`doubt” that they were, based solely on the fact that she “reviewed them.” Id.
`(citing IPR2021-00881, Ex. 1150, 30). Ms. Weber’s position and dates of
`employment at Patent Owner did not provide her with knowledge of Patent
`Owner’s document creation and record-keeping procedure for these exhibits.
`Id. (citing IPR2021-00881, Ex. 1150, 33–37; Kolmes v. World Fibers Corp.,
`107 F.3d 1534, 1542–43 (Fed. Cir. 1997)). Petitioner also notes that Ms.
`Weber did not speak to any of the custodians until after she submitted her
`declaration, allegedly further undermining the reliability of her sworn
`declaration attesting as to her personal knowledge of the facts and that each
`Weber Exhibit is a true and correct copy. Id. at 4 (citing IPR2021-00881,
`Ex. 1150, 129).
`
`Petitioner argues further that Patent Owner’s reliance on Dr. Brown as
`an additional source of authentication for Exhibit 2128 only undermines the
`exhibit’s authenticity. Pet. Reply MTE 4. According to Petitioner, Patent
`Owner’s allegation that Dr. Brown confirmed that Exhibit 2128 “is [his]
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`document, from [his] institution,” squarely contradicts its claim that
`Ms. Weber “personally collected” Exhibit 2128 “from Regeneron systems”
`and confirmed it was “kept in accordance with Regeneron’s procedures.” Id.
`(quoting PO Opp. 7, 2). Petitioner argues that, because it is unclear where
`Exhibit 2128 came from, Patent Owner has not met its burden to establish
`authenticity. Id.
`
`We are not persuaded by Petitioner’s argument that the challenged
`Exhibits are not authenticated. Federal Rule of Evidence 901 sets a
`relatively low bar for authentication. See Comcast, 2020 WL 4687062, at
`*28. Rule 901(a) states: “To satisfy the requirement of authenticating or
`identifying an item of evidence, the proponent must produce evidence
`sufficient to support a finding that the item is what the proponent claims it
`is.” Fed. R. Evid. 901(a). By way of example, Rule 901(b)(1) states that a
`witness with knowledge can provide authenticating testimony that an item is
`what it is claimed to be. Fed. R. 901(b)(1).
`
`Patent Owner contends that each of the challenged Exhibits
`constitutes an internal document in Patent Owner’s possession constituting:
`(1) a Regeneron sample analysis report (Ex. 2059); (2) a portion of the
`VIEW 1 Clinical Study Report (Ex. 2060); (3) a study from a Regeneron
`Sanofi Analytical Investigation Workshop (Ex. 2073); (4) Regeneron’s
`VIEW Protocol Signature Pages (Ex. 2128); and (5) a Clinical Study
`Agreement (Ex. 2096). Ms. Weber, in her capacity as a Senior Litigation
`Support Specialist with Patent Owner, has declared that the challenged
`Exhibits are “true and correct cop[ies]” of the original documents. Ex. 2131
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`¶¶ 1–5. Furthermore, Ms. Weber has testified that the challenged Exhibits
`were stored on the server at Regeneron, that access to the servers was
`restricted, and that she collected them for the purpose of this proceeding.
`See, e.g., Ex. 1135, 26–31. Ms. Weber also testified that, in preparing her
`Declaration, she consulted with Ms. Karen Chu, custodian of Regeneron’s
`clinical strategy and execution, ophthalmology, to ascertain the location of
`the documents on Regeneron’s regulatory archive. Id., e.g., at 36–37.
`Ms. Weber also testified that she was not offering any testimony regarding
`the substance of the challenged Exhibits. Id., e.g., at 31.
`
`Similarly, with respect to Exhibits 2128 and 2096, we find that
`Dr. Brown is an individual with knowledge who can testify that these
`exhibits are what they purport to be. Dr. Brown’s ability to recognize and
`authenticate the Exhibits is based upon his personal recognition of the
`Exhibits as an Investigator’s Agreement, his involvement as a principal
`investigator for the trial, his recognition of the signature of his partner in
`practice, who was the other principal investigator, on Exhibit 2128, and the
`retention of a copy of Exhibit 2128 according to his practice of retaining
`such copies. See Ex. 1110, 62–63.
`
`We therefore conclude that Patent Owner has met the standard set
`forth in Rule 901(b)(1) of presenting a witness with knowledge to
`authenticate the challenged Exhibits as being true and correct copies of
`records that are in the possession of Patent Owner. As a Senior Litigation
`Support Specialist, working in consultation with a Regeneron custodian of
`records, and with access to the restricted Regeneron server where the
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`Exhibits at issue are kept, Ms. Weber qualifies as a person with knowledge,
`under Rule 901(b)(1), that the Exhibits were true and correct copies of the
`records in Regeneron’s possession. Ms. Weber’s testimony does not speak to
`the substance of the challenged Exhibits, but merely that these are accurate
`copies of records that are in the possession of, and controlled by, Regeneron.
`As such, her testimony is sufficient to authenticate, under Federal Rule of
`Evidence 901, the challenged Exhibits as being what Patent Owner claims
`them to be. Petitioner’s Motion to Exclude the challenged Exhibits upon
`this ground is consequently denied.
`In addition to excluding the challenged Exhibits under Rule 901,
`Petitioner cites additional grounds for excluding certain exhibits. We
`consider each of these in turn.
`
`Exclusion under Fed. R. Evid. 402 and 403
`Petitioner moves to exclude challenged Exhibits 2059, 2060, 2073,
`and 2128 under Rule 402 as being irrelevant. Pet. Mot. Exclude 4, 6, 8, 9.
`Petitioner also moves to exclude challenged Exhibits 2060 and 2128 under
`Rule 403 as being unduly prejudicial. Id. at 6, 9.
`
`Petitioner asserts that Exhibits 2059, 2060, 2073, and 2128 are non-
`publicly available, internal documents, and do not demonstrate the
`knowledge of a person of ordinary skill in the art or are irrelevant prior art
`teachings, and should therefore be excluded as irrelevant non-prior art under
`FRE 402. Pet. Mot. Exclude 4, 6, 8. Petitioner also notes that Patent Owner
`also fails to cite Exhibits 2059, 2060, and 2073 in its Preliminary Response,
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`Response, or Sur-Reply (Papers 10, 39, 68), demonstrating that they do not
`have a tendency to make any fact of consequence more or less probable as
`Rule 401 requires and are therefore irrelevant to this proceeding. Id. (also
`citing SK Innovation Co. v. Celgard, LLC, IPR2014-00679, Paper 58, 49
`(PTAB Sept. 25, 2015).
`
`Petitioner also argues that any probative value of Exhibits 2060 and
`2128, which are excerpted from larger documents, is substantially
`outweighed by the dangers of unfair prejudice, confusion, and misleading
`the factfinder, because they could allegedly deny the factfinder a complete
`set of materials to judge the accuracy of its claim. Pet. Mot. Exclude 6, 9.
`
`Patent Owner argues that it relies on the challenged Exhibits 2059 and
`2073 not for their prior art teaching, but, rather, as illustrating the inherent
`variability in producing VEGF Trap-Eye. PO Opp. 4, 6 (citing Exhibit 2049
`at ¶¶ 91–96). Patent Owner also disputes Petitioner’s assertion that non-
`prior art evidence is necessarily irrelevant. Id. (citing, e.g., Organik Kimya
`AS v. Rohm & Haas Co., 873 F.3d 887, 893-94 (Fed. Cir. 2017)). Similarly,
`Patent Owner argues that Exhibit 2060 is relied upon to rebut Petitioner’s
`arguments on inherent efficacy of the claimed dosing regimen. Id. at 5
`(citing Ex. 2048 ¶¶ 107–08). Patent Owner also contends that Petitioner’s
`assertion that Exhibit 2128 is irrelevant because it is a non-public document
`fails because Patent Owner and its expert rely on Exhibit 2128 precisely to
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`show its confidentiality. Id. at 7 (citing, e.g., Ex. 2050 ¶ 71; PO Resp. 9–10,
`n.6).
`With respect to Rule 403, Patent Owner argues that Petitioner’s
`
`assertion that Exhibit 2128 is unreliable or prejudicial as a “hand-picked
`excerpt” is wrong because Patent Owner’s declarant, Dr. Brown, expressly
`confirmed the authenticity of the Exhibit. PO Opp. 7 (citing Ex. 1110, 63).
`
`We are not persuaded by Petitioner’s arguments that Exhibits 2059,
`2060, 2073, and 2128 should be excluded under Rule 402 as being
`irrelevant. We acknowledge Petitioner’s point that Exhibits 2059, 2060, and
`2073 are not cited in Patent Owner’s Preliminary Response, Response, or
`Sur-Reply. Nevertheless, they are cited in the various Declarations of Patent
`Owner’s experts. Specifically, Exhibit 2059 is cited by Dr. Klibanov (see
`Ex. 2049 ¶¶ 95, 97, 98, 101) and Dr. Del Priore (see Ex. 2048 ¶¶ 98, 99,
`100–103). Exhibit 2060 is also cited by Dr. Del Priore (see Ex. 2048 ¶ 107)
`and Dr. Del Priore also testified about the Exhibit at his deposition. See
`Ex. 1111, 174–175. Dr. Klibanov testified with respect to Exhibit 2073 at
`his deposition (see Ex. 1108, 198). Exhibit 2128 was cited in Dr. Brown’s
`Declaration (see Ex. 2050 ¶ 71), and Dr. Brown testified about the Exhibit in
`his deposition. See Ex. 1110, 62–63, 122. We consequently find that these
`Exhibits are relevant to this proceeding because these exhibits have a
`tendency to make a fact more or less probable. Fed. R. Evid. 401.
`
`Nor are we persuaded by Petitioner’s argument that Exhibits 2060 and
`2128 should be excluded under Rule 403 as unduly prejudicial. Rule 403
`states that “[t]he court may exclude relevant evidence if its probative value
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`is substantially outweighed by a danger of one or more of the following:
`unfair prejudice, confusing the issues, misleading the jury, undue delay,
`wasting time, or needlessly presenting cumulative evidence.” Petitioner’s
`generalized allegation that “[a]llowing [Patent Owner] to cherry-pick a
`portion of a document denies the factfinder a complete set of materials to
`judge the accuracy of its claim” (see Pet. Mot. Exclude 6, 9) by itself, lacks
`particularity as to the potential unfair prejudice posed by admission of these
`particular Exhibits, particularly when weighed against the relatively minor,
`if relevant, role played by the Exhibits in Patent Owner’s arguments. We
`consequently deny Petitioner’s motion to exclude challenged Exhibits 2059,
`2060, 2073, and 2128 under Fed. R. Evid. 402 and/or 403.
`
`Exclusion under Fed. R. Evid. 802
`3.
`Finally, Petitioner urges us to exclude challenged Exhibits 2059,
`
`2060, 2128 and 2096 as inadmissible hearsay under Rule 802 because they
`constitute out-of-court statements offered for the truth of the matters
`asserted.10 Pet. Mot. Exclude 5, 6–7, 9, 10.
`
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`10 Petitioner also moves to exclude Exhibit 2059 under Rule 801. Pet. Mot.
`Exclude 5. Rule 801 addresses “Definitions That Apply to This Article;
`Exclusions From Hearsay.” Petitioner makes no separate arguments for
`Rule 801, and we therefore address Petitioner’s combined Rules 801-802
`argument as being under Rule 802.
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`Patent Owner contends that Exhibit 2059 falls within the business
`
`records exception to the Rule, as demonstrated by Ms. Weber’s Declaration.
`PO Opp. MTE 3. Patent Owner states that Exhibit 2059 is a scientific report
`that was stored on Regeneron servers, and bears facial indications of
`trustworthiness (e.g., written on Regeneron letterhead and dated and signed
`by Dr. Koehler-Stec, a study director and Regeneron employee). Id. at 4
`(citing Ex. 2059; IPR2021-00881, Ex. 1150 at 24–26; Ex. 2131 ¶ 2).
`
`Patent Owner similarly argues that Exhibit 2060 is a clinical study
`protocol, stored in Regeneron’s regulatory archive, and bears facial indicia
`of trustworthiness (Regeneron protocol headers and file path information on
`each page), and was authenticated by Ms. Weber. PO Opp. MTE (citing
`Ex. 2060; Ex. 2131 ¶ 3; IPR2021-00881, Ex. 1150, 24–26).
`
`With respect to Exhibits 2128 and 2096, Patent Owner argues that
`Dr. Brown’s and Ms. Weber’s testimony support the position that the
`Exhibits falls within the business records exception under Rule 803. PO
`Opp. MTE 8–9. Patent Owner contends that both Exhibits 2128 and 2096
`were generated in the ordinary course of regularly conducted activity (i.e., a
`clinical investigation), was stored by Regeneron in its regulatory archives
`and by Dr. Brown’s practice at Iron Mountain, and bears facial indications
`of trustworthiness (i.e., dated signatures by Dr. Brown’s partner on every
`page). Id. (citing Ex. 1110, 62–63).
`
`Petitioner replies that Ms. Weber’s testimony does not demonstrate
`sufficient personal knowledge of Patent Owner’s business practices for her
`to testify regarding these practices. Pet. Reply MTE 5. According to
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`Petitioner, Ms. Weber cannot testif
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