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
`
`____________
`
`Case IPR2021-008801
`Patent No. 9,669,069 B2
`____________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC.,
`and APOTEX, INC.,
`Petitioners
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
`
`____________
`
`Case IPR2021-008801
`Patent No. 9,669,069 B2
`____________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`Introduction .......................................................................................................... 1
`I.
`Petitioner’s Motion to Exclude Documents Authenticated by Ms. Weber ...... 1
`II.
`Exhibit 2059—Regeneron Sample Analysis Report: PK06005-9-SA-01V1,
`A.
`Signed by Study Director Ellen M. Koehler-Stec .................................................. 3
`B.
`Exhibit 2060—Table 14.2.3/2a of the VIEW1 Clinical Study Report
`(Protocol VGFT-OD-0605) .................................................................................... 5
`C.
`Exhibit 2073—Zaltrap Non-comparability Issue: Regeneron Sanofi
`Analytical Investigation Workshop ........................................................................ 6
`D.
`Exhibit 2128—Regeneron’s VIEW Protocol Signature Pages ..................... 6
`III. Exhibit 2096—Clinical Study Agreement ....................................................... 8
`IV. Portions of Exhibits 2048-50: Corresponding Expert Opinions ...................... 9
`V.
`Conclusion ......................................................................................................10
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Actifo, Inc. v. Delphix Corp.,
`IPR2015-00016, 2016 WL 1534236 (P.T.A.B. Apr. 13, 2016) ............................. 8
`Comcast Cable Comms., LLC v. Veveo, Inc.,
`IPR2019-002990, 2020 WL 4687062 (P.T.A.B. Aug. 12, 2020) .......................... 1
`Nippon Suisan Kaisha Ltd. v. Pronova Biopharma Norge AS,
`PGR2017-00033, 2019 WL 237114 (P.T.A.B. Jan. 16, 2019) ............................10
` Organik Kimya AS v. Rohm & Haas Co.,
`873 F.3d 887 (Fed. Cir. 2017) ................................................................................ 4
`
`Rules
`Fed. R. Evid. 803 ....................................................................................................... 4
`Fed. R. Evid. 901 ....................................................................................................... 1
`Fed. R. Evid. 902 ....................................................................................................... 4
`
`ii
`
`
`
`I.
`
`Introduction
`Petitioner’s motion to exclude evidence mischaracterizes the record, lacks
`
`particularity, and falls woefully short of meeting Petitioner’s burden. Patent Owner
`
`respectfully requests that the Board deny Petitioner’s motion.
`
`II.
`
`Petitioner’s Motion to Exclude Documents Authenticated by Ms. Weber
`Petitioner asserts that multiple Patent Owner Exhibits,2 which Petitioner terms
`
`the “Weber Exhibits,” should be excluded from evidence pursuant to Federal Rule
`
`of Evidence 901. Specifically, Petitioner complains that these documents, which
`
`were authenticated both through written declaration and at deposition, have still not
`
`been addressed to Petitioner’s satisfaction. Petitioner’s complaints mischaracterize
`
`both the facts and the law, and should be rejected.
`
`“Federal Rule of Evidence 901 requires that a proponent need only ‘produce
`
`evidence sufficient to support a finding that the item is what the proponent claims it
`
`is’ to meet its burden on authentication.” Comcast Cable Commc’ns, LLC v. Veveo,
`
`Inc., IPR2019-00290, 2020 WL 4687062, at *28 (P.T.A.B. Aug. 12, 2020) (quoting
`
`Fed. R. Evid. 901(a)). “Authenticity, therefore, is not an especially high hurdle for
`
`a party to overcome.” Id. (emphasis added).
`
`Each of the Weber Exhibits was authenticated by Doris Weber, a Senior
`
`2 Exhibits 2059, 2060, 2073, and 2128. Paper 75 at 2.
`
`1
`
`
`
`Litigation Support Specialist with Patent Owner Regeneron Pharmaceuticals, Inc.
`
`Ex.2131 at ¶1. Ms. Weber explained in her sworn declaration 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. See generally id. Thereafter, at
`
`Petitioner’s request, Ms. Weber appeared for deposition, where she testified as to
`
`the processes whereby she confirmed the authenticity of the Exhibits. By way of
`
`example, 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 kept in accordance with Regeneron’s
`
`procedures. See, e.g., Ex.1150 at 25:16-26:18, 29:23-30:23, 34:10-14, 41:7-13,
`
`42:13-43:24, Mylan Pharms. Inc. v. Regeneron Pharms., Inc., IPR2021-00881
`
`(P.T.A.B. May 27, 2022).3 Where possible, Ms. Weber also personally confirmed
`
`these details with individual custodians. See, e.g., id. at 35:23-37:2; 40:6-24, 44:3-
`
`45:6 (Ms. Weber testifying that she spoke with custodians to confirm document
`
`storage locations). Ms. Weber’s declaration and deposition testimony thus fully
`
`satisfy the threshold for authentication under FRE 901. Notwithstanding Petitioner’s
`
`3 Petitioner deposed Ms. Weber in this proceeding, but only filed that deposition
`
`transcript in the parallel proceeding IPR2021-00881. Consequently, citations to
`
`Ms. Weber’s deposition transcript reference Exhibit 1150 in IPR2021-00881.
`
`2
`
`
`
`assertions to the contrary, Ms. Weber need not have personally authored or
`
`maintained the documents in order to serve as an authenticating witness. See, e.g.,
`
`Comcast, 2020 WL 4687062 at *28 (rejecting petitioner’s argument that a witness
`
`lacked sufficient personal knowledge to authenticate emails that he neither sent nor
`
`received).
`
`Further, Petitioner’s assertion that certain of the authenticated Weber
`
`Exhibits4 are “incomplete and/or excerpted versions of unproduced” originals (Paper
`
`75 at 3) is unsupported—and in some cases directly contradicted—by the record.
`
`See, e.g., IPR2021-00881, Ex.1150 at 32:10-15.
`
`For all of these reasons, Petitioner’s motion to exclude the Weber Exhibits
`
`should be denied.
`
`A.
`
`Exhibit 2059—Regeneron Sample Analysis Report: PK06005-9-
`SA-01V1, Signed by Study Director Ellen M. Koehler-Stec
`Petitioner argues that Exhibit 2059 (authenticated by Ms. Weber) should
`
`nonetheless be excluded under FRE 402 and/or 802 (in addition to FRE 901,
`
`discussed above). Paper 75 at 4-5. Petitioner is wrong.
`
`Exhibit 2059 is not inadmissible hearsay. Ms. Weber’s testimony
`
`demonstrates that Exhibit 2059 falls within the business records exception to the rule
`
`4 Exs. 2060 and 2128. Paper 75 at 3.
`
`3
`
`
`
`against hearsay, as set forth in FRE 803(6): it is a scientific report, was stored on
`
`Regeneron servers, and bears facial indications of trustworthiness (written on
`
`Regeneron letterhead and dated and signed by Dr. Koehler-Stec, a study director and
`
`Regeneron employee). Ex.2059; IPR2021-00881, Ex.1150 at 24:18-26:18; see also
`
`Ex.2131 at ¶2. Petitioner does not challenge the foundation laid for the business
`
`records exception, and does not identify any condition of FRE 803(6) that has not
`
`been met.5
`
`With respect to FRE 402, Petitioner argues that Exhibit 2059, an internal
`
`Patent Owner document, “does not demonstrate the POSA’s knowledge or a prior
`
`art teaching,” so cannot be relevant in an IPR proceeding. Paper 75 at 4. But Patent
`
`Owner and its experts do not rely on Exhibit 2059 for its prior art teaching; rather,
`
`Exhibit 2059 illustrates the inherent variability in producing VEGF Trap-Eye.6
`
`Exhibit 2049 at ¶¶ 91-96. Nor is petitioner correct in asserting that non-prior-art
`
`evidence is necessarily irrelevant. Paper 75 at 4. See, e.g., Organik Kimya AS v.
`
`5 Further, the Federal Rules of Evidence expressly provide that applicability of the
`
`business records exception to hearsay may be established through the declaration
`
`of a custodian of records. Fed. R. Evid. 803(6), 902(11).
`
`6 In any event, this inherent variability in producing recombinant proteins was
`
`known in the art. Ex.2049 at ¶¶93, 96; see also Exs. 2058, 2071, 2072, 2074.
`
`4
`
`
`
`Rohm & Haas Co., 873 F.3d 887, 893-94 (Fed. Cir. 2017) (affirming Board’s
`
`reliance on experimentation by PO’s expert to find no inherent anticipation).
`
`B.
`
`Exhibit 2060—Table 14.2.3/2a of the VIEW1 Clinical Study
`Report (Protocol VGFT-OD-0605)
`Contrary to Petitioner’s argument (Paper 75 at 5-6), Exhibit 2060 should not
`
`be excluded under FRE 901. As set forth above, Ms. Weber, who spoke with the
`
`custodian of the Exhibit in preparation for her deposition, authenticated Exhibit
`
`2060. IPR2021-00881, Ex.1150 at 31:10-33:1; 35:23-37:2; see also Ex.2131 at ¶3.
`
`It is simply not necessary that Dr. Del Priore (an expert witness) separately
`
`authenticate, let alone have personal knowledge of, this document.
`
`Petitioner’s argument that Exhibit 2060 is necessarily irrelevant and/or
`
`prejudicial under FRE 402-403 because it was not publicly available also lacks
`
`merit. Patent Owner and its experts did not rely on Exhibit 2060 for its prior art
`
`teachings, but rather to rebut Petitioner’s arguments on inherent efficacy of the
`
`claimed dosing regimen. Ex.2048 at ¶¶107-08.
`
`Exhibit 2060 is also not hearsay: it was authenticated by Ms. Weber, who
`
`spoke with the custodian of the Exhibit in preparation for her deposition. IPR2021-
`
`00881, Ex.1150 at 35:23-37:2. Ms. Weber’s testimony also makes clear that Exhibit
`
`2060 falls within the business records exception to the rule against hearsay, as set
`
`forth in FRE 803(6): it is a clinical study protocol, stored in Regeneron’s regulatory
`
`archive, and bears facial indicia of trustworthiness (Regeneron protocol headers and
`5
`
`
`
`file path information on each page). Ex.2060; Ex.2131 at ¶3; IPR2021-00881,
`
`Ex.1150 at 24:14-26:18. Again, Petitioner neither challenges the foundation laid for
`
`the business records exception, nor identifies any condition of FRE 803(6) that has
`
`not been met.
`
`C.
`
`Exhibit 2073—Zaltrap Non-comparability Issue: Regeneron
`Sanofi Analytical Investigation Workshop
`Similarly, Petitioner’s motion to exclude Exhibit 2073 should be denied.
`
`Exhibit 2073 was authenticated by Ms. Weber. Ex.2131 at ¶4; IPR2021-00881,
`
`Ex.1150 at 40:6-41:13. Dr. Klibanov (an expert witness) need not separately
`
`authenticate this document, let alone have “firsthand knowledge” of the experiments
`
`it describes, to satisfy FRE 901. Paper 75 at 7. That Exhibit 2073 was filed under
`
`seal does not render it irrelevant under FRE 402. Further, Patent Owner and its
`
`experts do not rely on Exhibit 2073 as prior art, but rather to illustrate the inherent
`
`variability in the producing VEGF Trap-Eye, a recombinant fusion protein.7
`
`Ex.2049 at ¶¶91-95.
`
`Exhibit 2128—Regeneron’s VIEW Protocol Signature Pages
`D.
`Petitioner’s assertion that Exhibit 2128 should be excluded under FRE 901
`
`because “no witness with personal knowledge has authenticated it” is demonstrably
`
`7 In any event, this inherent variability in producing recombinant proteins was
`
`known in the art. Ex.2049 at ¶¶93, 96; see also Exs. 2058, 2071, 2072, 2074.
`
`6
`
`
`
`false. Paper 75 at 8. In addition to the authentication by Ms. Weber,8 Patent Owner’s
`
`expert Dr. Brown testified at deposition that: (a) he personally recognizes Exhibit
`
`2128 as an Investigator’s Agreement; (b) he was a principal investigator for the trial;
`
`(c) Exhibit 2128 is signed by Dr. Brown’s partner, who was the other principal
`
`investigator; and (d) Dr. Brown’s practice retains a copy of the agreement that is
`
`Exhibit 2128, which is stored at Iron Mountain. Ex.1110 at 62:18-63:17. In fact,
`
`Dr. Brown expressly confirmed that Exhibit 2128 “is our document, from my
`
`institution.” Id. at 63:7-17. Petitioner’s allegations surrounding the authenticity of
`
`Exhibit 2128 are thus thoroughly belied by the record.
`
`Petitioner’s assertion that Exhibit 2128 is irrelevant pursuant to FRE 402
`
`because it is a non-public document is equally specious. Patent Owner and its expert
`
`rely on Exhibit 2128 precisely to show its confidentiality. See, e.g., Ex.2050 at ¶71;
`
`Paper 38 at 9-10 & n.6. Petitioner’s suggestion that Exhibit 2128’s confidential
`
`status deprives it of relevance therefore defies logic. Nor does the record support
`
`Petitioner’s assertion that Exhibit 2128 is unreliable or prejudicial as a “hand-picked
`
`excerpt.” Paper 75 at 9. Again, Dr. Brown expressly confirmed the authenticity of
`
`Exhibit 2128. Ex.1110 at 63:7-17.
`
`Finally, Exhibit 2128
`
`is not
`
`inadmissible hearsay, notwithstanding
`
`8 See Ex.2131 at ¶5; IPR2021-00881, Ex.1150 at 43:19-45:6.
`
`7
`
`
`
`Petitioner’s assertion to the contrary. Dr. Brown’s and Ms. Weber’s testimony make
`
`clear that Exhibit 2128 falls within the business records exception to the rule against
`
`hearsay, as set forth in FRE 803: it was 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 (dated signatures by Dr. Brown’s partner on every
`
`page), all as confirmed by individuals with knowledge. See Ex.1110 at 62:18-63:17;
`
`IPR2021-00881, Ex.1150 at 41:18-45:6; Ex.2131 at ¶5. Indeed, Dr. Brown has
`
`personal knowledge of Exhibit 2128 and was cross examined about it at his
`
`deposition in this proceeding. Ex.1110 at 62:18-63:20. Exhibit 2128 and Dr.
`
`Brown’s testimony about it are thus the exact opposite of hearsay. See Actifio, Inc.
`
`v. Delphix Corp., IPR2015-00016, 2016 WL 1534236, at *48-49 (P.T.A.B. Apr. 13,
`
`2016) (denying motion to exclude declaration testimony because declarant was
`
`subject to cross-examination). Indeed, Petitioner neither challenges the foundation
`
`laid for the business records exception, nor identifies any unmet condition of FRE
`
`803(6).
`
`III. Exhibit 2096—Clinical Study Agreement
`Petitioner’s challenge to Exhibit 2096 likewise falls flat. Paper 75 at 9-10.
`
`Dr. Brown testified that Exhibit 2096 is a Clinical Study Agreement between Dr.
`
`Brown’s institution, Vitreoretinal Consultants of Houston, and Regeneron. Ex.2050
`
`8
`
`
`
`at ¶71. 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 regular,
`
`FDA-mandated document retention policies. Ex.1110 at 59:19-62:17. Against this
`
`backdrop, Petitioner’s assertion that Exhibit 2096 was not authenticated strains
`
`credulity.
`
`Nor is Exhibit 2096 hearsay. Exhibit 2096 falls within the business records
`
`exception to the rule against hearsay, as set forth in FRE 803(6): It was generated
`
`in the ordinary course of regularly conducted activity (i.e., a clinical study), was
`
`stored by Dr. Brown’s practice in accordance with their regular document retention
`
`policies, and bears facial indications of trustworthiness (dated signature by Dr.
`
`Brown’s partner). Ex.1110 at 59:23-62:17. Petitioner neither challenges the
`
`foundation laid for the business records exception, nor identifies any condition of
`
`FRE 803(6) that has not been met. Moreover, Dr. Brown has personal knowledge
`
`of the Clinical Study Agreement and its terms, and was cross-examined on the
`
`subject at his deposition in these proceedings. Id.; Ex.2050 at ¶71.
`
`IV. Portions of Exhibits 2048-50: Corresponding Expert Opinions
`Petitioner concludes its Motion to Exclude with a blanket request that the
`
`Board exclude multiple paragraphs of Patent Owner’s expert testimony, spanning
`
`9
`
`
`
`across the declarations of Drs. Del Priore, Klibanov, and Brown, on the grounds that
`
`these paragraphs purportedly cite one or more of the challenged exhibits. Paper 75
`
`at 10-11. But Petitioner’s motion fails even to identify which declaration paragraphs
`
`correspond to which exhibits, let alone to explain how or why the experts’ use of
`
`any particular exhibit is allegedly improper. Such vague assertions do not satisfy
`
`Petitioner’s burden on a motion to exclude. This problem is compounded by the fact
`
`that Petitioner’s original objections to evidence failed to identify the portions of the
`
`expert declarations that it now moves to exclude with any particularity, instead
`
`vaguely asserting that the FRE 703 objection applies to each of Exhibits 2048, 2049,
`
`and 2050 in their entirety. Paper 39 at 3; see Nippon Suisan Kaisha Ltd. v. Pronova
`
`Biopharma Norge AS, PGR2017-00033, 2019 WL 237114, at *23-24 (P.T.A.B. Jan.
`
`16, 2019) (finding argument waived when patent owner’s objections to evidence
`
`failed to identify with sufficient particularity the complaint raised in patent owner’s
`
`motion to exclude). Consequently, Petitioner’s request to exclude expert declaration
`
`paragraphs should be denied.
`
`V.
`
` Conclusion
`For all of these reasons, Patent Owner respectfully requests that the Board
`
`deny Petitioner’s Motion to Exclude Evidence.
`
`10
`
`
`
`Dated: July 27, 2022
`
`Respectfully Submitted,
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on July 27, 2022, a true and entire copy of this
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION TO
`
`EXCLUDE EVIDENCE was served via e-mail to the Petitioners at the following
`
`email addresses:
`
`MYL_REG_IPR@rmmslegal.com
`paul@ rmmslegal.com
`wrakoczy@ rmmslegal.com
`dmazzochi@rmmslegal.com
`hsalmen@ rmmslegal.com
`jmarx@rmmslegal.com
`ehunt@rmmslegal.com
`nmclaughlin@rmmslegal.com
`sbeall@rmmslegal.com
`tehrich@rmmslegal.com
`sbirkos@rmmslegal.com
`lgreen@wsgr.com
`ychu@wsgr.com
`rcerwinski@geminilaw.com
`azalcenstein@geminilaw.com
`bmorris@geminilaw.com
`TRea@Crowell.com
`Dyellin@Crowell.com
`SLentz@Crowell.com
`
`/s/ Deborah E. Fishman
`Deborah E. Fishman (Reg. No. 48,621)
`3000 El Camino Real #500
`Palo Alto, CA 94304
`
`Counsel for Patent Owner,
`Regeneron Pharmaceuticals, Inc.
`
`12
`
`
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