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 IPR2021-008811
`Patent No. 9,254,338 B2
`____________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00258 and IPR2022-00298 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 IPR2021-008811
`Patent No. 9,254,338 B2
`____________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00258 and IPR2022-00298 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
`E.
`Ex.2096: Clinical Study Agreement.............................................................. 8
`III. Exs.2169-70, 2279-85, and Portions of Ex.2052 (¶¶11, 28-29, 50-55, 60-61,
`63-69, 72, 74-75, 108-09, 113-16 and Attachments C1-C12, D1-D4, D7, and X2):
`Financial Documents.................................................................................................. 9
`IV. Exs.2136-40, 2163, 2190, 2197, 2208, 2277-78, and Portions of Ex.2052
`(¶¶88-94): Marketing Materials ...............................................................................13
`V.
`Ex.2052 (¶¶48-117): “Lack of Nexus Evidence” ...........................................14
`VI. Portions of Exs.2048-50, 2052: Corresponding Expert Opinions ..................15
`VII. Conclusion ......................................................................................................15
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Cardiovascular Sys., Inc. v. Shockwave Med., Inc.,
`IPR2019-00408, Paper 70 (PTAB July 20, 2020) .................................................. 5
`Comcast Cable Comms., LLC v. Veveo, Inc.,
`IPR2019-002990, 2020 WL 4687962 (P.T.A.B. Aug. 12, 2020) ................. 1, 2, 3
`EMC Corp. v. PersonalWeb Techs. LLC,
`IPR2013-00085, 2014 WL 2090664 (P.T.A.B. May 15, 2014) ............................. 9
`FMC Techs., Inc. v. OneSubsea IP UK Ltd.,
`IPR2019-00935, Paper 45 (P.T.A.B. Oct. 14, 2020) ............................................14
`Genband US LLC v. Metaswitch Networks Corp.,
`No. 2:14-cv-33-JRG-RSP, 2016 WL 125503 (E.D. Tex. Jan. 9, 2016) ...............12
`Nippon Suisan Kaisha Ltd. v. Pronova Biopharma Norge AS,
`PGR2017-00033, 2019 WL 237114 (P.T.A.B. Jan. 16, 2019) ............................15
`Organik Kimya AS v. Rohm & Haas Co.,
`873 F.3d 887 (Fed. Cir. 2017) ................................................................................ 4
`Rules
`Fed. R. Evid. 901 ....................................................................................................... 1
`Regulations
`37 C.F.R. § 42.64 ....................................................................................................... 9
`Other Authorities
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(Nov. 2019) ...........................................................................................................14
`
`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 forty of Patent Owner’s 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. Fed. R. Evid. 901(a).” Comcast Cable
`
`Comms., LLC v. Veveo, Inc., IPR2019-002990, 2020 WL 4687062, at *28. (P.T.A.B.
`
`Aug. 12, 2020). “Authenticity, therefore, is not an especially high hurdle for a party
`
`2 Exhibits 2059-2060, 2073, 2128, 2133-40, 2163, 2169-70, 2176, 2197, 2200,
`
`2205, 2208, 2218, 2229, 2272-85, 2243-44, 2250, and 2259. Paper 81 at 2.
`
`1
`
`
`
`to overcome.” Id. (emphasis added).
`
`Each of the Weber Exhibits was authenticated by Doris Weber, a Senior
`
`Litigation Support Specialist with Patent Owner Regeneron Pharmaceuticals, Inc.
`
`Ex.2286 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 storage, 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,
`
`42:13-43:24.3 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 testified that she spoke with custodians to confirm document storage
`
`locations). Ms. Weber’s declaration and deposition testimony satisfies the threshold
`
`3 These citations are just a subset of Ms. Weber’s testimony on the forty Weber
`
`Exhibits that are the subject of Petitioner’s motion. Patent Owner can readily
`
`provide similar citations for each of the Weber Exhibits if it is helpful to the Board.
`
`2
`
`
`
`for authentication under F.R.E. 901. Notwithstanding Petitioner’s assertions to the
`
`contrary, Ms. Weber need not have personally authored or maintained the documents
`
`to serve as an authenticating witness. See, e.g., Comcast, 2020 WL 4687062 at *28
`
`(holding that witness could 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
`
`81 at 3) is unsupported—and in some cases directly contradicted—by the record.
`
`See, e.g., Ex.1150 at 32:10-15; 74:13-76:5 (Petitioner’s counsel explaining that he
`
`excerpted a portion from Exhibit 2169, a 25,000 page document produced by Patent
`
`Owner, for use during deposition).
`
`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 be
`
`excluded under FRE 402 and/or 802. Petitioner is wrong.
`
`Exhibit 2059 is not inadmissible hearsay. Ms. Weber’s testimony
`
`demonstrates that Exhibit 2059 falls within the business records exception to
`
`hearsay, as set forth in FRE 803(6): it is a scientific report, was stored on Regeneron
`
`4 Exs.2060, 2128, 2169-70, 2229, 2273, 2285. Paper 81 at 3.
`
`3
`
`
`
`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.1150 at 24:14-26:18. 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.
`
`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 under FRE 402 in an IPR proceeding. Paper 81
`
`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.5 Ex.2049 at ¶¶95-105; Paper 40 at 41. 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. 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). Petitioner is also incorrect that Exhibit 2059 is not cited in Patent
`
`Owner’s pleadings. Paper 81 at 4. Both Drs. Del Priore and Klibanov rely on
`
`Exhibit 2059 in their declarations, and those declaration paragraphs are cited in
`
`5 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
`
`
`
`Patent Owner’s Response. Paper 40 at 41 (citing Ex.2049 at ¶¶97-102; Ex.2048 at
`
`¶¶96-103). This is sufficient.6 Cardiovascular Sys., Inc. v. Shockwave Med., Inc.,
`
`IPR2019-00408, 2020 WL 4196581, at *22 (P.T.A.B. Jul. 20, 2020) (denying
`
`motion to exclude exhibits under FRE 401 and 402 where the non-movant’s expert
`
`indirectly cited and relied upon the exhibits).
`
`B.
`
`Exhibit 2060—Table 14.2.3/2a of the VIEW1 Clinical Study
`Report (Protocol VGFT-OD-0605)
`Contrary to Petitioner’s argument, 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. Ex.1150 at
`
`31:10-33:1; 35:23-37:2. It is simply not necessary that Dr. Del Priore (PO’s expert
`
`witness) separately authenticate, let alone have personal knowledge of, this
`
`document. Petitioner’s argument that Exhibit 2060 is necessarily irrelevant and/or
`
`prejudicial because it was non-public also lacks merit, for the same reasons as
`
`discussed with respect to Exhibit 2059. See Section II.A, supra. Exhibit 2060 is
`
`also not hearsay. Ms. Weber’s testimony makes clear that Exhibit 2060 falls within
`
`FRE 803(6), the business records exception to the rule against hearsay: it is a clinical
`
`6 In contrast, Patent Owner seeks to exclude Petitioner’s exhibits that are neither
`
`directly cited in the pleadings, nor incorporated by citation to expert paragraphs.
`
`5
`
`
`
`study protocol, stored in Regeneron’s regulatory archive, and bears facial indicia of
`
`trustworthiness (Regeneron protocol headers and file path information on each
`
`page). Ex.2286 at ¶3; Ex.1150 at 24:14-26:18. Again, Petitioner neither challenges
`
`the foundation laid for the business records exception, nor identifies any unmet
`
`condition of FRE 803(6).
`
`C.
`
`Exhibit 2073—Zaltrap non-comparability issue: Regeneron
`Sanofi Analytical Investigation Workshop
`Exhibit 2073 was authenticated by Ms. Weber (Ex.2286 at ¶4; Ex.1150 at
`
`37:24-38:1, 40:11-41:13). 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. Further, with respect to Petitioner’s challenge under
`
`FRE 402, Exhibit 2073 was cited and relied on by Dr. Klibanov, and in the POR
`
`through citation to the relevant paragraph of Dr. Klibanov’s report. Paper 40 at 40
`
`(citing Ex.2049 at ¶94). 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 ¶¶91-94.
`
`Exhibit 2128—Regeneron’s VIEW Protocol Signature Pages
`D.
`Petitioner’s assertion that Exhibit 2128 should be excluded under FRE 901
`
`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
`
`
`
`because “no witness with personal knowledge has authenticated it” is demonstrably
`
`false. Paper 81 at 7. In addition to Ms. Weber’s authenticating testimony,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 62:18-63:20. In
`
`fact, Dr. Brown expressly confirmed that Exhibit 2128 “is our document, from my
`
`institution.” Id. at 63:7-17.
`
`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 40 at 24, n.11. 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 81 at 8. Again, Dr. Brown expressly authenticated Exhibit 2128.
`
`Ex.1110 at 63:7-17.
`
`Finally, Exhibit 2128 is not inadmissible hearsay. Dr. Brown’s and Ms.
`
`8 Ex.2286 at ¶5; Ex.1150 at 43:19-45:6.
`
`7
`
`
`
`Weber’s testimony make clear that Exhibit 2128 falls within FRE 803(6), the
`
`business records exception to the rule against hearsay: 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; Ex.1150 at 41:18-44:20. Indeed, Petitioner neither
`
`challenges the foundation laid for the business records exception, nor identifies any
`
`unmet condition of FRE 803(6).
`
`Ex.2096: Clinical Study Agreement
`E.
`Petitioner’s challenge to Exhibit 2096 likewise falls flat. Dr. Brown testified
`
`that Exhibit 2096 is a Clinical Study Agreement between Dr. Brown’s institution,
`
`Vitreoretinal Consultants of Houston, and Regeneron. Ex.2050 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 59:23-62:17. 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
`
`8
`
`
`
`the rule against hearsay (Ex.1110 at 59:23-62:17), and Petitioner neither challenges
`
`the foundation laid for the business records exception, nor identifies any unmet
`
`condition of FRE 803(6). 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.
`
`III. Exs.2169-70, 2279-85, and Portions of Ex.2052 (¶¶11, 28-29, 50-55, 60-
`61, 63-69, 72, 74-75, 108-09, 113-16 and Attachments C1-C12, D1-D4,
`D7, and X2): Financial Documents
`Petitioner next alleges that a group of Patent Owner’s exhibits (Exs.2169-70,
`
`2279-85) that it dubs “Financial Exhibits,” and all portions of Dr. Manning’s
`
`declaration that reference these exhibits, should be excluded from evidence. As a
`
`threshold matter, Petitioner’s motion fails to tie its objections to the contents of the
`
`complained of Financial Exhibits with any specificity, but rather asserts that the
`
`entire tranche should be excluded, in its entirety, under some combination of FRE
`
`1006, 901, and/or 801.9 These vague assertions cannot support Petitioner’s burden
`
`on a motion to exclude. 37 C.F.R. § 42.64(c) (motions to exclude “must identify the
`
`objections in the record in order and must explain the objections”); see also EMC
`
`Corp. v. PersonalWeb Techs. LLC, IPR2013-00085, 2014 WL 2090664, at *37
`
`9 This deficiency is even more glaring with respect to the portions of Dr.
`
`Manning’s expert declaration that Petitioner seeks to exclude.
`
`9
`
`
`
`(P.T.A.B. May 15, 2014) (finding insufficient basis to exclude exhibits where party
`
`failed to identify specific portions of exhibits to which it objected). Even setting
`
`aside this failing, however, Petitioner’s arguments with respect to the Financial
`
`Exhibits lack merit.
`
`The Financial Exhibits are internal Regeneron business records relied upon
`
`by Dr. Manning for his opinions on commercial success. Specifically, these Exhibits
`
`are, respectively: records of Eylea sample disbursement (Ex.2169); Eylea P&L and
`
`net sales statements (Exs.2170, 2285); and Eylea market research data (Exs.2279-
`
`2284). Each of these documents (Exs.2169-70, 2279-85) was authenticated by Ms.
`
`Weber in her declaration and at her deposition. Ex.2286 at ¶¶15, 16, 31-37; Ex.1150
`
`at 76:17-79:19, 65:12-66:21, 115:3-126:20. Contrary to Petitioner’s suggestion,
`
`none of these documents is a summary created for this proceeding—these are
`
`original Regeneron business records. Petitioner’s complaint that it was not provided
`
`with “underlying business records” relating to the Financial Exhibits thus makes no
`
`sense—the Exhibits themselves are the underlying records.10 Tellingly, Petitioner’s
`
`only request in this proceeding for discovery relating to the Financial Exhibits was
`
`actually a request for the same documents produced, albeit in a different format (i.e.,
`
`10 Petitioner had the opportunity to question Dr. Manning about these documents at
`
`his deposition, but failed to do so.
`
`10
`
`
`
`native spreadsheets as opposed to PDF files). See Petitioner’s email to the Board
`
`dated May 13, 2022; Ex.1116 at 17. Accordingly, there is no factual or legal basis
`
`for Petitioner’s objections to the Financial Exhibits under FRE 901 and/or 1006. 11
`
`Petitioner’s tortured attempt to argue that the Financial Exhibits are not
`
`business records, and thus objectionable under FRE 801, should also be rejected.
`
`Petitioner incorrectly alleges that “at least Exhibits 2169-70 and 2285…are not
`
`original, but prepared for these proceedings,” yet the testimony that Petitioner cites
`
`for its hypothesis does not mention these exhibits at all, let alone support this
`
`assertion. Paper 81 at 11. Even more convoluted, Petitioner faults Regeneron’s
`
`“profit/loss numbers”12 as “not trustworthy” because they do not support the
`
`allegations set forth in third-party complaints filed against Regeneron. Id. at 11. But
`
`this argument turns the Rules of Evidence on their head: the fact that unsworn
`
`allegations made by a non-party, in another proceeding, are inconsistent with a
`
`party’s produced business records does not render the business records less reliable.
`
`11 That the Financial Exhibits, which are themselves the “underlying documents” to
`
`Dr. Manning’s analysis, were produced further invalidates Petitioner’s FRE 1006
`
`and 801 complaints about the attachments to Dr. Manning’s report (e.g., Manning
`
`Attachments D1-D4 and D7) that summarize these exhibits. Paper 81 at 10-11.
`
`12 Paper 81 at 11-12 (presumably referring to Exhbit 2170).
`
`11
`
`
`
`Petitioner’s attempt to exclude the Financial Exhibits as hearsay accordingly fails.
`
`Finally, the Board should reject Petitioner’s attempt to exclude portions of Dr.
`
`Manning’s declaration that reference conversations with Regeneron directors under
`
`FRE 702. First, it is entirely proper for an expert to rely on knowledgeable
`
`employees in forming his opinions, and “an expert’s report need not catalog all the
`
`details of the experiential knowledge upon which the expert relies.” Genband US
`
`LLC v. Metaswitch Networks Corp., 2016 WL 125503, at *3 (E.D. Tex. Jan. 9, 2016)
`
`(rejecting the argument that an expert’s reliance on conversations with plaintiff’s
`
`employees should be excluded because his report did not “disclose the content of
`
`those conversations”). Also, here none of the Manning declaration testimony that
`
`Petitioner identifies as objectionable relies on employee interviews as its sole source;
`
`each additionally cites documents and data, and explains Dr. Manning’s reasoning
`
`and methodology. This is consistent with Dr. Manning’s testimony that the
`
`information he obtained from Regeneron employees “was more confirmatory and
`
`background in nature.” Ex.1151 at 18:23-19:18. In addition, where Dr. Manning
`
`relies on information obtained from Regeneron employees, he expressly discloses
`
`such reliance in his declaration, along with the full professional titles of the relevant
`
`individuals. See, e.g., Ex.2052 at ¶53, n.110. For all of these reasons, Petitioner’s
`
`FRE 702 objections do not justify excluding Dr. Manning’s testimony.
`
`12
`
`
`
`IV. Exs.2136-40, 2163, 2190, 2197, 2208, 2277-78, and Portions of Ex.2052
`(¶¶88-94): Marketing Materials
`Petitioner also asserts that Regeneron’s produced “Marketing Exhibits,” and
`
`Dr. Manning’s commercial success testimony that relies on them, should be
`
`excluded as prejudicial under FRE 403. Paper 81 at 13. The Marketing Exhibits
`
`show that the patented extended dosing regimens are emphasized in Eylea’s
`
`marketing materials. Notably, Petitioner does not argue that the Marketing Exhibits
`
`are irrelevant and, indeed, such materials are regularly relied upon by economic
`
`experts opining on commercial success, including Petitioner’s own expert, Mr.
`
`Hofmann. See, e.g., Ex.1137 at ¶¶64, 81, 93.
`
`Instead, Petitioner complains that Patent Owner should have produced every
`
`marketing document that Dr. Manning reviewed, not just the marketing materials on
`
`which he relied for his opinions. Paper 81 at 13. But even if additional marketing
`
`materials existed that did not explicitly address extended dosing, such documents
`
`would not undermine the fact that Eylea is marketed, at least in part, on the basis of
`
`its claimed extended dosing regimen. Moreover, Petitioner’s prejudice argument is
`
`a rehash of the arguments it made in requesting leave to move for additional
`
`discovery, which leave was denied. Ex.1116 at 17:24-18:12, 28:14-22, 30:3-23,
`
`42:20-45:1. Indeed, the Board previously considered Petitioner’s request to obtain
`
`all marketing materials reviewed by Dr. Manning and determined that such materials
`
`13
`
`
`
`do not constitute routine discovery or additional discovery that is in the interests of
`
`justice. Ex.1116 at 43:4-24.
`
`V.
`
`Ex.2052 (¶¶48-117): “Lack of Nexus Evidence”
`Petitioner next argues that Dr. Manning’s opinions on Eylea’s commercial
`
`success (Ex.2052 at ¶¶48-117) should be excluded as “irrelevant” under FRE 401-
`
`402 because, according to Petitioner, Patent Owner has not sufficiently shown the
`
`nexus between Eylea’s commercial success and the challenged claims. Paper 81 at
`
`14. Patent Owner strenuously disagrees. See Paper 40 at 59-60 (citing Ex.2051 at
`
`¶¶95-170). But, in any event, this complaint goes to the substance of Patent Owner’s
`
`arguments, not to the admissibility of evidence; it is not a proper basis for a motion
`
`to exclude. Patent Trial and Appeal Board Consolidated Trial Practice Guide 79
`
`(Nov. 2019) (“A motion to exclude…may not be used to challenge the sufficiency
`
`of the evidence to prove a particular fact.”) Moreover, Petitioner’s motion for
`
`blanket exclusion of these more than sixty paragraphs of Dr. Manning’s declaration
`
`lacks sufficient particularity to support its burden. See FMC Techs., Inc. v.
`
`OneSubsea IP UK Ltd., IPR2019-00935, 2020 WL 6065820, at *5 (P.T.A.B. Oct.
`
`14, 2020) (finding that petitioner’s “broad attack” seeking to exclude large swaths
`
`of an expert declaration under FRE 401-403 “lacks the specificity necessary to
`
`establish it is entitled to the relief it seeks”). Petitioner’s attempt to exclude these
`
`paragraphs should be denied.
`
`14
`
`
`
`VI.
`
` Portions of Exs.2048-50, 2052: Corresponding Expert Opinions
`Petitioner concludes its Motion to Exclude with a blanket request that the
`
`Board exclude more than 80 paragraphs of Patent Owner’s expert testimony,
`
`including testimony from Drs. Del Priore, Klibanov, Brown, and Manning, on the
`
`grounds that these paragraphs purportedly cite one or more of the challenged
`
`exhibits. 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,
`
`2050, and 2052 in their entirety. Paper 43 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) (waiver resulted from lack of particularity in objections).
`
`Consequently, Petitioner’s request to exclude expert declaration paragraphs should
`
`be denied.
`
`VII.
`
` Conclusion
`For all of these reasons, Patent Owner respectfully requests that the Board
`
`deny Petitioner’s Motion to Exclude Evidence.
`
`15
`
`
`
`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.
`
`16
`
`
`
`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.
`
`17
`
`
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