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 MOTION TO EXCLUDE
`
`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 MOTION TO EXCLUDE
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ............................................................................................... 2
`I.
`II. PETITIONER’S IMPROPER EXHIBITS AND ARGUMENTS SHOULD BE
`EXCLUDED .............................................................................................................. 2
`A. Petitioner’s New Argument on Reply .............................................................. 2
`B. Petitioner’s Exhibits and Expert Testimony Not Cited in the Pleadings
`Should Be Excluded as Irrelevant .......................................................................... 6
`C. Exhibits 1154 and 1173 (Third-Party Complaints) and the Arguments and
`Expert Testimony that Rely on These Exhibits Should Be Excluded .................... 8
`1. The Third-Party Complaints Are Inadmissible as Irrelevant ....................... 9
`2. The Third-Party Complaints Are Inadmissible Hearsay ............................10
`D. Appendix A to the Albini Reply Declaration Should be Excluded ...............11
`III. CONCLUSION .................................................................................................13
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Elec. Arts Inc. v. Terminal Reality, Inc.,
`IPR2016-00929, IPR2016-00930, Paper 50 (PTAB Oct. 19, 2017) ....................11
`Hynix Semiconductor Inc. v. Rambus Inc.,
`CV-00-20905 RMW, 2008 WL 350638 (N.D. Cal. Feb. 2, 2008) ........................ 9
`Icon Health & Fitness, Inc. v. Strava, Inc.,
`849 F.3d 1034 (Fed. Cir. 2017) .............................................................................. 9
`Intel Corp. v. Parkervision, Inc.,
`IPR2020-01265, Paper 44 (PTAB Jan. 21, 2022) .................................................. 3
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 3
`L’Oréal USA, Inc. v. Liqwd, Inc.,
`PGR2017-00012, Paper 17 (PTAB Jul. 19, 2017) ................................................. 9
`Laboratoire Francais du Fractionnement et des Biotechnologies SA v. Novo
`Nordisk Healthcare AG,
`IPR2017-00028, Paper 109 (PTAB Apr. 13, 2022) ...........................................3, 4
`One World Techs., Inc. v. Chamberlain Grp., Inc.,
`IPR2017-00126, Paper 56 (PTAB Oct. 24, 2018) .................................................. 6
`Orchestrate HR, Inc. v. Trombetta,
`3:13-CV-2110-KS, 2017 WL 273669 (N.D. Tex. Jan. 20, 2017) ........................12
`Stevenson v. Hearst Consol. Publ’ns, Inc.,
`214 F.2d 902 (2d Cir. 1954) .................................................................................10
`United States v. Koskerides,
`877 F.2d 1129 (2d Cir. 1989) ...............................................................................12
`United States v. O'Connor,
`237 F.2d 466 (2d Cir. 1956) .................................................................................12
`
`ii
`
`
`
`Statutes
`35 U.S.C. § 311 .......................................................................................................... 5
`35 U.S.C. § 312 .......................................................................................................... 3
`
`Rules & Regulations
`Fed. R. Evid. 401 ....................................................................................................... 6
`Fed. R. Evid. 402 ....................................................................................................... 6
`Fed. R. Evid. 403 ....................................................................................................... 9
`Fed. R. Evid. 801 .....................................................................................................10
`Fed. R. Evid. 802 .....................................................................................................10
`Fed. R. Evid. 803 .....................................................................................................11
`Fed. R. Evid. 804 .....................................................................................................11
`Fed. R. Evid. 807 .....................................................................................................11
`Fed. R. Evid. 1006 ................................................................................................... 12
`37 C.F.R. § 42.23 ...................................................................................................1, 4
`37 C.F.R. § 42.6 .......................................................................................................11
`37 C.F.R. § 42.64 ....................................................................................................... 1
`
`Other Authorities
`Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) ...... 4
`
`iii
`
`
`
`Pursuant to 37 C.F.R. § 42.64, Patent Owner Regeneron Pharmaceuticals, Inc.
`
`(“Patent Owner”) hereby moves to exclude (i) Portions of Petitioner Mylan
`
`Pharmaceuticals Inc.’s (“Petitioner”) Reply (Paper 61) that untimely present new
`
`arguments; (ii) Exhibit Nos. 1118, 1121 and 1124, which are not cited in the
`
`pleadings; (iii) portions of Petitioner’s expert declarations not cited in the pleadings;
`
`(iv) Exhibits 1154 and 1173, and portions of Petitioner’s Reply and expert
`
`declaration discussing those exhibits; and (v) Appendix A to the Albini Reply
`
`Declaration (Ex. 1114). 2 The Exhibits and portions of Petitioner’s Reply and expert
`
`declarations that Patent Owner seeks to exclude contravene 37 C.F.R. § 42.23(b),
`
`are irrelevant under Federal Rule of Evidence 402, are unfairly prejudicial under
`
`Federal Rule of Evidence 403, are hearsay under Federal Rule of Evidence 802,
`
`and/or constitute improper attorney argument. Pursuant to 37 C.F.R. § 42.64, Patent
`
`Owner timely raised its objections to these materials on November 24, 2021, and
`
`June 6, 2022 (Paper Nos. 30 and 59), and in its communication with the Board dated
`
`June 3, 2022.
`
`2 For ease of reference, a table listing specific locations of the Petitioner submissions
`
`that are the subject of this motion to exclude is included infra at 13.
`
`1
`
`
`
`I.
`
`INTRODUCTION
`Petitioner has cluttered the record with improper and irrelevant submissions
`
`that violate the Regulations and the Federal Rules of Evidence. First, Petitioner has
`
`submitted new argument for the first time on Reply, expanding its Grounds 1 and 3-
`
`5 anticipation theories beyond those set forth in its Petition. Next, Petitioner has
`
`submitted exhibits and expert testimony that are not cited, let alone relied upon, in
`
`any of its pleadings. In addition, in an effort to explain away EYLEA’s billions of
`
`dollars of net sales, Petitioner has submitted purported “evidence” that is in fact no
`
`more than unproven allegations from third-party complaints filed against Regeneron.
`
`Finally, Petitioner has attempted to circumvent the word limits of the pleadings by
`
`improper incorporation of an “Appendix” that compiles hand-picked excerpts from
`
`expert deposition testimony. Patent Owner respectfully requests that the Board
`
`exclude these improper Petitioner submissions, as set forth below.
`
`II.
`
`IMPROPER EXHIBITS AND ARGUMENTS
`PETITIONER’S
`SHOULD BE EXCLUDED
`A.
`Petitioner’s New Argument on Reply
`Petitioner seeks to broaden its anticipation theories in Grounds 1 and 3-5
`
`beyond what was set forth in its Petition by arguing for the first time on Reply that
`
`VEGF Trap-Eye was “publicly distributed long before 2011.” Paper 61 at 22; id. at
`
`2
`
`
`
`29 (citing Ex. 1112 (a 2008 article)). Petitioner’s attempt to alter its Grounds on
`
`Reply should be rejected, and this new argument excluded.3
`
`“It is of the utmost importance that petitioners in [] IPR proceedings adhere
`
`to the requirement that the initial petition identify ‘with particularity’ the ‘evidence
`
`that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc.
`
`v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016) (quoting 35
`
`U.S.C. § 312(a)(3)) (affirming Board’s decision to exclude argument and evidence
`
`3 While a motion to exclude is generally not the appropriate vehicle for consideration
`
`of whether a party has improperly raised new arguments, the Board has previously
`
`ruled on this issue in the context of motions to exclude, essentially treating a motion
`
`to exclude as a motion to strike. See, e.g., Laboratoire Francais du Fractionnement
`
`et des Biotechnologies SA v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper
`
`109 at 11-14, 18-21 (PTAB Apr. 13, 2022) (granting in part Patent Owner’s motion
`
`to exclude, which the panel treated as motion to strike); Intel Corp. v. Parkervision,
`
`Inc., IPR2020-01265, Paper 44 at 55-56, 66 n.22, 71-75, 77 (PTAB Jan. 21, 2022)
`
`(granting Petitioner’s motion to exclude new arguments and evidence improperly
`
`raised by Patent Owner on sur-reply). If the Board deems appropriate, this portion
`
`of Patent Owner’s motion to exclude may be treated as a motion to strike.
`
`3
`
`
`
`presented for first time in petitioner’s reply brief). “Petitioner may not submit new
`
`evidence or argument in reply that it could have presented earlier, e.g. to make out a
`
`prima facie case of unpatentability.” Patent Trial and Appeal Board Consolidated
`
`Trial Practice Guide 73 (Nov. 2019) [hereinafter, Trial Practice Guide]; see also 37
`
`C.F.R. § 42.23(b). Rather, a reply may only respond to arguments raised in the
`
`corresponding opposition, patent owner preliminary response, patent owner
`
`response, or decision on institution. 37 C.F.R. § 42.23(b). The Trial Practice Guide
`
`further explains that “‘[r]espond,’ in the context of 37 C.F.R. § 42.23(b), does not
`
`mean proceed in a new direction with a new approach as compared to the positions
`
`taken in a prior filing,” Trial Practice Guide 74, and “while replies can help crystalize
`
`issues for decision, a reply that raises a new issue or belatedly presents evidence will
`
`not be considered and may be returned.” Laboratoire Francais du Fractionnement
`
`et des Biotechnologies S.A. v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper
`
`109 at 13 (PTAB Apr. 13, 2022) (citing Trial Practice Guide 74).
`
`Here, Petitioner alleged in Grounds 1 and 3-5 of the Petition that the amino
`
`acid and nucleic acid sequences encoding VEGF Trap-Eye were known in the art.
`
`Paper 1 at 23-25, 40-41, 47, 51, 56, 63, 66. But the record evidence establishes that
`
`none of Petitioner’s references expressly discloses sequences encoding VEGF Trap-
`
`Eye. Paper 73 at 14; Ex. 1115, ¶ 35; Paper 40 at 25-26. Faced with this fact,
`
`Petitioner broadens its Grounds 1 and 3-5 theory on Reply, arguing that VEGF Trap-
`4
`
`
`
`Eye was “publicly distributed long before 2011.” Paper 61 at 22; id. at 29 (citing
`
`Ex. 1112 (a 2008 article)). In other words, the theory relied on in the Petition was
`
`that the prior art disclosed the sequence of VEGF Trap-Eye to the POSA; by contrast
`
`the Reply alleges (incorrectly) that Regeneron provided VEGF Trap-Eye to the
`
`public, without confidentiality restrictions, such that the sequence of VEGF Trap-
`
`Eye could be discerned and disseminated. This is a new argument, and one that
`
`Petitioner could have presented earlier. Rather than arguing that VEGF Trap-Eye
`
`was being publicly “distributed” in its Petition, Petitioner chose to improperly
`
`introduce its new theory on Reply.4
`
`Patent Owner timely and specifically objected to this argument in its June 3,
`
`2022, communication with the Board, wherein Patent Owner identified the issue and
`
`requested authorization to file a motion to strike. Subsequently, pursuant to
`
`responsive instructions received from the Board in an email communication dated
`
`June 7, 2022, Patent Owner addressed this new argument on sur-reply, and reiterated
`
`that it is untimely and in contravention of 37 C.F.R. § 42.23(b). See Paper 73 at 18.
`
`Patent Owner respectfully requests that the Board exclude this argument.
`
`4 Patent Owner does not concede that this argument is properly within the scope of
`
`inter partes review as defined in 35 U.S.C. § 311(b).
`
`5
`
`
`
`B.
`
`Petitioner’s Exhibits and Expert Testimony Not Cited in the
`Pleadings Should Be Excluded as Irrelevant
`Petitioner’s exhibits and expert testimony that are not cited in the pleadings
`
`are irrelevant, and should be excluded.
`
`Exhibits and expert testimony that are not cited in the pleadings “ha[ve] no
`
`bearing on any fact that is of consequence in determining the outcome of the
`
`proceeding” and should be excluded pursuant to F.R.E. 401 and 402. One World
`
`Techs., Inc. v. Chamberlain Grp., Inc., IPR2017-00126, Paper 56 at 16 (PTAB Oct.
`
`24, 2018) (Board adopting petitioner’s argument.). “Evidence is relevant if: (a) it
`
`has any tendency to make a fact more or less probable than it would be without the
`
`evidence; and (b) the fact is of consequence in determining the action.” Fed. R.
`
`Evid. 401. Irrelevant evidence is not admissible. Fed. R. Evid. 402.
`
`None of Exhibits 1118, 1121, or 1124 was cited in Petitioner’s pleadings.
`
`Similarly, the following paragraphs from Petitioner’s expert declaration paragraphs
`
`were not cited in the pleadings: (i) Albini Declaration (Ex. 1002) ¶¶ 50-52; (ii)
`
`Gerritsen Declaration (Ex. 1003) ¶¶ 16, 17, 30-32, 34-36, 38, 68-70, 91, 92; (iii)
`
`Albini Reply Declaration (Ex. 1114) ¶¶ 56, 59, 80, 81, 86; and (iv) Hofmann Reply
`
`6
`
`
`
`Declaration (Ex. 1137) ¶¶ 57, 59-66, 68-74.5 Patent Owner timely objected to each
`
`of these uncited exhibits and expert declaration paragraphs under 37 C.F.R.
`
`§ 42.64(b), and provided sufficient particularity in its objections, specifically
`
`arguing that Exhibits 1118, 1121, and 1124 and each of the above-listed declaration
`
`paragraphs are inadmissible pursuant to F.R.E. 401, 402 and 403. Paper 30 at 1-2;
`
`Paper 68 at 4-8, 11-12.6 These uncited exhibits and testimony were not relied upon
`
`by Petitioner and should therefore be excluded as irrelevant.
`
`5 In fact, this is just a subset. While not the subject of this motion, the following
`
`paragraphs from Mylan’s expert declarations were also never cited in its pleadings:
`
`(i) Albini Declaration (Ex. 1002) ¶¶ 1-26, 29-34, 35-40, 45-49, 53, 73, 83, 110-113,
`
`251-254, 404; (ii) Gerritsen Declaration (Ex. 1003) ¶¶ 1-15, 18, 19, 25-29, 33, 37,
`
`39-48, 57-63, 65-67, 71-74, 90, 93--101; (iii) Albini Reply Declaration (Ex. 1114)
`
`¶¶ 1-8, 54, 55, 57, 58, 60-65, 69-70, 79, 82, 85; (iv) Gerritsen Reply Declaration (Ex.
`
`1115) ¶¶ 1-8, 9, 49, 50, 52; and (v) Hofmann Reply Declaration (Ex. 1137) ¶¶ 1-17,
`
`20, 22-24, 90.
`
`6 Patent Owner also objected to Exhibits 1118, 1121, and 1124 as inadmissible under
`
`F.R.E. 901 and 802 because they are unauthenticated hearsay evidence, and to
`
`Exhibits 1118 and 1124 as inadmissible under F.R.E. 1006 because they are
`
`7
`
`
`
`C.
`
`Exhibits 1154 and 1173 (Third-Party Complaints) and the
`Arguments and Expert Testimony that Rely on These Exhibits
`Should Be Excluded
`Petitioner’s Reply cites allegations from two third-party complaints against
`
`Regeneron (Ex. Nos. 1154 and 1173) in purported rebuttal to Patent Owner’s
`
`arguments on commercial success. But those complaints and the allegations therein
`
`are attorney argument, not evidence. Patent Owner respectfully submits that
`
`Exhibits 1154 and 1137 and the portions of Petitioner’s Reply and expert declaration
`
`that purport to rely on them are inadmissible and should be excluded as irrelevant
`
`under Federal Rules of Evidence 401 and 402, unduly prejudicial under Federal Rule
`
`of Evidence 403, and hearsay under Federal Rule of Evidence 802. 7
`
`improper summary. Paper 68 at 6-8. Because Petitioner has not relied on these
`
`exhibits, Patent Owner does not address these additional objections here. However,
`
`to the extent that Petitioner seeks to rely on these exhibits in the future, they should
`
`also be excluded on these additional bases.
`
`7 Patent Owner timely objected to each of Exhibits 1154 and 1173, and to the
`
`portions of Petitioner’s expert declaration that rely on them, under 37 C.F.R. §
`
`42.64(b). Paper 68 at 11, 14, 18. Patent Owner also provided sufficient particularity
`
`in its objections. Specifically, Patent owner argued that Exhibits 1154 and 1173 and
`
`the declaration paragraphs that rely on them are inadmissible pursuant to pursuant
`
`8
`
`
`
`The Third-Party Complaints Are Inadmissible as Irrelevant
`1.
`Allegations in a complaint are, at base, attorney argument, and it is well
`
`established that “[a]ttorney argument is not evidence.” Icon Health & Fitness, Inc.
`
`v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017); see also L’Oréal USA, Inc. v.
`
`Liqwd, Inc., PGR2017-00012, Paper 17 at 16-17 (PTAB Jul. 19, 2017) (district court
`
`complaints prepared by counsel for Patent Owner and offered as evidence of copying
`
`were nothing “more than mere attorney argument, which is not evidence.”); Hynix
`
`Semiconductor Inc. v. Rambus Inc., CV-00-20905 RMW, 2008 WL 350638, at *2
`
`(N.D. Cal. Feb. 2, 2008) (“Attorney argument is not admissible evidence.”).
`
`Moreover, even if the third-party complaints were relevant evidence (and they are
`
`not), relevant evidence may be excluded “if its probative value is substantially
`
`outweighed by a danger of … unfair prejudice [or] confusing the issues.” Fed. R.
`
`Evid. 403.
`
`As legal complaints, Exhibits 1154 and 1173 are allegations—not admissible
`
`evidence. These Exhibits are unsworn attorney argument, submitted in unrelated
`
`proceedings, by entities not participating here. Such attorney argument is not
`
`to F.R.E. 401, 402 and 403. Id. Patent Owner also argued that Exhibits 1154 and
`
`1173 are inadmissible pursuant to F.R.E. 901, 802 as unauthenticated and hearsay
`
`evidence. Id.
`
`9
`
`
`
`evidence, let alone relevant evidence in these proceedings. Compounding the issue,
`
`while Exhibits 1154 and 1173 lack any probative value, they are undisputedly
`
`prejudicial against Patent Owner. Indeed, Petitioner’s expert acknowledged as much
`
`at his deposition. E.g., Ex. 2289 at 316:16-317:17 (admitting he is “not in the weeds”
`
`with respect to facts underlying the allegations, but is “just saying that there’s a
`
`taint.”); id at 328:21-330:8 (admitting that the complaint is cited because of the
`
`“taint” that it put on Regeneron); see also id. at 314:7-18 (admitting allegations are
`
`not proven facts). Both the cited complaints (Ex. Nos. 1154 and 1173) and
`
`Petitioner’s and its expert’s arguments that rely upon them (at Paper 61 at 37; Ex.
`
`1137 at ¶¶ 85-89 & n.134-39) should therefore be excluded pursuant to F.R.E. 401,
`
`402, and 403.
`
`The Third-Party Complaints Are Inadmissible Hearsay
`2.
`Exhibits 1154 and 1173 are further inadmissible under F.R.E. 802 as hearsay.
`
`Hearsay is a statement made by a declarant who is not “testifying at the current trial
`
`or hearing” that is offered “to prove the truth of the matter asserted in the statement.”
`
`Fed. R. Evid. 801. Hearsay is not admissible unless an exception applies. Fed. R.
`
`Evid. 802. Absent an applicable exception, allegations made in a legal complaint
`
`are hearsay and are not admissible to prove the truth of their contents. See, e.g.,
`
`Stevenson v. Hearst Consol. Publ’ns, Inc., 214 F.2d 902, 907 (2d Cir. 1954) (“Of
`
`10
`
`
`
`course, the complaint was inadmissible as hearsay to prove the truth of its
`
`contents.”).
`
`Exhibits 1154 and 1173 are hearsay. They are statements being offered by
`
`Petitioner for their truth, but they were not made by a declarant involved in these
`
`proceedings. The third-party attorneys that drafted Exhibits 1154 and 1137 were not
`
`under oath and are not subject to cross-examination here. Nor does any hearsay
`
`exception apply. See Fed. R. Evid. 803-804, 807. Exhibits 1154 and 1173 should
`
`therefore be excluded.
`
`Appendix A to the Albini Reply Declaration Should be Excluded
`D.
`Appendix A to the Albini Reply Declaration is a twenty-nine page long exhibit
`
`that cherry-picks excerpts from Dr. Albini’s deposition testimony from these
`
`proceedings. See generally Ex. 1114 at app. A. Petitioner’s Appendix A should be
`
`excluded on the grounds that it is an improper attempt to circumvent the Board’s
`
`word count rules through incorporation by reference, and improper summary under
`
`F.R.E. 1006.
`
`Incorporation of large and non-specific sections of declarations is a
`
`particularly egregious and Board-recognized violation of the rules. 37 C.F.R.
`
`§ 42.6(a)(3); see Elec. Arts Inc. v. Terminal Reality, Inc., IPR2016-00929, IPR2016-
`
`00930, Paper 50 at 37 (PTAB Oct. 19, 2017) (finding that petitioner did not provide
`
`a persuasive argument in its reply as to the relevance of its citation to its expert’s
`11
`
`
`
`declaration). In addition, F.R.E. 1006 does not authorize the introduction of
`
`summaries when the original can be conveniently examined in court. Fed. R. Evid.
`
`1006; see also, Orchestrate HR, Inc. v. Trombetta, 3:13-CV-2110-KS, 2017 WL
`
`273669, at *11 (N.D. Tex. Jan. 20, 2017) (stating, in excluding an affidavit
`
`summarizing deposition testimony as hearsay, “[t]he Court knows of no precedent
`
`stating that a single deposition can be said to fall under F.R.E. 1006’s requirement
`
`of a ‘voluminous writing[], recording[], or photograph[] that cannot be conveniently
`
`examined in court’”). “The district court must determine as part of the foundation
`
`that the summary charts ‘fairly represent and summarize the evidence on which they
`
`are based.’” United States v. Koskerides, 877 F.2d 1129, 1134 (2d Cir. 1989)
`
`(quoting United States v. O'Connor, 237 F.2d 466, 475 (2d Cir. 1956)).
`
`Patent Owner timely objected to Appendix A under 37 C.F.R. §42.64(b).
`
`Paper 68 at 4. Patent Owner further provided sufficient particularity in its objections,
`
`specifically arguing that Appendix A is inadmissible pursuant to F.R.E. 106 and/or
`
`1006 as relying on incomplete evidence or improper summary and/or improperly
`
`cherry-picking selective passages of a reference. Id. Appendix A is cited once in
`
`the Albini Reply Declaration (Ex. 1114 at ¶9), and is indirectly cited, but never relied
`
`on in Petitioner’s Reply. Paper 61 at 7 (citing Ex. 1114 ¶¶9-44). This vague
`
`incorporation by reference of thirty-five paragraphs of Dr. Albini’s declaration,
`
`which in turn incorporates the twenty-nine page long Appendix A, is precisely the
`12
`
`
`
`sort of large and non-specific incorporation of declaration material that this Board’s
`
`rules prohibit. In addition, Appendix A is an improper summary in violation of
`
`F.R.E. 1006 because (i) the deposition transcript excerpted in Appendix A is of
`
`record in this proceeding, so can independently be examined by the Board; and (ii)
`
`the Appendix does not fairly reproduce the entirety of Dr. Albini’s deposition
`
`testimony. Appendix A should therefore be excluded.
`
`III. CONCLUSION
`For the reasons presented herein, Patent Owner respectfully requests that the
`
`Board exclude the following Exhibits and argument:
`
`Material for Exclusion
`New Reply argument that VEGF
`Trap-Eye/aflibercept was being
`publicly distributed to others prior
`to the filing date
`
`Location
` Paper 61 at 22 (lines 4 and 5), 29 (lines 2
`and 3)
`
`Uncited Exhibits
`
` Exhibit Nos. 1118, 1121 and 1124
`
`Uncited Expert Declaration
`Testimony
`
` Albini Declaration (Ex. 1002) ¶¶ 50-52
` Gerritsen Declaration (Ex. 1003) ¶¶ 16,
`17, 30-32, 34-36, 38, 68-70, 91, 92
` Albini Reply Declaration (Ex. 1114),
`¶¶ 56, 59, 80, 81, 86
` Hofmann Reply Declaration (Ex. 1137),
`¶¶ 57, 59-66, 68-74
`
`13
`
`
`
`Exhibits 1154 and 1173 (Third-
`Party Complaints) and Related
`Argument
`
` Exhibit Nos. 1154 and 1173
` Paper 61 at 37 (first paragraph)
` Ex. 1137 at ¶¶85-89 & n.134-39
`
`Improper Incorporation by
`Reference/Improper Summary
`
` Albini Reply Declaration (Ex. 1114), ¶9,
`Appendix A
` Paper 61 at 7 (§ III.A.1 last sentence)
`
`Dated: July 20, 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.
`
`14
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on July 20, 2022, a true and entire copy of this
`
`PATENT OWNER’S MOTION TO EXCLUDE 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.
`
`15
`
`
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