`____________
`
`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 REPLY ON
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`
`I.
`
`TABLE OF CONTENTS
`The Board May Strike Petitioner’s Improper New Arguments in the Context
`of a Motion to Exclude ..................................................................................... 1
`Petitioner’s Ground-Expanding Reply Argument Should Be Excluded .......... 2
`II.
`III. Uncited Exhibits and Expert Testimony Should Be Excluded ........................ 4
`IV. Exhibits 1154 and 1173 (Third-Party Complaints) Should be Excluded ......... 4
`V. Appendix A to the Albini Reply Should Be Excluded..................................... 5
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Dexcom Inc. v. Waveform Techs, Inc.,
`IPR2016-01680, Paper 46 (P.T.A.B. Feb. 28, 2018) ............................................. 1
`Intel Corp. v. Parkervision, Inc.,
`IPR2020-01265, Paper 44 (P.T.A.B. Jan. 21, 2022) .............................................. 1
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 1
`
`Laboratoire Francais du Fractionnement et des Biotechnologies SA v. Novo
`Nordisk Healthcare AG,
`IPR2017-00028, Paper 109 (P.T.A.B. Apr. 13, 2022) .......................................1, 2
`Reactive Surfaces Ltd., LLP v. Toyota Motor Corp.,
`IPR2017–0057, 2017 WL 5447195 (P.T.A.B. Nov. 9, 2017) ................................ 4
`Satco Prods. Inc. v. Seoul Viosys Co., Ltd.,
`IPR2020-00750, 2021 WL 4822806 (P.T.A.B. Sept. 20, 2021) ............................ 3
`Other Authorities
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(Nov. 2019) ............................................................................................................. 5
`
`ii
`
`
`
`I.
`
`The Board May Strike Petitioner’s Improper New Arguments in the
`Context of a Motion to Exclude
`PO asks the Board to exclude or strike Petitioner’s new Reply arguments that
`
`expand its asserted Grounds of unpatentability. Paper 83 at 2. As explained in PO’s
`
`opening brief, there is no procedural barrier to the grant of this request: On multiple
`
`occasions, and on analogous facts, the Board has treated party motions to exclude as
`
`motions to strike and has excluded arguments that exceed the permitted scope of
`
`reply.
`
` Id. at 3 (citing Laboratoire Francais du Fractionnement et des
`
`Biotechnologies SA v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper 109 at
`
`13 (P.T.A.B. Apr. 13, 2022); Intel Corp. v. Parkervision, Inc., IPR2020-01265,
`
`Paper 44 at 55-56, 66 n.22, 71-75, 77 (P.T.A.B. Jan. 21, 2022)); see also Dexcom
`
`Inc. v. Waveform Techs, Inc., IPR2016-01680, Paper 46 at 30-31 (P.T.A.B. Feb. 28,
`
`2018) (“Federal Circuit case law indicates that a motion to exclude is a proper
`
`vehicle for enforcing our rule and trial practice guide regarding the scope of evidence
`
`that may be submitted with a reply brief.”) (citing, inter alia, Intelligent Bio-Systems,
`
`Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359 (Fed. Cir. 2016)).
`
`Petitioner’s assertion that PO failed to provide the requisite notice misses the
`
`forest for the trees. PO identified Petitioner’s improper, Ground-expanding Reply
`
`argument early and often: First in direct correspondence with Petitioner, then in its
`
`June 3, 2022, communication with the Board requesting authorization to file a
`
`1
`
`
`
`motion to strike, and again, per the Board’s instructions, in its Sur-reply.2 See Paper
`
`73 at 18. This record does not support Petitioner’s suggestion that it was denied
`
`timely notice — Petitioner was specifically notified of these issues before the due
`
`date for PO’s evidentiary objections, and duly responded to these arguments in its
`
`Opposition. See Laboratoire Francais, IPR2017-00028, Paper 109 at 12 (striking
`
`new reply arguments on PO’s motion to exclude where petitioner had the
`
`opportunity to respond in opposition). Finally, Petitioner’s contention that it was
`
`deprived of an opportunity to “correct[] in the form of supplemental evidence”
`
`makes no sense. Paper 84 at 2. The filing of supplemental evidence would not cure
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`Petitioner’s improper expansion of its Grounds.
`
`II.
`
`Petitioner’s Ground-Expanding Reply Argument Should Be Excluded
`Petitioner’s Opposition takes a broad (and incorrect) view of what constitutes
`
`“responsive” argument on Reply. In Petitioner’s view, if a theory advanced in the
`
`Petition is rebutted in the POR, Petitioner may then raise a new theory “in response,”
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`which PO can address in sur-reply. Paper 84 at 5-6. But “[s]hifting arguments in
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`2 PO did not file a separate table identifying arguments exceeding the scope of
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`Reply because the Board’s June 7 Order provided that such a table should be filed
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`only as an alternative to identifying and addressing such arguments in Sur-Reply,
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`which PO did.
`
`2
`
`
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`this fashion is foreclosed by statute, Board precedent, and Board guidelines.” Satco
`
`Prods. Inc. v. Seoul Viosys Co., Ltd., IPR2020-00750, 2021 WL 4822806, at *12
`
`(P.T.A.B. Sept. 20, 2021). The Reply argument identified by PO advances a new
`
`basis for Petitioner’s allegations of unpatentability, and should be excluded.
`
`Petitioner’s argument that VEGF Trap-Eye was “publicly distributed long
`
`before 2011” is a new theory from that advanced in its Petition: namely, that the
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`sequence of VEGF Trap-Eye was published in the prior art. Compare Paper 61 at
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`22, 29 with Paper 1 at 24-25. As part of PO’s Response, it demonstrated that
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`Regeneron’s clinical investigators were required to keep information about VEGF
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`Trap-Eye confidential—i.e., not publish it. In Reply, Petitioner dismissed PO’s
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`evidence of confidentiality as “irrelevant.” Petitioner then tacked on its new theory:
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`that, even if the sequence of VEGF Trap-Eye was not published in the prior art,
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`Regeneron “publicly distributed” VEGF Trap-Eye, such that the sequence of VEGF
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`Trap-Eye could be discerned and known by the POSA. Paper 61 at 22, 28-29. This
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`would be an improper ground even if raised in the Petition. But by failing to disclose
`
`it until Reply, Petitioner deprived PO of the opportunity to present rebuttal
`
`evidence.3 This new, incorrect theory should be excluded.
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`3 Moreover, since Petitioner offered no expert testimony in support, cross-
`
`examination of its witnesses could not address the point.
`
`3
`
`
`
`III. Uncited Exhibits and Expert Testimony Should Be Excluded
`PO moves to exclude multiple Petitioner exhibits and expert declaration
`
`paragraphs that were never cited in the pleadings (directly or indirectly). Petitioner
`
`does not contest that this material was never relied upon in any of its pleadings.4
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`Rather, Petitioner suggests that keeping this irrelevant evidence in the record is
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`harmless. PO disagrees—allowing uncited evidence to clutter the record and
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`potentially be used by Petitioner in the future is prejudicial.5 In any event, FRE 402
`
`is clear that irrelevant evidence is not admissible, regardless of prejudice. These
`
`uncited exhibits and testimony should be excluded.
`
`IV. Exhibits 1154 and 1173 (Third-Party Complaints) Should be Excluded
`PO moves to exclude 1154 and 1173—third-party complaints filed against
`
`Regeneron—as irrelevant and prejudicial hearsay. To address PO’s hearsay
`
`objection, Petitioner asserts that it is not relying on these Exhibits for the truth of the
`
`matter asserted, but then immediately returns to faulting Dr. Manning for not
`
`addressing “kickbacks” alleged in the third-party complaints. Paper 84 at 9. This
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`4 Other experts’ reliance on three of the uncited paragraphs does not cure this
`
`absence from the pleadings. Reactive Surfaces Ltd., LLP v. Toyota Motor Corp.,
`
`IPR2017–0057, 2017 WL 5447195, at *4 (P.T.A.B. Nov. 9, 2017).
`
`5 PO specifically objected to the uncited material under FRE 403. Papers 30, 68.
`
`4
`
`
`
`use of Exhibits 1154 and 1173 necessarily assumes the truth of the allegations: i.e.,
`
`that improper “kickback” payments occurred. Id.; see also Ex. 1137 at ¶89 (asserting
`
`that the alleged payments “taint the marketplace performance of Eylea®.”).
`
`Petitioner also does not deny that these Exhibits are prejudicial—Petitioner’s expert
`
`admitted that he is relying on them specifically to “taint” Regeneron. Finally,
`
`Petitioner suggests that it should be allowed to treat the complaints as evidence
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`because attached exhibits purport to be internal Regeneron documents. But it is the
`
`attorney-drafted allegations of Exhibits 1154 and 1173 on which Petitioner’s Reply
`
`arguments unambiguously rely. Paper 61 at 37.
`
`V.
`
` Appendix A to the Albini Reply Should Be Excluded
` PO moves to exclude Albini Appendix A for improper incorporation by
`
`reference, and as improper summary under F.R.E. 1006. Petitioner’s assertion in
`
`Opposition that Appendix A is exempt from scrutiny because it is “not argument” is
`
`incorrect. First, Appendix A is unquestionably argumentative, lining up cherry-
`
`picked deposition testimony with portions of the POR that Dr. Albini disputes.
`
`Second, Appendix A is only indirectly cited in the pleadings though incorporation
`
`by reference of 28 paragraphs of Dr. Albini’s declaration, which paragraphs are
`
`replete with argumentation. Finally, expert testimony is not exempt from the
`
`Board’s prohibition against improper incorporation by reference. See, e.g., Patent
`
`Trial and Appeal Board Consolidated Trial Practice Guide at 35 (Nov. 2019).
`
`5
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`
`
`Dated: August 2, 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.
`
`6
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`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on August 2, 2022, a true and entire copy of
`
`this PATENT OWNER’S REPLY ON 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.
`
`7
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`