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 REPLY ON
`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 REPLY ON
`MOTION TO EXCLUDE EVIDENCE
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`The Board May Strike Petitioner’s Improper New Arguments in the Context
`of a Motion to Exclude ..................................................................................... 1
`
`II.
`
`Petitioner’s Ground-Expanding Reply Arguments Should Be Excluded ........ 2
`
`III. Uncited Exhibits and Expert Testimony Should Be Excluded ........................ 5
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Ariosa Diagnostics v. Verinata Health, Inc.,
`805 F.3d 1359 (Fed. Cir. 2015) ..........................................................................4, 5
`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-Sys., 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 (PTAB Apr. 13, 2022) ...........................................1, 2
`Satco Prods., Inc. v. Seoul Viosys Co.,
`IPR2020-00750, 2021 WL 4822806 (P.T.A.B. Sept. 20, 2021) ............................ 3
`
`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 77 at 3. 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. (citing Laboratoire Francais du Fractionnement et des Biotechnologies
`
`SA v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper 109 at 11-14, 18-21
`
`(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 (PTAB 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-Sys., Inc. v.
`
`Illumina Cambridge, Ltd., 821 F.3d 1359, 1369-70 (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
`
`arguments 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
`
`68 at 10, 19-20, 25 n.19, 28, 33 n.24. 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, 2022 WL 1153444,
`
`at *5-9 (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 78 at 2. The filing of supplemental evidence would not cure
`
`Petitioner’s improper expansion of its Grounds.
`
`II.
`
`Petitioner’s Ground-Expanding Reply Arguments 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,”
`
`which PO can address in sur-reply. Paper 78 at 6-7. But “[s]hifting arguments in
`
`this fashion is foreclosed by statute, [Board] precedent, and Board guidelines.”
`
`2 PO did not file a separate table identifying arguments exceeding the scope of Reply
`
`because the Board’s June 7 Order provided that such a table should be filed only as
`
`an alternative to identifying and addressing such arguments in Sur-Reply.
`
`2
`
`
`
`Satco Prods., Inc. v. Seoul Viosys Co., IPR2020-00750, 2021 WL 4822806, at *12
`
`(P.T.A.B. Sept. 20, 2021). Each Reply argument identified by PO advances a new
`
`basis for Petitioner’s allegations of unpatentability, and each should be excluded.
`
`First, Petitioner’s argument that VEGF Trap-Eye was “being distributed to
`
`others” before 2011 is a new theory from that advanced in its Petition: namely, that
`
`the sequence of VEGF Trap-Eye was published in the prior art. Compare Paper 56
`
`at 17 with Paper 1 at 26-27. As part of PO’s Response, it demonstrated that
`
`Regeneron’s clinical investigators were required to keep information about VEGF
`
`Trap-Eye confidential—i.e., not publish it. Paper 38 at 9-10 & n.6. In Reply,
`
`Petitioner dismissed PO’s evidence of confidentiality as “irrelevant.” Paper 56 at
`
`16-17. Petitioner then tacked on its new theory: that, even if the sequence of VEGF
`
`Trap-Eye was not published in the prior art, Regeneron publicly “distributed” VEGF
`
`Trap-Eye, such that the sequence of VEGF Trap-Eye could be discerned and known
`
`by the POSA. Id. This 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.
`
`Similarly, the Reply’s new Ground 4 anticipation argument, which relies for
`
`3 Moreover, since Petitioner offered no expert testimony in support, cross-
`
`examination of its witnesses could not address the point.
`
`3
`
`
`
`the first time on Year 2 PRN dosing of VIEW, is not “responsive.” Again, this is a
`
`case where the Petition raised one argument (2Q8=PRN for anticipation), PO
`
`rebutted that argument, and then Petitioner adopted an alternative argument on Reply
`
`(3 monthly loading doses, followed by fixed Q8 dosing through the end of Year 1,
`
`followed by PRN dosing in Year 2 anticipates). Paper 56 at 20-21; Paper 68 at 19-
`
`20. This use of a different disclosure from an earlier-cited reference to alter
`
`patentability grounds on Reply is not permissible. Ariosa Diagnostics v. Verinata
`
`Health, Inc., 805 F.3d 1359, 1367-68 (Fed. Cir. 2015).
`
`Likewise, Petitioner’s attempted expansion of its Ground 5 obviousness
`
`arguments should also be rejected. First, while the Petition generally described the
`
`dosing regimens of CLEAR-IT-2 (Heier-2009), PrONTO (Mitchell) and VIEW
`
`(Dixon), its specific combination of these disclosures was unambiguous: “A skilled
`
`artisan [would] combine the successful PRN regimen of CLEAR-IT-2 from Heier-
`
`2009 with the widely used loading regimen of three monthly doses disclosed in
`
`Mitchell and Dixon—to arrive at a regimen falling squarely within Challenged
`
`Claim 1.” Paper 1 at 65. In contrast, the Reply expands Ground 5 to allow for any
`
`combination of dosing elements from these studies. Paper 56 at 24, 28-31. Next,
`
`the new Reply argument that dropping from 4 to 3 loading doses is inconsequential
`
`in PRN dosing is not “responsive” simply because Petitioner claims it is relevant to
`
`motivation to combine, and Petitioner’s assertion that it “was not foreseeable” that
`
`4
`
`
`
`PO would “raise lack-of-motivation arguments” in the POR strains credulity. Paper
`
`78 at 10-11. Finally, Petitioner’s opposition to excluding the new Ground 5
`
`obviousness arguments relying on Exhibit 1068 is a bait-and-switch. Petitioner
`
`claims that the Exhibit 1068 arguments are responsive and points to pages 22 and 24
`
`of its Reply. Paper 78 at 10. But those are not the arguments that PO has moved to
`
`exclude. Rather, PO objects to the new use of Exhibit 1068 (which was never cited
`
`in the Petition) as allegedly supplying motivation for Petitioner’s Ground 5
`
`obviousness combination(s). Paper 56, 27-28; see also Ariosa, 805 F.3d at 1367-68.
`
`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), let alone
`
`relied upon. Petitioner does not contest that this material was never relied upon in
`
`its pleadings.4 Petitioner suggests that keeping this irrelevant evidence in the record
`
`is harmless. Paper 56 at 13. PO disagrees and objected under FRE 403—allowing
`
`uncited evidence to clutter the record and potentially be used by Petitioner in the
`
`future is prejudicial. In any event, FRE 402 is clear that irrelevant evidence is not
`
`admissible, regardless of prejudice. The uncited material should be excluded.
`
`4 Except for a single declaration paragraph that Petitioner argues is incorporated into
`
`its Reply through a daisy chain of indirect citations. Paper 78 at 13.
`
`5
`
`
`
`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
`
`
`
`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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