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 REPLY ON
`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 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
`
`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,”
`
`which PO can address in sur-reply. Paper 84 at 5-6. But “[s]hifting arguments in
`
`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,
`
`which PO did.
`
`2
`
`
`
`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
`
`sequence of VEGF Trap-Eye was published in the prior art. Compare Paper 61 at
`
`22, 29 with Paper 1 at 24-25. 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. In Reply, Petitioner dismissed PO’s
`
`evidence of confidentiality as “irrelevant.” 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. Paper 61 at 22, 28-29. 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.
`
`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
`
`Rather, Petitioner suggests that keeping this irrelevant evidence in the record is
`
`harmless. PO disagrees—allowing uncited evidence to clutter the record and
`
`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
`
`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
`
`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
`
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
