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 MOTION TO EXCLUDE
`
`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 MOTION TO EXCLUDE
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
`
`
`
`TABLE OF CONTENTS
`INTRODUCTION ............................................................................................... 1
`I.
`II. Petitioner’s Improper Exhibits And Arguments Should Be Excluded ................ 3
`A. Petitioner’s New Arguments on Reply ............................................................. 3
`B. Petitioner’s Exhibits Not Cited in the Pleadings Should Be Excluded as
`Irrelevant ................................................................................................................. 9
`III. CONCLUSION ..............................................................................................11
`
`i
`
`
`
`TABLE OF CONTENTS
`
`Page(s)
`
`Cases
`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) .............................................................................. 4
`
`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) .................................................. 9
`
`Statutes
`35 U.S.C. § 311 .......................................................................................................... 6
`35 U.S.C. § 312 .......................................................................................................... 4
`
`Rules
`Fed. R. Evid. 401 .................................................................................................9, 10
`Fed. R. Evid. 402 .................................................................................................9, 10
`Fed. R. Evid. 403 .....................................................................................................10
`
`Regulations
`37 C.F.R. § 42.23 .............................................................................................. 1, 4, 8
`37 C.F.R. § 42.64 ....................................................................................................... 1
`
`ii
`
`
`
`Other Authorities
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(Nov. 2019) .........................................................................................................4, 8
`
`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 56) that untimely present new
`
`arguments; (ii) Exhibit Nos. 1118, 1121 and 1124, which are not cited in the
`
`pleadings; and (iii) portions of Petitioner’s expert declarations not cited in the
`
`pleadings.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) and/or are
`
`irrelevant under Federal Rule of Evidence 402. 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 60), and in its communication with the Board dated
`
`June 3, 2022.
`
`I.
`
`INTRODUCTION
`Petitioner’s Reply in this proceeding introduces new arguments that alter or
`
`expand its originally asserted Grounds 1-5. First, Petitioner argues for the first time
`
`on reply that VEGF Trap-Eye was “being distributed to others prior to the filing
`
`date.” Paper 56 at 17. Petitioner’s new conjecture expands the anticipation
`
`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 11-12.
`
`1
`
`
`
`arguments in Petition Grounds 1-4, which relied exclusively on alleged prior art
`
`disclosure of the amino acid or nucleic acid sequence recited in the Challenged
`
`Claims. Next, Petitioner expands its Ground 4 anticipation theory by arguing on
`
`Reply that Dixon’s prospective disclosure of VIEW’s Year-2 PRN dosing
`
`anticipates the tertiary PRN dosing limitation of the Challenged Claims. Again, this
`
`contrasts with the Petition, which relied exclusively on Dixon’s disclosure of
`
`VIEW’s fixed 8-week dosing as allegedly anticipating the claimed PRN dosing.
`
`Finally, Petitioner expands its Ground 5 arguments by alleging for the first time on
`
`Reply that a POSA would have looked to references other than Heier-2009 to supply
`
`the disclosure of PRN dosing for Petitioner’s obviousness combination(s). Each of
`
`these new arguments is in violation of the regulations and Trial Practice Rules and
`
`should be excluded or stricken.
`
`In addition, Petitioner has submitted exhibits and expert testimony that are not
`
`cited, let alone relied upon, in any of its pleadings. These uncited exhibits and
`
`testimony cannot be of consequence in determining the outcome of this action, and
`
`are therefore, by definition, irrelevant.
`
`Patent Owner respectfully requests that the Board exclude each of these
`
`improper and irrelevant Petitioner submissions, as set forth below.
`
`2
`
`
`
`II.
`
` Petitioner’s Improper Exhibits And Arguments Should Be Excluded
`A.
`Petitioner’s New Arguments on Reply
`Petitioner’s Reply in the present proceedings raises multiple new arguments
`
`that improperly alter its asserted Grounds of unpatentability, in contravention of 37
`
`C.F.R. § 42.23 and the Trial Practice Rules. Each of these untimely arguments
`
`should be 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
`
`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
`
`
`
`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
`
`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 and sur-replies
`
`can help crystalize issues for decision, a reply or sur-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).
`
`Patent Owner timely and specifically objected to each of Petitioner’s new
`
`arguments in its June 3, 2022, communication with the Board, wherein Patent Owner
`
`4
`
`
`
`identified the issues 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 these new
`
`arguments in its Sur-reply, and reiterated that they are untimely and in contravention
`
`of 37 C.F.R. § 42.23(b). See Paper 68 at 10, 19-20, 25 n.19, 28, 33 n.24. As detailed
`
`below, these new arguments should be excluded.
`
`Petitioner’s New Argument that VEGF Trap-Eye Was Publicly Distributed
`
`Petitioner alleges in Grounds 1-4 of the Petition that the amino acid and
`
`nucleic acid sequences encoding VEGF Trap-Eye were known in the art. Petition
`
`26-28, 50, 53, 56. But the record evidence establishes that none of Petitioner’s
`
`references expressly discloses sequences encoding VEGF Trap-Eye. Paper 68 at 5;
`
`Ex. 1115 ¶ 35; Paper 38 at 10-11. Faced with this fact, Petitioner broadens its
`
`Grounds 1-4 theory on Reply, arguing that VEGF Trap-Eye was “being distributed
`
`to others” before 2011. Paper 56 at 17 (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
`
`5
`
`
`
`“distributed” in its Petition, Petitioner chose to improperly introduce its new theory
`
`on Reply.4 Petitioner’s untimely argument should be excluded.
`
`Petitioner’s New Ground 4 Anticipation Argument
`
`Petitioner attempts to expand its asserted Ground 4 by arguing for the first
`
`time on Reply that Dixon’s prospective disclosure of the intended 2-year dosing
`
`regimen of VIEW’s 2Q8 arm (3 monthly loading doses, followed by fixed Q8 dosing
`
`through the end of Year 1, followed by PRN dosing in Year 2) anticipates the
`
`Challenged Claims. Paper 56 at 21; Paper 68 at 19-20. This argument was not
`
`disclosed in the Petition, where Petitioner’s Ground 4 anticipation arguments are
`
`instead built on a single theory—namely, that Dixon’s Year 1 fixed Q8 dosing is the
`
`claimed PRN method of treatment. Paper 1 at 54-56.5 Petitioner’s attempts to
`
`expand its Ground 4 anticipation arguments on Reply to now rely on Dixon’s
`
`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 Tellingly, the only basis advanced in the Petition for this Ground 4 anticipation
`
`argument was Petitioner’s flawed interpretation of Patent Owner’s statements in the
`
`prosecution history, which interpretation led Petitioner to conclude (incorrectly) that
`
`fixed Q8 dosing equals PRN dosing. Paper 1 at 55; Paper 38 at 22-25.
`
`6
`
`
`
`disclosure of the Year-2 PRN dosing regimen from VIEW—Paper 56 at 21 (first
`
`sentence)—should be excluded.
`
`Petitioner’s New Ground 5 Obviousness Arguments
`Petitioner similarly seeks to alter its Ground 5 obviousness arguments, using
`
`several new theories raised for the first time on Reply.
`
`First, Petitioner attempts to expand Ground 5 by broadening its base reference
`
`from Heier-2009 (Ex. 1018) (which disclosed CLEAR-IT-2) to now include other
`
`“PRN regimen art.” Compare Paper 56 at 24; Ex. 1114 ⁋ 39, with Paper 1 at 8. The
`
`Reply and accompanying Albini Reply Declaration propose to use Mitchell’s
`
`disclosure of PrONTO and/or Dixon’s disclosure of Year 2 of VIEW dosing to
`
`supply the disclosure of PRN dosing for Petitioner’s Ground 5 obviousness
`
`argument. Paper 56 at 24, 30-31; Ex. 1114 ⁋ 39. In contrast, Petition Ground 5
`
`relied solely on Heier-2009 (and its disclosure of CLEAR-IT-2’s PRN dosing
`
`regimen) to supply PRN dosing, then proposed that a POSA would use Dixon and
`
`Mitchell’s disclosures of three loading doses to modify the CLEAR-IT-2 PRN
`
`regimen. See, e.g., Paper 1 at 65 (“A skilled artisan naturally would have been
`
`motivated to 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.”).
`
`Petitioner’s attempts to shift the foundation of its Ground 5 Obviousness arguments
`
`7
`
`
`
`through this new use of Dixon and Mitchell on Reply should be rejected, and these
`
`new arguments excluded.
`
`Petitioner also argues for the first time on Reply that four loading doses is no
`
`different than three loading doses in the context of PRN dosing. Paper 56 at 25. In
`
`essence, Petitioner now asserts that the differences between CLEAR-IT-2 (4 loading
`
`doses) and the challenged claims (3 loading doses) should be disregarded altogether
`
`because “[d]ropping from four loading doses to, e.g., three, is inconsequential when
`
`following the loading dosing with PRN.” Paper 56 at 25, 34. Again, this argument
`
`was never raised in the Petition and should be excluded.
`
`Petitioner’s new use of Exhibit 1068 (which discloses a Phase II DME trial of
`
`VEGF Trap-Eye) to bolster its Ground 5 arguments on Reply is likewise improper.
`
`Paper 56 at 27-28. Exhibit 1068 was never cited in the original Petition, and neither
`
`Petitioner nor its experts relied upon Ex. 1068’s disclosure of the DME trial at any
`
`time prior to Petitioner’s Reply. Consequently, Petitioner’s Reply arguments on
`
`Exhibit 1068 should be excluded.
`
`In sum, Petitioner chose to make each of these arguments on Reply, rather
`
`than in its Petition. These arguments should be excluded as outside the scope of the
`
`instituted grounds and in violation of 37 C.F.R. § 42.23(b) and the Trial Practice
`
`Guide rules.
`
`8
`
`
`
`B.
`
`Petitioner’s Exhibits 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 FRE 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.
`
`Petitioner submitted into the record multiple exhibits and paragraphs of expert
`
`declaration testimony that were never cited in the pleadings (directly or indirectly),
`
`let alone relied upon. None of Exhibit Nos. 1118, 1121 and 1124 was cited in
`
`Petitioner’s pleadings. Similarly, the following paragraphs from Petitioner’s expert
`
`declarations were not cited in the pleadings: (i) Albini Declaration (Ex. 1002): ¶¶
`
`31, 156, 160-165, 174; and (ii) Gerritsen Declaration (Ex. 1003): ¶¶ 16, 17, 30-32,
`
`9
`
`
`
`34-36, 38, 67, 84, 86, 87, 94, 97, 98.6 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 403.7 Paper 30 at 1-2; Paper 60 at 7-9.
`
`6 In fact, this is just a subset. While not the subject of this motion, the following
`
`paragraphs from Petitioner’s expert declarations were also never cited in its
`
`pleadings: (i) Albini Declartion (Ex. 1002): ¶¶ 1-15, 29, 30, 32-38, 53, 75, 112, 114,
`
`157-159 and 224; (ii) Gerritsen Declaration (Ex. 1003): ¶¶ 1-15, 18-29, 33, 37, 41-
`
`59, 68-71, 73-75, 79-83, 88-92, 96, 99-105, 106-107; (iii) Albini Reply Declaration
`
`(Ex. 1114) ¶32; and (iv) Gerritsen Reply Declaration (Ex. 1115) ¶¶ 1-9, 49, 50, 52
`
`and 78-95.
`
`7 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
`
`improper summary. Paper 60 at 7-9. 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.
`
`10
`
`
`
`These uncited exhibits and testimony cannot be of consequence in determining the
`
`outcome of this action, and should therefore be excluded as irrelevant.
`
`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
`prior to the filing date
`New Ground 4 anticipation argument based on
`Dixon’s disclosure of VIEW year 2 PRN dosing
`
`New Ground 5 obviousness arguments using
`“PRN regimen art” other than Heier 2009 to
`supply disclosure of PRN dosing
`
`Uncited exhibits
`
`Uncited expert declaration testimony
`
`11
`
`Location
` Paper 56 at 17 (first
`paragraph)
`
` Paper 56 at 20 (last
`sentence) to 21 (top
`paragraph)
` Paper 56 at 24 (last
`sentence)
` Paper 56 at 30-31 (chart
`and paragraph spanning
`both pages)
` Albini Reply Declaration
`(Ex. 1114) ¶ 39
` Paper 56 at 25 (first
`paragraph)
` Paper 56 at 34 (second
`paragraph, lines 3-6)
` Paper 56, citations to
`Exhibit 1068 at 27,
`(second paragraph, lines
`2 and 3), 28 (second
`paragraph, lines 3-5)
` Exs. 1118, 1121 and
`1124
` Albini Decl. (Ex. 1002),
`¶¶ 31, 156, 160-65, 174
` Gerritsen Decl. (Ex.
`1003), ¶¶ 16, 17, 30-32,
`
`
`
`Material for exclusion
`
`Location
`34-36, 38, 67, 84, 86, 87,
`94, 97, 98
`
`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.
`
`12
`
`
`
`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.
`
`13
`
`
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