IPR2021-00816
` U.S. Patent 9,220,631
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION
`Patent Owners
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`___________________
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`Case No. IPR2021-00816
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`U.S. Patent No. 9,220,631
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`___________________
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`PATENT OWNER’S REPLY IN SUPPORT OF
`ITS MOTION TO EXCLUDE
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` U.S. Patent 9,220,631
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION
`Patent Owners
`
`___________________
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`Case No. IPR2021-00816
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`U.S. Patent No. 9,220,631
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`___________________
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`PATENT OWNER’S REPLY IN SUPPORT OF
`ITS MOTION TO EXCLUDE
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`Petitioner opposes Patent Owner’s Motion as procedurally improper and
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`IPR2021-00816
` U.S. Patent 9,220,631
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`directed to responsive, not new, evidence. Petitioner’s arguments are without merit.
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`PATENT OWNER’S MOTION IS PROCEDURALLY PROPER
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`Petitioner’s assertion that Patent Owner was required to file a motion to strike,
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`rather than to exclude, Petitioner’s untimely expert declarations (Opp’n at 2) is
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`incorrect. As the Federal Circuit has found, “if the petitioner submits a new expert
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`declaration with its Reply, the patent owner can respond in multiple ways. . . . It can
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`move to exclude the declaration.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081
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`(Fed. Cir. 2015); see also CTPG at 73 (citing Belden, 805 F.3d at 1081-82). Further,
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`while the PTAB’s practice has varied,1 the Board’s order denying Patent Owner’s
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`request to submit supplemental evidence with its surreply specifically cited to CTPG
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`73: “To the extent Petitioner presented new evidence in its Reply that may be
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`deemed improper, (see 37 C.F.R. § 42.23(b); CTPG 73-74) we will consider such
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`arguments upon a completed record.” Order (Paper 88) at 4. Patent Owner’s motion
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`to exclude was therefore properly filed.
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`1 Compare, e.g., Merck Sharp v. Wyeth LLC, IPR2017-00390, Paper 62, 63-64
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`(PTAB June 8, 2018), with Laboratoire Francais v. Novo Nordisk Heathcare AG,
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`IPR2017-00028, 2022 WL 1153444, at *5 (PTAB Apr. 13, 2022).
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`1
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`IPR2021-00816
` U.S. Patent 9,220,631
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`PETITIONER’S NEW EVIDENCE SHOULD BE EXCLUDED
`A. The Motion to Exclude Paragraphs 28-29 of the Koller Reply (Ex.
`1105) Satisfied the Procedural Requirements
`Parties are required to object to evidence “with sufficient particularity to allow
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`correction in the form of supplemental evidence.” 37 C.F.R. § 42.64(b)(1); see 37
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`C.F.R. § 42.64(b)(2). This is meant to “trigger the ability of the other party to
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`respond.” Les Ateliers Beau-Roc Inc. v. Air Power Sys. Co., LLC, No. IPR2020-
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`01702, 2022 WL 1158445, at *24 (PTAB Apr. 18, 2022). Here, Patent Owner timely
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`objected to Ex. 1105 as unsupported and prejudicial. Paper 76 at 20-22. Patent
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`Owner then further identified specific paragraphs of Mr. Koller’s declaration, to
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`Petitioner and then to the Board, as newly presented, and sought to submit
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`responsive, supplemental evidence. See Ex. 3002. Petitioner has therefore been on
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`notice of Patent owner’s objections, with multiple opportunities to respond. Paper
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`88 at 2; Ex. 3002; see Paper 76 at 20-22. In keeping with the Board’s Order denying
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`Patent Owner’s request to submit supplemental evidence, Patent Owner has
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`preserved the issue for decision through its motion to exclude. See Paper 88 at 4.
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`Exs. 1105 and 1108 Are Improper Reply
`B.
`Petitioner argues that both Mr. Koller’s Reply and Dr. Cohen’s Declaration
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`are proper reply to arguments made in Patent Owner’s Response. Opp’n at 3-6
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`(Koller) and 6-10 (Cohen). This is incorrect. In its Petition, Regeneron argued that
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`a POSA would be motivated to combine Boulange’s Stopper B1 with Sigg’s VEGF-
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`IPR2021-00816
` U.S. Patent 9,220,631
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`antagonist, because a POSA “would have expected that Parylene C would not
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`interact negatively with drug products (e.g., VEGF-antagonists).” Petition (Paper 1)
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`at 37-38 (citing Ex. 1003 (Koller) ¶¶ 171-77). When Patent Owner pointed out
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`significant evidentiary gaps, Resp. (Paper 40) at 10-11, Petitioner changed tack: Mr.
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`Koller offered a new mechanical, rather than chemical, motivation to combine, based
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`on a new reading of Boulange, see Ex. 1105 ¶¶ 28-29, and Regeneron proffered Dr.
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`Cohen, as a new expert in an effort to provide more reliable testimony, Ex. 1108.
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`Both Mr. Koller’s new theory and Mr. Cohen’s Declaration are improper reply:
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`“‘Respond,’ in the context of 37 C.F.R. § 42.23(b), does not mean proceed in a new
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`direction with a new approach as compared to the positions taken in a prior filing.”
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`CTPG at 74; see, e.g., Qualcomm Inc. v. Apple Inc., 24 F.4th 1367, 1377 (Fed. Cir.
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`2022) (affirming Board’s rejection of a new theory of motivation to combine, where
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`petitioner had previously focused on another part of the prior art); Toyota Motor
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`Corp. v. Am. Vehicular Sci. LLC, IPR2013-00424, Paper 50 at 21 (PTAB Jan. 12,
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`2015) (rejecting new testimony on what a POSA would have known because
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`“[r]eplies that … belatedly present evidence will not be considered”). Petitioner’s
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`reliance on Aisin to argue the contrary is misplaced. See Opp’n at 6. In Aisin, the
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`parties disputed whether the patent’s preambles were limiting. Aisin Seiki Co., v.
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`Intellectual Ventures II LLC, IPR2017-01539, Paper 43 at 67-70 (PTAB Dec. 12,
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`2018). There was no untimely evidence, only untimely claim construction.
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`IPR2021-00816
` U.S. Patent 9,220,631
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`Petitioner’s assertion that it could not have anticipated these evidentiary gaps
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`is not credible. Opp’n at 7-8 (arguing it could not have anticipated the need for a
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`toxicologist). In prior litigation, including Petitioner’s previous IPR of the ’631
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`patent, Patent Owner has repeatedly raised the issue of Parylene C’s untested and
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`likely adverse interaction with VEGF-antagonists. See, e.g., IPR2020-01317, POPR
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`(Paper 10) at 3-4 (Oct. 22, 2020). Petitioner had the onus of presenting sufficient
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`evidence with its Petition to support its motivation to combine theory. See Intelligent
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`Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016);
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`CPTG at 73-74. “Petitioner cannot … use the Reply as a means to fill in the holes
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`that Patent Owner points out.” Reactive Surfaces Ltd. v. Toyota Motor Corp.,
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`IPR2016-01462, 2017 WL 3741335, at *2 (PTAB Aug. 29, 2017).2
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`Patent Owner is Prejudiced
`C.
`Finally, despite Petitioner’s assertions to the contrary, Patent Owner is
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`prejudiced by Petitioner’s untimely expert declarations. Opp’n at 10-11. A Petition
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`2 Petitioner’s assertion that it did not use Dr. Cohen’s testimony for its motivation
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`to combine argument is contrary to its Reply. Compare Opp’n at 8-9, with Reply
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`(Paper 72) at 1-7 (discussing a POSA’s “[m]otivation to combine” Sigg and
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`Boulange, relying on Dr. Cohen’s testimony); Ex. 1108 at 11 (similar).
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`IPR2021-00816
` U.S. Patent 9,220,631
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`must identify “with particularity” the “evidence that supports the grounds for [its
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`invalidity] challenge to each claim.” 35 U.S.C. § 312(a)(3). This ensures the Patent
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`Owner has “notice of and a fair opportunity to meet alleged grounds of invalidity”—
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`including the ability to offer responsive evidence. Everstar Merch. Co. v. Willis
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`Elec. Co., No. 2021-1882, 2022 WL 1089909, at *3 (Fed. Cir. Apr. 12, 2022); see
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`37 C.F.R. §§ 42.120(a), 42.23(b). Here, Petitioner raised new expert testimony on
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`reply, and Patent Owner did not have the ability to provide responsive evidence.
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`This deprivation is prejudicial. See 3M Co. v. Westech Aerosol Corp., IPR2018-
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`00576, 2019 WL 1878045, at *3 (PTAB Apr. 26, 2019).
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`Petitioner’s assertion that the opportunity to depose its experts cures any
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`prejudice is unsupported—neither case it cites is on point. See Opp’n at 11. In
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`Liquidia, the Board found “no undue prejudice” in a timely, but unsworn
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`declaration—deposition cured a procedural defect, it did not replace opportunity to
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`respond. Liquidia Tech. Inc. v. United Therapeutics Corp., IPR2020-00770, Paper
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`45 at 58 (PTAB Oct. 08, 2021). In Merck, the Board denied Patent Owner’s motion
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`to exclude because the challenged evidence was within the scope of proper reply and
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`therefore not prejudicial—Patent Owner had opportunity to respond. Paper 62 at
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`63-64. Deposition cannot replace the opportunity to present responsive evidence, or
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`obviate Petitioner’s obligation to make its case in its Petition. The Scotts Co. LLC
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`v. Encap, LLC, IPR2013-00110, 2014 WL 2886290, at *3 (PTAB June 24, 2014).
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`IPR2021-00816
` U.S. Patent 9,220,631
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`Respectfully submitted,
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`/Elizabeth Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, NY 10020
`Tel: 212-610-6375
`elizabeth.holland@allenovery.com
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`Counsel for Patent Owners Novartis
`Pharma AG, Novartis Technology
`LLC, and Novartis Pharmaceuticals
`Corporation
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`Dated: July 18, 2022
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`CERTIFICATE OF SERVICE
`I hereby certify that a copy of PATENT OWNER’S REPLY IN
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`IPR2021-00816
` U.S. Patent 9,220,631
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`SUPPORT OF ITS MOTION TO EXCLUDE has been served on Petitioner’s
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`attorneys of record as follows via electronic mail on July 5, 2022:
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`Elizabeth Stotland Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Natalie Kennedy (Reg. No. 68,511)
`Andrew Gesior (Reg. No. 76,588)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`Regeneron.IPR.Service@weil.com
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`Brian E. Ferguson (Reg. No. 36,801)
`Christopher M. Pepe (Reg. No. 73,851)
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`Regeneron.IPR.Service@weil.com
`Attorneys for Regeneron Pharmaceuticals, Inc.
`Dated: July 18, 2022
`By:
`/Elizabeth Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, NY 10020
`Phone: + 212 610 6365
`Elizabeth.Holland@allenovery.com
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