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 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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`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 MOTION TO EXCLUDE
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`INTRODUCTION
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`IPR2021-00816
`U.S. Patent 9,220,631
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`Pursuant to 37 C.F.R. §§ 42.62, 42.64(c), the Board’s Scheduling Order
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`(Paper 14), and the Federal Rules of Evidence (“FRE”), Patent Owner Novartis
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`Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation
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`(collectively, “Patent Owner”), move to exclude from evidence the following:
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`Exhibit
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`Description
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`Petitioner’s Citations
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`Ex. 1105 ¶¶ 28-29
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`Ex. 1108
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`Koller Reply
`Declaration
`Cohen Declaration
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`Paper 72 at 6
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`Paper 72 at 5-6
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`FACTUAL BACKGROUND
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`In order to meet its burden of proving unpatentability of the challenged claims,
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`Petitioner supported its petition with the expert declaration of Horst Koller (Ex.
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`1003). See Pet. (Paper 1). In its Response, Patent Owner demonstrated that there
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`were significant deficiencies in Petitioner’s prima facie case and Mr. Koller’s
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`declaration, and that, accordingly, Petitioner could not meet its burden of proof.
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`Resp. (Paper 40) at 10-13.
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`In its Reply, Petitioner attempted to fill the deficiencies in its evidence by
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`submitting a reply declaration from Mr. Koller (Ex. 1105), which raised brand new
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`arguments, and the declaration of an entirely new invalidity expert, Dr. Joel Cohen
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`(Ex. 1108). Patent Owner timely filed and served its objections to the new
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`arguments and declaration, identifying them as new evidence that was outside the
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`IPR2021-00816
`U.S. Patent 9,220,631
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`scope of proper reply. Objections (Paper 76) at 20-22, 26-28; see 37 C.F.R. §
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`42.23(b). Patent Owner deposed Mr. Koller with respect to his reply declaration on
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`May 16, 2022 (Ex. 2347), and Dr. Cohen on May 19, 2022 (Ex. 2340).
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`Patent Owner requested leave to file a reply expert declaration to address
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`Petitioner’s new evidence. Order (Paper 88) at 2. Petitioner opposed. Id. On May
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`25, 2022, the Board denied Patent Owner’s request. See id. at 4 (citing Patent Trial
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`and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“CTPG”) at 73).
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`However, the Order also provided that “[t]o the extent Petitioner presented new
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`evidence in its Reply that may be deemed improper,” the Board would “consider
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`such arguments upon a completed record.” Id. (citing 37 C.F.R. § 42.23(b); CTPG
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`73-74).
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` LEGAL STANDARD
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`USPTO regulations and the Federal Rules of Evidence govern the
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`admissibility of evidence and expert testimony in an inter partes review (“IPR”). 37
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`C.F.R. §§ 42.61(a), 42.62(a). “Because of the expedited nature of IPR proceedings,”
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`petitioners must “adhere to the requirement that the initial petition identify with
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`particularity the evidence that supports the grounds for the challenge to each claim.”
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`Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1330 (Fed. Cir. 2019)
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`(internal quotation marks and citations omitted). “A reply may only respond to
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`arguments raised in the corresponding opposition, patent owner preliminary
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`IPR2021-00816
`U.S. Patent 9,220,631
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`response, patent owner response, or decision on institution.” 37 C.F.R. § 42.23(b).
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`But a petitioner “may not submit new evidence or argument in reply that it could
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`have presented earlier, e.g. to make out a prima facie case of unpatentability.” CTPG
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`at 73; see Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1370
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`(Fed. Cir. 2016). Such new evidence is inadmissible and subject to exclusion. 37
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`C.F.R. § 42.61(a); see Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081 (Fed. Cir.
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`2015).
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` ARGUMENTS
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`A.
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`Patent Owner’s Motion Satisfies the Procedural Requirements
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`Patent Owner’s Motion to Exclude satisfies the procedural requirements.
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`Patent Owner timely filed and served its objections to Exhibits 1105 and 1108. 37
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`C.F.R. § 42.64(b); see Objections II at 20-22, 26-28. The chart below, identifies
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`where in the record the evidence sought to be excluded was relied upon by Petitioner.
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`See 37 C.F.R. § 42.64(c).
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`Exhibit
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`Description
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`Petitioner’s Citations
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`Ex. 1105 ¶¶ 28-29
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`Ex. 1108
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`Koller Reply
`Declaration
`Cohen Declaration
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`Paper 72 at 6
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`Paper 72 at 5-6
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`Patent Owner explains the bases for these objections below. See Section
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`IV(B); see also 37 C.F.R. § 42.64(c) (requiring that the moving party’s “motion must
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`identify the objections in the record in order and must explain the objections”).
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`3
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`Petitioner’s New Evidence Should Be Excluded
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`IPR2021-00816
`U.S. Patent 9,220,631
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`B.
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`Portions of the Koller reply declaration (Ex. 1105 ¶¶ 28-29) and the entirety
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`of the Cohen declaration (Ex. 1108; Regeneron cites specifically to ¶¶ 26, and 29-
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`44) are outside the scope of proper reply. Petitioner “cannot rely belatedly” on
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`Reply Declarations “to make up for the deficiencies in its Petition.” Toyota Motor
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`Corp. v. Am. Vehicular Sci. LLC, IPR2013-00424, 2015 WL 183909, at *10 (PTAB
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`Jan. 12, 2015); see also Laboratoire Francais du Fractionnement et des
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`Biotechnologies SA v. Novo Nordisk Heathcare AG, No. IPR2017-00028, 2022 WL
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`1153444, at *7 (PTAB Apr. 13, 2022) (Petitioner cannot offer new arguments and
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`evidence “at the reply stage to bolster the bare bones analysis presented in [its]
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`Petition.”). This evidence is improper on reply, prejudicial to Patent Owner, and,
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`as such, should be excluded. 37 C.F.R. § 42.23(b); see CTPG at 73-74; The Scotts
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`Co. LLC v. Encap, LLC, IPR2013-00110, 2014 WL 2886290 at *3 (PTAB June 24,
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`2014).
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` Mr. Koller’s Opinions Regarding Parylene C Not
`Contacting the VEGF Antagonist Are Untimely
`Petitioner’s central reference on unpatentability is WO 2009/030976
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`(“Boulange”). See Pet. at 21; Ex. 1008 (Boulange). Boulange is a patent application
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`directed to the invention of using a chemical called Parylene C to coat syringe
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`stoppers. See Ex. 1008.003-004. Petitioner and Patent Owner have offered
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`4
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`IPR2021-00816
`U.S. Patent 9,220,631
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`extensive arguments and counter-arguments concerning Boulange over the course
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`of the years-long dispute between the parties, as the reference has been raised by
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`Petitioner as part of its obviousness defense in the ITC, District Court, and multiple
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`IPR petitions (including here). Pet. at 21; see also Ex. 1064 (IPR2020-01317, Inst.
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`Dec. (Paper 15)) at 7-8; ITC Inv. No. 337-TA-1207, EDIS Doc. 738360 (Pre-
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`Hearing Brief) at xvi, 118-203; Novartis Pharma AG v. Regeneron Pharmaceuticals,
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`Inc., Case No. 1:20-cv-00690-DNH-CFH, ECF No. 74 (Answer and Counterclaim)
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`at 11-12. In response to Petitioner’s arguments, Patent Owner offered, among other
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`things, the opinion of Dr. John Dillberger, a toxicologist, explaining that, for a
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`myriad of reasons, a POSA would not be motivated to use an unproven chemical
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`such as Parylene C in a device like a PFS where the chemical will contact the drug
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`during storage. Ex. 2202 ¶¶ 13-74.
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`In its Reply evidence, Petitioner offered, for the first time, the opinion of Mr.
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`Koller to the effect that there is no reason why Parylene C would ever come into
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`contact with the VEGF drug product using Boulange’s design. Ex. 1105 ¶¶ 28-29;
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`see Reply (Paper 72) at 6. Despite addressing Boulange and the potentially negative
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`impact of Parylene C on a number of occasions, Petitioner and Mr. Koller had never
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`previously raised this argument. Because this argument was not raised in support of
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`the Petition and, thus, outside the proper scope of reply, Patent Owner sought
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`permission from the Board to offer responsive evidence on surreply—that request
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`IPR2021-00816
`U.S. Patent 9,220,631
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`was, however, denied. Order (Paper 88) at 4; see also Intelligent Bio-Sys., 821 F.3d
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`at 1369; Scotts Co., 2014 WL 2886290 at *3.
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`Mr. Koller’s evidence, and Petitioner’s reliance on it, should be struck from
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`the record and ignored by the Board. The PTAB’s decisions are clear: “[A]
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`petitioner cannot present, in a reply, a new argument necessary for its case-in-chief.”
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`Intex Rec. Corp. v. Team Worldwide Corp., No. IPR2018-00873, 2019 WL 5295724,
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`at *11 (PTAB Oct. 18, 2019); see CTPG at 73-74; Toyota Motor, 2015 WL 183909
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`at *10 (“Replies that raise new issues or belatedly present evidence will not be
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`considered.”). Petitioner is “obliged to make an adequate case in its Petition and the
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`Reply limited to a true rebuttal role.” Ariosa Diagnostics v. Verinata Health, Inc.,
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`805 F.3d 1359, 1367 (Fed. Cir. 2015); see Henny Penny, 938 F.3d at 1330
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`(concluding that “the Board did not abuse its discretion by holding [petitioner] to the
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`obviousness theory in its petition”). Mr. Koller’s opinions in this regard represent a
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`paradigmatic example of the type of improper reply evidence that is not allowed by
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`the PTAB. As such, the Board should exclude and ignore the recited paragraphs of
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`Mr. Koller’s reply declaration and the portions of Petitioner’s reply that rely on them.
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`Dr. Cohen’s Declaration is Untimely
`In its Petition, relying on the testimony of Mr. Koller, Regeneron asserted
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`that a POSA would be motivated to combine Boulange with WO 2011/006877
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`(“Sigg”) because a POSA “would have expected that Parylene C would have been
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`6
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`suitable for use in a pre-filled syringe comprising a VEGF-antagonist.” Pet. at 37-
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`IPR2021-00816
`U.S. Patent 9,220,631
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`38 (citing, inter alia, Ex. 1003 ¶¶ 171-77). Mr. Koller opined that because “[i]t
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`was well-known that Parylene C was suitable for use in medical applications,” Ex.
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`1003 ¶ 174, and “Parylene C was known to be chemically inert and would not react
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`with drug formulations,” id. ¶ 177, a POSA “would have reasonably expected that
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`Parylene C would be suitable for use with a terminally sterilized syringe with a
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`VEGF antagonist for intravitreal injection.” Id. ¶ 174; see id. ¶ 177.
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`In Response, Patent Owner pointed out that Regeneron’s argument had
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`“significant evidentiary gaps,” including that it was well-known in the prior art
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`that Parylene C interacts adversely with proteins, such as VEGF antagonists.
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`Resp. at 10-11. Patent owner further noted that “Mr. Koller is not a toxicologist”
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`and, as such, his testimony did not “reflect the motivations of a POSA with a
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`sufficient under understanding of toxicology or input from a toxicologist.” Id.; see
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`also Ex. 2202 ¶¶ 66-68.
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`In an effort to bolster its prima facie obviousness position, Petitioner
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`supplemented Mr. Koller’s testimony with a reply declaration from Dr. Cohen, a
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`toxicologist. Reply (Paper 72) at 5-6 (citing Ex. 1108 ¶¶ 26, 29-44). In support
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`of Petitioner’s reply, Dr. Cohen offered opinions on a POSA’s motivation to use
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`Boulange and the alleged reasonable expectation of success the POSA would have
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`based on Parylene C’s known characteristics with respect to interaction with
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`proteins and expected toxicity risk. Ex. 1108 ¶¶ 26, 29-44. Regeneron relied on
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`IPR2021-00816
`U.S. Patent 9,220,631
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`Dr. Cohen’s declaration in support of its motivation to combine rationale. Reply
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`at 5-6.
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`Petitioner’s submission of Dr. Cohen’s declaration and its reliance on it to
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`support its prima facie case were improper and untimely. Petitioner could have
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`employed Dr. Cohen, or some other toxicologist, to support its original petition,
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`but it chose not to do so. Instead, Petitioner relied on Mr. Koller. While Petitioner
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`may regret that decision in view of Patent Owner’s arguments, it cannot simply
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`provide an entirely new declaration on reply in order to patch the deficit.
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`“Petitioner cannot, without consequence, use the Reply as a means to fill in the
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`holes that Patent Owner points out.” Reactive Surfaces Ltd., LLP v. Toyota Motor
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`Corp., No. IPR2016-01462, 2017 WL 3741335, at *2 (PTAB Aug. 29, 2017). A
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`Petitioner “may not submit new evidence or argument in reply that it could have
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`presented earlier,” such as here, “to make a prima facie case of unpatentability.”
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`CTPG at 73. Regeneron’s untimely expert testimony and arguments should be
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`excluded.
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`Prejudice
`“Shifting arguments” as Petitioner has done “is foreclosed by statute,
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`[Federal Circuit] precedent, and Board guidelines.” Wasica Fin. GmbH v. Cont'l
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`8
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`Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017); see CTPG at 73-74. There
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`IPR2021-00816
`U.S. Patent 9,220,631
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`is good reason: Patent Owner is prejudiced by Petitioner’s untimely arguments
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`and evidence.
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`Petitioner was obligated “to make [its] case in [its] petition”—this is a
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`“strict” requirement “of which petitioners are aware when they seek to institute an
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`IPR.” Intelligent Bio-Sys., 821 F.3d at 1369; see 35 U.S.C. § 312(a)(3). Here,
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`instead, Petitioner belatedly presented new arguments and new evidence in support
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`of its prima facie invalidity case in its Reply. CTPG at 74; see Laboratoire
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`Francais, 2022 WL 1153444, at *7; Toyota Motor, 2015 WL 183909 at *10. This
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`prejudices Patent Owner by limiting its ability to respond. Specifically, Patent
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`Owner could not provide expert evidence in response to Regeneron’s new
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`arguments and evidence. See Scotts Co., 2014 WL 2886290 at *3 (“By waiting to
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`serve [new] evidence” until reply, petitioner “was denied the opportunity to file
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`responsive evidence.”). Patent Owner sought permission to do so, but permission
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`was denied. Order (Paper 88) at 4; see 37 C.F.R. § 42.23(b). And the fact that
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`Patent Owner could take the depositions of Mr. Koller and Dr. Cohen does not
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`eliminate the prejudice, as a deposition is not equivalent to the ability to submit
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`affirmative contrary evidence. The Board should, therefore, exclude Petitioner’s
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`new evidence as untimely, 37 C.F.R. §§ 42.23(b), 42.61, and unfairly prejudicial
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`to Patent Owner, FRE 403; see Scotts Co., 2014 WL 2886290 at *3 (declining to
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`consider two expert declarations served on reply, because “[b]y waiting to serve
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`IPR2021-00816
`U.S. Patent 9,220,631
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`this evidence,” petitioner “denied [Patent Owner] the opportunity to file
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`responsive evidence”).
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` CONCLUSION
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`For the foregoing reasons, in accordance with Board regulation and the
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`Federal Rules of Evidence, Exhibit 1105 ¶¶ 28-29 and Ex. 1108, in particular ¶¶
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`26, 29-44, should be excluded from the record and ignored by the Board.
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`Dated: July 5, 2022
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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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`10
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`IPR2021-00816
`U.S. Patent 9,220,631
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`CERTIFICATE OF SERVICE
`I hereby certify that a copy of PATENT OWNER’S MOTION TO
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`EXCLUDE has been served on Petitioner’s attorneys of record as follows via
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`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.
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`Dated: July 5, 2022
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`
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`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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`11
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