Paper 88
`Trials@uspto.gov
`571-272-7822 Date: May 25, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822 Date: May 25, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG, NOVARTIS TECHOLOGY LLC,
`
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owner.
`____________
`
`IPR2021-00816
`Patent 9,220,631 B2
`____________
`
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`JAMIE T. WISZ, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`
`A conference call in this proceeding was held on May 18, 2022,
`
`among counsel for Petitioner, Anish Desai, counsel for Patent Owner,
`
`Elizabeth Holland, and Judges Franklin, Kinder, and Wisz. The purpose of
`
`the call was to address Patent Owner’s request to file additional evidence
`
`with its Sur-reply. During the conference call, Patent Owner stated that it
`
`requests authorization to file an expert declaration in response to arguments
`
`and evidence it asserts were newly presented in the Reply. Petitioner
`
`opposed the request.
`
`Patent Owner contends that three declarations each contain several
`
`paragraphs of testimony that “contain new arguments and/or evidence.”
`
`Ex. 3002. Specifically, the Reply Declaration of Horst Koller (Ex. 1105),
`
`the Declaration of Dr. Kenneth S. Graham (Ex. 1102), and the Declaration
`
`of Joel M. Cohen (Ex. 1108) allegedly each contain some form of new
`
`argument or evidence. Id. During the conference call, Patent Owner
`
`highlighted the alleged issues with each of these exhibits, including:
`
`introduction of new expert testimony (toxicology report) that should have
`
`accompanied the Petition, introduction of secondary considerations evidence
`
`(such as related to long-felt need) that Patent Owner could not have
`
`anticipated, and new expert testimony as to the function and teachings of the
`
`prior art. Patent Owner seeks to file a Sur-reply declaration responding to
`
`the alleged new arguments and evidence.
`
`
`
`During the call, Petitioner argued that the declarations supporting its
`
`Reply merely provided evidence that directly rebut contentions raised by
`
`Patent Owner in the Response. Petitioner discussed the challenged
`
`declarations submitted with its Reply and its position how each either
`
`responded directly to an argument made in the Patent Owner Response or
`
`2
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`was consistent with Petitioner’s original arguments set forth in the Petition.
`
`Petitioner also noted that Patent Owner was aware of its positions as they
`
`were developed and briefed in the related International Trade Commission
`
`proceeding that progressed through discovery to the eve of trial. See, e.g.,
`
`Decision on Institution (Paper 13), 3, 9; Ex. 1006, 1.
`
`“A petitioner may file a reply to a patent owner response,” but,
`
`“[g]enerally, a reply . . . may only respond to arguments raised in the
`
`preceding brief.” Patent Trial and Appeal Board Consolidated Trial Practice
`
`Guide (“CTPG”) 73–74 (Nov. 2019).1 “‘Respond,’ 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.” Id. at 74. “A
`
`party also may submit rebuttal evidence in support of its reply.” Id. at 73.
`
`However, a 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.” Id. Further, “[i]f a party submits a new expert declaration
`
`with its reply, the opposing party may cross-examine the expert, move to
`
`exclude the declaration, and comment on the declaration and cross-
`
`examination in any sur-reply.” Id.
`
`Our Trial Practice Guide further notes that “[t]he sur-reply may not be
`
`accompanied by new evidence other than deposition transcripts of the cross-
`
`examination of any reply witness.” Id. As with a reply, “a . . . sur-reply that
`
`raises a new issue or belatedly presents evidence may not be considered,”
`
`and “[t]he Board is not required to attempt to sort proper from improper
`
`portions of the reply or sur-reply.” Id. at 74 (emphasis added). Based on the
`
`
`
`1 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`
`3
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`circumstances before us, we see no need to deviate from our standard
`
`practice of not allowing any new evidence other than deposition transcripts
`
`of the cross-examination of any reply witness to accompany Patent Owner’s
`
`Sur-reply.
`
`Patent Owner is free to respond to Petitioner’s arguments and
`
`purported new evidence in its Sur-reply and may reiterate such response at
`
`oral hearing. To the extent Petitioner presented new evidence in its Reply
`
`that may be deemed improper (see 37 C.F.R. § 42.23(b); CTPG 73–74), we
`
`will consider such arguments upon a completed record. However,
`
`introducing additional new evidence at this phase of the proceeding is not
`
`the proper recourse for Patent Owner. Accordingly, Patent Owner’s request
`
`to file a declaration with its Sur-reply is denied. See CTPG 73 (“The sur-
`
`reply may not be accompanied by new evidence.”).
`
`
`
`
`
`
`
`4
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`FOR PETITIONER:
`
`Elizabeth Weiswasser
`Anish Desai
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`christopher.pepe@weil.com
`
`
`
`For PATENT OWNER:
`
`Elizabeth Holland
`William James
`Linnea Cipriano
`Joshua Weinger
`
`Nicholas Mitrokostas
`GOODWIN PROCTER LLP
`eholland@goodwinprocter.com
`wjames@goodwinlaw.com
`lcipriano@goodwinlaw.com
`jweinger@goodwinprocter.com
`nmitrokostas@goodwinlaw.com
`
`
`5
`
`
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