Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 99
`Entered: June 27, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY 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
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 99
`Entered: June 27, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY 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
`Setting Oral Argument
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`
`I. ORAL ARGUMENT
`
`A. Time and Format1
`Oral arguments will commence at 11:30 AM ET, on Thursday, July
`21, 2022, at USPTO Headquarters in Alexandria, Virginia. 2 The Board will
`provide a court reporter for the hearing, and the reporter’s transcript will
`constitute the official record of the hearing. 3
`Petitioner will have a total of forty-five (45) minutes to present
`argument in this case and Patent Owner will have a total of forty-five (45)
`minutes to respond. Petitioner will open the hearing by presenting its case
`regarding the challenged claims for which the Board instituted trial. 4
`Thereafter, Patent Owner will respond to Petitioner’s argument. Petitioner
`may reserve rebuttal time to respond to arguments presented by Patent
`
`
`1 If a party is no longer able to appear in-person for the hearing, the party
`must contact PTABHearings@uspto.gov as soon as possible.
`2 The U.S. Patent and Trademark Office (“USPTO”) is concerned with the
`health and safety of all of its stakeholders, and will continue to follow all
`applicable health guidance. Prior to arriving at any USPTO office location,
`please consult the following to verify entry requirements:
`https://www.uspto.gov/coronavirus.
`3 If there are any concerns about disclosing confidential information, the
`parties must contact the Board at Trials@uspto.gov at least ten (10) business
`days before the hearing date.
`4 On May 26, 2022, Patent Owner filed a “Notice of Withdrawal of Its
`Contingent Motion to Amend,” which states “[p]ursuant to the
`Board’s Pilot Program Concerning Motion to Amend Practice and
`Procedures . . . Patent Owner hereby withdraws its Contingent Motion to
`Amend [Paper 37].” Paper 89, 1. Accordingly, the oral hearing will not
`address any issues raised only in the withdrawn Contingent Motion to
`Amend.
`
`2
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`Owner. In accordance with the Consolidated Trial Practice Guide5
`(“CTPG”), issued in November 2019, Patent Owner may request to reserve
`time for a brief sur-rebuttal. See CTPG 83.
`The parties may request a pre-hearing conference in advance of the
`hearing. See id. at 82. “The purpose of the pre-hearing conference is to
`afford the parties the opportunity to preview (but not argue) the issues to be
`discussed at the hearing, and to seek the Board’s guidance as to particular
`issues that the panel would like addressed by the parties.” Id. If either party
`desires a pre-hearing conference, the parties should jointly contact the Board
`at Trials@uspto.gov at least seven (7) business days before the hearing date
`to request a conference call for that purpose.
`
`B. Demonstratives
`As set forth in 37 C.F.R. § 42.70(b), demonstratives shall be served on
`opposing counsel at least seven (7) business days before the hearing date and
`emailed to the Board at least two business days prior to the day of the
`hearing (July 19). 6
`Demonstratives are not a mechanism for making new arguments.
`Demonstratives also are not evidence, and will not be relied upon as
`evidence. Rather, demonstratives are visual aids to a party’s oral
`presentation regarding arguments and evidence previously presented and
`discussed in the papers. Accordingly, demonstratives shall be clearly
`
`
`5 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
`6 The parties may stipulate to an alternative schedule for serving and filing
`demonstratives, and request that the Board modify the schedule for filing
`and serving demonstratives at least seven (7) business days before the
`hearing date.
`
`3
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`marked with the words “DEMONSTRATIVE EXHIBIT – NOT
`EVIDENCE” in the footer. See Dell Inc. v. Acceleron, LLC, 884 F.3d 1364,
`1369 (Fed. Cir. 2018) (holding that the Board is obligated under its own
`regulations to dismiss untimely argument “raised for the first time during
`oral argument”). “[N]o new evidence may be presented at the oral
`argument.” CTPG 85; see also St. Jude Med., Cardiology Div., Inc. v. The
`Bd. of Regents of the Univ. of Mich., IPR2013-00041, Paper 65, 2–3 (PTAB
`Jan. 27, 2014) (explaining that “new” evidence includes evidence already of
`record but not previously discussed in any paper of record).
`Furthermore, because of the strict prohibition against the presentation
`of new evidence or arguments at a hearing, it is strongly recommended that
`each demonstrative include a citation to a paper in the record, which allows
`the Board to easily ascertain whether a given demonstrative contains “new”
`argument or evidence or, instead, contains only that which is developed in
`the existing record.
`Due to the nature of the Board’s consideration of demonstratives and
`the opportunity afforded for the parties to reach an agreement without
`involving the Board, the Board does not anticipate that objections to
`demonstratives are likely to be sustained. Nevertheless, to the extent that a
`party objects to the propriety of any demonstrative, the parties shall meet
`and confer in good faith to resolve any objections to demonstratives prior to
`filing the objections with the Board. If such objections cannot be resolved,
`the parties may file any objections to demonstratives with the Board no later
`than two days before the hearing. The objections shall identify with
`particularity which portions of the demonstratives are subject to objection
`(and should include a copy of the objected-to portions) and include a one (1)
`
`4
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`sentence statement of the reason for each objection. No argument or further
`explanation is permitted. The Board will consider any objections, and may
`reserve ruling on the objections. 7 Any objection to demonstratives that is
`not timely presented will be considered waived.
`Finally, the parties are reminded that each presenter should identify
`clearly and specifically each paper (e.g., by slide or screen number for a
`demonstrative) referenced during the hearing to ensure the clarity and
`accuracy of the court reporter’s transcript and for the benefit of all
`participants appearing electronically.
`
`C. Presenting Counsel
`The Board generally expects lead counsel for each party to be present
`at the hearing. See CTPG 11. Any counsel of record may present the
`party’s argument as long as that counsel is present in person.
`
`D. Remote Attendance Requests
`Members of the public may request to listen to and/or view this
`hearing. If resources are available, the Board generally expects to grant such
`requests. If either party objects to the Board granting such requests, for
`example, because confidential information may be discussed, the party must
`notify the Board at PTABHearings@uspto.gov at least ten (10) business
`days prior to the hearing date.
`The parties have requested that the option be made available for
`representatives (in-house counsel) to attend the hearing virtually, either by
`video or telephone. This request is granted. Each party should contact the
`
`
`7 If time permits, the Board may schedule a conference call with the parties
`to discuss any filed objections.
`
`5
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`PTAB hearings team at least seven (7) days prior to the hearing to determine
`the requirements for accessing the hearing remotely.
`
`E. Audio/Visual Equipment Requests
`Any special requests for audio-visual equipment should be directed to
`PTABHearings@uspto.gov. A party may also indicate any special requests
`related to appearing at a video hearing, such as a request to accommodate
`deaf or hard-of-hearing individuals and blind or low vision individuals, and
`indicate how the PTAB may accommodate the special request. Any special
`requests must be presented in a separate communication at least five (5)
`business days before the hearing date.
`Counsel has requested permission to have laptops in the hearing room
`and at the counsel table. This request is granted. Please ensure laptops are
`in silent mode during the hearing and decorum is maintained with the
`content displayed.
`
`F. Legal Experience and Advancement Program
`The Board has established the “Legal Experience and Advancement
`Program,” or “LEAP,” to encourage advocates with less legal experience to
`argue before the Board to develop their skills. The Board defines a LEAP
`practitioner as a patent agent or attorney having three (3) or fewer
`substantive oral arguments in any federal tribunal, including PTAB. 8
`
`
`8 Whether an argument is “substantive” for purposes of determining whether
`an advocate qualifies as a LEAP practitioner will be made on a case-by-case
`basis with considerations to include, for example, the amount of time that
`the practitioner argued, the circumstances of the argument, and whether the
`argument concerned the merits or ancillary issues.
`6
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`
`The parties are encouraged to participate in the Board’s LEAP
`program. Either party may request that a qualifying LEAP practitioner
`participate in the program and conduct at least a portion of the party’s oral
`argument. The Board will grant up to fifteen (15) minutes of additional
`argument time to that party, depending on the length of the proceeding and
`the PTAB’s hearing schedule. A party should submit a request, no later than
`at least five (5) business days before the oral hearing, by email to the Board
`at PTABHearings@uspto.gov. 9
`The LEAP practitioner may conduct the entire oral argument or may
`share time with other counsel, provided that the LEAP practitioner is offered
`a meaningful and substantive opportunity to argue before the Board. The
`party has the discretion as to the type and quantity of oral argument that will
`be conducted by the LEAP practitioner. 10 Moreover, whether the LEAP
`practitioner conducts the argument in whole or in part, the Board will permit
`more experienced counsel to provide some assistance to the LEAP
`practitioner, if necessary, during oral argument, and to clarify any statements
`on the record before the conclusion of the oral argument. Importantly, the
`Board does not draw any inference about the importance of a particular issue
`
`
`9 Additionally, a LEAP Verification Form shall be submitted by the LEAP
`practitioner, confirming eligibility for the program. A combined LEAP
`Practitioner Request for Oral Hearing Participation and Verification Form is
`available on the LEAP website, www.uspto.gov/leap.
`10 Examples of the issues that a LEAP practitioner may argue include claim
`construction argument(s), motion(s) to exclude evidence, or patentability
`argument(s) including, e.g., analyses of prior art or objective indicia of non-
`obviousness.
`
`7
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`or issues, or the merits of the party’s arguments regarding that issue, from
`the party’s decision to have (or not to have) a LEAP practitioner argue.
`All practitioners appearing before the Board shall demonstrate the
`highest professional standards. All practitioners are expected to have a
`command of the factual record, the applicable law, and Board procedures, as
`well as the authority to commit the party they represent.
`
`II. ORDER
`
`Accordingly, it is
`ORDERED that oral argument for this proceeding shall commence at
`11:30 AM ET, on Thursday, July 21, 2022, at USPTO Headquarters in
`Alexandria, Virginia, and proceed in the manner set forth herein.
`
`
`
`8
`
`
`
`IPR2021-00816
`Patent 9,220,631 B2
`
`FOR PETITIONER:
`
`Anish Desai
`Elizabeth Weiswasser
`Christopher Pepe
`WEIL, GOTSHAL & MANGES LLP
`anish.desai@weil.com
`elizabeth.weiswasser@weil.com
`christopher.pepe@weil.com
`
`
`For PATENT OWNER:
`
`Elizabeth Holland
`Nicholas Mitrokostas
`William G. James
`ALLEN & OVERY LLP
`elizabeth.holland@allenovery.com
`nicholas.mitrokostas@allenovery.com
`william.james@allenovery.com
`
`
`Linnea Cipriano
`Duncan Greenhalgh
`Joshua Weinger
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinprocter.com
`
`
`9
`
`
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