Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
` Paper 72
`Entered: July 15, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and APOTEX,
`INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`
`
`
` IPR2021-00880 (Patent 9,669,069 B2)1
` IPR2021-00881 (Patent 9,254,338 B2)2
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`PER CURIAM.
`
`
`ORDER3
`Granting Requests for Oral Hearing
`37 C.F.R. § 42.70
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding.
`2 IPR2022-00258 and IPR2022-00298 have been joined with this
`proceeding.
`3 The combined caption is for administrative convenience only and does not
`indicate that IPR2021-00880 and IPR2021-00881 have been joined
`together. The parties are not authorized to use this caption without express
`permission of the Board.
`
`
`Tel: 571-272-7822
`
`
`
`
` Paper 72
`Entered: July 15, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and APOTEX,
`INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`
`
`
` IPR2021-00880 (Patent 9,669,069 B2)1
` IPR2021-00881 (Patent 9,254,338 B2)2
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`
`PER CURIAM.
`
`
`ORDER3
`Granting Requests for Oral Hearing
`37 C.F.R. § 42.70
`
`
`1 IPR2022-00257 and IPR2022-00301 have been joined with this
`proceeding.
`2 IPR2022-00258 and IPR2022-00298 have been joined with this
`proceeding.
`3 The combined caption is for administrative convenience only and does not
`indicate that IPR2021-00880 and IPR2021-00881 have been joined
`together. The parties are not authorized to use this caption without express
`permission of the Board.
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`
`We instituted inter partes review on November 10, 2021. Paper 21.4
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) and Regeneron Pharmaceuticals,
`
`Inc. (“Patent Owner”) have separately requested an in-person oral hearing
`
`pursuant to 37 C.F.R. § 42.70(a). See Papers 69, 70, respectively. The
`
`requests are GRANTED, as specified in this Order.
`
`The hearing will be conducted in-person on August 10, 2022, in
`
`Hearing Room B, on the ninth floor of Madison Building East, 600 Dulany
`
`Street, Alexandria, Virginia at 2:00 PM EDT. The hearing will be open to
`
`the public for in-person attendance, which will be accommodated on a first
`
`come, first served basis. The Board will provide a court reporter for the
`
`hearing, and the reporter’s transcript will constitute the official record of the
`
`hearing. At the parties’ request, video attendance by in-house counsel and
`
`other non-arguing attorneys will also be accommodated.
`
`To facilitate planning, each party must contact PTAB Hearings at
`
`PTABHearings@uspto.gov no later than three (3) business days prior to the
`
`date of the oral hearing to receive any video set-up information. As a
`
`reminder, all arrangements and expenses involved with appearing by video,
`
`such as the selection of the facility from which a party will attend by video,
`
`must be borne by that party. If a video connection cannot be established, the
`
`parties will be provided with dial-in connection information. Should a party
`
`prefer to participate in the oral hearing telephonically, they should notify
`
`
`4 Papers cited in this Order are those filed in IPR2021-00880. Unless
`otherwise noted, corresponding papers have also been filed in IPR2021-
`00881.
`
`
`
`2
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`PTAB Hearings at the above email address three (3) business days prior to
`
`the hearing to receive dial-in connection information.
`
`At the hearing, the Board will consider arguments concerning the two
`
`cases together. Each party will have a total of sixty (60) minutes to present
`
`its case. Petitioner bears the ultimate burden of demonstrating that the
`
`claims as challenged in the petition and proposed in the revised motion to
`
`amend are unpatentable. Thus, Petitioner will open the hearing by
`
`presenting its case regarding the unpatentability of both the challenged
`
`claims and the proposed substitute claims. Patent Owner will follow with its
`
`response to Petitioner’s presentation. Petitioner may reserve rebuttal time
`
`(of no more than half their total presentation time) to reply to Patent
`
`Owner’s arguments. Likewise, Patent Owner may reserve sur-rebuttal time
`
`(of no more than half its total presentation time) to reply to Petitioner’s
`
`rebuttal. See Office Consolidated Trial Practice Guide, November 2019
`
`Edition, 83, available at
`
`https://www.uspto.gov/TrialPracticeGuideConsolidated; see also 84 Fed.
`
`Reg. 64,280 (Nov. 21, 2019). A party may only present argument and
`
`evidence at the hearing for which a proper foundation exists in the record.
`
`Unless ordered otherwise, the parties are to refrain from disclosing
`
`any confidential information during the hearing or including any confidential
`
`information in a demonstrative exhibit. We note that a Protective Order has
`
`been entered in these proceedings (see Paper 71) and certain evidence has
`
`been filed under seal pursuant thereto. If protected material is intended to
`
`be discussed at the oral hearing, the parties are instructed to (1) meet and
`
`confer with respect to the use or discussion of such material at the oral
`
`
`
`3
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`hearing, and (2) contact the Board at least three (3) business days before the
`
`hearing to discuss the matter.5
`
`At least three (3) business days prior to the hearing, each party shall
`
`serve on the other party any demonstrative exhibits it intends to use during
`
`the hearing. See 37 C.F.R. § 42.70(b). Demonstrative exhibits are not
`
`evidence and may not introduce new evidence or arguments. Demonstrative
`
`exhibits should be clearly marked as such. At least three (3) business days
`
`before the hearing, the parties must submit a copy of any demonstrative
`
`exhibits to the Board by filing them as an exhibit. Any demonstrative
`
`exhibit not served on a party or filed with the Board may not be used during
`
`the hearing.
`
`The parties must meet and confer in good faith to resolve any
`
`objections to the propriety of any demonstrative exhibit. Any objection that
`
`is not timely presented will be deemed waived. If any objections to
`
`demonstrative exhibits cannot be resolved, the objecting party may file a
`
`statement of objections with the Board at least two (2) business days before
`
`the hearing. The statement of objections should identify with particularity
`
`each demonstrative exhibit subject to objection and include a brief statement
`
`(no more than a few sentences) of the reason for such objection. No
`
`
`5 We note that we have granted Petitioner’s request that its Lead Counsel be
`relieved of any requirement to attend Oral Argument. Petitioner represents
`that it expects that its designated Backup Counsel will attend in person to
`make arguments for Petitioner.
`
`
`
`4
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`argument or further explanation is permitted. Nor is a party permitted to file
`
`a response to the statement of objections.
`
`The Board will consider the statement of objections and schedule a
`
`conference call if necessary. Otherwise, the Board will reserve ruling on the
`
`objections until the time of the hearing. The parties are advised to limit
`
`objections to demonstrative exhibits to egregious violations that are
`
`prejudicial to the administration of justice. Generally, if the content of a
`
`slide cannot be readily associated with an argument made or evidence
`
`referenced in a substantive paper of record, the slide is inappropriate.
`
`Conversely, if the content of a slide can be readily associated with an
`
`argument made or evidence referenced in a substantive paper, it is proper.
`
`Ideally, parties should indicate on each slide where support may be found in
`
`a substantive paper and/or exhibit of record.
`
`During the hearing, counsel must identify clearly and specifically each
`
`demonstrative exhibit (e.g., by slide or screen number) referenced to ensure
`
`clarity and accuracy of the transcript. The parties may only rely upon
`
`evidence that has been previously submitted in the proceeding and may only
`
`present arguments that have been previously made in the submitted papers.
`
`No new evidence or arguments may be presented at the hearing. Nor will
`
`live testimony be permitted at the hearing.
`
`Either party may request a prehearing conference. See Office
`
`Consolidated Trial Practice Guide, 82. The request for a prehearing
`
`conference must be made by July 27, 2022. To request such a conference,
`
`an email should be sent to Trials@uspto.gov, and propose several dates and
`
`
`
`5
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`times of availability for both parties, as appropriate, that are no later than
`
`three (3) business days prior to the oral hearing.
`
`The Board expects lead counsel for each party to be present in person
`
`at the hearing. Any counsel of record, however, may present the party’s
`
`argument. If either party expects that its lead counsel will not be attending
`
`the hearing, the parties should initiate a joint conference call with the Board
`
`no later than three (3) business days prior to the hearing to discuss the
`
`matter.
`
`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 oral hearing, such as a request to
`
`accommodate visual or hearing impairments, and indicate how the PTAB
`
`may accommodate the special request. Any special requests must be
`
`presented in a separate communication not less than three (3) days before the
`
`hearing.
`
`The panel will have access to all papers filed with the Board,
`
`including demonstratives. During the oral hearing, the parties are advised to
`
`remain muted and unmute yourself only when speaking, and identify clearly
`
`and specifically each demonstrative (e.g., by slide or screen number), paper,
`
`and exhibit referenced to ensure the clarity and accuracy of the court
`
`reporter’s transcript. In addition, the parties are advised to identify
`
`themselves each time they speak. Furthermore, the remote nature of the oral
`
`hearing may also result in an audio lag, and so the parties are advised to
`
`observe a pause prior to speaking, so as to avoid speaking over others.
`
`Members of the public may request to listen in on this oral hearing. If
`
`resources are available, the Board generally expects to grant such requests.
`
`
`
`6
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`If either party objects to the Board granting such requests, for example,
`
`because confidential information may be discussed, the party must notify the
`
`Board by contacting PTABHearings@uspto.gov at least three (3) business
`
`days prior to the oral hearing date.
`
`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.
`
`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 three (3) business days before the oral hearing, by email to the Board
`
`at PTABHearings@uspto.gov.
`
`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. 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
`
`
`
`7
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`Board does not draw any inference about the importance of a particular issue
`
`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.
`
`In instances where an advocate does not meet the LEAP eligibility
`
`requirements due to the number of “substantive” oral hearing arguments, but
`
`nonetheless has a basis for considering themselves to be in the category of
`
`advocates that this program is intended to assist, the Board encourages
`
`argument by such advocates during oral hearings. Even though additional
`
`argument time will not be provided when the advocate does not qualify for
`
`LEAP, a party may share argument time among counsel and the Board will
`
`permit the more experienced counsel to provide some assistance, if
`
`necessary, during oral argument, and to clarify any statements on the record
`
`before the conclusion of the oral argument.
`
`
`
`It is hereby
`
`ORDERED that, subject to the procedures set forth above, the parties’
`
`request for an oral hearing is granted; and
`
`FURTHER ORDERED that an oral hearing, conducted in accordance
`
`with the procedures set forth above, shall commence at 2:00 PM ET on
`
`August 10, 2022.
`
`
`
`
`
`8
`
`
`
`IPR2021-00880 (Patent 9,669,069 B2)
`IPR2021-00881 (Patent 9,254,338 B2)
`
`
`PETITIONER:
`
`Paul Molino
`William Rakoczy
`Neil McLaughlin
`Heinz Salmen
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`paul@rmmslegal.com
`wrakoczy@rmmslegal.com
`nmclaughlin@rmmslegal.com
`hsalmen@rmmslegal.com
`
`Teresa Rea
`Deborah Yellin
`Shannon Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`slentz@crowell.com
`
`Lora Green
`Yahn-Lin Chu
`WILSON SONSINI GOODRICH & ROSATI
`lgreen@wsgr.com
`ychu@wsgr.com
`
`PATENT OWNER:
`
`Deborah Fishman
`Amanda Antons
`Alice Sin Yu Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`deborah.fishman@kayescholer.com
`amanda.antons@arnoldporter.com
`alice.ho@arnoldporter.com
`
`
`
`9
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
