Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 40
`
` Entered: January 6, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-002071
`Patent 9,517,219 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`ORDER
`Oral Hearing
`37 C.F.R. § 42.70
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this
`proceeding.
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 40
`
` Entered: January 6, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-002071
`Patent 9,517,219 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`ORDER
`Oral Hearing
`37 C.F.R. § 42.70
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this
`proceeding.
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`I.
`
`HEARING AND ATTENDANCE
`Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, of New
`York, LLC (collectively “Petitioner”) and Almirall, LLC (“Patent Owner”)
`have each requested an oral hearing for the above-captioned proceeding
`pursuant to 37 C.F.R. § 42.70. Papers 36 and 38. The requests are granted.
`Oral arguments will commence at 1:00 PM Eastern Time on February 7,
`2020, on the ninth floor of Madison Building East, 600 Dulany Street,
`Alexandria, Virginia.
`Each side will have sixty (60) minutes to present arguments.
`Petitioners will open the hearing by presenting their case. Patent Owner will
`then present their case. Next, Petitioner may use any time it has reserved for
`rebuttal to respond to Patent Owner’s arguments. Lastly, Patent Owner may
`use any time it has reserved for sur-rebuttal to respond to Petitioner’s
`arguments made during reply.
`The hearing will be open to the public for in-person attendance, which
`will be accommodated on a first-come-first-served basis. The parties are
`directed to contact the Board at least ten (10) days in advance of the hearing
`if there are any concerns about disclosing confidential information. The
`Board will provide a court reporter for the hearing, and the reporter’s
`transcript will constitute the official record of the hearing. Hearing room
`space is limited. To facilitate planning, each party must send an email
`message to PTABHearings@uspto.gov five (5) days prior to the hearing if
`the number planning to attend the hearing in-person for its side (attorneys
`and others) exceeds five (5) people.
`The Board expects lead counsel for each party to be present in person
`at the oral hearing. However, any counsel of record may present the party’s
`
`2
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`argument as long as that counsel is present in person. If either party expects
`that its lead counsel will not be attending the oral argument, the parties
`should initiate a joint telephone conference with the Board no later than two
`(2) business days prior to the oral hearing to discuss the matter.
`If necessary, a party may request that counsel be permitted to present
`arguments remotely from an alternative USPTO location. The available
`remote locations include the Texas Regional Office in Dallas, Texas; the
`Rocky Mountain Regional Office in Denver, Colorado; the Elijah J. McCoy
`Midwest Regional Office in Detroit, Michigan; and the Silicon Valley Office
`in San Jose, California. To request that counsel be permitted to present
`arguments from a remote location, a party should send an email message to
`PTABHearings@uspto.gov at least ten (10) business days, or as soon as
`practical, prior to the hearing and provide a short statement of reasons for
`the request. The Board will notify the parties if the request is approved.
`Approval of the request does not guarantee that a panel member will be
`present at the remote location.
`A party may also request remote video attendance for one or more of
`its other attendees to view the hearing from any USPTO location. To
`request remote video viewing, a party must send an email message to
`PTABHearings@uspto.gov ten (10) business days prior to the hearing,
`indicating the requested location and the number planning to view the
`hearing from the remote location. The Board will notify the parties if the
`request for video viewing is granted. Note that it may not be possible to
`grant the request due to the availability of resources.
`
`3
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`II. DEMONSTRATIVE EXHIBITS
`Under 37 C.F.R. § 42.70(b), demonstrative exhibits must be served at
`least seven (7) business days before the hearing. The parties also shall
`provide the demonstrative exhibits to the Board at least two (2) business
`days prior to the hearing by emailing them to Trials@uspto.gov. Despite the
`requirement in § 42.70(b) for parties to file demonstratives, the parties shall
`not file any demonstrative exhibits in this case without prior authorization
`from the Board. A hard copy of the demonstratives should be provided to
`the court reporter at the hearing.
`Demonstrative exhibits used at the oral hearing are aids to oral
`argument and not evidence, and should be clearly marked as such. For
`example, each slide of a demonstrative exhibit may be marked with the
`words “DEMONSTRATIVE EXHIBIT – NOT EVIDENCE” in the footer.
`Demonstrative exhibits cannot be used to advance arguments or introduce
`evidence not previously presented in the record. See Dell Inc. v. Acceleron,
`LLC, 884 F.3d 1364, 1369 (Fed. Cir. 2018) (noting that the “Board was
`obligated to dismiss [the petitioner’s] untimely argument . . . raised for the
`first time during oral argument”).
`The parties are directed to St. Jude Medical, Cardiology Division, Inc.
`v. The Board of Regents of the University of Michigan, IPR2013-00041,
`Paper 65 (PTAB Jan. 27, 2014), regarding the appropriate content of
`demonstrative exhibits. The Board expects that the parties will meet and
`confer in good faith to resolve any objections to demonstrative exhibits, but
`if such objections cannot be resolved the parties may file any objections to
`demonstratives with the Board at least two (2) business days before the
`hearing. The objections should identify with particularity which portions of
`
`4
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`the demonstrative exhibits are subject to objection, include a copy of the
`objected-to portions, and include a one-sentence statement of the reason for
`each objection. No argument or further explanation is permitted. The Board
`will consider any objections and schedule a conference call if deemed
`necessary. Otherwise, the Board will reserve ruling on the objections. Any
`objection to demonstrative exhibits that is not timely presented will be
`considered waived.
`The parties are also reminded that the presenter must clearly and
`specifically identify each demonstrative exhibit (e.g., by slide or screen
`number) referenced during the hearing to ensure the clarity and accuracy of
`the reporter’s transcript. The Board requests such identification for all
`exhibits discussed during oral argument in the interest of providing a clear
`record.
`Per the Office Patent Trial Practice Guide, either party may request a
`pre-hearing conference. See Office Patent Trial Practice Guide, 84 Fed.
`Reg. 64,280 (Nov. 21, 2019), which is available at the following link:
`https://www.uspto.gov/sites/default/files/documents/tpgnov.pdf?MURL=.
`Requests for a pre-hearing conference must be made by January 24, 2020.
`To request such a conference, an email should be sent to Trials@uspto.gov
`including several dates and times of availability for one or both parties, as
`appropriate, that are generally no later than three business days prior to the
`oral hearing. Please refer to the Trial Practice Guide for more information
`on the pre-hearing conference.
`We note the parties’ indications that each may use audio-visual
`equipment at oral argument. Any special requests for audio-visual
`equipment, or other specific technology requests, should be directed to
`
`5
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`Trials@uspto.gov. A party may also indicate any special requests related to
`appearing at an in-person oral hearing, such as a request to accommodate
`physical needs that limit mobility or 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 five
`(5) days before the hearing. If the request is not received timely, the
`equipment may not be available on the day of the hearing.
`
`
`
`6
`
`
`
`IPR2019-00207
`Patent 9,517,219 B2
`
`FOR PETITIONERS:
`
`Representing Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of
`New York, LLC
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`PTAB@skgf.com.
`
`Representing Mylan Pharmaceuticals Inc.
`
`Jitendra Malik, Ph.D.
`Alissa M. Pacchioli
`Lance Soderstrom
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`heike.radeke@kattenlaw.com
`
`
`FOR PATENT OWNER:
`
`James Trainor
`Richard J. Shea
`Elizabeth B. Hagan
`Jennifer R. Bush
`Fenwick & West LLP
`jtrainor@fenwick.com
`rshea@fenwick.com
`ehagan@fenwick.com
`jbush@fenwick.com
`
`
`7
`
`
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