Trials@uspto.gov
`571-272-7822
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`
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` Paper No. 70
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`
` Entered: November 17, 2016
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`ORDER
`Oral Hearing
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
` Paper No. 70
`
`
` Entered: November 17, 2016
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`STEADYMED LTD.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2016-00006
`Patent 8,497,393 B2
`____________
`
`
`
`Before LORA M. GREEN, JONI Y. CHANG, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`ORDER
`Oral Hearing
`37 C.F.R. § 42.70
`
`
`
`
`
`
`
`
`IPR2016-00006
`Patent 8,497,393 B2
`
`
`
`On April 8, 2016, we instituted the instant inter partes review
`(Paper 12), and issued a Scheduling Order (Paper 13), which set the date for
`oral hearing to November 29, 2016, if oral hearing is requested by either
`party and granted by the Board. Both parties request an oral hearing
`pursuant to 37 C.F.R. § 42.70. Papers 61 and 64. We grant those requests.
`The parties request a total of 90 minutes of oral argument time. Id.
`Upon review of the record, we agree that the parties’ requests are
`appropriate, and grant a total of 90 minutes of oral argument time, with a
`total of 45 minutes allocated to each side.
`Some information in the record of this trial has been sealed pending
`the outcome of the ruling on the parties’ Motions to Seal. Patent Owner
`requests that the hearing be closed to the public, and further, that any
`attendees from Petitioner’s side sign the Protective Order prior to the
`hearing. Paper 64, 3. We deny Patent Owner’s requests.
`There is a strong public policy interest in making all information
`presented in these proceedings public, as the review determines the
`patentability of claims in an issued patent and thus affects the rights of the
`public. Put differently, there is a strong public policy for making all
`information filed in an inter partes review in support of a substantive
`argument open to the public, so that a complete and understandable file
`history is maintained. The default rule is that all papers filed in an inter
`partes review will be open and available for access by the public; only
`“confidential information” may be protected from disclosure upon a showing
`of good case. See 35 U.S.C. §§ 316(a)(1), 316(a)(7); 37 C.F.R. §§ 42.14,
`
`2
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`IPR2016-00006
`Patent 8,497,393 B2
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`42.54(a). This policy is reflected in part in 35 U.S.C. § 316(a)(1), which
`provides that the file of any inter partes review shall be made available to
`the public, except that any petition or document filed with the intent that it
`be sealed, if accompanied by a motion to seal, shall be “provisionally sealed
`on receipt of the motion and remain so pending the outcome of the decision
`on motion.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760
`(Aug. 14, 2012).
`We have considered the strong public interest in making all aspects of
`the trial available to the public, while also considering the Patent Owner’s
`interest in protecting truly confidential information. See 37 C.F.R. §§ 42.14,
`42.54; Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,760. In this
`proceeding, for example, the public has a strong interest in knowing what
`evidence Patent Owner is relying on to establish that the process steps
`recited in the challenged claims impart structural or functional differences to
`the claimed product. We further note that should a final written decision
`rely upon any information in a sealed exhibit, such a sealed exhibit, in its
`entirety, will be unsealed and open to the public. In addition, any argument
`or information that the parties consider to be persuasive at the oral hearing
`also should be open to the public. At oral argument, each party should be
`mindful not to make public information that the other party has asserted in a
`motion to be confidential and has requested to be sealed. Rather, the parties
`may present their arguments without disclosing specifically any allegedly
`confidential information during oral argument. Accordingly, we make the
`
`3
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`
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`IPR2016-00006
`Patent 8,497,393 B2
`
`
`oral hearing publically available via in-person attendance, and the transcript
`of the oral hearing will be open to the public.
`The hearing will commence at 1:00 PM Eastern Time, on
`November 29, 2016, and will be conducted at the USPTO central
`headquarters located in Alexandria, Virginia. Each party will have
`45 minutes of total time to present its arguments. At the oral hearing,
`Petitioner will proceed first to present its case as to the challenged claims
`and instituted grounds of unpatentability. Thereafter, Patent Owner will
`respond to Petitioner’s case. After that, Petitioner will make use of the rest
`of its time responding to Patent Owner’s presentation on all matters.
`The hearing will be open to the public for in-person attendance at the
`USPTO central headquarters, the ninth floor of Madison Building East,
`600 Dulany Street, Alexandria, Virginia, 22314. In-person attendance 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.
`Under 37 C.F.R. § 42.70(b), demonstrative exhibits must be served no
`later than five business days before the hearing date. They shall be filed
`with the Board no later than three business days prior to the hearing date.
`Because the hearing will be open to the public, any demonstrative exhibits
`shall not contain any information alleged to be confidential by either party.
`The parties must initiate a conference call with the Board at least two
`business days prior to the hearing to resolve any dispute over the propriety
`of each party’s demonstrative exhibits. The parties are directed to St. Jude
`
`4
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`IPR2016-00006
`Patent 8,497,393 B2
`
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`Medical, Cardiology Division, Inc. v. The Board of Regents of the University
`of Michigan, Case IPR2013-00041 (PTAB Jan. 27, 2014) (Paper 65), for
`guidance regarding the appropriate content of demonstrative exhibits. See
`also CBS Interactive Inc. v. Helferich Patent Licensing, LLC, Case
`IPR2013-00033 (PTAB Oct. 23, 2013) (Paper 118) (The Board has the
`discretion to limit the parties’ demonstratives to pages in the record should
`there be no easy resolution to objections over demonstratives.).
`The Board expects lead counsel for each party to be present at oral
`hearing, although any backup counsel may make the actual presentation, in
`whole or in part. If lead counsel for either party is unable to attend the oral
`argument, the Board should be notified via a joint telephone conference call
`no later than two business days prior to the oral hearing to discuss the
`matter.
`Any requests regarding special equipment or needs, such as for audio
`visual equipment, should be directed to Trials@uspto.gov. Requests for
`audio-visual equipment are to be made at least five business days in advance
`of the hearing date. Judge Harlow (Denver) shall participate in the hearing
`remotely. If a demonstrative is not made available to the Board in the
`manner indicated above, that demonstrative may not be available to each of
`the judges during the hearing and may not be considered. Further, images
`projected, using audio visual equipment in Alexandria, will not be visible to
`Judge Harlow in Denver. Because of limitations on the audio transmission
`systems in our hearing rooms, the presenter may speak only when standing
`at the hearing room podium. The parties are reminded that the presenter
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`IPR2016-00006
`Patent 8,497,393 B2
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`must identify clearly and specifically 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. If the parties have questions as to
`whether demonstrative exhibits would be sufficiently visible and available to
`all of the judges, the parties are invited to contact the Board at
`(571) 272-9797.
`
`
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`6
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`IPR2016-00006
`Patent 8,497,393 B2
`
`
`PETITIONER:
`
`Stuart E. Pollack
`Lisa A. Haile
`DLA Piper LLP
`stuart.pollack@dlapiper.com
`lisa.haile@dlapiper.com
`steadymed-ipr@dlapiper.com
`
`PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`ut393-ipr@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ut393-ipr@foley.com
`
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`ut393-ipr@foley.com
`
`
`7
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`
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