`Tel: 571-272-7822
`
`
`Paper 144
`Entered: November 30, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`TEVA PHARMACEUTICALS USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`SAINT REGIS MOHAWK TRIBE and ALLERGAN, INC.,
`Patent Owners.
`____________
`
`Case IPR2016-01127 (8,685,930 B2); Case IPR2016-01128 (8,629,111 B2);
`Case IPR2016-01129 (8,642,556 B2); Case IPR2016-01130 (8,633,162 B2);
`Case IPR2016-01131 (8,648,048 B2); Case IPR2016-01132 (9,248,191 B2)1
`_______________
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`ORDER
`Rescheduling the Date for Oral Argument;
`Authorizing Supplemental Briefing
`37 C.F.R. § 42.5
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-
`00599, IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and
`IPR2017-00601, have respectively been joined with the captioned
`proceedings. This Order addresses issues that are the same in the identified
`cases. Paper numbers and exhibits cited in this Order refer to those
`documents filed in IPR2016-01127.
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`I.
`
`INTRODUCTION
`On November 20, 2018, the Court of Appeals for the Federal Circuit
`issued a mandate (Ex. 3004) in accordance with its judgment entered July
`20, 2018, thereby lifting the stay of these cases set forth in the Order from
`the Federal Circuit entered March 28, 2018 (Ex. 3003). We now advance
`these proceedings to oral hearing.
`This Order replaces previous orders scheduling oral argument for
`these proceedings. Papers 59 and 138. Oral argument for these cases is
`hereby rescheduled to January 11, 2019.
`
`A. Time and Format
`
`The hearing will commence at 1:00 PM Eastern Time on January
`11, 2019. The hearing will be open to the public, for in-person attendance,
`on the ninth floor of Madison Building East, 600 Dulany Street, Alexandria,
`Virginia. In-person attendance will be accommodated on a first come, first
`served basis.
`Petitioners will have a combined 60 minutes to present argument in
`these cases. Patent Owners will have 60 minutes to respond. Petitioners
`bear the ultimate burden of proof that Patent Owners’ claims at issue in these
`reviews are unpatentable. Therefore, Petitioners will open the hearing by
`presenting their case regarding the challenged claims for which the Board
`instituted trial. After Petitioners’ presentation, Patent Owners will respond
`to Petitioners’ argument. Petitioners may reserve rebuttal time to respond to
`arguments presented by Patent Owners. In accordance with the Board’s
`August 2018 Trial Practice Guide Update (“TPGU”), Patent Owner may
`reserve up to 5 minutes of time for sur-rebuttal.
`
` 2
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`The Board will provide a court reporter for the hearing and the
`reporter’s transcript will constitute the official record of the hearing. There
`will be only one transcript, which will be entered into each case. For the
`purposes of maintaining a clear record, however, the parties should clearly
`state whether certain arguments are applicable to all cases or whether the
`issue is limited to a particular case.
`The Trial Practice Guide Update provides an opportunity for the
`parties to request a pre-hearing conference. See TPGU 19 (“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 oral hearing, and to seek the
`Board’s guidance as to particular issues that the panel would like addressed
`by the parties.”). If either party desires a pre-hearing conference, the parties
`should jointly contact the Board at least seven business days before the
`hearing to request a conference call for that purpose.
`
`B. Supplemental Briefing
`On November 13, 2018, the Federal Circuit affirmed under Fed. Cir.
`R. 36 the district court’s decision invalidating a subset of the claims
`challenged in certain of these proceedings. Allergan, Inc. v. Teva Pharms.
`USA, Inc., No. 2018-1130 (Fed. Cir. Nov. 13, 2018) (“District Court Case”).
`The panel is interested in receiving supplemental briefing from the parties on
`the impact of the Federal Circuit’s Rule 36 affirmance on the patentability
`issues in these proceedings. In particular, the panel is interested in what
`preclusive effect the District Court Case has on our proceedings.
`Petitioners’ supplemental brief on these issues shall be limited to fifteen (15)
`pages and due no later than December 7, 2018. Patent Owners’
`
` 3
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`supplemental brief on these issues shall also be limited to fifteen (15) pages
`and due no later than December 14, 2018. No further briefing is authorized
`at this time.
`As an alternative, we authorize the parties to file, within one week of
`the date of this Order, a joint motion to limit the petition(s) to claims not
`determined to be invalid in the District Court Case in the applicable
`proceedings.
`The oral hearing shall be limited to the issues authorized in this
`supplemental briefing request and the arguments and evidence of record.
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14,
`2012). Any new arguments or evidence will not be considered.
`
`C. Demonstratives
`
`As set forth in 37 C.F.R. § 42.70(b), demonstrative exhibits shall be
`served on opposing counsel at least seven business days before the hearing.
`However, in regard to filing demonstrative exhibits, and in contrast to what
`is expressly stated in § 42.70(b), the parties shall file the demonstrative
`exhibits no later than two business days before the hearing, to allow the
`panel sufficient time to review the materials.
`The panel reminds the parties that demonstrative exhibits are not
`evidence, but are intended to assist the parties in presenting their oral
`arguments to the Board. The panel will distinguish evidence in the record
`from argument appearing in demonstrative exhibits, and all arguments must
`be supported by evidence already of record. The panel also reminds the
`parties that demonstrative exhibits are not a mechanism for making
`
` 4
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`arguments not previously addressed in the Papers. The panel will not
`consider arguments or evidence appearing only in demonstrative exhibits.
`Due to the nature of the panel’s consideration of demonstrative
`exhibits, the panel does not anticipate that objections to such exhibits would
`likely be sustained. Nevertheless, to the extent that the parties object to the
`propriety of any demonstrative exhibit, we expect that the parties will meet
`and confer in good faith to resolve any objections to demonstrative exhibits.
`If such objections cannot be resolved, the parties may file any objections to
`demonstratives with the Board at least two business days before the hearing.
`The objections should identify with particularity which portions of 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. We will
`consider any objections and schedule a conference call if deemed necessary.
`Otherwise, we will reserve ruling on the objections. Any objection to
`demonstrative exhibits that is not timely presented will be considered
`waived.
`Finally, the parties are reminded that each presenter 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 and for the benefit of the judge(s) who will be
`participating electronically from USPTO Regional Offices.
`
`D. Lead Counsel
`
`The Board expects lead counsel for each party to be present at the oral
`hearing, although any backup counsel may present the party’s argument. If
`
` 5
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`either lead counsel is unable to be present at the hearing, the Board shall be
`advised by email no later than two (2) business days prior to the oral
`hearing, and such lead counsel shall be available for a conference call if
`necessary.
`
`E. Audio/Visual Equipment Requests
`
`Questions regarding specific audio-visual equipment should be
`directed to the Board at (571) 272-9797. Requests for audio-visual
`equipment are to be made 5 days in advance of the hearing date. The
`request is to be sent to Trials@uspto.gov. If the request is not received
`timely, the equipment may not be available on the day of the hearing.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 6
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`PETITIONER MYLAN:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Richard Torczon
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`rtorczon@wsgr.com
`
`PETITIONER TEVA:
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURH,
`LINDQUIST & SCHUMAN, P.A.
`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`
`
`PATENT OWNERS:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Coletti
`Robert Oakes
`Jonathan Singer
`FISH & RICHARDSON P.C.
`whelan@fr.com
`coletti@fr.com
`oakes@fr.com
`singer@fr.com
`PTABInbound@fr.com
`
`
`
`
` 7
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`Alfonso Chan
`Michael Shore
`Joseph DePumpo
`Christopher Evans
`Marsha Schmidt
`SHORE CHAN DEPUMPO LLP
`achan@shorechan.com
`mshore@shorechan.com
`jdepumpo@shorechan.com
`cevans@shorechan.com
`marsha@mkschmidtlaw.com
`
`
` 8
`
`
`
`
`
`