Trials@uspto.gov
`571-272-7822
`
`Paper 10
`Entered: February 27, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEPTUNE GENERICS, LLC,1
`Petitioner,
`v.
`ELI LILLY & COMPANY,
`Patent Owner.
`
`SANDOZ INC.,2
`Petitioner,
`v.
`ELI LILLY & COMPANY,
`Patent Owner
`____________
`Cases IPR2016-00237,3 IPR2016-00240,4 IPR2016-003185
`Patent 7,772,209 B2
`____________
`
`1 Neptune Generics is the first named Petitioner in both IPR2016-00237 and
`IPR2016-00240. Apotex, Inc., Apotex Corp., Teva Pharmaceuticals,
`Fresnius Kabi USA, LLC, and Wockhardt Bio AG are the remaining
`Petitioners in both IPR2016-00237 and IPR2016-00240.
`
`2 Sandoz is the first named Petitioner in IPR2016-00318. Apotex, Inc.,
`Apotex Corp., Emcure Pharmaceuticals, Ltd., Heritage Pharma Labs Inc.,
`Heritage Pharmaceuticals Inc., Glenmark Pharmaceuticals, Inc., USA,
`Glenmark Holding SA, Glenmark Pharmaceuticals, Ltd., Mylan
`Laboratories Limited, Teva Pharmaceuticals, Fresnius Kabi USA, LLC, and
`Wockhardt Bio AG are the remaining Petitioners.
`3 Cases IPR2016-01190, IPR2016-01335, and IPR2016-01341 have been
`joined with IPR2016-00237.
`
`4 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been
`joined with IPR2016-00240.
`
`5 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been
`joined with IPR2016-00318.
`
`
`571-272-7822
`
`Paper 10
`Entered: February 27, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEPTUNE GENERICS, LLC,1
`Petitioner,
`v.
`ELI LILLY & COMPANY,
`Patent Owner.
`
`SANDOZ INC.,2
`Petitioner,
`v.
`ELI LILLY & COMPANY,
`Patent Owner
`____________
`Cases IPR2016-00237,3 IPR2016-00240,4 IPR2016-003185
`Patent 7,772,209 B2
`____________
`
`1 Neptune Generics is the first named Petitioner in both IPR2016-00237 and
`IPR2016-00240. Apotex, Inc., Apotex Corp., Teva Pharmaceuticals,
`Fresnius Kabi USA, LLC, and Wockhardt Bio AG are the remaining
`Petitioners in both IPR2016-00237 and IPR2016-00240.
`
`2 Sandoz is the first named Petitioner in IPR2016-00318. Apotex, Inc.,
`Apotex Corp., Emcure Pharmaceuticals, Ltd., Heritage Pharma Labs Inc.,
`Heritage Pharmaceuticals Inc., Glenmark Pharmaceuticals, Inc., USA,
`Glenmark Holding SA, Glenmark Pharmaceuticals, Ltd., Mylan
`Laboratories Limited, Teva Pharmaceuticals, Fresnius Kabi USA, LLC, and
`Wockhardt Bio AG are the remaining Petitioners.
`3 Cases IPR2016-01190, IPR2016-01335, and IPR2016-01341 have been
`joined with IPR2016-00237.
`
`4 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been
`joined with IPR2016-00240.
`
`5 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been
`joined with IPR2016-00318.
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`Patent 7,772,209 B2
`
`Before JACQUELINE WRIGHT BONILLA and MICHAEL P. TIERNEY,
`Vice Chief Administrative Patent Judges, LORA M. GREEN, Administrative
`Patent Judge.
`
`GREEN, Administrative Patent Judge.
`
`
`ORDER
`Oral Hearing
`37 C.F.R. § 42.70
`
`The Revised Scheduling Order in these three proceedings initially set
`
`oral hearing for March 7, 2017. All parties requested an oral hearing
`
`pursuant to 37 C.F.R. § 42.70(a). In an email dated February 14, 2017, we
`
`asked if counsel would be available for a hearing the morning of
`
`March 16, 2017. Shortly thereafter, counsel for both parties informed us via
`
`email that they were available. Accordingly, the parties’ request for oral
`
`hearing is granted.
`
`The hearing will commence at 9:30 AM Eastern Time, on
`
`MARCH 16, 2017, and will be conducted at the USPTO Central
`
`Headquarters located in Alexandria, Virginia (the ninth floor of Madison
`
`Building East, 600 Dulany Street, Alexandria, Virginia, 22314). The
`
`hearing will be open to the public for in-person attendance that will be
`
`accommodated on a first-come first-serve basis.
`
`Patent Owner, and Petitioners collectively, will each have 90 minutes
`
`of total time to present their arguments. Because Petitioners bear the
`
`ultimate burden of proof that the challenged claims are unpatentable,
`
`Petitioners will proceed first to present their case regarding the challenged
`
`claims and ground for which the Board instituted trial. Patent Owner will
`
`then respond to Petitioners’ arguments. Petitioners may reserve time to
`
`2
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`Patent 7,772,209 B2
`
`respond to arguments presented by Patent Owner. Patent Owner may not
`
`reserve time.
`
`The hearing will address three separate proceedings challenging the
`
`same patent. Thus, the parties must meet and confer and come to a decision
`
`as to how they would like the hearing to proceed. For example, the parties
`
`may choose to address all the issues in all cases together. In that situation,
`
`Petitioners collectively will have 90 minutes for their presentations, and
`
`Patent Owner will have 90 minutes for its presentation. In the alternative,
`
`the parties may choose to address the cases sequentially. For example, the
`
`parties may choose to address the issues in IPR2016-00237 and 2013-00240
`
`together, with 50 minutes of Petitioners’ 90 minute time allotted to that
`
`argument, and then address the issues in IPR2016-00318, with 40 minutes of
`
`Petitioner’s 90 minute time allotted to that argument. Patent Owner could
`
`allot its 90 minutes how it then wishes between the two arguments. The
`
`parties must inform the Board by email how they plan to divide the allotted
`
`time between the three proceeding at least two days before oral argument,
`
`that is, no later than close of business on March 14, 2017.
`
`The Board expects lead counsel for each party to be present in person
`
`at the oral hearing. Lead or backup counsel, however, may present the
`
`party’s argument. If any party anticipates that its lead counsel will not be
`
`attending the oral argument, the parties should request a joint telephone
`
`conference with the Board no later than (2) two business days prior to the
`
`oral hearing to discuss the matter.
`
`The Board will provide a court reporter for the oral argument and the
`
`reporter’s transcript will constitute the official record of the oral argument.
`
`The hearing transcript will be entered in the record of this proceeding.
`
`3
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`Patent 7,772,209 B2
`
`
`Under 37 C.F.R. § 42.70(b), demonstrative exhibits must be served at
`
`least (7) seven business days before the hearing date and filed no later than
`
`the time of the oral argument. The parties also shall provide a courtesy copy
`
`of any demonstrative exhibits to the Board at least (3) three business days
`
`prior to the hearing by emailing them to Trials@uspto.gov.
`
`Demonstrative exhibits are not evidence, but merely a visual aid at the
`
`oral arguments. Demonstrative exhibits may not introduce new evidence or
`
`raise new arguments, but instead, should cite to evidence in the record. The
`
`parties are directed to St. Jude Medical, Cardiology Division, Inc. v. The
`
`Board of Regents of the University of Michigan, Case IPR2013-00041
`
`(PTAB Jan. 27, 2014) (Paper 65) and CBS Interactive Inc. v. Helferich
`
`Patent Licensing, LLC, Case IPR2013-00033 (PTAB Oct. 23, 2013)
`
`(Paper 118) for guidance regarding the appropriate content of demonstrative
`
`exhibits.
`
`The Board requests that the parties attempt to resolve any objections
`
`to the demonstratives, and if any objections cannot be resolved, the parties
`
`must file any such objections with the Board at least (2) two business days
`
`before the hearing. Any objection to demonstrative exhibits that is not
`
`timely presented will be considered waived. The objections should identify
`
`with particularity which demonstratives are subject to objection, and include
`
`a short (one sentence or less) statement of the reason for each objection. No
`
`argument or further explanation is permitted. The Board will consider the
`
`objections and schedule a conference if deemed necessary. Otherwise, the
`
`Board will rule on the objections at the hearing.
`
`To aid in the preparation of an accurate transcript, each party shall
`
`provide a paper copy of any demonstratives to the court reporter on the day
`
`4
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`Patent 7,772,209 B2
`
`of the oral arguments. Such paper copies shall not become part of the record
`
`of this proceeding. The parties are reminded that the 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.
`
`Requests for audio-visual equipment are to be made (5) five 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.
`
`
`
`
`
`5
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`Patent 7,772,209 B2
`
`PETITIONER:
`
`Sarah Spires
`237Neptune@skiermontderby.com
`
`Parvathi Kota
`237Neptune@skiermontderby.com
`
`Ralph Gabric
`rgabric@brinksgilson.com
`
`Bryan Richardson
`brichardson@brinksgilson.com
`
`Joshua James
`jjames@brinksgilson.com
`
`Laura Lydigsen
`llydigsen@brinksgilson.com
`
`
`PATENT OWNER:
`
`Dov Grossman
`dgrossman@wc.com
`
`David Krinsky
`dkrinsky@wc.com
`
`James Leeds
`Leeds_james@lilly.com
`
`Adam L. Perlman
`aperlman@wc.com
`
`John Demeter
`Demeter_john_c@lilly.com
`
`
`
`6
`
`
`
`IPR2016-00237, IPR2016-00240, IPR2016-00318
`IPR2016—O0237, IPR2016—OO240, IPR2016—O03 18
`Patent 7,772,209 B2
`Patent 7,772,209 B2
`
`
`
`
`
`
`
`
`
`
`
`7
`
`
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