`571-272-7822
`
`Paper 54
`Entered: February 23, 2018
`
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`
`
`APOTEX INC., APOTEX CORP.,
`ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMACEUTICAL INDUSTRIES, INC., and
`SUN PHARMA GLOBAL FZE,
`Petitioners,
`
`v.
`
`NOVARTIS AG.,
`Patent Owner.
`____________
`
`Case IPR2017-008541
`Patent US 9,187,405 B2
`_______________
`
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
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`
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`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`joined with this proceeding.
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`
` A
`
` conference call in the above proceedings was held on February 21, 2018,
`among counsel for the respective Petitioners, Patent Owner, and Judges Pollock,
`Green, and Kaiser to discuss issues raised in Patent Owner’s email dated February
`20, 2018. Ex. 3004.
`In short, Patent Owner seeks authorization to file a motion to strike
`Petitioner’s Reply Brief or, in the alternative, for additional pages in its Reply to
`Petitioner’s Opposition to Motion to Amend, in which to submit sur-reply
`arguments. This issue relates to Patent Owner’s argument that “pharmacokinetic
`data evidenced by Webb, Kahan 2003, and Park would have indicated to those of
`ordinary skill in the art that 0.5mg/day of fingolimod would not result in sufficient
`lymphopenia to successfully treat RR-MS.” See Paper 11, 19. In our Decision on
`Institution we informed the parties that “[w]e . . . look forward to further
`development of this issue at trial.” Id. at 20. In addressing Patent Owner’s
`pharmacokinetic argument, Petitioner filed the declaration of a new expert,
`Dr. Leslie Benet, with its Reply to the Patent Owner Response, which Patent
`Owner contends is prejudicial.
`Also during the conference call, the parties indicated disagreement in
`scheduling Dr. Benet’s deposition prior to Due Date 3, the due date for Patent
`Owner’s Reply to Petitioner’s Opposition to Motion to Amend. Petitioner took the
`position that there was no need to schedule Dr. Benet’s deposition before Due
`Date 3 because Petitioner did not cite Dr. Benet’s testimony in its Opposition to
`Patent Owner’s Motion to Amend.
`Patent Owner engaged a court reporter for the call. Patent Owner will
`submit a copy of the transcript as an exhibit, which will serve as the official record
`
` 2
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`IPR2017-00854
`Patent 9,187,405 B2
`of the call.
`
`
`ORDER
`Having considered the parties’ positions, it is:
`ORDERED that Patent Owner’s request to file a motion to strike is denied.
`FURTHER ORDERED that Patent Owner’s request for additional pages in
`its Reply to Petitioner’s Opposition to Motion to Amend is denied.
`FURTHER ORDERED that, on or before March 16, 2018, Patent Owner
`may file a sur-reply not to exceed 15 pages addressing Petitioner’s response to
`Patent Owner’s pharmacokinetic argument. Patent Owner’s sur-reply may be
`supported by additional testimonial evidence.
`FURTHER ORDERED that the parties will hold the deposition of Dr. Benet
`at least 10 days prior to DUE DATE 3. Dr. Benet may be cross-examined on any
`issue raised in his expert report.
`FURTHER ORDERED that the parties will use best efforts to adjust DUE
`DATES 3 through 6 in order to effect the timely cross-examination of Dr. Benet,
`as well as any other person submitting testimonial evidence in connection with
`Patent Owner’s sur-reply.
`FURTHER ORDERED that in the unlikely event the parties cannot agree on
`a schedule in accordance with the above, they shall jointly submit proposed
`schedules for the efficient conduct of this case, showing areas of agreement and
`disagreement, with a bullet point explanation for each area of disagreement.
`
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` 3
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`IPR2017-00854
`Patent 9,187,405 B2
`FOR PETITIONER APOTEX:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`FOR PETITIONER ARGENTUM:
`
`Teresa Stanek Rea
`Deborah H. Yellin
`Shannon M. Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`slentz@crowell.com
`
`FOR PETITIONER TEVA:
`
`Amanda Hollis
`Eugene Goryunov
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`egoryunov@kirkland.com
`
`FOR PETITIONER SUN PHARMA:
`
`Samuel Park
`WINSTON & STRAWN LLP
`spark@winston.com
`
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`IPR2017-00854
`Patent 9,187,405 B2
`FOR PATENT OWNER:
`
`Jane M. Love
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
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