UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`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 USA, INC.,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG,
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`Petitioners
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`v .
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`ELI LILLY AND COMPANY,
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`Patent Owner.
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`Case IPR2016-003181
`U.S. Patent 7,772,209
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`PETITIONER SANDOZ INC.’S REQUEST FOR ORAL ARGUMENT
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`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
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`with the instant proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SANDOZ INC.,
`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 USA, INC.,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG,
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`Petitioners
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`v .
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`ELI LILLY AND COMPANY,
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`Patent Owner.
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`Case IPR2016-003181
`U.S. Patent 7,772,209
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`PETITIONER SANDOZ INC.’S REQUEST FOR ORAL ARGUMENT
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`1 Cases IPR2016-01429, IPR2016-01393, and IPR2016-01340 have been joined
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`with the instant proceeding.
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`Pursuant to 37 C.F.R. § 42.70(a), and the Scheduling Order entered on June
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`17, 2016, Paper 15 at 6, Petitioner Sandoz Inc. (“Sandoz”) respectfully requests the
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`oral argument as scheduled for March 7, 2017.2
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`Without intending to waive any issue not specifically identified, Sandoz
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`identifies below the issues to be argued:
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`1.
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`The first ground of unpatentability instituted in IPR2016-00318:
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`Claims 1-22 of U.S. Patent No. 7,772,209 (“the ’209 patent”) as being obvious
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`under 35 U.S.C. § 103 over Calvert (Ex. 1007), Niyikiza I (Ex. 1006), Worzalla
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`(Ex. 1013), European Patent Application No. 0 595 005 (“EP 005”) (Ex. 1033),
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`and the ’974 Patent (Ex. 1005), together with the knowledge of the person of
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`ordinary skill (“POSA”). Paper 14 at 21; Paper 2 at 7.
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`2.
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`The second ground of unpatentability instituted in IPR2016-00318:
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`Claims 1-22 of the ’209 patent as being obvious under 35 U.S.C. § 103 over
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`Calvert (Ex. 1007), Niyikiza I (Ex. 1006), Hammond I (Ex. 1015), EP 005 (Ex.
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`1033), and the ’974 Patent (Ex. 1005), together with the knowledge of the POSA.
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`Paper 14 at 21; Paper 2 at 7.
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`3.
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`Any issues, exhibits, or factual matters raised in Petitioner’s Petition
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`2 On February 14, 2017, we received correspondence from the Board indicating
`that the date for the oral hearing would need to change. Sandoz will work with
`the Board and Lilly to reschedule the hearing date.
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`1
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`for an IPR of the ’209 patent. Paper 2.
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`4.
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`Any issues, exhibits, or factual matters raised in the Board’s Decision
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`to institute the present proceeding. Paper 14.
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`5.
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`Any issues, exhibits, or factual matters raised in Patent Owner’s
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`Response. Paper 36.
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`6.
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`Any issues, exhibits, or factual matters raised in Sandoz’s Reply.
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`Paper 49.
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`7.
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`Sandoz’s Motion To Exclude and any opposition by Patent Owner Eli
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`Lilly and Company (“Lilly”) thereto.
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`8.
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`Pursuant to the teleconference held January 25, 2017, any issues,
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`exhibits, or factual matters raised in Lilly’s Sur-Reply, which is due on February
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`14, 2017.
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`9.
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`Any issues specified by Lilly in a Request for Oral Argument, but
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`only to the extent the Board grants Lilly’s Request on those issues.
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`The ’209 patent is also at issue in IPR2016-00237 and IPR2016-00240,
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`which were filed by Neptune Generics, LLC (“Neptune”) and also have oral
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`arguments scheduled for March 7, 2017. IPR2016-00237, Paper 15 at 3; IPR2016-
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`00240, Paper 15 at 3. Sandoz requests that the arguments for the Sandoz IPR and
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`Neptune IPRs be scheduled as separate sequential arguments rather than as a
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`combined oral hearing. Sandoz believes the arguments should be treated
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`2
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`separately because Sandoz is not a party to IPR2016-00237 and IPR2016-00240.
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`Further, the Neptune IPRs were instituted on different grounds, specifically,
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`obviousness of claims 1-22 based on: (i) Niyikiza I in view of the ’974 patent, and
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`further in view of EP 005 (IPR2016-00237, Paper No. 13 at 19); and
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`(ii) Rusthoven in view of EP 005 (IPR2016-00240, Paper No. 14 at 19). The
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`Neptune IPRs also involve different evidence, including testimony from three
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`different experts who did not present testimony in the Sandoz IPRs. Thus, given
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`the differences in the parties, grounds, and evidence between IPR2016-00318 on
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`one hand and IPR2016-00237 and -00240 on the other, Sandoz believes that
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`separate sequential arguments are appropriate.
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`Because of the technical complexity of the issues in dispute, Sandoz,
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`individually, requests sixty (60) minutes of time to address the issues. Should Lilly
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`be granted more time for those IPRs, Sandoz requests an equal amount of time as
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`Lilly be allocated for Sandoz.
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`Sandoz reserves the right for rebuttal. Sandoz will inform the Board of its
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`specific allocation of time for its opening and rebuttal at the beginning of the oral
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`argument.
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`Sandoz also requests the ability to use computers at counsel’s table to
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`display demonstrative exhibits, and respectfully requests that PTAB provide a
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`projector with VGA and HDMI connections for that purpose.
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`3
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`Dated: February 14, 2017
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`Respectfully submitted,
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
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`4
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`CERTIFICATE OF SERVICE
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`I hereby certify that true and correct copies of the foregoing document was
`served on February 14, 2017 via email to the following individuals at the email
`addresses below.
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`Dov P. Grossman (Reg. No. 72,525)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
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`David M. Krinsky (Reg. No. 72,339)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
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`Adam L. Perlman
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5244
`aperlman@wc.com
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`James P. Leeds (Reg. No. 35,241)
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
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`John C. Demeter (Reg. No. 30,167)
`Eli Lilly and Company
`Lilly Corporate Center
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`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`Email: demeter_john_c@lilly.com
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`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
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