Filed: March 21, 2016
`
`
`
`Filed on behalf of Petitioners,
`Lupin Limited and Lupin Pharmaceuticals, Inc.
`By: Christy G. Lea
`
`Kerry S. Taylor
`
`Benjamin Anger
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`
`
`Irvine, CA 92614
`
`Tel.: (949) 760-0404
`
`Fax: (949) 760-9502
`
`Email: BoxLupin15B@knobbe.com
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`LUPIN LIMITED
`AND LUPIN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`iCEUTICA PTY LTD.
`
`Patent Owner
`
`
`
`
`
`
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`
`
`Case No. IPR2016-00399
`U.S. Patent No. 9,017,721
`
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`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`Filed on behalf of Petitioners,
`Lupin Limited and Lupin Pharmaceuticals, Inc.
`By: Christy G. Lea
`
`Kerry S. Taylor
`
`Benjamin Anger
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`
`
`Irvine, CA 92614
`
`Tel.: (949) 760-0404
`
`Fax: (949) 760-9502
`
`Email: BoxLupin15B@knobbe.com
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`LUPIN LIMITED
`AND LUPIN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`iCEUTICA PTY LTD.
`
`Patent Owner
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2016-00399
`U.S. Patent No. 9,017,721
`
`
`
`
`
`
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`
`
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`PETITIONERS’ UPDATED EXHIBIT LIST
`
`
`
`
`
`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners Lupin Limited and Lupin
`
`Pharmaceuticals, Inc. hereby provide a current list of its exhibits.
`
`Description
`
`Exhibit
`No.
`1001 U.S. Patent No. 9,017,721
`
`1002 Declaration of Mansoor Amiji, Ph.D.
`
`1003 Curriculum Vitae of Mansoor Amiji, Ph.D.
`
`Short
`Citation
`’721 patent
`
`
`
`
`
`
`
`1004
`
`1005
`
`List of documents reviewed by Mansoor Amiji, Ph.D.
`in preparation of his declaration
`
`PCT Publication No. WO2008/000042, published
`January 3, 2008
`
`Meiser
`
`1006 Novartis Package Insert for Cataflam®, Voltaren®,
`and Voltaren®-XR, dated May 2000
`
`Novartis
`Package Insert
`
`1007 United States Pharmacopeia 30, Section <711> (2007) USP <711>
`
`1008 United States Pharmacopeia 30, Section <1092>
`(2007)
`
`1009 Chuasuwan et al., “Biowaiver Monographs for
`Immediate Release Solid Oral Dosage Forms
`Diclofenac Sodium and Diclofenac Potassium,”
`98(4):1206-1219 (2009)
`
`USP <1092>
`
`Chuasuwan
`
`1010
`
`1011
`
`PCT Publication No. WO2006/133954, published
`December 21, 2006
`
`Reiner
`
`PCT Publication No. WO2006/069419, published July
`6, 2006
`
`Payne
`
`- 1 -
`
`
`
`Description
`
`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`Exhibit
`No.
`1012 Moore, “Diclofenac Potassium 12.5mg Tablets for
`Mild to Moderate Pain and Fever: A Review of Its
`Pharmacology, Clinical Efficacy and Safety,”
`27(3):163-195 (2007)
`
`Short
`Citation
`Moore
`
`1013 U.S. Patent No. 5,256,699 to Murphy et al.
`
`
`
`1014 Dokoumetzidis et al., “A century of dissolution
`research: From Noyes and Whitney to the
`Biopharmaceutics Classification System,” Int’l Journal
`of Pharmaceutics 321:1-11 (2006)
`
`Dokoumetzidis
`
`1015 Kesisoglou et al., “Nanosizing – Oral Formulation
`Development and Biopharmaceutical Evaluation,”
`Advanced Drug Delivery Reviews, 59:631-644 (2007)
`
`Kesisoglou
`
`1016 U.S. Patent No. 5,202,129 to Samejima et al.
`
`1017 U.S. Patent Publication 2006/0159628 to Liversidge
`
`1018 Vogt et al., “Dissolution enhancement of Fenofibrate
`by Micronization, Cogrinding and Spray-drying:
`Comparison with Commercial Preparations,”
`European Journal of Pharmaceutics and
`Biopharmaceutics 68:283-288 (2008)
`
`Samejima
`
`Liversidge
`’628
`
`Vogt
`
`1019 U.S. Patent Publication 2006/0204588 to Liversidge et
`al.
`
`Liversidge
`’588
`
`1020 U.S. Patent No. 8,808,751 to Cammarano, et al.
`
`Cammarano
`
`1021
`
`Iroko F-1 Prospectus filed with the Securities and
`Exchange Commission on June 18, 2013
`
`Iroko
`Prospectus
`
`
`
`Description
`
`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`Exhibit
`No.
`1022 Khazaeinia et al., “A Comparison of Gastrointestinal
`Permeability Induced by Diclofenac-phospholipid
`complex with Diclofenac Acid and its Sodium Salt,”
`Journal of Pharmaceutical Sciences 6(3):352-359
`(2003)
`
`Short
`Citation
`Khazaeinia
`
`1023
`
`iCeutica Press Release, “iCeutica Receives Key Patent
`for SoluMatrix Fine Particle Technology Platform”
`(September 24, 2014)
`
`iCeutica Press
`Release
`
`1024 Memorandum dated April 6, 2005, from John Jenkins,
`M.D., at FDA re: “Analysis and recommendations for
`Agency action regarding non-steroidal anti-
`inflammatory drugs and cardiovascular risk”
`
`1025 U.S. Dep’t of Health & Human Servs., Food and
`Drug Admin., CDER, Guidance for Indus.,
`Dissolution Testing of Immediate Release Solid Oral
`Dosage Forms (1997)
`
`Jenkins Memo
`
`FDA Guidance
`
`1026 Royal Hanson et al. Handbook of Dissolution Testing
`1-53 (3rd ed. 2004)
`
`Handbook
`
`1027
`
`’721 Patent Reduced File History
`
`File History
`
`1028
`
`1029
`
`iCeutica Press Release dated April 28, 2011: iCeutica
`Announces Sale to Partner Iroko; 10X uplift on
`original value
`
`FDA Orangebook listing for Zorvolex; available at:
`http://www.accessdata.fda.gov/scripts/cder/ob/docs
`/obdetail.cfm?Appl_No=204592&TABLE1=OB_Rx;
`and
`http://www.accessdata.fda.gov/scripts/cder/ob/docs /
`/patexclnew.cfm?Appl_No=204592&Product_No=001
`&table1=OB_Rx (accessed November 2, 2015)
`
`
`
`
`
`
`
`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`Exhibit
`No.
`1030
`
`Description
`
`Loewenstein and Roberts “The Ionization of Citric
`Acid Studied by the Nuclear Magnetic Resonance
`Technique” J. of Am. Chem. Soc. 82(11) 2705-2710
`(1960)
`
`Short
`Citation
`
`
`1031 Rune and Viskum, “Duodenal pH values in normal
`controls and in patients with duodenal ulcer,” Gut
`10:569-571 (1969)
`
`1032 Countdown to the 10th Anniversary Scrip Awards,
`available at: https://ibiawards.com/scrip-awards/wp-
`content/uploads/sites/41/2014/11/script_shottlist_ad6_
`141125_16.pdf (accessed November 2, 2015)
`
`1033 U.S. Patent No. 3,558,690
`
`1034 United States Pharmacopeia 30, Official Monographs
`for Diclofenac Potassium and Diclofenac sodium, pp.
`1921-1924 (2007)
`
`1035 Remington’s Pharmaceutical Handbook Excerpt, 18th
`ed., pp. 715-716 (1990)
`
`1036 HPPS Operators Guide, Malvern Instruments, 2.0
`(2003)
`
`1037 U.S. Provisional Application No. 61/172,291
`
`1038 Australian Provisional Application No. 2009901748
`
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`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`Exhibit
`No.
`1039 Declaration of William R. Zimmerman in Support of
`Motion to Appear Pro Hac Vice
`
`Description
`
`Short
`Citation
`
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`By:/Benjamin Anger/
`Christy G. Lea (Reg. No. 51,754)
`Kerry Taylor (Reg. No. 43,947)
`Benjamin B. Anger (Reg. No. 62,207)
`
`Attorneys for Petitioners, Lupin Limited
`and Lupin Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`Dated: March 21, 2016
`
`
`
`
`
`Lupin v. iCeutica Pty Ltd
`IPR2016-00399
`
`
`
`
`I hereby certify
`
`that a
`
`the foregoing
`
`CERTIFICATE OF SERVICE
`
`true and correct copy of
`
`PETITIONERS’ UPDATED EXHIBIT LIST AND EXHIBIT 1039 are being
`
`served on March 21, 2016, via email pursuant to 37 C.F.R. § 42.6(e), per
`
`agreement of the parties, to counsel for iCeutica Pty Ltd. at the address below:
`
`
`
`Dorothy P. Whelan
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR31215-0011IP4@fr.com
`
`
`Martina Tyreus Hufnal
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR31215-0011IP4@fr.com
`
`
`
`
`Dated: March 21, 2016
`
`
`22369048
`
`
`
`
`
`
`/Benjamin Anger/
`Christy G. Lea (Reg. No. 51,754)
`Kerry Taylor (Reg. No. 43,947)
`Benjamin B. Anger (Reg. No. 62,207)
`
`Attorneys for Petitioners, Lupin Limited
`and Lupin Pharmaceuticals, Inc.
`
`- 6 -
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