`
`Materials Considered By Mansoor M. Amiji, Ph.D., RPH
`
`U.S. Patent No. 8,679,544
`
`File History of U.S. Patent No. 8,679,544
`
`U.S. Patent No. 8,99,387
`
`File History of U.S. Patent No. 8,99,387
`
`U.S. Patent No. 9,017,721
`
`File History of U.S. Patent No. 9,017,721
`
`PCT Publication No. WO2008/000042, published January 3, 2008 (Meiser)
`
`Novartis Package Insert for Cataflam®, Voltaren®, and Voltaren®-XR, dated
`May 2000
`
`United States Pharmacopeia 30, Section <711> (2007)
`
`United States Pharmacopeia 30, Section <1092> (2007)
`
`Chuasuwan et al., “Biowaiver Monographs for Immediate Release Solid
`Oral Dosage Forms Diclofenac Sodium and Diclofenac Potassium,”
`98(4):1206-1219 (2009)
`
`PCT Publication No. WO2006/133954, published December 21, 2006 (Reiner)
`
`PCT Publication No. WO2006/069419, published July 6, 2006 (Payne)
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`12.
`
`13.
`
`14. 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)
`
`15.
`
`16.
`
`17.
`
`U.S. Patent No. 5,256,699 (Murphy)
`
`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)
`
`Kesisoglou et al., “Nanosizing – Oral Formulation Development and
`Biopharmaceutical Evaluation,” Advanced Drug Delivery Reviews, 59:631-644
`(2007)
`
`18.
`
`U.S. Patent No. 5,202,129 (Samejima)
`
`1
`
`LUPIN EX. 1004
`Lupin v. iCeutica
`US Patent No. 9,017,721
`
`
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`U.S. Patent Publication 2006/0159628 (Liversidge)
`
`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)
`
`U.S. Patent Publication 2006/0204588 (Liversidge)
`
`U.S. Patent No. 8,808,751 (Cammarano)
`
`Iroko F-1 Prospectus filed with the Securities and Exchange Commission on
`June 18, 2013
`
`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)
`
`iCeutica Press Release, “iCeutica Receives Key Patent for SoluMatrix Fine
`Particle Technology Platform” (Sept. 24, 2014)
`
`26. 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”
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`32.
`
`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)
`
`Royal Hanson et al., Handbook of Dissolution Testing 1-53 (3rd ed. 2004)
`
`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)
`
`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)
`
`Rune and Viskum, “Duodenal pH values in normal controls and in patients with
`duodenal ulcer,” Gut 10:569-571 (1969)
`
`2
`
`
`
`33.
`
`34.
`
`35.
`
`36.
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`46.
`
`47.
`
`48.
`
`49.
`
`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)
`
`U.S. Patent No. 3,558,690
`
`United States Pharmacopeia 30, Official Monographs for Diclofenac Potassium
`and Diclofenac sodium, ¶ 1921 (2007)
`
`Remington’s Pharmaceutical Handbook Excerpt, 18th ed., pp. 715-716 (1990)
`
`HPPS Operators Guide, Malvern Instruments, 2.0 (2003)
`
`U.S. Provisional Application No. 61/172,291
`
`Australian Provisional Application No. 2009901748
`
`U.S. Patent No. 5,145,684 (Liversidge)
`
`Rohrs, Brian, “Dissolution Method Development for Poorly Soluble
`Compounds,” Dissolution Technologies (Aug. 2001)
`
`January 10, 2008 email string from Adrian Russell to Felix Meiser and Aaron
`Dodd Re: Lab mill for API and excipient (ICT0085082-085)
`
`November 3, 2014 email from Bill Bosch to Seamus Mulligan Re: Introduction
`to iCeutica (ICT0006103-104)
`
`iCeutica Pty Ltd and Iroko Pharmaceuticals, LLC’s Opening Claim
`Construction Brief (D.I. 67)
`
`Declaration of Elizabeth M. Flanagan in Support of iCeutica Pty Ltd and Iroko
`Pharmaceuticals, LLC’s Opening Claim Construction Brief, and all exhibits
`attached thereto (D.I. 68)
`
`Opadry® Enteric Application Data, “Development of Diclofenac Sodium
`Delayed Release Tablets USP Opadry® Enteric (94 Series),” Colorcon
`Technical Literature (2010)
`
`Semalty, et al., Development and physicochemical evaluation of
`pharmacosomes of diclofenac,” Acta Pharm. 59:335-344 (2009)
`
`Cristofoletti, et al., “Biowaiver Monographs for Immediate Release Solid Oral
`Dosage Forms: Efavirenz,” J. of Pharm. Scis., Vol. 102, No. 2 (February 2013)
`
`Gowthamarajan, et al., “Dissolution Testing for Poorly Soluble Drugs: A
`Continuing Perspective,” Dissolution Technologies (Aug. 2010)
`
`3
`
`
`
`50.
`
`List of Drugs in the FDA Dissolution Methods database, available at:
`http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm (accessed
`Sept, 18, 2015)
`
`51. Malvern Instruments Ltd. Product Brochure Re: Mastersizer 3000, Smarter
`Particle Sizing
`
`52.
`
`53.
`
`54.
`
`Hackley and Clogston, NIST - NCL Joint Assay Protocol, PCC-1 (Version 1.1),
`“Measuring the Size of Nanoparticles in Aqueous Media Using Batch-Mode
`Dynamic Light Scattering,” Nat’l Institute of Standards and Technology (Nov.
`2007, rev. Feb. 2010)
`
`Horiba Scientific, “A Guidebook to Particle Size Analysis,” (2002)
`
`Pobudkowska, et al., “Study of pH-Dependent Drugs Solubility in Water,”
`Chem. Ind. Chem. Eng. Q. 20 (1) 115(cid:237)126 (2014)
`
`55. Martin, et al., “Selection of Dissolution Medium for QC Testing of Drug
`Products,” J. of Validation Technology (Summer 2011)
`
`56.
`
`57.
`
`58.
`
`59.
`
`Singla, et al., “A Discriminatory and Biorelevant Dissolution Test Method for
`Simvastatin Drug Products,” Dissolution Technologies (Nov. 2009)
`
`Noory, et al., “Steps for Development of a Dissolution Test for Sparingly
`Water-Soluble Drug Products,” Dissolution Technologies, Article 3 (Feb. 2000)
`
`Zhao, et al., “Effect of Sodium Lauryl Sulfate in Dissolution Media on
`Dissolution of Hard Gelatin Capsule Shells,” Pharm. Research, Vol. 21, No. 1
`(Jan. 2004)
`
`Jamzad, et al., “Role of Surfactant and pH on Dissolution Properties of
`Fenofibrate and Glipizide—A Technical Note,” AAPS PharmSciTech 2006; 7
`(2) Article 33
`
`4