Petitioner
`Exhibit #
`1001
`1002
`1003
`1004
`1005
`
`1006
`
`1007
`1008
`
`1009
`
`1010
`
`1011
`1012
`
`1013
`1014
`1015
`1016
`1017
`
`1018
`1019
`1020
`1021
`
`1022
`
`Petitioner’s Updated Exhibit List of 1/16/2020
`
`Description
`U.S. Patent No. 8,633,194 (“the ’194 patent”)
`Declaration of Dr. Laskar
`CV of Dr. Laskar
`European Patent Application Publication No. 0605203 A2 (“EP ’203”)
`Wang D.Y., “Effect of cetirizine, levocetirizine, and dextrocetirizine on
`histamine-induced nasal response in healthy adult volunteers,” Allergy 56
`(2001), pp. 339-343 (“Wang”)
`Kibbe, “Handbook of Pharmaceutical Excipients,” 3rd ed. 2000 (the
`“Handbook”)
`International Patent Application No. WO 2004/050094 (“WO ’094”)
`Tillement, Jean-Paul et al., “Compared pharmacological characteristics in
`humans of racemic cetirizine and levocetirizine, two histamine H1-receptor
`antagonists,” Biochemical Pharmacology Volume 66, Issue 7, 1 October
`2003, pages 1123-1126
`Potter, P.C., “Levocetirizine is effective for symptom relief including nasal
`congestion in adolescent and adult (PAR) sensitized to house dust mites,”
`Allergy (Oxford, United Kingdom) Volume 58, Issue 9, pages 893-899,
`Journal 2003
`Gandon, J.M. et al., “Lack of effect of single and repeated doses of
`Levocetirizine, a new antihistamine drug, on cognitive and psychomotor
`functions in healthy volunteers,” British Journal of Clinical Pharmacology
`(2002), 54(1), 51-58
`Orange Book Entry for XYZAL
`R.J. Davies et al., Antihistamines: topical vs. oral administration,
`Clinical and Experimental Allergy 26(3):11-17 (1996) (“Davies”)
`File Wrapper of ’194 patent
`Gennaro, A. R., Remington: The Science and Practice of Pharmacy 20th ed.
`(2000)
`U.S. Patent No. 5,698,558 to Nancy M. Grey (“US ’558”)
`EPO opposition
`Saeedi et al., “The treatment of atopic dermatitis with licorice gel,” Journal
`of Dermatological Treatment (2003) 14, 1–5
`Duconge et al., “Topical disposition of two strengths of a 125I-rhEGF jelly
`in rat skin wounds,” Biopharm. Drug Dispos. 25: 193–201 (2004)
`U.S. Patent No. 4,275,076
`U.S. Patent No. 5,643,584
`Ansel et al., Pharmaceutical Dosage Forms and Drug Delivery Systems 7th
`ed. 1999
`Soni et al., “Evaluation of the health aspects of methyl paraben:
`a review of the published literature,” Food and Chemical Toxicology 40
`(2002) 1335–1373
`
`

`

`1023
`
`1024
`
`1025
`1026
`1027
`
`1028
`
`1029
`1030
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`Sutton et al., “Development of the Antimicrobial Effectiveness Test as USP
`Chapter <51>” PDA Journal of Pharmaceutical Science and Technology,
`Vol. 56, No. 6, 300-311, November/December 2002
`Darwish et al., Effect of ethanol, propylene glycol and glycerol on the
`interaction of methyl and propyl p-hydroxybenzoate with Staphylococcus
`aureus and Pseudomonas aeruginosa,” Int. J. of Pharm. 147:51-60 (1997).
`November 19, 2008 Applicant Amendment and Remarks
`April 24, 2009 Applicant Amendment and Remarks
`November 23, 2010 Declaration of Domenico Fanara Under 37 1.132 and
`Exhibits
`Fukugasako et al., Effects of methyl p-hydroxybenzoate (methyl paraben)
`on Ca2+ concentration and histamine release in rat peritoneal mast cells
`U.S. Patent No. 6,159,491 to Durrani
`Preservation, Sterilization, and Sterility Testing of Ophthalmic Preparations
`Compilation From Niazi, Handbook of Pharmaceutical Manufacturing
`Formulations, 1st Ed., Vols. 1-6
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations,
`Compressed Solid Products, Volume 1
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations,
`Compressed Solid Products, Volume 2
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Liquid
`Products, Volume 3
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations,
`Semisolid Products, Volume 4
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Over-the-
`Counter Products, Volume 5
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Sterile
`Products, Volume 6
`Copyright Materials for Naizi Series
`Deposition of Domenico Fanera
`Amazon: Handbook of Pharmaceutical Manufacturing Formulations, Third
`Edition
`Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Liquid
`Products, Volume 3, Second Edition
`
`

`

`1042
`
`1043
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`1049
`1050
`
`Opening Expert Report of Sarfaraz K. Niazi, Ph.D. from the District Court
`Action
`Deposition of Sarfaraz K. Niazi, Ph.D.
`Official Copyright Certificates of Naizi Series
`Kibbe, “Handbook of Pharmaceutical Excipients,” 3rd ed. 2000, Glycerin
`Excerpt
`Final Written Decision (IPR2017-00163) incorrectly designated as Exhibit
`1025 during the deposition of Dr. Laskar
`Rowe et al., “Handbook of Pharmaceutical Excipients,” 6th ed. 2009
`incorrectly designated as Exhibit 1026 during the deposition of Dr. Niazi
`Remington Excerpt pp. 749-754.
`Excerpt from Brown Textbook
`Reply Declaration of Dr. Laskar
`
`