`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`APOTEX, INC.
`Petitioner,
`v.
`UCB BIOPHARMA SPRL
`Patent Owner.
`U.S. Patent No. 8,633,194 to Fanara et al.
`Issue Date: January 21, 2014
`Title: Pharmaceutical composition of piperazine derivatives
`Inter Partes Review No.: IPR2019-00400
`
`Petitioner’s Exhibit List
`
`
`
`Petitioner
`Exhibit #
`1001
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`1012
`
`1013
`1014
`1015
`1016
`1017
`
`Petitioner’s Exhibit List
`
`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”)
`levocetirizine, and
`Wang D.Y., “Effect of cetirizine,
`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
`
`
`
`1018
`
`1019
`1020
`1021
`
`1022
`
`1023
`
`1024
`
`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
`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).
`
`
`
`
`
`
`
`
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