`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC
`Patent Owner
`
`_____________________
`
`Case IPR2019-00207
`U.S. Pat. No. 9,517,219
`_____________________
`
`PETITIONERS’ EXHIBIT LIST
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Amneal
`Exhibit #
`1001
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`1002
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`1003
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`1004
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`1005
`1006
`1007
`1008
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`1009
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`1010
`1011
`1012
`1013
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`1014
`
`1015
`
`1016
`1017
`1018
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`
`
`Description
`
`U.S. Patent No. 9,517,219
`Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`Curriculum Vitae for Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`International Patent Application Publication No. WO 2009/061298
`(“Garrett”)
`International Application Publication No. WO 2010/072958
`(“Nadau-Fourcade”)
`Certification for Translation of WO 2010/072958
`U.S. Patent Publication No. 2006/0204526 (“Lathrop”)
`U.S. Patent Publication No. 2010/0029781 (“Morris”)
`Osborne, D.W., “Diethylene glycol monoethyl ether: an emerging
`solvent in topical dermatology products,” J. Cosmetic Derm.
`10:324-329 (2011) (“Osborne I”)
`Physician’s Desk Reference, 65th ed., pp. 599-602 (2011) (ACZONE
`Gel 5% Label)
`U.S. Patent No. 7,820,186 (“Orsoni”)
`Epiduo Product Label, approved December 8, 2008 (“Epiduo
`Label”)
`U.S. Patent Publication No. 2007/0190019 (“Guo”)
`Rowe, R.C. et al. (Eds.), Handbook of Pharmaceutical Excipients,
`6th Ed., Pharmaceutical Press: London, UK (2009)
`Bonacucina, G., et al., “Characterization and Stability of Emulsion
`Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate
`Copolymer,” AAPS PharmaSciTech 10:368-375 (2009)
`(“Bonacucina”)
`U.S. Patent No. 5,863,560 (“Osborne II”)
`File History of U.S. Patent No. 9,517,219
`Declaration of Elaine S. Gilmore, M.D., Ph.D.
`
`
`
`Description
`
`Curriculum Vitae for Elaine S. Gilmore, M.D., Ph.D.
`Affidavit of Christopher Butler
`Intentionally left blank
`Wozel, D., “Innovative Use of Dapsone” Dermatol. Clin. 28: 599–
`610 (2010) (“Wozel”)
`Thiboutot, D., et al., “Pharmacokinetics of Dapsone Gel, 5%
`for the Treatment of Acne Vulgaris” Clin. Pharmacokinet. 46: 697-
`712 (2007) (“Thiboutot”)
`Nguyen, R. and Su, J., “Treatment of Acne Vulgaris” Pediatrics and
`Child Health 21: 119-125 (2010) (“Nguyen”)
`Williams, H., et al., “Acne vulgaris” Lancet 379: 361–72 (2012)
`(“Williams”)
`Sepineo™ P 600 Brochure
`Barclay, L., “Use of Topical Corticosteroids for Dermatologic
`Conditions Reviewed” Medscape - Jan 21, 2009, accessed from
`https://www.medscape.com/viewarticle/587159_print (“Barclay”)
`Remington: The Science and Practice of Pharmacy, 21st Ed.,
`Lippincott Williams & Wilkins: Baltimore, MD (2005)
`(“Remington”)
`Kim, J-Y., et al., “Rheological properties and microstructures of
`Carbopol gel network system,” Colloid. Polym. Sci. 281:614–
`623(2003) (“Kim”)
`Intentionally left blank
`Spain's Almirall bets on dermatology with $650 million U.S. deal,
`Retrieved from https://www.reuters.com/article/us-allergan-m-a-
`almirall/spains-almirall-bets-on-dermatology-with-650-million-us-
`deal-idUSKBN1KO10N, last accessed October 26, 2018
`Piskin, S. et al. “A review of the use of adapalene for the treatment
`of acne vulgaris,” Therapeutics and Clinical Risk Management 3(4):
`621–624 (2007) (“Piskin”)
`Intentionally left blank
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`Amneal
`Exhibit #
`1019
`1020
`1021
`
`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`1032
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`1033
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`
`
`Amneal
`Exhibit #
`
`Description
`
`1034
`
`Andersson, D., “Evonik-Degussa expands its
`cooperation with Alsiano,” Pharma & Healthcare News : 1-10
`(2007)
`10252301_1.docx
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: November 6, 2018
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Exhibit List”, along with exhibits 1001 – 1034, were served in their entirety on
`
`November 6, 2018, upon the following parties via FedEx®:
`
`Allergan, Inc Almirall, LLC
`2525 Dupont Drive, T2-7H 2525 Dupont Drive, T2-7H
`Irvine, CA 92612-1599 Irvine, CA 92612-1599
`Patent owner's correspondence Additional address known to
`address of record for Petitioner as likely to effect service
`U.S. Patent No. 9,517,219
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` Litigation counsel of record:
`
` James S. Trainor, Jr.
` FENWICK & WEST LLP,
` 902 Broadway, Suite 14,
` New York, NY 10010
`
` Elizabeth B. Hagan
` Ewa M. Davison
` FENWICK & WEST LLP,
`
`
`
` 1191 Second Avenue, 10th Floor,
` Seattle, Washington 98101
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`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: November 6, 2018
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`
`
`