`_____________________
`
`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
`
`1002
`
`1003
`
`1004
`
`1005
`1006
`1007
`1008
`
`1009
`
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`1017
`1018
`
`
`
`
`
`
`
`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
`
`Amneal
`Exhibit #
`1019
`1020
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`
`
`
`
`
`
`
`
`
`
`Amneal
`Exhibit #
`
`Description
`
`1034
`
`1035
`
`Andersson, D., “Evonik-Degussa expands its
`cooperation with Alsiano,” Pharma & Healthcare News : 1-10
`(2007)
`Poster Abstracts for the Journal of the American Academy of
`Dermatology 2017 Annual Meeting
`Email dated October 8, 2019 from Liz Hagan to Tyler Liu, Dennies
`Varughese, Adam LaRock and James Trainor regarding conference
`call
`Email dated October 8, 2019 from Tyler Liu to trials@uspto.gov
`requesting authorization to file a motion for additional discovery
`Almirall, LLC v. Taro Pharmaceutical Industries Ltd. and Taro
`Pharmaceuticals, Inc., Case 1:17-cv-00663 [Proposed] Joint
`Pretrial Order, Document 142, February 5, 2019
`10252301_1.docx
`
`1036
`
`1037
`
`1038
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: October 18, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`
`
`
`
`
`
`
`
`
`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 1035 – 1038, were served in their entirety on
`
`October 18, 2019, via electronic mail upon the following counsel for Patent
`
`Owner:
`
`
`
`
`
`
`
`
`
`
`
`James Trainor
`Vanessa Park-Thompson
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`vpark-thompson@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwich.com
`
`
`
`
`
`
`
`
`
`
`
`Elizabeth B. Hagen
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: October 18, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`
`
`