IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC.
`Patent Owner.
`
`_____________________
`
`CASE: IPR2018-00608
`U.S. Pat. No. 9,161,926
`_____________________
`
`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
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC.
`Patent Owner.
`
`_____________________
`
`CASE: IPR2018-00608
`U.S. Pat. No. 9,161,926
`_____________________
`
`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. 9,161,926
`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”)
`Aczone® Gel 5% Product Label, approved July 7, 2005 (“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”)
`U.S. Patent No. 9,161,926 File History
`Declaration of Elaine S. Gilmore, M.D., Ph.D.
`
`
`
`Amneal
`Exhibit #
`1019
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`
`
`
`
`Description
`
`Curriculum Vitae for Elaine S. Gilmore, M.D., Ph.D.
`Viscosity of Carbopol® Polymers in Aqueous Systems, published
`August 13, 2010 (“Lubrizol Technical Data Sheet”)
`“Formulating Semisolid Products,” published October 29, 2008
`(“Lubrizol Pharmaceutical Bulletin 21”)
`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”)
`Neutralizing Carbopol® and Pemulen® Polymers in Aqueous and
`Hydroalcoholic Systems, published January 2002 (“Noveon
`Technical Data Sheet”)
`U.S. Patent No. 9,517,219 File History
`Piskin, S., et al. “A review of the use of adapalene for the treatment
`of acne vulgaris,” Therapeutics and Clinical Risk Management 3:
`621–624 (2007) (“Piskin”)
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent and Exclusivity for: N207154
`
`
`
`
`
`Amneal
`Exhibit #
`SUPPL.
`AMN1034
`SUPPL.
`AMN1035
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`Description
`
`Supplemental Declaration of Bozena B. Michniak-Kohn, Ph.D.,
`FAAPS, M.R.Pharm.S. 1 (served not filed)
`Andersson, D., “Evonik-Degussa expands its cooperation with
`Alsiano,” Pharma & Healthcare News 7:1-10 (2007) (served not
`filed)
`Second Declaration of Elaine S. Gilmore, Ph.D.
`Tanghetti, E., et al., “The Efficacy and Tolerability of Dapsone So/o
`Gel in Female vs Male Patients With Facial Acne Vulgaris: Gender
`as a Clinically Relevant Outcome Variable,” Journal of Drugs in
`Dermatology 11: 1417-1421 (2012)
`Fleisher, Jr., A., et al., “Dapsone Gel So/o in Combination With
`Adapalene Gel 0.1 o/o, Benzoyl Peroxide Gel 4 o/o or Moisturizer
`for the Treatment of Acne Vulgaris: A 12-Week, Randomized,
`Double-Blind Study,” Journal of Drugs In Dermatology 9: 33-40
`(2010)
`Physicians’ Desk Reference, 60th ed., Solagé®, pp. 740-742 (2006)
`Physicians’ Desk Reference, 61st ed., Tri-Luma® , pp. 1213-1215
`(2007)
`Physicians’ Desk Reference, 63rd ed., Ziana® , pp. 1942-1945 (2009)
`Physicians’ Desk Reference, 65th ed., Veltin®, pp. 3145-3148
`(2011)
`Dollars for Docs, available at https://projects.probulica.org/d4d-
`arcive/payments/9854537
`Dollars for Docs, available at https://projects.propublica.org/d4d-
`archive/11947951
`Julie C. Harper -2013-Top Companies Making General Payments,
`available at
`https://openpaymentsdata.cms.gov/physician/264589/general-
`payments
`
`
`1 The Supplemental Declaration of Bozena B. Michniak-Kohn, Ph.D.,
`FAAPS, M.R.Pharm.S. was inadvertently marked as AMN1035 when served on
`opposing counsel. This declaration should be marked as AMN1034.
`
`
`
`
`
`Amneal
`Exhibit #
`
`Description
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`1052
`
`1053
`
`1054
`1055
`
`1056
`
`Julie C. Harper -2014-Top Companies Making General Payments,
`available at
`https://openpaymentsdata.cms.gov/physician/264589/general-
`payments
`Julie C. Harper -2015-Top Companies Making General Payments,
`available at
`https://openpaymentsdata.cms.gov/physician/264589/general-
`payments
`Julie C. Harper -2016-Top Companies Making General Payments,
`available at
`https://openpaymentsdata.cms.gov/physician/264589/general-
`payments
`Julie C. Harper -2017-Top Companies Making General Payments,
`available at
`https://openpaymentsdata.cms.gov/physician/264589/general-
`payments
`Aczone – Dollars for Docs, available at
`https://projects.propublica.org/docdollars/products/drug-aczone
`Transcript from the Deposition of Dr. Julie Harper, M.D., Case
`IPR2018-00608 (March 11, 2019)
`Second Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`List of Dr. Klibanov’s clerical errors
` intentionally left blank
`Sullivan, D., et al., “A review of the nonclinical safety of
`Transcutol®, a highly purified form of diethylene glycol monoethyl
`ether (DEGEE) used as a pharmaceutical excipient,” Food and
`Chemical Toxicology 72: 4-50 (2014)
`FDA Inactive Ingredient Database Field Descriptions
`FDA Inactive Ingredient Database FAQs
`FDA Drug Master File Database, available at:
`https://www.fda.gov/drugs/developmentapprovalprocess/formssubm
`issionrequirements/drugmasterfilesdmfs/default.htm.
`
`
`
`
`
`
`
`
`
`Amneal
`Exhibit #
`
`Description
`
`1057
`
`1058
`
`2010 Inactive Ingredient Database, available at:
`http://wayback.archive-it.org/7993/20170112022245/http:/www.fda.
`gov/Drugs/InformationOnDrugs/ucm113978.htm.
`Transcript from the Deposition of Klibanov, Case IPR2018-00608
`(March 13, 2019)
`Andersson, D., “Evonik-Degussa expands its cooperation with
`Alsiano,” Pharma & Healthcare News 7:1-10 (2007) (previously
`submitted as Suppl. Evidence AMN1035)
`Decision Institution of Inter Partes Review, Amneal
`Pharmaceuticals LLC and Amneal Pharmaceuticals of New York,
`LLC v. Almirall, LLC, IPR2019-00207 (May 10, 2019)
`9037812_1.docx
`
`1059
`
`1060
`
` Respectfully submitted,
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Date: May 15, 2019
`
`
` Dennies Varughese, Pharm.D.
`Lead Counsel for Petitioners
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Exhibit List”, along with Exhibit 1060, were served in their entirety on May 15,
`
`2019, upon the following parties via email:
`
`
`
`
`
`
`
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`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@fenwick.com
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
` Dennies Varughese (Reg. No. 61,868)
`
`Date: May 15, 2019
` Lead Counsel for Petitioners
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`
`
`
`
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