`
`
`Nichole M. Valeyko
`908.518.6327
`nvaleyko@lernerdavid.com
`
`April 20, 2018
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`Inter Partes Review IPR2018-00943 (Patent No. 7,919,499)
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`Dear Patent Trial and Appeal Board:
`This transmittal letter identifies Exhibits 1001-1060, being filed concurrently with the
`present Petition for Inter Partes Review. Pursuant to 37 C.F.R. § 42.6(e)(4)(ii), the Certificate of
`Service attached to the end of the Petition for Inter Partes Review filed herewith, incorporates
`Exhibits 1001-1060, as listed below:
`Exhibit #
`Reference
`
`1001
`U.S. Patent No. 7,919,499 (“the ’499 Patent”)
`1002
`
`U.S. Serial Number 11/083,167, Office Action, May 5, 2009
`1003
`
`Serial No. 11/083,167, Declaration Under 37 C.F.R. § 1.132 of Elliot Ehrich
`(undated)
`U.S. Serial Number 11/083,167, Amendment and Response, Oct. 5, 2009
`U.S. Serial Number 11/083,167, Office Action, Jan. 6, 2010
`U.S. Serial Number 11/083,167, Amendment and Response, Apr. 5, 2010
`U.S. Serial Number 11/083,167, Final Rejection, July 20, 2010
`U.S. Serial Number 11/083,167, Amendment After Final, Oct. 20, 2010
`U.S. Serial Number 11/083,167, Notice of Allowance, Dec. 1, 2010
`Sandra D. Comer et al., Depot naltrexone: long-lasting antagonism of the effects
`of heroin in humans, 159(4) Psychopharmacology (Feb. 2002), at 351-360
`Henry R. Kranzler et al., Sustained-Release Naltrexone for Alcoholism
`Treatment: A Preliminary Study, 22(5) Alcoholism: Clinical and Experimental
`Research (Aug. 1998), at 1074-79
`C.N. Chiang et al., Clinical Evaluation of A Naltrexone Sustained-Release
`Preparation, 16 Drug & Alcohol Dependence (1985), at 1-8
`T.N. Alim et al., Tolerability Study of A Depot Form of Naltrexone Substance
`Abusers, Problems of Drug Dependence, 1994: Proceedings of the 56th Annual
`Scientific Meeting, The College on Problems of Drug Dependence, Inc.,
`Vol. II: Abstracts, National Institute on Drug Abuse Research Monograph 153
`(1995), at 253
`U.S. Patent No. 7,157,102 (“the ’102 Patent” or “Nuwayser”)
`
`1004
`1005
`1006
`1007
`1008
`1009
`1010
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`1011
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`1012
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`1013
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`1014
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`5388947_1.docx
`AMNEAL 7.1R-005
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`April 20, 2018
`Page 2
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`Exhibit #
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`1015
`1016
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`1017
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`1018
`1019
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`1020
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`1021
`1022
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`1023
`1024
`1025
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`1026
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`1027
`1028
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`1029
`1030
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`1031
`1032
`1033
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`1034
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`Reference
`U.S. Patent No. 6,306,425 (“Tice”)
`U.S. Securities and Exchange Commission, FORM 10-K, Annual Report
`Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the
`fiscal year ended March 31, 2002. Alkermes, Inc. (July 2002)
`U.S. Trademark Application Serial Number 76/271,990, Allegation of Use of a
`Mark & specimen of the mark as used in commerce, Aug. 15, 2002 (“Vivitrex
`Specimen” or “Specimen”)
`U.S. Patent No. 6,264,987 (“the ’987 Patent” or “Wright”)
`S.J. Heishman et al., Safety And Pharmacokinetics of a New Formulation of
`Depot Naltrexone, Problems of Drug Dependence, 1993: Proceedings of the
`55th Annual Scientific Meeting, The College on Problems of Drug
`Dependence, Inc., Volume II: Abstracts, National Institute on Drug Abuse
`Research Monograph 141 (1994)
`U.S. Patent and Trademark Office, 1265(2) Official Gazette of the United States
`Patent and Trademark Office, Trademarks, Dec. 10, 2002
`Intentionally left blank
`Stewart B. Leavitt, PhD, ed., Evidence for the Efficacy of Naltrexone in the
`Treatment of Alcohol Dependence (Alcoholism), Addition Treatment Forum
`Naltrexone Clinical Update (2002 Clinco Communications, Inc.), at 1-8
`ReVia, Physicians’ Desk Reference 936-938 (53rd ed. 1999) (“PDR”)
`U.S. Patent No. 4,882,335 (“Sinclair”)
`Chiang et al., Kinetics of a naltrexone sustained-release preparation, 36(5) Clin.
`Pharmacol. Ther. (Nov. 1984), at 704-08 “Kinetic of a naltrexone
`sustained-release preparation.”
`Reuning et al., Pharmacokinetic Quantitation of Naltrexone Release From
`Several Sustained-Release Delivery Systems, Naltrexone: Research Monograph
`28 (R. E. Willette and G. Barnett, eds. National Institute on Drug Abuse 1980)
`Appeal Brief, Application No. 13/871,534, Oct. 19, 2015
`G. Rubio et al., Naltrexone Versus Acamprosate: One Year Follow-Up of
`Alcohol Dependence Treatment, 36(5) Alcohol & Alcoholism (2001), at 419-425
`Intentionally left blank
`Declaration of Kinam Park Ph.D in Support of Inter Partes Review of U.S.
`Patent No. 7,919,499
`Curriculum Vita of Kinam Park
`U.S. Provisional Application No. 60/564,542
`Manit Srisurapanont & Ngamwong Jarusuraisin, Naltrexone for the treatment of
`alcoholism: a meta-analysis of randomized controlled trials, 8 Int’l J. of
`Neuropsychopharmacology (2005), at 267-280
`Bouza Carmen et al., Efficacy and safety of naltrexone and acamprosate in the
`treatment of alcohol dependence: a systematic review, 99(7) Addiction (July
`2004), at 811-828
`
`5388947_1.docx
`AMNEAL 7.1R-005
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`

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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`April 20, 2018
`Page 3
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`Exhibit #
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`1035
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`1036
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`1037
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`1038
`1039
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`1040
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`1041
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`1042
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`1043
`1044
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`1045
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`1046
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`1047
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`1048
`1049
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`1050
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`Reference
`J.S. Hopkins et al., Naltrexone and Acamprosate Meta-Anaylsis of Two Medical
`Treatments for Alcoholism, 26(5) Alcoholism Clinical and Experimental
`Research, 2002 Scientific Meeting of the Research Society on Alcoholism and
`the 11th Congress of the Int’l Society for Biomedical Research on Alcoholism,
`June 28-July 3, 2002, San Francisco, California (Suppl. May 2002)
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations, Product Details for NDA 018932, REVIA (NALTREXONE
`HYDROCHLORIDE) 50MG
`Bioequivalence, Center for Drug Evaluation and Research, Application
`Number: 75-434, Naltrexone Hydrochloride Tablets, Eon Labs Manufacturing,
`Inc., at 1-8
`Synopsis, Naltrexone HCl, ALZA Corporation (Nov. 3, 2003)
`In-hwan Baek et al., Evaluation of the Bioequivalence of Two Brands of
`Naltrexone 50 mg Tablet in Healthy Volunteers, 16(1) Kor. J. Clin. Pharm.
`(2006), at 69-74
`TREXAN™, Physicians’ Desk Reference 936-938 (46 ed. 1992) (“PDR”),
`at 937-939
`Trademark Manual of Examining Procedure (TMEP) (3rd ed. Jan. 2002),
`at 100-5 to 100-11
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations, NALTREXONE (VIVITROL) FOR SUSPENSION, EXTENDED
`RELEASE 380MG/VIAL
`General Notices and Requirements, USP 32/NF 27 (2009) at 8
`Bertil Abrahamsson and Anna-Lena Ungell, Biopharmaceutical support in
`formulation development:A Practical Guide from Candidate Drug Selection to
`Commercial Dosage Form, Pharmaceutical Preformulation and Formulation
`(Mark Gibson ed., Interpharm/CRC) (2004), 239-291, at 262
`Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally
`Administered Products—General Considerations. FDA CDER (March 2003)
`Riddle et al., Anxiolytics, adrenergic agents, and naltrexone, 38(5) J. Am. Acad.
`Child. Adolesc. Psychiatry, 546-556 (May 1999)
`Food and Drug Administration, FDA PSYCHOPHARMACOLOGIC DRUGS
`ADVISORY COMMITTEE MEETING VIVITROL® (naltrexone for
`extended-release injectable suspension), NDA 21-897 (Sept. 16 2010)
`Intentionally left blank
`Rothenberg et al., Behavioral naltrexone therapy: an integrated treatment for
`opiate dependence, 23 J. of Substance Abuse Treatment (2002), at 351-360
`B.A. Johnson, Naltrexone long-acting formulation in the treatment of alcohol
`dependence, 3(5) Ther. Clin. Risk Manag., 741-749 (2007), at 742.
`
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`5388947_1.docx
`AMNEAL 7.1R-005
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`April 20, 2018
`Page 4
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`Exhibit #
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`1051
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`1052
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`1053
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`1054
`1055
`1056
`1057
`1058
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`1059
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`1060
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`Reference
`Food and Drug Administration, Guidance for Industry, Exposure-response
`relationships – study design, data analysis, and regulatory applications, FDA
`CDER (April 2003)
`Food and Drug Administration, Guidance for Industry, Statistical approaches to
`establishing bioequivalence, FDA CDER (April 2003)
`Schenker et al., Antecedent liver disease and drug toxicity, 31 J. of Hepatology
`1098-1105 (1999)
`Résumé of Mike Ramstack, as obtained from LinkedIn
`Résumé of Richard Reuning, as obtained from LinkedIn
`Résumé of Steve Wright, as obtained from LinkedIn
`U.S. Patent No. 3,332,950
`Filing Details for Alkermes Inc. 10-K dated July 1, 2002 from the Security and
`Exchange Commission’s EDGAR Online Filing System
`WayBack Machine capture of Security and Exchange Commission’s Information
`Page regarding the Electronic Data Gathering, Analysis, and Retrieval System
`(EDGAR), June 6, 2002
`WayBack Machine capture of Security and Exchange Commission’s Regulator
`Overview of the Electronic Data Gathering, Analysis, and Retrieval System
`(EDGAR), June 6, 2002
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`
`Nichole M. Valeyko
`Registration No. 55,832
`
`
`
`/dmf
`
`5388947_1.docx
`AMNEAL 7.1R-005
`
`