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`Paper No. ______
`Filed: June 21, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner
`v.
`ALKERMES PHARMA IRELAND LIMITED,
`Patent Owner
`______________________
`Case IPR2018-00943
`Patent 7,919,499
`______________________
`Patent Owner’s Current List of Exhibits
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`
`Description
`
`Previously
`Submitted
`
`April 13, 2006 Vivitrol® Approval Letter for NDA No.
`21897 (https://www.accessdata.fda.gov/drugsatfda_docs
`/nda/2006/021897_toc_Vivitrol.cfm)
`October 12, 2010 Vivitrol® Approval Letter (New
`Indication) for NDA No. 21897
`(https://www.accessdata.fda.gov/drugsatfda_
`docs/nda/2006/021897_toc_Vivitrol.cfm)
`Vivitrol® Prescribing Information, revised 12/2015
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2
`015/021897s029lbl.pdf)
`“Drug Facts: Treatment Approaches for Drug Addiction”
`published by the National Institute on Drug Abuse
`(https://www.drugabuse.gov/
`publications/drugfacts/treatment-approaches-drug-
`addiction (revised January 2018))
`“Overdose Death Rates,” published by the National
`Institute on Drug Abuse
`(https://www.drugabuse.gov/related-topics/trends-
`statistics/overdose-death-rates)
`“Principles of Drug Abuse Treatment for Criminal Justice
`Populations | A Research Guide,” published by the
`National Institute on Drug Abuse, NIH Publication No.
`11-5316, (revised April 2014)
`(https://www.drugabuse.gov/publications/principles-drug-
`abuse-treatment-criminal-justice-populations/principles)
`November 21, 2005 Clinical Pharmacology and
`Biopharmaceutics Review for NDA No. 21897
`(https://www.accessdata.fda.gov/
`drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm)
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`Exhibit
`No.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`Exhibit
`No.
`
`Previously
`Submitted
`
`2008
`
`2009
`
`2010
`
`“Incorporating Alcohol Pharmacotherapies Into Medical
`Practice, Treatment Improvement Protocol (TIP) Series
`49 (2009) (‘TIP 49’),” published by Center for Substance
`Abuse Treatment (https://store.samhsa.gov/shin/content/
`/SMA13-4380/SMA13-4380.pdf)
`Leavitt, S.B., “Evidence for the Efficacy of Naltrexone in
`the Treatment of Alcohol Dependence (Alcoholism),”
`published by Addiction Treatment Forum, March 2002,
`(https://www.samhsa.gov/medication-assisted-treatment/
`treatment/naltrexone)
`Bartus et al., “Vivitrex®, in Injectable, Extended-Release
`Formulation of Naltrexone, Provides Parmacokinetic and
`Pharmacodynamic Evidence of Efficacy for 1 Month in
`Rats,” Neuropsychopharmacology, 28, 1973-1982 (2003)
`July 11, 2011 Alkermes Comment to Docket No. FDA-
`2007-D-0369, Draft Guidance for Industry Describing
`Product-Specific Bioequivalence Recommendations for
`Naltrexone Extended Release Suspension/Intramuscular
`(https://www.regulations.gov/document?D=FDA-2007-
`D-0369-0061)
`2012 U.S. Patent No. 7,919,499
`
`2011
`
`2013
`
`June 2, 2014 Alkermes Comment to Docket No. FDA-
`2007-D-0369, Draft Guidance for Industry Describing
`Product-Specific Bioequivalence Recommendations for
`Naltrexone Extended Release Suspension/Intramuscular
`(https://www.regulations.gov/document?D=FDA-2007-
`D-0369-0291)
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`Previously
`Submitted
`
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent Listing for Vivitrol®
`(https://www.accessdata.fda.gov/scripts/cder/ob/patent_in
`fo.cfm?Product_No=001&Appl_No=021897&Appl_type
`=N)
`“Practice Guidelines for the Pharmacological Treatment
`of Patients with Alcohol Use Disorder,” published by The
`American Psychiatric Association (January 2018)
`(https://psychiatryonline.org/doi/pdf/10.1176/appi.books.
`9781615371969)
`December 23, 2005 Division Director Approvable Memo
`for NDA No. 21897(https://www.accessdata.fda.gov/
`drugsatfda_docs/nda/2006/021897_toc_Vivitrol.cfm)
`Vereby et al., “Naltrexone: disposition, metabolism, and
`effects after acute and chronic dosing,” Clinical
`Pharmacology & Therapeutics, 20:315-329 (1976)
`“Medication for the Treatment of Alcohol Use Disorder:
`A Brief Guide,” published by National Institute on
`Alcohol Abuse and Alcoholism, Substance Abuse and
`Mental Health Services Administration (SAMHSA)
`(2015) (https://store.samhsa.gov/shin/content/SMA15-
`4907/SMA15-4907.pdf)
`American Psychiatric Association, “DSM-5 Frequently
`Asked Questions,” (https://www.psychiatry.org/
`psychiatrists /practice/dsm/feedback-and-
`questions/frequently-asked-questions)
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`Exhibit
`No.
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`Exhibit
`No.
`
`Previously
`Submitted
`
`2020
`
`2021
`
`“An Introduction to Extended-Release Injectable
`Naltrexone for the Treatment of People with Opioid
`Dependence,” published by the Substance Abuse and
`Mental Health Services Administration (SAMHSA)
`(2012) (https://www.integration.samhsa.gov/
`Intro_To_Injectable_Naltrexone.pdf)
`Annual Report Pursuant to Section 13 or 15(d) of the
`Securities Exchange Act of 1934 for Alkermes PLC,
`Form 10-K, for the fiscal year ended December 31, 2017
`(http://phx.corporate-ir.net/External.File?item=
`UGFyZW50SUQ9NjkzNjEzfENoaWxkSUQ9NDA0OD
`MwfFR5cGU9MQ==&t=1)
`2022 Declaration of J. M. O’Malley
`Yun et al., “Controlled Drug Delivery: Historical
`2023
`perspective for the next generation,” Journal of
`Controlled Release, 219 2–7 (2015)
`2024 Kleber et al., “Nontolerance to the Opioid Antagonism of
`Naltrexone,” Biological Psychiatry, 20:66–72 (1985)
`Transcription of January 23, 2019 Deposition of Kinam
`2025
`Park, Ph.D.
`Guidance for Industry. Bioequivalence Studies with
`Pharmacokinetic Endpoints for Drugs Submitted Under
`an ANDA. FDA CDER (December 2013)
`Reserved
`Meyer et al., “Bioequivalence, Dose-Proportionality, and
`Pharmacokinetics of Naltrexone after Oral
`Administration,” Journal of Clinical Psychiatry, 45:9
`(Sept. 1984)
`Reserved
`
`2026
`
`2027
`
`2028
`
`2029
`
`X
`
`X
`
`X
`X
`
`X
`
`X
`
`X
`
`
`
`X
`
`
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`Exhibit
`No.
`
`2030
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`Previously
`Submitted
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`
`X
`
`X
`
`Hamilton et al., “Pharmacokinetics and
`Pharmacodynamics of Hyaluronan Infused into Healthy
`Human Volunteers,” Open Drug Metabolism J. 3 43–55
`(2009)
`2031 Dale et al., “Bioavailability of Rectal and Oral Methadone
`in Healthy Subjects” British J. Clin. Pharmac., 58(2):156–
`162 (Aug. 2004)
`Saghir & Schultz, Low-Dose Pharmacokinetics and Oral
`Bioavailability of Dichloroacetate in Naïve and GSTζ-
`Depleted Rats, Environmental Health Perspectives,
`110(8) 757–763 (Aug. 2002)
`Swanson et al., Development of a New Once-a-Day
`Formulation of Methylphenidate for the Treatment of
`Attention-deficit/Hyperactivity Disorder, Arch Gen
`Psychiatry, 60 204–211 (Feb. 2003)
`Remington: The Science and Practice of Pharmacy,
`(2000)
`Berkland et al., “Precise control of PLG microsphere size
`provides enhanced control of drug release rate,” J.
`Controlled Release 82 137–138 (2002)
`Reserved
`“FDA Approves Injectable Drugs to Treat Opioid-
`Dependent Patients,” PR Newswire (Oct. 2010)
`(https://www.prnewswire.com/news-releases/fda-
`approves-injectable-drug-to-treat-opioid-dependent-
`patients-104818409.html)
`2038 Karl Verebey, “The Clinical Pharmacology of
`Naltrexone: Pharmacology and Pharmacodynamics,”
`NIDA Monograph Series, 28 147–158 (1980)
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`2040
`
`2041
`
`Exhibit
`No.
`2039 Adam Bisaga, “XR-Naltrexone. As an Element of the
`Comprehensive Response to the Opioid Epidemic,”
`National Academies, Public Workshop on MAT
`(Oct. 2018) (http://www.nationalacademies.org/hmd/
`~/media/Files/Activity%20Files/MentalHealth/MATopioi
`dUseDisorder/BISAGA_MAT%20Public%20Workshop
`%20Final.pdf)
`“Medication Assisted Treatment for Opioid Addiction
`Phased Approach,” Quantum Units Education
`Comer et al., “Injectable, sustained-release naltrexone for
`the treatment of opioid dependence: a randomized,
`placebo-controlled trial,” Archives of General Psychiatry,
`63(2):210–18 (2006)
`Bardo et al., “Chronic naltrexone increases opiate binding
`in brain and produced supersenstitivty to morphine in the
`locus coeruleus of the rat,” Brain Res. 19 223–234 (1983)
`Lee et al., “Extended-Release Naltrexone to Prevent
`Opioid Relapse in Criminal Justice Offenders” N. Engl. J.
`Med. 374(13):1232–1242 (Mar. 2016)
`Reserved
`Lucey et al., “Hepatic Safety of Once-Monthly Injectable
`Extended-Release Naltrexone Administered to Actively
`Drinking Alcoholics,” Alcoholism: Clinical &
`Experimental Research, 32(3):498–504 (2008)
`Guidance for Industry: Expedited Programs for Serious
`Conditions – Drugs and Biologics. FDA CDER (May
`2014)
`Reserved
`Food and Drug Administration, “Kaopectate
`reformulation and upcoming labeling changes,” Drug
`Topics (2004)
`
`2042
`
`2043
`
`2044
`2045
`
`2046
`
`2047
`
`2048
`
`Previously
`Submitted
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`
`X
`
`
`X
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`LIST OF EXHIBITS
`(continued)
`Description
`
`Exhibit
`No.
`
`Previously
`Submitted
`X
`
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`
`
`2049
`
`2050
`
`2051
`
`University of Michigan Comprehensive Cancer Center,
`“Intramuscular (IM) Self-Injection,” UMCCC Skills Lab
`(Aug. 2008) (http://www.med.umich.edu/cancer/files/im-
`self-injection.pdf)
`Reserved
`“Cephalon Agrees to Buy Alcohol-Treatment Drug,”
`Bloomberg News (June 2005)
`(https://www.deseretnews.com/article/600144016/Cephal
`on-agrees-to-buy-alcohol-treatment-drug.html)
`Enersen et al., “Beating Heroin With ‘Willpower in a
`Shot,’” USA Today (Feb. 2015)
`(https://www.usatoday.com/story/news/health/2015/02/12
`/addiction-heroin-vivitrol/23263073/)
`2017 Top Ten Awardees, Clinical Research Forum (2017)
`(https://www.clinicalresearchforum.org/page/2017TopTe
`n)
`2054 Merriam-Webster’s Collegiate Dictionary, Eleventh
`Edition (2003) (excerpt)
`2055 Declaration of Cory J. Berkland, Ph.D.
`2056 Declaration of Charles P. O’Brien, M.D., Ph.D.
`Transcript of the deposition of Sara Quinney, Ph.D., taken
`on May 24, 2019
`
`2052
`
`2053
`
`2057
`
`
`
`
`
`
`Dated: June 21, 2019
`
`
`
`Case IPR2018-00943
`
`Respectfully submitted,
`
`By: /Naveen Modi/
`Naveen Modi
`Registration No. 46,224
`
`Counsel for Alkermes
`
`
`
`
`
`
`
`
`
`
`Case IPR2018-00943
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Petitioner a true and correct copy of the foregoing Patent Owner’s
`
`Current List of Exhibits by electronic means on June 21, 2019, at the following
`
`address of record:
`
`Michael H. Teschner
`Tedd W. Van Buskirk
`Lerner, David, Littenberg,
`Krumholz & Mentlik, LLP
`600 South Avenue West
`Westfield, NJ 07090
`
`MTeschner.ipr@ldlkm.com
`tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`
`Respectfully submitted,
`
`
`By: /Naveen Modi/
`Naveen Modi
`Reg. No. 46,224
`
`Counsel for Alkermes
`
`
`
`
`
`
`Dated: June 21, 2019
`
`
`
`
`
`
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