UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA OPERATIONS LIMITED, AND
`OPIANT PHARMACEUTICALS, INC.
`Patent Owners.
`_____________________
`
`CASE IPR2019-00685
`U.S. Patent No. 9,211,253
`_____________________
`
`PETITIONER NALOX-1 PHARMACEUTICALS, LLC’S
`UPDATED EXHIBIT LIST
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA OPERATIONS LIMITED, AND
`OPIANT PHARMACEUTICALS, INC.
`Patent Owners.
`_____________________
`
`CASE IPR2019-00685
`U.S. Patent No. 9,211,253
`_____________________
`
`PETITIONER NALOX-1 PHARMACEUTICALS, LLC’S
`UPDATED EXHIBIT LIST
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`TABLE OF EXHIBITS
`
`Description
`
`Nalox1001 U.S. Patent No. 9,211,253 (the ’253 patent)
`Nalox1002 Expert Declaration of Maureen Donovan
`Nalox1003 Expert Declaration of Günther Hochhaus
`Excerpt of File History of U.S. Patent No. 9,561,177, Aug. 22, 2016
`Office Action, Non-Final Rejection (Aug. 22, 2016 Non-Final
`Rejection)
`
`Nalox1004
`
`Nalox1005
`
`Excerpt of File History of U.S. Patent No. 9,561,177, Oct. 21, 2016
`Amendment and Response to Office Action (Oct. 21, 2016 Response
`to Office Action)
`
`Nalox1006
`
`Excerpt of File History of U.S. Patent No. 9,561,177, Dec. 21, 2016
`Office Action, Notice of Allowance and Fees Due (Notice of
`Allowance)
`Nalox1007 U.S. Patent No. 9,192,570 (Wyse)
`Nalox1008 Chinese Patent No. 1,575,795 (Wang)
`Nalox1009 PCT International App. Pub. No. WO00/62757 (Davies)
`Djupesland, P., Nasal Drug Delivery Device: Characteristics and
`Performance in a Clinical Perspective - A Review, 3 Drug Deliv. &
`Transl. Res. 42–62 (2013) (Djupesland)
`
`Nalox1010
`
`Nalox1011
`
`Grassin-Delyle, S. et al., Intranasal Drug Delivery: An Efficient and
`Non-invasive Route for Systemic Administration, Focus on Opioids,
`134 Pharm. & Ther. 366–79 (2012) (Grassin-Delyle)
`
`Nalox1012
`
`Handbook of Pharmaceutical Excipients, 56–60, 64–66, 78–81, 220–
`22, 242–44, 270-72, 441–45, 517–22, 596–98 (Rowe, R. et al. eds., 6th
`ed. 2009) (HPE)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Description
`
`Exhibit
`Number
`Nalox1013 Kushwaha, S. et al., Advances in Nasal Trans-Mucosal Drug Delivery,
`(1)7 J. Applied Pharm. Sci. 21–28 (2011) (Kushwaha)
`Nalox1014 U.S. Patent No. 5,866,154 (Bahal)
`Nalox1015 U.S. Patent No. 8,198,291 (the ’291 patent)
`Wermeling, D., A Response to the Opioid Overdose Epidemic:
`Naloxone Nasal Spray, 3 Drug Deliv. & Transl. Res. 63–74 (2013)
`(Wermeling 2013)
`Nalox1017 Alabama Department of Public Health, Alabama EMS Patient Care
`Protocols (7th ed., Oct. 2013) (Alabama EMS Protocols)
`
`Nalox1016
`
`Nalox1018
`
`Aptar Pharma, Press Release, Aptar Pharma Provides Unit-Dose Nasal
`Spray Technology for Treatment of Opioid Overdose (Apr. 20, 2016)
`(Aptar Press Release)
`
`Nalox1019
`
`Ashton, H. et al., Best Evidence Topic Report Intranasal Naloxone in
`Suspected Opioid Overdose, 23(3) Emerg. Med. J. 221–23 (2006)
`(Ashton)
`Nalox1020 Barton, E. et al., Intranasal Administration of Naloxone by
`Paramedics, 6 Prehosp. Em. Care 54–58 (Barton 2002)
`
`Nalox1021
`
`Barton, E. et al., Efficacy of Intranasal Naloxone as a Needleless
`Alternative for Treatment of Opioid Overdose in the Prehospital
`Setting, 29(3) J. Emerg. Med. 265–71 (2005) (Barton 2005)
`Nalox1022 Bitter, C. et al., Nasal Drug Delivery in Humans, 40 Curr. Probl.
`Dermatol. 20–35 (2011) (Bitter)
`Nalox1023 Boyer, E., Management of Opioid Analgesic Overdose, 367(2) N.
`Engl. J. Med. 146–55 (2012) (Boyer)
`Nalox1024 CDC, NDA No. 21-450 Clinical Pharmacology & Biopharmaceutics
`Review (2002) (Zomig Review)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Description
`
`Exhibit
`Number
`Nalox1025 Excerpt of Commonwealth of Kentucky, Kentucky Patient Care
`Protocols (Mar. 13, 2015) (Kentucky Patient Care Protocols)
`Nalox1026 Costantino, H. et al., Intranasal Delivery: Physiochemical and
`Therapeutic Aspects, 337 Int’l. J. of Pharm. 1–24 (2007) (Constantino)
`
`Nalox1027
`
`Dowling, J. et al., Population Pharmacokinetics of Intravenous,
`Intramuscular, and Intranasal Naloxone in Human Volunteers, 30(4)
`Ther. Drug. Monit. 490–96 (2008) (Dowling)
`
`Nalox1028
`
`FDA, Center for Drug Evaluation and Research, Guidance for
`Industry, Nasal Spray and Inhalation Solution, Suspension, and Spray
`Drug Products – Chemistry, Manufacturing, and Controls
`Documentation (2002) (2002 FDA Guidance)
`
`Nalox1029
`
`FDA, Center for Drug Evaluation and Research, Guidance for
`Industry, Bioavailability and Bioequivalence Studies for Nasal
`Aerosols and Nasal Sprays for Local Action (2003) (2003 FDA
`Guidance)
`
`Nalox1030
`
`Freise, K. et al., Naloxone Reversal of an Overdose of a Novel, Long-
`Acting Transdermal Fentanyl Solution in Laboratory Beagles, 35(2) J.
`Vet. Pharmacol. Therap. 45–51 (2012) (Freise)
`
`Nalox1031
`
`Glende, O., Development of non-injectable naloxone for pre-hospital
`reversal of opioid overdose: A Norwegian project and a review of
`international status (May 2016) (unpublished M.A. thesis, Norwegian
`University of Science and Technology) (on file with Norwegian
`University of Science and Technology) (Glende)
`
`Nalox1032
`
`Hertz, S., Naloxone for Outpatient Use: Data Required to Support an
`NDA, PowerPoint Presentation (Hertz Presentation)
`
`Nalox1033
`
`Intentionally left blank
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Description
`
`Nalox1034
`
`Kelly, A-M. et al., Randomised Trial of Intranasal Versus
`Intramuscular Naloxone in Prehospital Treatment for Suspected
`Opioid Overdose, 182(1) Med. J. Austl. 24–27 (2005) (Kelly)
`Nalox1035 Kerr, D. et al., Intranasal Naloxone for the Treatment of Suspected
`Heroin Overdose, 103 Addiction 379–86 (2008) (Kerr 2008)
`
`Nalox1036
`
`Kerr, D. et al., Randomized Controlled Trial Comparing the
`Effectiveness & Safety of Intranasal & Intramuscular Naloxone for the
`Treatment of Suspected Heroin Overdose, 104 Addiction 2067–74
`(2009) (Kerr 2009)
`
`Nalox1037
`
`Kleiman-Wexler, R. et al., Pharmacokinetics of Naloxone-An Insight
`into the Locus of Effect on Stress-Ulceration, 251(2) J. Pharmacol.
`Exp. Ther. 435–38 (1989) (Kleiman-Wexler)
`
`Nalox1038
`
`Marple, B. et al., Safety Review of Benzalkonium Chloride Used as a
`Preservative in Intranasal Solutions: An Overview of Conflicting Data
`and Opinions, 130 Otolaryngol Head Neck Surg. 131–41 (2004)
`(Marple)
`Nalox1039 Merck Index, Isotonic Solutions, MISC-47–69 (Windholz, M. et al.
`eds., 10th ed. 1983) (Merck Index)
`
`Nalox1040
`
`Merlin, M. et al., Intranasal Naloxone Delivery is an Alternative to
`Intravenous Naloxone for Opioid Overdoses, 28 Am. J. Emerg. Med.
`296–303 (2010) (Merlin)
`
`Nalox1041
`
`Middleton, L. et al., The Pharmacodynamic & Pharmacokinetic
`Profile of Intranasal Crushed Buprenorphine &
`Buprenorphine/Naloxone Tablets in Opioid Abusers, 106(8) Addiction
`1460–73 (2011) (Middleton)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Description
`
`Nalox1042
`
`Monitto, C. et al., The Optimal Dose of Prophylactic Intravenous
`Naloxone in Ameliorating Opioid-Induced Side Effects in Children
`Receiving Intravenous Patient-Controlled Analgesia Morphine for
`Moderate to Severe Pain: A Dose Finding Study, 113(4) Anesthesia &
`Analgesia 834–42 (2011) (Monitto)
`Nalox1043 Pharmacodynamic Agents, in Foye’s Principles of Medicinal
`Chemistry, 670 (Lemke, T. et al. eds., 6th ed. 2008) (Lemke)
`
`Nalox1044
`
`Physicians’ Desk Reference, NARCAN [Naloxone Hydrochloride
`Injection, USP], IMITREX Nasal Spray [Sumatriptan], 1300–02,
`1546–50 (57th ed., 2003) (PDR 2003)
`Nalox1045 Physicians’ Desk Reference, ZOMIG Nasal Spray [Zolmitriptan],
`768–78 (64th ed., 2010) (PDR 2010)
`
`Nalox1046
`
`Robertson, T. et al., Intranasal Versus Intravenous Naloxone for
`Prehospital Narcotic Overdose, Abstract, 12(5)(1) Acad. Emerg. Med.
`166–67 (2005) (Robertson 2005)
`
`Nalox1047
`
`Robertson, T. et al., Intranasal Naloxone is a Viable Alternative to
`Intravenous Naloxone for Prehospital Narcotic Overdose, 13 Prehosp.
`Emerg. Care 512–15 (2009) (Robertson 2009)
`
`Nalox1048
`
`Role of Naloxone in Opioid Overdose Fatality Prevention; Public
`Workshop; Request for Comments, 76 Fed. Reg. 71,348 (Nov. 17,
`2011) (Role of Naloxone Fed. Reg. Notice)
`Nalox1049 Role of Naloxone in Opioid Overdose Fatality Prevention FDA
`Meeting Transcript (Apr. 12, 2012) (2012 FDA Meeting)
`
`Nalox1050
`
`Rosanske, T., Morphine, in Chemical Stability of Pharmaceuticals: A
`Handbook for Pharmacists, 604–11 (Connors, K. et al. eds., 2d ed.
`1986) (Rosanske)
`
`Nalox1051
`
`Sabzghabaee, A. et al., Naloxone Therapy in Opioid Overdose
`Patients: Intranasal or Intravenous? A Randomized Clinical Trial,
`10(2) Arch. Med. Sci. 309–14 (2014) (Sabzghabaee)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Nalox1052
`
`Intentionally left blank
`
`Description
`
`Nalox1053
`
`Trows, S. et al., Analytical Challenges and Regulatory Requirements
`for Nasal Drug Products in Europe and the U.S., 6 Pharm. 195–219
`(2014) (Trows)
`Nalox1054 United States Pharmacopeia and National Formulary (USP 36-NF 31)
`Vol 1., 54–55, 930–33 (2013) (USP)
`Nalox1055 U.S. Patent Appl. No. 61/918,802 (the ’802 Appl.)
`Nalox1056 U.S. Patent No. 5,307,953 (’953 patent)
`Nalox1057 U.S. Patent No. 5,813,570 (’570 patent)
`Nalox1058 U.S. Provisional Patent Appl. No. 61/953,379 (the ’379 provisional)
`Wermeling, D., Opioid Harm Reduction Strategies: Focus on
`Expanded Access to Intranasal Naloxone, 30(7) Pharmacotherapy
`627–31 (2010) (Wermeling 2010)
`
`Nalox1059
`
`Nalox1060
`
`Loimer, N. et al, Nasal Administration of Naloxone is as Effective as
`the Intravenous Route in Opiate Addicts, 29(6) Int’l J. of Addictions
`819–27 (1994) (Loimer)
`
`Nalox1061
`
`Doe-Simkins, M. et al., Saved by the Nose: Bystander-Administered
`Intranasal Naloxone Hydrochloride for Opioid Overdose, 99(5) Am. J.
`Pub. Health 788–91 (2009)
`
`Nalox1062
`
`McDermott, C. & Collins, N., Prehospital Medication Administration:
`A Randomised Study Comparing Intranasal and Intravenous Routes,
`Em. Med. Int’l. 1–5 (2012)
`
`Nalox1063
`Intentionally left blank
`Nalox1064 Authenticating Affidavit of Christopher Butler (“Butler Affidavit”)
`Nalox1065 Authenticating Affidavits of Rachel J. Watters
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Description
`
`Nalox1066 Authenticating Affidavit of Pamela Lipscomb
`Nalox1201 Supplemental Expert Declaration of Maureen Donovan
`Nalox1202 Supplemental Expert Declaration of Günther Hochhaus
`Agency for Healthcare Research & Quality, H.H.S., Comparative
`Effectiveness Review, Management of Suspected Opioid Overdose
`With Naloxone by Emergency Medical Services Personnel No. 193
`(2017) (AHRQ 2017)
`Nalox1204 Asali, L.A. & Brown, K.F., Naloxone Protein Binding in Adult and
`Foetal Plasma, 27 Eur. J. Clin. Pharmacol. 459–63 (1984) (Asali)
`
`Nalox1203
`
`Nalox1205
`
`Intentionally left blank
`
`Nalox1206
`
`Bureš, F., Quaternary Ammonium Compounds: Simple in Structure,
`Complex in Application, 377(14) Topics in Current Chemistry (2019)
`(Bureš)
`
`Nalox1207
`
`Committee on Drugs, American Academy of Pediatrics, Naloxone
`Dosage and Route of Administration for Infants and Children:
`Addendum to Emergency Drug Doses for Infants and Children, 86(3)
`Pediatrics 484–85 (1990) (Pediatrics 1990)
`
`Nalox1208
`
`Connors, K. et al., Oxidation and Photolysis, in Chemical Stability of
`Pharmaceuticals: A Handbook for Pharmacists 82–114 (2d ed. 1986)
`(Connors)
`
`Nalox1209
`
`Intentionally left blank
`
`Nalox1210
`
`Ehrick, J. et al., Considerations for the Development of Nasal Dosage
`Forms, in Sterile Product Development: Formulation, Process, Quality
`and Regulatory Considerations 99–144 (Parag Kolhe, et al., eds.,
`2013) (Ehrick)
`Nalox1211 Exploring Naloxone Uptake and Uses, FDA Meeting Transcript (July
`1, 2015) (2015 FDA Meeting)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Description
`
`Nalox1212
`
`Intentionally Left Blank
`
`Nalox1213
`
`FDA, Center for Drug Evaluation and Research, Guidance for
`Industry, Q8(R2) Pharmaceutical Development (Revision 2 2009)
`(2009 FDA Guidance)
`
`Nalox1214
`
`Hiom, S., Preservation of Medicines and Cosmetics, in Principles and
`Practice of Disinfection, Preservation & Sterilization 484–514 (Fraise,
`A.P. et al., eds., 4th ed. 2004) (Hiom)
`
`Nalox1215
`
`Hochhaus, G. & Derendorf, H., Dose Optimization Based on
`Pharmacokinetic/Pharmacodynamic Modeling, Handbook of
`Pharmacokinetic/Pharmacodynamic Correlation 79-120 (1995)
`(Hochhaus 1995)
`
`Nalox1216
`
`Hochhaus, G. et al., A New Solution-Based Intranasal Triamcinolone
`Acetonide Formulation in Patients with Perennial Allergic Rhinitis:
`How Does the Pharmacokinetic/Pharmacodynamic Profile for
`Cortisol Suppression Compare with an Aqueous Suspension-Based
`Formulation?, 42 J. Clin. Pharmacol. 662–69 (2002) (Hochhaus 2002)
`
`Nalox1217
`
`Hochhaus, G. et al., Pharmacokinetic/Pharmacodynamic Aspects of
`Aerosol Therapy using Glucocorticoids as a Model, 37 J. Clin.
`Pharmacol. 881–92 (1997) (Hochhaus 1997)
`
`Nalox1218
`
`Hsu, H. et al., Effect of Formulation Variables on the Nasal
`Permeability and Stability of Naloxone Intranasal Formulations,
`20(232) AAPS PharmaSciTech (2019) (Hsu)
`
`Nalox1219
`
`Inactive Ingredient Search for Approved Drug Products, Search
`Names Beginning with B, U.S. FDA (Mar. 3, 2020, 12:08 PM),
`https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?event=brow
`seByLetter.page&Letter=B (FDA B Names)
`
`
`
`Exhibit
`Number
`
`Nalox1220
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Description
`
`Inactive Ingredient Search for Approved Drug Products: Frequently
`Asked Questions, U.S. FDA (Mar. 3, 2020, 12:12 PM),
`https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-
`ingredient-search-approved-drug-products-frequently-asked-questions
`(FDA FAQ)
`
`Nalox1221
`
`Jambhekar S. & Breen, P., Extravascular Routes of Drug
`Administration, in Basic Pharmacokinetics, 97-124 (2009)
`(Jambhekar)
`
`Nalox1222
`
`Kanaan, M. et al., P-glycoprotein Is Not Involved in the Differential
`Oral Potency of Naloxone and Naltrexone, 23 Fundamental & Clin.
`Pharmacol. 543–48 (2009) (Kanaan)
`
`Nalox1223
`
`Kerensky, T. & Walley, A., Opioid Overdose Prevention and
`Naloxone Rescue Kits: What We Know and What We Don’t Know,
`12(4) Addict. Sci. Clin. Pract. 1–7 (2017) (Kerensky)
`
`Nalox1224
`
`Kim, S. et al., Longer Occupancy of Opioid Receptors by Nalmefene
`Compared to Naloxone as Measured In Vivo by a Dual-Detector
`System, 38(11) J. Nuclear Med. 1726–31 (1997) (Kim)
`
`Nalox1225
`
`Kreiter, P. et al., Pharmacokinetic Interaction between Naloxone and
`Naltrexone Following Intranasal Administration to Healthy Subjects,
`47(7) Drug Metabolism and Disposition 690–98 (2019) (Kreiter 2019)
`
`Nalox1226
`
`Krieter, P. et al., Pharmacokinetic Properties and Human Use
`Characteristics of an FDA-Approved Intranasal Naloxone Product for
`the Treatment of Opioid Overdose, 00(0) J. Clin. Pharmacol. 1–11
`(2016) (Kreiter 2016)
`Nalox1227 Marx, D. et al., Intranasal Drug Administration – An Attractive
`Delivery Route for Some Drugs, InTech Open (2015) (Marx)
`
`Nalox1228
`
`Melichar, J.K. et al., Naloxone Displacement at Opioid Receptor Sites
`Measured In Vivo in the Human Brain, 459 Eur. J. Pharmacol. 217–19
`(2003) (Melichar)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Description
`
`Mueller, S.R., A Review of Opioid Overdose Prevention and Naloxone
`Prescribing: Implications for Translating Community Programming
`into Clinical Practice, 36(2) Subst. Abus. 240–53 (2015) (Mueller)
`
`Exhibit
`Number
`
`Nalox1229
`
`Nalox1230
`
`Pace, N.L. et al., Pharmacokinetics of Naloxone and Naltrexone in the
`Dog, 208(2) J. Pharmacol. Experimental Therapeutics 254–56 (1979)
`(Pace)
`
`Nalox1231
`
`Quarry, M. et al., Investigation of 4,5-epoxymorphinan Degradation
`During Analysis by HPLC, 30 J. Pharm. Biomed. Anal. 99–104 (2002)
`(Quarry)
`
`Nalox1232
`Intentionally left blank
`Nalox1233 Sporer, K.A. et al., Out-of-hospital Treatment of Opioid Overdoses in
`an Urban Setting, 3(7) Academic Em. Med. 660–67 (1996) (Sporer)
`
`Nalox1234
`
`Suarez, S. et al., Effect of Dose and Release Rate on Pulmonary
`Targeting of Liposomal Triamcinolone Acetonide Phosphate, 15(3)
`Pharm. Res. 461–465 (1998) (Suarez)
`
`Nalox1235
`
`Sugano, K., Estimation of Effective Intestinal Membrane Permeability
`Considering Bile Micelle Solubilisation, 368 Int. J. Pharms. 116–22
`(2009) (Sugano)
`
`Nalox1236
`
`Suzuki, T. et al., Involvement of an Influx Transporter in the Blood-
`Brain Barrier Transport of Naloxone, 31 Biopharm. & Drug
`Disposition 243–52 (2010) (Suzuki)
`
`Nalox1237
`
`Talton, J. et al., Nano-Thin Coatings for Improved Lung Targeting of
`Glucocorticoid Dry Powders: In-Vitro and In-Vivo Characteristics,
`Respiratory Drug Delivery VII (2000) (Talton)
`
`Nalox1238
`
`Wanger, K. et al., Intravenous vs Subcutaneous Naloxone for Out-of-
`hospital Management of Presumed Opioid Overdose, 5(4) Acad.
`Emerg. Med. 293–99 (1998) (Wanger)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Description
`
`Weinstein, S. et al., Absorption and Distribution of Naloxone in Rats
`after Oral and Intravenous Administration, 62(9) J. Pharm. Sci. 1416–
`19 (1973) (Weinstein)
`
`Exhibit
`Number
`
`Nalox1239
`
`Nalox1240
`
`Yeh, S. & Lach, J., Stability of Morphine in Aqueous Solution III:
`Kinetics of Morphine Degradation in Aqueous Solution, 50(1) J.
`Pharm. Sci. 35–42 (1961) (Yeh)
`Nalox1241 Yu, L. et al., Understanding Pharmaceutical Quality by Design, 16(4)
`The AAPS J. 771–83 (2014) (Yu)
`Nalox1242 Zuckerman, M. et al., Pitfalls of Intranasal Naloxone, 18(4) Prehosp.
`Em. Care 550–54 (2014) (Zuckerman)
`
`Nalox1243
`
`Nalox1244
`
`Nalox1245
`
`Nalox1246
`
`Astepro Label (Aug. 31, 2009), U.S. FDA Drug Label Database (Mar.
`2, 2020)
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s0
`03lbl.pdf (ASTEPRO)
`
`Patanase Label (Feb. 22, 2012) U.S. FDA Drug Label Database (Mar.
`2, 2020)
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021861s0
`09lbl.pdf (PATANASE)
`
`Nasacort Allergy 24H Label (July 2, 2013), U.S. FDA Drug Label
`Database (Mar. 2, 2020)
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s0
`33s034lbl.pdf (NASACORT)
`
`Flonase Sensimist Label (Aug. 2, 2016), U.S. FDA Drug Label
`Database (Mar. 2, 2020)
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022051Or
`ig1s013lbl.pdf (FLONASE)
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`Exhibit
`Number
`
`Description
`
`Nalox1247
`
`Xhance Label (Sept. 18, 2017), U.S. FDA Drug Label Database (Mar.
`2, 2020)
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209022s0
`00lbl.pdf (XHANCE)
`PROTECTIVE ORDER MATERIAL
`February 21, 2020 Transcript of Deposition of Dr. Stuart Allen Jones
`(Jones Dep.)
`Nalox1249 Handbook of Pharmaceutical Excipients, 579–81 (Rowe, R. et al. eds.
`6th ed. 2009) (HPE Potassium Sorbate)
`
`Nalox1248
`
`Nalox1250
`
`Lemiuex, M., Police Dog Saved with Narcan after Accidental
`Exposure to Fentanyl During Drug Bust, Newsweek (Mar. 11, 2020),
`https://www.newsweek.com/police-dog-saved-narcan-after-accidental-
`exposure-fentanyl-during-drug-bust-1479419 (Lemiuex)
`Nalox1251 U.S. Patent No. 9,468,747 (’747 patent)
`Nalox1252 May 4, 2020 Transcript of Deposition of Dr. Stuart Allen Jones (2d
`Jones Dep.)
`
`Date: May 8, 2020
`
`Respectfully submitted,
`
`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
`
`
`
`IPR2019-00685 – U.S. Patent No. 9,211,253
`Updated Exhibit List
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned “Petitioner Nalox-
`
`1 Pharmaceuticals, LLC’s Updated Exhibit List,” was served in its entirety on May
`
`8, 2020, upon the following parties via e-mail:
`
`Jessamyn S. Berniker (jberniker@wc.com)
`Ana C. Reyes (areyes@wc.com)
`David M. Krinsky (dkrinsky@wc.com)
`Anthony H. Sheh (asheh@wc.com)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`(202) 434-5000
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
`
`Jessica Tyrus Mackay (jmackay@greengriffith.com)
`Ann K. Kotze (akotze@greengriffith.com)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
`
`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, D.C. 20006
`(202) 857-6000
`yelee.kim@arentfox.com
`
`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
`
`
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