IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Mylan Laboratories Ltd.
`Petitioner,
`
`v.
`
`Janssen Pharmaceutica NV
`Patent Owner.
`
`U.S. Patent No. 9,439,906 to Vermeulen et al.
`Issue Date: September 13, 2016
`Title: Dosing Regimen Associated with Long
`Acting Injectable Paliperidone Esters
`
`Inter Partes Review No.: IPR2020-00440
`
`PETITIONER’S EXHIBIT LIST AS OF FEBRUARY 7, 2020
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Mylan Laboratories Ltd.
`Petitioner,
`
`v.
`
`Janssen Pharmaceutica NV
`Patent Owner.
`
`U.S. Patent No. 9,439,906 to Vermeulen et al.
`Issue Date: September 13, 2016
`Title: Dosing Regimen Associated with Long
`Acting Injectable Paliperidone Esters
`
`Inter Partes Review No.: IPR2020-00440
`
`PETITIONER’S EXHIBIT LIST AS OF FEBRUARY 7, 2020
`
`
`
`Exhibit #
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`1006
`
`1007
`
`1008
`1009
`
`1010
`
`1011
`
`1012
`
`U.S. Patent No. 9,439,906 (“the ’906 patent”)
`
`Declaration of Dr. Mansoor M. Amiji, Ph.D and Accompanying
`Exhibits
`Abstracts of the Annual Meeting of the American Society for
`Clinical Pharmacology and Therapeutics, 83 Supp. 1 Clin.
`Pharmacol. & Therapeutics S31, PI-74 and PI-75 (Mar. 2008)
`(“Cleton”)
`
`L. Citrome, Paliperidone: quo vadis?, Int. J. Clin. Pract. 61(1):653-
`662 (Apr. 2007) (“Citrome”)
`U.S. Patent No. 6,555,544 (“the ’544 patent”)
`Formulary Drug Reviews – Paliperidone, Hospital pharmacy
`42(7):637-647 July 2007 (“Paliperidone Formulary”)
`N. Washington, C. Washington, C. Wilson. Physiological
`Pharmaceutics: Barriers to Drug Absorption. (2001), pages 26-29
`(“Physiological Pharmaceutics”)
`U.S. Patent No. 6,495,534 (“the ’534 patent”)
`J.M. Kane, et al. Guidelines for depot antipsychotic treatment in
`schizophrenia. B. Eur. Neuropharmacol. 8(1):55-65 (1995)
`(“Kane”)
`N. Marder, et al. Pharmacokinetics of long-acting injectable
`neuroleptic drugs: clinical implications. Psychopharmacology.
`98:433-439 (1989) (“Marder”)
`
`M.E. Aulton. Pharmaceutics: The Science of Dosage Form Design
`(2002), Chapter 19 (“Aulton”)
`
`Comparison of the ’276 and the ’918 provisional application
`specifications (“Specification Comparison”)
`
`1013
`
`U.S. Patent No. 5,254,556 (“the ’556 patent”)
`
`
`
`Exhibit #
`
`Description
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`1024
`
`1025
`1026
`1027
`1028
`
` U.S. Patent No. 7,449,184 (“the ’184 patent”)
`
`R. Urso, P. Blardi, G. Giorgi. A short introduction to
`pharmacokinetics, Rev. Med. Pharmacol. Sci. 6: 33-44 (2002)
`(“Urso”)
`U.S. Provisional Application No. 61/014,918 (“the ’918
`provisional”)
`U.S. Provisional Application No. 61/120,276 (“the ’276
`provisional”)
`Excerpt of ’906 Patent Prosecution History (“6-12-2016
`Amendment and Response”)
`
`’906 Patent Prosecution History
`
`L. Ereshefsky, et al., Future of Depot Neuroleptic Therapy:
`Pharmacokinetic and Pharmacodynamic Approaches. J. Clin.
`Psychiatry, 45(5):50-59 (1984) (“Ereshefsky”)
`Goodman & Gilman’s, The Pharmacological Basis of Therapeutics
`(2001), Chapter 1 (“Goodman & Gilman”)
`D. Waller & A. Renwick, Principles of Medical Pharmacology
`(1994) (“Principles of Medical Pharmacology”)
`U.S. Patent No. 6,818,633 (“the ’633 patent”)
`
`Ansel et al., Pharmaceutical Dosage Forms and Drug Delivery
`Systems 8th ed. (2005) (“Added Substances”)
`Orange Book Entry for Invega Sustenna®
`
`Excerpt of ’906 Patent Prosecution History (“11-11-2015 IDS”)
`
`Curriculum Vitae of Dr. Mansoor Amiji
`
`Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA,
`Inc. et al., 2-18-cv-00734 (D.N.J.) (“Joint Claim Construction”)
`
`
`
`Exhibit #
`
`1029
`
`1030
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Description
`
`Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA,
`Inc. et al., 2-18-cv-00734 (D.N.J.) (“Claim Construction
`Agreement”)
`INVEGA SUSTENNA® Label (“INVEGA LABEL”)
`
`ClinicalTrials.gov, A Safety and Tolerability Study of Paliperidone
`Palmitate Injected in the Shoulder or the Buttock Muscle in
`Patients With Schizophrenia (July 2006),
`https://clinicaltrials.gov/ct2/history/NCT00119756?V_10=View#St
`udyPageTop (“NCT00119756”)
`ClinicalTrials.gov, A Study to Evaluate the Effectiveness and
`Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects
`With Schizophrenia (October 2006),
`https://clinicaltrials.gov/ct2/history/NCT00210548?V_11=View#St
`udyPageTop (“NCT00210548”)
`
`ClinicalTrials.gov, Safety and Efficacy of an Anti-Psychotic
`Versus Placebo in Subjects With Schizophrenia (November 2005),
`https://clinicaltrials.gov/ct2/history/NCT00101634?V_4=View#Stu
`dyPageTop (“NCT00101634”)
`
`ClinicalTrials.gov, A Study to Compare the Effectiveness and
`Safety of Flexibly Varied Doses of Paliperidone Palmitate and
`Risperidone in Treating Patients With Schizophrenia (July 2006),
`https://clinicaltrials.gov/ct2/history/NCT00210717?V_10=View#St
`udyPageTop (“NCT00210717”)
`
`ClinicalTrials.gov, Intramuscular Injections of Paliperidone
`Palmitate in the Arm or Buttock of Subjects With Schizophrenia
`(June 2005),
`https://clinicaltrials.gov/ct2/history/NCT00073320?V_1=View#Stu
`dyPageTop (“NCT00073320”)
`
`
`
`Exhibit #
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`Description
`
`ClinicalTrials.gov, Evaluate the Efficacy in the Prevention of
`Recurrence of the Symptoms of Schizophrenia (April 2006),
`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#Stu
`dyPageTop (“NCT00111189”)
`Guarino, Richard A. “Clinical research protocols.” New Drug
`Approval Process. CRC Press, 2004, pages 257-61
`Bishara, Delia, and David Taylor. “Upcoming agents for the
`treatment of schizophrenia.” Drugs 68.16 (2008): 2269-2292
`Kramer, M., et al. “322–Efficacy/tolerability of paliperidone
`palmitate: 9-week, placebo-controlled study in schizophrenia
`patients.” Schizophrenia Research 98 (2008): 165-166
`
`’906 Patent Specification as Filed
`
`Kramer M, Litman R, Lane R, et al. “908. Efficacy and tolerability
`of two fixed dosages of paliperidone palmitate in the treatment of
`schizophrenia: results of a 9-week placebo-controlled trial.” Biol
`Psychiatry 2008;63:1S-319S
`
`Declaration of Laboratory Research Analyst Alys Tryon
`
`Nankivell, Brian J. Creatinine clearance and the assessment of
`renal function. Australian Prescriber, 2001
`
`Perry, Paul J., ed. Psychotropic drug handbook. Lippincott Williams
`& Wilkins, 2007, pages 74-77
`
`Traynor, Jamie, et al. How to measure renal function in clinical
`practice. Bmj 333.7571 (2006): 733-737
`Janicak, Philip G., and Elizabeth A. Winans. Paliperidone ER: a
`review of the clinical trial data. Neuropsychiatric disease and
`treatment 3.6 (2007):869
`
`
`
`Exhibit #
`
`1047
`
`Description
`
`Physicians’ Desk Reference (2002), HALDOL® Decanoate
`
`
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