UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`_________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`_________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`EXHIBIT LIST
`
`Exhibit Description
`
`Exhibit
`No.
`2001
`
`López-Muñoz et al., “History of the discovery and clinical introduction
`of chlorpromazine,” Annals of Clinical Psychiatry. 17:113–35 (2005).
`ZYPREXA® (olanzapine) Label (2000).
`ABILIFY® (aripiprazole) Label (2002).
`LATUDA® (lurasidone) Label (2018).
`Laursen, “Excess Early Mortality in Schizophrenia,” Annu. Rev. Clin.
`Psychol. 10:425-48 (2014).
`Olfson et al., “Premature Mortality Among Adults with Schizophrenia
`in the United States,” JAMA Psychiatry 72(12) 1172-81(2015).
`Complaint filed 2/13/2018 in Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc. v. Emcure Pharmaceuticals Ltd.,
`Case 2:18-cv-02065.
`Complaint filed 2/23/2018 in Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc. v. Aurobindo Pharm Ltd. et al.,
`Case 2:18-cv-02620.
`Complaint filed 8/31/2018 in Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc. v. Piramal Healthcare UK
`Limited, Case 2:18-cv-13478.
`Complaint filed 9/12/2018 in Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc. v. Macleods Pharmaceuticals Ltd.
`and Macleods Pharma USA Inc., Case 2:18-cv-13833.
`Complaint filed 10/09/2018 in Sumitomo Dainippon Pharma Co., Ltd.
`and Sunovion Pharmaceuticals Inc. v. Alkem Laboratories Ltd., Case
`2:18-cv-14787.
`Press Release: “Sumitomo Dainippon Pharma Announces Resolution
`of Disputes Under Consolidated Patent Infringement Lawsuit
`Regarding ANDAs for Latuda® in the U.S.,” November 27, 2018.
`2013 Meltzer, “Treatment of Schizophrenia and Spectrum Disorders:
`Pharmacotherapy, Psychosocial Treatments, and Neurotransmitter
`Interactions,” Biol. Psychiatry 46:1321-1327 (1999).
`
`2002
`2003
`2004
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`1
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`Stip, “Novel antipsychotics: issues and controversies. Typicality of
`atypical antipsychotics,” J. Psychiatry Neurosci 25(2):137-53 (2000).
`Tarazi and Stahl, “Iloperidone, Asenapine and Lurasidone: A Primer
`on their Current Status,” Expert Opin. Pharmacother. 13(13): 1911-22
`(2012).
`Diagnostic and Statistical Manual of Mental Disorders, 3rd Edition,
`1980 (Excerpt).
`Neel Burton, A Short History of Bipolar Disorder, Psychology Today,
`updated September 7, 2017.
`RESERVED
`Diagnostic and Statistical Manual of Mental Disorders, 4th Edition,
`2005, pp. 350-358.
`Newcomer, “Second-Generation (Atypical) Antipsychotics and
`Metabolic Effects: A Comprehensive Literature Review,” CNS
`DrugsTM Supplement, vol. 19, supplement 1, pp. 1-93 (2005).
`Allison et al., “Antipsychotic-Induced Weight Gain: A
`Comprehensive Research Synthesis,” Am J Psychiatry 156:1686-96
`(1999).
`Green et al., “Weight Gain from Novel Antipsychotic Drugs: Need for
`Action,” General Hospital Psychiatry 22:224-35 (2000).
`Risperdal® Label.
`Attachment 1 Ziprasidone (Ziprasidone HCI) NDA 20-825 Approval
`Letter and Labeling (2001).
`Geodon® Label (2017).
`Dawkins et al., “Antipsychotics: Past and Future, National Institute of
`Mental Health Division of Services and Intervention Research
`Workshop, July 14, 1998,” Schizophrenia Bulletin 25(2):395-405
`(1999).
`Stahl, S., 2013. Stahl’s Essential Psychopharmacology. 4th ed.
`Cambridge University Press, Chapter 5.
`Casey et al., “The Pharmacology of Weight Gain with Antipsychotics,”
`J Clin. Psychiatry 62[suppl 7]:4-10 (2001).
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`2024
`
`2025
`2026
`
`2027
`
`2028
`
`2
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`2029
`
`2030
`
`2036
`
`2038
`
`2039
`
`2040
`
`2037
`
`Reynolds, “Weight Gain, Antipsychotic Drug Treatment and
`Pharmacogenomics,” Pharmacogenomics 3(5):567-70 (2002).
`Loebel and Citrome, “Lurasidone: a novel antipsychotic agent for the
`treatment of schizophrenia and bipolar depression,” BJPsych Bulletin
`39:237-41 (2015).
`Notice of allowance mailed 8/13/15 (U.S. 9,174,975).
`2031
`2032 Wong et al., U.S. Patent No. 6,964,962.
`2033
`Pozuelo, U.S. Patent Pub. No. 2001/0047010.
`2034
`Seroquel XR (quetiapine fumarate) Extended-Release Tablets Label
`2009.
`2035 Wirshing et al., “Novel Antipsychotics: Comparison of Weight Gain
`Liabilities,” J Clin Psychiatry 60:358-63 (1999).
`Jones et al., “Weight Change and Antipsychotic Treatment in Patients
`with Schizophrenia,” J Clin Psychiatry 62[suppl 2]:41-44 (2001).
`Loebel et al., “Efficacy and safety of lurasidone 80 mg/day and 160
`mg/day in the treatment of schizophrenia: A randomized, doubleblind,
`placebo- and active-controlled trial,” Schizophrenia Research 145:101-
`109 (2013).
`Daniel et al., “Ziprasidone 80 mg/day and 160 mg/day in
`the Acute Exacerbation of Schizophrenia and
`Schizoaffective Disorder: A 6-Week Placebo-Controlled
`Trial,” Neuropsychopharmacology 20(5):491-505 (1999).
`Reynolds et al., “The 5-HT2C receptor and antipsychotic induced
`weight gain – mechanisms and genetics,” J. Psychopharmacology
`20(4) Supplement 15-18 (2006).
`Certified Translation of Horisawa et al., Japanese Journal of
`Neuropsychopharmacology 19(6) 1999.
`2041 Mentalhelp.net “Schizophrenia Symptoms, Patterns and Statistics and
`Patterns”, downloaded from the internet at
`https://www.mentalhelp.net/schizophrenia/statistics/ on September 10,
`2020.
`Ritchie et al. “Mental Health,” downloaded from the internet at
`https://ourworldindata.org/mental-health on September 10, 2020.
`
`2042
`
`3
`
`
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`2049
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`FDA Atypical Antipsychotic Drugs Information, downloaded from the
`internet at https://www.fda.gov/drugs/postmarket-drug-safety-
`information-patients-and-providers/atypical-antipsychotic-drugs-
`information on September 10, 2020.
`Franklin, “Lurasidone for the treatment of bipolar depression: an
`evidence-based review,” Neuropsychiatric Disease and Treatment,
`2015:11 2143–2152 (2015).
`Shayegan et al., “Atypical Antipsychotics: Matching Receptor Profile
`to Individual Patient’s Clinical Profile,” CNS Spectrums 9(10)(suppl
`11):6-14 (October, 2004).
`Kane et al. “Clozapine for the Treatment-Resistant Schizophrenia.”
`Arch Gen Psychiatry, Vol. 45, September 1988, pp. 789-796.
`Nashed et al., “Olanzapine-Induced Weight Gain in Patients with
`Bipolar I Disorder: A Meta-Analysis,” Prim. Care Companion CNS
`Disord. 13(6) (2011).
`Symbyax® Label.
`Seroquel® Label.
`Lieberman et al., “Effectiveness of Antipsychotic Drugs in Patients
`with Chronic Schizophrenia,” New Eng. J. Med. 353(12) 1209-1223
`(September 22, 2005).
`Thase, “Quetiapine monotherapy for bipolar depression,”
`Neuropsychiatric Disease and Treatment 4(1) 21-31, pp. 11-21 (2008).
`Hoyberg et al., “Risperidone versus perphenazine in the treatment of
`chronic schizophrenic patients with acute exacerbations,” Acta
`Psychiatr. Scand 88:395-402 (1993).
`Lombardo et al., “Two 6-Week, randomized, Double-Blind, Placebo-
`Controlled Studies of Ziprasidone in Outpatients with Bipolar I
`Depression,” J Clin Psychopharmacol. 32(4) pp. 470-478 (2012).
`Sachs et al., “Efficacy and Safety of Adjunctive Oral Ziprasidone for
`Acute Treatment of Depression in Patients With Bipolar I Disorder: A
`Randomized, Double-Blind, Placebo-Controlled Trial,” J Clin
`Psychiatry 72(10):1413-1422 (2011).
`
`4
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`2055
`
`2056
`
`2057
`
`2058
`
`Pacher et al., “Cardiovascular Side Effects of New Antidepressants and
`Antipsychotics: New Drugs, Old Concerns?” Curr Pharm Des.
`10(20):2463-2475, 6 (2004).
`Stimmel at al., “Ziprasidone: An Atypical Antipsychotic Drug for the
`Treatment of Schizophrenia,” Clinical Therapeutics 24(1): 21-37
`(2002).
`Fala, “Latuda (Lurasidone HCL) Receives 2 New Indications for Use
`in Bipolar Depression as Monotherapy and as Adjunctive Therapy with
`Lithium or Valproate,” American Health & Drug Benefits, Vol. 7, pp.
`123-126 (2014).
`CONFIDENTIAL D1050231 Clinical Study Report, October 23,
`2009.
`CONFIDENTIAL D1050233 Clinical Study Report, May 3, 2011.
`2059
`CONFIDENTIAL D1050249 Clinical Study Report, October 5, 2009.
`2060
`2061 Meltzer et al., “Lurasidone in the Treatment of Schizophrenia: A
`Randomized, Double-Blind, Placebo- and Olanzapine-Controlled
`Study,” Am J Psychiatry 168:957-967 (2011).
`RESERVED
`RESERVED
`Correll et al., “Effects of Olanzapine Combined With Samidorphan on
`Weight Gain in Schizophrenia: A 24-Week Phase 3 Study”, Am. J.
`Psych., vol. 177, No. 12, 1168-78 (Dec. 2020).
`RESERVED
`Reiffen et al., “Generic Drug Industry Dynamics,” The Review of
`Economics and Statistics, Vol. 87, No. 1, pp. 37-49 (2005).
`DiMasi et al. “The price of innovation: new estimates of drug
`development costs,” Journal of Health Economics, Vol. 22, 151-185
`(2003).
`Samalin et al., “Clinical potential of lurasidone in the management of
`schizophrenia,” Therapeutics and Clinical Risk Management, Vol. 7,
`pp. 239–250 (2011).
`CONFIDENTIAL Lurasidone, Strategic Business Plan, October 1,
`2009.
`
`2062
`2063
`2064
`
`2065
`2066
`
`2067
`
`2068
`
`2069
`
`5
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`2070
`2071
`
`2072
`
`2073
`
`2074
`2075
`
`2076
`
`2077
`
`2078
`2079
`
`2080
`
`2081
`2082
`
`2083
`
`Latuda® Product Monograph.
`O’Day et al., “Long-term cost-effectiveness of atypical antipsychotics
`in the treatment of adults with schizophrenia in the U.S.,”
`ClinicoEconomics and Outcomes Research, Vol. 5, pp. 459–470
`(2013).
`Dainippon Sumitomo Pharma Co., Ltd., Supplementary Financial Data
`for Year Ended March 31, 2014.
`Jancin, Newer Atypical Antipsychotics Draw Praise, Internal Medicine
`News, March 22, 2011.
`CONFIDENTIAL Latuda Financial Information FY11-FY20 YTD.
`CONFIDENTIAL LATUDA Monthly Commercial Analytics
`Meeting, June 2016.
`CONFIDENTIAL LATUDA Situational Assessment – FY 2020, Aug
`2, 2020.
`Albright, “Three key antipsychotics lose patent protection,”
`downloaded from the internet at:
`https://www.behavioral.net/article/three-key-antipsychotics-lose-
`patent-protection on September 20, 2018.
`CONFIDENTIAL Latuda® (lurasidone HCl) 2013 Brand Plan.
`Pareek, “Factors Affecting Non-Compliance to Psychotropic Drugs of
`Patients with Psychosis as Perceived by their Family Members
`Attending the Psychiatric Outpatient Department at Selected Hospital,
`Mangalore”, Nursing and Midwifery Research Journal, Vol. 9, No. 2,
`April 2013 pp. 56-62.
`CONFIDENTIAL Latuda Physician ATU Tracker Findings, Q3’11
`Insights Report.
`RESERVED
`CONFIDENTIAL LATUDA – Bipolar Depression HCP ATU, FY16-
`Q4, March 20, 2017.
`CONFIDENTIAL The Bipolar Disorder Patient Journey, Sunovion
`Commercial Insights & Analytics, INSYNC, June 22, 2020.
`
`6
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`2084
`
`2085
`
`2086
`
`Ng-Mak et al., “Patient Preferences for Important Attributes of Bipolar
`Depression Treatments: A Discrete Choice Experiment,” Patient
`Preference and Adherence, Vol. 12, pp. 35-44 (2018).
`Ng-Mak et al., “Efficacy and Metabolic Effects of Lurasidone Versus
`Brexpiprazole in Schizophrenia: A Network Meta-Analysis,” J. Comp.
`Eff.Res., 7(8), pp. 737-748 (2018).
`Rajagopalan et al., “Cost-Utility Analysis of Lurasidone Versus
`Aripiprazole in Adults with Schizophrenia,” Pharmacoeconomics,
`34:709-721 (2016).
`2087 Mattingly et al., “Switching to Lurasidone Following 12 Months of
`Treatment with Risperidone: Results of a 6-Month, Open-Label
`Study,” BMC PSYCHIATRY, 20:199 (2020).
`2088 Mak et al., Cost Savings Associated with Improved Adherence Among
`Patients with Schizophrenia Using Lurasidone, APA Annual Meeting
`Abstract Submission, 2016.
`CONFIDENTIAL Sunovion Senior Leadership Budget Presentation,
`Latuda Brand Strategy and Budget, December 10, 2010.
`CONFIDENTIAL Latuda® 2012 Budget Presentation Meeting,
`November 7, 2011.
`Comparison of Atypical Antipsychotics,” Pharmacists Letter (2015).
`Available at:
`http://pharmacistsletter.therapeuticresearch.com/pl/ArticlePDF.aspx?D
`etailID=310701.
`CONFIDENTIAL Covance Cardiac Safety Services, Phase III
`Repolarization Assessment Plan, Lurasidone, Feb. 13, 2007.
`CONFIDENTIAL Medifacts International, Review of the Preliminary
`Results from MK-3756 Protocol 023, February 7, 2007.
`CONFIDENTIAL Clinical Pharmacology and Biopharmaceutics
`Review Aid, Dainippon Sumitomo Pharma America, Inc., Lurasidone.
`CONFIDENTIAL Sunovion FDA Contact Report, Lurasidone HCl,
`October 25, 2010.
`Poyurovsky et al., “Attentuation of Olanzapine-Induced Weight Gain
`in Patients with Schizophrenia: A Double Blind, Placebo-Controlled
`Study,” Am J. Psychiatry, 160:297-302 (2003).
`
`2093
`
`2089
`
`2090
`
`2091
`
`2092
`
`2094
`
`2095
`
`2096
`
`7
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`Poyurovsky et al., “Attentuating Effect of Reboxetine on Appetite and
`Weight Gain in Olanzapine-Treated Schizophrenia Patients: A
`Double-Blind, Placebo-Controlled Study,” Psychopharmacology,
`192:441-448 (2007).
`Zhuo et al., “Topiramate and Metformin Are Effective Add-On
`Treatments in Controlling Anti-Psychotic Weight Gain: A Systematic
`Review and Network Meta-Analysis,” Frontiers in Pharmacology,
`9:1393 (2018).
`RESERVED
`
`2097
`
`2098
`
`2099-
`2130
`2131
`2132
`2133
`2134
`2135
`
`CONFIDENTIAL Declaration of Dr. Stephen Stahl.
`CONFIDENTIAL Declaration of Dr. Brian Reisetter.
`Declaration of Scott Stancell-Condron.
`Deposition Transcript (Dr. Thomas Kosten).
`Hummel et al., “Clozapine as Add-On Medication in the Maintenance
`Treatment of Bipolar and Schizoaffective Disorder,” Neuropsychology,
`45 (suppl. 1):37-42 (2002).
`2136 McElroy et al., “Pharmacologic Agents for the Treatment of Acute
`Bipolar Mania,” Biol. Psychiatry, 48:539-557 (2000).
`2137 Weiden, “Partial Compliance and Risk of Rehospitalization Among
`California Medicaid Patients with Schizophrenia, Psychiatric
`Services,” August 2004, Vol. 55, No. 8.
`CONFIDENTIAL Memorandum With Respect to Lurasidone
`Development Handover Status (2007).
`Tohen et al., Am J. Psychiatry, 156:702-709 (1999).
`2139
`2140 Möller, J. Clin. Psych., 64 (Suppl. 6):23-27 (2003).
`2141
`News Release: “FDA Approves Once-Daily Latuda® (lurasidone
`HCl) for Treatment of Patients with Schizophrenia,” October 28, 2010.
`News Release: “Sunovion Pharmaceuticals Inc. Announces FDA
`Approval of Latuda® (lurasidone HCl) as Monotherapy and
`Adjunctive Therapy in Adult Patients with Bipolar Depression,” June
`28, 2013.
`Patent Owner’s Demonstratives
`
`2138
`
`2142
`
`2143
`
`8
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`Respectfully submitted,
`
`
`
`/Dorothy P. Whelan/_____________
`Dorothy P. Whelan, Reg. No. 33,814
`
`
`
`Date: August 9, 2021
`
`
`
`Customer Number 26191
`Fish & Richardson P.C.
`Telephone:-(612) 337-2509
`Facsimile:-(612) 288-9696
`
`
`
`9
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`CERTIFICATE OF SERVICE
`Pursuant to 37 CFR § 42.6(e)(4) and 42.205(b), the undersigned certifies
`
`that on August 9, 2021, a complete and entire copy of this Patent Owner’s Updated
`
`Exhibit List and Exhibit 2143 were provided via email, to the Petitioner by serving
`
`the email correspondence address of record as follows:
`
`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLP
`1 Giralda Farms
`Madison, NJ 07940
`
`E-mail: lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`/Diana Bradley/
`Diana Bradley
`Fish & Richardson P.C.
` 60 South Sixth Street, Suite 3200
` Minneapolis, MN 55402
` (858) 678-5667
`
`10
`
`
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