`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`
`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 No. IPR2020-01053
` Patent No. 9,815,827
`
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`TO PATENT OWNER’S RESPONSE
`
`
`
`{80263631:1}
`
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Slayback Pharma LLC
`
`
`
`
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owner Sumitomo Dainippon Pharma Co., Ltd. (“Patent Owner”) in the Patent
`
`Owner’s Response (Paper No. 15) in the above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because
`
`they are being filed and served within five business days of the filing of Patent
`
`Owner’s Response (Paper No. 15) in this matter on March 11, 2021.
`
`Petitioner’s objections provide notice to Patent Owner that Petitioner may move
`
`to exclude these exhibits under 37 C.F.R. § 42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence
`
`and a reference to “CFR” means the Code of Federal Regulations.
`
`Petitioner’s objections t o Patent Owner’s exhibits under FRE 801-803
`
`(hearsay) apply to the extent Patent Owner seeks to rely on such exhibits for the
`
`truth of any matters stated in such exhibits.
`
`Petitioner objects to all of Patent Owner’s exhibits under FRE 901-902
`
`(authenticity) to the extent that Patent Owner fails to provide a sponsoring witness
`
`who can attest to the authenticity of such documents, including translations of
`
`{80263631:1}
`
`
`
`1
`
`
`
`
`foreign publications, or to demonstrate that such exhibits are self authenticating
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`under the FRE.
`
`Exhibit descriptions provided in this table are taken from Patent
`
`Owner’s Response Exhibit List and are used for identification purposes only.
`
`Petitioner’s use of Patent Owner’s descriptions does not indicate that Petitioner
`
`agrees with Patent Owner’s descriptions or any other characterizations of such
`
`exhibits.
`
`
`
`Description
`
`Exhibit
`No.
`2043 FDA Atypical Antipsychotic Drugs Information,
`downloaded from the internet at
`https://www.fda.gov/drugs/postmarket-drug-
`safetyinformation- patients-and-providers/atypical-
`antipsychotic-drugs information on September 10, 2020.
`2044 Franklin, “Lurasidone for the treatment of bipolar
`depression: an evidence-based review,” Neuropsychiatric
`Disease and Treatment, 2015:11 2143–2152 (2015).
`2045 Shayegan et al., “Atypical Antipsychotics: Matching
`Receptor Profile to Individual Patient’s Clinical Profile,”
`CNS Spectrums 9(10)(suppl 11):6-14 (October, 2004).
`2046 Kane et al. “Clozapine for the Treatment-Resistant
`Schizophrenia.” Arch Gen Psychiatry, Vol. 45, September
`1988, pp. 789-796.
`2047 Nashed et al., “Olanzapine-Induced Weight Gain in
`Patients with Bipolar I Disorder: A Meta-Analysis,” Prim.
`Care Companion CNS Disord. 13(6) (2011).
`2048 Symbyax® Label.
`
`{80263631:1}
`
`
`
`2
`
`Objection
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Objection
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`
`
`Exhibit
`No.
`2049 Seroquel® Label.
`
`Description
`
`2050 Lieberman et al., “Effectiveness of Antipsychotic Drugs in
`Patients with Chronic Schizophrenia,” New Eng. J. Med.
`353(12) 1209-1223 (September 22, 2005).
`2051 Thase, “Quetiapine monotherapy for bipolar depression,”
`Neuropsychiatric Disease and Treatment 4(1) 21-31, pp.
`11-21 (2008).
`2052 Hoyberg et al., “Risperidone versus perphenazine in the
`treatment of chronic schizophrenic patients with acute
`exacerbations,” Acta Psychiatr. Scand 88:395-402 (1993).
`2053 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).
`2054 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).
`2055 Pacher et al., “Cardiovascular Side Effects of New
`Antidepressants and Antipsychotics: New Drugs, Old
`Concerns?” Curr Pharm Des. 10(20):2463-2475, 6
`(2004).
`2056 Stimmel at al., “Ziprasidone: An Atypical Antipsychotic
`Drug for the Treatment of Schizophrenia,” Clinical
`Therapeutics 24(1): 21-37 (2002).
`2057 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).
`
`{80263631:1}
`
`
`
`3
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Exhibit
`No.
`2058 CONFIDENTIAL D1050231 Clinical Study Report,
`October 23, 2009.
`
`Description
`
`2059 CONFIDENTIAL D1050233 Clinical Study Report,
`May 3, 2011.
`
`2060 CONFIDENTIAL D1050249 Clinical Study Report,
`October 5, 2009.
`
`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).
`2062 RESERVED
`
`2063 RESERVED
`
`2064 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).
`2065 RESERVED
`
`2066 Reiffen et al., “Generic Drug Industry Dynamics,” The
`Review of Economics and Statistics, Vol. 87, No. 1, pp.
`37-49 (2005).
`2067 DiMasi et al. “The price of innovation: new estimates of
`drug development costs,” Journal of Health Economics,
`Vol. 22, 151-185 (2003).
`
`Objection
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`Exhibit
`Not
`Supplied
`Exhibit
`Not
`Supplied
`FRE 801-
`803, 402,
`403
`
`Exhibit
`Not
`Supplied
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`{80263631:1}
`
`
`
`4
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Description
`
`Exhibit
`No.
`2068 Samalin et al., “Clinical potential of lurasidone in the
`management of schizophrenia,” Therapeutics and Clinical
`Risk Management, Vol. 7, pp. 239–250 (2011).
`2069 CONFIDENTIAL Lurasidone, Strategic Business Plan,
`October 1, 2009.
`
`2070 Latuda® Product Monograph.
`
`2071 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).
`2072 Dainippon Sumitomo Pharma Co., Ltd., Supplementary
`Financial Data for Year Ended March 31, 2014.
`
`2073
`
`Jancin, Newer Atypical Antipsychotics Draw Praise,
`Internal Medicine News, March 22, 2011.
`
`2074 CONFIDENTIAL Latuda Financial Information FY11-
`FY20 YTD.
`2075 CONFIDENTIAL LATUDA Monthly Commercial
`Analytics Meeting, June 2016.
`
`2076 CONFIDENTIAL LATUDA Situational Assessment –
`FY 2020, Aug 2, 2020.
`
`2077 Albright, “Three key antipsychotics lose patent
`protection,” downloaded from the internet at:
`https://www.behavioral.net/article/three-key-
`antipsychotics-losepatent- protection on September 20,
`2018.
`
`Objection
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`{80263631:1}
`
`
`
`5
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Exhibit
`No.
`2078 CONFIDENTIAL Latuda® (lurasidone HCl) 2013 Brand
`Plan.
`
`Description
`
`2079 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.
`2080 CONFIDENTIAL Latuda Physician ATU Tracker
`Findings, Q3’11 Insights Report.
`
`2081 RESERVED
`
`2082 CONFIDENTIAL LATUDA – Bipolar Depression HCP
`ATU, FY16- Q4, March 20, 2017.
`
`2083 CONFIDENTIAL The Bipolar Disorder Patient Journey,
`Sunovion Commercial Insights & Analytics, INSYNC,
`June 22, 2020.
`2084 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).
`2085 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).
`2086 Rajagopalan et al., “Cost-Utility Analysis of Lurasidone
`Versus Aripiprazole in Adults with Schizophrenia,”
`Pharmacoeconomics, 34:709-721 (2016).
`
`Objection
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`Exhibit
`Not
`Supplied
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`{80263631:1}
`
`
`
`6
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Description
`
`Exhibit
`No.
`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.
`2089 CONFIDENTIAL Sunovion Senior Leadership Budget
`Presentation, Latuda Brand Strategy and Budget,
`December 10, 2010.
`2090 CONFIDENTIAL Latuda® 2012 Budget Presentation
`Meeting, November 7, 2011.
`
`2091 Comparison of Atypical Antipsychotics,” Pharmacists
`Letter (2015). Available at:
`http://pharmacistsletter.therapeuticresearch.com/pl/Article
`PDF.aspx?D etailID=310701.
`2092 CONFIDENTIAL Covance Cardiac Safety Services,
`Phase III Repolarization Assessment Plan, Lurasidone,
`Feb. 13, 2007.
`2093 CONFIDENTIAL Medifacts International, Review of the
`Preliminary Results from MK-3756 Protocol 023,
`February 7, 2007.
`2094 CONFIDENTIAL Clinical Pharmacology and
`Biopharmaceutics Review Aid, Dainippon Sumitomo
`Pharma America, Inc., Lurasidone.
`2095 CONFIDENTIAL Sunovion FDA Contact Report,
`Lurasidone HCl, October 25, 2010.
`
`2096 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).
`
`Objection
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`{80263631:1}
`
`
`
`7
`
`
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Description
`
`Exhibit
`No.
`2097 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).
`2098 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
`
`2099-
`2130
`
`2131 CONFIDENTIAL Declaration of Dr. Stephen Stahl.
`
`2132 CONFIDENTIAL Declaration of Dr. Brian Reisetter.
`
`2133 Declaration of Scott Stancell-Condron.
`
`2134 Deposition Transcript (Dr. Thomas Kosten).
`
`2135 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.
`
`{80263631:1}
`
`
`
`8
`
`Objection
`
`FRE 801-
`803, 402,
`403
`
`FRE 801-
`803, 402,
`403
`
`Exhibits
`Not
`Supplied
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`
`Exhibit
`No.
`2138 CONFIDENTIAL Memorandum With Respect to
`Lurasidone Development Handover Status (2007).
`
`Description
`
`2139 Tohen et al., Am J. Psychiatry, 156:702-709 (1999).
`
`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.
`2142 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.
`
`Objection
`
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`FRE 801-
`803, 402,
`403
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/s/ Louis H. Weinstein
`Louis H. Weinstein
`Reg. No. 45205
`Counsel for Petitioner Slayback
`Pharma LLC
`
`
`
`
`
`Date: March 18, 2020
`
`
`
`
`
`
`
`
`
`{80263631:1}
`
`
`
`9
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`
`
`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
`CERTIFICATE OF SERVICE
`
`I, Louis H. Weinstein, certify that on March 18, 2021 I caused to be served a
`
`
`
`
`
`
`true and correct copy of the foregoing PETITIONER’S OBJECTIONS TO
`
`PATENT OWNER’S EXHIBITS TO PATENT OWNER’S RESPONSE by
`
`e-mail to counsel for Patent Owner.
`
`
`
`Dated: March 18, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Louis H. Weinstein
`
`Louis H. Weinstein
`Reg. No. 45,205
`
`{80263631:1}
`
`
`
`10
`
`
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