`
`
`
` 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
`PRELIMINARY RESPONSE
`
`
`
`{80259207:1}
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`
`
`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 Preliminary Response 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 ten business days of the institution of trial
`
`in this matter on December 9, 2020. (Paper No. 7) 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
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`{80259207:1}
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`1
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`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 Preliminary 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.
`
`
`
`Exhibits
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`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.
`
`Objection
`
`FRE 801-803,
`402, 403, 1006
`
`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
`
`{80259207:1}
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`
`
`2
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`
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`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
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`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
`
`
`
`Exhibits
`
`Description
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`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.
`Meltzer, “Treatment of Schizophrenia and Spectrum
`Disorders: Pharmacotherapy, Psychosocial
`Treatments, and Neurotransmitter Interactions,”
`Biol. Psychiatry 46:1321-1327 (1999).
`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).
`
`{80259207:1}
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`3
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`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
`Exhibit
`Supplied
`FRE 801-803,
`402, 403
`FRE 801-803,
`402, 403
`
`Not
`
`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
`
`
`
`Exhibits
`
`Description
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`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.
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`{80259207:1}
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`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
`
`FRE 801-803,
`402, 403
`
`FRE 801-803,
`402, 403
`
`
`
`Exhibits
`
`Description
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`Casey et al., “The Pharmacology of Weight Gain
`with Antipsychotics,” J Clin. Psychiatry 62[suppl
`7]:4-10 (2001).
`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).
`Wong et al., U.S. Patent No. 6,964,962.
`
`Pozuelo, U.S. Patent Pub. No. 2001/0047010.
`
`Seroquel XR (quetiapine fumarate) Extended-
`Release Tablets Label 2009.
`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-
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`Inter Partes Review
`U.S Patent No. 9,815,827
`Case No. IPR2020-01053
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`Exhibits
`
`Description
`
`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.
`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.
`
`2039
`
`2040
`
`2041
`
`2042
`
`
`
`Objection
`
`
`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: December 23, 2020
`
`
`
`
`
`
`
`{80259207:1}
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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 December 23, 2020 I caused to be served
`
`
`
`
`
`
`a true and correct copy of the foregoing PETITIONER’S OBJECTIONS TO
`
`PATENT OWNER’S EXHIBITS IN PRELIMINARY RESPONSE by e-mail,
`
`as follows:
`
`
`
`/s/ Louis H. Weinstein
`Louis H. Weinstein
`Reg. No. 45,205
`
`
`
`Dorothy P. Whelan
`whelan@fr.com
`
`W. Chad Shear
`shear@fr.com
`
`IPR46094-0002IP1@fr.com (No. 46094-0002IP1)
`PTABInbound@fr.com
`
`
`Dated: December 23, 2020
`
`
`
`
`
`
`
`
`
`
`{80259207:1}
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`7
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