Inter Partes Review
`United States Patent No. 9,815,827
`Filed: June 5, 2020
`
`
`
`
`
`
`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
`
`Patent No. 9,815,827
`Filing Date: August 28, 2014
`Issue Date: November 14, 2017
`
`Title: AGENT FOR TREATMENT OF SCHIZOPHRENIA
`
`
`
`Case No. IPR2020-01053
`
`
`
`PETITION FOR INTER PARTES REVIEW
`
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`{80245289:1}
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`Inter Partes Review
`United States Patent No. 9,815,827
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`TABLE OF CONTENTS
`
`Page
`LISTING OF EXHIBITS ........................................................................................... 8
`I.
`INTRODUCTION ......................................................................................... 13
`A. Summary of Grounds ............................................................................... 14
`II. U.S. PATENT 9,815,827 ............................................................................... 14
`A. Overview .................................................................................................. 14
`1. Specification of the ‘827 Patent ..................................................... 14
`2. Excerpts from ‘827 Patent Prosecution History ............................. 15
`a.
`Provisional Application ...................................................... 15
`b.
`Priority Application ............................................................ 16
`c.
`‘827 Patent Application ...................................................... 17
`III. CLAIM CONSTRUCTION .......................................................................... 18
`A. “a patient” and “the patient” .................................................................... 18
`B. “treating a patient with an antipsychotic” ................................................ 20
`C. “manic depressive psychosis” .................................................................. 21
`D. “a pharmaceutical composition comprising…a sole active ingredient” . 22
`IV. CLAIMS 1-75 ARE UNPATENTABLE ...................................................... 23
`A. Person of Skill in the Art (POSA) ........................................................... 23
`B. Manic Depressive Claims Cannot Claim Priority Before August 28,
`2014 Filing Date of ‘827 Patent Application ...................................... 23
`1. Manic Depressive Claims............................................................... 24
`a.
`Claims 8-18......................................................................... 24
`b.
`Claims 25-28, 30-31 and 33-39 .......................................... 24
`c.
`Claims 40-44, 46 and 48-55 ............................................... 24
`d.
`Claims 56-60, 62, 64, 66, 67, 69, 71, 73 and 75 ................ 25
`2. Priority Application Lacks Written Description of the Manic
`Depressive Claims..................................................................... 25
`Law of Written Description ................................................ 25
`The Priority Application Does Not Contain Written
`
`a.
`b.
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`Inter Partes Review
`United States Patent No. 9,815,827
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`Description of Using Lurasidone or its Salts to Treat Manic
`Depressive Psychosis .......................................................... 26
`C. Ground 1: Latuda® Information Anticipates the Manic Depressive
`Claims .................................................................................................. 31
`1. treating manic depressive psychosis in a patient ........................... 32
`2. administering orally ........................................................................ 32
`3. lurasidone or a pharmaceutically acceptable salt thereof............... 33
`4. at a dose of from 20 to 120 mg/day ................................................ 33
`5. no clinically significant weight gain .............................................. 33
`6. hydrochloride .................................................................................. 34
`7. no weight gain after six weeks of administration .......................... 34
`8. detecting a weight gain after six weeks of administration ............. 34
`9. without concurrently administering another antipsychotic
`medication ................................................................................. 35
`10. treating a patient with an antipsychotic ........................................ 35
`11. sole active ingredient .................................................................... 35
`12. tablet ............................................................................................. 35
`13. without a weight gain ................................................................... 36
`14. once daily administration ............................................................. 36
`15. amounts in composition (for once daily administration) ............. 37
`D. Ground 2: Manic Depressive Claims Obvious Over Latuda® Infomation
`and Loebel ........................................................................................... 38
`1. Prior Art for Ground 2 .................................................................... 38
`a.
`Latuda® Information .......................................................... 38
`b.
`Loebel ................................................................................. 39
`c.
`June 2013 Press Release ..................................................... 40
`d.
`Latuda Label 2012 .............................................................. 40
`e.
`Latuda Label July 2013 ...................................................... 40
`2. Ground 2 Limitation By Limitation Analysis ................................ 41
`a.
`treating manic depressive psychosis in a patient ................ 41
`b.
`administering orally ............................................................ 41
`c.
`lurasidone or a pharmaceutically acceptable salt thereof ... 42
`d.
`at a dose of from 20 to 120 mg/day .................................... 42
`e.
`no clinically significant weight gain .................................. 42
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`Inter Partes Review
`United States Patent No. 9,815,827
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`f.
`g.
`h.
`i.
`
`hydrochloride ...................................................................... 43
`no weight gain after six weeks of administration ............... 43
`detecting a weight gain after six weeks of administration . 44
`without concurrently administering another antipsychotic
`medication .......................................................................... 45
`treating a patient with an antipsychotic .............................. 45
`j.
`sole active ingredient .......................................................... 46
`k.
`tablet ................................................................................... 46
`l.
`m. without a weight gain ......................................................... 46
`n.
`once daily administration ................................................... 47
`o.
`amounts in composition (for once daily administration) ... 48
`E. Ground 3: Claims 1-75 Obvious Over Saji Patent ................................... 50
`1. Prior Art for Ground 3 .................................................................... 50
`a.
`Saji Patent EX-1009 ........................................................... 50
`b.
`Saji Amendment ................................................................. 50
`c.
`Olanzapine 2001 ................................................................. 51
`d.
`Horisawa ............................................................................. 51
`e.
`Allison and Wetterling ....................................................... 53
`f.
`ICH-4 .................................................................................. 54
`2. Ground 3 Limitation By Limitation Analysis ................................ 54
`a.
`treating manic depressive psychosis in a patient ................ 54
`b.
`administering orally ............................................................ 54
`c.
`lurasidone or a pharmaceutically acceptable salt thereof ... 55
`d.
`at a dose of from 20 to 120 mg/day .................................... 55
`e.
`no clinically significant weight gain .................................. 55
`f.
`hydrochloride ...................................................................... 56
`g.
`no weight gain after six weeks of administration ............... 56
`h.
`detecting a weight gain after six weeks of administration . 57
`i.
`without concurrently administering another antipsychotic
`medication .......................................................................... 57
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`Inter Partes Review
`United States Patent No. 9,815,827
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`
`
`treating a patient with an antipsychotic .............................. 58
`j.
`sole active ingredient .......................................................... 58
`k.
`tablet ................................................................................... 58
`l.
`m. without a weight gain ......................................................... 59
`n.
`once daily administration ................................................... 59
`o.
`amounts in composition (for once daily administration) ... 60
`p.
`treating schizophrenia ......................................................... 61
`q.
`BPRS .................................................................................. 61
`V. MANDATORY NOTICES ......................................................................... 644
`A. Real Parties-In-Interest .......................................................................... 644
`B. Related Matters ...................................................................................... 644
`C. Identification of Counsel and Service Information ................................. 64
`VI. CERTIFICATION UNDER 37 C.F.R. § 42.24(D) ..................................... 655
`VII. GROUNDS FOR STANDING .................................................................... 655
`VIII. STATEMENT OF PRECISE RELIEF REQUESTED FOR EACH CLAIM
`CHALLENGED ............................................................................................ 65
`IX. CONCLUSION ............................................................................................ 666
`
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`Inter Partes Review
`United States Patent No. 9,815,827
`
`Table of Authorities
`
` Page(s)
`
`
`
`Cases
`
`Apator Miitors ApS v. Kamstrup A/S,
`Case IPR2015-01403 (PTAB Dec. 20, 2016 (Paper 28), aff’d 887
`F.3d 1293 (Fed. Cir. 2018) ................................................................................. 53
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .................................................... 26, 26
`
`Boehringer Ingelheim Pharm’s, Inc. v. HEC Pharm Co., Ltd.,
`No. 15-cv-5982-PGS, slip op. (D.N.J. Oct. 25, 2018), aff’d
`Boehringer Ingelheim Pharm’s, Inc. v. Mylan Pharm’s, Inc., 2020
`U.S. App. LEXIS 8393 (Fed. Cir. 2020) ........................................................... 62
`
`Bruckelmyer v. Ground Heaters, Inc.,
`445 F.3d 1374 (Fed. Cir. 2006) .......................................................................... 50
`
`Enzo Biochem, Inc. v. Gen-Probe Inc.,
`323 F.3d 956 (Fed. Cir. 2002) ............................................................................ 26
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ...................................................................... 62, 63
`
`Idenix Pharmaceuticals LLC v. Gilead Sciences Inc.,
`No. 2018-1691, slip op. (Fed. Cir. 2019) ........................................................... 26
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 24
`
`Propel Orthodontics, LLC v. Orthoaccel Techs., Inc.,
`Case IPR2018-00296 (PTAB June 11, 2018) (Paper 10) ................................... 31
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) .......................................................................... 25
`
`Sumitomo Dainippon Pharma Co. v. Emcure Pharm. Ltd.,
`No. CV 18-2065 (SRC), 2018 WL 4906268 (D.N.J. Oct. 5, 2018) ............. 19, 20
`
`Tyco Healthcare Grp. LP v. Mut. Pharm. Co., Inc.,
`642 F.3d 1370 (Fed. Cir. 2011) .......................................................................... 63
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`In re Wiseman,
`596 F.2d 1019 (CCPA 1979) .............................................................................. 55
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`Inter Partes Review
`United States Patent No. 9,815,827
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`Statutes
`
`35 U.S.C. § 102 ............................................................................................ 13, 38, 43
`
`35 U.S.C. § 102(a) .................................................................................................. 53
`
`35 U.S.C. § 102(b) ................................................................................................... 50
`
`35 U.S.C. § 103 ...................................................................................... 13, 49, 61, 63
`
`35 U.S.C. §§ 311(a), 314(a) ..................................................................................... 63
`
`37 C.F.R. § 42.24 ..................................................................................................... 65
`
`37 C.F.R. § 42.24(D)................................................................................................ 65
`
`37 C.F.R. § 42.108(c) ............................................................................................... 31
`
`Other Authorities
`
`83 Fed. Reg. 39,989 (Aug. 13, 2018) Sec. II(B)(6) ................................................. 19
`
`83 Fed. Reg. 51,340, 51,353 (Oct. 11, 2018)........................................................... 18
`
`Patents
`
`U.S. Patent No. 5,532,372 ........................................................... 14, 50, 54-59, 61-63
`
`U.S. Patent No. 9,174,975 ........................................................................................ 17
`
`U.S. Patent No. 9,815,827 .................................................................................passim
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`Inter Partes Review
`United States Patent No. 9,815,827
`
`LISTING OF EXHIBITS
`
`
`
`
`
`Exhibit
`1001
`
`Description
`U.S. Patent No. 9,815,827, Agent for Treatment of
`Schizophrenia (filed Aug. 28, 2014) (issued Nov. 14, 2017)
`(the “‘827 Patent”)
`
`1002
`
`Expert Declaration of Dr. Thomas R. Kosten, M.D.
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`U.S. Patent Application 14/471,919 (filed Aug. 28, 2014)
`(“the ‘827 Patent Application”)
`
`U.S. Patent Application 10/525,021 (filed Aug. 20, 2003)
`(“Priority Application”)
`
`U.S. Application 60/404,927 (filed Aug. 22, 2002)
`(“Provisional Application”) with translation from Japanese to
`English)
`
`Preliminary Amendment in the ‘827 Patent Application
`(October 5, 2015) (“Second Preliminary Amendment”)
`
`Information published in American Journal of Psychiatry,
`Vol. 170, No. 8, August 2013, regarding approval of
`“Latuda® (lurasidone HCl) tablets” for “treatment of major
`depressive episodes associated with bipolar I disorder
`(bipolar depression) as monotherapy and as adjunctive
`therapy with lithium or valproate in adults” (“Latuda®
`Information”) (Stamped “AUG 06 2013”)
`
`Neuropsychopharmacology, Vol. 38 (2012), pp. S314–S446,
`including, Loebel, Antony, et al. “Lurasidone Monotherapy
`for the Treatment of Bipolar Depression: Results of the 6-
`Week, Double-blind, Placebo-controlled PREVAIL-2
`Study,” Neuropsychopharmacology, Vol 38 (2012), W183,
`pp. S422–423 (“Loebel”)
`
`U.S. Patent No. 5,532,372, Imide Derivatives, and Their
`Production and Use (filed Aug. 30, 1993) (issued Jul. 2,
`1996) (“Saji Patent”)
`
`1010
`
`Preliminary Amendment in Priority Application (Feb. 18,
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`Exhibit
`
`2005).
`
`Inter Partes Review
`United States Patent No. 9,815,827
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`Description
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`Restriction Requirement in Priority Application (Aug. 29,
`2007).
`
`Reply to Restriction Requirement in Priority Application
`(Oct. 1, 2007).
`
`Office Action in Priority Application (Dec. 17, 2007)
`
`Amendment in Priority Application (June 17, 2008)
`
`Declaration of Masaaki Ogasa in Priority Application (June
`17, 2008)
`
`Amendment in Priority Application (March 16, 2009)
`
`Office Action in Priority Application (June 12, 2009)
`
`Amendment in Priority Application (December 10, 2009)
`
`U.S. Patent No. 9,174,975, Remedy for Integration
`Dysfunction Syndrome (filed Aug. 20, 2003) (issued Nov. 3,
`2015) (“the ‘975 patent”)
`
`Preliminary Amendment in ‘827 Patent Application (Aug.
`28, 2014)
`
`Sumitomo Dainippon Pharma Co., Ltd. v. Emcure
`Pharmaceuticals Limited, No. 18-cv-02065-SRC, slip op.
`(D.N.J. Oct. 5, 2018)
`
`Diagnostic and Statistical Manual of Mental Disorders,
`Fourth Edition: (DSM-IVTM), Washington, DC, American
`Psychiatric Association, 1994, pp. 273-391 (“DSM-IV”)
`
`Diagnostic and Statistical Manual of Mental Disorders,
`Fourth Edition, Text Revision: (DSM-IV-TRTM),
`Washington, DC, American Psychiatric Association, 2000,
`pp. 297-428 (“DSM-IV TR”)
`
`Diagnostic and Statistical Manual of Mental Disorders, Fifth
`Edition: (DSM-5®), Arlington, VA, American Psychiatric
`Association, 2013, pp. 87-154 (“DSM-5”)
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`Exhibit
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Inter Partes Review
`United States Patent No. 9,815,827
`
`Description
`Boehringer Ingelheim Pharm’s, Inc. v. HEC Pharm Co.,
`Ltd., No. 15-cv-5982-PGS, slip op. (D.N.J. Oct. 25, 2018),
`aff’d Boehringer Ingelheim Pharm’s, Inc. v. Mylan Pharm’s,
`Inc., 2020 U.S. App. LEXIS 8393 (Fed. Cir. 2020)
`
`Amendment in U.S. Patent Application 08/113,320
`(December 29, 1994) (“Saji Amendment”)
`
`Amendment in U.S. Patent Application 08/113,320 (March
`1, 1993) (“Saji March 1993 Amendment”)
`
`Horisawa, Tomoko, et al. “Pharmacological Characteristics
`of the Novel Antipsychotic SM-13496: Evaluation of Action
`on Various Receptors in the Brain.” Japanese Journal of
`Neuropsychopharmacology, vol. 19, no. 6, Dec. 1999, p. 363
`(“Horisawa” with translation from Japanese to English)
`
`Horisawa, Tomoko, et al. “Pharmacological Characteristics
`of the Novel Antipsychotic SM-13496: Evaluation of Action
`on Various Receptors in the Brain.” Japanese Journal of
`Neuropsychopharmacology, vol. 19, no. 6, Dec. 1999, p.
`363.
`
`Guideline for Industry: Dose-Response Information to
`Support Drug Registration, International Conference of
`Harmonisation of Technical Requirements for the
`Registration of Pharmaceuticals for Human Use, ICH-E4,
`November 1994 (“ICH-4”)
`
`Hubbard, William K., Guideline for Industry: Dose-
`Response Information to Support Drug Registration., vol. 59,
`No. 216, Federal Register, 1994, pp. 55972-55976 (“Federal
`Register Dose Optimization Guidelines 1994”)
`
`European Patent No. 0,464,846, Imide Derivatives, and Their
`Production and Use (filed July 5, 1991) (issued Apr. 22,
`1998) (“Saji EP ‘846”)
`
`Office Action in the ‘827 Patent Application (Oct. 19, 2016)
`
`Amendment in the ‘827 Patent Application (Mar. 17, 2017)
`
`Moriarity, Patricia. “Sunovion Pharmaceuticals Inc.
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`
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`Exhibit
`
`1036
`
`1037
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`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`Inter Partes Review
`United States Patent No. 9,815,827
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`Description
`Announces FDA Approval of Latuda® (Lurasidone HCl) as
`Monotherapy and Adjunctive Therapy in Adult Patients with
`Bipolar Depression.” Sunovion Pharmaceuticals Inc., 28
`June 2013, pp. 1–7 (“June 2013 Press Release”)
`
`Declaration of Sylvia D. Hall-Ellis, Ph.D.(“Librarian’s
`Affidavit”)
`
`“LATUDA (Lurasidone HCl) Tablets for Oral
`Administration.” Physicians’ Desk Reference, 66th ed., PDR
`Network, LLC, 2012, pp. 2798–2805 (“Latuda Label 2012”)
`
`“LATUDA (Lurasidone Hydrochloride) Tablets, for Oral
`Use.” Sunovion Pharmaceuticals Inc., July 2013. U.S. Food
`& Drug Administration, Drugs@FDA,
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/
`200603s015lbl.pdf. (“Latuda Label July 2013”)
`
`“ZYPREXA® (Olanzapine) Tablets.” Physicians' Desk
`Reference , 55th ed., Medical Economics Company, Inc.,
`2001, pp. 1788–1793 (“Olanzapine 2001)
`
`WO 01/76557 A1, Sustained Release Preparations (filed
`Apr. 9, 2001) (published Oct. 18, 2001) (with translation
`from Japanese to English)
`
`Allison, David B., et al. “Antipsychotic-Induced Weight
`Gain: A Comprehensive Research Synthesis.” American
`Journal Psychiatry, vol. 156, no. 11, Nov. 1999, pp. 1686–
`1696 (“Allison”)
`
`Wetterling, Tilman. “Bodyweight Gain with Atypical
`Antipsychotics: A Comparative Review.” Drug Safety, vol.
`24, no. 1, January 2001, pp. 59–73 (“Wetterling”)
`
`Not Used
`
`Caccia, Silvio, et al. “Critical Appraisal of Lurasidone in the
`Management of Schizophrenia.” Neuropsychiatric Disease
`and Treatment, vol. 8, 2012, pp. 155–168 (“Caccia”)
`
`1045
`
`Not Used
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`Inter Partes Review
`United States Patent No. 9,815,827
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`
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`Exhibit
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`Description
`File History from PAIR for the ‘827 Patent Application
`
`PTE Application in U.S. Patent Application 08/113,320
`(December 9, 2010)
`
`U.S. Patent Application 08/113,320 (also 07/762172) (“Saji
`Application”)
`
`Office Action in the Saji Application (August 30, 1994)
`
`Petitioner’s limitation by limitation Claim Listing for the
`‘827 Patent
`
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`Inter Partes Review
`United States Patent No. 9,815,827
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`
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`Petitioner Slayback Pharma LLC requests inter partes review (IPR) of
`
`claims 1-75 of U.S. Patent 9,815,827 (EX-1001, ‘827 Patent), assigned to
`
`Sumitomo Dainippon Pharma Co., Ltd. (Patent Owner). This Petition, supported
`
`by the Expert Declaration of Dr. Thomas R. Kosten (EX-1002), establishes that
`
`claims 1-75 of the ‘827 Patent are anticipated and/or obvious under either the pre-
`
`AIA or AIA versions of 35 U.S.C. §§ 102 and/or 103.
`
`I.
`
`INTRODUCTION
`
`The ‘827 Patent claims priority to U.S. Patent Application 10/525,021 (EX-
`
`1004, Priority Application), filed August 20, 2003, and U.S. Application
`
`60/404,927 (EX-1005, Provisional Application) filed August 22, 2002.
`
`The ‘827 Patent claims relate to using lurasidone or its salts to treat
`
`psychiatric disorders. EX-1002, ¶ 13. The claims divide into two groups:
`
`Claims comprising treating
`
`Claims 8-18, 25-28, 30-31, 33-44, 46, 48-60, 62,
`
`manic depressive psychosis
`
`64, 66, 67, 69, 71, 73 and 75 (manic depressive
`
`claims)
`
`Claims limited to treating
`
`Claims 1-7, 19-24, 29, 32, 45, 47, 61, 63, 65, 68,
`
`schizophrenia
`
`70, 72 and 74 (schizophrenia claims)
`
`
`For Grounds 1 and 2, the manic depressive claims are anticipated and
`
`obvious over intervening art published after the Priority Application was filed.
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`For Ground 3, claims 1-75 are obvious over references published before the
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`Inter Partes Review
`United States Patent No. 9,815,827
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`Provisional Application was filed.
`
`A.
`
`Summary of Grounds
`
`Ground 1 Manic depressive claims anticipated by Latuda® Information, EX-1007
`
`Ground 2 Manic depressive claims obvious over Latuda® Information, EX-1007,
`
`and Loebel, EX-1008
`
`Ground 3 Claims 1-75 obvious over Saji Patent, EX-1009
`
`
`II. U.S. PATENT 9,815,827
`
`A. Overview
`
`1.
`
`Specification of the ‘827 Patent
`
`‘827 Patent Application (EX-1003) was filed August 28, 2014 as a
`
`continuation of Priority Application (EX-1004). Like Priority Application, ‘827
`
`Patent Application repeatedly states the “present invention” is a method of using a
`
`specific chemical or its salts to treat “schizophrenia.” EX-1001, Abstract,
`
`Technical Field (1:14-17), Disclosure of the Invention (2:45-46), Detailed
`
`Description of the Invention (3:42-53) and Industrial Applicability (10:29-41)
`
`(emphasis added).
`
`The compound of the self-proclaimed “present invention” is identified in the
`
`‘827 Patent by chemical name and structure:
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`Inter Partes Review
`United States Patent No. 9,815,827
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`
`
`Chemical name (id. 2:51-54):
`
`(1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(l,2-benzoisothiazol-3-
`
`yl)-l-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-
`
`bicyclo[2.2.1]heptane-dicarboximide; and
`
`Structural formula (id. 2:55-67):
`
`This compound is “lurasidone.” EX-1002 ¶¶41-42. The hydrochloride salt
`
`of lurasidone, lurasidone HCl, is identified as “SM-13496.” EX-1001, 4:47-50;
`
`
`
`EX-1002 ¶42.
`
`The specification reports a “First Stage Phase II Clinical Trial,” where
`
`“patients with schizophrenia” were administered placebo or SM-13496 (i.e.
`
`lurasidone HCl) -- but the specification does not report giving any drug to any
`
`patient with “manic depressive psychoses.” EX-1001, 5:1-12; EX-1002 ¶43.
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`2.
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`Excerpts from ‘827 Patent Prosecution History
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`a.
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`Provisional Application
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`Provisional Application, EX-1005, was filed August 22, 2002. “[M]anic
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`depressive psychoses” appears exactly once, under “Background Art.” Id. p. 2,
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`ln. 25. Provisional Application contains no mention of using lurasidone to treat
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`anything besides schizophrenia and there is no association of lurasidone with
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`“manic depressive psychoses.” EX-1005; EX-1002 ¶45.
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`b.
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`Priority Application
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`Priority Application, EX-1004, was filed August 20, 2003 and entered
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`National Phase February 18, 2005 with a Preliminary Amendment, EX-1010,
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`claiming priority to Provisional Application and incorporating it by reference. The
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`Priority Application’s claims were limited to: “treatment of schizophrenia” (claims
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`1-13); “agent for treatment of schizophrenia” (claims 14-16); and “preparation of
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`an agent for treatment of schizophrenia” (claims 17-19). EX-1004.
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`In Priority Application “manic depressive psychoses” appears exactly once,
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`under “Background Art.” EX-1004, p. 2, ln. 30. Priority Application contains no
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`mention of using lurasidone to treat anything besides schizophrenia, and like
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`Provisional Application, there is no association in Priority Application of
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`lurasidone with “manic depressive psychoses.” EX-1004; EX-1002 ¶48.
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`The Examiner required restriction. EX-1011. Applicants elected treating
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`schizophrenia. EX-1012. Examiner rejected the claims as obvious, citing prior art
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`that taught using “SM-13496” to treat “schizophrenia.” EX-1013, pp. 3-4
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`(“[lurasidone HCl] is known in the art as SM-13496,” citing p. 7, lns. 5-8 of
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`Priority Application, EX-1004, for support).
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`Applicants admitted Examiner correctly noted “SM-13496” was known in
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`the prior art to be lurasidone (EX-1014, p. 7) and filed the Declaration of Masaaki
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`Ogasa (a named inventor of ‘827 Patent), which equated “SM-13496” with
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`“Lurasidone” (EX-1015, p. 1).
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`On March 16, 2009 inventors again admitted the prior art disclosed “SM-
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`13496” as “lurasidone.” EX-1016, p. 7 (“The Ogasa Declaration compares the
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`administration of lurasidone as disclosed in [the cited prior art] to the
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`administration of lurasidone as disclosed in the present invention.”)
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`The Examiner (EX-1017, p. 3, ¶4) rejected the claims over EP 464846 (EX-
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`1032, “Saji EP ‘846”). Applicants responded that: “Nowhere in Saji EP ‘846 is
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`the particular compound recited in the present claim 1 (Lurasidone) associated
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`with effective treatment of schizophrenia….” EX-1018, p. 4 (emphasis added).
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`Priority Application issued November 3, 2015 as U.S. Patent 9,174,975
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`(EX-1019), with all claims limited to using lurasidone to treat “schizophrenia.”
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`c.
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`‘827 Patent Application
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`‘827 Patent Application (EX-1003) was filed August 28, 2014 as a
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`continuation of Priority Application (EX-1004) with a Preliminary Amendment
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`(EX-1020) canceling all original claims and adding new claims. The new claims
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`were limited to using lurasidone to treat “schizophrenia.” EX-1020.
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`More than a year later, and more than two years after U.S. FDA approved
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`Patent Owner’s lurasidone HCl product for something other than schizophrenia
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`(EX-1035, June 2013 Press Release), applicants filed an October 5, 2015 Second
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`Preliminary Amendment (EX-1006) amending the claims for the very first time to
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`comprise treating “manic depressive psychoses.”
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`‘827 Patent (EX-1001) issued November 14, 2017 with some claims limited
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`to treating “schizophrenia” and other claims directed to treating “manic depressive
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`psychosis.”
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`Clearly, the ‘827 Patent was Patent Owner’s afterthought gambit to obtain
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`claims to treating “manic depressive psychosis” -- when the disclosure of its
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`application and priority applications only addressed treating “schizophrenia.”
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`III. CLAIM CONSTRUCTION
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`
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`Claim construction is needed only to the extent necessary to resolve issues
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`raised herein. See Changes to the Claim Construction Standard for Interpreting
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`Claims in Trial Proceedings Before the Patent Trial and Appeal Board, 83 Fed.
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`Reg. 51,340, 51,353 (Oct. 11, 2018) (Final Rule) (citing Nidec Motor Corp. v.
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`Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017)).
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`A.
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` “a patient” and “the patient”
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`The ‘827 Patent claims include “a patient” and “the patient.” In ANDA
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`litigation by Patent Owner in District of New Jersey on the ‘827 Patent, Plaintiffs
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`asserted “a patient” meant “a patient population.” EX-1021, Sumitomo Dainippon
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`Pharma Co. v. Emcure Pharm. Ltd., No. CV 18-2065 (SRC), 2018 WL 4906268,
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`at *2 (D.N.J. Oct. 5, 2018) (EX-1021).
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`Judge Chesler rejected Patent Owner’s proposed construction, finding
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`“Plaintiffs have not overcome the heavy presumption that ‘a patient’ has its
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`ordinary meaning.” Id. at *10. Rather, Judge Chesler concluded that “‘a patient’
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`and ‘the patient’ mean ‘one or more patients.’” Id. (citing 01 Communique Lab.,
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`Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012)). Judge Chesler’s
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`construction is relevant here. See Office Patent Trial Practice Guide August 2018
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`Update, Sec. II(B)(6), 83 Fed. Reg. 39,989 (Aug. 13, 2018) (“The Board will give
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`such other claim construction determinations appropriate weight.”)
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`Petitioner, who was not a party to litigation involving the ‘827 Patent, agrees
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`with Judge Chesler’s construction. In particular:
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`a) The general rule is that a court must presume that the claims mean what
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`they say and construe them according to their ordinary and accustomed meaning.
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`Sumitomo Dainippon Pharma Co., 2018 WL 4906268 at *1–2. Here, the plain
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`meaning of “a patient” includes “a patient.” EX-1002 ¶51;
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`b) The “heavy” presumption in favor of “ordinary meaning” is overcome
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`when “a different meaning is clearly and deliberatively set forth in the intrinsic
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`evidence.” Sumitomo Dainippon Pharma Co., 2018 WL 4906268 at *10. Here, no
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`United States Patent No. 9,815,827
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`different meaning is set forth in the intrinsic evidence;
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`c) Because the BPRS score recited in claim 6 “is clearly a characteristic of
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`an individual,” construing “patient” to mean “population” would cause claim 6 to
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`not make sense. Sumitomo Dainippon Pharma Co., 2018 WL 4906268, at *6.
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`EX-1002, ¶52.
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`Accordingly, “a patient” and “the patient” mean “one or more patients.”
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`B.
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`“treating a patient with an antipsychotic”
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`
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`Three independent claims of ‘827 Patent (EX-1001, claims 25, 40 and 56)
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`recite “treating a patient with an antipsychotic.” The claim language compels that
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`“treating a patient with an antipsychotic” must comprise “treating a patient for
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`schizophrenia with an antipsychotic” and “treating a patient for manic depressive
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`psychosis with an antipsychotic.”
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`
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`In particular, each of claims 25, 40 and 56 has a dependent claim reciting
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`“the method treats schizophrenia in the patient,” and another dependent claim
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`reciting “the method treats manic depressive psychosis in the patient.” EX-1001:
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`claims 25, 29 and 30; claims 40, 45 and 46; and claims 56, 61 and 62.
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`For these independent/dependent pairings to make sense, “treating a patient
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`with an antipsychotic” must