PDX-100
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`DEMONSTRATIVEEXHIBIT –NOT EVIDENCE
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`Patent Owner’s Presentation
`August 11, 2021 Oral Hearing
`
`IPR2020‐01053
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`Slayback Pharma LLC. v. Sumitomo Dainippon Pharma Co.,
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`Ltd.
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`1
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`Exhibit 2143
`Slayback v. Sumitomo
`IPR2020-01053
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`
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`DEMONSTRATIVEEXHIBIT –NOT EVIDENCE
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`Patent Owner’s Presentation
`August 11, 2021 Oral Hearing
`
`IPR2020‐01053
`
`Slayback Pharma LLC. v. Sumitomo Dainippon Pharma Co.,
`
`Ltd.
`
`1
`
`Exhibit 2143
`Slayback v. Sumitomo
`IPR2020-01053
`
`
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`PDX-101
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`•Obviousness (Ground 3) –Claims 1‐75 are patentable over Saji, US
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`5,532,372, a reference previously considered by the Patent Office
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`•Because these claims are entitled to the Provisional Filing date, Grounds 1 and 2 fail as the art relied on is
`•These claims are entitled to the August 22, 2002 provisional filing date
`•These claims recite treating “manic depressive psychosis” or treating a patient with “an anti‐psychotic.”
`56‐60, 62, 64, 66, 67, 69, 71, 73, and 75.
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`–Grounds 1 and 2 apply only to claims 8‐18, 25‐28, 30‐31, 33‐39, 40‐44, 46, 48‐55,
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`after that date.
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`•Priority (Grounds 1 and 2)
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`Overview
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`2
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`PDX-102
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053, Ex. 1001
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`–Without either clinically significant weight gain or weight gain
`–Administered: Once daily, oral administration of 20‐120 mg
`–To treat schizophrenia or manic depressive psychosis
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`•Claims cover use of lurasidone as an antipsychotic
`•75 Claims (5 independent)
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`The Patented Invention
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`3
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`PDX-103
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`•See IPR2020‐01053 Petition at 21.
`bipolar disorder
`person of skill to mean
`psychoses” is understood by a
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`–“Manic depressive
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`•Specification refers to both
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`–See IPR2020‐01053Ex. 1001
`schizophrenia
`psychoses,” and
`“manic depressive
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`’827 Patent col. 2, ll. 5‐10.
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`’827 Patent Specification Discloses Both Schizophrenia and
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`Manic Depressive Psychoses
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`4
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`PDX-104
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`POR at 12-13
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`IPR2020-01053 Ex. 2022
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`Weight Gain is a Known and Substantial Problem
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`5
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`PDX-105
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`POR at 6
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`IPR2020-01053, Ex. 2027
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`Stahl’s Essential 2013
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`Antipsychotics are Complex
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`6
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`PDX-106
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`Ziprasidone –POR at 11‐12
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`Risperidone –POR at 10‐11
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`Quetiapine –POR at 8‐9
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`Olanzapine –POR at 7
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`Antipsychotics are Complex
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`POR at 6
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`IPR2020-01053, Ex. 2027
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`Stahl’s Essential 2013
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`7
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`PDX-107
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053 Ex. 2131 ¶¶ 81-89
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`at 81; POR at 12-13
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`Dr. Stephen Stahl
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`Mechanisms Underlying Weight Gain are Complex and
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`Poorly Understood
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`8
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`PDX-108
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053 Ex. 2028 at 5-
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`6; POR at 13
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`“Weight gain . . . Difficult to Predict”
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`9
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`PDX-109
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053 Ex. 1001, 7:49-
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`67
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`Inventors Surprisingly Discovered the Novel Dosing
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`Regimen did not Cause Weight Gain
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`10
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`PDX-110
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053 Ex. 1001,
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`Claim 1
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`Inventors Surprisingly Discovered the Novel Dosing
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`Regimen did not Cause Weight Gain
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`11
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`PDX-111
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`Grounds 1 and 2 –Priority
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`12
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`PDX-112
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`–A POSA, reading the ’927 provisional application in light of what was known about
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`understand that the inventors were in possession of the MDP claims –POR 27‐32
`the link between schizophrenia and manic depressive psychosis (“MDP”) would
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`–Slayback’s priority argument is legally flawed and not properly before the Board –
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`POR at 32‐33 et seq.
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`•Slayback’s argument fails both legally and factually:
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`•Grounds 1 and 2 (priority) apply only to claims 8‐18, 25‐28, 30‐31, 33‐39,
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`“antipsychotic”
`–Claims recite treating “manic depressive psychosis” or treating a patient with an
`40‐44, 46, 48‐55, 56‐60, 62, 64, 66, 67, 69, 71, 73, and 75.
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`’827 Patent Claims Entitled to Priority to Aug. 22, 2002
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`13
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`PDX-113
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`U.S.C. §311
`for the MDP claims and that is not an issue properly before the Board. 35
`•Thus, the question is purely whether there is written description support
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`filing
`August 28, 2014 filing date as they were not part of the August 28, 2014
`•Therefore, the MDP claims cannot be legally considered “entitled” to the
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`•The MDP claims were notfiled with the August 28, 2014 application, they
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`were added later by amendment
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`•Slayback argues that the MDP claims are entitled to a filing date no
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`earlier than August 28, 2014.
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`Slayback’s Priority Argument is Legally Flawed
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`14
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`
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`PDX-114
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`•Ex. 1001, 5:1‐10:25; Ex. 1005, pp. 32‐41; see Ex. 2131 (Stahl), ¶¶ 98‐99. POR 28
`MDP specifically, without weight gain.
`claimed dosing regimen could treat psychoses generally, and schizophrenia and
`–Both describe the results of a Phase IIaclinical study that demonstrated that the
`
`•The specifications of the ’927 provisional application and the ’827 patent
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`•Compare Ex. 1001, 2:7‐39 with Ex. 1005, p. 27, line 23 to p. 28, line 4.POR 28
`depressive psychoses, and nervous breakdown (U.S. 5,532,372)”
`especially as an agent for treatment of schizophrenia, senile insanity, manic
`of compounds “useful as an antipsychotic (c.f. neuroleptic agent, antianxiety, etc.),
`–Both describe the Saji ’372 patent (IPR2020‐01053 Ex. 1009) as disclosing a genus
`are identical in all relevant respects –POR 28
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`The MDP Claims are Entitled to the ’927 Provisional Filing
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`Date
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`15
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`
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`PDX-115
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`5:31mozm.n=>m_._.02I._._m=._Xm_m_>_._.<N_._.mZOs_m_n_
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`POR 28
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`wNm0;
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`Ex. 1005, p. 27, line 21 -26
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`Ex. 1001,’827 Patent, 2:5-11
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`The MDP Claims are Entitled to the ’927 Provisional Filing Date
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`16
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`16
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`PDX-116
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`9:31
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`Ex. 2131, ¶¶ 101-102
`
`Schizophrenia and MDP are not Unrelated, Distinct
`
`Diseases
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`mmmmmmfi.
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`17
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`mozm.n=>m_._.02I._._m=._Xm_m_>_._.<N_._.mZOs_m_n_
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`17
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`PDX-117
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`–Slayback’s Expert, Dr. Kosten, agrees . . .
`
`•Ex. 2131, ¶ 102; Ex. 2140 –Surreplyat 3
`targeting the D2receptor
`–Antipsychotics were known to treat schizophrenia and the manic phase of MPD by
`–Psychotic symptoms are the result of excess dopamine
`
`•Ex. 2131, ¶¶ 37, 102; Ex. 2140 –Surreplyat 3
`
`–Both include psychotic symptoms
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`•Schizophrenia and MDP are not unrelatedconditions
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`Treating Schizophrenia is Treating the Manic Phase of MDP
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`18
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`PDX-118
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`Ex. 2134, 34:15-17
`Dr. Thomas Kosten
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`A. That’s correct.
`
`schizophrenia and the manic phase of bipolar disorder.
`Q. So the antispsychoticcan be used to treat both
`
`Treating Schizophrenia Treats the Manic Phase of Bipolar
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`Disorder (MDP)
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`19
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`PDX-119
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`Ground 3 -Obviousness
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`20
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`
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`PDX-120
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`–Extrapolating From Other Chemical Structures Is Improper.
`–Receptor Binding Affinity Data Are Inconsistent and Inconclusive.
`
`•The lurasidone prior art did not disclose a weight effect.
`•Weight gain is a multifactorial process.
`•Multiple receptors are involved.
`•The relationship between pharmacological profile and weight gain was not (and is not) well understood.
`
`•A Skilled Artisan Would Have No Reasonable Expectation of Success In Achieving
`
`–The Pharmacology of Antipsychotics is Complex.
`the Claimed Invention Because the Art is Unpredictable.
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`35 U.S.C. §103: No Reasonable Expectation of Success
`
`21
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`
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`PDX-121
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`•“Guideline for Industry: Dose‐Response Information to Support Drug Registration” (1994) (“ICH‐4;” Ex.
`
`1030).
`
`Drug Safety (2001) (“Wetterling;” Ex. 1042);
`(“Allison;” Ex. 1041) and Wetterling, “Bodyweight Gain with Atypical Antipsychotics: A Comparative Review,”
`•Allison, “Antipsychotic‐Induced Weight Gain: A Comprehensive Research Synthesis” Am. J. Psychiatry (1999)
`
`Various Receptors in the Brain,” Jap. J. of Neuropsychopharmacology(Dec. 1999) (“Horisawa;” Ex. 1028);
`•Horisawa, “Pharmacological Characteristics of the Novel Antipsychotic SM‐13496: Evaluation of Action on
`•“ZYPREXA® (Olanzapine) tablets.” Physicians’ Desk Reference, 55thed. (2001) (“Olanzapine;” Ex. 1039);
`•“Saji amendment” (Ex. 1026) submitted during prosecution of the Saji patent;
`the following references:
`–Although not formally part of the unpatentability ground, Slayback also relies on
`over Saji, U.S. 5,532,372 –Ex. 1009.
`
`•As the Patent Office previously determined, Claims 1‐75 are patentable
`
`Claims 1‐75 are Patentable over Saji
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`22
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`
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`PDX-122
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`POR 36‐37
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`(objections from counsel
`
`removed)
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`Ex. 2134; 88:8-24; 89:16-
`
`90:10
`
`Dr. Thomas Kosten
`
`information. So that's not irrelevant.
`with this medication.ꞏYou need to know that
`what? I mean, they're relevant to treatment of patients
`THE WITNESS:ꞏI guess I don’t ‐‐irrelevant to
`. . .
`all of those other things are irrelevant; right?
`regimen leads to weight gain –it’s your position that
`not you give it with something else, whether or not that
`use, how often you're supposed to give it, whether or
`limitations --how much of the drug you're supposed to
`QꞏꞏSo it’s your position that all of those other
`AꞏꞏOkay.
`lurasidone molecule itself; right?
`the use of lurasidone hydrochloride are due to the
`ꞏunexpected results for any secondary consideration to
`QꞏꞏYou have a blanket statement now that any
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`Slayback’s Expert Disagrees with Slayback
`
`23
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`
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`PDX-123
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`POR 36‐37
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`(objections from counsel
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`removed)
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`Ex. 2134; 88:8-24; 89:16-
`
`90:10
`
`Dr. Thomas Kosten
`
`objection to them having been patented for schizophrenia.
`THE WITNESS: They were patented. I don’t have any
`A They were –
`drawn, and the claims to schizophrenia are patentable?
`QꞏꞏSo you agree that it was fair for claims to be
`BY MR. SHEAR:
`
`idea.ꞏThat was fair.
`in fact, given a patent.ꞏAnd I agree.ꞏThat’s a good
`presented for use of this in schizophrenia, which was,
`THE WITNESS:ꞏThere are data that were
`. . .
`came after that is patentable?
`after that patent published, that none of the work that
`Saji patent which covers the compound of lurasidone --
`QꞏꞏSo is it your view, Dr. Kosten, that after the
`
`Slayback’s Expert Disagrees with Slayback
`
`24
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`
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`PDX-124
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`IPR2020-01053 Ex. 1001,
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`Claim 1
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`Saji ’372 Patent does not Teach the Claimed Dosing
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`Regimen
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`25
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`
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`PDX-125
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`£331mozm_n=>m_._.02I._._m_=._xm_m_>_._.<~_._.szEm_n_
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`understood
`mechanisms of which are entirely complex and poorly
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`9:62%EmEEScammE£>cmgammago:800.
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`>208tammeE828chEnFEESU6mEmEmgumE
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`•Does not teach anything about weight gain, the
`•Discloses varying dosing frequencies
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`86528:mc_mo_omart?mmmoUmE.
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`POR 37‐40
`Ex. 1009
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`91mmom.
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`Saji ’372 Patent
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`•Discloses varying dose amounts, none of which are tied
`•Discloses billions of compounds
`•Was considered by the PTO
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`to lurasidone
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`Saji ’372 Patent
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`238N?:8
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`26
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`PDX-126
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`$331mozm—n=>m_._.02I._._m=._Xm_m_>_._.<m_._.mZO_2m_n_
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`Ex. 1009 at Abstract
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`PDX-127
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`SEE
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`Saji Teaches Very Little About Dosing
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`38¢58:2::>a>88mm:5mm
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`Ex. 1009 at 12:15-24
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`PDX-128
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`Saji5,532,372
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`SajiSilent Regarding Weight Gain
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`29
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`PDX-129
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`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
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`$331mozm.n=>m_._.02I._._m=._Xm_m_>_._.<N_._.mZO_>_m_n_
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`Horisawa does not Establish that Lack of Weight Gain was
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`
`38b»25:ommoiuv35:8was539?boa—5:“.m::2:
`
`
`.23m:3:83#330.8gramwamaubfi5%?3:598
`
`Saab“«63ficfifisaabfiMmficwe:2:~3me£36.”2:
`
`-9?$53»:252658.“2:.8caromE3:82—uzamw98
`
`253i$05825E555«5SB
`
`
`
`hue—3«a:29.5.?nah—oz
`
`
`
`
`
`Ex. 1028 at 3
`
`
`
`m:9mms.km
`
`7“
`
`
`’QEEEEEEhEm—fina
`
`fi
`
`30
`
`$0236>
`
`$9.83
`
`ac13.5.._.«$535.
`
`30
`
`
`
`
`
`PDX-130
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`POR at 43
`
`Ex. 2028 at pp. 5-6
`
`Receptor Binding Affinity Does Not Predict Weight Gain
`
`31
`
`
`
`PDX-131
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`POR at 43
`Ex. 2035 at 1
`
`Receptor Binding Affinity Does Not Predict Weight Gain
`
`32
`
`
`
`PDX-132
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`Ziprasidone –Does Not Cause Weight Gain
`
`POR at 43
`
`IPR2020-01053, Ex. 2027
`
`Stahl’s Essential 2013
`
`Quetiapine –Causes Weight Gain
`
`Olanzapine –Causes Weight Gain
`
`Receptor Binding Affinity Does Not Predict Weight Gain
`
`33
`
`
`
`PDX-133
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`Ziprasidone
`
`Lurasidone
`
`•BUT: Lurasidone Is NotStructurally Similar To Ziprasidone. Ziprasidone
`
`has an indole structure. Lurasidonedoes not.
`
`•Slayback, relying on Allison and Wetterling, argues that lack of weight
`
`lurasidone and did not cause weight gain.
`gain was expected because ziprasidone is structurally similar to
`
`35 U.S.C. §103: Unpredictability of the Claimed Invention
`
`34
`
`
`
`PDX-134
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`–Binding affinities are quite different
`
`for treating bipolar depression.
`–Lurasidoneis indicated for treating bipolar depression. Ziprasidone is not indicated
`
`–Ziprasidone causes QT prolongation, which required a black box warning on its
`
`label. Lurasidonedoes not cause QT prolongation.
`
`•Ziprasidone and lurasidonehave very different properties:
`
`35 U.S.C. §103: Unpredictability of the Claimed Invention
`
`35
`
`
`
`PDX-135
`
`POR 49
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`Ziprasidone and Lurasidone have Different Receptor
`
`Binding Profiles
`
`36
`
`
`
`PDX-136
`
`$381
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`
`
`
`
`._.02I._._m=._Xm_m_>_._.<m_._.wZOs_m_n_
`
`
`
`gozfi:_Eu=uwamacocoa“:239:.“:mwow—Eu”PE2:35.259
`
`
`
`
`
`
`
`Ex. 2131, ¶¶ 148-149
`
`37
`
`:mcmEszUS
`
`Lack of Weight Gain was not Expected Based on “Diversity
`
`
`
`
`
`35529::0vmmmmvmtmgxm“0:mm;Emu393$U6v_um._
`
`of Humans”
`
` mozm.n=>m_
`lgfluwuwcu5floaty2.5noEwan—Ea2:55¢25%»;
`
`
`
`
`.mp6a2E533ufiuuzaan.555baa:28:3256.9538you.maugaininga
`:83;<.ouumnmfi_autumnafisnnobays“.2::2:o.2%Evans—aEEnmEmmy:
`
`wasgash—Pam5ucfimbmucao.956%:3?32.5.5mocow—um<.03
`
`
`:2:5352.5.52:?b55330«5&2.a:E.3%.;:23!.5.wE
`
`
`
`
`
`
`
`o.EEEutG2.0%“...22.:352333.36.::2...uNEMSE2:95:6?@268.3
`
`5:2:95Exmbaggagesambaa45:8Bwim«we3.5%“:on.nowomanSm
`
`
`
`
`Emu—baa3.53:5Ho3%Ems»,3:38:2:955:.memime—uBEE?2:
`
`
`
`E3Eat—a12635553w.>5“>5:mEEEBEu:o@35quanE:2.5.:Mac
`
`37
`
`
`
`PDX-137
`
`E331
`
`Ex. 2134, 42:4-13
`Dr. Thomas Kosten
`
`EMmafia:«n
`
`2-meFEWgm
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`
`
`
`
`
`
`
`
`mozmosm._.02I._._m=._Xm_m_>_._.<N_._.mZO_>_m_n_rum.
`
`Lack of Weight Gain is not Inherent
`
`mH.50h«H0 E825Hocm_EmuEmfigU6v_um._
`nounommH.§ohHAI::mdosu.mGmemfi
`
`
`95mu.do>mg50%find.hHw>oomfivmUHfiMmooafiflfifimfiunfl
`
`
`wHuuMHmm.uH.mmumfiwumAna;mamafiaMfihHMMHnUfiuumm
`
`
`
`HmfiuoGMuflm.mowvdumunadouEon“unavohmouHovumn
`
`
`HahnnofiumEH0mfifiufiomummHH.=ohflflmmmfivflumHmfififim
`
`
`
`
`
`
`
`.unmfl03uvnfimmmamfifinmunohHwauonk0»mmomonu
`
`
`
`.uuhdownwmmounfiunummum
`
`38
`
`38
`
`
`
`
`PDX-138
`
`mmtxal
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`mozmQ>MHOZ.HszXmm>F<mhmZOEmo
`
`Ex. 2134, 84:24-85:3
`Dr. Thomas Kosten
`
`
`
`muwmfimuwmhwmwmRm
`
`
`
`=§me~33:3:HQ
`
`Lack of Weight Gain is not Inherent
`
`cm0 289::“0:m_EmwEm_w>>U6v_um._
`.3onxu.novHow.umnuumumwuHm>wnhummfiou03Hm
`
`
`
`
`
`hounmflwsdfimmcasesmwnumamomfimumflaafificommafixmu
`
`
`
`
`.unfiomUMMfiuwmmwanOuu-umfihH.hHHOm
`mnowEOmnonHoHanumgkmmuwhumwbmgno»on"£m50£u
`
`
`muoq
`
`39
`
`39
`
`
`
`
`PDX-139
`
`DEMONSTRATIVE EXHIBIT –NOT EVIDENCE
`
`•Slayback’s nexus argument is contrary to established law
`
`•Slayback fails to rebut Patent Owner’s objective evidence of
`
`nonobviousness
`
`Objective Indicia
`
`40
`
`
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