`
`
`
`
`Petitioner’s Demonstrative Exhibits
`Slayback Pharma LLC
`Petitioner,
`v.
`Sumitomo Dainippon Pharma Co. Ltd.
`Patent Owner
`_____________________
`
`IPR2020‐01053
`Patent 9,815,827
`
`Oral Argument August 11, 2021
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 1
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Hinge on Written Description in ‘927 Provisional
`
`
`
` Ground 1 Manic Depressive Claims
`
`
` Anticipated by Latuda Information
`
` Ground 2 Manic Depressive Claims
`
`
` Obvious over Latuda information and Loebel
`
`
`
`
`[Paper 2, pp. 31‐49; Paper 20, pp. 12‐13]
`
`
`
`{80269798:1}
`
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 2
`IPR2020‐01053
`
`
`
`Grounds 1 and 2
`Written Description = Method With All Limitations
`
`
`
`
`
`
`Written description requires disclosure of method with “all”
`limitations.
`Stored Value v. Card Activation, 796 F. Supp. 2d 520,
`539 (Dist. Del. 2011), aff’d, 499 Fed. Appx 5, 14 (Fed.
`Cir. 2012)
`Patent Owner Sur‐Reply
`‘the claimed
`that
`“It goes without saying
`lurasidone dosing regimen’ means ‘the claimed
`method with all limitations.’”
`[Paper 20, pp. 16‐17; Paper 25, p. 8 (emphasis by Patent Owner)]
`
`
`{80269798:1}
`
`
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 3
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Patent Owner Ignored Illustrative Claim 8
`
`
`
`
`Claim 8
`a. Treating manic depressive psychosis
`b. Oral Administration
`c.
`Lurasidone or its salt
`d. 20 to 120 mg/day
`e. No clinically significant weight gain
`
`
`
`
`[Paper 2, pp. 27‐28; Paper 7, p. 7; Paper 20, p. 17]
`
`
`
`{80269798:1}
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` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 4
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Patent Owner Admits Field is “Complex”
`
`
`
`According to Patent Owner:
`“Antipsychotic drugs exhibit some of the most
`complex pharmacologic mechanisms of any drug
`class in clinical psychopharmacology.”
`“antipyschotics . . . do indeed exhibit complex
`behavior . . . .”
`“Slayback [] continues to ignore the complexity of
`atypical antipsychotics”
`
`
`[Paper 15, p. 6, citing e.g. EX‐2131 (Stahl Decl.) ¶77; Paper 25, pp. 1, 7. (emphasis added)]
`{80269798:1}
`
`
`
`
`EX‐1057 p. 5
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Single Passing Reference in Complex Field
`
`
`
`
`
`* * *
`
`
`
`[EX‐1005 (‘927 Provisional), p. 27; Paper 20, p. 14]
`
`
`
`{80269798:1}
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` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 6
`IPR2020‐01053
`
`
`
`
`
`
`
`Grounds 1 and 2
`Patent Owner Argued Not “Associated”
`
`
`
`Schizophrenia claims in parent rejected over Saji EP ‘846
`
`Patent Owner argued
`“Nowhere
`is the particular
`‘846
`in Saji EP
`the present claim 1
`compound recited
`in
`(Lurasidone) associated with effective treatment
`of schizophrenia . . .”
`
`[Paper 2, p. 17; EX‐1017, pp. 3‐4; EX‐1018, p. 4 (emphasis added]
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 7
`IPR2020‐01053
`
`
`
`
`
`
`
`Grounds 1 and 2
`‘927 Provisional Never Associates
`Lurasidone With Manic Depressive Psychosis
`- “Agent for Treatment of Schizophrenia” [title]
`- “The present invention relates to a novel method for
`treatment of schizophrenia” [technical field]
`- “Namely, the present invention provides a method for
`treatment of schizophrenia” [summary of invention]
`- “Placebo‐controlled double blind experiment was done
`on 149 patients with schizophrenia” [clinical trial]
`- “Treatment of schizophrenia” [all original claims]
`[EX‐1005 (‘927 Provisional), pp. 26, 29, 32, 43‐46 (emphasis added); Paper 20, p. 13]
`{80269798:1}
`
`
`
`
`EX‐1057 p. 8
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Obviousness Is Not Written Description
`
`
`
`“[A] description that merely renders the invention obvious
`does not satisfy the [written description] requirement.”
`Ariad Pharm., Inc. v. Eli Lilly & Co. Inc., 598 F.3d 1336,
`1352 (Fed. Cir. 2010) (en banc); Lockwood v. American
`Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)
`
`“[I]t is the specification itself which must demonstrate
`possession.”
`Ariad, 598 F.3d at 1352
`
`[Paper 20, pp. 17‐18]
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 9
`IPR2020‐01053
`
`
`
`
`
`Grounds 1 and 2
`Patent Owner Improperly Relies on Hybritech
`
`
`
`Patent Owner Sur‐Reply
`“The law does not require that a patent explicitly disclose
`information that would have been known to a POSA. See
`Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d
`1367, 1384 (Fed. Cir. 1986) (‘a patent need not teach, and
`preferably omits, what is well known in the art.’)”
`In Fact
`Hybritech is enablement case
`Hybritech says nothing about written description
`[Paper 25, p. 5]
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 10
`IPR2020‐01053
`
`
`
`
`
`
`
`
`
`Ground 3
`Admitted Evidence of Prima Facie Obviousness
`a. Lurasidone is a preferred compound of Saji Patent
`b. ‘827 Patent “logical outcome” of Saji Patent
`c. Everyone knew lurasidone could treat schizophrenia
` “A profound statement of the obvious”
`d. ‘827 Patent includes Saji Patent’s “preferred range”
`e. No “difficulties finding safe and effective dose”
`f. Lurasidone half‐life suggested once‐a‐day
`g. Half of patients on other antipsychotics no weight gain
`
`[Paper 25, p. 10; EX‐1054 (Stahl Tr.), pp. 34, 35, 37, 42, 93, 101‐102, 127, 130, 135‐139, 141‐
`142, 148; Paper 20, pp. 20‐24]
`
`
`
`{80269798:1}
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` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 11
`IPR2020‐01053
`
`
`
`
`
`
`
`Ground 3
`Even With Olanzapine ‐ Large Majority No Weight Gain
`According to Dr. Stahl
` Olanzapine has “Big Time” weight gain
`But Dr. Stahl
`• Admits the olanzapine label said “71% of the
`olanzapine patients” did not gain a clinically
`significant amount of weight ‐‐ “It is what it is.”
`• Did not know the range of weight gain outcomes
`• Could not recall study where more than half the
`olanzapine patients gained a clinically significant
`amount of weight
` [Paper 20, p. 24; EX‐1054 (Stahl Tr.), pp. 34, 35, 37, 41]
`
`
`
`{80269798:1}
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` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 12
`IPR2020‐01053
`
`
`
`
`
`Ground 3
`No Nexus to Something Novel in the Claim
`
`
`
`Patent Owner must “establish” objective evidence
`has “nexus” to “something . . . novel in the claim”
`In re Kao, 639 F.3d 1052, 1068 (Fed. Cir. 2011)
`
`Patent Owner’s two experts could not identify
`anything novel in claimed invention of ‘827 Patent
`
`
`
`[Paper 20, pp. 27‐29; EX‐1054 (Stahl Tr.), p. 142; EX‐1055 (Reisetter Tr.), p. 26]]
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 13
`IPR2020‐01053
`
`
`
`
`
`
`
`Ground 3
`Claims Not Directed to Patient Population
`
`
`
`Patent Owner focused on average weight gain
`
`“Rather, the relevant question is how a
`
` population of patients will respond.”
`
`In fact:
`
`Therefore: Lack of weight gain in patient population
`
`
`
`does not defeat evidence of obviousness
`
` All claims directed to “one or more patients”
`
`[Paper 15, p. 51; Paper 25, p. 19; Paper 20, p. 31]
`
`
`
`
`
`{80269798:1}
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`
`EX‐1057 p. 14
`IPR2020‐01053
`
`
`
`
`
`Ground 3
`SM‐13496 Was Known to Be Lurasidone
`
`
`
`Petitioner cited Horisawa (EX‐1028) for its discussion of
`efficacy and side effect profile of “SM‐13496”
`
`Petitioner cited WO 01/76557 (EX‐1040) to show
`“SM‐13496” known to be lurasidone 10 months before
`earliest application
`
`By not attempting to antedate WO 01/76557 Patent Owner
`conceded “SM‐13496” was known to be lurasidone
`
`[Paper 2, pp. 52‐53; Paper 20, p. 26]
`
`
`
`{80269798:1}
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` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 15
`IPR2020‐01053
`
`
`
`
`
`Ground 3
`Horisawa Suggested Efficacy and Low Side Effects
`
`
`
`Petitioner’s translation (EX‐1028)
`“These results suggest that SM‐13496 improves schizophrenic
`symptoms via D2 and 5‐HT2 receptor blocking action and that its
`circulatory system and central depression side effects and body
`weight increasing action are weak….”
`Patent Owner’s translation (EX‐2040)
`“These results suggest that SM‐13496 ameliorates symptoms of
`schizophrenia via D2 and 5‐HT2 receptor blocking effects and also
`has low binding affinity for α1, H1 and 5‐HT2C receptors;
`therefore it is suggested that its cardiovascular system and
`central suppressive side effects and weight gain effect are weak.”
`[Paper 2, pp. 52‐53; Paper 20, pp. 26‐27; (emphasis added)]
`
`
`
`
`
`{80269798:1}
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`
`EX‐1057 p. 16
`IPR2020‐01053
`
`
`
`
`
`
`
`Ground 3
`Dr. Kosten Did Not Recant on Schizophrenia Claims
`
`
`
`Patent Owner argues Dr. Kosten recanted
`that schizophrenia claims were obvious
`
`Dr. Kosten did not recant
`“Rather, when I testified . . . that I did not have an
`‘objection’ to the ‘schizophrenia claims’ . . . I meant
`that the clinical data in the ‘827 Patent . . .
`demonstrated the safety and efficacy of using
`lurasidone to treat schizophrenia.”
`
`
`[Paper 15, p. 35; EX‐1051, ¶4; Paper 20, p. 11]
`
`
`
`
`
`{80269798:1}
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`
`EX‐1057 p. 17
`IPR2020‐01053
`
`
`
`
`
`
`
`Grounds 1, 2 and 3
`Dr. Stahl Undermined His Own Credibility
`Dr. Stahl’s Declaration
`“EX. 2032 (Wong), which first published in 2002,
`teaches that it was necessary to co‐administer a
`second active agent with a number of antipsychotic
`drugs, including “SM‐13496,” in a single formulation
`to minimize weight gain.”
`
`In fact: Wong says the two drugs may be given
`“separately”and at “different times”
`“over a 24 hour period”
`[EX‐2131 (Stahl Decl.) ¶177 (emphasis added); Paper 20, p. 30 (emphasis added)]
`{80269798:1}
`
`
`
`
`EX‐1057 p. 18
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`IPR2020‐01053
`
`
`
`
`
`Ground 3
`Patent Owner Redefines “Single Formulation”
`
`
`
`Patent Owner Response
`“A skill [sic] artisan, reading Wong, would have
`believed it necessary to combine an antipsychotic
`drug with a
`second different drug
`in a
`single formulation to avoid or reduce weight gain.”
`Patent Owner Sur‐Reply
`“In other words, ‘single formulation’ . . . means both
`single unit dose and separate administration.”
`[Paper 15, p. 61; Paper 25, p. 25; (emphasis added)]
`
`
`
`
`
`
`{80269798:1}
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`
`EX‐1057 p. 19
`IPR2020‐01053
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Louis H. Weinstein, certify that I caused to be served a true and correct copy of the foregoing PETITIONER’S
`
`DEMONSTRATIVE EXHIBITS, Exhibit 1057, by e-mail, as follows:
`
`Chad Shear
`
`shear@fr.com
`
`Dorothy Whelan whelan@fr.com
`
`Michael Kane
`
`kane@fr.com
`
`IPR46094-0002IP1 IPR46094-0002IP1@fr.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: August 9, 2021
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
` By: /s/ Louis H. Weinstein
`
` Louis H. Weinstein
`
` Reg. No. 45,205
`
`
`
`
`
`{80269798:1}
` PETITIONER’S DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX‐1057 p. 20
`IPR2020‐01053
`
`
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