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 IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`PATENT OWNER SUMITOMO DAINIPPON PHARMA CO., LTD.’S
`PRELIMINARY RESPONSE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`_________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`_________________
`
`PATENT OWNER SUMITOMO DAINIPPON PHARMA CO., LTD.’S
`PRELIMINARY RESPONSE
`
`
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`TABLE OF CONTENTS
`
`
`INTRODUCTION ............................................................................................... 1
`I.
`II. BACKGROUND ................................................................................................. 3
`A. Schizophrenia, Manic Depressive Psychoses, The Prior Standard of Care,
`and Antipsychotic-Induced Weight Gain ........................................................... 3
`B. The Mechanisms Underlying Weight Gain Are Complex and Poorly
`Understood ......................................................................................................... 5
`III. THE ’827 PATENT AND ITS PROSECUTION HISTORY ............................. 6
`A. The Claimed Invention Solved Prior Problems Associated with
`Antipsychotics .................................................................................................... 6
`B. The ’827 Patent Prosecution History ........................................................... 8
`IV. CLAIM CONSTRUCTION .............................................................................. 14
`V. ARGUMENT ..................................................................................................... 15
`A. The “Manic Depressive” Claims are Entitled to the August 22, 2002
`Provisional Application Filing Date (Grounds 1 and 2) .................................. 16
`B. Claims 1-75 are Patentable over Saji ’372 (Ground 3) ............................. 20
`1. Slayback fails to articulate its obviousness ground with particularity. 21
`2. Saji ’372 does not disclose or suggest the claimed dosing regimen. .... 22
`3. The claimed dosing regimen unexpectedly does not cause weight gain.
` 24
`4. Lack of weight gain is not inherent. ..................................................... 30
`VI. CONCLUSION .................................................................................................. 31
`
`
`
`
`
`i
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`
`
`Exhibit No.
`2001
`
`2002
`2003
`2004
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`EXHIBIT LIST
`Exhibit Description
`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.
`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.
`
`ii
`
`
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`2024
`
`2025
`2026
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`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).
`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
`
`iii
`
`
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`2032
`2033
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`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.
`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-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).
`
`iv
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
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`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.
`
`2040
`
`2041
`
`2042
`
`
`
`
`v
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`I.
`
`INTRODUCTION
` Over 60 million people worldwide suffer from schizophrenia and bipolar
`
`disorder.1 Medications for treating these conditions have been around since the
`
`1950s, but suffer from problems ranging from lack of efficacy to dangerous side
`
`effects.2 Patent Owner’s product, Latuda®, approved in 2010, offered a unique
`
`treatment option to psychiatrists, not only because of its efficacy but also its unique
`
`safety profile.3 That unique profile enabled it to fill an unmet need in the market,
`
`propelling it to blockbuster status despite the majority of its competition being
`
`cheaper generic alternatives. That unique safety profile included drastically
`
`reducing the risk of weight gain, a side effect that had plagued this class of drugs
`
`for decades. 4 For their innovation, the inventors were awarded U.S. 9,815,827
`
`(Ex. 1001, “the ’827 patent”).
`
`The ’827 patent covers a method for treating psychoses, including
`
`schizophrenia and bipolar disorder, by administering lurasidone (the active
`
`ingredient in Latuda®), or a salt thereof, to a patient without a weight gain.
`
`Latuda® embodies the methods claimed in the ’827 patent.5
`
`
`1 Exs. 2041 at 1; 2042 at 2.
`2 Exs. 2001 at 1; 2002, 13-20; 2003, 7-10; 2022 at 2.
`3 Ex. 2004, 2-7.
`4 Ex. 2022 at 1; see generally also Exs. 2005 and 2006.
`5 Exs. 1001; 2004.
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`Over a 16 month period, Patent Owner asserted the ’827 patent against
`
`almost 20 different generic drug companies,6 every single case resulting in a
`
`favorable settlement.7 Slayback, not one of those original challengers, now alleges
`
`that claims 1-75 of the ’827 patent are invalid based on three grounds. The first
`
`two grounds rely on a flawed priority analysis that has no basis in law or in fact,
`
`and is nothing more than an attempted end-run around the statutory prohibition
`
`against §112 arguments. The third ground relies on a reference (Ex. 1009, “Saji
`
`’372”) that the ’827 patent explicitly discusses and that the Examiner previously
`
`considered. Slayback’s superficial analysis of obviousness does not define the
`
`ground with particularity, and, more importantly, ignores the complexity and
`
`unpredictability of atypical antipsychotics generally and the weight gain
`
`phenomenon specifically. As such, Slayback fails to demonstrate a reasonable
`
`likelihood that at least one challenged claim is unpatentable. Accordingly, the
`
`Board should deny the petition.
`
`
`
`
`
`
`6 Exs. 2007-2011.
`7 See e.g. ex. 2012.
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`
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`II. BACKGROUND
`A.
`Schizophrenia, Manic Depressive Psychoses, The Prior Standard
`of Care, and Antipsychotic-Induced Weight Gain
`Schizophrenia is a chronic and severe mental disorder characterized by
`
`abnormal social behavior and failure to understand reality. Schizophrenia
`
`manifests in several ways: (1) positive symptoms (e.g., visual and auditory
`
`hallucinations); (2) negative symptoms (e.g., social isolation and withdrawal); (3)
`
`cognitive symptoms (e.g., loss of attention and working memory); and (4)
`
`neurodevelopmental and neurodegenerative problems.8 Bipolar disorder, once
`
`known as manic depressive psychosis, is a chronic and often severely disabling
`
`mental disorder. Relevant here, bipolar I disorder involves periods of severe mood
`
`episodes from mania to depression.9 While treatable, patient compliance is critical
`
`and can be negatively impacted by undesirable side effects.10
`
`First generation, or “typical” antipsychotics, were a mainstay of
`
`schizophrenia treatment from the 1950s until the 1990s, but these drugs were
`
`linked to severe side effects, most commonly extrapyramidal symptoms (“EPS”).11
`
`
`8 Exs. 2013 at 1; 2014 at 2; 2015 at 1.
`9 Exs. 2016 at 236; 2017 at 1 and 2019 at 6.
`10 See e.g. Ex. 2022 at 1.
`11 Ex. 1001, 1:47-67.
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`EPS are drug-induced movement disorders often presenting as Parkinson-like tics
`
`and tremors. In the 1990s, FDA began approving second generation drugs, or
`
`“atypical,” antipsychotics (“AAPs”) for schizophrenia.12 The AAPs generally
`
`carried a lower risk of EPS than previous drugs but many are associated with
`
`substantial weight gain.
`
`The weight gain caused by AAPs is far more than a cosmetic problem. It is
`
`one of the primary reasons for treatment non-compliance, which leads to relapse,
`
`psychotic episodes, and higher hospitalization rates.13 Just as critical, weight gain
`
`can lead to serious health problems. The life expectancy of patients with
`
`schizophrenia and bipolar disorder is 20-30 years less than healthy people, in part
`
`because these patients suffer from higher rates of major medical conditions,
`
`including premature cardiovascular disease (“CVD”).14 Excess CVD risk in these
`
`patients results from higher rates of obesity, lipid abnormalities, diabetes,
`
`hypertension, and physical inactivity, often because of the weight gain and related
`
`metabolic side effects of psychiatric medications.15
`
`
`
`
`
`
`12 Exs. 2022 at 2; 2020, 24-28.
`13 Exs. 2021 at 1; 2022 at 1.
`14 Ex. 2006, Table 1.
`15 Ex. 2022 at 3.
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`Most of the early AAPs caused substantial weight gain. For example,
`
`olanzapine (Zyprexa®) is associated with significant short- and long-term weight
`
`gain.16 Quetiapine (Seroquel®) and risperidone (Risperdal®) are two other AAPs
`
`that carry substantial weight gain risk.17
`
`Although there are some AAPs that do not carry a risk of substantial weight
`
`gain, those drugs suffer from other problems that limit their utility. For example,
`
`ziprasidone (Geodon®) is associated with smaller increases in body weight than
`
`many AAPs, but may lead to QT prolongation—a cardiac side effect that can end
`
`in sudden death.18
`
`B.
`
`The Mechanisms Underlying Weight Gain Are Complex and
`Poorly Understood
`Antipsychotic drugs exhibit some of the most complex pharmacologic
`
`mechanisms of any drug class in clinical psychopharmacology. Each AAP drug
`
`has a unique and multifaceted pharmacological profile, along with variable
`
`receptor binding profiles.19
`
`
`16 Exs. 2002 at 19; 2022, 2-3.
`17 Ex. 2022, 2-3; See generally exs. 2023 and 2034, 18-20. Please note that while
`Ex. 2023, the label for Risperdal® (Risperidone), is undated, the product was
`approved before the priority date of the ’827 patent. See ex. 2022 at 2.
`18 Exs. 2024, 5-6; 2025, 1, 4; and 2026 at 5.
`19 Ex. 2027, 6, 30-31.
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`In addition, the mechanisms underlying weight gain, even in the absence of
`
`
`
`antipsychotic drug treatment, are complicated, were poorly understood at the time
`
`of invention, and remain poorly understood today. Because of that complexity and
`
`lack of understanding, researchers explained that the “plethora of … systems and
`
`receptors involved in body weight gain regulation make the weight gain liability of
`
`a potential novel agent difficult to predict.”20 This led skilled artisans to propose a
`
`variety of factors that might contribute to weight gain associated with antipsychotic
`
`treatments.21 However, because there was no consistent or predictable relationship
`
`between a drug’s affinity for a particular receptor and subsequent weight gain, a
`
`skilled artisan could not predict the effect a particular drug would have on weight
`
`gain based on its receptor binding profile.
`
`III. THE ’827 PATENT AND ITS PROSECUTION HISTORY22
`A. The Claimed Invention Solved Prior Problems Associated with
`Antipsychotics
`The ’827 patent covers the inventors’ discovery of a method of treating one
`
`
`
`or more patients with an antipsychotic by orally administering once daily to the
`
`patient(s) a pharmaceutical composition comprising 20 to 120 mg of lurasidone
`
`
`20Exs. 2028, 5-6; 2029 at 2.
`21 Ex. 2022 at 3; see also ex. 2029 at 1.
`22 With the exception of Ex. 1001 (’827 patent), all citations to prosecution
`histories and priority applications are to the numbered pages of individual exhibits.
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`hydrochloride without a weight gain or clinically significant weight gain. The
`
`specification contains results from a Phase II clinical trial demonstrating
`
`lurasidone’s efficacy and safety, and notes that “weight gain … was not observed”
`
`in the study.23 The discussion of the clinical trial refers to lurasidone
`
`hydrochloride as “SM-13496,” an internal designation that Patent Owner used at
`
`the time.24
`
`
`
`Lurasidone itself, and its salts, are covered by the Saji ’372 patent, which the
`
`’827 patent describes in its Background section.25 As discussed in greater detail
`
`below, Saji ’372 does not describe the molecule as either “lurasidone” or “SM-
`
`13496,” does not teach the claimed dosing regimen, and does not describe or
`
`suggest the lack of weight gain or clinically significant weight gain associated with
`
`the claimed dosing regimen.
`
`The claimed invention, embodied in Latuda®,26 represents a substantial and
`
`surprising improvement over prior AAP treatments. Not only does it have the
`
`
`23 Ex. 1001, 7:66-67.
`24 Id., 4:47-50.
`25 See Ex. 1009, claim 14; Ex. 1001, 2:5-39.
`26 Latuda® is indicated to treat schizophrenia at a dose of 40-160 mg once daily
`(and 20 mg once daily for certain classes of patients), and as monotherapy or
`adjunctive therapy for depressive episode associated with Bipolar I Disorder
`(bipolar depression) at a dose of 20-120 mg or 20-80 mg, respectively, once daily.
`Ex. 2004.
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`lowest risk of weight gain reported to date for an efficacious and FDA-approved
`
`AAP, but it also lacks many of the other significant side effects that plagued other
`
`antipsychotics, such as QT prolongation.27
`
`B.
`The ’827 Patent Prosecution History
`The inventors filed the application to which the ’827 patent claims priority
`
`(Ex. 1005, “the ’927 provisional application”) on August 22, 2002.28 The
`
`specifications of the ’927 provisional application and the ’827 patent are identical
`
`in all relevant respects. Indeed, Slayback has identified no differences between the
`
`two. Significantly, for purposes of this IPR, both describe the Phase II clinical
`
`results demonstrating lurasidone’s efficacy and safety, and note that “weight gain
`
`… was not observed” in the study.29 Moreover, the background sections of both
`
`characterize Saji ’372 as describing a genus of compounds “useful as an
`
`antipsychotic (c.f. neuroleptic agent, antianxiety, etc.), especially as an agent for
`
`treatment of schizophrenia, senile insanity, manic depressive psychoses, and
`
`nervous breakdown (U.S. 5,532,372).”30 As noted above, the genus includes
`
`lurasidone.
`
`
`27 Ex. 1001, 10:29-48; Ex. 2030; see generally Ex. 2004.
`28 Ex. 1001, p. 1; Ex. 1005.
`29 Compare Ex. 1001, 7:66-67 with Ex. 1005, p. 37, lines 16-17.
`30 Compare Ex. 1001, 2:7-39 with Ex. 1005, p. 27, line 23 to p. 28, line 4.
`
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`The ’827 patent is a continuation of U.S.S.N. 10/525,021, filed February 18,
`
`2005 as a national stage application of PCT/JP2003/010490, filed August 20, 2003,
`
`and now issued as U.S. 9,174,975 (Ex. 1019, “the ’975 patent”).31 The
`
`specifications of the ’827 and ’975 patents are identical in all relevant respects.
`
`During prosecution of the ’975 patent, the Examiner rejected claims drawn to
`
`treating schizophrenia with lurasidone as anticipated by or obvious over the
`
`European counterpart of Saji ’372 (Ex. 1032; “Saji EP ’846”).32 With respect to
`
`obviousness, the Examiner stated that it would have been obvious to optimize the
`
`dosing range taught in Saji EP ’846 to obtain the claimed dosing range with
`
`minimal side effects.33 The Examiner’s position is similar to the obviousness
`
`ground Slayback now raises based on Saji ’372.34 Ultimately, the Examiner
`
`allowed the claims and the application issued as the ’975 patent.35
`
`The ’827 patent was filed as a continuation of U.S. Application No.
`
`10/525,021 (now the ’975 patent) on August 28, 2014. On the same day, the
`
`applicant filed an amendment canceling originally filed claims 1-19, each of which
`
`
`31 Ex. 1001, p. 1.
`32 Ex. 1017, pp. 4-5. The Examiner had previously included the U.S. Saji ‘372
`patent as a secondary reference in a rejection. See Ex. 1016, p. 4.
`33 Ex. 1017, pp. 4-5.
`34 See Petition, pp. 55, 59-63.
`35 Ex. 2031.
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`Attorney Docket No.: 46094-0002IP1
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`was directed towards treating schizophrenia, and adding claims 20-27.36 Claims
`
`20-27 similarly were limited to the treatment of schizophrenia. Claim 20, the sole
`
`independent claim, read as follows:
`
`20. A method for treating schizophrenia in a patient, without causing
`clinically significant body weight gain in the patient, the method
`comprising administering to the patient a dose of 5 mg to 120 mg of
`the active compound: (1R,2S,3R,4S)—[sic]N-[(1R,2R)-2-[4-(1,2-
`benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-cyclohexylmethyl]-2,3-
`bicyclo[2.2.1]heptanedicarboximide or a pharmaceutically acceptable
`salt thereof.37
`
`Thus, as of August 28, 2014˗the filing date of the application that led to the ’827
`
`patent, each of the pending claims recited a method of treating schizophrenia.
`
`
`
`On October 5, 2015, the applicant filed a second preliminary amendment in
`
`which the applicant amended claim 20 to recite a “method for treating
`
`schizophrenia or manic depressive psychoses.”38 The applicant also added a
`
`dependent claim to manic depressive psychoses.39 For support, the applicant cited
`
`page 2, lines 26-30 of the application,40 which states:
`
`On the other hand, it has been known that the imide derivative of the
`following formula, which was found by the co-workers of the present
`inventors, may be useful as an antipsychotic (c.f. neuroleptic agent,
`
`
`36 Ex. 1020, pp. 3-5.
`37 Id., p. 3.
`38 Ex. 1006, p. 2.
`39 Id., p. 3.
`40 Id., p. 4.
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`Attorney Docket No.: 46094-0002IP1
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`anti-anxiety, etc.), especially as an agent for schizophrenia, senile
`insanity, manic depressive psychoses, and ….41
`
`
`This passage corresponds to p. 27, lines 21-25 of Ex. 1005 (the ’927 provisional
`
`application) and col. 2, lines 5-10 of the ’827 patent, both of which describe the
`
`Saji ’372 patent and a genus of compounds that includes lurasidone.
`
`
`
`On April 8, 2016, the Examiner, who also examined the ’975 patent, issued a
`
`restriction requirement, stating that “[t]he present application is being examined
`
`under the pre-AIA first to invent provisions.”42 Because the ’927 provisional
`
`application and the ’975 patent were filed pre-AIA, while the ’827 patent was filed
`
`post-AIA, this statement is evidence that the Examiner agreed that the ’827 patent
`
`claims were entitled to their priority date and that the ’927 provisional application
`
`provided written description support for claims reciting treating manic depressive
`
`psychosis.
`
`
`
`In an Office Action dated October 19, 2016, the Examiner reiterated that
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`“[t]he present application is being examined under the pre-AIA first to invent
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`provisions.”43 The Examiner did not reject the claims for lacking written
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`description in the specification as filed. Because the specification as filed is
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`41 Ex. 1003, p. 5. On the next page, the quote continues: “nervous breakdown
`(U.S. 5,532,372).” Id., p. 6.
`42 Ex. 1046, p. 93.
`43 Ex. 1033, p. 3.
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`Attorney Docket No.: 46094-0002IP1
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`identical in all relevant respects to the ’927 provisional application, this is further
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`evidence that the Examiner considered and concluded that the manic depressive
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`psychosis claims were entitled to the August 22, 2002 priority date of the ’927
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`provisional application.
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`
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`The Examiner also rejected the pending claims as being obvious over Wong,
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`U.S. Patent No. 6,964,962 (Ex. 2032; “Wong”) as evidenced by Pozuelo, U.S.
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`Patent Pub. No. 2001/0047010 (Ex. 2033; “Pozuelo”).44 The Examiner cited
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`Pozuelo for disclosing manic depressive psychosis, which is additional evidence
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`that she was aware of the manic depressive psychosis limitations when she
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`examined the application.
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`
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`The Examiner reasoned that Wong taught the range of “0.05 to 7500
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`mg/day/patient of SM-13496” for the treatment of schizophrenia, and that this may
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`be a “daily dose” or “once a day administration” of the compound.45 The
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`Examiner found that the Wong range overlapped with the claimed range and
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`therefore “creates case [sic] of obviousness.”46 The Examiner also noted that an
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`object of the Wong invention was to provide an effective schizophrenia treatment
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`44 Id., pp. 3-5.
`45 Id., p. 3.
`46 Id.
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`with reduced side effects.47 Accordingly, the Examiner found it would be obvious
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`to utilize SM-13496 for treating schizophrenia or manic depressive psychosis.48
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`These arguments are very similar to the arguments Slayback makes to support its
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`obviousness ground based on Saji ’372.49
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`
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`On March 17, 2017, the applicant filed an amendment and response in which
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`the applicant added claims reciting treating a patient “with an antipsychotic.”50
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`The applicant also amended each of the pending claims to recite treating either
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`schizophrenia or manic depressive psychosis.51
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`
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`To overcome the obviousness rejection based on Wong, the applicant argued
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`that Wong’s broad dosing range failed to teach or suggest the specific dosing range
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`set forth in the pending claims.52 The applicant also submitted a later-dated study
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`(“the Newcomer study”) to prove that lurasidone performed unexpectedly better
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`than another antipsychotic (risperidone) with respect to weight gain, and further
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`pointed the Examiner to the Phase II clinical data in the specification showing the
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`absence of side effects, including weight gain.53
`
`
`47 Id., p. 4.
`48 Id., pp. 4-5.
`49 See e.g., Petition, pp. 61-63.
`50 Ex. 1034, pp. 5-13.
`51 Id., pp. 2-5.
`52 Id., pp. 18-19.
`53 Id., pp. 14-15 and 19-21.
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`On July 17, 2017, in response to applicant’s arguments and evidence, the
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`
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`Examiner issued a notice of allowance.54 The Examiner reiterated that
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`“[t]he present application is being examined under the pre-AIA first to invent
`
`provisions,”55 thus reinforcing that the claims, including the newly added claims,
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`were entitled to the August 22, 2002 filing date. See Wombat Security
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`Technologies v. PHISHME, Inc., PGR2017-00009, Paper No. 7 at 10-11 (PTAB
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`June 8, 2017) (statements in notice of allowance that Examiner examined claims
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`under pre-AIA first to invent provisions “are at least an indication that the issue of
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`whether the ‘038 patent is entitled to the priority dates of its parent applications
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`was considered by the Examiner during prosecution.”). The Examiner also stated
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`that the claims were allowable on the basis of the evidence of unexpected results
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`relating to lack of weight gain.56
`
`IV. CLAIM CONSTRUCTION
`Claims are construed using the Phillips standard that aims to determine “the
`
`ordinary and customary meaning of [each] claim as understood by [a POSA] and
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`the prosecution history pertaining to the patent.” 37 C.F.R. § 42.200; see also
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-14 (Fed. Cir. 2005) (en banc). Claim
`
`
`54 Ex. 1046, pp. 177-184.
`55 Id., p. 182.
`56 Id.
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`Attorney Docket No.: 46094-0002IP1
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`terms are construed only to the extent necessary to resolve a controversy. Vivid
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`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
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`Here, Slayback proposes constructions of several terms: (a) “a patient” or
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`“the patient;” (b) “treating a patient with an antipsychotic;” (c) “manic depressive
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`psychosis;” and (d) “pharmaceutical composition comprising … a sole active
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`ingredient.”57 Patent Owner does not concede that Slayback’s proposed
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`constructions are correct and submits that no construction is necessary at this stage
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`in order to deny the Petition. Nevertheless, even under Slayback’s proposed
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`constructions, Slayback fails to demonstrate a reasonable likelihood that any of the
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`challenged claims are unpatentable.
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`V. ARGUMENT
`Each of the three grounds that Slayback proposes regarding why claims 1-75
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`of the ’827 patent are unpatentable falls far short of the threshold required to
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`institute an IPR. To institute, the Board must find that Slayback has shown a
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`reasonable likelihood that it would prevail with respect to at least one of the
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`challenged claims. 35 U.S.C. § 324(a). But Slayback has not shown that any
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`claim of the ’827 patent is unpatentable for any of the reasons it identifies.
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`
`
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`
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`57 Petition, pp. 18-23.
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`15
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`Attorney Docket No.: 46094-0002IP1
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`
`
`A. The “Manic Depressive” Claims are Entitled to the August 22,
`2002 Provisional Application Filing Date (Grounds 1 and 2)
`Grounds 1 and 2 only apply to claims 8-18, 25-28, 30-31, 33-39, 40-44, 46,
`
`
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`48-55, 56-60, 62, 64, 66, 67, 69, 71, 73, and 75. These claims are not limited to
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`treating schizophrenia. Instead, they recite treating “manic depressive psychosis”
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`or treating a patient with “an anti-psychotic.” Slayback refers to these claims as
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`the “manic depressive claims,” and argues that these claims are not entitled to the
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`benefit of the ’927 provisional application’s filing date (August 22, 2002) because
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`they are not limited to schizophrenia.58 Instead, Slayback argues that they are only
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`entitled to the August 28, 2014 filing date of the ’827 patent, and thus unpatentable
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`over alleged intervening prior art: Ex. 1007 (“Latuda® Information”),59 which
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`describes the approval of Latuda® for treating bipolar depression and Latuda®
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`Information plus Ex. 1008 (“Loebel”), which also describes the use of Latuda® for
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`treating bipolar depression.60
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`
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`Slayback must be correct on its priority argument for its first two grounds to
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`have any possible chance of success. However, Slayback’s priority argument is
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`
`58 Petition, pp. 23-31.
`59 Ex. 1007 appears to be an insert included in a periodical. Although Slayback
`goes to great lengths to prove that the periodical was a printed publication, there is
`no evidence that the periodical included this particular insert.
`60 Petition, pp. 31-49.
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`based on a flawed legal analysis of the priority issue. As an initial matter, as
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`discussed above, claims 8-18, 25-28, 30-31, 33-39, 40-44, 46, 48-55, 56-60, 62, 64,
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`66, 67, 69, 71, 73, and 75 were added by amendments filed during prosecution and
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`after the August 28, 2014 filing date of the ’827 patent. Thus, even if Slayback is
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`correct that these claims lack written description support in the ’927 provisional
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`application, the claims would not be entitled to the August 28, 2014 filing date.
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`Rather, they would be invalid under § 112, para. 1 as lacking written description in
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`the application as filed. See ICU Medical, Inc. v. Alaris Medical Sys., Inc., 558
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`F.3d 1368, 1377 (Fed. Cir. 2009) (claims added during prosecution years after
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`filing held invalid for lacking written description support in application as filed).
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`
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`Grounds based on § 112, para. 1 (written description) are not proper grounds
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`in an IPR petition. See 35 U.S.C. § 311 (IPR challenges limited to §§ 102 and 103
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`grounds based on patents or printed publications). For this reason alone, Grounds
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`1 and 2 fail
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