PTAB

IPR2020-01053

Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co Ltd

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Agent for Treatment of Schizophrenia
  • Brief Description: The ’827 patent claims methods of treating psychiatric disorders, specifically schizophrenia and manic depressive psychosis, by administering the compound lurasidone or a pharmaceutically acceptable salt thereof.

3. Grounds for Unpatentability

Ground 1: Manic Depressive Claims Anticipated by Latuda® Information - Claims 8-18, 25-28, 30-31, 33-44, 46, 48-60, 62, 64, 66, 67, 69, 71, 73, and 75 are anticipated by Latuda® Information.

  • Prior Art Relied Upon: Latuda® Information (an August 2013 publication in the American Journal of Psychiatry).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the Latuda® Information, which announced the FDA approval of Latuda® (lurasidone HCl), expressly or inherently disclosed every limitation of the challenged "manic depressive claims." The publication allegedly disclosed treating patients with "Bipolar Depression" (construed by Petitioner as manic depressive psychosis), using "(lurasidone HCl) tablets" administered orally. It further disclosed a clinical study with daily doses from 20 to 120 mg/day and reported a mean weight change of -0.02 kg, satisfying the limitations of the specific dosage range and no clinically significant weight gain. The reference also disclosed monotherapy, satisfying claims requiring lurasidone as the sole active ingredient.
    • Key Aspects: This ground's applicability depends on Petitioner's assertion that the manic depressive claims are not entitled to the patent’s 2003 priority date, making the 2013 Latuda® Information intervening prior art.

Ground 2: Manic Depressive Claims Obvious over Latuda® Information and Loebel - Claims 8-18, 25-28, 30-31, 33-44, 46, 48-60, 62, 64, 66, 67, 69, 71, 73, and 75 are obvious over Latuda® Information in view of Loebel.

  • Prior Art Relied Upon: Latuda® Information (August 2013 publication) and Loebel (a 2012 detailed abstract from Neuropsychopharmacology).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Latuda® Information announced the approval of lurasidone for treating bipolar depression, and Loebel described the results of the PREVAIL-2 clinical trial that supported this use. Loebel disclosed a 6-week, placebo-controlled study using lurasidone monotherapy, flexibly dosed at 20-60 mg/day or 80-120 mg/day, to treat bipolar I depression. Together, Petitioner argued these references taught treating the claimed condition with the claimed compound, at the claimed dosages, via the same administration route, and with the same minimal effect on patient weight.
    • Motivation to Combine (for §103 grounds): A POSITA would combine these references because they addressed the identical subject matter. The Latuda® Information was a public announcement of an FDA approval, and Loebel provided the underlying clinical data demonstrating the drug's efficacy, making their combination logical and straightforward for a POSITA assessing the new treatment.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success, as Loebel reported statistically significant positive results from a clinical trial and Latuda® Information announced the resulting regulatory approval.

Ground 3: Obviousness over Saji - Claims 1-75 are obvious over the Saji Patent.

  • Prior Art Relied Upon: Saji (Patent 5,532,372), Saji Amendment (from the prosecution of Saji), Horisawa (a 1999 journal article), Allison (a 1999 journal article), and ICH-4 (1994 FDA guidance).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the primary reference, Saji, disclosed the core invention. Saji taught using lurasidone HCl in tablets as a sole active ingredient for treating both schizophrenia and manic depressive psychosis. It further disclosed a preferred oral daily dose of "about 5 to 100 mg." Petitioner contended that the claimed dose range of 20 to 120 mg/day would have been obvious, as Saji's disclosed range substantially overlaps and provides a clear starting point for routine dose-optimization studies. The Horisawa and Allison references were cited to show that minimal weight gain was an expected property of lurasidone and structurally similar compounds.
    • Motivation to Combine (for §103 grounds): A POSITA would have been motivated to confirm and optimize the treatment disclosed in Saji. Given Saji's broad effective dose range (5-100 mg), a POSITA would perform routine dose-ranging studies, as suggested by the ICH-4 guidance, to identify the optimal therapeutic window, which would lead to the claimed range. The known 18-hour half-life of lurasidone provided a strong motivation for the claimed once-daily administration for patient compliance.
    • Expectation of Success (for §103 grounds): A POSITA would have had a high expectation of success because Saji explicitly taught that lurasidone was effective for the claimed indications, and any further work was merely routine optimization of a known therapy.

4. Key Claim Construction Positions

  • "manic depressive psychosis": Petitioner argued this is an old and vague term that, based on the patent's prosecution history, a POSA would construe to mean "Bipolar Disorders." This construction is critical to mapping prior art references that discuss "bipolar depression" or "bipolar I disorder" onto the claims.
  • "a patient": Petitioner adopted a district court's construction of "one or more patients." This construction is important for limitations related to clinical outcomes (e.g., "the patient does not experience a clinically significant weight gain"), as it allows the limitation to be met even if not all patients in a study achieve the outcome.

5. Key Technical Contentions (Beyond Claim Construction)

  • Lack of Priority for Manic Depressive Claims: A central contention underpinning Grounds 1 and 2 was that the ’827 patent’s "manic depressive claims" were not entitled to the 2003 filing date of their priority application. Petitioner argued that the priority application's disclosure was directed exclusively to treating schizophrenia, mentioning "manic depressive psychoses" only once in a generic list of potential uses. This alleged lack of written description support would make the 2012 Loebel and 2013 Latuda® Information publications valid intervening prior art against those claims.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-75 of the ’827 patent as unpatentable.