United States Patent 9,259,423 Scope and Claims for Lurasidone Methods of Improving Attention in Schizophrenia or Bipolar Disorder
Executive summary: US Drug Patent 9,259,423 covers a method-of-treatment claim for improving attention function in schizophrenia and/or bipolar disorder using lurasidone (or an acid addition salt) as the sole active ingredient. The independent claim is limited to (i) the indication pair (schizophrenia and/or bipolar disorder), (ii) the endpoint (attention function improvement), and (iii) the composition constraint (lurasidone or pharmaceutically acceptable acid addition salt, and as the sole active ingredient). Dependent claims narrow to attention improvement specifically in bipolar disorder, and specify attention sub-domains (continuous concentration, rapid-reaction, visual/perceptual seeking). The patent landscape for US 9,259,423 is dominated by earlier lurasidone composition and use coverage (likely including the core schizophrenia indication and general psychiatric use), with the practical risk for generic entrants tied to whether later filings carve around “attention function” outcomes and/or the “sole active ingredient” constraint.
What does US Patent 9,259,423 claim for lurasidone in schizophrenia and bipolar attention?
Core scope (Claim 1):
A method for improving attention function in schizophrenia and/or bipolar disorder, comprising administering a therapeutically effective amount of lurasidone (or a pharmaceutically acceptable acid addition salt) to a mammal in need thereof, where lurasidone is the sole active ingredient.
Meaning of each limiting element:
- “Method for improving attention function” is a treatment claim tied to a functional outcome. It is not limited to a particular clinical test in the text you provided, but it is likely construed to require a measurable improvement in attention-related domains (see Claim 3).
- “In schizophrenia and/or bipolar disorder” provides an indication set, not an individual disorder-only requirement. If construed broadly, it covers schizophrenia patients, bipolar patients, and potential crossover populations if the trial or treatment is directed to those conditions.
- “Administering… as the sole active ingredient” creates a composition constraint. A regimen that adds a second active agent would typically fall outside the claim language for “sole active ingredient,” unless another agent is argued to be non-active (e.g., placebo) or otherwise not “active.”
- “lurasidone or pharmaceutically acceptable acid addition salt thereof” covers the parent drug and its acid addition salt forms.
Practical implication: A direct infringement theory would focus on whether a competitor markets instructions or conducts clinical practice that administers lurasidone alone for improving attention in schizophrenia or bipolar disorder. For method claims, infringement typically depends on evidence of use, not just presence of a product in commerce.
How do “attention function” and “therapeutically effective amount” constrain claim coverage?
- Attention function: The claim is outcome-based. Courts generally interpret functional language based on the specification and the claims’ dependent structure. Here, Claim 3 supplies explicit sub-components, which can guide construction.
- Therapeutically effective amount: This is dosing-agnostic. It does not require a specific milligram range in the claim text provided. A regimen could infringe even at lower doses if it is “therapeutically effective” to improve attention.
What does “sole active ingredient” do to infringement risk?
This is a major narrowing feature. It can create:
- Higher freedom for combination regimens (e.g., lurasidone plus a separate cognitive or attention agent).
- Higher infringement risk for monotherapy trials or prescribing that uses lurasidone alone.
If a competitor pursues an FDA label augmentation that includes attention improvement, monotherapy language becomes a key legal and commercial focal point.
What do Claims 2 and 3 narrow to: bipolar attention and attention sub-domains?
Claim 2:
Adds that the attention function is attention function in bipolar disorder.
Claim 3:
Defines “improving attention function” as one or more of:
- improving continuous concentration
- improving rapid-reaction
- improving visual/perceptual seeking
Scope impact:
- Claim 2 reduces the indication from “schizophrenia and/or bipolar disorder” to bipolar disorder.
- Claim 3 narrows the “attention function improvement” concept into specific cognitive/behavioral sub-domains. This helps in two ways:
- It can make infringement easier to prove where the clinical protocol uses these constructs.
- It provides a potential defense angle: if improvement is argued only in other cognitive domains not covered (e.g., working memory or executive function without attention targeting), the patent owner may still argue “attention” is broader, but Claim 3 gives color to what the patentee meant by “attention function.”
Could a competitor avoid infringement by targeting different cognitive endpoints?
The claim language itself ties to “attention function” broadly (Claim 1) and to specific sub-domains for Claim 3. A competitor that demonstrates improvement solely in non-attention domains may attempt to steer practice away from “improving attention function.” However, Claim 1 is not limited to the Claim 3 sub-domains. So endpoint avoidance is more effective against Claim 3 than Claim 1 unless the court construes “attention function” to incorporate only those sub-domains.
Where does this fit in the US lurasidone patent estate: composition vs use vs method-of-treatment?
Structural placement in a typical patent landscape for an atypical antipsychotic like lurasidone:
- Composition patents usually cover the drug substance and/or formulations (e.g., crystalline forms, salts, dosage forms, bioavailability-enhancing formulations).
- Method-of-use patents cover therapeutic uses (e.g., treating schizophrenia, bipolar depression, agitation, etc.).
- Specialized method patents (like this one, based on your claim text) target a subpopulation of therapeutic outcomes (attention function) tied to a defined psychiatric indication set.
US 9,259,423 is a method-of-treatment claim that uses the same active ingredient as the broader lurasidone portfolio but targets a different clinical endpoint.
Business consequence: In licensing or litigation strategy, this type of patent is commonly asserted to constrain label expansion, clinical trial positioning, or off-label marketing that frames lurasidone as improving attention in schizophrenia/bipolar disorder.
Which prior lurasidone patents are likely to overlap the same parties and same jurisdiction?
Without the patent’s bibliographic metadata (application number, filing date, assignee, inventor list) and the specification text, it is not possible to reliably enumerate the exact overlapping patents. The overlap pattern is nonetheless predictable: other lurasidone patents likely include:
- salts and polymorphs (fitting the “acid addition salt” phrasing),
- core indications for schizophrenia and bipolar-related disorders,
- and other cognitive/functional improvement claims.
However, any attempt to name specific US patents would require bibliographic data.
What is the Orange Book status of US 9,259,423 for lurasidone?
No complete Orange Book mapping can be produced from the claim text alone. Orange Book status depends on:
- whether the patent is listed for a specific lurasidone NDA,
- whether it is listed under drug substance vs drug product, and
- whether listing is for method-of-use coverage corresponding to a particular label section.
A determination of Orange Book listing and corresponding exclusivity windows cannot be generated from the claim excerpts provided.
When does exclusivity or patent protection related to US 9,259,423 expire?
No expiration timeline can be computed from the claim text alone. Patent expiration is a function of:
- priority date and filing date (for term),
- whether terminal disclaimers exist,
- and whether any adjustments apply,
none of which are present in the provided information.
A correct “lose exclusivity” statement for the US right tied to this specific patent requires bibliographic and prosecution data.
How do Paragraph IV generic challenges interact with a method-of-use patent like 9,259,423?
For a method-of-use claim, generic risk typically hinges on:
- whether the generic is induced to infringe through label instructions or promotional statements,
- whether the patent is listed for the NDA in a manner that triggers certifications tied to the method claim,
- and how the label is carved to avoid the claimed method.
In practice, an ANDA filer may seek to avoid infringement by using a section carve-out that removes attention-function language from indications or avoids describing that lurasidone improves attention function in schizophrenia/bipolar disorder.
However, the ability to carve depends on FDA labeling history and the precise scope of the claims as tied to the reference product’s approved labeling.
What would a design-around look like for generics or branded competitors?
Given “sole active ingredient,” design-around options include:
- Combination regimens (lurasidone plus a second active agent) where attention improvement is attributable to the combination, not lurasidone alone.
- Different dosing regimens might not avoid infringement because the claim only requires a therapeutically effective amount unless the specification restricts doses.
- Different endpoint framing that avoids “attention function improvement” may help at the margin, but it is weak against Claim 1’s broader “attention function” language if the practice results in attention improvement.
How strong is the patent estate around 9,259,423 for lurasidone attention claims?
Claim strength indicators based on claim construction:
- Strong elements for patent owner:
- outcome-based limitation (“improving attention function”)
- defined psychiatric disorder set (schizophrenia and/or bipolar disorder)
- composition constraint (“sole active ingredient”)
- Potentially litigable elements:
- meaning of “attention function” as construed in view of the specification
- whether “improving” requires statistically significant clinical improvement or merely directionally improved attention metrics
- whether “sole active ingredient” permits adjunct non-active components (e.g., excipients) or tolerates background medications
Net: The “sole active ingredient” restriction is a meaningful narrowing lever. If competitors can credibly deliver attention improvements via combination therapy or through practices not directed to attention function improvement, enforcement leverage weakens. If lurasidone is used as monotherapy and marketed/used specifically for attention improvement, enforcement leverage strengthens.
What litigation or settlement patterns typically affect enforcement of lurasidone method-of-use patents?
Method-of-use patents often face:
- FDA label carve-out negotiations in ANDA litigation.
- Settlement terms that delay generic entry into the carved label scope.
- Disputes over whether the generic’s label and promotional materials induce the claimed method.
A specific assessment of what litigation affects US 9,259,423 requires docket-level data tied to the patent, which is not supplied.
Which companies are challenging similar lurasidone patents, and what generic entry risks exist?
No competitor list can be produced from the claim text alone. Generic entry risk depends on:
- whether the patent is listed for the relevant NDA strength,
- the time to earliest possible ANDA launch,
- and the existence of settlements or adverse litigation outcomes.
What formulations are protected: does “acid addition salt” broaden claim coverage beyond tablets?
Covered subject matter in the claims provided:
- lurasidone base and pharmaceutically acceptable acid addition salts.
Not specified in claims provided:
- immediate-release vs extended-release,
- particle size,
- crystalline form,
- or excipient systems.
So the claim scope is driven by active ingredient salt identity, not by a dosage form. Still, enforceability of method-of-treatment claims typically does not require a specific formulation beyond the ability to deliver therapeutically effective lurasidone dosing.
Key Takeaways
- US 9,259,423 is a method-of-treatment patent focused on improving attention function in schizophrenia and/or bipolar disorder using lurasidone (or an acid addition salt) as the sole active ingredient.
- Claim 2 narrows the indication to bipolar disorder attention improvement.
- Claim 3 narrows “attention function improvement” to specified domains: continuous concentration, rapid-reaction, and visual/perceptual seeking.
- The single-active-ingredient requirement is a central design-around lever for combination strategies.
- Exact Orange Book status, litigation map, and expiration timeline cannot be derived from the claim excerpts alone.
FAQs
Does US 9,259,423 require a specific attention test or biomarker to prove infringement?
The claim text you provided does not specify a test or biomarker. The scope is framed by “improving attention function,” with dependent language in Claim 3 describing attention sub-domains.
Can a combination regimen with lurasidone avoid infringement of claim 1?
Claim 1 requires lurasidone or its acid addition salt “as the sole active ingredient,” so adding another active ingredient would typically fall outside the literal language.
Are acid addition salts of lurasidone included in the claim coverage?
Yes. Claim 1 includes “lurasidone or a pharmaceutically acceptable acid addition salt thereof.”
Does Claim 2 cover schizophrenia attention improvement?
No. Claim 2 narrows to attention function in bipolar disorder.
Is improving attention in a domain like working memory covered?
The claims you provided define attention sub-domains in Claim 3, but Claim 1 uses broader “attention function.” Working memory improvements would only clearly fit if they are construed as part of “attention function” under the patent’s construction.
References
No sources are included because the prompt provides only the claims and does not include the patent’s bibliographic record, specification, assignee, priority data, prosecution history, or Orange Book/listing or litigation records necessary to cite.
