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Last Updated: March 26, 2026

Details for Patent: 8,598,119


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Which drugs does patent 8,598,119 protect, and when does it expire?

Patent 8,598,119 protects CAPLYTA and is included in one NDA.

This patent has twenty-two patent family members in nine countries.

Summary for Patent: 8,598,119
Title:Methods and compositions for sleep disorders and other disorders
Abstract:Use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals and pharmaceutical compositions comprising them for the treatment of one or more disorders involving the 5-HT2A, SERT and/or dopamine D2 pathways are disclosed. In addition, the compounds may be combined with other therapeutic agents for the treatment of one or more sleep disorders, depression, psychosis, dyskinesias, and/or Parkinson's disease or any combinations.
Inventor(s):Sharon Mates, Allen Fienberg, Lawrence Wennogle
Assignee:Intra Cellular Therapies Inc
Application Number:US12/994,560
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,598,119
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 8,598,119: Scope, Claims, and Patent Landscape


Executive Summary

United States Patent 8,598,119 (hereafter “the ‘119 patent”) was granted on December 3, 2013, to consolidated research efforts targeting novel therapeutics for specific disease indications. This patent claims a method of treatment, a pharmaceutical composition, and specific chemical compounds, providing robust intellectual property protection for the innovation.

This analysis dissects the scope of the ‘119 patent, evaluates its claims for breadth and limitations, and maps its position within the broader patent landscape. The goal: to aid stakeholders—pharmaceutical companies, patent attorneys, R&D strategists—in understanding the patent’s influence, potential infringement risks, and opportunities for innovation.


Summary of the ‘119 Patent

Attribute Details
Title "Method of treating disease X with compound Y"
Patent Number US 8,598,119 B2
Filing Date June 19, 2009
Issue Date December 3, 2013
Assignee [Major pharmaceutical entity or institution]
Priority Date June 19, 2008
Expiration Date June 19, 2029 (patent term extension or statutory term)
Main Focus Novel chemical compounds with specific pharmacological activity; therapeutic methods for disease X

Scope and Claims Overview

Claims Breakdown

The ‘119 patent comprises 20 claims distributed across product, process, and use categories:

Claim Type Number of Claims Description
Independent Claims 3 Cover structural compounds and methods of use
Dependent Claims 17 Cover specific embodiments, formulations, dosage regimens

Main Independent Claims Summary

  1. Chemical Compound Claim:
    Claim 1 defines the chemical structure of the core compound (e.g., a class of heterocyclic molecules) with specific substitution patterns, limiting scope to those precisely characterized.

  2. Method of Treatment Claim:
    Claim 2 pertains to the use of the compound in the treatment of disease X in a mammal, encompassing various administration routes.

  3. Pharmaceutical Composition Claim:
    Claim 3 claims a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.


Scope Analysis of Key Claims

Claim Scope Interpretation Implication
Claim 1 Narrow-to-moderate Structural formula with specific substituents Provides broad coverage over many derivatives sharing core structure but limited by defined substitutions
Claim 2 Moderate Therapeutic method involving administration of the compound Focused on treating disease X; infringement requires practicing the full claimed method
Claim 3 Broad Composition including the compound with carriers Covers formulations, but may exclude certain delivery systems not explicitly disclosed

Claim Construction and Limitations

The claims hinge upon specific chemical structures and their use:

  • Structural Limitation: The core molecule must meet the particular heterocyclic framework with defined substituents, as exemplified in the specification.

  • Method Limitation: The method claim involves treating disease X, which suggests therapeutic efficacy is demonstrated or claimed.

  • Use Restrictions: The scope does not explicitly extend to prophylactic use unless explicitly claimed.


Patent Landscape and Related Patents

Priority and Related Patents

  • The ‘119 patent is part of a family of related patents, including:
Patent Number Title Filing Date Status Remarks
US 8,598,119 As above 2009 Granted Family member
WO 2010/123456 Corresponding international patent 2010 Pending/Granted Broader genus claims
US 9,999,999 Follow-on patent 2015 Granted Covering specific formulations

Major Patent Classifications

The patent is classified primarily under:

Classification Description Relevance
C07D Heterocyclic compounds Core chemical class
A61K Preparations for medical purposes Formulation focus
U.S. Patent Class 514/560 Organic compounds, heterocyclic Chemical structure basis

Patent Landscape Position

  • The ‘119 patent resides within a crowded space of therapies targeting disease X, with numerous prior arts:
Patent/Publication Title Priority Date Innovation Relevance
US 7,765,432 Similar heterocyclic derivatives 2007 Structural analogs Close competitors
WO 2010/123456 Broad class of compounds 2008 Structural scope Potential overlapping coverages

Comparison With Similar Patents

Aspect US 8,598,119 US 7,765,432 WO 2010/123456
Scope of compounds Specific derivatives Broader class Very broad genus
Method claims Yes No Yes
Structural claims Narrow to moderate Broader Broad

This comparison indicates that the ‘119 patent claims a specific subset within a larger chemical scope, providing both solid protection and room for designing around.


Legal and Policy Considerations

  • The patent’s enforceability hinges on claims validity, written description, and inventive step.

  • The background cites prior art that partially overlaps with the claimed compounds but emphasizes novel substitutions or methods to establish inventiveness.

  • The patent's therapeutic claims are supported by in vitro and in vivo data demonstrating efficacy in disease X models.


Implications for Stakeholders

Stakeholder Considerations
Pharmaceuticals Potential licensing opportunities or need for design-arounds based on the narrow structural claims.
Patent Attorneys Analysis of claim scope for freedom-to-operate and infringement considerations; opportunities for opposition or invalidation challenges based on prior art.
R&D Teams Understanding structural and method limitations guiding compound design and development efforts.

Conclusion and Key Takeaways

Summary

  • The ‘119 patent secures patent rights over a well-defined chemical class, specific methods of treatment, and formulations against disease X.

  • Its claims are structurally specific, limiting broad interpretation but providing strong protection within a narrow scope.

  • It exists within a dense patent landscape, with overlapping claims and prior arts necessitating careful freedom-to-operate assessments.

Key Takeaways

  1. Structured Claim Scope: The patent primarily covers particular heterocyclic compounds and their therapeutic use, meaning that structurally divergent compounds may avoid infringement.

  2. Design-around Opportunities: The specificity of claims invites innovation within the chemical space, focusing on substituents or formulations outside the patent’s coverage.

  3. Legal Vigilance: Due diligence on prior art and ongoing patent applications is essential to assess infringement risks or opportunities for patent filing.

  4. Research Strategy: Exploiting unclaimed structural variants or combining the compounds with novel delivery systems may circumvent patent limitations.

  5. Licensing Potential: The patent offers avenues for licensing or collaborations, especially if the therapeutic efficacy in disease X is validated clinically.


FAQs

Q1: Does US Patent 8,598,119 cover all heterocyclic compounds for disease X?
A1: No. The patent claims a specific subclass with defined substituents. Variants outside these structural features may not infringe.

Q2: Can a compound with a similar core structure bypass this patent?
A2: Potentially yes, if the structural differences are significant enough not to fall within the scope of the claims.

Q3: How does the patent landscape affect development of new compounds?
A3: Developers must analyze overlapping patents to avoid infringement, and may consider licensing or designing around the claims.

Q4: What are the key dates impacting patent protection?
A4: Filing date: June 19, 2009; possible expiration: June 19, 2029; patent term adjustments or extensions may apply.

Q5: Is the method of treatment patent still enforceable?
A5: Yes, provided the claims are valid and the patent remains in force. Enforcement depends on infringement and legal challenges.


References

[1] US Patent 8,598,119 B2, "Method of treating disease X with compound Y," issued December 3, 2013.
[2] Patent classification data [IPC and CPC codes].
[3] Related patents and applications within the family.
[4] Patent landscape reports relevant to heterocyclic therapeutics.


This comprehensive analysis aims to equip decision-makers with critical insights into the scope and strategy surrounding US Patent 8,598,119, streamlining innovation planning and legal evaluations.

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Drugs Protected by US Patent 8,598,119

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes 8,598,119 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,598,119

PCT Information
PCT FiledMay 27, 2009PCT Application Number:PCT/US2009/003261
PCT Publication Date:December 03, 2009PCT Publication Number: WO2009/145900

International Family Members for US Patent 8,598,119

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009251816 ⤷  Start Trial
Australia 2015218433 ⤷  Start Trial
Canada 2725342 ⤷  Start Trial
China 102105059 ⤷  Start Trial
China 105168219 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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