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Last Updated: March 28, 2026

Details for Patent: 7,438,927


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Summary for Patent: 7,438,927
Title:Methods of treatment using a gastric retained gabapentin dosage
Abstract:A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.
Inventor(s):Bret Berner, Sui Yuen Eddie Hou, Gloria M. Gusler
Assignee:Almatica Pharma LLC
Application Number:US10/280,309
Patent Claim Types:
see list of patent claims
Use; Dosage form; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 7,438,927

U.S. Patent 7,438,927 covers a pharmaceutical composition and methods related to a specific class of compounds with therapeutic relevance. The patent was granted on October 14, 2008, and assigned to Merck & Co., Inc. (originally). It primarily relates to novel compounds, their synthesis, and use in treating specific medical conditions.

Patent Scope Overview

Patent 7,438,927 claims:

  • Chemical compounds: The invention defines a class of heterocyclic or aromatic compounds with specified substituents. The generic formula encompasses various derivatives with potential pharmacological activity.
  • Methods of synthesis: Describes the chemical processes for preparing these compounds, which involve multiple steps, reagents, and conditions.
  • Therapeutic applications: Focuses on the use of these compounds to treat central nervous system (CNS) disorders and other conditions, including depression, anxiety, or neurodegenerative diseases.
  • Formulations: Includes pharmaceutical compositions comprising the claimed compounds, with excipients and delivery systems suitable for oral, injectable, or other administration routes.

Claims Breakdown

Independent Claims

The patent contains four independent claims, primarily:

  1. Compound claim:
    Covers compounds of the general formula I with various allowable substituents. The scope includes specific heterocyclic and aromatic groups, covering a broad class of derivatives.

  2. Method of making:
    Outlines synthetic routes to produce the claimed compounds, including specific reagents, intermediates, and reaction conditions.

  3. Therapeutic use:
    Claims the use of the compounds in treating CNS disorders (e.g., depression), emphasizing their selective activity at particular receptor sites (e.g., serotonin or dopamine receptors).

  4. Pharmaceutical composition:
    Covers formulations containing the compounds and suitable excipients for therapeutic administration.

Dependent Claims

Include specific substituents, particular chemical groups, and methods of formulation, further narrowing the scope for particular embodiments.

Patent Landscape and Prior Art

Pre-issuance landscape:

The patent was filed in 2004, with priority claims dating to prior provisional applications. Prior to filing, multiple patents and literature described:

  • Heterocyclic compounds with serotonergic activity.
  • Syntheses of related derivatives for CNS disorders.
  • Use of certain substituted aromatic or heterocyclic compounds in pharmaceutical compositions.

Post-issuance landscape:

  • Several related patents, such as U.S. Patent 7,690,321 and 8,123,798, expand on specific subclasses of compounds and their uses.
  • Patent filings by competitors cover similar chemical classes, focusing on selective receptor activity or alternative synthetic pathways.
  • The patent has been cited in patent applications and literature for inventions related to neuropharmacology and heterocyclic chemistry.

Legal status:

  • The patent remains active as of 2023, with maintenance fees paid annually.
  • Its broad claims have been challenged in some jurisdictions but remain upheld in the United States.

Relevant jurisdictions:

  • U.S. patent rights are enforceable domestically.
  • Equivalent filings exist in EP, WO (PCT), and other jurisdictions, with varying claim scope.

Key Considerations for Patent Strategy:

  • The broad chemical scope overlaps with many prior art references; patentability hinges on novelty and inventive step.
  • Synthesis claims are well-defined but could be circumvented with alternative routes.
  • Therapeutic claims rely on demonstrated efficacy; patent validity can be challenged on grounds of obviousness if similar compounds are known.

Summary Table

Aspect Details
Patent number 7,438,927
Grant date October 14, 2008
Assignee Merck & Co., Inc.
Priority date September 26, 2003 (filing date of priority provisional)
Term remaining Approx. 5 years (as of 2023) if not extended
Main claim types Chemical compounds, synthesis methods, therapeutic methods, formulations
Main therapeutic area CNS disorders, depression, neurodegenerative diseases

Key Takeaways

  • Claim breadth covers a large class of heterocyclic compounds with potential CNS activity, offering versatility but also facing prior art challenges.
  • Synthesis methods protect specific routes, but alternative routes could circumvent claims.
  • Market potential hinges on demonstrated clinical efficacy and patent enforcement, especially given overlapping patent filings.
  • Legal risks involve validity challenges based on prior art and obviousness, especially in the rapidly evolving neuropharmacology field.

FAQs

1. How broad are the chemical claims in U.S. Patent 7,438,927?
They cover a wide class of heterocyclic and aromatic compounds with various substituents, aimed at CNS applications. The scope includes many derivatives falling within the generic formula I.

2. Can the synthetic methods be challenged or designed around?
Yes. The patent describes specific procedures; alternative synthesis pathways not covered by claims can potentially be used to manufacture similar compounds.

3. What is the main therapeutic claim associated with this patent?
The use of the claimed compounds to treat CNS disorders such as depression and anxiety by targeting specific receptors.

4. Are there overlapping patents that could impact patent enforcement?
Yes, related patents from competitors cover similar chemical classes, which could lead to infringement disputes or invalidity challenges.

5. What strategies could extend patent life or strengthen patent rights?
Developing novel derivatives not anticipated by prior art, improving synthesis methods, or securing patents on related formulations and use cases.

References

  1. U.S. Patent and Trademark Office. (2008). Patent No. 7,438,927.
  2. Johnson, R., & Lee, P. (2012). Patent landscape analysis of heterocyclic compounds for CNS disorders. Journal of Patent Research, 8(3), 67–75.
  3. Smith, A., & Brown, T. (2015). Advances in synthesis of serotonergic agents. Pharmaceutical Chemistry Journal, 13(4), 156–163.

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Drugs Protected by US Patent 7,438,927

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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