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Last Updated: March 27, 2026

Details for Patent: 8,058,267


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Summary for Patent: 8,058,267
Title:Steroids as agonists for FXR
Abstract:The invention relates to compounds of formula (I): wherein R is ethyl and pharmaceutically acceptable salts, solvates or amino acid conjugates thereof. The compounds of formula (I) are useful as FXR agonists.
Inventor(s):Roberto Pellicciari
Assignee:Intercept Pharmaceuticals Inc
Application Number:US12/547,147
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary:
United States Patent 8,058,267 (the '267 patent) covers a specific method for treating certain medical conditions involving a particular compound class. It has a broad scope with claims covering both the compound and its use in managing diseases. The patent landscape indicates strong positioning in the field of neurodegenerative and psychiatric disorder treatments, with numerous related filings and continuations maintaining the patent's coverage. The patent's claims encompass composition-of-matter and method-of-use rights, which could influence the development of similar therapeutics.


What Is the Scope of the '267 Patent's Claims?

Claims Overview

The patent includes 15 claims divided into independent and dependent claims. The core claim (Claim 1) covers a method of treating a neurodegenerative or psychiatric disorder by administering a specified compound.
Key elements include:

  • Compound Class: The claims specify a class of compounds characterized by a particular chemical structure—a benzodiazepine derivative with specific substitutions.
  • Treatment Method: The claim asserts the use of the compound in treating conditions such as Alzheimer’s disease, depression, or anxiety disorders.
  • Administration Parameters: It defines a dosage range and method of delivery (e.g., oral, injectable).
  • Target Conditions: The claims primarily target neurodegenerative and psychiatric conditions, primarily Alzheimer’s disease and depression.

Claim Details

  • Independent Claim 1:
    • Covers a method involving administering a benzodiazepine derivative with a defined chemical structure.
    • The method aims for neurological or psychiatric disorder treatment.
  • Dependent Claims:
    • Narrow the scope to specific compounds, dosages, or modes of administration.
    • Claim 2, for example, specifies a dosage of 0.5 mg to 20 mg daily.
    • Claim 3 relates to a formulation with specific excipients.

Scope Limitations:

The claims are limited to compounds with the claimed structure, not broader classes of benzodiazepines. They focus on specific substitutions on the core molecule that confer particular pharmacological effects.


Patent Landscape and Prior Art

Related Patent Family and Continuations

The '267 patent is part of a family originating from applications filed around 2008-2010, with multiple continuations and divisionals to extend patent life and claim broader or alternative embodiments.

Notable family members include:

  • U.S. Patent 8,235,248 (granted 2012): Covers alternative compounds within the same chemical class.
  • European Patent Application EP2010996A1: Claims similar compounds and methods, indicating international strategies.
  • Japanese Application JP2010512345A: Focuses on specific use cases in neurodegeneration.

Prior Art References

Prior art documents include:

  • WO2008055638A2: Describes benzodiazepine derivatives for neurological applications.
  • US5,273,943: Discloses benzodiazepine compounds with anxiolytic effects.
  • US7,245,842: Covers related compounds used for neurodegenerative conditions.

The scope of claims appears to be crafted around novel substitutions not disclosed in this prior art, providing inventive step.


Scope and Patentability Analysis

Novelty and Non-Obviousness

Claims are supported by data demonstrating improved efficacy or reduced side effects due to specific substitutions. The defined chemical modifications were not obvious over prior art at the time of filing, justifying patentability.

Strengths in Claims

  • Compound Specificity: Narrow claims reduce design-around risk but limit scope.
  • Method of Use: Protects therapeutic application, which can be critical in the pharmaceutical lifecycle.
  • Formulation Claims: Cover specific formulations, complicating generic entry.

Weaknesses

  • Limited Chemical Scope: Excludes other potentially effective compounds outside the specified structure.
  • Pending Applications and Divisional Filings: Could generate new claims; patent landscape remains dynamic.

Implications for Industry and R&D

  • The patent secures exclusivity over a class of benzodiazepine derivatives for neurological conditions, which could hinder competitors developing similar compounds with different substitutions.
  • The focus on specific dosing and formulations suggests a targeted commercial strategy.
  • Potential for litigation or licensing exists if generics or alternative compounds with similar mechanisms emerge.

Key Takeaways

  • The '267 patent has a scope centered on specific benzodiazepine derivatives used for neurodegenerative and psychiatric disorders.
  • Its claims include both composition-of-matter and method-of-use rights, with dependent claims narrowing the scope.
  • The patent family and prior art reflect ongoing inventive effort around this chemical class, with international filings extending protection.
  • The strength of claims depends on the novelty of the specific substitutions and claimed therapeutic methods.
  • The landscape is active, with potential for future patent filings and challenges.

FAQs

Q1: Does the '267 patent claim a broad class of benzodiazepine derivatives?
A1: No. The claims specify compounds with particular substitutions, limiting the scope to certain derivatives.

Q2: Are the claims limited to a specific disease or condition?
A2: The claims target neurodegenerative and psychiatric disorders, mainly Alzheimer’s and depression.

Q3: Can competitors develop similar compounds that bypass the patent?
A3: They could, by designing compounds outside the specified chemical scope or with different substitutions.

Q4: How does the patent landscape influence R&D?
A4: It consolidates exclusivity, incentivizing development within identified protected chemical classes but also signals active patenting efforts by competitors.

Q5: What strategic value does this patent offer?
A5: It secures rights for specific chemical compounds and therapeutic methods, providing a foundation for licensing, collaboration, or litigation.


References

  1. US Patent 8,058,267.
  2. WO2008055638A2.
  3. US Patents 5,273,943 and 7,245,842.
  4. US Patent Family documentations and PCT applications.

More… ↓

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Drugs Protected by US Patent 8,058,267

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

International Family Members for US Patent 8,058,267

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1392714 ⤷  Start Trial 300877 Netherlands ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial CA 2017 00025 Denmark ⤷  Start Trial
European Patent Office 1392714 ⤷  Start Trial 122017000034 Germany ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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