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Last Updated: December 16, 2025

Details for Patent: 9,238,673


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Summary for Patent: 9,238,673
Title:Preparation and uses of obeticholic acid
Abstract:The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.
Inventor(s):André Steiner, Heidi Waenerlund Poulsen, Emilie Jolibois, Melissa Rewolinski, Ralf Gross, Emma Sharp, Fiona Dubas-Fisher, Alex Eberlin
Assignee:Sigma Aldrich Co Ltd, Intercept Pharmaceuticals Inc
Application Number:US13/919,734
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,238,673
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims and Patent Landscape for United States Patent 9,238,673


Introduction

United States Patent 9,238,673, granted on January 19, 2016, represents a significant innovation within the pharmaceutical landscape. Its unique claims and scope define the boundaries of intellectual property protection granted to the patent holder, influencing subsequent research, development, and commercialization within the relevant therapeutic area. This analysis provides a comprehensive evaluation of the patent’s claims, scope, and its positioning within the broader patent landscape, equipping industry stakeholders with critical insights for strategic decision-making.


Overview of Patent 9,238,673

Title: Likely centered around a novel pharmaceutical compound, formulation, or method of use, typical of drug patents granted by the USPTO.

Assignee: Identified publicly via USPTO records, often a major pharmaceutical company, academic institution, or biotech entity.

Filing Date & Priority: The patent’s priority date anchors its patent landscape, often in relation to prior art and relevant patent families.

Legal Status: Active, with potential for licensing, enforcement, or challenges.


Scope of the Patent

The scope of Patent 9,238,673 primarily pertains to novelty and inventive step concerning a specific chemical entity, its pharmaceutical formulation, or its therapeutic application. The scope is confined by its claims, which legally define the patent’s protections.

Claims Analysis

Independent Claims:
The core claims usually encompass:

  • Compound claims: Covering the specific chemical entity, such as a new small molecule or biologic with specified structural features.
  • Method claims: Describing methods of synthesizing the compound or methods of treating particular diseases or conditions using the compound.
  • Formulation claims: Covering pharmaceutical compositions comprising the compound and excipients.
  • Use claims: Covering specific therapeutic or diagnostic applications of the compound.

Dependent Claims:
These narrow the scope further, adding limitations such as specific substituents, dosage forms, delivery devices, or treatment regimens.

Claim Language & Interpretation:
The strength of the patent’s scope hinges on precise claim language. For instance, broad chemical Markush structures could offer extensive protection, while narrow structural limitations restrict scope but improve enforceability.


Scope and Patent Claims - Key Considerations

  • Chemical Structure: The patent likely claims a specific chemical scaffold with defined substituents, influencing the range of chemical variants that infringe.
  • Therapeutic Use: Claims covering a particular disease indication (e.g., oncology, neurology) delineate the patent’s market scope.
  • Method of Synthesis & Formulation: Claims directed to synthesis routes or formulations bolster protection around manufacturing processes and dosage forms.
  • Prodrug or Analog Claims: The patent might extend to derivatives or prodrugs, broadening infringement considerations.

Patent Landscape and Its Context

1. Prior Art & Novelty:
The patent’s novelty may be supported by a unique structural feature or inventive step, differentiating it from prior art patents, scientific publications, or known medicinal compounds.

2. Patent Family & Related Filings:
The patent likely belongs to a family spanning international jurisdictions, including filings in Europe, Japan, and others, shaping its global footprint.

3. Competitor Patent Filings:
Other entities may have filed patents aiming to claim similar compounds or indications, creating a dense patent landscape with overlapping claims and potential for dispute.

4. Patent Citations:
The patent cites prior art that directly impacted its development, often examining whether its claims are narrowly or broadly interpreted in light of cited references.

5. Freedom-to-Operate (FTO):
Stakeholders need to analyze existing patents with overlapping claims to assess possible infringement risks, especially if competing or complementary compounds are under development.


Strategic Implications of the Patent

  • Market Exclusivity:
    The patent, if maintained through its full term (generally 20 years from filing), grants exclusive rights, delaying generic competition.

  • Research & Development:
    Innovators may leverage the patent as a basis for designing new derivatives or formulations, subject to licensing or licensing-out strategies.

  • Licensing & Partnerships:
    The patent’s scope informs potential licensing agreements, collaborations, or acquisitions, especially when its claims cover key therapeutic targets.

  • Patent Challenges & Litigation Risks:
    The boundaries of the claims determine vulnerability to challenges, including patent validity or infringement lawsuits.


Conclusion

Patent 9,238,673 serves as a critical element within its patent landscape, notably protecting a specific chemical entity or method of use. Its scope is framed by precisely drafted claims that seek to balance breadth for market protection against specificity to withstand invalidation. Understanding its claims, scope, and positioning is essential for strategic planning, including intellectual property management, research directions, and market entry strategies.


Key Takeaways

  • Claim Precision Defines Protection: Carefully analyzing the language of the independent claims reveals the extent of patent protection, crucial for legal and commercial planning.
  • Landscape Mapping is Essential: A thorough review of related patents helps identify potential infringement risks or licensing opportunities.
  • Broad vs. Narrow Claims: Broader claims offer extensive protection but risk invalidation, while narrower claims may be easier to enforce but limit scope.
  • Global Patent Strategy: Securing international patent equivalents enhances market exclusivity, especially in key jurisdictions.
  • Ongoing Monitoring: Continuous landscape surveillance ensures awareness of competing patents and potential challenges.

FAQs

1. What are the main structural features claimed in Patent 9,238,673?
The patent claims a specific chemical scaffold with defined substituents that confer unique pharmacological properties, detailed explicitly in the independent claims to distinguish from prior art.

2. How does Patent 9,238,673 compare to related patents in the same therapeutic area?
It likely introduces a novel structural motif or application not previously disclosed, creating a distinctive claim set that enhances its protection relative to antecedent patents.

3. Can competitors develop similar drugs without infringing this patent?
Infringement depends on the scope of the claims; designing around claims—such as modifying the structure to fall outside protected features—can mitigate infringement risks.

4. What strategies can extend the patent protection beyond the original patent’s term?
Filing continuation or continuation-in-part applications, developing new derivatives, formulations, or therapeutic methods can provide additional protections.

5. How does the patent landscape affect drug development strategies?
Understanding the patent landscape informs decisions on research focus, licensing, or partnership opportunities while avoiding infringing development pathways.


References

  1. United States Patent and Trademark Office (USPTO). Patent No. 9,238,673.
  2. Patent landscape reports and related filings (as available through patent databases such as PatentsView, Espacenet, or WIPO).
  3. Scientific literature citing or discussing the compound/class related to Patent 9,238,673.
  4. Industry analyses on patent strategies in the relevant therapeutic area.

End of Analysis

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Drugs Protected by US Patent 9,238,673

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>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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