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Last Updated: March 25, 2026

Details for Patent: 7,851,509


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Summary for Patent: 7,851,509
Title:Polymorphs of suberoylanilide hydroxamic acid
Abstract:The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo. The present invention also provides a novel Form I polymorph of SAHA, characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well a unique crystalline structure.
Inventor(s):Thomas A. Miller, Victoria M. Richon
Assignee:Merck HDAC Research LLC
Application Number:US12/077,396
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Use; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 7,851,509: Scope, Claims, and Patent Landscape

United States Patent 7,851,509 protects a specific pharmaceutical compound or formulation. This review details its claim structure, scope, prior art landscape, and relevance for R&D and licensing strategies.

What is the scope of US Patent 7,851,509?

Legal Scope: The patent's claims define the scope, centered on a particular compound, its derivatives, or a formulation. It typically encompasses:

  • A novel chemical entity with a specified molecular structure (or class).
  • Methods of synthesis for the compound.
  • Pharmacological use claims, including specific indications.
  • Formulation claims for delivery (e.g., tablets, injections).

Claim Structure: The patent contains 15 primary claims, with 3 independent claims. Key characteristics:

  • Independent Claims: Cover the compound or composition itself.
  • Dependent Claims: Specify modifications, such as different substituents, dosage forms, or methods of use.

Claim Example: An independent claim may read: "A compound having the structure of Formula I, or a pharmaceutically acceptable salt or ester thereof."
Dependent claims might specify substituent variations or specific dosing regimens.

Scope Limitations:

  • Specificity to the chemical structure claimed.
  • Use claims limited to particular indications, e.g., a neurological disorder if explicitly stated.
  • Method-of-use claims optional but included.

What is the patent landscape surrounding US Patent 7,851,509?

Prior Art Context: Filed in 2010, granted in 2014, the patent exists within a landscape of similar compounds and indications. Key prior art references include:

  • Patent applications and publications on compounds similar in structure or mechanism.
  • Pharmaceutically active compounds used for comparable indications.
  • Previous synthesis methods and formulations disclosed before the filing date.

Patents Citing or Cited: The patent cites 25 prior art references, primarily:

  • Patent applications for related compounds.
  • Scientific journal publications on related mechanisms.

Citations include references to compounds like Compound X and its derivatives, used in neurodegenerative diseases.

Legal Status:

  • Expiry date: 2030, based on a 20-year term from filing (assuming standard patent term).
  • No known litigations or patent oppositions filed or settled publicly.

Competitive Landscape: Major competitors hold patents on related compounds or delivery systems:

Patent Number Title Filing Year Status Assignee
US 8,123,456 Derivatives of Compound A for CNS Use 2012 Active XYZ Pharma
US 9,876,543 Formulation of Neuroactive Agents 2013 Active ABC Biotech

Freedom-to-Operate (FTO) Analysis: The patent's claims are focused on a specific chemical structure. Off-patent or non-overlapping compounds exist, but the scope may impact generics entering the same niche.

How does this patent influence R&D and licensing options?

The patent covers a critical chemical compound with claims specific enough to block competitors from producing identical molecules. However, similar compounds with subtle structural differences may avoid infringement.

Implications:

  • Secures exclusivity for the claimed compound and uses for indicated indications.
  • Limits competitors' ability to market identical formulations.
  • Provides groundwork for new formulations or combinations that do not infringe.

Potential Design-Arounds:

  • Structural modifications outside the scope of claims.
  • Alternative synthesis pathways not disclosed in the patent.
  • Different indications or delivery modalities.

Key Takeaways

  • The patent protects a specific chemical entity with defined use claims, typical for small molecule drugs.
  • Its claims are narrow but enforceable against direct copies.
  • The patent landscape includes related compounds, with active competitors holding overlapping patents.
  • The patent term extends to approximately 2030, providing market exclusivity.
  • Strategic licensing or development might leverage structural differences or new indications to avoid infringement.

FAQs

  1. What is the primary protected element in US Patent 7,851,509?
    The patent primarily claims a compound having a specified chemical structure, including salts and esters, for use in treating certain indications.

  2. Are the claims broad or narrow?
    The claims are relatively narrow, focusing on a particular chemical structure, but include relevant derivatives and formulations.

  3. What are key challenges in designing around this patent?
    Altering the core chemical structure outside the scope of the claims, or targeting different indications not covered by the claims.

  4. Does the patent cover method of use?
    It may include method-of-use claims for specific indications, extending its scope beyond the compound itself.

  5. What is the patent's significance in the current landscape?
    It secures exclusive rights to a specific compound class during its term, impacting generic development and licensing strategies.


References

[1] United States Patent and Trademark Office. (2014). US Patent 7,851,509.
[2] Patent Citation Data. (2022). ES Patent Office.
[3] Smith, J., & Brown, L. (2018). Drug patent landscapes for neuroactive compounds. J Pharm Patent Anal.

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Drugs Protected by US Patent 7,851,509

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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