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Last Updated: December 14, 2025

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 the Scope, Claims, and Patent Landscape for U.S. Patent 7,851,509


Introduction

U.S. Patent 7,851,509, granted on December 14, 2010, exemplifies a strategic patent in the pharmaceutical and biotechnology sectors, covering an innovative chemical entity, formulation, or a method of use. An in-depth understanding of its scope and claims reveals both its commercial potential and positioning within the patent landscape. This analysis provides a comprehensive review, integrating claim interpretation, scope delineation, and the intellectual property environment surrounding the patent.


Overview of U.S. Patent 7,851,509

Patent Title: [Insert patent title]
Assignee: [Insert assignee]
Inventors: [Insert inventors, if available]
Filing Date: [Insert filing date]
Issue Date: December 14, 2010

The patent primarily covers a novel chemical compound or a pharmaceutical composition with specified therapeutic indications. The subject matter may encompass specific molecular structures, their synthesis methods, or their use in treating particular diseases. The claims are crafted to protect the compound, its pharmaceutically acceptable salt or derivative, and related methods of treatment.


Scope of the Patent Claims

Claim Types and Composition:

  • Independent Claims: These broadly define the chemical entity or composition, establishing the core inventive concept. They often specify the molecular structure, core scaffold, or a particular formula such as a Markush structure.
  • Dependent Claims: Narrower claims that specify particular substitutions, stereochemistry, formulations, or methods of use, thereby providing fallback positions if broader claims face validity challenges.

Structural and Functional Limitations:

The claims likely specify structural parameters with ranges for substitutions that characterize the molecule, such as R-groups or heteroatoms, defining the chemical space claimed. Functional claims may also include methods of synthesis or specific therapeutic methods, expanding the patent's protective scope.

Claim Interpretation:

  • The scope hinges on the chemical scope—how broad or narrow the molecular formula is—and method claims—the process or mode of use.
  • The claims' language emphasizes novelty and inventive step, using precise chemical language, such as "wherein R is selected from..." to limit or encompass various embodiments.
  • The scope of protection depends on the breadth of terms like "comprising," "consisting of," or "consisting essentially of," which impact patent robustness and enforceability.

Patents Landscape Analysis

Prior Art and Patent Citations:

  • The patent was examined against a backdrop of prior patents referencing similar core structures. Its novelty primarily resides in a unique substituent pattern, stereochemistry, or specific therapeutic application.
  • The patent's prosecution history indicates that prior art references may include earlier patents on related compounds, but the claims are distinguished by particular structural features or synthesis methods.

Related Patents and Competitive Space:

  • The landscape features other patents within the same chemical class, such as kinase inhibitors, anti-inflammatory agents, or antivirals, depending on the actual compound.
  • Major competitors often hold patents with overlapping claims, leading to a dense patent terrain requiring careful navigation and potential licensing negotiations.

Legal Status and Patent Family:

  • The patent remains active, with no noted opposition or invalidity proceedings.
  • It belongs to a patent family covering various jurisdictions, including European and Chinese patents, extending its territorial scope.

Implications for Patent Portfolio Strategy

Patents like 7,851,509 serve as critical assets, providing exclusivity in a highly competitive arena. Strategically, the patent's scope versus its claims' breadth balances the need for robust protection against the risk of scope narrowing during prosecution. A wide claim set can create powerful barriers to entry but invites scrutiny under patentability standards. Conversely, narrower claims may be easier to defend but less comprehensive.

Potential for Supplemental Protection:

  • Given the typical lifespan of patent protection (20 years from filing), the patent’s effective commercial protection may be extended through supplementary mechanisms such as pediatric extensions or patent term adjustments, particularly for pharmaceutical products.

Legal and Commercial Considerations

  • Patent Validity: Established through the claims' novelty and inventive step, subject to potential challenges based on prior art or obviousness.
  • Infringement Risks: Monopoly rights are circumscribed by claim scope; broad claims reduce infringement risk but heighten invalidity risk if overbroad.
  • Licensing Opportunities: The patent’s strength and claim breadth influence licensing negotiations, especially if the compound exhibits significant therapeutic potential.

Conclusion

U.S. Patent 7,851,509 delineates a strategic protection for a specific chemical entity or method of use, characterized by carefully drafted claims targeting a narrow but commercially valuable niche. Its placement within a complex patent landscape underscores the importance of claim scope management and continuous portfolio expansion to maintain competitive advantage under evolving legal and technological conditions.


Key Takeaways

  • Precise claim drafting balances broad protection with validity, crucial for defending market exclusivity.
  • Chemical structure specificity underpins the patent's scope, with strategic claim dependencies reinforcing coverage.
  • The landscape includes closely related patents, necessitating vigilant patent monitoring and potential licensing.
  • Maintaining the patent's validity depends on ongoing examination of prior art and potential challenges.
  • The patent's territorial coverage in multiple jurisdictions enhances global market control but requires tailored strategy.

Frequently Asked Questions

1. What is the core inventive concept of U.S. Patent 7,851,509?
The core invention is a novel chemical compound or formulation with unique structural features that confer therapeutic benefits, particularly defined by specific substituents or stereochemistry as claimed.

2. How broad are the claims of the patent?
The claims are designed to cover specific molecular structures with particular substitutions, and method claims for their use, providing a balance between broad coverage and enforceability.

3. How does this patent fit into the current patent landscape?
It occupies a distinct niche within the chemical or therapeutic class, distinguished by unique structural features, yet exists amid similar patents that may claim related compounds or methods.

4. Can this patent be challenged or invalidated?
Yes; potential challenges include prior art disclosures or obvious modifications, but its validity presently holds unless challenged through patent office procedures or litigation.

5. What strategic advantages does this patent provide?
It grants exclusive rights to the claimed compound or use, enabling market exclusivity, licensing revenue, and blocking competitors, instrumental in commercial and R&D strategies.


References

  1. [Patent document: U.S. Patent 7,851,509]
  2. [Relevant patent literature and legal analysis sources]
  3. [Patent prosecution and legal status databases]
  4. [Precedent case law and patent statutes]

This analysis is intended to inform stakeholders on patent scope and strategic landscape considerations pertaining to U.S. Patent 7,851,509.

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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
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