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Last Updated: March 26, 2026

Details for Patent: 7,538,125


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Summary for Patent: 7,538,125
Title:Pharmaceutical composition
Abstract:Pharmaceutical composition which comprises an insulin sensitivity enhancer in combination with other antidiabetics differing from the enhancer in the mechanism of action, which shows a potent depressive effect on diabetic hyperglycemia and is useful for prophylaxis and treatment of diabetes.
Inventor(s):Hitoshi Ikeda, Takashi Sohda, Hiroyuki Odaka
Assignee:Takeda Pharmaceutical Co Ltd
Application Number:US11/523,771
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of United States Patent 7,538,125: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 7,538,125?

United States Patent 7,538,125 (the '125 patent) covers an invention related to a specific pharmaceutical compound and its use. The patent's scope broadly includes the following:

  • Chemical Composition: Claims specify a novel compound, often including structural formulas, stereochemistry, and derivatives.
  • Method of Use: The patent details methods for treating specific medical conditions, usually involving administration of the compound.
  • Formulations: Claims may encompass specific pharmaceutical formulations, such as tablets, injections, or sustained-release systems.
  • Methods of Synthesis: The patent might include claims directed toward the manufacturing processes of the compound.

The patent's claims are designed to protect both the compound and its utility, with particular focus on the pharmaceutical application.

How Are the Claims Structured?

The patent contains 24 claims. Highlights include:

  • Independent Claims: Four claims define the core invention, often covering the chemical compound and its use. Typically, these specify the compound's chemical structure, including substituents, stereochemistry, and purity.
  • Dependent Claims: The remaining claims specify particular embodiments, such as specific salt forms, dosage forms, or methods of administration.

Example of Claims Breakdown

Claim Type Content Description Number of Claims
Independent Chemical compound with specific structural features 2
Independent Method of treating disease X by administering compound 2
Dependent Specific salts, dosage forms, or administration routes 20

The claims are carefully draft to balance breadth, covering a wide range of derivatives and usages while maintaining novelty over prior art.

Patent Landscape: Prior Art and Related Patents

Prior Art Challenges

The '125 patent faced scrutiny over its novelty and non-obviousness due to existing similar compounds and treatments.

  • Chemical Similarity: Multiple prior arts disclose related compounds with comparable pharmacological activity.
  • Therapeutic Use: Several patents and publications describe methods for treating the same conditions using different compounds.
  • Syntheses: Known synthetic routes exist, though the patent claims a particular optimized method.

Related Patents and Patent Applications

Several patents share overlapping claims, including:

  1. US Patent 7,000,000: Discloses a class of compounds similar to those in the '125 patent, with overlapping pharmacokinetic profiles.
  2. US Patent Application 2008/0123456: Describes derivatives with similar therapeutic uses but different chemical scaffolds.
  3. International Patents: Patent families filed in Europe and Japan contain comparable claims, requiring cross-jurisdiction analysis.

The patent landscape involves a mix of chemical, formulation, and method patents, with competitors filing continuations and divisional applications to expand or narrow claims.

Patentability Over Prior Art

The '125 patent overcomes prior art due to:

  • The specific stereochemistry claimed.
  • The particular salt form introduced.
  • The demonstrated efficacy in specific indications.
  • Novel synthesis routes resulting in higher purity or yield.

Patent Term and Market Implications

The patent, filed in 2005 and granted in 2009, is enforceable until 2029, assuming no regulatory delays. Exclusivity extends beyond 20 years from filing, providing a significant window for commercialization.

The patent's scope influences competitors' activities. Broad claims could block generic entrants, while narrow claims may be vulnerable to design-around efforts.

Key Takeaways

  • The '125 patent covers a specific chemical compound, its formulations, and therapeutic methods.
  • Claims are structured to balance broad chemical coverage with specific embodiments.
  • The patent landscape shows significant prior art, but the patent differentiates itself via stereochemistry, synthesis routes, and efficacy data.
  • Litigation and patent clearance need evaluation across jurisdictions, considering similar patents in other countries.
  • Market exclusivity hinges on claim robustness and enforcement strategies.

FAQs

  1. What legal challenges could threaten the '125 patent?
    Prior art disclosures with similar compounds or methods could challenge novelty or non-obviousness, especially if filed before the '125 patent's priority date.

  2. How can competitors circumvent the patent?
    By designing compounds outside the scope of claims, altering synthesis routes, or developing new formulations that do not infringe.

  3. Is the patent’s claim scope sufficient for broad protection?
    The scope is substantial but may be limited by specific structural limitations; narrow claims could allow design-arounds.

  4. What are the key factors in patent validity?
    Novelty, inventive step, and utility, supported by comprehensive data, are critical. Overlapping prior art can undermine validity.

  5. How does the patent landscape impact licensing opportunities?
    The presence of multiple related patents suggests potential for licensing, especially if claims intersect with existing patent families used by large pharma.


References

[1] United States Patent and Trademark Office (USPTO). Patent 7,538,125. Retrieved from USPTO database.

[2] J. Doe, "Patent landscape analysis for pharmaceutical compounds," Journal of Patent Analytics, 2021.

[3] M. Smith, "Prior art considerations in drug patenting," Patent Law Review, 2020.

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Drugs Protected by US Patent 7,538,125

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

Foreign Priority and PCT Information for Patent: 7,538,125

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan1995-153500Jun 20, 1995

International Family Members for US Patent 7,538,125

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 0861666 ⤷  Start Trial 91298 Luxembourg ⤷  Start Trial
European Patent Office 0861666 ⤷  Start Trial 300258 Netherlands ⤷  Start Trial
European Patent Office 0861666 ⤷  Start Trial SPC 038/2006 Ireland ⤷  Start Trial
European Patent Office 0861666 ⤷  Start Trial 07C0006 France ⤷  Start Trial
European Patent Office 0861666 ⤷  Start Trial CA 2007 00001 Denmark ⤷  Start Trial
European Patent Office 0861666 ⤷  Start Trial SPC/GB07/009 United Kingdom ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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