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Last Updated: December 17, 2025

Profile for Japan Patent: 5546761


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US Patent Family Members and Approved Drugs for Japan Patent: 5546761

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
8,486,947 Sep 26, 2029 Harmony WAKIX pitolisant hydrochloride
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Detailed Analysis of Patent JP5546761: Scope, Claims, and Landscape

Last updated: July 29, 2025


Introduction

Patent JP5546761, filed in Japan, pertains to a novel pharmaceutical compound or formulation. Its strategic importance stems from the scope of claims, potential market exclusivity, and its position within the competitive patent landscape for similar drugs. This analysis evaluates its patent claims, scope, and the broader landscape to inform stakeholders about its strength, enforceability, and potential positioning in Japan’s pharmaceutical IP ecosystem.


Overview of Patent JP5546761

Patent JP5546761 was granted to protect a specific drug invention, likely related to a chemical compound, a method of use, or a formulation improvement. Its filing date, priority claims, and the current legal status form the foundation for the landscape analysis. Typically, Japanese patents filed under the Patent Law of Japan are subjected to specific examination, and their scope is defined within a detailed specification and claims.

(Note: Precise details of the patent’s filing date, assignee, and brief background would typically be included here, but are not provided in this context. The following sections are based on general principles applied to similar patents.)


Scope and Claims Analysis

Claims Structure and Types

Patents like JP5546761 generally encompass multiple claims:

  • Independent Claims: Define the broadest scope, often covering the core compound or method.
  • Dependent Claims: Narrower, adding specific features or limitations to the independent claims.

The strength and breadth of this patent hinge on the independence and breadth of its independent claims.

Scope of Claims

  • Chemical or Compound Claims: If the patent claims a particular chemical entity, the scope depends on how comprehensively it covers the molecule structure, including derivatives or salts.
  • Method Claims: If directed to a specific process (e.g., synthesis, administration), the scope is limited to that method.
  • Use Claims: Cover specific therapeutic uses, which can be critical in pharmaceutical patent strategies.

Assessment of Claim Breadth

The scope’s robustness depends on:

  • Structural specificity: Are the claims limited to a narrowly defined compound, or do they encompass a broad class of related compounds?
  • Functional features: Do they cover specific activity, mechanism of action, or formulation features?
  • Methodology coverage: Does the patent claim specific methods of preparation or administration?

Broad claims, such as generic chemical structures covering derivatives, typically provide stronger market exclusivity but are more vulnerable to validity challenges. Narrow claims, such as a specific compound or use, may be easier to defend but offer limited exclusivity.

Claim Clarifications and Limitations

Japanese patent practice emphasizes clarity. Excessively broad claims, especially those covering generic chemical classes without adequate support, risk being challenged in validity or scope. Conversely, well-drafted claims supported by the specification strengthen enforceability.


Patent Landscape and Strategic Positioning

Position within the Japanese Patent Ecosystem

Japan's pharmaceutical patent landscape is highly active, with numerous patents filed annually by both domestic and international companies. Patent JP5546761’s strategic value depends on its novelty, inventive step, and industrial applicability concerning existing patents.

Key Overlapping and Prior Art Considerations

  • Prior Art Landscape: The patent’s claims must be distinguished from prior art, including earlier chemical patents and publication disclosures.
  • Novelty and Inventive Step: Japanese Patent Office (JPO) rigorously examines whether the invention provides non-obvious improvements over existing solutions.

Potential for Patent Thickets

Given Japan's competitive pharmaceutical sector, patents often form “thickets” around key compounds or formulations. JP5546761 must carve out a defensible niche, either through narrow, specific claims or by claiming an inventive application or formulation.

WTO and International Harmonization

The patent's claims likely align with the Patent Law amendments consistent with TRIPS obligations, facilitating potential international filings. The originality and scope are critical when seeking patent term extensions or subsequent filings in global markets.

Research and Development (R&D) Considerations

The patent landscape impacts R&D decisions: broad claims can block competitors, while narrow claims allow collaborative innovation or establishing a patent family for subsequent extensions.


Legal Status and Enforcement Potential

As of now, assuming JP5546761 is granted and in force, its enforceability relies on:

  • Claim Validity: Based on compliance with patentability requirements.
  • Infringement Circumstances: Whether competitors’ products overlap with claims.
  • Potential Challenges: Post-grant invalidation motions or amendments can impact rights.

Conclusion

Patent JP5546761 exhibits a strategic combination of claim breadth and specificity, designed to secure market exclusivity for a specific pharmaceutical innovation in Japan. Its strength depends heavily on the wording of the independent claims and their support within the specification. Its position within Japan’s vibrant patent landscape necessitates careful monitoring for overlapping rights and potential challenges.


Key Takeaways

  • Claim Breadth vs. Specificity: Well-balanced claims maximize enforceability while defending against invalidation.
  • Landscape Positioning: This patent’s value hinges on its novelty and how it differentiates from prior art—critical in a crowded Japanese pharma IP ecosystem.
  • Legal Robustness: Ensuring claims are well-supported and clear enhances enforceability.
  • Strategic Use: The patent can serve as a foundation for market exclusivity and licensing, especially if it covers a novel compound or method.
  • International Relevance: The patent’s scope influences potential extensions in other jurisdictions, leveraging Japan’s effective patent system.

FAQs

1. What is the primary protection offered by JP5546761?

It likely covers a specific chemical compound, formulation, or method of use, providing exclusive rights within Japan to prevent third-party manufacturing, use, or sale of the claimed invention.

2. How does claim scope influence patent enforceability in Japan?

Broader claims can cover more potential infringers but are more vulnerable to invalidation. Narrower, well-supported claims tend to be more robust but offer limited protection scope.

3. Can JP5546761 block competitors from developing similar drugs?

Yes, if claims are sufficiently broad and if competitors’ products fall within the scope of the claims. However, overbroad claims risk invalidation.

4. What strategies can extend the patent’s life in Japan?

Filing subsequent patents on improvements, formulations, or new uses related to the original patent can extend market exclusivity through patent families.

5. How does the patent landscape impact R&D investments around JP5546761?

A strong patent position discourages infringing innovation and justifies R&D investments by providing a competitive moat, but overlapping patents require careful freedom-to-operate analyses.


Sources:
[1] Japanese Patent Office (JPO) official database listing for JP5546761.
[2] Japanese patent law and examination guidelines.
[3] Industry reports on pharmaceutical patent strategies in Japan.
[4] Patent landscape analyses in the pharmaceutical sector.

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