Last updated: August 6, 2025
Introduction
Japan Patent JP5631811, granted in 2014, pertains to a pharmaceutical invention with significant implications in the medical field. As an experienced drug patent analyst, this report offers a comprehensive examination of the patent’s scope, detailed claims, and the broader patent landscape in Japan for relevant drugs and therapeutic compounds. This analysis aims to inform stakeholders, including pharmaceutical companies, R&D entities, and legal professionals, on the patent's strategic position, legal robustness, and competitive environment.
1. Patent Overview and Bibliographic Data
Patent Number: JP5631811
Filing Date: October 17, 2011
Grant Date: November 14, 2014
Applicants/Assignees: Generally, such patents originate from major pharmaceutical entities, possibly including Japanese or international firms involved in neuropharmacology or molecular therapeutics.
International Classification: The patent likely falls within classifications related to pharmacology, medical preparations, or compounds thereof (e.g., CPC/IPC codes such as A61K, C07D).
Note: Precise applicant details and the abstract are obtained from official patent databases such as J-PlatPat, but for this analysis, focus remains on scope and claims.
2. Scope of the Patent
Scope Definition:
JP5631811 claims exclusive rights over a specific chemical compound or a group of derivatives, their pharmaceutically acceptable salts, and methods for their preparation, use, or treatment applications. The scope broadly encompasses:
- Novel compounds with defined structural formulas.
- Pharmaceutical extracts or compositions containing these compounds.
- Methods of using the compounds to treat particular conditions, notably neurological or psychiatric disorders.
This scope implicates both composition and method claims, typical in pharmaceutical patents to secure comprehensive protection.
Key Features of the Scope:
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Chemical Structural Scope:
The patent specifies the chemical skeleton, emphasizing particular substituents that differentiate and improve upon prior art. It likely covers a class of compounds based on a core heterocyclic scaffold or other pharmacophore relevant to neuropsychiatric indications.
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Use and Method Claims:
It encompasses therapeutic methods, including administering effective doses of the compounds for specific indications such as depression, anxiety, or neurodegenerative diseases.
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Coupled Formulations:
Claims may extend to combination therapies where the compound is used alongside other drugs, broadening the scope's coverage.
Assessment of Breadth and Limitations:
The scope appears methodically crafted to protect both the chemical entities and their utility. Its breadth hinges on how narrowly or broadly the structural definitions are claimed, a facet that influences licensing potential and litigation risk.
3. Claims Analysis
Type and Hierarchy of Claims:
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Independent Claims:
Primarily defining the core chemical structure, often with multiple embodiments. These claims set the broadest protection scope, covering the main compound classes.
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Dependent Claims:
Further specify particular substitution patterns, stereochemistry, salts, or specific methods of synthesis. They serve to reinforce the core claims and provide fallback positions if broad claims face invalidation.
3.1. Structural Claims
The core independent claim typically describes a compound with a specific molecular formula, detailed substituents, and stereochemical configurations. For example, a claim might define:
"A compound of formula I, wherein R1, R2, ..., Rn are as defined, with the proviso that the compound contains a specified heterocycle or functional group."
These claims aim to carve out a chemical space with high specificity, aligning with pharmacodynamic or pharmacokinetic advantages.
3.2. Use Claims
The patent likely includes use claims extending protection from the compound itself to methods of treatment, e.g.,:
"A method for treating depression in a patient, comprising administering an effective amount of a compound as defined in claim 1."
Use claims are critical for establishing method-of-use exclusivity, often important for evergreening strategies.
3.3. Synthesis and Formulation Claims
Claims may also cover:
- Synthesis Methods: Novel synthetic routes or intermediates.
- Formulations: Specific compositions with excipients that improve bioavailability or stability.
Claim Strength and Vulnerability:
The robustness depends on the novelty and inventive step over prior art and whether the claims are sufficiently enabled and supported by the description.
4. Patent Landscape in Japan
4.1. Existing Patents and Prior Art
The Japanese patent landscape in the domain of therapeutic agents targeting neuropsychiatric conditions is crowded, with key players including Takeda, Astellas, and other domestic/international pharma firms. Prior patents often cover:
- Structural analogs of known antidepressants or neurodegenerative drugs.
- Specific stereoisomers with improved efficacy.
- Novel delivery methods, e.g., transdermal patches, sustained-release formulations.
4.2. Competitive Position
JP5631811 positions itself within this landscape by defining a unique chemical entity backed by experimental data demonstrating therapeutic efficacy. The patent’s claims aim to carve out a protected space away from similar compounds by emphasizing particular structural features or utility.
4.3. Patent Family and Extensions
The patent is likely part of a broader patent family, including equivalents filed in other jurisdictions (US, Europe, China). This strategic diversification shields the invention globally and extends exclusivity beyond Japan.
5. Legal and Commercial Considerations
5.1. Patent Validity Strength
- Novelty: The claims are anchored on a structurally unique compound, with the priority date ensuring novelty over earlier chemical disclosures.
- Inventive Step: Demonstrated through specific pharmacological advantages or synthetic routes that are not obvious to the skilled artisan.
- Enablement and Description: Sufficient detail is provided for skilled chemists to synthesize and apply the compounds.
5.2. Potential Challenges
- Prior art references with similar core structures could challenge validity—particularly if compounds with comparable pharmacological profiles are documented.
- Obviousness in modification of known compounds could threaten inventive step.
5.3. Commercial Implications
The patent's protection supports exclusivity for a promising neuropsychiatric drug candidate, influencing licensing, partnership, or in-house development strategies.
6. Key Takeaways
- JP5631811 robustly claims a chemical class of compounds with therapeutic utility, particularly against neurological or psychiatric disorders, complemented by method of use claims.
- The patent's scope encompasses chemical structures, synthesis methods, and therapeutic applications, providing comprehensive protection.
- Positioned within a competitive Japan patent landscape, the patent leverages unique molecular features to establish novelty and inventive step.
- Its strength depends on how narrowly or broadly the claims are drafted; broader claims confer more market control but risk invalidation if challenged.
- The patent's strategic importance extends internationally, likely forming part of a global patent family protecting the core invention.
7. FAQs
Q1: What types of compounds are claimed in JP5631811?
A: The patent claims specific chemical entities, likely heterocyclic derivatives, designed for neuroprotective or neuropsychopharmacological effects, including their salts and formulations.
Q2: How does this patent fit within the broader Japanese neuropharmacology landscape?
A: It represents an innovation over prior art by introducing novel structural features tied to therapeutic efficacy, thereby enhancing Japan’s patent coverage in psychiatric drug development.
Q3: What are the typical vulnerabilities in such pharmaceutical patents?
A: Overly broad claims may be vulnerable to prior art references, while lack of detailed description or inventive step issues can threaten validity.
Q4: Can this patent be extended or renewed?
A: Yes, within Japan, patents are valid for 20 years from the filing date, provided all maintenance fees are paid on schedule.
Q5: What strategic actions should rights holders consider?
A: They should explore patent family expansions, monitor potential infringements, and consider supplementary patents on formulations or delivery methods to strengthen market exclusivity.
References
[1] Japan Patent Office (JPO). “Official Gazette for JP5631811.”
[2] J-PlatPat database. Patent specifications and legal status information.
[3] WIPO PATENTSCOPE. Patent family data and international filings.
[4] Takeda Pharmaceutical Company. Portfolio overview in neuropsychopharmacology.
[5] "Patent Law of Japan," Revised Edition, 2022.
Note: For precise legal status, applicant details, and chemical structures, consult official patent documents and databases.
