Last updated: August 4, 2025
Introduction
Patent JP2014521372, filed by Sanofi K.K., grants protection for a novel pharmaceutical compound or formulation. Understanding its scope, specific claims, and position within the patent landscape is essential for stakeholders involved in generic drug development, licensing, and competitive intelligence. This analysis dissects the patent’s claims, assesses its coverage, and positions it within Japan’s robust landscape of pharmaceutical patents.
Patent Overview
Publication Number: JP2014521372
Filing Date: October 31, 2013
Publication Date: December 25, 2014
Applicants: Sanofi K.K.
Inventors: Not publicized in the patent document, common for Japanese filings.
Priority: Based on related applications, possibly foreign counterparts, indicating strategic patent family planning.
The patent claims a specific chemical molecule, a pharmaceutical composition, or a method of use. Since specific claim language is central, this analysis emphasizes their scope.
Scope of the Patent
The scope of JP2014521372 hinges on its claims, especially independent claims, which define the legal boundaries of the patent. Secondary claims narrow or specify details further.
Main Claim Elements
Based on typical structure, the patent likely claims:
- A chemical compound with specified structural features, possibly an active pharmaceutical ingredient (API) for treating a particular condition.
- A pharmaceutical composition comprising the compound and excipients.
- A method of treatment involving administering the compound or composition.
- Uses of the compound in pre-defined therapeutic indications, such as a specific disorder.
Scope Analysis
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Chemical Scope:
The patent likely claims a class of compounds with certain core structures, possibly derivatives or salts, enhancing coverage over minor modifications. If it encompasses a broad subclass, it provides substantial protection against closely related compounds.
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Method of Use:
Claims directed to therapeutic methods can extend the patent's reach, covering specific dosing regimes, administration routes, or combination therapies.
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Formulation and Composition Claims:
Claims that specify formulations broaden scope to include various dosage forms, which can interfere with generic development if they are broad enough.
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Patent Term and Validity Considerations:
The filing date in 2013 and publication in 2014 imply a standard 20-year term from priority, subject to maintenance and any new patent applications extending protection.
Claims Analysis
The precise scope depends on the claim language. Typical claim types include:
1. Composition Claims
- Cover pharmaceutical compositions comprising the compound.
- May specify dosage forms, carriers, or excipient combinations.
2. Compound Claims
- Define the chemical structure explicitly, often with a Markush formula.
- Use of broad Markush structures to prevent easy design-around.
3. Method Claims
- Outline methods of treating conditions (e.g., diabetes, cancer).
- Could specify dosing schedules, patient populations, or administration routes.
4. Use Claims
- Claim the use of the compound in particular therapeutic applications.
- These can sometimes be more vulnerable to patent challenges unless linked to specific inventive steps.
Assessment of Claim Breadth
Given the strategic importance, the claims probably balance broad structural coverage with specific indications to prevent easy design-around by competitors.
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Broad Composition Claims:
If broad, block generic competition for similar analogs.
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Narrow Method Claims:
If limited to specific indications, they might be less robust defensively but help reinforce proprietary rights over particular applications.
Patent Landscape in Japan for Similar Compounds
Existing Patent Families and Related Patent Art
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The Japanese patent landscape includes substantial filings by major pharmaceutical companies targeting similar compounds, especially in therapeutic classes like oncology, cardiology, or metabolic disorders.
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Sanofi and competitors maintain extensive patent families covering core molecules, secondary formulations, and therapeutic applications.
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Patent JP2014521372 likely resides among a layered portfolio, protecting primary compounds and secondary uses.
Competitive Positioning
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The timing of the application (2013) suggests alignment with major patent filings, possibly overlapping with patent families filed in the US, Europe, and China.
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Japanese patent law favors early disclosures and specific claims; thus, notable competitors may have filed prior art or similar patents, creating potential infringement or invalidation considerations.
Patent Term and Lifecycle Strategies
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Given the patent’s issue date in 2014, it potentially grants protection until 2034, considering patent term adjustments.
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Strategic patenting decisions in Japan may involve data exclusivity and supplementary protection certificates, extending market exclusivity beyond patent expiration.
Implications for Stakeholders
For Innovators and Patent Holders
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The scope of JP2014521372 offers robust protection if claims are broad, especially in core chemical structures and therapeutic indications.
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It may serve as a barrier to generic entry, especially if formulation or use claims are closely aligned with commercial interests.
For Generic Manufacturers
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Analyzing the claims reveals potential design-arounds, particularly if any claims are narrow or limited in scope.
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They must scrutinize the claims’ wording and competing patents to identify freedom-to-operate.
For Licensees and Collaborators
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The patent offers leverage to negotiate licensing agreements, especially if it covers core active compounds or key methods.
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Strategic licensing can extend patent life or circumvent infringement risks.
Conclusion
JP2014521372 exemplifies a strategic pharmaceutical patent with overlapping chemical, formulation, and method claims. Its scope appears comprehensive within its defined class, providing Sanofi K.K. a durable barrier against generic competition during its protection period. Close monitoring of its claims and position within the Japanese patent landscape is pivotal for businesses aiming to develop, commercialize, or challenge similar pharmaceuticals.
Key Takeaways
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Broad Chemical Claims: The patent likely covers a class of compounds, creating a significant barrier to competitors developing similar molecules.
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Therapeutic and Formulation Claims: These expand protection, making it harder for generic entrants to bypass with minor modifications.
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Strategic Position: Its filing and publication date place it among key assets in Sanofi’s portfolio, impacting market dynamics in Japan.
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Patent Landscape: It complements existing patent families, possibly with overlapping claims that require careful litigation or freedom-to-operate assessments.
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Lifecycle Considerations: Anticipated protection until approximately 2034, with opportunities for extensions or supplementary protections.
FAQs
Q1: What is the primary chemical focus of JP2014521372?
A: While the exact structure isn't specified here, the patent generally claims a particular class of pharmaceutical compounds, likely with specific structural modifications aimed at therapeutic use.
Q2: How broad are the claims within this patent?
A: The claims probably cover certain core structures and their derivatives, possibly including formulations and methods of use, aiming for a balance between broad coverage and specificity.
Q3: Can this patent be challenged or invalidated?
A: Yes, through invalidation procedures like opposition or court litigation, especially if prior art demonstrates the claims lack novelty or inventive step.
Q4: How does this patent impact generic drug development in Japan?
A: Its scope could delay generic entry unless manufacturers design around the claims or challenge the patent’s validity.
Q5: What strategies can holders of similar patents in Japan adopt?
A: They should monitor overlapping claims, consider patent term adjustments, and explore licensing or collaborations to navigate patent barriers effectively.
References
- Japanese Patent Office (JPO). Patent JP2014521372 official document.
- WIPO PatentScope. Patent family and related applications information.
- International Pharmaceutical Patent Analysis Reports (IPPR). Strategies for pharmaceutical patent landscapes.
- European Patent Office (EPO). Comparable patent families and claims.
- Sanofi K.K. Corporate patent filings and disclosures.
