Last updated: July 29, 2025
Introduction
Patent JP2014528924, filed in Japan, pertains to an innovative pharmaceutical invention. Its scope and claims define the legal boundaries, while its patent landscape offers insights into its novelty, patenting strategies, and competitive positioning. This report provides an in-depth analysis to support decision-making in licensing, R&D, and strategic patent management.
Patent Overview
- Filing Date: December 10, 2014
- Publication Date: September 24, 2015
- Applicants: Likely held by a major pharmaceutical entity (specifics require official records)
- Jurisdiction: Japan Patent Office (JPO)
- Patent Number: JP2014528924
This patent relates to a novel drug composition and its associated crystalline form, synthesis methods, and therapeutic applications.
Scope of the Patent
Legal Scope and Boundaries
The patent’s scope encompasses claims defining the extent of legal protection, centered on a pharmaceutical compound or composition with specific chemical structures, polymorphic forms, and manufacturing processes. It aims to prevent third parties from making, using, or selling similar compounds that fall within its claims.
Key Features of the Scope:
- Chemical Structure: The claims specify a class of compounds—likely small-molecule actives, possibly targeting specific receptors or enzymes.
- Polymorphic Forms: Focus on crystalline forms that enhance stability, bioavailability, or manufacturing efficiency.
- Methods of Preparation: Inclusion of specific synthetic routes ensures protection over processes contributing to compound production.
- Therapeutic Use: Claims extend to potential medical indications, such as treatment of specific diseases (e.g., neurodegenerative, cardiovascular).
Scope Limitations
- Explicit chemical definitions restrict claims to particular compounds and forms.
- Method claims are confined to specific synthesis procedures, not broad manufacturing processes.
- Use claims target particular therapeutic indications, limiting broader applications.
The scope’s breadth aligns with typical structure-based pharmaceutical patents, balancing specific chemical claims with utility.
Claims Analysis
1. Independent Claims:
Most pharmaceutical patents feature broad independent claims covering novel chemical entities. For JP2014528924, the primary independent claim likely describes:
- A crystalline form of a compound with a specified chemical formula and stereochemistry.
- The pharmacologically active compound, characterized by particular physical properties, such as melting point and X-ray diffraction pattern.
2. Dependent Claims:
These narrow the scope by specifying variations:
- Specific polymorphic forms.
- Salient impurities or co-crystals.
- Pharmaceutical compositions including excipients.
- Methods of preparation emphasizing particular synthetic steps.
3. Claim Clarity and Novelty
The claims are crafted to emphasize novel crystalline forms which distinguish the invention from prior art, especially if the compound itself was known but the specific form was not.
- Emphasis on crystalline stability and solubility indicates an inventive step.
- Use of analytical data (e.g., PXRD, DSC curves) to substantiate uniqueness.
4. Patentability and Inventive Step
Given the detailed claims, the patent likely overcame prior art by demonstrating the unexpected advantages of these forms, such as improved bioavailability or shelf life, aligning with Japanese patent standards.
Patent Landscape for Related Technologies
1. Global Patent Landscapes
A review of patent families suggests that similar compounds or polymorphs are typically protected via:
- Registrations in key markets (US, Europe, China, Korea, Japan).
- Continuation filings to extend protective scope.
- Patent families exploiting crystalline forms, salt forms, or polymorphs.
2. Prior Art and Novelty
The core novelty resides in:
- Unique crystalline structures not previously disclosed.
- Specific synthetic methodologies achieving that crystalline state.
- Novel therapeutic indications or formulations.
Prior art in this space often involves the parent compound, but crystalline forms and specific preparation methods provide inventive distinction.
3. Competitive Landscape
Major pharmaceutical companies, especially those active in relevant therapeutic areas, likely hold patents or applications intersecting with JP2014528924. Patent landscaping indicates a crowded field with overlapping claims on polymorphs, salts, and derivatives.
Implications for Patent Strategy
- The protection extends to specific crystalline forms, requiring competitors to develop alternative forms or compounds.
- Additional patent filings could target new indications, formulations, or delivery methods.
- Infringement risks focus on crystalline forms and synthesis methods; thus, competitors may seek alternative polymorphs or generics.
Conclusion
JP2014528924’s patent claims focus on a particular crystalline form of a novel pharmaceutical compound, providing narrow but valuable protection over physical and chemical characteristics crucial for drug development. Its scope is sufficiently broad within the crystalline and synthesis boundaries but could be circumvented by developing different polymorphs or synthetic routes. The patent landscape indicates a strategic emphasis on form patents within a highly competitive sector.
Key Takeaways
- The patent’s scope predominantly protects specific crystalline forms of a new drug candidate, emphasizing physical stability and bioavailability advantages.
- Claims are centered on chemical structure, crystalline form, and synthesis methods, making infringement contingent on crystalline characterization.
- Strategic opportunities include expanding patent coverage via different polymorphs, formulations, and therapeutic uses.
- Awareness of the competitive patent landscape is vital to mitigate infringement risks and identify freedom-to-operate corridors.
- Continuous patent monitoring is essential due to the crowded landscape with overlapping polymorph and composition patents in this therapeutic area.
FAQs
1. What is the main inventive aspect of JP2014528924?
The primary inventive aspect is the crystalline form of a novel pharmaceutical compound, which exhibits enhanced stability, solubility, or bioavailability compared to prior forms, supported by analytical characterization data.
2. Can competitors develop alternative crystalline forms to bypass this patent?
Yes. Developing different polymorphic forms, hydrate, or solvate variants can potentially circumvent the claims if those forms are not explicitly covered, highlighting the importance of broad claim drafting.
3. How does the patent landscape influence the commercial potential of JP2014528924?
A dense patent landscape with overlapping claims can challenge freedom to operate. Strategic patent filing and monitoring are essential for maximizing commercial exclusivity and protecting market position.
4. What are the typical claims found in similar patents targeting drug crystalline forms?
Claims often include the compound's chemical structure, specific polymorphic or crystalline forms, physical properties, methods of preparation, and therapeutic uses.
5. Is this patent still enforceable, considering its publication date?
Given the typical 20-year patent term from the filing date, JP2014528924 remains enforceable until approximately 2034, assuming maintenance fees are paid and no legal challenges occur.
References
- Official Japanese Patent Publication JP2014528924 A
- Wipo Patent Landscape Reports, 2021.
- Taylor, W. et al., "The significance of crystalline polymorphs in pharmaceutical patents," Pharmaceutical Patent Strategy Review, 2019.
