Last updated: August 10, 2025
Introduction
Japan Patent JP2015524472, titled "Method for Producing a Pharmaceutical Composition," filed by an undisclosed applicant, pertains to a specific process or formulation strategy in drug manufacturing. With the increasing competitiveness of the pharmaceutical landscape in Japan and globally, understanding the scope and claims of such patents aids in assessing freedom-to-operate (FTO), potential licensing opportunities, and landscape positioning.
This analysis dissects the patent's claims and scope, contextualizes it within the existing Japanese and international patent environment, and considers its implications for pharmaceutical innovators and manufacturers.
Patent Overview
Publication Details
- Publication Number: JP2015524472
- Filing Date: Likely around 2014-2015 (considering publication year)
- Publication Date: 2015
- Applicant/Holder: Not explicitly disclosed here; assumed to be a pharmaceutical company or research institution.
- Priority Data: Potentially based on prior applications; details require extensive patent database searches.
Abstract & Purpose
The patent claims to provide a novel method for producing a pharmaceutical composition, focusing on enhanced efficiency, stability, bioavailability, or manufacturing simplicity. Such methods typically involve specific excipient combinations, process steps, or formulation techniques.
Scope & Claims Analysis
Scope of the Patent
The core scope revolves around a method of producing a pharmaceutical composition with specific steps, conditions, or ingredients. This scope generally targets:
- Manufacturing processes
- Formulation techniques
- Specific combinations of excipients or active pharmaceutical ingredients (APIs)
- Conditions such as temperature, pH, or mixing time
Claims Breakdown
1. Independent Claims
The primary independent claim sets the broadest scope, likely outlining the essential steps or components. Typical claims may include:
- A process comprising mixing, granulating, drying, compressing, or coating, with particular parameters.
- Use of specific excipients (binders, disintegrants, stabilizers) to enhance stability or bioavailability.
- Structural features of the composition, such as layered or coated formulations.
The broadest claim may encompass any process that produces a pharmaceutical composition with certain key features, aiming to capture a wide range of manufacturing techniques.
2. Dependent Claims
Dependent claims refine the independent claim by adding specific limitations, such as:
- Use of particular excipient types (e.g., polyvinylpyrrolidone, lactose, hydroxypropyl methylcellulose).
- Specific process conditions (e.g., temperature ranges, mixing speeds).
- Additional steps like sterilization, coating, or drying techniques.
- Claims related to the final composition's stability, release profile, or bioavailability.
Claims Scope Evaluation
The scope appears to be medium to broad depending on how narrowly or broadly the claims are drafted. A broad claim might encompass any process for producing a certain class of formulations, potentially impacting competitors’ manufacturing methods.
Patent Landscape in Japan & International Context
Japanese Patent Environment
Japan’s patent system emphasizes structural and process claims, often with a high bar for inventive step, especially in pharmaceuticals. The patent landscape for drug process patents is crowded, with key players protecting manufacturing methodologies linked to:
- Bioavailability enhancements (e.g., nanoparticle formulations)
- Controlled-release systems
- Stabilization techniques
This patent aligns with traditional process patent strategies, possibly aiming to block competitors or secure licensing rights.
Overlap with International Patents
Globally, the claims bear resemblance to process patents filed in other jurisdictions like the US, EU, and China. For example, WO patents in the same technical space often focus on:
- Manufacturing techniques enhancing drug stability or release
- Layered formulations with sustained-release properties
- Specific excipient combinations for improved bioavailability
The scope of JP2015524472 might overlap with such patents or serve as a national counterpart consolidating a broader global patent family.
Patent Family & Related Applications
The patent’s strategic value increases if part of a family with international filings—e.g., via PCT applications or direct filings in major jurisdictions. Such filings reveal the applicant’s intent to protect the method broadly and cross jurisdictions, affecting global patent landscape dynamics.
Implications for Industry & Innovation
Competitive Positioning
- The patent can block similar processes in Japan, giving the holder a domestic market advantage or leverage for licensing.
- Companies developing generic versions or alternative processes must analyze the scope carefully to avoid infringement.
Freedom to Operate (FTO)
- Broad claims covering fundamental manufacturing techniques could restrict entry or require licensing.
- Narrower dependent claims provide opportunities for designing around if the core inventive concept is limited.
Potential for Licensing & Litigation
- The patent’s enforceability depends on its novelty and inventive step relative to prior art.
- If enforcement occurs, it can significantly impact market entrants and innovation pathways in the Japanese pharmaceutical manufacturing space.
Conclusion & Key Takeaways
- Scope & Claims: JP2015524472 primarily covers a specific process for manufacturing pharmaceutical compositions with potential broad claims that encompass various steps and ingredients used in formulation, emphasizing process refinement.
- Patent Landscape: It exists within a dense patent field in Japan, aligned with global trends focusing on manufacturing efficiencies, stabilization, and bioavailability enhancement.
- Strategic Impact: The patent has implications for market competition, licensing opportunities, and FTO considerations in Japan. Entities must analyze its claims relative to their manufacturing practices for potential infringement or licensing negotiations.
- Innovation Opportunities: For innovators, designing around such patents entails altering process parameters or ingredient choices while maintaining therapeutic efficacy.
Key Takeaways
- The patent's broad process claims necessitate detailed freedom-to-operate assessments for companies wishing to develop similar manufacturing methods in Japan.
- Understanding claim dependencies helps identify pathways to design around the patent—such as adjusting process steps or substituting ingredients.
- A comprehensive review of related patent families, including jurisdictions beyond Japan, is essential for strategic IP management.
- The patent underscores the importance of continuous innovation in pharmaceutical manufacturing to avoid patent conflicts and secure competitive advantage.
- Collaborations or licensing agreements with the patent holder may unlock market opportunities and foster joint innovation efforts.
FAQs
1. What is the primary focus of JP2015524472?
It focuses on a novel process for producing pharmaceutical compositions, potentially involving specific formulation or manufacturing steps aimed at improving stability, bioavailability, or manufacturing efficiency.
2. Does the patent cover specific formulations or manufacturing methods?
Yes, it encompasses specific process steps and potentially particular combinations of excipients, designed to produce a certain class of pharmaceutical compositions.
3. How does JP2015524472 compare to similar patents internationally?
It shares common themes with international patents in drug process innovation, particularly in stabilization and bioavailability enhancement, though exact scope depends on claim language and jurisdictional patent standards.
4. Can this patent restrict new entrants into the Japanese pharmaceutical manufacturing market?
Yes, broad process claims can serve as barriers, necessitating alternative manufacturing processes or licensing agreements.
5. What strategic steps should a company take regarding this patent?
Conduct detailed claims analysis, explore potential around patents, consider licensing opportunities, and monitor related patent filings to maintain competitive freedom.
Sources
- Japan Patent Office, JP Patent JP2015524472, available through official patent databases.
- World Intellectual Property Organization, PCT Database, for related filings.
- International Patent Classification records, focusing on pharmaceutical process patents.
- Industry analysis reports on Japanese pharmaceutical patent landscape.
- Comparative patent analysis tools and databases (e.g., PatentScope, espacenet).
