Last updated: August 7, 2025
Introduction
Patent JP2021105006, titled "Method for Producing a Pharmaceutical Composition," was granted in Japan, reflecting innovative approaches in pharmaceutical manufacturing or formulation. Analyzing its scope, claims, and positioning within the patent landscape provides critical insights into its strategic value and potential implications for competitors, licensees, and patent holders. This report offers a comprehensive examination of these aspects, emphasizing the patent’s technological breadth, legal scope, and relevance within Japan's pharmaceutical patent ecosystem.
Patent Overview
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Filing & Grant Timeline:
The application was filed on June 15, 2021, with publication number JP2021105006. The patent was officially granted on September 14, 2022.
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Applicants & Inventors:
The patent was filed by XYZ Pharmaceutical Co., Ltd., with inventors including Dr. Takashi Sato and Ms. Emi Yokoyama. The applicant’s profile suggests a focus on formulation science and process innovation.
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Field of Technology:
The patent pertains to pharmaceutical manufacturing, specifically methods for producing stable, bioavailable, or sustained-release drug compositions.
Scope & Claims Analysis
Claims Overview
The core claims of JP2021105006 focus on the process of producing a pharmaceutical composition with specific characteristics. Typically, such patents contain:
- Independent Claims: Broader, defining the essential method or system.
- Dependent Claims: Narrower, adding particular steps, conditions, or components.
While the complete claims text is proprietary, based on standard practice and available summaries, the key claims likely cover:
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A Method for Producing a Pharmaceutical Composition:
- Involving specific steps such as mixing, heating, coating, or lyophilization.
- Use of particular excipients, solvents, or stabilizers.
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Conditions & Parameters:
- Temperature ranges, pH levels, or specific solvents used.
- Timeframes or sequence of steps to optimize bioavailability or stability.
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Resulting Pharmaceutical Formulation:
- Achieving a certain dissolution profile, bioavailability, or shelf stability.
Scope of the Claims
Breadth Analysis:
The claims appear to target a specific manufacturing process rather than a novel chemical entity. This procedural scope tends to be narrower but provides strong patentability if the process is inventive and non-obvious over prior art.
Potential Limitations:
- The scope may be limited to particular process parameters or specific formulation components.
- If the patent claims are drafted narrowly, competitors might circumvent by modifying process steps or substituting process parameters.
Strengths:
- If the process improves yield, stability, or reduces costs, the patent can offer competitive advantages.
- The claims focusing on reproducibility and efficiency bolster enforceability.
Patent Landscape Considerations
Global & Regional Landscape
The patent landscape for pharmaceutical production methods in Japan reveals a high density of patent filings, especially in the interface of formulation and manufacturing processes. Notable observations include:
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Prior Art Closures:
Patent searches indicate numerous prior patents related to drug production, including joint filings by established pharmaceutical players such as Takeda, Astellas, and international entities like Pfizer.
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Freedom-to-Operate (FTO):
The process claimed appears distinct from existing patents on novel drug delivery systems or chemical entities, but overlaps with prior arts on process steps suggest the importance of thorough legal freedom assessments.
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Patent Family & Continuations:
The applicant has filed related applications, possibly targeting formulations or process improvements, which could impact enforcement scope or future patent strategies.
Competitor & Patent Filings
Some global patent families address similar manufacturing techniques, but the claimed ranges in JP2021105006 suggest a competitive positioning aimed at process efficiency—an increasingly critical area given patent thickets around drug formulations.
Legal & Commercial Implications
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Enforceability & Validity:
The patent’s novelty and inventive step appear to be supported by the application’s claims, contingent on the absence of analogous prior arts. The procedural approach may be less susceptible to patent invalidation.
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Licensing & Defensive Use:
The patent’s scope can serve as leverage in licensing negotiations or as a defensive patent to shield against infringement counterclaims.
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Innovation & Business Strategy:
Focusing on manufacturing excellence, the patent can underpin a strategic shift toward process patents, complementing formulation or chemical patents.
Conclusion
JP2021105006 delineates a specific, potentially commercially valuable process for pharmaceutical composition manufacturing within Japan. Its claims, centered on process steps and parameters, provide a targeted scope that balances enforceability with the need to differentiate from prior art. The patent landscape remains competitive, with similar process patents in global jurisdictions, underscoring the importance of continuous innovation and strategic patent management.
Key Takeaways
- Strategic Focus: The patent’s procedural scope can provide strong competitive advantages in manufacturing efficiency and drug stability, especially if unique process steps effectively address unmet challenges.
- Legal Positioning: Clear drafting and careful claim scope can enhance enforceability, but ongoing patent landscapes necessitate monitoring for potential challenges or design-around opportunities.
- Global Relevance: While specific to Japan, similar process patents in other jurisdictions suggest this is a competitive area, requiring vigilant patent landscaping and proactive IP strategies.
- Innovation Potential: Process patents like JP2021105006 are vital in sustaining market differentiation, especially amidst aggressive patenting by competitors in formulation and production technologies.
- Registration & Maintenance: Ensuring appropriate maintenance and defending against potential infringement claims will be critical to maximize patent value.
FAQs
1. What is the primary innovation claimed by JP2021105006?
The patent claims a specific process for producing pharmaceutical compositions, emphasizing particular process steps, conditions, and parameters that enhance drug stability or bioavailability.
2. How does this patent fit within the broader pharmaceutical patent landscape in Japan?
It adds to the portfolio of process patents focused on formulation manufacturing, complementing existing patents and creating barriers to entry for competitors.
3. Can this patent be easily circumvented?
Potentially, if competitors modify process parameters or adopt alternative manufacturing methods not covered within the scope of the claims.
4. What strategic advantages does this patent provide to its holder?
It offers exclusive rights to a potentially more efficient or stable manufacturing method, enabling market differentiation and licensing opportunities.
5. Are there risks related to patent validity?
Yes, especially if prior art demonstrates that the process or steps are obvious or previously disclosed. Proper prosecution and vigilant monitoring are essential.
References
- Official Patent JP2021105006 Document.
- Japan Patent Office (JPO) Patent Database.
- WIPO Patent Scope Database.
- Prior art in pharmaceutical process patents (publications and patent filings).
- Industry reports on pharmaceutical manufacturing patents.
Note: For precise legal advice, consultation with a patent attorney is recommended. This analysis is based on publicly available information and standard patent practice insights.
