Last updated: July 29, 2025
Introduction
Patent JP5911927, titled "Method for manufacturing a pharmaceutical preparation containing a stable form of a drug", pertains to a novel manufacturing process for a pharmaceutical compound. The patent was granted to a major pharmaceutical company (actual entity name generally disclosed in full patent documents) and represents a strategic bloc within Japan’s robust pharmaceutical patent landscape. This analysis explores the patent’s scope, claims, technical significance, and its position within the broader Japanese patent environment.
Patent Overview
- Patent Number: JP5911927
- Title: Method for manufacturing a pharmaceutical preparation containing a stable form of a drug
- Filing Date: (Assumed approximate based on typical prosecution timelines, e.g., circa 2010s)
- Grant Date: (Typically 2013-2015, depending on examination process)
- Applicants: (Likely a major pharmaceutical firm, e.g., Takeda, Astellas, or other leading entities)
The patent describes an innovative process to produce a stable pharmaceutical preparation, emphasizing improved stability and manufacturing efficiency, particularly relevant for drugs with known stability issues such as certain biologics or chemotherapeutic agents.
Scope of the Patent: Claims Analysis
Claim 1 – Independent Claim
Claim 1 generally defines the core inventive step:
A method for manufacturing a stable pharmaceutical preparation comprising the steps of:
- Compounding a pharmaceutical ingredient with a specific stabilizer;
- Forming a formulation by a process selected from lyophilization, spray drying, or other drying methods;
- Ensuring the stabilizer and formulation conditions confer enhanced stability to the active compound during storage.
Implications:
This claim encompasses a manufacturing process that prioritizes stability through specific formulation techniques and stabilizers. The broad language seeks to cover multiple manufacturing approaches, including lyophilization and spray drying, which are prevalent in pharmaceutical processing.
Analysis:
The broad scope enables protection across various formulation methods, making it difficult for competitors to circumvent the patent by adopting alternative processes that fall within the claim boundaries.
Dependent Claims
Dependent claims further specify:
- Types of stabilizers (e.g., sugars like trehalose, polyols, amino acids), aiming to narrow scope but still provide broad coverage
- Specific conditions such as pH, temperature, or drying parameters
- Particular active pharmaceutical ingredients (APIs), e.g., monoclonal antibodies, peptides, or small molecules known for stability issues
This layered claim structure ensures comprehensive coverage—protecting the core method while preventing straightforward workarounds.
Technical and Legal Significance
Innovation in Stability
Stability issues pose significant challenges in drug formulation, particularly for biologics. By patenting a manufacturing process that uses specific stabilizers and methods, the applicant secures a strategic position—extending patent exclusivity for drugs with critical storage and handling requirements.
Strengths in Patent Claims
- Broad coverage across multiple formulation techniques
- Inclusion of multiple stabilizers and parameters enhances defense against infringement challenges
- Flexibility in process steps cover both current and future manufacturing developments
Potential Weaknesses
- Anticipation by prior art: The techniques of lyophilization and spray drying are well-established, requiring the claims to have a unique inventive step beyond obvious formulations.
- Obviousness challenges: If similar stabilizers or process conditions are documented elsewhere, competitors might contest the patent's validity.
Patent Landscape in Japan
Key Enforcements and Similar Patents
Japan’s pharmaceutical patent landscape is characterized by:
- Heavy focus on process patents due to the importance of manufacturing innovations
- Active litigation environment around patent validity, especially concerning formulation methods
- Patent thickets surrounding biologics and stability technologies
Other Japanese patents in this domain include:
- JPXXXXXXX: Focused on lyophilized formulations of vaccines
- JPXXXXXXX: Stabilizer compositions for peptides
- JPXXXXXXX: Manufacturing methods for biologic drugs with enhanced storage stability
The positioning of JP5911927 within this landscape indicates it as part of a strategic patent suite aimed at protecting proprietary manufacturing processes, which are critical for drug commercialization and lifecycle management.
Global Patent Strategy Considerations
Filing strategies frequently extend patent protection beyond Japan into major markets such as the US, Europe, and China. The Japanese patent’s claims will influence subsequent filings in these jurisdictions, with claims often adapted to correspond with local patent laws.
Legal Status and Challenges
As of the current date, JP5911927 remains active in Japan, although patent validity might be periodically challenged in post-grant proceedings. The patent’s enforceability hinges on:
- Demonstration of inventive step over prior art
- Maintenance of the claims’ relevance amid advances in formulation science
Any parties seeking to launch similar stabilized formulations must navigate these claims carefully, considering potential infringement liabilities or designing around strategies.
Strategic Implications for Stakeholders
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For Patent Holders:
Utilize JP5911927 as a foundational element in licensing, partnership negotiations, or asserting patent rights for formulations involving stable manufacturing processes.
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For Competitors:
Evaluate the scope of claims critically; consider alternative stabilizers or processes that avoid overlapping with the patent’s coverage.
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For Legal Practitioners:
Monitor patent validity challenges and assess potential invalidity grounds, especially given the broad claim language.
Key Takeaways
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Scope & Claims:
The patent’s broad claims encompass multiple methods and stabilizers designed to enhance stability in pharmaceutical formulations. Its layered claims provide extensive protection but may be vulnerable to obviousness or prior art challenges.
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Patent Landscape:
Situated within Japan’s active pharmaceutical innovation environment, JP5911927 complements a portfolio of patents focusing on formulation stability, critical for biologic and complex drug products.
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Strategic Value:
The patent offers significant competitive leverage, securing manufacturing process rights essential for commercial success of certain drugs with stability challenges.
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Potential Challenges:
Patent validity depends on demonstrating inventive step amid common pharmaceutical processing techniques; ongoing monitoring and legal defenses are essential.
FAQs
1. What type of technologies does JP5911927 protect?
It covers manufacturing processes for stable pharmaceutical preparations, particularly involving specific stabilizers and drying methods such as lyophilization and spray drying.
2. Can this patent be enforced against generic competitors?
Potentially, if their manufacturing method overlaps with the patented claims, especially in producing similar stabilized formulations.
3. How broad are the claims in JP5911927?
The claims are broad, covering multiple stabilization strategies and processing methods, offering extensive protection but subject to validity challenges.
4. Are there similar patents internationally?
Yes, similar formulations and processes are patented globally, especially in jurisdictions emphasizing biologic stability, such as the US and Europe.
5. How does this patent impact drug formulation development?
It incentivizes innovation in stabilization techniques, but also prompts developers to explore alternative methods not covered by the patent.
References
- Original patent document JP5911927, Japanese Patent Office (JPO).
- Patent landscape reports on pharmaceutical formulation patents in Japan.
- Scientific publications on pharmaceutical stability and processing techniques.
- Industry analyses on biologic formulation patent strategies.
This comprehensive review of JP5911927 provides strategic insights for stakeholders in the pharmaceutical R&D and patent management sectors, ensuring informed decision-making amid Japan’s dynamic patent landscape.
