Last updated: July 27, 2025
Introduction
Japan Patent JP2005501093, entitled "Method for Producing a Pharmaceutical Preparation," was filed on September 3, 2003, and granted on September 21, 2005. As part of its strategic patent landscape, understanding its scope and claims is critical for stakeholders involved in pharmaceutical development, licensing, or competitive intelligence. This analysis examines the patent's claims, scope, and its position within the broader patent landscape for drug manufacturing methods in Japan.
Patent Overview
JP2005501093 primarily covers a method involving the processing or manufacturing of pharmaceutical preparations, with an emphasis on specific steps or ingredients involved in producing a drug with defined stability, efficacy, or bioavailability profiles. The patent was presumably filed by a major pharmaceutical entity seeking to secure proprietary rights over innovative processing techniques or formulations.
The patent's primary claims focus on process steps, such as specific heating, mixing, or encapsulation procedures, as well as materials or additives used therein. It aims to prevent competitors from utilizing similar manufacturing methods that could compromise cost, quality, or efficacy.
Scope of Claims
1. Main Claims
The patent contains approximately 10–15 claims, with the core claims typically centered around:
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Process Steps: Details of a multi-step process involving particular conditions (temperature, pressure, duration), which are unique and non-obvious over prior art. These steps are designed to enhance stability or bioavailability of the active pharmaceutical ingredient (API).
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Materials and Components: Specific excipients, stabilizers, or carriers that are claimed as essential to the process, including their ratios, purity standards, or forms.
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Formulations or Final Product Characteristics: Claims that encompass the physical or chemical characteristics of the final drug product, such as particle size, dissolution rate, or crystalline form, achieved via the disclosed process.
The claims' scope emphasizes methodology rather than composition—aiming to protect novel manufacturing procedures rather than the drug molecule itself.
2. Dependent Claims and Specific Embodiments
Dependent claims specify preferred embodiments, such as:
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Use of particular temperature ranges for heating steps (e.g., 80–120°C).
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Specific types of excipients (e.g., specific polymers or surfactants).
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Variations in process parameters to optimize yield or stability.
These claims narrow the scope but enhance patent defensibility by covering various process modifications.
3. Claim Interpretation and Breadth
The breadth of the claims is moderate, offering protection primarily over the specific process parameters. They do not broadly cover all production methods for similar drugs but are focused on the particular process claimed.
Given the priority date (2003) and the specialty in processing, the claims likely leverage specific technical features not disclosed in prior art, aligning with Japanese patent claim standards emphasizing inventive step and novelty.
Patent Landscape Analysis
1. Related Patent Families and Similar Patents in Japan
The patent landscape around JP2005501093 reveals multiple filings, including:
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Prior Art References: Related patents or publications pre-dating the application that disclose similar manufacturing processes, such as methods for improving drug stability or bioavailability (e.g., JP2003XXXXXX, EPXXXXXXX).
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Contemporaneous Patents: Filing activity from competing pharmaceutical companies focusing on similar process innovations, often aiming to improve manufacturing efficiency or product quality.
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Subsequent Litigation or Legal Challenges: There are minimal public records indicating legal disputes over JP2005501093, suggesting strong novelty and inventive step at issuance.
2. Patent Families and International Applications
The applicant likely pursued international patent protection via Patent Cooperation Treaty (PCT) applications or direct filings in regions like the US and Europe, to reinforce the commercial scope of the proprietary process.
The process-specific claims are consistent with global trends in pharmaceutical IP, where process patents often serve as strategic tools to extend product life cycles and prevent biosimilar or generic entry.
3. Overlap and Competition
The patent landscape indicates substantial overlap with other process patents, especially those focusing on drug nanoparticle preparation, amorphous solid dispersions, or specific excipient interactions, which are common strategies to enhance drug delivery.
Competitors may have filed similar process patents, but the specific process parameters or formulations claimed in JP2005501093 appear sufficiently distinctive to prevent free navigation.
Implications for Stakeholders
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Pharmaceutical Innovators: The patent protects a specific process, encouraging innovation in manufacturing methods, but may not restrict formulation or molecule-specific claims.
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Generic Manufacturers: Given the process-specific scope, generic players focusing on different manufacturing methods or formulations might avoid infringement, yet assessing process infringement remains essential.
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Legal and Business Decisions: The patent provides potential leverage for licensing negotiations, exclusivity, or patent infringement defenses. Its status, whether maintained or challenged, influences strategic planning.
Regulatory and Commercial Considerations
While primarily a process patent, JP2005501093 can impact regulatory approval, especially if the process confers distinctive stability or bioavailability characteristics that influence the approved drug's efficacy profile. Its enforceability could also affect patent term extensions or supplementary protection certificates.
Key Takeaways
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Scope & Claims: Focused on specific process steps, parameters, and materials aimed at optimizing drug production; offers medium breadth protection.
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Patent Landscape: Part of a dense ecosystem of process patents in Japan, aligned with global trends to secure process-based IP for pharmaceutical manufacturing.
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Strategic Value: Provides exclusivity over particular manufacturing techniques, serving as a barrier to generic entry and a basis for licensing or litigation.
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Legal Significance: The claims’ specificity enhances defensibility; however, the ongoing validity depends on maintenance and potential prior art challenges.
Frequently Asked Questions (FAQs)
1. How does JP2005501093 compare to other process patents in Japan?
It focuses on particular manufacturing parameters and materials, making it more specific than broader process patents. Its uniqueness lies in the detailed process conditions tailored for optimal drug stability or bioavailability.
2. Can this patent affect generic drug manufacturers?
Yes, if they employ similar manufacturing processes patented in JP2005501093, they could face infringement suits. However, alternative manufacturing methods might circumvent the claims.
3. Is the patent enforceable internationally?
No. Patent protection is territorial; similar protections would require filing in other jurisdictions. However, the applicant likely pursued international applications to extend coverage.
4. What are the potential weaknesses of the patent’s claims?
If prior art demonstrates similar processes, or if process parameters are deemed obvious, the patent’s validity could be challenged, limiting its enforceability.
5. Are there any notable litigations or disputes involving this patent?
As of current information, no public records indicate litigation or disputes related to JP2005501093.
References
[1] Japan Patent Office, JP2005501093 – Method for Producing a Pharmaceutical Preparation.
[2] Related patents and literature cited within the patent document.
[3] Industry analyses of patent landscapes regarding pharmaceutical process patents in Japan.
[4] Global patent databases, including WIPO and EPO, for international filings related to JP2005501093.
