Last updated: October 2, 2025
Introduction
Japan Patent JP5543991, titled "Method for producing a pharmaceutical composition," was granted in 2014 and relates to pharmaceutical formulations and production methods. An understanding of its scope, claims, and the intellectual property (IP) landscape is critical for pharmaceutical companies and patent strategists assessing freedom to operate, potential licensing opportunities, or infringement risks within the Japanese market.
This comprehensive analysis provides an in-depth review of the patent's claims, scope, and the relevant patent landscape, offering actionable insights for stakeholders.
Patent Overview
Title: Method for Producing a Pharmaceutical Composition
Patent Number: JP5543991 B2
Filing Date: March 16, 2009
Publication Date: April 16, 2014
Applicant: Otsuka Pharmaceutical Co., Ltd.
The patent primarily addresses a method for manufacturing a pharmaceutical composition with improved stability and bioavailability, focusing on specific processing steps that influence the quality of the final drug product.
Scope and Claims Analysis
Claims Overview
Patent JP5543991 contains multiple claims, with a focus on process steps and formulation specifics. The key claims are as follows:
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Claim 1 (Independent):
Describes a method for producing a pharmaceutical composition, including specific steps:
- Milling or granulating an active pharmaceutical ingredient (API).
- Mixing the API with a specific vehicle or excipient.
- Applying heat and pressure to form particles or granules under certain conditions.
- Final formulation involving filling into capsules or tablets.
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Claims 2-10:
Depend on Claim 1, detailing particular embodiments concerning temperature ranges, types of excipients, particle size distributions, and processing parameters.
Scope of Claims
The core claims emphasize the processing method, particularly:
- The specific sequence of milling, mixing, and heat treatment.
- Conditions such as temperature (e.g., 50°C–70°C), pressure, and duration, which are critical in controlling product stability.
- The use of particular excipients or vehicles for improved bioavailability.
- The formation of stable granules conducive to high-dose or sustained-release formulations.
The claims are method-centric, reflecting a focus on manufacturing processes rather than the compound itself, implying potential patentability and infringement considerations are tied mainly to operational techniques.
Patent Landscape Analysis
1. Patent Families and Related Patents
Otsuka holds multiple patents related to pharmaceutical formulations, especially around processing techniques and stable formulations. While JP5543991 centers on manufacturing processes, similar patents exist in broader patent families covering active ingredients and formulations.
- Related JP and US Patents:
- U.S. Patent US8393603 B2 (related process for drug manufacturing)
- Other Japanese patents focusing on stable pharmaceutical compositions.
These related patents may share overlapping claims or complement JP5543991’s scope.
2. Prior Art and Patentability Landscape
Key prior art includes:
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Conventional granulation and milling processes:
Standard methods prior to 2009, which involve exposing APIs to heat or pressure to improve stability or bioavailability.
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Active process innovations:
Patent citations reveal that prior art may lack the specific temperature ranges or process sequences claimed here.
The patent’s claims are crafted to be novel in their specific operational parameters, such as the combination of heat treatment at defined temperatures and the sequence of steps.
3. Competitor Patents and Filed Applications
Major competitors in the Japanese pharmaceutical sector have filed patents on similar processing techniques, including:
- Technologies for controlled-release formulations.
- Manufacturing methods aimed at reducing particle size or enhancing stability.
Companies like Takeda, Astellas, and Daiichi Sankyo have patents in related fields, which could pose freedom-to-operate challenges.
4. Patent Litigation and Litigation Risk
While no public litigation has been noted specifically related to JP5543991, the patent’s broad process claims could be subject to challenge or licensing negotiations, particularly where manufacturing techniques overlap.
Legal status: The patent is valid and enforceable as of the latest publication, providing robust protection for process-based rights.
5. Regional and Global Patent Considerations
In terms of geographic scope, the process patent is Japan-specific. However:
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Filing strategy:
Companies intending to commercialize similar processes globally may consider filing corresponding patents in major jurisdictions such as the U.S., Europe, China, and Korea.
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Patent term:
As filed in 2009, the patent is expected to expire around 2029, providing a lengthy window for commercialization and licensing.
Implications for Industry
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Freedom to Operate (FTO):
Companies employing similar processing steps must review claims to avoid infringement, especially when using heat and pressure in production.
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Licensing Opportunities:
Given the specificity, licensors or patent holders can advantageously license the process to generic manufacturers seeking to produce stable formulations.
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Innovation and Design-around Strategies:
Competitors may explore different processing conditions or alternative methods to circumvent the patent’s claims.
Conclusion
Patent JP5543991 embodies a process-centric approach to manufacturing stable pharmaceutical compositions, with claims covering specific heat, pressure, and sequence parameters. Its scope effectively protects the manufacturing process, but the patent landscape suggests opportunities for non-infringing process innovation.
Critical for stakeholders is understanding patent validation and potential licensing pathways, especially in the context of similar process techniques already established or under development. While Japan-specific, companies operating globally should consider filing comparable patents to secure broad protection.
Key Takeaways
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Claims target specific processing steps including heat, pressure, and sequence, making process modifications a strategic way to avoid infringement.
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Patent landscape is crowded with related innovations, especially in formulation stability and manufacturing techniques, requiring thorough freedom-to-operate assessments.
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Commercial strategies should consider patent expiration dates (circa 2029) for planning product launches or licensing deals.
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Patentual risk mitigation involves either licensing or designing around the detailed process parameters specified in the patent.
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Global patent filing should mirror the Japanese patent to secure simultaneous rights elsewhere, especially in major markets like China, U.S., and Europe.
FAQs
1. What is the most innovative aspect of JP5543991?
The patent’s key innovation lies in the specific process sequence involving controlled heat and pressure to produce stable, bioavailable pharmaceutical granules, rather than the chemical composition itself.
2. Can I produce a similar drug using a different manufacturing process?
Potentially, yes. If your process employs different steps, parameters, or sequence to achieve similar results, it may not infringe. However, a detailed legal review is recommended.
3. How long does the patent protection last?
Expected expiry is around 2029, assuming standard Japanese patent terms from the filing date, offering a substantial period for commercialization.
4. Are there any competitor patents that challenge JP5543991?
While no direct challenge is publicly documented, related patents by competitors may pose infringement risks, requiring comprehensive freedom-to-operate analysis.
5. Should I seek licensing or pursue design-around strategies?
Depends on your product development timeline and IP portfolio. Licensing can provide quick access; design-around may be preferable for long-term independence.
References
[1] Japan Patent Office, JP5543991 B2.
[2] Patent Scope Document – Detailed claims and legal status analysis.
[3] Industry insights on pharmaceutical manufacturing patents.
[4] Patent landscape reports by patent analytics firms.
Note: Specific claim language and detailed patent figures can be reviewed directly from the official patent database for comprehensive legal or technical due diligence.
