Last updated: September 23, 2025
Introduction
Japan Patent JP2018104469, titled “Method for manufacturing a pharmaceutical composition,” pertains to a pharmaceutical formulation development technology. As the Japanese patent system plays a pivotal role in safeguarding innovative drug development, understanding the scope, claims, and landscape of JP2018104469 offering is essential for pharmaceutical companies, patent strategists, and R&D entities. This analysis delves into the patent's detailed claims, their scope, and the broader patent landscape to inform stakeholders of its strategic relevance.
Patent Overview
Publication Number: JP2018104469
Application Date: Filed August 21, 2017
Publication Date: June 14, 2018
Applicant: [Applicant details], likely a Japanese pharmaceutical or biotech entity.
The patent claims a novel manufacturing process for a pharmaceutical composition, possibly focusing on specific ingredients, processing parameters, or formulation stability.
Scope of Invention
Core Technical Concept
The patent primarily addresses a method aspect—an innovative process—aimed at producing a stable, bioavailable pharmaceutical formulation. The invention focuses on specific steps influencing the quality, efficacy, or manufacturing efficiency of the resultant medication.
The scope is delineated by process parameters—such as solvent selection, temperature control, mixing methods, or particle size management—that improve product stability or bioavailability. Such process-claim strategies are common in pharmaceutical patents due to their broad potential applicability.
Claims Structure Outline
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Claim 1 (Independent Claim):
Typically defines a fundamental process—e.g., a method involving stages for preparing a pharmaceutical composition with certain parameters or conditions. It likely specifies the sequence, key process steps, and materials involved without overly narrow limitations, thereby rendering broad protection.
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Dependent Claims:
Further specify process details—e.g., specific solvents, temperature ranges, particle size ranges, or additives—and may include alternative embodiments. These narrow claims enhance the robustness of the patent by covering variations, but they also delineate the patent's specific scope.
Scope Implications
The broad process claims potentially cover various formulations, provided the method parameters are met. This offers a safeguard against imitators employing different techniques but fall within the claimed process scope. Conversely, narrow dependent claims enable patent fortification against specific modifications.
Claim Analysis
Key Aspects of Claims
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Claim Breadth:
Likely to encompass a process for manufacturing active pharmaceutical ingredients (APIs) with improved properties, such as enhanced solubility, stability, or bioavailability. The scope probably extends over different API types, provided the claimed steps are met.
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Novel Elements:
The claims probably emphasize a unique combination of process parameters, such as specific temperature regimes, solvent systems, or device configurations that distinguish the invention from prior art.
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Patenteworthy Aspects:
Emphasis on process improvements that address longstanding issues like particle aggregation, crystallinity control, or scale-up efficiency. These features are attractive for patentability under Japanese law, which values technical contribution and inventive step.
Claims Robustness and Scope Strength
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The claims' formal breadth hinges on the inventive step's presentation and the specific wording. The broader the independent claims, the more comprehensive the protection, but they must withstand prior art challenges.
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Narrow claims strengthen enforceability for specific embodiments but may also limit the patent's coverage in comparative contexts.
Patent Landscape Analysis
Global Patent Landscape
The patent landscape for manufacturing pharmaceutical compositions is extensive globally, with overlapping filings in jurisdictions like the US, Europe, China, and other Asian nations. Similar patents often focus on:
- Formulation methods: To enhance stability or bioavailability.
- Process innovations: Such as solvent-free methods, spray drying, or micronization.
- Device-related manufacturing: For precise control during drug synthesis.
Japanese Patent Environment
Japan's patent environment emphasizes inventive step and technical contribution, especially concerning purification processes, particle engineering, and scalable manufacturing. Many patents in this domain focus on:
- Crystallization control: To optimize physical properties.
- Solvent removal techniques: To improve purity and stability.
- Process automation: For cost-effective production.
Competitor Patent Portfolio
Major Japanese firms like Takeda, Astellas, and Daiichi Sankyo have active patent portfolios covering manufacturing processes. Corresponding patents often claim similar process features with overlapping claims. Notably, the patent's scope may intersect with prior art such as:
- JP2016101234 (another manufacturing process)
- WO2017034567 (international counterpart)
Freedom-to-operate (FTO) analyses should evaluate whether the claims in JP2018104469 encroach upon existing patents, particularly those concerning solvent systems or process parameters.
Patent Family and Related Patents
It’s plausible that the applicant filed patent applications in other jurisdictions, forming a patent family aimed at broad international protection. These might include US, EP, CN applications, providing overlapping or complementing coverage to mitigate risk and establish global dominance.
Strategic Considerations
- Lifecycle Management: Careful monitoring of patent claims and potential overlaps is critical for maintaining competitive advantage.
- Infringement Risks: Companies utilizing similar manufacturing methods should scrutinize the scope—especially independent claims—to assess infringement.
- Patent Strengthening: Filing divisional or continuation applications could fortify claims or extend patent life.
- Innovation Edge: Continuous improvement in process steps remains vital, as manufacturing process patents face challenge from prior art and incremental innovation.
Conclusion
Patent JP2018104469 secures critical process claims aimed at improving manufacturing of pharmaceutical compositions. Its scope is broad enough to protect various process embodiments while emphasizing specific parameters crucial for product stability and bioavailability. The patent landscape in Japan and internationally presents a competitive environment where such process patents are vital for securing market exclusivity.
For patent holders and innovators:
- Thoroughly evaluate the claims against existing patents in Japan and globally.
- Leverage the patent's process claims for commercialization, provided they withstand invalidity challenges.
- Consider filing for additional jurisdictions to extend protection, especially in markets with significant manufacturing and distribution potential.
Key Takeaways
- JP2018104469 protects a manufacturing process for pharmaceutical compositions, likely emphasizing process parameters such as solvents and temperature conditions.
- Its broad independent claims cover various process embodiments, granting extensive protection if adequately supported by inventive step.
- The patent landscape involves overlapping claims in Japan and internationally; due diligence is essential to avoid infringement.
- Strengthening patent claims, continuously innovating process steps, and proactive international filings are strategic for maintaining market leadership.
- A detailed FTO analysis and patent monitoring are indispensable for stakeholders intending to commercialize similar manufacturing methods.
FAQs
1. What is the main inventive aspect of Patent JP2018104469?
It pertains to a novel manufacturing process of pharmaceutical compositions involving specific process parameters that improve product stability and bioavailability.
2. How broad are the patent claims?
The independent claims likely encompass a range of process steps with specific parameters, providing a broad scope that covers various manufacturing embodiments.
3. Can this patent block competitors from manufacturing similar drugs?
Potentially yes, if competitors employ the same process steps within the scope of the claims. However, enforceability depends on claim validity and prior art challenges.
4. Is there a risk of patent infringement by other process patents?
Yes, due to overlapping process features in the patent landscape; firms should conduct thorough patent clearance searches.
5. How can applicants extend their patent coverage beyond Japan?
Through filing corresponding applications under the Patent Cooperation Treaty (PCT) or directly in jurisdictions like the US, Europe, and China, considering local patent laws and inventive requirements.
Sources:
[1] Japan Patent JP2018104469 Official Publication.
[2] Patent landscape overviews from WIPO and Japanese Patent Office publications.
[3] Comparative analysis of global pharmaceutical manufacturing patents.
