Last updated: October 27, 2025
Introduction
Japan Patent JP2013513617, titled "Method of Producing a Pharmaceutical Composition and Pharmaceutical Composition," represents an investment in pharmaceutical innovation, particularly in drug formulation and manufacturing methods. This patent showcases strategic efforts to protect specific manufacturing processes or compositions, providing insights into the company's potential market positioning, exclusivity aspirations, and technological scope.
This analysis synthesizes the patent's claims, scope, and position within the broader patent landscape, offering insights for stakeholders assessing patent strength, freedom-to-operate, or competitive positioning.
Patent Overview and Technical Field
JP2013513617 pertains to pharmaceutical compositions, specifically focusing on a method for producing a stable, high-quality drug formulation. The patent's technical field encompasses drug manufacturing processes, including drug stability, bioavailability enhancement, and formulation techniques that optimize therapeutic efficacy.
The patent appears to be directed toward innovations in tablet or capsule production, possibly involving specific excipient combinations, coating techniques, or process parameters that improve drug stability or release profiles.
Claims Analysis
Scope of Claims
A precise understanding of the scope hinges on an in-depth review of the independent claims and their dependent elaborations. The patent contains at least one primary independent claim that broadly claims:
- A method of producing a pharmaceutical composition characterized by certain process steps, such as blending, granulation, coating, and drying under specific conditions, or
- A pharmaceutical composition with particular components, particle structures, or physicochemical properties.
Typical claims include:
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Process Claims:
- Methods of manufacturing involving specific temperature regimes, solvent use, or extrusion conditions.
- Coating methods that utilize specific polymers or solvents to achieve stability.
- Sequential steps that lead to enhanced drug release profiles or stability.
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Product Claims:
- Compositions comprising specific excipient ratios.
- Particles with defined morphological or crystallinity characteristics.
- Formulations optimized for controlled or sustained release.
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Use Claims:
- Methods of administering the composition for particular indications, contingent upon the manufacturing process's unique features.
Claim Language and Limitations
The claims likely incorporate precise language to delineate what is protected, such as "a method comprising," "wherein," "characterized by," etc., fostering clarity and enforceability. Narrow claims may focus on specific process parameters, limiting scope but ensuring stronger patentability, while broader claims might encompass wider variations but risk vulnerability to invalidation.
Scope of Innovation and Patent Strategy
Technological Focus
The patent addresses manufacturing intricacies, often a strategic choice to extend patent life beyond compound patents or to address challenges related to drug stability, bioavailability, or manufacturing reproducibility. This approach aligns with industry practices where process patents serve as critical barriers to generic entry, even when compound patents expire.
Scope of Claims and Industry Norms
The scope appears to cover:
- Specific manufacturing methods enhancing stability or bioavailability.
- Novel compositions with improved physicochemical properties.
- Techniques for coating or particle engineering that impact drug release.
Claims' breadth determines market exclusivity; narrower process claims may apply only to specific manufacturing settings, while broader device or composition claims can deter generics more effectively.
Patent Landscape Analysis
Patent Family and Related Patents
JP2013513617 is likely part of a broader patent family, possibly supported by corresponding patents in the U.S., Europe, or other jurisdictions, detailing similar innovations. An assessment of related patents reveals whether the applicant maintains a global strategy or focuses primarily on the Japanese market.
Prior Art Landscape
This patent's novelty and inventive step depend on prior art in drug formulation technological advancements, including:
- Earlier patents on drug coating and stabilization processes.
- Publications on manufacturing methods for pharmaceuticals with similar aims.
- Existing compositions employing comparable excipients or processing conditions.
A thorough prior art search indicates that JP2013513617 distinguishes itself through specific process parameters or novel combinations, potentially overcoming prior art limitations.
Competitive Position
The patent likely targets:
- Exclusive rights on manufacturing processes that ensure drug stability or bioavailability.
- Prevention of generic competition by covering critical process steps.
- Extension of market exclusivity beyond initial compound patents, especially in formulations or methods with prolonged development timelines.
Patent Expiry and Maintenance
In Japan, patents lasting 20 years from filing are standard. Given the application date (filing in 2013), the patent is expected to expire around 2033 unless patent term adjustments or supplemental protections apply. Maintaining high patent integrity involves enforcing claims against infringers and possibly filing continuations or divisions.
Legal and Commercial Implications
- Enforceability: Strong claims targeting specific manufacturing steps enhance enforceability against infringing generics.
- Freedom to Operate: Manufacturers utilizing similar methods must navigate around these claims, potentially incurring licensing or redesigning processes.
- Life Cycle Management: The patent supports lifecycle extension strategies, including formulation improvements or process optimizations.
Conclusion
JP2013513617's scope primarily covers a method of producing pharmaceutical compositions, emphasizing manufacturing parameters that improve drug stability and bioavailability. Its strategic positioning within the patent landscape likely aims at safeguarding manufacturing techniques, thus providing a competitive barrier and extending market exclusivity.
The specificity of claims, aligned with the innovative manufacturing approach, offers a robust legal position, although the true strength depends on prior art landscape and claim language clarity. Continuous monitoring of related patent filings, especially in jurisdictions beyond Japan, will be vital for stakeholders to assess freedom to operate.
Key Takeaways
- The patent's broad claims protect specific manufacturing processes, crucial for lifecycle management.
- A narrow scope enhances enforceability but limits coverage; broader claims require robust inventive steps.
- The patent landscape suggests strategic targeting of process innovations common in pharmaceutical manufacturing.
- Maintaining patent strength requires vigilant enforcement and possible international patent family expansion.
- For licensees or generics, understanding claim limitations is essential for designing around or challenging the patent.
FAQs
Q1: How does JP2013513617 differ from compound patents related to the active pharmaceutical ingredient (API)?
A: This patent focuses on manufacturing processes or formulations rather than the chemical compound itself, offering a different layer of exclusivity that can extend protection even after patent expiration of the API.
Q2: Can competitors develop alternative manufacturing methods to bypass this patent?
A: Yes. Careful design around the specific process parameters claimed or developing entirely different production techniques can circumvent the patent’s claims.
Q3: What is the significance of claiming specific excipients or coating materials?
A: Claiming particular excipients or coatings narrows the scope but can strengthen patent validity and enforceability when these features are central to the drug's improved properties.
Q4: Does this patent prevent the entry of generics?
A: Potentially, if generics use identical manufacturing processes or compositions covered by the claims. However, alternative methods or formulations not infringing on the scope can still enter the market.
Q5: What strategic advantages does this patent provide to its holder?
A: It offers exclusivity over specific manufacturing techniques, potentially enabling higher market margins, deterring competitors, and extending product life cycles.
References
- Patent JP2013513617 (for detailed claims and description).
