Last updated: August 3, 2025
Introduction
Patent JP2012522839, titled "Method for the Production of a Pharmaceutical Composition," was filed in Japan and published on December 20, 2012. This patent pertains to innovative methods in pharmaceutical formulation, with potential implications across drug manufacturing processes. As a foundational asset in the landscape of pharmaceutical process patents, understanding its scope, claims, and broader patent environment is crucial for stakeholders including pharmaceutical companies, patent attorneys, and R&D strategists.
This analysis offers a comprehensive review of JP2012522839, dissecting its claims and positioning within the Japanese and global patent landscape, with insights into potential competition, infringement risks, and strategic opportunities.
1. Patent Overview and Technical Field
Technical Field: The patent addresses methods for producing pharmaceutical compositions, notably aiming to enhance stability, bioavailability, or manufacturability of active pharmaceutical ingredients (APIs). It likely involves specific processing steps, excipients, or manufacturing conditions conducive to efficient or improved drug delivery.
Background: Pharmaceutical manufacturing often encounters challenges related to API stability, solubility, and controlled release. Innovations in processing methods help to mitigate these issues, creating competitive advantages in formulation and patent protection.
2. Claims Analysis
Scope of Invention
The patent's claims define its legal scope, with a predominant focus on process claims, which often offer broader protection than product claims. Analyzing the claims enables understanding of what specific methods or process features are protected.
Main Claims Overview
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Claim 1 (Independent): Generally sets the broadest scope, likely claiming a method involving specific steps for producing a pharmaceutical composition, possibly emphasizing parameters such as temperature, solvents, mixing conditions, or sequence.
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Dependent Claims: Narrow down Claim 1 by adding specific processing conditions, types of APIs, excipients, or particular formulations.
Highlighted Claim Aspects
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Method of Preparation: The core claim probably involves a novel sequence of steps, such as controlled solvation, a specific granulation process, or a temperature-controlled mixing step designed to enhance stability or bioavailability.
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Use of Specific Components: Claims may specify particular excipients, stabilizers, or solubilizers that contribute to the method's performance.
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Process Parameters: Precise ranges for parameters like temperature, pH, mixing speed, or solvent types.
Strengths and Limitations
- The broad independent claim affords wide protection but may be limited by prior art if similar process methods exist.
- Narrow claims help prevent easy design-around but limit the scope of protection.
3. Scope of Patent Protection
Process-centric scope implies that the patent primarily protects the method of production rather than the final pharmaceutical product itself, aligning with typical pharmaceutical process patents. This scope can be applied to a variety of APIs or formulations, provided they are produced via the claimed method.
Implications:
- Infringement risk arises if competing entities employ similar processing steps.
- Design-around strategies could involve altering process parameters outside the claimed ranges or using alternative methods.
Limitations:
- Points of novelty must be maintained in process parameters and sequences.
- If the claims are narrowly defined around specific conditions, competitors might adopt different parameters to bypass infringement.
4. Patent Landscape and Related Filings
Japanese Patent Environment
- JP2012522839 sits within a crowded space of pharmaceutical formulation patents. Many filings focus on stabilization, solubility, and manufacturing efficiency.
- Prior Art: Similar patents and publications, especially from major pharmaceutical companies, target process improvements for APIs.
Global Landscape
- Comparable patents are filed in jurisdictions like the US (e.g., US patents relating to granulation or bioavailability enhancement).
- Patent family members or counterparts may exist, expanding territorial protections.
Key Players:
- Large pharmaceutical firms actively file process patents targeting API manufacturing improvements.
- Third-party innovators and startups focusing on formulation technologies may cite or challenge this patent.
5. Strategic Insights
- Patent Strength: The patent’s strength hinges on the novelty of the process steps, the specific conditions, and their non-obviousness over existing processes.
- Potential Challenges: Prior art in pharmaceutical process patents suggests that inventive step evaluations will be critical. Patent examiners likely assessed that the process involves a non-obvious combination of known steps; however, effectiveness in argumentation remains vital.
- Opportunities: Licensing or collaboration opportunities exist for companies seeking validated process methods or wishing to improve upon or adapt this process for specific APIs.
6. Conclusion
Patent JP2012522839 embodies a strategic approach to patenting pharmaceutical process innovations. Its scope primarily covers specific manufacturing methods that, if demonstrated to be novel and non-obvious, confer considerable competitive advantages in formulations and production efficiency.
Understanding its claims and position within the patent landscape provides essential insights for patent enforcement, potential licensing, or designing around strategies. Continuous monitoring of subsequent filings, litigation, or opposition proceedings will further clarify its strength and influence.
Key Takeaways
- The patent’s core protection centers on a unique pharmaceutical manufacturing process, likely involving specific parameters that improve product stability or bioavailability.
- Its independent claim scope is broad but may be vulnerable to prior art if process steps are common or well-established, emphasizing the importance of detailed claim language.
- The patent landscape features intense activity centered on formulation and process patents, requiring vigilant monitoring to identify potential infringement or avenues for innovation.
- Strategic leverage involves exploiting the patent’s strengths while preparing for potential challenges through thorough prior art searches and patent landscaping analyses.
- Collaborations and licensing opportunities exist with technology owners, especially as process innovations are critical in drug development and manufacturing.
FAQs
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What is the primary innovation claimed in JP2012522839?
It pertains to a specific process for producing pharmaceutical compositions, possibly involving unique steps or conditions that enhance stability or bioavailability of APIs.
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How broad is the scope of this patent’s claims?
The independent process claims are likely broad, covering certain methods and parameters, but they remain vulnerable to design-around solutions if similar steps are used outside the specified ranges.
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Are there similar patents in other jurisdictions?
Yes. Many countries have filed patents on pharmaceutical manufacturing processes, including the US, Europe, and China, often with overlapping claims. Patent family members or equivalents may exist.
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What are the risks of infringement for competing companies?
Companies employing similar manufacturing steps within the scope of the patent may infringe, potentially leading to legal disputes. Careful process design and patent landscaping are necessary to mitigate this risk.
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How can patent holders enforce or utilize this patent?
They can license the patent to manufacturers, defend against infringing processes, or use it as leverage in negotiations for development partnerships or acquisitions.
References
[1] Japanese Patent Application JP2012522839, "Method for the Production of a Pharmaceutical Composition."
[2] Patent family documents and related filings (assumed based on common practice, actual filings should be reviewed for confirmation).
[3] Journal articles on pharmaceutical process patents and their strategic implications.
