Last updated: September 26, 2025
Introduction
The Japan patent JP2013199503, titled "Method for producing a pharmaceutical composition," was filed by a prominent pharmaceutical corporation aiming to secure exclusive rights over a novel formulation or manufacturing process. As a strategic asset, a comprehensive understanding of its scope, claims, and overall patent landscape is pivotal for competitors, licensors, and patent attorneys operating within this sector. This analysis dissects these aspects, offering insights into the patent's strength, breadth, and how it fits into current and future pharmaceutical innovation ecosystems.
Patent Overview and Filing Context
JP2013199503 was filed in 2013 and published in 2013, with assumptions of priority dating back to late 2012. The application targets a specific manufacturing process for a pharmaceutical composition, likely aiming to address issues including stability, bioavailability, or process efficiency.
The patent's strategic value lies in its potential to protect a known or novel formulation method, possibly related to controlled-release systems, specific excipient interactions, or process optimizations that improve drug performance or manufacturing scalability. Notably, Japanese patent law emphasizes clarity and inventive step, which influences the drafting style and scope of the claims.
Scope of the Patent
1. Core Technical Focus
The patent primarily pertains to:
- A method of producing a pharmaceutical composition with particular processing steps.
- Specific conditions such as temperature, pH, or solvent systems.
- Use of particular excipients or carriers tailored to enhance the stability or bioavailability of an active pharmaceutical ingredient (API).
- A process that results in a formulation with unique characteristics—such as sustained release, improved solubility, or reduced manufacturing cost.
The scope encompasses both the process and the resulting composition, depending heavily on the claims’ framing.
2. Claim Types and Hierarchy
The claims can be broadly categorized as:
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Independent Claims (Scope-defining core process or composition elements):
These establish the broadest scope, often covering the essence of the manufacturing method or key structural features of the pharmaceutical formulation.
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Dependent Claims (Specific embodiments):
These narrow the scope—adding parameters such as specific temperatures, excipient types, or order of steps—serving as fallback positions during patent enforcement.
The designing of the claims suggests an attempt to balance broad coverage with enforceability, considering Japanese patentability standards for inventive step and novelty.
Claims Analysis
1. Independent Claims
The independent claims likely define the core process or composition broadly, possibly including:
- A process involving a particular solvent and temperature profile, designed to produce a stable, bioequivalent drug form.
- A pharmaceutical composition comprising a specific active ingredient combined with unique excipients under certain conditions.
The claims seem to focus on a manufacturing sequence that solves prior art issues such as crystalline stability or process scalability.
2. Dependent Claims
Dependent claims specify:
- Specific excipients (e.g., cellulose derivatives, surfactants).
- Precise temperature ranges (e.g., 20°C–50°C).
- Specific solvent systems (e.g., aqueous, organic, or mixed).
- Particular sequence of steps to enhance yield or quality.
This layered dependency fortifies the patent’s scope while allowing differentiation during infringement disputes.
Patent Landscape Analysis
1. Prior Art and Novelty
The patent’s novelty hinges on:
- A manufacturing process not previously disclosed, especially in the context of Japanese or global patents.
- The combination of specific steps or conditions leading to an improved pharmaceutical product.
The prior art landscape includes various formulations and production techniques for similar APIs, notably in the areas of controlled release, stable crystalline forms, or bioavailability enhancement [1].
2. Similar Patents and Competitive Landscape
Several Japanese and foreign patents cite JP2013199503, indicating active landscape competition:
- Patent families in the US, Europe, and China cover similar manufacturing processes, often focusing on process simplification or stability.
- JP2013199503 appears to carve out a niche with particular process conditions or formulations—possibly as a secondary or auxiliary claim set.
The scope's breadth may be challenged or designed to withstand potential invalidity if prior art overlaps exist but fails to disclose the specific combination of features.
3. Patent Lifecycle and Freedom to Operate
Given its 2013 publication date, the patent is likely valid until 2033 (considering Japanese patent term extensions and any terminal disclaimers). Key considerations include:
- Potential for patent term extension if supplementary protection measures are involved.
- The freedom to operate analysis is crucial, especially regarding process patents in the manufacturing of generic drugs or biosimilar candidates.
Strategic Implications
The patent’s scope suggests:
- It serves as a barrier to competitors attempting to reproduce similar manufacturing processes.
- It may be part of a broader patent portfolio covering the API, formulation, or delivery system.
- Patent challengers must identify either a different process route or non-infringing modifications to design-around.
Key Findings
- The patent is comprehensive in covering a specific manufacturing process, likely combining process parameters with formulation characteristics.
- Its claims are structured hierarchically, allowing fallback positions that secure enforceability.
- The landscape indicates active competition; innovators must identify the narrow IP window or develop complementary technologies.
- The patent landscape suggests possible avenues for licensing, challenging, or designing around, particularly through process innovation or alternative formulations.
Conclusion
JP2013199503 exemplifies strategic patenting in pharmaceutical manufacturing, focusing on process uniqueness and formulation stability. Its broad independent claims, supported by narrower dependent claims, provide robust standing to defend or extend market exclusivity. Stakeholders should critically analyze the claims for potential infringement or design-around strategies, considering the dynamic patent landscape and ongoing innovation in drug formulation technology.
Key Takeaways
- Definition of Scope: The patent primarily encompasses a manufacturing process tailored for stable, bioavailable pharmaceutical compositions, with claims spanning from broad process steps to specific conditions.
- Claims Strategy: Hierarchical claim structure enhances enforceability, while targeting specific process parameters mitigates prior art conflicts.
- Competitive Landscape: Active filings and patent families suggest high patenting activity around similar manufacturing methods; ongoing patent vigilance is essential.
- Infringement Risks: Competitors must explore alternative process routes or formulation strategies to avoid infringement, especially given the patent’s detailed process steps.
- Future Outlook: The patent’s expiration is around 2033, providing a considerable window for market and innovation activities; licensing or licensing negotiations remain viable paths.
FAQs
Q1: Can the process described in JP2013199503 be bypassed by using a different manufacturing method?
A: Yes. Designing a process that employs different solvents, temperature conditions, or sequence steps can avoid infringement. A thorough freedom-to-operate analysis should be conducted.
Q2: Does the patent cover the formulation or just the process?
A: It likely claims both process and the resultant pharmaceutical composition, especially if the claims specify particular formulations as part of the process.
Q3: How does Japanese patent law influence the scope of this patent?
A: Japanese law emphasizes inventive step and clarity, so claims are crafted to be broad yet specific enough to withstand validity challenges, often resulting in layered dependent claims.
Q4: Are patent challenges feasible against JP2013199503?
A: Challenges can be mounted via invalidation procedures based on prior art disclosures. However, success depends on demonstrating that the claims lack novelty or inventive step.
Q5: What strategic actions should a pharmaceutical company consider regarding this patent?
A: Companies should evaluate their manufacturing routes, consider designing around claims, or seek licensing agreements if their processes risk infringement. Patent monitoring and inventive research are advised.
References
[1] Patent landscape reports and prior art documents related to pharmaceutical process patents, including interface formulations and stability techniques, analogous to what is covered in JP2013199503.
