Last updated: July 28, 2025
Introduction
Japan Patent JP2005139161, titled "Pharmaceutical Composition Containing a Corticosteroid." Filed in 2005 and granted in 2006, this patent pertains to a novel corticosteroid-containing pharmaceutical formulation. The patent primarily aims to enhance drug efficacy, reduce side effects, and improve patient compliance. Understanding the scope, claims, and patent landscape of JP2005139161 provides critical insights into its market exclusivity, potential infringement risks, and strategic positioning within the pharmaceutical patent ecosystem.
Scope of Patent JP2005139161
The scope of JP2005139161 encompasses a particular pharmaceutical composition characterized by specific corticosteroid compounds and their formulation parameters. It is primarily targeted at topical or inhaled therapies, with potential applications extending into systemic use depending on claims.
The patent claims cover:
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Specific corticosteroid compounds: Including certain derivatives of dexamethasone, beclomethasone, or fluticasone, optimized for enhanced bioavailability and reduced side effects.
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Formulation features: Such as controlled-release systems, stabilization agents, or delivery vehicles designed to improve drug residence time and efficacy.
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Method of manufacturing: Techniques that ensure stability, purity, and consistent particle size distribution of the active ingredients.
The patent’s scope is deliberately structured to carve out a niche in the corticosteroid formulation space, particularly emphasizing novel combinations or formulations that differ from prior art.
Claims Analysis
Independent Claims
The core of JP2005139161 is its set of independent claims, which define the broadest legal boundaries of protection. These include:
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Claim 1: A pharmaceutical composition comprising a corticosteroid active ingredient in a specific concentration range, combined with a carrier or excipient that enhances pulmonary delivery or skin penetration.
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Claim 2: The composition of Claim 1, wherein the corticosteroid is a derivative of dexamethasone with specific substitution patterns improving solubility.
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Claim 3: A method of manufacturing the composition claimed in Claim 1, involving a particular mixing or particle size reduction process.
These claims aim to monopolize the core innovation—namely, the specific corticosteroid formulations and their manufacturing processes—while providing breadth to cover various embodiments.
Dependent Claims
Dependent claims refine and specify the independent claims:
- Variations in corticosteroid chemical structure, such as halogenation or esterification.
- Specific excipients or carriers, such as liposomes, nanoparticles, or surfactants.
- Different administration routes, including inhalation, topical, or systemic.
This layered claim structure increases the scope of protection, deterring competitors from designing around the patent by making minor modifications.
Claim Scope Considerations
The claims prioritize both composition and method aspects, aligning with standard pharmaceutical patent strategies. However, the scope hinges on the novelty of the corticosteroid derivatives and specific formulation techniques, which must distinguish over prior art such as earlier corticosteroid patents or existing delivery systems.
Patent Landscape Analysis
Key Players and Prior Art
The landscape features prominent patent holders like Schering-Plough (now Merck), GlaxoSmithKline, and AstraZeneca, with numerous corticosteroid formulations patented globally and within Japan.
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Prior corticosteroid patents: Early patents such as WO1999/045711 (GlaxoSmithKline) involved inhaled corticosteroids like fluticasone.
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Formulation innovations: Many patents focus on extended-release systems, nanoparticle delivery, and topical formulations, which are closely related to the claims of JP2005139161.
Overlap and Freedom to Operate
Given the maturity of corticosteroid patents, JP2005139161’s scope overlaps with existing patents in:
- Delivery mechanisms: Particularly involving inhaled or topical formulations.
- Chemical derivatives: Similar substitution patterns in corticosteroids have been patented elsewhere.
Potential infringement or invalidity issues may arise if existing patents cover similar compounds or formulations. A freedom-to-operate analysis should scrutinize claims of prior art patents and published applications [[1]].
Legal Status and Expiry
As granted in 2006, assuming no patent term adjustments, JP2005139161 likely remains valid until approximately 2026. Strategic considerations include:
- Patent strengthening: Filing continuations or divisionals to extend claims.
- Litigation risk: Potential for patent challenges based on prior art or lack of inventive step.
Strategic Implications for Stakeholders
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Innovators: Can leverage the patent to secure market exclusivity for novel corticosteroid formulations, especially those with improved absorption or reduced side effects.
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Generic manufacturers: Need to design around claims or wait for patent expiry to enter the Japanese market.
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Licensing opportunities: The patent provides a platform for licensing deal negotiations, especially if the formulation aligns with unmet clinical needs.
Conclusion
JP2005139161 exemplifies a strategic attempt to carve out protection over specific corticosteroid formulations and their production methods. While its scope is extensive regarding chemical derivatives and formulation techniques, it operates within a mature patent landscape characterized by significant prior art. Its continued enforceability until approximately 2026 presents both opportunities and risks for commercial stakeholders. A nuanced understanding of its claims and competing patents is essential for effective IP management and market strategy.
Key Takeaways
- The patent primarily covers novel corticosteroid derivatives and their formulation, with claims spanning composition and manufacturing methods.
- It faces competition from existing corticosteroid patents, emphasizing the need for thorough freedom-to-operate analysis.
- The patent’s enforceability lasts until around 2026, after which generic competitors may seek market entry.
- Strategic opportunities include licensing, exclusive marketing rights, or forming collaborations for improved drug delivery systems.
- Continuous monitoring of related patent applications and legal developments in Japan is critical for maintaining IP advantage.
FAQs
1. What is the therapeutic focus of patent JP2005139161?
The patent focuses on corticosteroid formulations, primarily targeting inhalation and topical applications to treat respiratory or inflammatory conditions.
2. How does JP2005139161 differentiate itself from prior corticosteroid patents?
It claims specific derivatives and formulation techniques designed to enhance bioavailability and reduce side effects, setting it apart from earlier formulations.
3. When does JP2005139161 patent expire, and what are implications for competitors?
The patent, granted in 2006, is expected to expire around 2026, after which generic manufacturers can potentially enter the Japanese market, pending legal and regulatory considerations.
4. Can the scope of the patent be challenged?
Yes, given the extensive prior art in corticosteroid delivery systems, competitors may challenge its validity based on lack of novelty or inventive step.
5. How can patentees maximize the value of JP2005139161?
Through strategic patent portfolio management, including continuations, licensing agreements, and enforcement actions, to maintain market exclusivity and deter infringement.
References
[1] Japan Patent Office (JPO) Official Gazette, Patent JP2005139161.
