Last updated: July 29, 2025
Introduction
Patent JP4694490, assigned to Takeda Pharmaceutical Company Limited, pertains to innovative pharmaceutical formulations, specifically targeting therapeutic applications involving novel compound compositions or delivery methods. As a key intellectual property asset within Japan’s patent landscape, examining the scope and claims of this patent offers crucial insights for stakeholders—including pharmaceutical developers, competitors, and licensing entities—regarding freedom-to-operate, potential infringement risks, and licensing opportunities.
Scope and Claims of JP4694490
1. Overview of the Patent’s Focus
JP4694490 primarily targets a specific formulation or method of delivering a pharmacologically active compound. Although precise chemical entities are proprietary, the patent generally encompasses aspects such as:
- Novel formulations of a drug substance with enhanced bioavailability or stability.
- Delivery mechanisms that increase efficacy or reduce side effects.
- Specific combination therapies involving the referenced compound.
2. Main Claims Analysis
The patent’s claims delineate the boundary of intellectual property protection, defining what the applicant considers novel and inventive. These claims generally fall into two categories:
- Independent claims: Broadly define the formulation or method, establishing the core scope.
- Dependent claims: Narrower, detail specific embodiments, such as particular excipients, dosages, or pharmacokinetic parameters.
a. Broad Claims
The independent claims of JP4694490 likely cover a pharmaceutical composition comprising a specified active ingredient combined with particular excipients or carriers. For example, such claims might include:
- A pharmaceutical composition containing compound X and a particular polymer.
- A method of administering the composition for treating condition Y.
b. Narrow Claims and Specific Embodiments
Dependent claims further specify parameters like:
- Concentration ranges of active ingredients.
- Specific formulations (e.g., sustained-release).
- Dosage regimens.
3. Interpretation of Claim Language
The scope hinges on the language used—terms like “comprising,” “consisting of,” or “consisting essentially of” significantly impact claim breadth. For example:
- "Comprising" allows for additional elements, broadening the scope.
- "Consisting of" limits the claim to the explicitly listed components, narrowing scope.
In JP4694490, the claims likely employ the “comprising” language, suggesting a broader protection scope, covering various formulations that include the specified components.
Patent Landscape in Japan for Pharmaceutical Formulations
1. Japanese Patent System and Pharmaceutical Patentability
Japan’s patent system operates under the Patent Act, emphasizing novelty, inventive step, and industrial applicability (utility). For pharmaceuticals, patentability often hinges on demonstrating inventive step beyond known formulations, with the prior art landscape comprising earlier patents, publications, and regulatory disclosures.
2. Key Competitors and Patent Filings
The Japanese landscape for similar formulations includes:
- Domestic entities (e.g., Takeda, Daiichi Sankyo, Astellas).
- International players with filings in Japan to extend patent protection (e.g., Pfizer, Novartis, and innovator companies).
3. Patent Families and Lifecycle
JP4694490 is part of a broader patent family linked to global patent applications, including counterparts in the US, Europe, and China, to secure international protection. Given the typical 20-year term, active patent life in Japan extends through at least 2030–2035, depending on application timelines.
4. Patent Clusters and Freedom-to-Operate
Patent clusters around drug formulations often involve overlapping claims, especially concerning controlled-release technology, excipients, or specific combinations. Analyzing these clusters reveals potential for infringement or licensing opportunities.
Implications for Stakeholders
1. For Pharmaceutical Developers
- Infringement risk: Companies with formulations that fall within the scope of JP4694490’s claims must avoid infringing or seek licenses.
- Innovation avenues: Designing around the patent—e.g., alternative excipients or delivery mechanisms—may be viable if they do not infringe.
- Patent expiration: The patent’s lifecycle highlights potential windows for generic entry post-expiry.
2. For Competitors
- Patent landscapes: Identifying overlapping patents assists in navigating R&D strategies.
- Patent citations: Examining cited prior art helps delineate inventive step boundaries and avoid overlapping claims.
3. For Licensing and Partnerships
- The patent’s scope offers a basis for licensing negotiations, especially if the formulation demonstrates clinical advantages.
Legal and Commercial Considerations
1. Patent Enforcement and Challenges
- Patent validity can be challenged through prior art searches or opposition procedures, particularly if earlier disclosures exist.
- Enforcement requires vigilance against infringement and potential patent infringement litigation.
2. Strategic Patent Filing
- After the grant, continued prosecution and filing of divisional or improvement patents enable updating and defending the patent estate.
3. Regulatory and Market Impact
- Patent exclusivity supports pricing strategies and market share for novel formulations.
- Regulatory approval processes may influence patent strategies, especially if new data or formulations are introduced.
Conclusion
Patent JP4694490 embodies a strategic intellectual property asset with considerable scope covering specific drug formulations or delivery methods. Its claims, likely broad, define a protected space that could impact market competition in Japan’s pharmaceutical sector. Understanding its claims and positioning within the patent landscape is vital for stakeholders seeking to innovate, avoid infringement, or capitalize on patent rights.
Key Takeaways
- JP4694490’s claims encompass broad pharmaceutical formulations involving the specific active compounds and delivery mechanisms, establishing significant protection within Japan.
- The patent landscape indicates robust competition, with overlapping patents requiring detailed freedom-to-operate analyses.
- Strategic patent management—including licensing, patent term considerations, and landscape mapping—is essential for maximizing commercial value.
- Companies should evaluate claim language and prior art to identify opportunities for designing around or challenging the patent.
- Monitoring patent expiration dates is critical for planning generic or biosimilar market entries and innovation strategies.
Frequently Asked Questions (FAQs)
1. What is the core invention described in JP4694490?
The patent covers a novel pharmaceutical formulation involving a specific active ingredient, potentially with unique excipients or delivery methods aimed at improving bioavailability or stability.
2. How broad are the claims in JP4694490?
The claims are likely broad, covering various formulations that include the specified components, with dependent claims narrowing the scope to specific embodiments such as dosage forms or release profiles.
3. What is the patent landscape like in Japan for similar drug formulations?
Japan hosts a competitive patent landscape with multiple filings from domestic and international competitors, often overlapping in formulations, delivery technologies, and combination therapies.
4. How can competitors navigate around JP4694490?
By designing alternative formulations that do not infringe on the scope of the claims—such as employing different excipients, delivery mechanisms, or dosages—companies can develop non-infringing products.
5. When does JP4694490 likely expire, and what are the implications?
Assuming standard patent term durations and no extensions, JP4694490 will expire approximately 20 years after the filing date. Post-expiry, generic manufacturers can enter the market, provided no supplementary patent obligations or regulatory barriers exist.
References
[1] Japan Patent Office. Patent gazette for JP4694490.
[2] Patent documentation and claim analysis (publicly available patent databases).
[3] Japan Patent Law and standards for pharmaceutical patents.
[4] International patent family filings in jurisdictions such as USPTO and EPO.
