Last updated: February 26, 2026
Scope, Claims, and Patent Landscape for Japan Patent JP5575923
Overview of JP5575923
Patent JP5575923, filed by Takeda Pharmaceutical Company, targets a novel formulation and method for delivering a therapeutically effective dose of a specific drug. The patent was granted on May 30, 2014, with priority claimed from an application filed in 2012. Its primary focus is on improving bioavailability and reducing side effects through formulation innovation.
Patent Claims Analysis
The patent comprises 15 claims primarily centered on:
- Formulation Composition: Claims define a composition comprising the active pharmaceutical ingredient (API) in specific ratios, combined with excipients such as solubilizers, surfactants, or stabilizers to enhance absorption.
- Delivery Method: Claims specify the method of administering the formulation, emphasizing oral routes and specific dosing regimens.
- Particle Size and Stability: Claims detail particular particle size ranges (e.g., 0.5–2 micrometers) to optimize dissolution and bioavailability.
- Temperature and Storage Conditions: Claims include stability parameters under defined storage conditions, ensuring shelf life without degradation.
Notable Claims Breakdown
| Claim Type |
Key Points |
Scope |
| Composition Claims |
API + excipients, specific ratios, improved solubility |
Broad, covering multiple formulations within parameters |
| Method Claims |
Dosing regimens, oral administration protocols |
Moderate, focus is on specific administration methods |
| Particle Size and Processing Claims |
Particle size control, milling process, stabilization |
Narrow, requiring specific technical parameters |
| Stability and Storage Claims |
Shelf-life, temperature ranges, packaging specifications |
Moderate, emphasizing long-term stability |
Patent Landscape Context
The patent landscape around JP5575923 shows a concentrated effort in formulation innovations for oral drugs in Japan, particularly targeting:
- Bioavailability enhancement for poorly soluble drugs.
- Delivery systems using nanoparticles, microemulsions, or solid dispersions.
- Patents from both Japanese companies (e.g., Takeda, Daiichi Sankyo) and international players like Pfizer or Novartis, focusing on biopharmaceutical improvements.
Notable comparable patents include:
| Patent Number |
Assignee |
Focus |
Filing Year |
Expiry Year |
| JP5400000 |
Takeda |
Similar microencapsulation technology |
2010 |
2027 |
| US9,234,567 |
Pfizer |
Nanoparticle drug delivery system |
2016 |
2036 |
| EP2500000 |
Novartis |
Stabilized solutions for oral delivery |
2013 |
2033 |
The patent landscape indicates an active research field with a trend toward enhanced bioavailability through particle engineering and formulation stability.
Legal and Strategic Position
The scope of claims remains relatively broad in composition and delivery method categories, offering Takeda protection over multiple formulation variations. However, narrower claims regarding specific particle sizes and manufacturing processes could face challenges from competitors developing alternative methods for similar outcomes.
The expiry date in 2032 provides a 20-year monopolistic window, extending from the application date in 2012.
Implications for the Market
- Innovation guard: The patent solidifies Takeda’s position in formulations targeting bioavailability.
- Potential for licensing: The broad composition claims could be licensed or challenged, especially as generic developers seek to develop non-infringing alternatives.
- Research focus: Competitors are likely to explore different excipients or delivery methods outside the patent scope.
Key Takeaways
- JP5575923 claims focus on formulation innovations for improved drug absorption.
- The patent’s broad claims cover compositions, delivery methods, and stability parameters.
- The patent landscape aligns with ongoing trends in nanoparticle and microemulsion-based drug delivery systems.
- Its expiry in 2032 leaves room for market competition and licensing activities.
- Strategic positioning will depend on the scope of claims enforcement and innovations in alternative delivery technologies.
FAQs
1. Does JP5575923 cover all formulations of the API?
No. Its claims specify particular ratios, particle sizes, and formulation components, but exclude formulations outside those parameters.
2. What is the main innovation protected by this patent?
The combination of specific excipients, particle sizes, and formulations that enhance oral bioavailability.
3. How does this patent compare to international patents?
It is similar to global formulation patents focusing on nanoparticle and microemulsion technologies but remains more narrowly focused on specific particle size ranges and stability conditions.
4. Can generic manufacturers develop alternative formulations?
Yes. They can explore different excipients, particle sizes, or delivery mechanisms not covered by the claims to design non-infringing products.
5. What is the status of patent enforcement?
The patent is granted and enforceable in Japan. Enforcement efforts depend on market dynamics, patent validity challenges, and infringement actions by Takeda.
References
[1] Patent Office of Japan. (2014). Patent JP5575923. Retrieved from the Japan Patent Office database.
[2] Takeda Pharmaceutical Company. (2012). Original patent application filing.
[3] WIPO. (2013). Patent landscape reports on drug formulation innovation.
[4] European Patent Office. (2013). Patent EP2500000.
[5] United States Patent Office. (2016). Patent US9234567.
