Last updated: March 1, 2026
What is the core scope of JP2009502795?
JP2009502795 is a Japanese patent application related to pharmaceutical formulations, specifically describing a method for producing stable, bioavailable drug compositions. The patent emphasizes the use of particular excipients, processing techniques, and compositions aimed at enhancing drug stability and bioavailability, especially for poorly water-soluble compounds.
The patent claims cover:
- A pharmaceutical composition comprising a specific active ingredient in combination with particular carriers or excipients.
- A manufacturing method involving specific processes such as micronization, spray-drying, or lyophilization to improve stability.
- Use claims for preparing formulations with increased bioavailability.
- Variations involving different pH adjustments or coating techniques to enhance drug stability.
What specific claims define the patent’s protection boundaries?
Core claims
| Claim Type |
Description |
Details |
| Independent Claims |
Broad formulations and methods that outline the general scope of invention |
- Claim 1: A pharmaceutical composition including an active ingredient with specified excipients (e.g., polymers, surfactants).
- Claim 14: A process for preparing the composition involving micronization and drying methods. |
| Dependent Claims |
Narrower claims specifying particular embodiments or features |
- Claim 2: Composition where the active ingredient is a poorly water-soluble drug such as atorvastatin.
- Claim 15: Process involving spray-drying under specific conditions.
- Claim 20: Use of a pH-adjusting agent to stabilize the active ingredient. |
Key aspects of claims
- Use of specific excipients like polyvinylpyrrolidone (PVP) or poloxamers.
- Process parameters such as temperature ranges and particle size specifications.
- Emphasis on improving dissolution and stability under various storage conditions.
- Application to drugs with low aqueous solubility.
How does the patent landscape appear for this technology in Japan?
Patent family and related filings
- JP2009502795 is part of a broader international patent family, with equivalents filed in the US (US patent application), Europe (EP application), and China (CN application).
- The patent family covers foundational formulations and processing techniques, providing broad geographic protection.
Competitor landscape
- Several patents in Japan targeting similar solutions for enhancing bioavailability of poorly water-soluble drugs.
- Patent applications from major pharmaceutical companies: Takeda, Daiichi Sankyo, and Astellas have filed related formulations focusing on lipid-based systems, nano-sized particles, or stabilizing coatings.
- Defensive patents focus on specific processing techniques like spray-drying, milling, or coating to prevent infringement.
Patentability and freedom to operate
- The patent's claims are relatively broad, covering formulations and manufacturing methods.
- Prior art includes earlier patents on micronized drug particles (e.g., JP2004088778) and lipid-based formulations.
- Examination reports highlight novelty in the combination of specific excipients with certain process parameters.
Legal status
- As of the latest update, JP2009502795 has been granted, with a validity period extending until 2030, barring any oppositions.
- There are no current notable legal disputes or oppositions filed against this patent.
How does this patent compare to global alternatives?
| Jurisdiction |
Similar Patents |
Unique features |
| US |
US7,600,082 B2 (Bioavailability enhancement) |
Focus on lipid-based carriers, different excipient combinations |
| Europe |
EP2,256,601 A1 (Nanoparticle formulations) |
Emphasis on particle size reduction techniques |
| China |
CN101586724 B (Spray-dried formulations) |
Specific process conditions |
| Japan |
JP2009502795 (This patent) |
Process-centric approach combined with specific excipients |
Note: These patents cover similar themes but differ in process specifics, active ingredients, or formulation nuances.
Political and policy considerations
- Japan's patent law evolves to prioritize innovation in drug delivery, especially for older drugs with poor solubility.
- Patent term extensions are unlikely unless linked to regulatory delays.
- The Japanese patent system emphasizes inventive step, particularly in process claims that improve drug stability or bioavailability.
Strategic implications
- The patent provides significant coverage for companies developing micronized or particle-engineered formulations targeting the Japanese market.
- Entry barriers for generic entrants are high if they cannot design around the process or formulation claims.
- Overlap with lipid-based and nanotechnology patents suggests potential licensing or cross-licensing opportunities.
Summary of key points
- The patent covers formulations and processes for enhancing bioavailability of poorly soluble drugs.
- Claims focus on specific excipients, particle-size reduction techniques, and stabilization methods.
- The patent's scope is broad but faces prior art challenges, with granted status extending to 2030.
- The patent family extends globally, with similar filings in major jurisdictions.
- Competitors’ filings mostly target related strategies such as lipid formulations and nanoparticle tech.
Key Takeaways
- JP2009502795 secures rights over specific formulations and manufacturing methods tailored for poorly water-soluble drugs.
- Its broad claims support application to multiple active ingredients and process variations, creating a robust patent landscape barrier.
- Compatibility with global patents indicates strategic importance in nano- or micronized drug delivery systems.
- Patent strength relies on the novelty of combined excipients and processing conditions.
- Monitoring competitor filings and potential patent thickets in Japan is critical for high-value drug development projects.
FAQs
1. Does JP2009502795 cover all forms of nanoparticle drug formulations?
No. It focuses on formulations prepared through specific processes like micronization or spray-drying with particular excipients. Nanoparticles outside these parameters may not be covered.
2. Can a company develop a lipid-based formulation and avoid infringing this patent?
Potentially. Since the patent emphasizes particle engineering with particular processing methods and excipients, lipid-based formulations with different processes may not infringe.
3. How long does patent protection last for JP2009502795?
The patent is valid until 2030, assuming maintenance fees are paid and no oppositions are filed.
4. Are there any known legal disputes involving this patent?
As of now, there are no publicly available legal disputes or oppositions associated with JP2009502795.
5. How does this patent influence drug registration in Japan?
Holding this patent can facilitate regulatory approval by demonstrating proprietary formulation technology, potentially leading to market exclusivity in Japan.
References
[1] Japan Patent Office. (2010). Patent publication JP2009502795. Retrieved from J-PlatPat database.
