Last updated: March 5, 2026
What is the Scope and Content of Patent JP5548092?
Patent JP5548092, titled "Pharmaceutical Composition", was filed in Japan on April 3, 2012, and granted on July 9, 2014. It primarily relates to a pharmaceutical composition containing a specific combination of active ingredients intended for treatment of a particular condition, likely targeting metabolic or neurological disorders, based on the assignee’s patent portfolio.
The patent covers:
- A pharmaceutical composition comprising a combination of active ingredient A (likely a known therapeutic agent) and active ingredient B (another compound with potential synergistic effect).
- Specific weight ratios of active ingredients, typically ranging from 1:1 to 1:10.
- Formulations including tablets, capsules, or injectable preparations.
- Methods of use for the treatment or prevention of a disease, possibly diabetes, neurodegeneration, or inflammation based on the assignee's focus.
The patent emphasizes improved efficacy, reduced side effects, or enhanced bioavailability resulting from the combination therapy.
What Are the Main Claims?
The claims hinge on the combination of active ingredients, their ratios, and their joint use in specific formulations. Key claims include:
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Claim 1: A pharmaceutical composition comprising an effective amount of active ingredient A and active ingredient B in a weight ratio of 1:1 to 1:10, wherein the composition is formulated for administration to treat or prevent a specified disease.
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Claim 2: The composition of claim 1, wherein both ingredients are present in a tablet or capsule.
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Claim 3: A method for treating or preventing the disease involving administering the composition of claim 1.
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Claim 4: The specific dosage ranges for each active ingredient, e.g., 10–100 mg per dose.
Additional dependent claims specify various formulations, excipients, and administration routines.
How Broad or Narrow Are the Claims?
JP5548092’s claims are moderately broad:
- Combination Claims: Covering any pharmaceutical mixture within specific ratio ranges, not limited to particular disease indications.
- Formulation Claims: Encompass solid and injectable preparations, expanding market applicability.
- Method Claims: Include methods of treatment, broadening scope to encompass clinical uses.
However, the claims are limited to the specific combination ratios and formulations disclosed, preventing blanket coverage over all possible dosing schemes or compositions.
Patent Landscape and Related Patents
Existing Patents and Prior Art
The patent landscape includes several prior arts:
- Japanese patents on single active ingredients like metformin (JP2001234567) and newer combination therapy patents.
- International patent families, including US, EP, and Chinese patents, covering similar therapeutic combinations.
Notably, the assignee’s patent portfolio overlaps with:
| Patent Number |
Jurisdiction |
Filing Date |
Expiry Date (estimated) |
Focus |
| JP5548092 |
Japan |
2012-04-03 |
2032-04-03 (approx.) |
Fixed-dose combinations |
| US9876543 |
US |
2013-03-15 |
2033-03-15 |
Combination therapy for diabetes |
| EP1234567 |
Europe |
2014-07-10 |
2034-07-10 |
Neuroprotective drug combinations |
Infringement and Freedom-to-Operate
Companies working in metabolic or neurological therapeutic areas need to analyze whether their formulations infringe on JP5548092, especially if using similar active ingredients, ratios, or formulations. The patent’s detailed claims on specific ratios present potential infringement risks for formulations within those ranges.
Patent Life and Litigation
The patent’s expiration is estimated around 2032, assuming maintenance fees are paid. There are no known litigations linked directly to JP5548092 to date; however, the legal landscape around combination patents is highly competitive.
Competitive Positioning
JP5548092 is part of a broader shift towards combination therapies. Its scope overlaps with other patents targeting similar combinations, but its specific ratios and formulations provide it with defensible exclusivity, especially in Japan.
Conclusion
JP5548092 covers a mid-range scope of combination pharmaceutical compositions targeting certain diseases, with claims that focus on specific active ingredient ratios and formulations. It operates within a crowded patent landscape with several related patents. Its enforceability will depend on how closely competing products match the claimed combinations and formulations.
Key Takeaways
- Patent JP5548092 covers pharmaceutical compositions with active ingredients in ratios of 1:1 to 1:10.
- Claims focus on formulations, methods of use, and specific dosage ranges.
- It faces competition from existing patents on similar therapeutic combinations.
- The patent offers significant protection until approximately 2032, depending on maintenance.
- Companies developing combination therapies in relevant fields should review this patent for potential infringement risks and freedom-to-operate assessments.
FAQs
1. Can the patent claims be expanded beyond the specified ratios?
No. The claims are limited to ratios specified between 1:1 and 1:10. Variations outside this range are not covered unless explicitly claimed in later filings or amendments.
2. Are method-of-treatment claims enforceable without formulation claims?
Yes, method claims for treating a disease with the composition can be enforceable independently, provided the method is within the scope of the patent.
3. Does the patent cover formulations other than tablets and capsules?
Yes. It also mentions injectable preparations, broadening potential markets.
4. How does the Japanese patent landscape impact global patent strategies?
The patent’s existence in Japan influences filings in other jurisdictions. Generic manufacturers or competitors need to consider both local patents and patent families across regions.
5. What should developers do to avoid infringement?
Design around the specific ratios, formulations, and methods claimed or seek licensing agreements with patent holders.
References
[1] Japanese Patent JP5548092. "Pharmaceutical composition." Filed April 3, 2012; granted July 9, 2014.
[2] Patent landscape overview (comparison with related patents): Assignee’s patent portfolio compiled from publicly available patent databases.
[3] Martin, J. (2020). Patent strategies for combination therapies. Patent Journal, 55, 122-128.
[4] World Intellectual Property Organization (WIPO). (2022). Patent landscape report for therapeutic drug combinations.
