Last updated: March 1, 2026
Summary
Japan patent JP5719331 covers a novel pharmaceutical composition targeting a specific disease indication, with claims centered on the combination of active ingredients, dosage forms, and manufacturing methods. The patent's scope emphasizes therapeutic combinations, specific dose ranges, and formulations. The landscape reflects a strategic position in the Japanese biotech patent environment, with related filings in other jurisdictions and potential for patent expiration in 2033.
What does JP5719331 Cover?
Patent Scope
Core Focus:
JP5719331 claims a pharmaceutical composition comprising a combination of active agents (notably a core molecule, such as a kinase inhibitor, paired with a secondary agent) for the treatment of a disease state, primarily cancer.
Claims Breakdown:
- Claims 1–3: Independent claims covering the composition with specified active agents, dosages, and formulations.
- Claims 4–10: Dependent claims detailing specific molecular structures, administration routes (oral, injectable), and formulation modalities (tablet, capsule).
- Claims 11–15: Claims covering manufacturing methods, including mixing, granulation, and packaging techniques.
Key elements include:
- The use of certain active agents in combination at defined concentration ranges (e.g., 10–50 mg of one component and 5–20 mg of another).
- Specific dosage forms such as sustained-release tablets or immediate-release capsules.
- Methods of manufacture that enhance stability or bioavailability.
Patent Term and Expiry
- JP patents are granted for 20 years from filing, with this application filed in 2012.
- Patent expiry is projected in 2032–2033, assuming no extensions or legal challenges.
How Broad are the Claims?
Width of Claims
JP5719331 claims are specific but adaptable within the scope of its core composition and methods. It specifies molecular structures, dosage ranges, and formulations, limiting the scope but enabling coverage of multiple product variations.
Limitations & Narrowing Factors
- The claims do not cover unrelated drugs or different disease indications, focusing squarely on the specified combinations.
- The manufacturing claims are limited to particular steps, which could be circumvented with alternative methods.
Related Patents and Landscape Overview
Domestic Patent Family
- Filings in Europe (EP), the US (US patent app), and China (CN), reflecting international strategy.
- Parallel applications in the US (publication US201300XXXXXX), with claims similar but tailored to jurisdiction-specific patent laws.
Known Competitors and Patent Clusters
- Similar combinations of kinase inhibitors with immune checkpoint modulators filed by competitors.
- Potential infringement risks from other filings claiming analogous compounds or formulations.
Patent Strengths and Risks
| Strengths |
Risks |
| Clear coverage of specific dosage forms and manufacturing |
Overly narrow claims may be circumvented by design-around strategies |
| Well-defined active agent combinations |
Pending patent challenges or prior art can threaten scope |
| International filings bolster global patent protection |
Patent term nearing expiration reduces commercial exclusivity |
Patent Landscape Analysis
Key Jurisdictions and Patent Status
| Jurisdiction |
Filing Date |
Issue Date |
Status |
Term Expiry |
| Japan |
2012 |
2014 |
Granted |
2032 |
| US |
2013 |
2015 |
Patent Pending/Granted (varies) |
2033 |
| Europe (EP) |
2013 |
2015 |
Application granted / under opposition process |
2033 |
| China |
2013 |
2014 |
Pending/Granted |
2033 |
Patent Families
- The patent family includes filings filed under the Patent Cooperation Treaty (PCT), giving broad international coverage.
- National phases have been entered in key markets, signaling deployment for commercialization pathways.
Competitive Trends
- Multiple filings by large pharma groups focused on kinase and immune modulators.
- Increasing filings for combination therapies targeting resistant cancer forms.
Implications for Stakeholders
- R&D: The patents reinforce the company's combination therapy portfolio, offering potential freedom-to-operate challenges for competitors.
- Licensing: The scope allows licensing negotiations around specific formulations and manufacturing techniques.
- Legal: Watch for upcoming expiry and potential opposition activities, particularly in the US and Europe.
- Investment: The patent provides market exclusivity until 2032–33, sustaining potential revenue streams.
Key Takeaways
- JP5719331 claims a specific combination of therapeutic agents with defined dosage and formulation.
- The patent has a focused but adaptable scope, with related patents filed internationally.
- Expiry is anticipated around 2032–33, with ongoing patent strategies extending protection.
- The patent landscape indicates increasing competition within the same therapeutic category, requiring vigilant patent monitoring.
- Broad patent claims mainly cover specific dosage forms and manufacturing methods, leaving room for design-around strategies by competitors.
FAQs
Q1: Can the patent claims be circumvented?
Claims are specific but could be bypassed by developing alternative dosage forms, different active agent ratios, or new manufacturing methods not covered by the claims.
Q2: How does the scope compare to other patents in the field?
This patent's scope is narrower compared to broad composition patents but provides targeted protection for specific drug combinations and formulations.
Q3: Is the patent enforceable in jurisdictions beyond Japan?
Enforcement depends on national patents derived from the family filings in the US, Europe, and China, which are granted or pending.
Q4: What are the main risks for licensees?
Main risks include patent expiry, potential patent challenges, or invalidation of specific claims in key jurisdictions.
Q5: How does this patent impact development timelines?
The patent supports ongoing R&D primarily by protecting formulations and manufacturing techniques but does not block discovery of alternative compounds or methods.
References
[1] Japan Patent Office, JP5719331. "Pharmaceutical composition," 2014.
[2] European Patent Office, EPXXXXXXX. Parallel family filings.
[3] United States Patent and Trademark Office, US201300XXXXXX. American filings.
[4] Patent Cooperation Treaty, PCT Application, 2012.
