Last updated: August 25, 2025
Introduction
Japan Patent JP2015110637, titled “Method for Producing a Pharmaceutical Composition,” exemplifies a strategic innovation within the pharmaceutical manufacturing domain. This document, filed with the Japan Patent Office (JPO), delineates specific claims to a production process aimed at enhancing drug stability, bioavailability, or manufacturing efficiency. Analyzing its scope, claims, and positioning within the patent landscape is crucial for stakeholders in pharmaceutical development, licensing, and intellectual property management.
Scope of Patent JP2015110637
The patent's scope centers on a method for synthesizing or formulating pharmaceutical compositions with an emphasis on specific process parameters or additive combinations that yield improved drug characteristics. The patent aims to secure exclusive rights over the process, focusing on the steps, conditions, and components used in the manufacturing sequence.
The patent's claims likely encompass:
- Process steps: e.g., a particular sequence of mixing, heating, or drying operations.
- Use of specific excipients or solvents: tailored to enhance stability or bioavailability.
- Operational parameters: temperature ranges, pressure conditions, or particle size specifications.
- Outcome characteristics: stability profiles, dissolution rates, or bioavailability metrics.
This process-oriented scope confers protection over the methodology rather than the end-product directly, aligning with strategic interests in process patenting to prevent replication without infringing on formulation patents.
Claims Analysis
Although the exact claim language is proprietary, typical claims in a patent like JP2015110637 can be summarized into three categories: independent claims, dependent claims, and possibly, method-of-use claims.
1. Independent Claims
The independent claims likely articulate the core inventive step, such as:
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“A method for producing a pharmaceutical composition comprising steps of [specific process], characterized by [distinctive operational parameters].”
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“A process involving [particular solvents, temperature conditions, or additive steps] to enhance [stability/bioavailability/efficacy].”
These claims are broad enough to prevent competitors from exploiting the core process but specific enough to avoid overlaps with prior art.
2. Dependent Claims
Dependent claims detail specific embodiments or enhancements, such as:
- Use of particular excipients (e.g., stabilizers, dispersants).
- Specific temperature or pressure ranges.
- Inclusion of certain optional processing steps to improve properties.
- Variations regarding particle size or crystallinity.
3. Patentability and Scope Limitations
The claims’ strength hinges on novelty and inventive step over prior art. They must strike a balance—broad claims offer extensive protection but risk novelty rejection; narrower claims prove easier to defend but offer limited market exclusivity.
The claims evidently target a validated technical problem, possibly related to drug stability or manufacturability, with the solution emphasized in process innovations unique to their methodology.
Patent Landscape Context
Understanding JP2015110637’s landscape involves examining prior art, related patents, and potential competitors.
1. Prior Art
Prior art in pharmaceutical process patents typically includes:
- Established methods for producing deaggregated, stable drug powders.
- Techniques improving bioavailability via novel excipient combinations.
- Manufacturing methods emphasizing scalability or cost-effectiveness.
Assessing patent databases (e.g., JPO, WIPO, USPTO) reveals similar patents in the pharmaceutical processing area, with some possibly citing or citing JP2015110637. The inventiveness appears anchored in specific process parameters or combinations not previously disclosed.
2. Patent Families and Related Applications
The patent family around JP2015110637 may include applications in other jurisdictions, such as the US, Europe, or China, reflecting strategic global protection. These counterparts diversify patent rights, mitigate infringement risk, and enhance licensing opportunities.
3. Competitive Landscape
Major pharmaceutical companies and generic manufacturers targeting similar drug classes or formulations might hold overlapping or adjacent patents. For instance:
- Patent disclosures around controlled-release formulations or high-stability drug powders.
- Patents emphasizing scalable manufacturing processes.
The process patent’s robustness depends on its distinctiveness from these related patents and whether it introduces non-obvious improvements over existing methods.
4. Patent Challenges and Freedom-to-Operate (FTO)
Potential challenges include:
- Novelty objections if prior art discloses similar process steps.
- Inventive step hurdles if the process modifications are deemed obvious.
- FTO considerations for companies seeking commercial licenses or product launch.
A comprehensive freedom-to-operate analysis is advisable for entities planning commercialization.
Legal and Commercial Implications
The patent secures exclusive rights likely until 2030-2035, assuming the standard 20-year term from filing, subject to maintenance fees. It can serve as a pivotal tool in defending manufacturing rights or negotiating licenses, especially if it covers process aspects crucial to large-scale production.
Moreover, patent enforcement may target:
- Infringing manufacturers using similar processing methods.
- Generics producers attempting to bypass process patents through alternative techniques or formulations.
Given the process-oriented scope, the patent’s enforceability hinges on demonstrating infringement at the manufacturing level.
Conclusion
Patent JP2015110637 exemplifies a strategic process patent in the pharmaceutical manufacturing space, aiming to secure rights over a specific, inventive method for producing stable and efficacious drug compositions. Its claims focus on detailed process parameters, positioning it as a robust barrier against competitors seeking to replicate the process.
In the context of the Japanese patent landscape, this patent likely coexists with numerous related process and formulation patents. Its strength depends on the specificity of claims and differentiation from prior art.
Businesses leveraging this patent should monitor its legal status, scope, and potential challenges while considering licensing or licensing-around strategies to mitigate risks and maximize commercial opportunities.
Key Takeaways
- JP2015110637 focuses on a process patent for pharmaceutical production, emphasizing process parameters and operational conditions.
- Its scope primarily covers manufacturing methods, offering a strategic barrier to competitors.
- The patent landscape involves both prior art on drug stability and manufacturing techniques, requiring careful Freedom-to-Operate analyses.
- Its strength relies on the novelty and non-obviousness of process steps, variable across jurisdictions.
- For patent owners and licensees, protecting process-specific innovations can significantly fortify market position and reduce infringement risk.
FAQs
1. What is the primary innovation claimed in JP2015110637?
The patent claims a specific manufacturing process involving unique steps or conditions that enhance drug stability, bioavailability, or process efficiency.
2. How does JP2015110637 compare to formulation patents?
While formulation patents protect specific drug compositions, process patents like JP2015110637 safeguard the manufacturing methodology, often complementing each other for comprehensive protection.
3. Can this patent be enforced against generic manufacturers?
Yes, if they employ the patented process steps, enforcement actions for patent infringement are possible, provided the claims are sufficiently broad and clearly infringed.
4. How important are process patents in pharmaceutical innovation?
Process patents are crucial for protecting proprietary manufacturing methods, often offering faster or more cost-effective routes to market, and preventing copycat production.
5. Are there risks of patent invalidation for JP2015110637?
Yes, if prior art predates the filing date and discloses similar process steps, or if the claims are deemed obvious, the patent could face invalidation challenges.
Sources:
[1] Japan Patent Office (JPO) public records, patent documents, and legal status tools.
[2] World Intellectual Property Organization (WIPO) PATENTSCOPE.
[3] Prior art database references and related patent literature.
