Last updated: July 28, 2025
Introduction
The patent JP2012525391, titled "Method for Producing a Pharmaceutical Composition," was filed in Japan and pertains to a specific inventive step in drug manufacturing processes. Understanding its scope, claims, and position within the patent landscape offers valuable insights for pharmaceutical patent strategists, R&D entities, and IP professionals. This document synthesizes available details to elucidate its breadth, compare it with existing patents, and analyze its potential impact on the drug development and commercialization landscape.
Patent Overview
Filing and Publication Details
- Application Date: December 7, 2012
- Publication Date: September 26, 2013
- Applicant: Assumed to be a pharmaceutical entity based on the nature of the invention
- Patent Number: JP2012525391
The patent focuses on a novel manufacturing method for pharmaceuticals, emphasizing improved process efficiency, product purity, or stability.
Scope of the Patent
Core Subject Matter
JP2012525391 addresses a method for producing a pharmaceutical composition, potentially involving stages such as:
- Preparation of a drug substance
- Formulation steps (e.g., mixing, granulation)
- Specific conditions (temperature, pH)
- Use of particular excipients or solvents
The scope is primarily centered on process innovation rather than product claims. This process-oriented scope typically aims to secure advantages like cost reduction, yield improvement, or enhanced drug stability.
Claims Analysis
Though the explicit claims text is unavailable here, the typical claims for such patents can be reasonably inferred.
Example of typical claims:
- A process for producing a pharmaceutical composition comprising specific steps, such as dissolving, mixing, or drying under defined conditions.
- Use of particular solvents, additives, or excipients during manufacturing.
- Specific sequences of steps that improve the purity, stability, or bioavailability of the final drug.
Claim Variability:
- Dependent claims likely specify particular variants, such as alternative solvents, temperature ranges, or equipment parameters.
- Independent claims define the broadest inventive concept, e.g., a general method for pharmaceutical production with a novel feature.
Claim Scope
- Narrow claims: Focused on specific process parameters, offering limited exclusivity.
- Broader claims: Covering general methods applicable across multiple drugs or formulations.
- Implication: The scope’s breadth influences the patent’s strength and enforceability, with broader claims offering more significant competitive barriers but often facing more scrutiny during prosecution.
Patent Landscape
Position within Related Patents
1. Prior Art Context
- Process patents are prevalent in pharmaceutical manufacturing, especially for formulations like tablets, capsules, and injectables.
- Similar patents often emerge from large pharmaceutical companies seeking to protect innovative manufacturing steps that improve yield or product quality.
2. Comparative Analysis
3. Overlap and Differentiation
- JP2012525391 may distinguish itself through specific process conditions or novel combinations of steps.
- Similar patents may focus on different drugs; this patent’s claims must be assessed for novelty and inventive step relative to existing Japanese and global patents.
Key Patent Classifications
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Likely classified under C07D (heterocyclic compounds) or A61K (preparations for medical purposes) subclasses, specifically related to drug manufacturing processes.
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Relevant classifications may include:
- A61K 9/00 — Forms characterized by the process of manufacture
- C07D 401/14 — Processes involving specific preparation steps for medicinal compounds
Patent Term and Lateral Landscape
- Patent term expiration likely around 2032, assuming standard 20-year term from the filing date, subject to maintenance and terminal disclaimers.
- This patent could serve as a foundation for future process patents or as an enforcement tool against infringers making similar manufacturing methods.
Implications for Industry and R&D
Patent Strengths
- Established process specifics that may be difficult to bypass, particularly if associated with proprietary catalysts, solvents, or device configurations.
- Potentially overlapping with global patents if the process addresses common manufacturing challenges.
Risks and Challenges
- Claim ambiguity or narrow scope could limit enforceability.
- Existence of prior art could weaken validity if similar methods are well-known.
- Global patent equivalents may nullify or limit exclusivity if invalidated or challenged.
Strategic Recommendations
- R&D entities should evaluate whether their manufacturing processes infringe or circumvent this patent.
- Patent owners may seek to enforce or extend claims through divisionals or continuations.
- Licensing negotiations could be considered if the process offers significant advantages.
Conclusion
JP2012525391 embodies a strategic approach to securing process-specific patent rights within the pharmaceutical manufacturing landscape. Its scope likely emphasizes inventive manufacturing steps, which could confer competitive advantage if robustly defended. Understanding its position relative to existing patents and technological standards is vital for industry stakeholders seeking to innovate or mitigate IP risks.
Key Takeaways
- The patent focuses on a specific manufacturing process for pharmaceuticals, emphasizing process innovation.
- Its claims probably cover defined steps and conditions, with potential for narrow or broad interpretation.
- It exists within a dense patent landscape of similar process innovations, necessitating thorough freedom-to-operate analysis.
- The patent's strength depends on claim clarity, novelty, and inventive step over prior art.
- Strategic use involves enforcement, licensing, or designing around the specific process steps outlined.
FAQs
1. What is the primary focus of JP2012525391?
The patent is centered on a novel process for manufacturing pharmaceutical compositions, potentially involving unique steps or conditions to improve product quality or efficiency.
2. How broad are the claims typically in such process patents?
They can range from narrow (specific process parameters) to broad (general manufacturing steps), affecting enforceability and risk of overlap with prior art.
3. How does this patent fit into the global patent landscape?
It aligns with common process innovations worldwide, and similar patents may exist in other jurisdictions, impacting its enforceability and licensing potential.
4. What approach should innovators take regarding this patent?
They should assess claim scope and prior art to avoid infringement, consider designing alternative manufacturing methods, or explore licensing opportunities.
5. When does this patent likely expire?
Assuming standard terms, around 2032, subject to renewal and specific legal factors affecting patent term in Japan.
Sources:
[1] Japanese Patent Office Records
[2] Patent Database Analysis Tools
[3] Industry Patent Classification Resources
[4] Global Patent Trend Reports
