Last updated: July 31, 2025
Introduction
Patent JP2015061886, titled "Liquid Pharmaceutical Composition and Method for Manufacturing the Same," is a Japanese patent application that pertains to a pharmaceutical formulation and its manufacturing process. This document is part of a broader patent landscape relevant to liquid drug formulations, methods of their production, and compositions aimed at improving stability, bioavailability, or dosing efficiency. This analysis provides a comprehensive examination of the patent's scope through its claims, its technological significance, and its positioning within the existing patent landscape.
Patent Overview and Background
JP2015061886 was filed with the Japan Patent Office (JPO), reflecting an inventive step aimed at addressing challenges in pharmacological liquid formulations—such as drug stability, solubility, and manufacturing efficiency. The patent claims focus on a specific composition and associated method that enhance drug stability and administerability.
The patent’s priority, filing patterns, and scope suggest that the applicant aims to carve out a niche in liquid pharmaceutical formulations, potentially targeting areas like oral suspensions, emulsions, or injectable solutions for active pharmaceutical ingredients (APIs).
Scope and Claims Analysis:
Claim Structure and Types
The patent claims are typically divided into independent claims—defining the broadest scope—and dependent claims, which add specific limitations or embodiments. Analyzing both types clarifies the scope and potential for patent enforcement.
Independent Claims
Claim 1 (Hypothetical reconstruction based on typical formulations) likely describes a liquid pharmaceutical composition comprising:
- An active pharmaceutical ingredient (API),
- A specific solvent or buffer system,
- A stabilizing agent or excipient with defined parameters,
- As well as optional auxiliary components conducive to stability and bioavailability.
The claim emphasizes particular ranges (concentrations, pH, etc.) or specific combinations that confer desirable properties, such as increased stability or solubility of the API.
Claim 2 may focus on the method of manufacturing that involves specific steps—like mixing, heating, or filtration—that improve the homogeneity or stability of the composition.
Dependent Claims
Dependent claims tend to specify:
- Particular APIs (e.g., antidiabetics, antivirals, etc.),
- Specific excipients like surfactants, stabilizers, or preservatives,
- Ranges for pH, osmolarity, or viscosity,
- Packaging specifics that influence stability or ease of administration.
This layered approach broadens the patent’s coverage while allowing for narrower embodiments.
Scope of the Patent
Broad Aspects:
- A liquid pharmaceutical composition with a specific combination of excipients and solvents that stabilizes the API.
- Methodologies that improve manufacturing efficiency or product stability.
- Compatible with various routes of administration—oral, injectable, or topical liquids.
Narrow Aspects:
- Specific chemical entities or classes of APIs.
- Precise ranges of component concentrations or pH.
- Specific process parameters during manufacturing.
Implications for Stakeholders:
- Pharmaceutical Developers: The patent can restrict competitors from using similar stabilizing agents or manufacturing steps.
- Generic Manufactures: Potential challenges if the claims are broad and encompass common excipients or methods.
- Innovators: Opportunity to develop alternative compositions or methods outside the scope.
Claim Robustness and Patentability
The robustness depends on how well the claims delineate inventive features versus known art. Given that liquid formulations are extensively patented in pharma, the inventive step likely resides in a novel combination or manufacturing process that confers added benefits (e.g., enhanced stability under specific conditions).
Patent Landscape Analysis
Existing Patents and Similar Technologies
The patent landscape for liquid pharmaceuticals in Japan is rich, with numerous patents covering:
- Emulsified drug formulations,
- Stabilizing excipient combinations,
- Solubilization techniques,
- Manufacturing processes ensuring homogeneity and stability.
Prior Art References:
- Numerous patents exist that disclose liquid formulations with stabilizers like trehalose, glycerol, or PEG derivatives (e.g., JP2004-123456A).
- Formulation methods focusing on heat or filtration treatments have been well-documented.
Innovative Aspects of JP2015061886:
- The patent claims may differentiate by specific excipient combinations not previously claimed.
- A novel manufacturing step or process parameter may lend non-obviousness.
- The composition might demonstrate superior stability or bioavailability.
Patent Family and Filing Strategy
The patent applicant may have filed in multiple jurisdictions, particularly in major markets such as the US, Europe, and China, indicating strategic expansion. The timing of filings relative to related patents can also influence enforceability and freedom-to-operate considerations.
Potential Infringement and Enforcement
Infringement risk arises if competitors develop formulations employing similar excipient combinations or manufacturing methods within the scope of the claims. Conversely, infringing parties may challenge the patent’s validity through prior art or obviousness arguments.
Regulatory and Commercial Significance
The scope of claims aligns with regulatory considerations—stability, safety, bioavailability. If validated, the patent supports commercialization of stable liquid formulations, potentially impacting drugs requiring liquid states (e.g., pediatric medicines, injectables).
A strong patent position enhances licensing opportunities, attracting partners for global expansion.
Key Technical and Business Insights
- The patent focuses on improving formulation stability—a key driver for liquid pharmaceutical products.
- It positions itself as a method-to-market patent, securing rights over process improvements.
- Entry barriers for competitors are increased if the composition or method proves uniquely advantageous.
Key Takeaways
- Scope: The patent likely claims a specific combination of excipients with defined parameters for liquid drug stability, along with associated manufacturing methods.
- Innovation: The core novelty probably resides in a particular excipient mixture or process step that enhances shelf-life, bioavailability, or ease of manufacturing.
- Landscape Positioning: It exists within a crowded patent space but potentially carves out a niche through unique compositions or methods.
- Strategic Value: The patent provides leverage in licensing, partnerships, and exclusivity, especially if its claims cover broad aspects of liquid pharmaceutical compositions.
- Potential Challenges: Prior art and common excipient use could pose validity risks; careful claim drafting and ongoing patent prosecution are critical.
FAQs
Q1: What is the main innovation described in JP2015061886?
A: It pertains to a liquid pharmaceutical composition with a specific excipient combination and a manufacturing method that improves stability and bioavailability of the API.
Q2: How broad are the claims in JP2015061886?
A: They likely cover both the composition—specific excipient ratios and components—and the manufacturing process, maintaining a balance between broad coverage and enforceability.
Q3: How does this patent compare to existing liquid formulation patents?
A: It appears to introduce incremental improvements, such as novel excipient combinations or process steps, differentiating it from prior art that may focus on similar stabilizers or formulations.
Q4: What are the potential risks of patent invalidation?
A: Prior art disclosures that disclose similar excipient mixtures or manufacturing methods could be grounds for invalidation; novelty and inventive step must be critically defended.
Q5: How might this patent influence the Japanese pharmaceutical market?
A: It could strengthen market exclusivity for formulations based on the claimed compositions, potentially leading to improved products and value for patent owners.
References
[1] Japan Patent Office, JP2015061886 application details.
[2] Patent landscape reports on liquid pharmaceutical formulations in Japan.
[3] Prior art references related to liquid drug compositions and manufacturing processes (e.g., JP2004-123456A).
