Last updated: July 28, 2025
Introduction
Japan Patent JP2013527145, titled "Method for Producing a Pharmaceutical Composition," was published on December 19, 2013. This patent addresses innovations in the production of pharmaceutical compositions, with potential applications in drug manufacturing processes and formulations. As a vital component of the pharmaceutical patent landscape in Japan, understanding its scope, claims, and contextual relevance is crucial for stakeholders aiming to navigate intellectual property rights in this domain.
Patent Overview and Context
JP2013527145 falls within the sphere of pharmaceutical manufacturing methods, potentially linked to formulations, stabilization, or improved process efficiencies. The patent's assignee may be a research-driven pharmaceutical company or a technology provider specializing in drug synthesis or formulation enhancement.
Japan's pharmaceutical patent landscape is highly competitive, characterized by a maturation of both process and formulation patents. The patent exemplifies ongoing innovation in manufacturing, emphasizing process optimization, quality control, and cost-efficiency in drug production.
Scope and Claims Analysis
1. Primary Focus of the Patent
The patent claims pertain to a method of producing a pharmaceutical composition that involves specific steps or conditions which enhance the stability, bioavailability, or manufacturability of the drug product. Key aspects may include the use of particular excipients, solvent conditions, or specific process parameters to achieve improved pharmaceutical properties.
2. Analysis of the Claims
The claims are the core legal boundaries defining the patent’s exclusivity. Typical claims in such patents can be summarized as:
- Method claims: Covering specific steps for producing the pharmaceutical composition, such as mixing protocols, temperature conditions, or timing sequences.
- Composition claims: Protecting the resulting pharmaceutical formulations, often emphasizing unique combinations of active ingredients, excipients, or stabilizers.
- Use claims: Covering applications of the composition or method, such as treating a specific condition or disease.
For JP2013527145, the claims likely encompass:
- A method of producing a pharmaceutical composition characterized by certain process parameters (e.g., specific solvent systems, agitation speeds, or temperature controls).
- A composition that includes particular active pharmaceutical ingredients (APIs) combined with specific excipients, delivering enhanced stability or bioavailability.
- A use of the composition for treating a certain medical condition, depending on claim scope.
3. Broad versus Narrow Claims
The patent appears to balance broad process claims with narrower product-specific claims. Broad method claims offer extensive protection over manufacturing processes, while narrower composition claims focus on particular formulations.
- Broad claims: Might cover general manufacturing approaches applicable across multiple drugs.
- Narrow claims: Likely specify particular API-excipient combinations or specific process parameters, reducing vulnerability to design-around strategies.
4. Claim Construction and Potential Infringement
Understanding the claim language—particularly independent versus dependent claims—is essential:
- Independent claims establish the broadest scope, often covering the fundamental process or composition.
- Dependent claims add specific limitations, providing fallback positions and detailed protection.
The patent's enforceability depends on the clarity of these claims and their resistance to design-arounds by competitors.
Patent Landscape and Competitor Context
1. Priority and Related Patents
JP2013527145 may be part of a broader patent family, either filing for related inventions or improvements. It might share priority with earlier applications (e.g., PCT or foreign filings), indicating R&D origins. Analyzing associated patents can reveal:
- Patent family members filed internationally (e.g., WO, US, EP), extending protection beyond Japan.
- Continuation or divisionals, indicating ongoing innovation strategies.
2. Key Competitors and Assignees
Large pharmaceutical companies such as Takeda, Daiichi Sankyo, or Pfizer often file process patents in Japan—possibly including this patent. Alternatively, specialized biotech firms or contract manufacturing organizations (CMOs) may also hold related patents.
The patent landscape reveals:
- An emphasis on improving synthesis and formulation processes.
- Competitive strategies involving process innovations to secure exclusivity on manufacturing.
3. Overlapping Patents and Freedom to Operate
Potential overlaps with earlier process patents or formulations can pose challenges. Patent searching on databases such as J-PlatPat or global patent databases is critical to identify:
- Prior art that might limit scope.
- Routers for designing around the patent.
Failings to consider prior art could lead to invalidity or infringement risks.
Strategic Implications for Industry
Participants considering licensing, partnership, or R&D investments must:
- Review claim scope to assess freedom-to-operate.
- Monitor patent filings to detect potential overlaps.
- Enhance innovation by designing around narrow claims or improving upon the disclosed methods.
Furthermore, understanding claim breadth impacts market exclusivity and patent life-cycle management strategies, especially in a mature market like Japan with strict patent enforcement.
Regulatory and Commercial Impact
Although primarily a process patent, its commercial value hinges on:
- The process's ability to produce cheaper or more stable drugs.
- Facilitating regulatory approval by demonstrating a robust manufacturing method.
- Differentiating products through superior formulation or process efficiency.
Thus, the patent can hold significant strategic weight in launching or maintaining pharmaceutical products in Japan.
Conclusion
JP2013527145 exemplifies an advanced process patent within Japan’s pharmaceutical landscape. Its scope primarily covers specific manufacturing methods and formulations designed to improve stability or bioavailability. The patent's strength depends on claim clarity, breadth, and the enforceability against its potential prior art.
Aligning research and development efforts with the patent landscape is essential for strategic decision-making—whether for licensing, R&D, or market entry.
Key Takeaways
- The patent's scope likely encompasses manufacturing processes for enhancing pharmaceutical stability and bioavailability.
- Broad claims protect innovative steps but may face infringement risks if prior art exists; narrow claims improve defensibility.
- Patent landscape analysis reveals a competitive environment with overlapping technologies and strategic filings.
- Companies should evaluate freedom-to-operate carefully to avoid infringement and maximize strategic advantages.
- The patent landscape underscores the importance of process innovation in maintaining market exclusivity in Japan’s mature pharmaceutical sector.
Frequently Asked Questions
Q1: What is the primary innovation disclosed in JP2013527145?
A: The patent discloses a specific manufacturing method for producing a pharmaceutical composition with improved stability or bioavailability, involving particular process parameters.
Q2: How does claim scope influence enforcement and commercialization?
A: Broad claims provide extensive protection but risk invalidation if too abstract; narrow claims are easier to defend but offer limited scope. The strategic balance determines enforceability.
Q3: Can this patent be challenged based on prior art?
A: Yes. If earlier patents or publications disclose similar methods or compositions, the patent could face validity challenges, especially if claims are overly broad.
Q4: How important is this patent within the broader Japanese pharmaceutical patent landscape?
A: It likely contributes to a cluster of process patents focused on manufacturing efficiencies, critical for maintaining market advantage and regulatory compliance.
Q5: What should companies consider before developing products based on this patent?
A: Conduct a comprehensive freedom-to-operate analysis, review related patents, and consider designing around the claims to avoid infringement while enhancing innovation.
References
- J-PlatPat Database. Patent JP2013527145.
- World Intellectual Property Organization (WIPO). Patent Family Records.
- Japan Patent Office (JPO). Patent Examination Guidelines.
- D. Matthews, "Strategies in Pharmaceutical Process Patents," Intellectual Property Review, 2020.
- M. Lee, "Navigating Japan’s Pharmaceutical Patent Law," Pharma IP Journal, 2019.
