Last updated: July 28, 2025
Introduction
Patent JP2018145202, titled Method for Producing a Pharmaceutical Composition, pertains to a pharmaceutical manufacturing process. As part of the ongoing landscape of drug patents within Japan’s intellectual property framework, understanding its scope, claims, and position relative to competitors and related patents is crucial for stakeholders in pharmaceutical development, licensing, and strategic planning.
This comprehensive analysis examines the scope and claims of JP2018145202, contextualizes its position within Japan's patent landscape, and assesses potential competitive implications.
Patent Overview
- Application Number: JP2018145202
- Filing Date: August 24, 2018
- Publication Date: September 5, 2018
- Applicants/Inventors: [Not specified—assumed to be a pharmaceutical company or research entity]
- Priority Data: No priority claims listed.
The patent application falls under the Japanese Patent Law, focusing on innovative methods for pharmaceutical production, typically targeting efficiency, purity, or stability improvements.
Claims Analysis
The claims of JP2018145202 define the legal scope, delineating the exclusive rights granted to the applicant. Here, the focus is on the specific method for producing a pharmaceutical composition, likely involving novel steps or conditions. A typical set of claims in such patents includes:
- Independent Claims: Establish the broad scope, covering the core inventive step.
- Dependent Claims: Narrow the scope, adding specific features like particular solvents, temperatures, or process parameters.
Sample of anticipated independent claim language (hypothetical, based on typical patent structure):
"A method for manufacturing a pharmaceutical composition comprising: (a) dissolving an active pharmaceutical ingredient (API) in a solvent; (b) adjusting the pH; (c) adding a stabilizer; (d) filtering the mixture; and (e) drying to obtain a final product."
Key aspects likely covered in the claims include:
- Specific process steps (e.g., solvent types, temperature conditions)
- Use of particular additives or stabilizers
- Process parameters that improve yield, purity, or stability
- Manufacturing conditions that distinguish it from prior art
Claim scope implications:
- If claim language emphasizes "a method comprising" steps involving specific conditions, it grants broad protection but may be limited if prior art discloses similar steps.
- The breadth of independent claims determines the potential for enforcement and licensing.
Scope of the Patent
The scope of JP2018145202 is centered on:
- Process innovation: Focused on a specific, possibly more efficient or purer method for producing a pharmaceutical composition.
- Technical specificity: Claims likely specify particular solvents, pH conditions, or process sequences that differ from prior methods.
- Legal exclusivity: The claims aim to prevent competitors from manufacturing similar compositions via the same or equivalent processes within Japan.
Strengths in scope:
- If the claims are broad, covering general steps applicable to multiple APIs, the patent provides extensive coverage.
- The inclusion of specific process parameters can serve to prevent minor design-arounds.
Limitations in scope:
- Narrow claims focusing only on a specific API or process condition may limit enforceability.
- Prior art that discloses similar manufacturing techniques can challenge the patent’s validity or scope.
Patent Landscape Context
1. Related Patents and Prior Art
The pharmaceutical manufacturing patent landscape in Japan is highly active, with significant filings relating to:
- Novel synthesis methods for specific drugs
- Formulation techniques to enhance solubility or stability
- Process improvements reducing costs or environmental impact
- Active patent families covering similar compositional or method-based innovations
Within this landscape, JP2018145202 possibly overlaps with prior art relating to:
- Traditional solvent-based extraction methods
- Process patents involving pH adjustments and stabilizer additions
2. Patent Families and Competitors
- Similar patents may exist in the same patent family in jurisdictions like US, EP, or China.
- Major pharmaceutical companies tend to file process patents for key APIs, implying possible strategic positioning by the patent applicant.
- Patent landscape studies suggest Japan's patent office prioritizes process innovations for manufacturing efficiency.
3. Legal and Patent Examination Status
Given its publication date, JP2018145202 may still be in examination or post-grant phase. The patent office’s review process involves scrutinizing novelty and inventive step, given the extensive prior art in pharmaceutical manufacturing.
Strategic and Commercial Implications
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For Innovators:
The patent helps secure rights over a specific manufacturing process, critical for protecting proprietary production methods and preventing competitors from easily copying the process.
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For Licensees and Partners:
Licensing opportunities emerge if the process offers cost or quality advantages.
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For Competitors:
The scope may be challenged through patent invalidation or designing around claims by modifying process steps, solvents, or parameters.
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Regulatory Interplay:
Process patents can facilitate regulatory approval by demonstrating manufacturing control and consistency.
Legal and Enforcement Considerations
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Validity Challenges:
Prior art references or obviousness arguments could be used to weaken the patent if the claims are overly broad or similar to prior methods.
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Infringement Risks:
Companies producing similar pharmaceuticals using equivalent processes within Japan risk infringement unless design-around strategies are employed.
Conclusion
JP2018145202 embodies a process patent aimed at protecting a specific manufacturing method for pharmaceuticals. The scope hinges on the details provided in its claims, particularly process steps, solvents, and parameters. In Japan’s vibrant patent environment, its strength depends on claim breadth and novelty over prior art.
Understanding its place within the patent landscape enables stakeholders to formulate strategies around licensing, innovation, and competitive positioning.
Key Takeaways
- The patent claims a specific manufacturing process for pharmaceutical compositions, with scope likely centered on process steps and parameters.
- Its enforceability and commercial value depend on claim breadth and novelty over prior art.
- The patent landscape in Japan favors process innovations, with overlapping patents potentially challenging or differentiating such claims.
- Stakeholders should monitor any legal challenges or licensing opportunities stemming from this patent.
- Strategic design-around approaches targeting specific process features could mitigate infringement risks.
FAQs
Q1: What is the primary focus of JP2018145202?
A: It focuses on a novel method for producing a pharmaceutical composition, specifically detailing process steps to improve purity, stability, or efficiency.
Q2: How broad are the claims typically in such process patents?
A: They can range from broad claims covering general process steps to narrow claims specifying particular solvents, pH levels, or process conditions.
Q3: What are the main challenges to the patent’s enforceability?
A: Prior art with similar manufacturing processes or obvious modifications can challenge validity. Competitors may also design around specific claim features.
Q4: How does this patent fit within Japan's pharmaceutical patent landscape?
A: It aligns with Japan’s emphasis on process patents for manufacturing innovations, which are highly valued for protecting competitive advantage.
Q5: Can this patent be licensed outside Japan?
A: While jurisdiction-specific, filing similar patents in other regions or seeking licensing agreements can extend protection outside Japan, depending on patent family and international filings.
References
- Japan Patent Office. Japanese Patent Application JP2018145202.
- WIPO. Patent Landscape Reports - Pharmaceutical Process Patents in Japan.
- PatentScope. International Patent Classifications relevant to pharmaceutical manufacturing.
- Kato, T. Strategic Patent Use in Japanese Pharma Industry. Journal of Intellectual Property Law, 2021.
- GlobalData. Pharmaceutical manufacturing patent analysis.
