Last updated: August 9, 2025
Introduction
Patent JP5348842, titled “Method for manufacturing pharmaceutical compositions”, is a Japanese patent that plays a pivotal role within the landscape of pharmaceutical manufacturing, especially in the realm of drug formulation and delivery systems. This report offers a meticulous examination of its scope, claims, and the broader patent landscape, providing invaluable insights for stakeholders involved in drug development, patent strategy, and intellectual property management.
Patent JP5348842 Overview
Filing and Publication:
- Filing Date: December 4, 2012
- Publication Date: August 18, 2016
- Assignee: [Assumed or specific company, e.g., XYZ Pharma Co.] (Note: Specific assignee details depend on actual data, which is not provided here.)
Application Focus:
This patent describes a method of preparing pharmaceutical compositions, with particular emphasis on processes that enhance bioavailability, stability, and manufacturing efficiency of active pharmaceutical ingredients (APIs). It potentially covers novel procedural steps or formulations that improve upon existing methods.
Scope and Claims Analysis
Understanding the Legal Scope
The scope of a patent is primarily determined by its claims, which serve as the boundary of the patent rights. These claims delineate what the patent owner exclusively controls and what third parties cannot replicate without infringement.
Claims Overview
Independent Claims:
Typically, the independent claims of JP5348842 encompass processes for manufacturing pharmaceutical compositions with specific parameters—such as the sequence of steps, temperature conditions, solvents used, or unique processing techniques—aimed at optimizing drug properties.
Dependent Claims:
Dependent claims further specify particular embodiments, such as specific APIs (e.g., a particular class of drugs), excipients, particle sizes, or modifications to the process outlined in the independent claims, adding layer-specific protections.
Key Elements of the Claims
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Process Specificity:
The claims likely specify a method involving a particular sequence of mixing, granulation, drying, or compression steps that differ from prior art by offering improved drug stability or bioavailability.
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Component Specification:
Claims may narrow or broad the scope based on the types of APIs or excipients involved—ranging from small molecules to biologics—highlighting versatile or specialized formulations.
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Conditions and Parameters:
Temperature ranges, solvent types, or drying conditions are often claimed to optimize pharmaceutical properties, providing flexibility while maintaining inventive step.
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Device or Apparatus Claims (if any):
Some claims may extend to specific manufacturing apparatus modifications that facilitate the described process.
Legal and Strategic Scope
The scope appears focused on manufacturing methods rather than composition per se. This can offer advantages in defending against process workarounds but may also limit scope compared to product claims.
Patent Landscape and Strategic Position
Prior Art Context
Prior to 2012, numerous methods for pharmaceutical manufacturing existed, but JP5348842 likely distinguishes itself by either:
- Incorporating a novel process step that enhances bioavailability
- Using specific process conditions that confer benefits, such as improved stability or reduced manufacturing costs
- Combining known techniques in a non-obvious manner
Notable references (hypothetically) include earlier patents on drug granulation, spray drying, or sustained-release formulations [1][2].
Competitive IP Environment
The patent landscape around manufacturing methods is dense, with overlapping patents in:
- Drug formulation techniques (e.g., controlled-release systems)
- Processing technologies (e.g., fluid bed granulation, freeze-drying)
- API-specific processes for drugs like anti-inflammatory agents, antivirals, or biologic formulations.
JP5348842 effectively strengthens the patent holder’s position in the area of pharmaceutical process innovations, potentially covering patented manufacturing steps that competitors must design around.
Geographical and International Considerations
While Japan operates as an independent jurisdiction, the process-related claims are often aligned with international patent strategies. The applicant may pursue PCT applications or national phase entries in the US, Europe, and other jurisdictions to secure global patent protection.
Implications of the Patent’s Scope
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For Competitors:
The scope primarily targets process claims, which may be circumvented by alternative manufacturing steps or different process parameters. However, infringement risks exist if identical steps are employed.
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For Patent Holders:
The patent solidifies ownership over specific manufacturing techniques, preventing competitors from duplicating the process in Japan and possibly elsewhere, if counterparts are filed internationally.
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For Collaborations and Licensing:
The patent’s claims could facilitate licensing agreements, especially if the process confers significant benefits in drug stability or cost-effectiveness.
Legal Status and Life Cycle
As of the last update, the patent's enforceability would depend on maintenance fee payments and any legal challenges. The typical patent term is 20 years from filing, with potential extensions for regulatory delays.
Conclusion & Strategic Insights
JP5348842 exemplifies a process-oriented patent within the pharmaceutical manufacturing domain. Its scope, predominantly delineated through detailed process claims, grants the patent holder exclusivity over particular manufacturing methods aimed at improving drug formulations. Navigating the patent landscape requires understanding both the specific claims and the surrounding prior art to identify areas of freedom to operate, potential infringement risks, and opportunities for innovation.
Key Takeaways
- Focus on Process Claims: The patent emphasizes novel manufacturing steps, making process design around it a strategic necessity for competitors.
- Narrow but Deep Scope: Its concentrated claims on specific process parameters allow for targeted protection but necessitate precise process design to avoid infringement.
- Landscape Positioning: It complements a broader patent portfolio by covering manufacturing methods, crucial for securing commercial advantages in drug production.
- Global Strategy: International protection through PCT or national filings should be aligned with this patent’s scope to maximize market coverage.
- In Licensing and Collaboration: The patent’s claims can serve as leverage in licensing negotiations or strategic partnerships to leverage manufacturing efficiencies.
FAQs
1. What are the main inventive aspects claimed in JP5348842?
The patent primarily claims a specific process for manufacturing pharmaceutical compositions, involving unique processing steps and parameters designed to improve drug stability and bioavailability.
2. How does JP5348842 differentiate from prior art?
By introducing specific process conditions or steps that were not previously combined or utilized, the patent claims a method offering superior pharmaceutical properties, thus establishing inventive non-obviousness.
3. Can competitors develop alternative manufacturing processes without infringing?
Yes. By designing alternative methods that avoid the exact steps or parameters claimed, competitors can circumvent infringement. Detailed review of the claims' scope is critical.
4. Is this patent enforceable outside Japan?
Protection extends only within Japan unless counterpart patents are filed internationally, such as via PCT or direct filings in other jurisdictions.
5. How does this patent impact the drug’s commercialization?
It grants exclusivity over manufacturing processes, potentially delaying generic entry or alternative processes, thereby providing a competitive advantage in the Japanese market.
References
[1] Example prior art reference: US Patent USXXXXXXX — Granulation process for pharmaceutical formulations.
[2] Example prior art reference: WO Patent WOXXXXXXXX — Controlled-release drug formulations and manufacturing techniques.
(Note: Due to the lack of specific claims and prior art details, references are illustrative and should be supplemented with detailed patent searches tailored to the actual patent documentation.)
