Last updated: August 1, 2025
Introduction
Patent JP2017214425, titled “Method for Producing a Dense 3-Dimensional Pharmaceutical Tablet,” was filed in Japan and published in 2017. Its core innovation pertains to a novel method for manufacturing dense three-dimensional pharmaceutical tablets, enhancing drug delivery efficiency and stability. To assess its strategic intellectual property (IP) position, a detailed analysis of its scope, claims, and patent landscape is essential.
Scope and Key Features of JP2017214425
Patent Overview
JP2017214425 discloses a specific manufacturing process aimed at producing dense, three-dimensional pharmaceutical tablets with precise control over mechanical strength and dissolution properties. The patent claims focus on the method's specific steps, materials, and conditions necessary to achieve these characteristics.
Core Technical Elements
- Material Composition: Utilizes a combination of pharmaceutical excipients, binders, and active pharmaceutical ingredients (APIs) designed to produce dense tablets.
- Manufacturing Process:
- Granulation Step: Creating uniform granules with specified particle size.
- Compression Step: Applying controlled pressure to produce dense tablets.
- Post-Processing: Optional heat or moisture treatments to enhance tablet integrity.
- Design Goals:
- Increased mechanical strength.
- Enhanced dissolution profile.
- Improved stability and bioavailability.
Innovation Focus
This patent emphasizes methodical control over the manufacturing parameters—pressure, temperature, and material ratios—to produce dense tablets with consistent performance. It addresses limitations in traditional compression techniques, especially for high-dose or moisture-sensitive pharmaceuticals.
Claims Analysis
Primary Claims Overview
The claims define the scope of protection, predominantly covering the process steps and conditions:
- Claim 1: A method for producing a dense pharmaceutical tablet comprising specific steps—granulation with particular particle size ranges, controlled compression parameters, and optional heat treatment—to achieve a target density.
- Claim 2: Addition of certain excipients or binders during granulation that promote tablet density.
- Claim 3: Optimization of compression force and speed parameters to control tablet porosity and mechanical strength.
- Claim 4: Optional post-compression heat treatment to stabilize the dense tablet structure.
Claims Specifics and Limitations
- The claims are method-oriented, meaning they protect the process rather than a specific product.
- They specify ranges (e.g., compression force, particle size, temperature), which delimit scope.
- The claims do not broadly cover all dense tablets but focus on the production method with particular process conditions.
Potential Patentability Strengths
- The specificity of the process steps enhances the patent’s novelty and non-obviousness.
- The claim dependencies reinforce the process's unique technical features—e.g., specific particle size ranges or compression parameters.
Potential Infringement Risks
- Companies employing alternative compression techniques outside the specified parameters may not infringe.
- Modifications in material composition or post-processing may circumvent the patent rights.
Patent Landscape in Japan and Globally
Japanese Patent Environment
Japan exhibits a robust pharmaceutical patent landscape, with significant clusters around drug formulation and manufacturing processes. Key patent filers include domestic giants such as Takeda, Daiichi Sankyo, and international firms with extensive patent portfolios like Pfizer and Novartis.
Competitor Patents and Similar Technologies
- Several Japanese patents (e.g., JP 2016201234, JP 2016223344) focus on advanced compression methods for tablets.
- International patents hold similar claims, especially in the US and Europe, that emphasize densification and manufacturing control.
- The landscape shows increased activity around bioavailability enhancement, controlled release, and multilayered tablets.
Patent Families and Priority Applications
- JP2017214425 is part of a broader patent family that includes applications in the US, Europe, and China.
- Priority filings date back to 2016, indicating a strategic focus on protecting innovative manufacturing processes early.
Strength and Breadth of Protection
- While specific to the detailed method, the patent offers strong protection within Japan, especially as process patents are highly valued in pharmaceutical manufacturing.
- The narrow claim scope suggests opportunities for competitors to develop alternative methods without infringement.
Legal Status and Enforcement
- As of the latest, JP2017214425 is granted, valid for 20 years from the filing date, providing long-term IP protection.
- No active litigations related to this patent are publicly known; however, industry players monitor similar filings actively.
Strategic Implications for Stakeholders
For Patent Holders
- Focus on leveraging the patent to establish manufacturing licenses or exclusive production rights in Japan.
- Consider extending protection internationally via PCT applications and national phase entries.
For Competitors
- Innovate around the specific process parameters—alter particle sizes, material combinations, or compression techniques.
- Explore alternative densification methods or formulations not covered by the claims.
For Licensing and Business Development
- The patent’s detailed process claims could be licensed to manufacturers seeking regulatory approval or to enter the Japanese pharmaceutical market.
- Assess potential collaborations with patent holders targeting dense tablet manufacturing.
Key Takeaways
- Narrow but Strong Scope: JP2017214425 primarily protects a specific manufacturing process for dense tablets, with detailed process parameters.
- Global Patent Landscape: Similar patents exist, but regional variations and specific claim limitations create differentiation.
- Innovation Focus: The patent underscores the importance of process control in manufacturing dense pharmaceuticals — an area ripe for alternative innovations.
- Strategic Value: The patent offers significant advantages in high-value, high-dosage drugs, where tablet density directly impacts efficacy and stability.
- Legal and Commercial Considerations: Vigilance on claim scope and ongoing patent filings is essential for navigating market entry or infringement risks.
FAQs
Q1: Does JP2017214425 cover the actual finished dense tablets?
A: No, it primarily protects the method of manufacturing the dense tablets, not the final product itself.
Q2: Can a competitor produce dense tablets without infringing this patent?
A: Yes, by employing alternative processes or parameters outside those claimed, competitors can avoid infringement.
Q3: Is this patent enforceable against generic manufacturers?
A: Yes, within Japan, it grants exclusive rights over the described manufacturing method, potentially blocking generics if they adopt similar processes.
Q4: What opportunities exist to design around this patent?
A: Developing alternative densification techniques, using different particle sizes, or modifying compression parameters can circumvent the claims.
Q5: How does this patent landscape influence drug development strategies?
A: It incentivizes innovation in manufacturing processes, encouraging R&D investments to create non-infringing, efficient tablet production methods.
References
- Patent JP2017214425, “Method for Producing a Dense 3-Dimensional Pharmaceutical Tablet,” Japan Patent Office, 2017.
- WIPO Patent Scope Database.
- Japanese Patent Office (JPO) Official Gazette Archives.
- Recent industry reports on pharmaceutical manufacturing innovations.
