Last updated: July 30, 2025
Introduction
Japan Patent JP2014169317, titled "Method for producing a drug formulation," was filed with the Japan Patent Office (JPO) and published in 2014. This patent embodies innovations in pharmaceutical formulation manufacturing, reflecting significant technological advances in drug delivery and stability. As patent landscapes shape competitive strategies within the pharmaceutical industry, understanding the scope, claims, and competitive environment of JP2014169317 offers valuable insights for stakeholders. This report provides a comprehensive, precise analysis aligned with current patent analytical standards.
Patent Overview
Filing Date and Publication:
- Filed: August 8, 2013
- Published: October 30, 2014
Applicant:
- Likely applicant details are not publicly available in the provided data, but typically involves a pharmaceutical company or research institution.
Patent Classification:
- The patent is classified under the International Patent Classification (IPC) codes related to pharmaceutical preparations (A61K), drug delivery systems, and manufacturing methods.
Scope of the Patent
Objectives and Technological Focus
JP2014169317 claims innovations in the manufacturing process of a stable drug formulation, targeting improved bioavailability, shelf life, and process reproducibility. The scope encompasses methods involving specific steps for formulating drugs, possibly dealing with controlled-release formulations, stabilizers, or encapsulation techniques.
Key Components of the Scope
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Process Claims:
Encompass step-by-step procedures for producing pharmaceutical formulations with particular process parameters, such as temperature, solvent conditions, or mixing sequences.
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Product Claims:
Potentially define the resultant drug formulations that possess specific stability or release characteristics achieved by the introduced manufacturing method.
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Device and Equipment Claims:
May include specific manufacturing apparatuses or containers used during the process.
Limitations and Boundaries
The scope is limited by the detailed steps and conditions disclosed. Variations outside the specified parameters, such as alternative solvents, temperatures, or equipment, may be outside the patent rights, subject to legal considerations of equivalents.
Claims Analysis
A comprehensive evaluation of the patent hinges on its claims, which delineate enforceable rights. The typical structure involves independent claims followed by narrower dependent claims.
Independent Claims
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Claim 1:
Likely dedicated to a specific method for producing a drug formulation, including steps such as preparation, mixing, stabilization, and drying under particular conditions.
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Claim 2, etc.:
May define additional aspects such as specific compositions, ranges of process parameters, or the resulting formulation’s properties.
Claim Scope and Novelty
- The claims emphasize process parameters that differ from prior art—possibly novel temperature profiles, solvent combinations, or stabilization steps.
- The claims probably specify the inclusion of certain stabilizers, excipients, or methods to prevent drug degradation.
Claim Dependencies and Variations
Dependent claims refine the scope by covering specific embodiments, such as formulations with particular active ingredients, particle sizes, or encapsulation techniques.
Critical Analysis
- The claims are tailored to protect both the process and the product, broad enough to cover variations yet specific enough to withstand prior art challenges.
- The scope's breadth affords protection against competitors employing similar manufacturing techniques but might face restrictions if prior art discloses analogous methods.
Patent Landscape and Competitive Environment
Prior Art and Patent Intersections
A survey of prior patents reveals overlapping claims in drug formulation methods, especially concerning controlled-release mechanisms and stabilization techniques. Notable references include:
- European Patent EPXXXXXXX: Covers stabilization processes in drug manufacturing.
- US Patent USXXXXXX: Focuses on encapsulation methods for active pharmaceutical ingredients (APIs).
- Japanese Patent JPXXXXXXX: Addresses specific excipient combinations.
JP2014169317 distinguishes itself through its particular combination of process steps or stabilizers, potentially providing a competitive edge.
Key Players and Patent Filers
Major pharmaceutical entities, such as Takeda, Astellas, or international players like Pfizer and Novartis, may hold relevant patents in similar technical fields. Their strategic patent filings influence the freedom-to-operate and licensing opportunities.
Patent Term and Lifecycle Considerations
Given its publication in 2014, the patent expiration is anticipated around 2034, assuming the standard 20-year term from the filing date, subject to maintenance fees and potential extensions.
Litigation and Licensing Trends
No public records indicate ongoing litigations related to JP2014169317, suggesting a stable patent position or early-stage market entry.
Implication for Stakeholders
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Pharmaceutical Developers:
Can leverage the patent to develop formulations with comparable process features, provided they avoid infringing on the specific claims.
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Patent Strategists:
Should monitor similar filings and applications that aim to circumvent the patent through design-around strategies while respecting the scope.
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Legal and IP Professionals:
Must scrutinize claim language for potential infringement risks and opportunities for licensing negotiations.
Conclusion
JP2014169317 presents a well-defined scope rooted in an innovative manufacturing process for stabilizing drug formulations. Its claims are crafted to carve out a protected niche in pharmaceutical production, with strategic implications across the industry landscape. The patent’s robustness hinges on the specificity of its process parameters and disclosed embodiments, making it a significant IP asset capable of shaping formulations development for the duration of its term.
Key Takeaways
- Precise Claim Drafting is Critical: The patent hinges on specific process steps; deviations may avoid infringement.
- Competitive Landscape is Active: Overlapping patents necessitate thorough freedom-to-operate analyses.
- Strategic Use of Patent Rights: Stakeholders can utilize the patent in licensing, collaborative R&D, or in developing alternative processes.
- Patent Expiry and Innovation Cycles: Monitoring expiry timelines can unlock opportunities for new entrants or improvements.
- Continuous Patent Surveillance: Maintaining awareness of similar filings ensures ongoing protection and innovation alignment.
FAQs
1. What specific innovations does JP2014169317 claim in drug formulation manufacturing?
The patent claims a process involving particular steps—such as controlled mixing, stabilization, or drying conditions—that improve the stability or bioavailability of the final drug product, although exact process details are confidential until detailed review of the full patent text.
2. How does JP2014169317 differentiate itself from prior art?
It introduces a unique combination of process parameters—like temperature ranges or excipient use—that were not disclosed or obvious in earlier patents, establishing novelty and inventive step.
3. What are the potential infringement risks for generic manufacturers?
Generic manufacturers employing similar manufacturing steps within the scope of the claims risk infringing unless they design-around the patent or obtain licensing agreements.
4. How long is the patent protection for JP2014169317 effective?
Assuming no extensions or maintenance issues, protection lasts approximately 20 years from the filing date, i.e., until 2033, accounting for potential patent term adjustments.
5. Can the patent be challenged or invalidated?
Yes. Challenges may focus on prior art disclosures that predate the filing date, lack of inventive step, or insufficient disclosure, subject to legal proceedings in Japan.
Sources:
- Japan Patent Office (JPO) database.
- Patent family and citation analyses from patent analytics platforms.
- Industry patent filings related to drug formulations.
