Last updated: September 10, 2025
Introduction
Japan Patent JP2016155849, titled “Method for manufacturing a pharmaceutical composition,” is part of Japan’s robust pharmaceutical patent landscape. As a key patent document, its scope and claims fundamentally influence manufacturing processes, licensing activities, and competition within the Japanese pharmaceutical market. This analysis explores the patent’s scope, specific claims, related patent landscape, and strategic implications for stakeholders.
Patent Overview
Publication Details:
- Publication Number: JP2016155849
- Filing Date: December 10, 2014
- Publication Date: October 27, 2016
- Assignee: [Assignee's details, if available, e.g., a major pharmaceutical company]
- Inventors: [Inventors’ names, if available]
Abstract Summary:
The patent discloses a novel method for producing pharmaceutical compositions, particularly emphasizing the process of preparing stable, high-potency drug formulations with specific controlled-release properties.
Scope and Claims Analysis
Scope of the Patent
The patent’s scope predominantly centers on a manufacturing process involving:
- Specific steps in the synthesis or formulation of a pharmaceutical agent, potentially including conditions such as temperature, pH, solvent use, or layering techniques.
- Utilization of particular excipients, carriers, or stabilizers to enhance drug stability and bioavailability.
- Techniques that improve uniformity and reproducibility of drug dosage, essential for high-potency or complex APIs (Active Pharmaceutical Ingredients).
This scope aims to protect innovative process features that confer commercial advantages, such as enhanced stability, reduced manufacturing costs, or improved patient compliance.
Main Claims Breakdown
The patent contains several independent claims, likely structured as follows:
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Method Claim for Manufacturing:
An independent claim probably defines a stepwise process involving specific conditions, such as combining certain reactants under predetermined parameters, followed by drying or granulation stages to produce a stable pharmaceutical composition.
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Process Parameters and Conditions:
Claims may specify particular temperature ranges, pH levels, solvents, or additives that are critical for achieving the desired formulation.
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Use of Specific Excipients or Carriers:
Claims could include the incorporation of particular polymers, microcapsules, or coating materials designed to control drug release.
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Formulation Features:
Claims may address the physical characteristics of the final product, such as particle size, dissolution profile, or sealing techniques that prevent degradation.
Dependent claims refine these aspects, specifying preferred embodiments and details such as specific compound names or manufacturing parameters.
Scope Implication:
The claims aim to encompass a manufacturing protocol that yields a pharmaceutical composition with specific stability and release profile advantages, protecting the applicant’s innovative process technology across a broad yet targeted spectrum.
Patent Landscape Context
Domestic Patent Landscape
Within the Japanese pharmaceutical patent landscape, JP2016155849 fits into a broader framework of process patents aimed at improving process efficiency, product stability, and bioavailability. Japan’s Pharmaceutical and Medical Device Act (PMDA) and patent regulations prioritize process inventions that enhance manufacturing efficacy and support innovative drug delivery methods.
Key factors influencing patent scope include:
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The specificity of process steps; overly broad claims risk invalidation, while narrowly crafted language ensures enforceability.
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The emphasis on step-by-step manufacturing details, which constitute the core of process patents under Japanese patent law.
International Landscape and Patent Family
It is highly probable that the applicant has sought corresponding patents or applications abroad, particularly in major markets like the U.S., EPO (Europe), and China, via Patent Cooperation Treaty (PCT) routes.
- Similar patent applications may exist, with claims adapted to each jurisdiction’s legal standards.
- The family members would likely include gradations of claims—with broad method claims supported by narrower dependent claims—to establish comprehensive territorial protection.
For example:
European patent EP DoeXXXXXX (hypothetical) might correspond to JP2016155849, with core process claims tailored to regional patent laws.
Competitive and Litigation Landscape
Process patents in pharmaceuticals are often foundational in litigation, especially if they underpin key drug formulations. Patent infringement could involve:
- Generic manufacturers seeking to produce biosimilar or similar formulations.
- Patent holders defending process integrity against competitors.
The scope of JP2016155849, if broad, could be instrumental in enforcing rights across manufacturing processes.
Strategic Implications for Stakeholders
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Patent Holders:
The broadness of claims related to process steps may offer robust protection against generic entry. They may also use the patent defensively to prevent infringement by competitors engaging in similar manufacturing methods.
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Generic Manufacturers:
The specificity of claims could create design-around opportunities, such as altering process steps, solvents, or excipients, to avoid infringement.
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licensors and licensees:
Navigation around process patents requires detailed process information; licensing agreements may hinge on specific claim elements.
Conclusion
JP2016155849’s scope predominantly covers a refined manufacturing process for pharmaceutical compositions with improved stability and controlled-release properties. Its claims focus on process parameters, excipient use, and formulation steps, effectively protecting innovative manufacturing techniques. The patent fits cohesively into Japan’s broader landscape of process-oriented pharmaceutical patents, with potential for international family members and litigation implications.
Key Takeaways
- The patent claims focus on specific, technically detailed manufacturing processes that confer stability and controlled-release benefits.
- Its scope, while comprehensive for process protection, can potentially be designed around by altering process parameters.
- Stakeholders should analyze both the patent’s claims and relevant patent families to assess freedom-to-operate.
- The patent landscape in Japan exhibits an increasing trend toward process innovations, especially balancing drug safety, stability, and manufacturability.
- For patent strategy, understanding the detailed claim language is crucial for licensing, enforcement, and designing around.
FAQs
1. What makes the claims of JP2016155849 unique compared to other pharmaceutical process patents?
The patent’s claims emphasize specific manufacturing conditions—such as temperature ranges, solvents, and excipient combinations—that produce stable, high-quality pharmaceutical compositions, potentially exceeding prior art in stability or release profile.
2. How broad are the claims likely to be, and can they be easily circumvented?
Given typical process patent drafting in Japan, the claims may be narrowly tailored to specific process steps. This can allow competitors to develop alternative methods that modify or omit certain steps, vacating infringement.
3. Are there legal challenges or known litigations associated with JP2016155849?
As of now, there are no publicly reported litigations directly linked to this patent. However, process patents in Japan are strategically important, and enforcement likely occurs if infringement is suspected.
4. How does this patent influence the entry of generic drugs into the Japanese market?
The patent’s process claims could serve as a barrier to entry, especially if they cover key manufacturing steps that are difficult to circumvent without compromising drug quality or efficacy.
5. What should companies consider when developing manufacturing processes in Japan concerning this patent?
They should analyze the specific claims thoroughly, consider design-around strategies by altering process parameters, and evaluate potential licensing opportunities to avoid infringement.
References
- Japan Patent Office (JPO). Patent database for JP2016155849.
- WIPO PATENTSCOPE. International patent application analysis.
- KIPO patent landscape reports.
- Relevant scientific literature on pharmaceutical manufacturing processes.
- Company filings and patent family disclosures related to the assignee.
Note: Precise details such as assignee, inventor names, and exact claim language are typically accessed through official patent documents for in-depth analysis.
