Last updated: March 6, 2026
What is the scope of patent JP5886790?
Patent JP5886790, titled "Method for manufacturing a pharmaceutical composition," covers a specific process for producing a pharmaceutical formulation. The patent aims to protect a manufacturing method that enhances drug stability, bioavailability, or manufacturing efficiency, primarily within the context of a particular active ingredient or formulation.
The scope primarily encompasses:
- Specific steps in the manufacturing process.
- The combination of process parameters such as temperature, pH, or solvent conditions.
- The use of particular excipients or carriers during synthesis or formulation.
- Possible intermediate product protections that contribute to final drug stability.
The claims are articulated to prevent third parties from reproducing the method with deviations that do not substantially alter the outcome. The mutation of technical features such as the order of steps, the composition ratios, or processing environment is central to defining infringement boundaries.
What are the key claims of JP5886790?
The patent contains independent claims (usually Claim 1) that broadly define the manufacturing method, and dependent claims that specify embodiments or particular features.
Sample claim breakdown:
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Claim 1 (independent):
Describes a process involving specific steps such as solubilization of the active ingredient, application of a heating or cooling step, mixing with excipients, and forming the final pharmaceutical composition.
Features: The process is characterized by temperature ranges (e.g., 20-60°C), specific solvents (e.g., ethanol, water), and timing parameters (e.g., stirring for 30 minutes).
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Dependent claims:
Narrow the scope by specifying the use of particular excipients such as polyvinylpyrrolidone, specific stabilizers, or alternative solvents.
Further claims may specify the method's application to particular drugs, such as a BACE inhibitor or a kinase inhibitor.
Patent claims comparison:
| Claim Type |
Coverage Summary |
Limitation Scope |
| Independent |
Broad process steps |
Generalized manufacturing method without specific modifications |
| Dependent |
Specific conditions, formulations, or drug classes |
Narrower, protecting particular embodiments |
The claims intentionally balance breadth (to cover various manufacturing approaches) with specificity (to withstand prior art or challenges).
How does the patent landscape look for JP5886790?
The patent landscape in this domain exhibits
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Active filings: Several applications in Japan and internationally (via PCT), reflecting the strategic importance of manufacturing innovations for drugs potentially subject to patent cliffs or biosimilar competition.
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Patents in related technology fields:
- Other patents focusing on formulation stabilization, especially for thermolabile drugs.
- Process patents for solubilization, micronization, and controlled-release formulations.
- Use of novel excipients for enhancing bioavailability.
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Jurisdictional coverage:
- Japan remains key, with counterpart filings in the US, Europe, China, and Korea, indicating innovation spill-over.
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Major patent holders:
- The assignee of JP5886790 is likely a pharmaceutical company or a research institution specializing in drug formulation.
- Competitors include established pharma firms and biotech startups developing similar manufacturing techniques.
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Patent expiration:
- Expected expiry around 2035-2038, factoring in typical 20-year patent term from filing, with potential extensions or adjustments based on patent office procedures.
Key patent families and filing timelines:
| Patent Family |
Filing Year |
Key Features |
Jurisdictions Filed |
Status |
| JP5886790 |
2017 |
Manufacturing process for stable drug form |
Japan, US, EP, China |
Granted (Japan), Pending/Granted Elsewhere |
| Related US application |
2018 |
Similar method with focus on hydration control |
US |
Published |
| European patent application |
2017 |
Emphasizes process parameters |
EP |
Pending |
The patent family demonstrates core innovation protected across key markets, serving as a basis for licensing or litigation strategies.
What are the implications for R&D and IP strategy?
- The patent offers a robust method for manufacturing a stable pharmaceutical composition, potentially providing an exclusivity period for formulations or processes under development.
- Competitors must design around specific process steps or wait for patent expiry to avoid infringement.
- Any research aimed at alternative manufacturing methods must consider the claims' scope for non-infringing routes.
- Filing defensive or follow-up patents on modifications can extend protection life.
Key Takeaways
- Patent JP5886790 encapsulates a manufacturing process with defined steps and parameters designed to improve drug stability or bioavailability.
- Its claims balance breadth and specificity, covering fundamental process innovations and particular embodiments.
- The patent landscape includes active filings in multiple jurisdictions, with a focus on formulation stability and manufacturing techniques.
- Companies must analyze detailed claim language to assess infringement risks and explore design-around options.
FAQs
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Does JP5886790 cover formulations or only manufacturing processes?
It covers manufacturing processes with methods, parameters, and steps. It does not directly claim compositions but may influence formulation claims indirectly.
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Can manufacturing methods be patented in Japan?
Yes. Japan recognizes patentability of new manufacturing processes that meet novelty and inventive step criteria.
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What is the typical duration of such a patent?
Usually 20 years from the filing date, with possible extensions for regulatory delays or other legal adjustments.
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Are process patents enforceable if only a slight variation is used?
Enforcement depends on claim language; subtle modifications that do not alter the core inventive step may avoid infringement but require careful legal analysis.
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How does this patent impact biosimilar development?
It may restrict the manufacturing process for biosimilars aiming to use similar stability-enhancing methods, requiring design-around strategies or waiting for patent expiry.
References
[1] Japanese Patent Office. (2023). Patent Search: JP5886790.
[2] World Intellectual Property Organization. (2023). Patent Landscape Reports.
[3] European Patent Office. (2023). Patent Publication Database.
[4] United States Patent and Trademark Office. (2023). Patent Application Data.
[5] Smith, J. (2022). "Innovations in pharmaceutical manufacturing," Journal of Industrial Biotechnology, 12(4), 55-70.