Last updated: February 24, 2026
What does JP2018507891 cover in scope?
JP2018507891 relates to a pharmaceutical composition and its manufacturing method aimed at improving drug stability and bioavailability. The patent claims focus primarily on formulations containing a specific active pharmaceutical ingredient (API) combined with particular excipients.
The patent explicitly covers:
- Pharmaceutical compositions comprising a specified API, a stabilizing agent, and a carrier.
- The use of certain excipients to enhance API stability.
- Methods for preparing such formulations with claims emphasizing process steps that ensure API uniformity and stability.
- Therapeutic applications, notably in the treatment of a specified disease (details not provided in the brief summary).
The scope emphasizes formulations that improve pharmacokinetics and chemical stability, which addresses common issues for drugs with labile APIs.
What are the key claims of JP2018507891?
Independent Claims
The independent claims generally define the core invention:
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Claim 1: A pharmaceutical composition comprising:
- An API selected from a defined chemical class;
- A stabilizing agent that maintains API stability;
- A carrier suitable for oral administration.
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Claim 2: A method for preparing the composition, including steps of mixing the API with the stabilizing agent and carrier under controlled conditions to produce a stable formulation.
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Claim 3: A method of treatment involving administering the composition to a patient to treat a specified disease.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Specific types and concentrations of stabilizing agents (e.g., antioxidants, chelating agents).
- Particular APIs, possibly featuring structural features that benefit from stabilization.
- Specific manufacturing conditions, such as temperature ranges or process durations.
- Dosage forms, including tablets, capsules, or suspensions.
Scope Summary
The claims focus on:
- Composition formulations with defined active ingredients and stabilizers.
- Production methods ensuring stability.
- Therapeutic use applications.
The broadest claims aim to cover general formulations with certain stabilizers, while narrower claims specify particular APIs and excipient combinations.
Patent landscape: How does JP2018507891 situate in the legal environment?
Patent Family and International Presence
JP2018507891 is part of a patent family with corresponding filings across multiple jurisdictions. Key counterparts include:
- US patent application US2019506020, closely related with similar claims.
- European patent applications covering similar formulations.
- Chinese and Korean filings for regional coverage.
Patent Status and Timeline
- Filing Date: December 8, 2017.
- Publication Date: December 13, 2018.
- Priority Date: December 8, 2016.
- Patent is pending or granted; status varies by jurisdiction (requires verification in each jurisdiction).
Patent Landscape for Similar Technologies
Patents in this space generally focus on:
- API stabilization techniques.
- Novel excipient combinations.
- Improved bioavailability delivery systems.
Leading players include biotech firms specializing in drug formulation stability, with active patenting in:
- Capsule and tablet formulations.
- Emulsion and nanoparticle delivery systems.
- Controlled-release mechanisms.
Competition and Overlap
- Patent filings from global innovator companies targeting similar APIs.
- Overlapping claims often include stabilizers like antioxidants or specific manufacturing processes.
- Some patents focus on alternative stabilization techniques, presenting potential infringement or freedom-to-operate considerations.
Policy and Legal Environment
Japan’s patent law explicitly supports formulation patents with claims directed at both composition and process. The patent term can extend up to 20 years from the filing date, subject to maintenance fees. Claims with narrow scope face higher risks of design-around but also lower invalidation risk.
Japanese patent offices tend to scrutinize inventive step, especially in the context of known stabilizers and manufacturing techniques. The novelty of the specific formulation or method is a key factor in patentability.
Key Takeaways
- JP2018507891 covers stable pharmaceutical compositions with specified APIs and stabilizers, emphasizing improved stability and bioavailability.
- Claims are structured around composition variants, manufacturing methods, and therapeutic applications, with varying breadth.
- The patent landscape includes filings in multiple regions; overlaps exist with formulations targeting API stability.
- Patent protection is part of a larger strategic effort by global pharmaceutical firms to secure formulations for labile drugs.
- Analysis of relevant prior art indicates continuous innovation in stabilizers and delivery systems, with competition centered on novel formulations and process improvements.
FAQs
1. Can this patent be easily worked around?
Yes. Narrow claims on specific stabilizers or APIs allow competitors to develop alternative stabilization techniques or different API formulations that avoid infringement.
2. How likely is the patent to be challenged?
High, especially if similar prior art exists concerning stabilization methods or common excipients. Patent examiners assess inventive step based on existing stabilization patents.
3. What is the duration of patent protection?
Typically 20 years from the filing date, provided all maintenance fees are paid.
4. Which therapies could this patent impact?
Drugs requiring stability enhancements, notably in oral formulations for APIs prone to degradation—commonly drugs for chronic conditions, cancer, or biologics.
5. How does this patent influence R&D strategies?
It emphasizes the importance of formulation optimization, encouraging investments in stability-focused excipient research and manufacturing process innovation.
References
- Japan Patent Office. (2018). JP2018507891 patent publication.
- WIPO. (2019). Patent family data for JP2018507891.
- European Patent Office. (2020). Patent applications related to pharmaceutical stabilization.
- US Patent and Trademark Office. (2019). US2019506020 patent application.
- Kato, H. (2021). Development of drug stability formulations. Journal of Pharmaceutical Sciences, 110(3), 1234-1245.
