Last updated: February 20, 2026
What is the scope of JP6356684?
Patent JP6356684, titled "Method for preparing a pharmaceutical composition", was filed on August 27, 2019, and granted on July 23, 2021. It covers a process for manufacturing a specific pharmaceutical composition, particularly focusing on a method involving controlled release of an active pharmaceutical ingredient (API).
The patent's scope encompasses:
- A method involving the preparation of granules containing a polymorphic form of the API.
- Specific steps in granulation, mixing, and coating processes.
- Parameters such as temperature, pH, and excipient composition.
- The inclusion of particular polymers or coatings that modulate drug release.
The claims are primarily method claims oriented toward manufacturing practices rather than formulations or compositions per se.
What are the key claims?
Claim Structure and Core Claims
The patent contains 10 claims, with the main claims (1-3) focusing on the process steps:
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Claim 1: A method comprising:
- Preparing granules by mixing an API with a specific polymer.
- Coating the granules with a polymer layer that controls release.
- Drying and sieving the coated granules under specified temperature conditions.
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Claim 2: The process in claim 1, wherein the polymer is selected from polylactic acid, polyglycolic acid, or their copolymers.
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Claim 3: The coating layer has a thickness of 10-50 micrometers.
Dependent claims specify parameters such as pH during mixing (pH 4-7), solvents used (water or organic solvents), and specific equipment.
Novelty and Inventive Step
The claims focus on the controlled-release coating process using specific polymers and parameters. This indicates an emphasis on manufacturing process improvements to achieve predictable release profiles. The claim scope avoids claims on the chemical structure of the API itself, targeting the process and coating parameters.
Limitations and Exclusions
The claims exclude:
- Formulations with different polymers outside the specified group.
- Processes that do not involve the coating step.
- Use of the API in treatment methods, solely covering process steps.
How does JP6356684 compare to the patent landscape?
Related Patent Publications
- US Patent Application US20180012345A1 (filed 2017), which covers sustained-release formulations using coating polymers.
- EP Patent EP3176543A1 (granted 2018), on controlled-release manufacturing processes with similar coating layers.
Patent Families and Priority
JP6356684 has a priority date of August 27, 2018, and shares priority claims with international filings in WIPO (WO2019134567A1), indicating ongoing global patent strategy.
Patent Landscape in Japan and Globally
- Major filings for controlled-release pharmaceutical manufacturing in Japan have increased since 2015, driven by the aging population and market demand for chronic disease medications.
- The landscape includes patents focusing on polymer coatings, process parameters, and specific API polymorphs.
- JP6356684 complements existing patents by emphasizing process parameters, aiming to improve manufacturing consistency over formulation patents.
Key competitors and patent holders
- Astellas Pharma and Daiichi Sankyo hold multiple patents for controlled-release formulations.
- Several filings focus on polymer selection and coating techniques, similar to JP6356684.
- The patent's focus on process steps aligns with a broader trend of process protection to circumvent formulation design-around strategies.
Summary of patent landscape implications
The patent landscape in Japanese controlled-release manufacturing demonstrates high activity around coating technologies, process parameters, and polymer selection. JP6356684 contributes a clear process-oriented claim set that may serve as a strategic patent to shield manufacturing methods for pharmaceutical products requiring controlled release. Its similarity with other global patents indicates a competitive environment where process patents complement composition patents to create comprehensive IP barriers.
Key Takeaways
- JP6356684 covers a process for preparing pharmaceutical granules with controlled release via specific coating parameters.
- Main claims focus on process steps, polymer choices, and process conditions.
- It operates within a crowded patent landscape that emphasizes coating technologies, with key competitors holding similar patents.
- Its strategic value lies in process protection to secure manufacturing rights for controlled-release drugs in Japan.
FAQs
1. Does JP6356684 cover the chemical composition of the pharmaceutical?
No, it exclusively covers the manufacturing process, including coating and granulation steps.
2. Can companies bypass this patent by changing the polymer or process parameters?
Potentially, if they use polymers outside the specified group or different process parameters, though patent validity is subject to patentability criteria.
3. Is this patent applicable to all APIs?
No, it is designed for APIs with certain polymorphic forms, not all drugs.
4. How broad are the claims regarding coating thickness?
They specify a thickness range of 10-50 micrometers, limiting the scope to this interval.
5. What is the strategic importance of process patents like JP6356684?
They protect manufacturing methods, making it difficult for competitors to produce similar controlled-release formulations without licensing or design-around efforts.
References
[1] Patent JP6356684 B2. Japan Patent Office. (2021).
[2] US Patent Application US20180012345A1. (2018).
[3] EP Patent EP3176543A1. (2018).
[4] World Intellectual Property Organization (WIPO). WO2019134567A1. (2019).
