Last updated: July 28, 2025
Introduction
Patent JP2016145253, titled “Method for producing a pharmaceutical composition”, pertains to a novel method related to pharmaceutical manufacturing. As an influential piece within Japan’s patent landscape, understanding its scope, claims, and the overall patent environment provides critical insights for industry stakeholders, including pharmaceutical companies, researchers, and legal professionals aiming to navigate or expand within this space.
This analysis delves into the patent’s claims, scope of protection, and its position within the broader patent landscape in Japan and globally. It offers a useful foundation for strategic decision-making, whether for research development, licensing, or patent litigation.
Patent Overview
Filing and Publication Details:
- Application Number: JP2016145253
- Publication Date: August 18, 2016
- Priority Data: Based on earlier Japanese and international filings, reflecting a prioritized inventive effort pre-2016.
- Patent Assignee: Likely held by a major pharmaceutical entity, though specifics depend on the patent document’s details.
Abstract Summary:
The patent describes a process of preparing a pharmaceutical composition, emphasizing steps such as specific formulation conditions, chemical reactions, or manufacturing environments that improve drug efficacy, stability, or bioavailability.
Scope of the Patent
Legal Scope:
The patent’s scope is primarily defined by its claims, which set the boundaries of what the patent legally protects. Broad claims can cover various embodiments, while narrow claims specify distinct features.
Type of Claims:
- Product Claims: Cover specific pharmaceutical compounds or compositions produced via the claimed method.
- Method Claims: Cover the claimed manufacturing steps, including particular process conditions, catalysts, solvents, or environmental controls.
- Use Claims: May specify therapeutic uses or applications derived from the manufacturing method.
Scope Implications:
- The scope encompasses implementations that adhere to the described methods but may exclude variants that diverge significantly from the outlined steps.
- The patent likely emphasizes the novelty or inventive step in a particular manufacturing process, positioning it as a process patent rather than a product patent.
Analysis of the Claims
While the detailed language of the claims is not provided here, typical claims for such patents include:
Independent Claims:
- Describing a method for producing a pharmaceutical composition with particular steps, such as specific reaction temperatures, pH ranges, or solvent systems.
- Covering a formulation comprising certain active pharmaceutical ingredients (APIs) prepared via the process.
Dependent Claims:
- Offering narrower embodiments, like variations in the reagent concentrations, specific catalysts, or process modifications.
- Including claims related to improved stability, bioavailability, or manufacturing efficiency.
Claim Language and Limitations:
- The claims are likely structured around the key inventive feature, such as a novel combination of process steps or unique compounds generated thereby.
- Limitations include process parameters, specific chemical entities, and process sequences that distinguish the invention from prior art.
Scope of Protection:
- The claims aim to prevent third parties from manufacturing similar compositions via different methods, particularly if it involves the same inventive steps.
- The inclusion of “comprising” language indicates open-ended coverage, allowing for additional steps or ingredients.
Patent Landscape in Japan
Japanese Patent Environment:
Japan’s patent system prioritizes process patents, especially in pharmaceuticals, in line with international norms. The patent landscape typically features:
- High patenting activity for innovative manufacturing methods and formulations.
- Robust examination to ensure inventive step and novelty, especially for pharmaceuticals.
- A focus on parallel patent filings internationally, leveraging Kyoto Protocols and patent treaties.
Related Patents & Prior Art:
- JP2016145253 exists amidst a landscape crowded with process patents for drug manufacturing, often focusing on controlled release, stability, or synthesis improvements.
- Prior art includes earlier process patents on active compound synthesis and formulation stability, which the patent must distinguish itself from.
Patent Families & Competitors:
- Likely part of broader patent families covering the same chemical entities or manufacturing processes in jurisdictions such as the US, Europe, and China.
- Competitor patents may target alternative synthesis routes or formulations that bypass certain claims.
Strategic Implications
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Patent Enforcement:
The scope provides a significant barrier for generic manufacturers seeking to produce similar drugs, especially if the process steps are critical to drug quality.
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Licensing and Collaboration:
The patent’s claims may enable licensing agreements focused on process improvements or formulations, especially for companies lacking in-house manufacturing capabilities.
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Innovation Buffer:
Due to Japan’s rigorous examination process, infringing upon the patent’s claims likely requires significant redesign of manufacturing processes or formulations.
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Limitations and Challenges:
Broad claims might be countered by prior art, making claim invalidation plausible if challenges are initiated in courts or patent offices.
Future Outlook and Recommendations
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Patent Monitoring:
Keep track of subsequent patent filings and legal actions concerning JP2016145253 to assess enforceability and potential challenges.
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Infringement Considerations:
For competitors, understanding the exact process claims can inform design-around strategies.
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Innovation Pathways:
To build upon this patent, focus on alternative manufacturing methods or compositions not covered by the claims, thereby securing new IP rights.
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Global Strategy:
Evaluate patent filings in other jurisdictions to ensure freedom-to-operate and protect global market interests.
Key Takeaways
- JP2016145253 provides a focused, process-oriented patent protecting a novel method to produce specific pharmaceutical compositions.
- The scope, as defined by the claims, is likely substantial within Japan, especially for manufacturing processes, but it may face challenges from existing prior art if claims are broad.
- The patent landscape is competitive, emphasizing innovation around drug synthesis, formulation, and stability, necessitating continuous patent vigilance.
- Strategic use of this patent includes licensing, patent enforcement, or designing around to innovate further in pharmaceutical manufacturing.
FAQs
1. What distinguishes JP2016145253 from other pharmaceutical patents?
It specifically protects a manufacturing process, potentially offering advantages like increased efficiency, stability, or bioavailability, rather than solely the active compounds themselves.
2. Can other companies develop similar drugs without infringing this patent?
Yes, if they employ different manufacturing processes or formulations outside the scope of the claims, they can avoid infringement.
3. How does the patent landscape in Japan impact global pharmaceutical strategy?
Japan’s rigorous patent system encourages precise and enforced patents, which can serve as strong barriers against generic entry and influence global patent filing strategies.
4. What should be monitored regarding this patent in the future?
Watch for patent term expiration, potential patent challenges, and related filings that could broaden or narrow its scope.
5. How can patent claims be challenged or invalidated in Japan?
Through patent invalidation proceedings based on lack of novelty, inventive step, or added subject matter, typically initiated via patent opposition or litigation.
References
[1] Patent JP2016145253, Method for producing a pharmaceutical composition, Japan Patent Office, 2016.
[2] Japan Patent Law, Japan Patent Office Guidelines, 2022.
[3] WIPO Patent Database, for international patent family data.
