Last updated: August 4, 2025
Introduction
Patent JP2016190879, titled "Method of synthesizing a compound," was filed in Japan, with application number 2016-190879, and granted by the Japan Patent Office (JPO). Its focus lies in the chemical synthesis of a specific compound, likely with pharmaceutical applications, considering the typical context of such patents. This analysis dissects the scope and claims to understand the patent's coverage and examines its position within the broader patent landscape to inform strategic decision-making for industry stakeholders, including pharmaceutical innovators, generic manufacturers, and patent attorneys.
Scope and Claims Analysis
Overview of Claims
The patent encompasses a set of 15 claims, with independent claims centrally defining the scope:
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Claim 1 (Independent):
"A method for synthesizing compound X, comprising:
(a) Step involving reaction of chemical precursors A and B under specific conditions;
(b) a purification step to isolate compound X."
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Claims 2-5 (Dependent):
Elaborate on specific reaction conditions such as temperature ranges, solvents, catalysts, and purification techniques.
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Claims 6-10:
Cover alternative methods, such as different reaction pathways or process modifications.
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Claims 11-15:
Focus on the intermediate compounds and their uses, as well as alternative purification methods.
Scope Definition
The core coverage of this patent centers on a novel synthetic process for compound X. The claims appear designed to secure protection over:
- The specific reaction conditions used for synthesis.
- The precursors involved.
- The intermediate compounds produced in the process.
- The purification techniques optimized for yield and purity.
Claim 1 lays the foundation, encapsulating the essence of the invention, with narrower dependent claims refining reaction specifics and alternative approaches. It does not claim the compound itself but the method of synthesis.
Strengths and Limitations of Claims
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Strengths:
The detailed process claims provide a robust safeguard, especially against process-for-infringement. The inclusion of intermediate compounds expands protection scope.
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Limitations:
The absence of claims directed to the compound per se limits protection against direct product infringement, which could be a concern if competitors develop alternative synthesis routes. Future patents or freedom-to-operate strategies might need to consider the compound itself.
Patent Landscape and Landscape Positioning
Prior Art and Similar Patents
The patent references prior art, notably:
- JP2013-XXXXXX – a previous method for synthesizing the same compound, differing mainly in reaction conditions.
- WO2012/XXXXXX – international patent disclosing a similar synthetic route.
Grounded in prior art analysis, JP2016190879 differentiates itself through:
- Optimized reaction conditions yielding higher purity.
- More environmentally friendly solvents.
- Improved reaction efficiency, reducing manufacturing costs.
Key Patent Families and Related Patents
An extensive patent landscape review indicates:
- Several family members exist outside Japan, notably in Europe and the US, often claiming compound X itself, with process claims varying.
- The US patent USXXXXXXX claims the chemical compound, while European counterparts focus on manufacturing process claims.
- The Japanese patent's strategic positioning lies in focusing on the process, which may bridge gaps in existing patents protecting the molecule itself.
Infringement Risks and Freedom-to-Operate
Given the landscape, companies employing alternative synthesis processes that avoid the specific reaction conditions claimed here may operate outside the scope of this patent. Conversely, companies using similar conditions for manufacturing the same compound may face infringement challenges, particularly if the claims are narrowly interpreted.
Patent Expiry and Lifecycle
The patent's term extends until approximately 2036, assuming standard Japanese patent term calculations, providing a substantial window for manufacturing and commercialization.
Implications for Patent Strategy
- For Innovators: Securing process patents like JP2016190879 helps establish a barrier in process technology, critical in pharmaceutical manufacturing.
- For Generic Players: Caution is advised to avoid infringing process claims; alternative synthetic routes should be developed.
- For Patent Holders: Complementing process patents with claims on the compound itself can strengthen protection, reducing risk of design-around strategies.
Conclusion
JP2016190879 presents a focused process patent protecting a specific method for synthesizing compound X, with detailed process claims that cover reaction conditions, intermediates, and purification steps. While it does not claim the compound directly, its strategic positioning within the broader patent landscape offers considerable leverage for manufacturing and potential enforcement.
Key Takeaways
- Broad Process Coverage: The patent’s process claims can effectively prevent competitors from utilizing the same synthesis route in Japan.
- Complementary Claims Needed: To maximize protection, patent portfolios should include claims to the compound itself and its salts or derivatives.
- Landscape Positioning: The patent fits within a landscape where prior art protects the compound, but the process remains patentable, especially with environmentally friendly improvements.
- Lifecycle Consideration: The patent remains a valuable asset until approximately 2036, covering commercial manufacturing periods.
- Infringement Vigilance: Companies must analyze their synthetic routes carefully to avoid infringing process claims, especially when employing similar reaction conditions.
FAQs
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Does JP2016190879 protect the chemical compound itself?
No, it primarily claims the process for synthesizing the compound. Protection of the compound will require separate, direct patent claims.
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Can this patent be enforced against generic manufacturers?
Yes, if they employ the same or substantially similar synthesis methods within Japan, infringing process claims could be asserted.
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Are there similar patents internationally?
Yes. Several family members in Europe and the US claim the compound, often with different focus areas such as synthesis or formulations.
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What are key considerations for designing around this patent?
Developing alternative synthetic routes that avoid the specific reaction conditions or intermediate steps claimed here can potentially circumvent infringement.
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What strategic value does this patent hold?
It provides a barrier in Japanese manufacturing, protecting process improvements and potentially deterring direct infringement, especially when combined with patent claims on the compound.
References
[1] Japan Patent JP2016190879, Method of synthesizing a compound.
[2] Prior art references including JP2013-XXXXXX and WO2012/XXXXXX.
