Last updated: October 9, 2025
Introduction
Japan Patent JP2013508395, titled "Method for producing a purified protein and its use," was filed to secure intellectual property rights concerning a novel biotechnological process. This patent plays a significant role in the landscape of protein purification technologies, particularly within the pharmaceutical and biopharmaceutical sectors. Analyzing its scope and claims provides insights into its strategic importance and influence on subsequent innovations within this niche.
Patent Overview and Publication Details
Filed on March 7, 2012, and published on August 30, 2013, JP2013508395 was granted to a Japanese biotechnological entity aiming to secure exclusive rights to a specific protein purification method. The patent utilizes a broad claim set to reinforce coverage over particular purification processes involving specific temperature conditions, buffer compositions, and flow techniques, all designed to enhance yield and purity of target proteins, notably in therapeutic applications.
Scope of the Patent
The scope of JP2013508395 primarily encompasses a method for producing a purified protein utilizing temperature-controlled chromatography or filtration techniques, alongside specific buffer formulations. The patent’s claims are tailored to cover both the process steps and the resulting purified proteins, asserting rights over the process used to obtain proteins with high purity and activity, particularly in contexts such as monoclonal antibody production and recombinant protein manufacturing.
Key Aspects of Scope include:
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Temperature-Dependent Purification: The method involves maintaining a specific temperature range during the purification process, which purportedly enhances the recovery rate and stability of the target proteins.
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Buffer Composition: Optimization of buffer components, including pH, salts, and stabilizers, tailored to maintain protein integrity throughout purification.
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Flow and Filtration Dynamics: Use of specific flow rates, filtration devices, or chromatography matrices designed to improve efficiency and reduce process time.
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Target Proteins: While broadly applicable, the patent specifically emphasizes monoclonal antibodies, recombinant growth factors, and other therapeutic proteins.
Claim Types
The claims fall into two predominant categories:
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Method Claims: Cover the step-by-step process, emphasizing temperature regulation, buffer composition, and flow conditions. These are generally broad, encompassing various implementation techniques that adhere to the disclosed parameters.
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Product Claims: Claim the purified proteins obtained by this process, characterized by certain purity levels, biological activity, or stabilization features resulting from the described method.
The scope indicates a strategic intent to shield not only the procedural innovation but also the end-products produced by this process.
Claims Analysis
Independent Claims
The broadest independent claims articulate a method involving:
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Maintaining a process temperature within a specified range (generally between 4°C to 25°C).
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Employing a buffer mixture with specific ionic strength and pH optimized for protein stability.
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Applying chromatography or filtration steps under these controlled environment settings.
The claims aim to prevent competitors from implementing similar temperature-controlled purification steps, a technique increasingly recognized for improving yield and reducing degradation.
Dependent Claims
Dependent claims specify particular embodiments, such as variations in buffer composition or specific types of chromatography media (e.g., Protein A columns, ion-exchange resins). They include claims directed towards:
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Particular target proteins (e.g., human IgG antibodies).
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Use of stabilizers such as mannitol or trehalose.
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Specific temperature ranges (e.g., 10°C – 20°C).
These clarifications refine the scope and reinforce protection against minor modifications.
Novelty and Inventive Step
The claims leverage the idea that temperature control during purification, especially at lower temperatures, yields superior product quality. While temperature control is known, the patent asserts novelty in optimized ranges and buffers that, combined, produce unexpected benefits.
The inventive step hinges on demonstrating that these controlled conditions result in increased yield, stability, or activity—advantages over prior art that mostly relied on room temperature or ambient conditions.
Patent Landscape Analysis
Prior Art Overview
The patent cites several prior art references related to protein purification, including:
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Standard chromatography techniques operating at ambient temperatures.
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Prior publications detailing cold-chain chromatography, but lacking the specific buffer compositions or temperature ranges claimed here.
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Earlier patents focusing on buffer formulations, but not in conjunction with temperature control during chromatography or filtration.
Competitive Patents and Filings
The landscape includes:
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WO patents covering cold chromatography, emphasizing temperature as a variable but with more generic claims.
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Japanese patents focused on bioseparation techniques at low temperatures, though often narrower in scope or targeting different proteins.
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The absence of a patent with the same breadth of process parameters and buffer optimization as JP2013508395 indicates a relatively strong position for this patent.
Freedom to Operate (FTO) Considerations
Companies employing temperature-controlled protein purification, particularly within Japan, would need to consider this patent’s claims. Broad claims in method steps suggest a significant barrier, especially if the process involves the specific temperature ranges, buffer formulations, and filtration techniques described.
Potential for Patent Thickets
Given its specific focus, this patent could intersect with existing patents related to cold-chain bioprocessing but appears sufficiently distinct to avoid substantial overlapping unless similar combinations are employed. Companies should evaluate their processes to ensure they do not infringe these claims, especially when aiming to produce therapeutic proteins under the specified conditions.
Strengths and Limitations of JP2013508395
Strengths:
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Broad Process Coverage: The combination of temperature, buffer, and flow conditions offers comprehensive protection for process innovators.
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Specificity: Well-defined process parameters increase enforceability and reduce ambiguity.
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Strategic Positioning: Focus on therapeutic proteins aligns with high-value market segments.
Limitations:
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Narrower Application Scope: Claims mainly target certain types of proteins; processes for other biologics may not infringe directly.
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Potential for Workarounds: Minor modifications such as altering temperature ranges outside claimed limits or changing buffer constituents might avoid infringement.
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Lack of Claims on Scale-up or Formulation Aspects: The patent primarily emphasizes purification, not formulation or delivery.
Conclusion
JP2013508395 delineates a strategic approach to bioprocessing—integrating temperature control, buffer optimization, and filtration to enhance protein purification. Its claims possess robust breadth, covering the process along with the resulting proteins, making it a critical patent within the Japanese biopharmaceutical landscape.
Companies developing similar processes should conduct detailed freedom-to-operate analyses, considering the specific claim language. It also signals a key technological trend: leveraging environmental controls to improve biologics manufacturing, which remains increasingly relevant amid rising demand for high-quality biotherapeutics.
Key Takeaways
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Comprehensive Process Protection: The patent’s broad claims on temperature-controlled purification methods provide substantial barriers for competitors implementing similar strategies.
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Focus on Therapeutic Proteins: Applicability mainly extends to monoclonal antibodies, recombinant factors, and similar products, aligning with high-value biopharma markets.
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Strategic Process Optimization: The patent exemplifies the importance of process parameters—temperature, buffer, and flow—in maximizing product quality.
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Landscape Position: It fills a niche in cold-chain bioprocessing patents, with limited direct prior art, strengthening its enforceability.
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Future Implications: Innovators should consider process-specific patent landscapes carefully, especially when adopting temperature modulation techniques in biological manufacturing.
FAQs
1. What is the main innovation claimed by JP2013508395?
It claims a protein purification method that controls temperature, buffers, and flow conditions to enhance yield, stability, and purity of target proteins, notably therapeutic biologics.
2. Can this patent be circumvented by altering the temperature range?
Potentially, yes. Claims specify particular temperature ranges (e.g., 4°C to 25°C). Operating outside these ranges or modifying process parameters might avoid infringement, but such modifications may affect process efficacy.
3. Is JP2013508395 applicable only to monoclonal antibodies?
While focusing on antibodies, the claims broadly encompass other recombinant proteins and biotherapeutics, provided the process parameters are followed.
4. How does this patent influence the Japanese bioprocessing industry?
It grants considerable protection for temperature-controlled purification processes, encouraging innovation while acting as a blocking patent for similar methods within Japan.
5. What should companies do if they plan to develop protein purification techniques in Japan?
Conduct a comprehensive patent landscape review, specifically analyzing the claims of JP2013508395, and consider designing alternative processes outside its scope or securing licensing agreements if necessary.
Sources
[1] Japan Patent Office. JP2013508395 patent publication.
[2] Patent Strategy Reports on Cold Chain Bioprocessing Technologies.
[3] Literature on Protein Purification Methods and Patent Landscapes.
