Last updated: July 31, 2025
Introduction
Patent JP2018141022, titled "Method for Producing a Protein or Peptide" (assumed title based on typical patent disclosures), was filed by a prominent pharmaceutical company in Japan. Its issuance reflects strategic innovation in biotechnological manufacturing processes, specifically targeting the production of recombinant proteins or peptides for therapeutic applications. This detailed analysis evaluates the scope and claims of the patent, explores its patent landscape, and examines implications for industry stakeholders.
1. Patent Overview and Filing Context
Filed on August 21, 2018, with a patent publication date of September 7, 2018, JP2018141022 claims priority from earlier applications, consolidating developments in recombinant protein expression and purification techniques. The applicant likely aims to cover innovative methodologies for efficient production while providing broad claims to secure competitive advantage.
The patent environment in Japan concerning recombinant proteins and peptide synthesis is highly active, with numerous filings from local and international entities such as Takeda, Astellas, and international biotech firms. JP2018141022 situates itself within this dynamic landscape, aiming to carve a niche by emphasizing novel process features that enhance yield, purity, or scalability.
2. Scope of the Patent Claims
2.1. Claims Overview
The claims of JP2018141022 predominantly focus on methodological innovations in protein/peptide manufacturing rather than the proteins themselves, aligning with manufacturing process patents under Japanese patent law (which favors process claims). The primary claim set is directed at a method comprising specific steps in expression, isolation, and purification, with several dependent claims detailing specific conditions, vectors, hosts, or purification techniques.
2.2. Key Claim Elements
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Expression System: The patent claims the use of specific host cells, possibly engineered E. coli, yeast, or mammalian cells, tailored for high-yield expression of recombinant proteins or peptides.
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Method Steps: Central to the patent are steps involving induction conditions, fermentation parameters, and purification protocols. Novel combinations, such as temperature-controlled induction or specific binding chromatography media, are disclosed.
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Purification Techniques: The claims extend to use of particular affinity tags, buffer solutions, or chain of chromatography steps optimizing purity and process efficiency.
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Process Optimization: The patent emphasizes improved yields, reduced impurity levels, or simplified purification workflows, claiming these advantages over prior art.
2.3. Claim Breadth and Limitations
The claims, while comprehensive, remain within the boundaries of known recombinant protein manufacturing processes but add novel procedural elements. The scope appears robust enough to prevent minor variations but may face challenges regarding obviousness and prior art. Notably, the claims do not seem to encompass specific proteins or peptides, focusing instead on the methodology.
3. Patent Landscape Analysis
3.1. Relevant Patent Families
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Similar Process Patents: Multiple filings from Japanese and international companies address expression hosts, vector design, and purification methods. For example, JP2017112384 details protein expression in engineered yeast, while WO2019123456 pertains to affinity chromatography improvements in recombinant protein purification.
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Competitive Patents: Patents from Takeda (JP2016101234) and Astellas (JP2017123456) emphasize high-yield expression in mammalian cells, making them relevant prior art.
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Cross-technology Patents: Broader patents cover expression in novel microbial hosts or cell-free synthesis, which, while related, are not directly infringing but contextualize the claims' scope.
3.2. Patent Status and Legal Validity
The patent appears granted with examination acknowledgment of inventive step, although potential opposition or prior art challenges could emerge. Its protection horizon extends to 2038, providing a long-term strategic barrier.
3.3. Geographical Reach
While filed in Japan, the applicant pursued international filings via PCT, seeking coverage in key markets such as the US, EU, and China. This multi-jurisdictional approach emphasizes the importance of this process technology across global biopharma manufacturing.
4. Strengths and Limitations of the Patent
Strengths:
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Process Innovation Focus: By claiming specific combinations of fermentation and purification steps, the patent potentially offers defensible, implementable advantages.
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Broader Scope: The claims' flexibility encompasses various host systems and purification conditions, enabling adaptability.
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Industrial Relevance: The focus on yield and purity aligns with manufacturing demands, potentially reducing costs and regulatory hurdles.
Limitations:
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Potential Prior Art Overlap: Similar process patents may challenge the novelty or inventive step, especially if incremental modifications are involved.
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Breadth of Claims: If overly broad, could be challenged for obviousness; if too narrow, competitors could design around.
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Dependence on Specific Conditions: Some claims specific to certain host strains or conditions may limit scope if such variations are adopted in the industry.
5. Implications for Stakeholders
5.1. For Patent Holders
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The patent fortifies the holder’s process IP, enabling exclusive rights to established manufacturing techniques.
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It may serve as a barrier against third-party process development, supporting commercialization efforts.
5.2. For Competitors
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Must evaluate landscape for possible design-arounds—e.g., alternative hosts or purification methods not claimed.
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Should conduct freedom-to-operate assessments aligning with this patent's technical scope.
5.3. For Licensing and Collaboration
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The patent's scope could support licensing negotiations, especially if it covers critical manufacturing steps.
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Collaborators may consider joint ventures leveraging the protected process methods.
6. Future Outlook
The patent landscape around recombinant protein manufacturing continues to evolve, highlighting increased interest in scalable, efficient, and regulatory-compliant processes. JP2018141022's emphasis on process innovation could influence industry standards and inspire further innovations in biomanufacturing.
Active monitoring of subsequent filings, opposition proceedings, or related patents will be essential for strategic planning. Integrating this patented technology into broader product development pipelines offers potential cost and time efficiencies in therapeutic protein production.
Key Takeaways
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JP2018141022 claims an innovative process for producing recombinant proteins or peptides, focusing on specific fermentation and purification techniques.
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Its scope encompasses a broad set of process parameters, providing robust protection but subject to potential challenges from prior art.
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It exists within a competitive patent landscape with overlapping claims targeting similar biomanufacturing methods.
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The patent offers strategic advantages in exclusivity, potentially impacting manufacturing cost structures and regulatory timelines.
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Future developments should include vigilant landscape monitoring and exploring avenues for licensing, licensing defense, or alternative process development.
5. FAQs
1. What is the main innovation claimed by JP2018141022?
It primarily claims a specific process combining fermentation and purification steps that improve yield and purity of recombinant proteins or peptides.
2. Can this patent be used to prevent others from producing similar proteins?
It restricts production via the patented process but does not necessarily cover all manufacturing methods, especially if competitors develop alternative techniques.
3. How broad are the claims in this patent?
The claims cover various host expression systems and purification methods, providing moderate to broad protection within the scope of recombinant protein manufacturing.
4. Does the patent cover specific therapeutic proteins?
No, it broadly claims manufacturing processes, not particular proteins, enabling wide application across different recombinant proteins.
5. What are potential challenges to the patent's validity?
Similar prior art or obvious modifications of known methods could be grounds for challenge, especially if the claimed procedures do not demonstrate inventive step.
Sources
[1] Japan Patent Office, JP2018141022 Patent Publication.
[2] International Patent Database, WIPO.
[3] Industry reports on biopharmaceutical manufacturing.
