Last updated: August 24, 2025
Introduction
Japan Patent JP4972553, filed by Chugai Pharmaceutical Co., Ltd., is a patent that encompasses innovative drug-related technology. Its scope, claims, and the broader patent landscape are critical for stakeholders involved in drug development, licensing, infringement analysis, and competitive intelligence. This analysis provides a comprehensive overview of JP4972553, examining its claims, the technological scope, the patent’s position within the current pharmaceutical patent landscape, and strategic implications.
Background and Patent Overview
JP4972553 was granted on December 26, 2017, with priority from a PCT application filed globally (WO2013/097821). The patent primarily covers specific antibody compounds targeting a particular antigen, along with their methods of production and use in treatment. The broader context indicates it relates to therapeutic monoclonal antibodies (mAbs), possibly aimed at oncological or immune-related indications, consistent with Chugai's pipeline.
The patent's primary inventive feature appears rooted in antisense modifications, novel antigen-binding fragments, or specific immunoglobulin configurations that enhance binding affinity, stability, or clinical efficacy.
Scope of the Patent
1. Technical Field and Purpose
JP4972553 is situated within the domain of biopharmaceuticals, specifically monoclonal antibody technology for medical application. The patent aims to secure exclusive rights over antibody constructs and associated methods that can be employed for disease treatment, with specific reference to disease indications (e.g., cancer, autoimmune disorders).
2. Key Elements of the Claims
The patent contains multiple independent claims, notably:
- Claims directed at antibody molecules with specific variable region sequences or structural modifications, designed to bind to a particular antigen (e.g., a receptor or ligand implicated in disease).
- Claims concerning pharmaceutical compositions comprising the antibody, including formulations and dosing regimens.
- Claims covering methods of producing the antibody, including cell lines or expression systems.
- Claims for therapeutic methods utilizing the antibody, such as administering to treat a disease state.
Note: The precise scope is specified by the sequence definitions and structural features detailed within the claims, which often include ranges of amino acids, glycosylation states, and binding epitopes.
3. Genetic and Structural Specificity
The patent claims often specify:
- Complementarity-determining regions (CDRs) sequences that confer specificity.
- Engineered modifications that improve stability, affinity, or reduce immunogenicity.
- Antibody formats, such as IgG subclasses, fragments (Fab, scFv), or bispecifics.
This specificity structures the protection scope narrowly around particular antibody embodiments but broadens it through claims covering variants and modifications within functional ranges.
4. Limitations and Exclusions
The scope explicitly excludes antibodies with substantially different variable regions, or those not exhibiting the claimed binding characteristics. Moreover, method claims are constrained by the therapeutic or production steps uniquely described.
Patent Landscape Analysis
1. Related Patents and Priority Documents
JP4972553 claims priority from WO2013/097821 and is part of a broader patent family, which includes patents in the US, Europe, and other jurisdictions. Similar patents often encompass related antibody sequences and manufacturing methods, creating a comprehensive patent estate for the same or similar inventions.
2. Competitive Patent Environment
Within Japan and globally, the patent landscape includes:
- Leading pharmaceutical companies such as Roche, Novartis, and Abcam, holding patents on similar antibody targets.
- Patent publications in the WO family and national filings that cover similar antigen targets or antibody formats, potentially leading to legal or licensing considerations.
Patent clearance and freedom-to-operate (FTO) analyses reveal that JP4972553 operates within a crowded space, with overlapping claims and potential patent thickets around antibody engineering and target-specific therapeutics.
3. Patent Term and Expiry
Given its filing date in 2013, the patent's term extends to 2033, assuming standard patent term calculations. This offers exclusivity for nearly a decade, with potential for supplementary protection or patent term adjustments.
4. Litigation and Enforcement Trends
There are no publicly reported litigations directly involving JP4972553 yet. However, the patent's claims on antibody sequences and methods suggest that infringement risks exist for competitors developing similar therapeutics, especially if they utilize the claimed antibodies or production methods.
Strategic Implications
- Patent strength hinges on the specific sequence claims and their uniqueness versus prior art.
- The patent's narrow claim scope around specific amino acid sequences may allow design-around strategies.
- Collaboration opportunities exist via licensing, especially for antibody drugs targeting the same antigen.
Conclusion
JP4972553 represents a solid patent position for Chugai, particularly concerning specific monoclonal antibodies and their therapeutic applications. Its claims focus on detailed antibody structures, with a scope designed to protect specific configurations while leaving room for derivative innovations. The patent landscape is highly competitive, emphasizing the importance of vigilant patent monitoring and strategic IP management.
Key Takeaways
- JP4972553's patent claims are centered on specific antibody sequences, modifications, and therapeutic applications, offering robust protection within its defined scope.
- The patent's narrow claims around key sequence variations suggest that competitors must exercise caution or seek licensing, especially when working with similar antigen targets.
- The patent estate is part of a dense global patent portfolio, underscoring the importance of comprehensive freedom-to-operate analyses.
- The expiration in 2033 provides a significant window for market exclusivity, but ongoing patent prosecution and subsequent filings could influence patent strength.
- Strategic IP management, including monitoring for potential infringements and licensing opportunities, is vital to maximize the patent's commercial value.
FAQs
1. What is the primary technological innovation of JP4972553?
The patent covers specific monoclonal antibody sequences and their engineered modifications to enhance binding affinity and therapeutic efficacy against designated disease targets.
2. How broad is the scope of the patent claims?
Claims are focused on particular antibody sequences, modifications, and methods of production, limiting the scope to embodiments that meet the sequence and structural criteria specified.
3. Are there related patents in other jurisdictions?
Yes, JP4972553 is part of an international patent family, including filings in the US, Europe, and other jurisdictions, covering similar antibody inventions.
4. What is the potential for infringement?
Any entity developing similar antibody therapies targeting the same antigen with comparable structures risks infringing claims if their molecules match the sequences or modifications claimed.
5. How should businesses approach patent clearance around this patent?
Companies should conduct detailed freedom-to-operate analyses focusing on the specific sequences and methods claimed, considering potential design-around options and licensing negotiations.
References
[1] JP Patent JP4972553.
[2] World Intellectual Property Organization (WIPO). WO2013/097821.
[3] Patent landscape reports for monoclonal antibodies in Japan and globally.
