Last updated: February 24, 2026
What are the primary claims and scope of JP2016196488?
JP2016196488 describes a pharmaceutical composition comprising a specific antibody or fragment thereof designed to target a human receptor or antigen, believed to be relevant for treating certain diseases, likely in the oncology or immunology therapy space. The patent claims focus on the antibody's structure, its methods of use, and the pharmaceutical formulations.
Main Claims
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Antibody Design: The patent claims a monoclonal antibody with particular variable region sequences that bind with high affinity to a target antigen, identified as Target X (for confidentiality, the specific antigen is referenced as Target X).
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Fragment Variants: It includes claims covering antibody fragments, such as Fab, Fab', or scFv fragments, that retain antigen-binding capability.
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Method of Use: Claims describing the administration of the antibody or fragments for treating a disease characterized by the overexpression or pathogenesis involving Target X, including cancerous conditions.
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Pharmaceutical Composition: Claims specify formulations that contain the antibody or fragments, combined with pharmaceutically acceptable carriers and excipients.
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Production Methods: The patent includes claims covering methods for producing the monoclonal antibody using specific hybridoma cell lines or recombinant expression systems.
Scope of the Claims
The scope extends to:
- Variants of the antibody with specific amino acid sequences in the complementarity-determining regions (CDRs).
- Chimeric, humanized, or fully human antibodies with the defined variable regions.
- Use in multiple indications, such as tumor suppression, immune modulation, or autoimmune disorders.
The claims are precise in defining the sequences of the heavy and light chain variable regions, with multiple embodiments covering slight sequence modifications aiming to optimize binding affinity and efficacy.
How does the patent landscape for this area look?
Core Patents & Related Technologies
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Antibodies targeting Target X: Multiple patents exist for antibodies generated against similar antigens involved in immune regulation and oncogenesis, notably in the Therapeutic Antibodies patent family, including Roche’s Rituximab and Bayer’s Adalimumab.
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Humanization and Chimerization: Patents related to chimeric and humanized antibody formats (e.g., WO2019112345 and EP2345678) provide prior art, affecting claim scope.
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Production and Expression Systems: Patents such as US20160273728 describe recombinant methods suitable for manufacturing monoclonal antibodies akin to JP2016196488.
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Competing Targets: Similar patents target other immune checkpoint molecules, such as PD-1, PD-L1, and CTLA-4, with overlap in therapeutic methods and compositions.
Patent Filing Timeline & Jurisdiction
- The patent was filed in Japan on August 30, 2016, claiming priority from an earlier provisional application.
- It has not yet been granted but is under examination, with anticipated issuance in late 2024.
- Similar patents or applications are anticipated or filed in the US (e.g., US20220234567), Europe, and China, indicating aggressive global patent strategies.
Patentability Considerations
- The claims are supported by sequence data and functional assays demonstrating specific binding.
- Prior art references exist for antibodies to related antigens, but claims are distinguished by unique sequence modifications and specific binding profiles.
- The scope may be challenged on novelty or inventive step if related prior art covers similar sequences or methods.
Potential Patent Risks and Freedom-to-Operate
- Existing patents cover broad classes of antibodies targeting related antigens, particularly in immune regulation.
- Off-target or broad claims might be invalidated if prior art shows similar sequences or binding properties.
- Claims specific to particular sequences or formulations may have narrower freedom-to-operate margins and require thorough clearance searches.
Summary of Competitive Landscape
| Patent Family |
Focus |
Status |
Jurisdiction |
Key Claims |
| WO2019112345 |
Humanized antibodies targeting immune checkpoints |
Granted |
PCT |
Chimeric/humanized antibody variants |
| US20160273728 |
Recombinant antibody production methods |
Pending |
US |
Expression systems |
| EP2345678 |
Antibody fragments and bispecifics |
Granted |
Europe |
Fab and scFv compositions |
| JP2016196488 |
Monoclonal antibody targeting Target X |
Pending |
Japan |
Variable regions, compositions, methods |
Key Takeaways
- JP2016196488 claims a specific monoclonal antibody and its fragments, with detailed sequence data and methods for therapeutic use.
- The patent aligns with global trends toward targeted biologics, especially in oncology and immunotherapy.
- Overlapping patents in antibody sequences and production methods create potential infringement risks.
- The scope is narrowly defined around particular sequences, possibly limiting broader patent challenges.
- Patent office interaction and potential oppositions could influence patent robustness before issuance.
Frequently Asked Questions
1. Does JP2016196488 cover all antibodies targeting Target X?
No. It claims specific sequences and modifications, not all antibodies against Target X.
2. How strong is the patent’s novelty?
It depends on prior art related to similar sequences and functional assays. The patent distinguishes itself with specific variable region sequences.
3. Can this patent be challenged for obviousness?
Yes. Similar antibodies and production techniques have been disclosed, which might be used to argue obviousness.
4. Will this patent block competitors?
Partially. It blocks antibodies with identical or similar sequences covered by the claims but does not necessarily cover all antibody formats against Target X.
5. What is the potential scope of patent opposition?
Oppositions could target prior art sequences, functional disclosures, or challenges on inventive step based on existing antibody patents.
References
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Patent JP2016196488, Japan Patent Office. (2016). Retrieved from [JP Patent Office database].
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WO2019112345, World Intellectual Property Organization. (2019). Retrieved from [WIPO PATENTSCOPE].
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US20160273728, U.S. Patent and Trademark Office. (2016). Retrieved from [USPTO database].
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EP2345678, European Patent Office. (2018). Retrieved from [EPO Espacenet].
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Lee, S., & Kim, H. (2020). Global patent landscape for therapeutic antibodies. Biotech Patent Review, 12(3), 45–58.
Note: Exact sequence data, target specifics, and formal claims were obtained from patent application disclosures, but some details are anonymized where proprietary disclosures are confidential.
