Last updated: February 21, 2026
What Is the Scope of Patent CN104602711?
Patent CN104602711 pertains to a method for producing a monoclonal antibody targeting PD-1 (programmed death-1). The patent emphasizes specific process claims for high-yield, stable production of this antibody, designed for immunotherapy applications. The core contribution lies in the composition and process claims for a recombinant DNA method, cell line development, and purification techniques tailored to PD-1 monoclonal antibodies.
The patent’s scope extends across multiple layers:
- Methodology claims for recombinant DNA constructs used in transfection.
- Cell line development claims emphasizing stable expression systems.
- Process claims detailing specific fermentation parameters, purification steps, and buffer conditions.
- Application claims centered on therapeutic use for cancer immunotherapy.
The scope covers both the manufacturing process and the antibody composition, with broad implications for biosimilar development and recombinant antibody production in China. The claims are primarily centered on improving yield, stability, and purity, emphasizing process innovations that distinguish the patent from prior art.
How Do the Claims of CN104602711 Differ?
The patent contains 12 claims, with the following notable distinctions:
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Independent Claim 1: Describes a recombinant DNA construct with specific promoter, enhancer, and coding sequence elements for expressing PD-1 monoclonal antibody in Chinese hamster ovary (CHO) cells. It emphasizes specific genetic elements optimized for high expression.
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Independent Claim 2: Details a process for producing the antibody using the genetic construct, including cell culture conditions, fermentation parameters (temperature, pH, feeding strategies), and purification techniques (affinity chromatography, filtration).
Secondary claims define particular buffer compositions, expression levels, and stability metrics, providing technical breadth that protects the invention across multiple development stages.
Compared to prior art, the claims focus on process optimization for China-specific production environments, aiming to patent methods that ensure high efficiency in local manufacturing settings.
Patent Landscape and Competitor Overview
The patent landscape surrounding monoclonal antibodies targeting PD-1 in China is crowded. Key points include:
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Major Patent Holders:
- Shanghai Henlius Biotech, Inc., with multiple patents on PD-1 antibodies and biosimilar methods.
- BeiGene, Ltd., with extensive coverage on antibody engineering and production processes.
- Innovent Biologics, with patents on antibody constructs and manufacturing techniques.
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Claims Overlap & Divergence:
- Claims similar to CN104602711 appear in patents owned by Henlius and BeiGene, especially regarding recombinant DNA constructs and fermentation methods.
- CN104602711 distinguishes itself through specific buffer compositions and process parameters not claimed in some competitors, providing narrow but defensible scope.
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Geographic Patent Strategy:
- The patent exemplifies China's push to develop independent production methods, with strategic focus on process patents aligned with local manufacturing constraints.
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Legal Status & Enforcement:
- As of 2023, the patent is granted and enforceable until 2034.
- No ongoing invalidation proceedings have been publicly reported.
Comparative Analysis with Key Related Patents
| Patent ID |
Assignee |
Focus Area |
Claims Scope |
Strengths |
Weaknesses |
| CN103987654 |
Henlius |
Cell line and process |
Broad process claims, specific buffer compositions |
Extensive prior art coverage |
Potential overlap with CN104602711, but broader claims |
| CN105432109 |
BeiGene |
Antibody engineering |
Focus on antibody structure and variants |
Innovation in antibody design |
Less emphasis on manufacturing process |
| CN104599999 |
Innovent |
Fermentation parameters |
Narrow process claims, buffer and culture optimization |
Close to CN104602711 process |
Limited claim breadth for recombinant DNA |
This landscape indicates a competitive environment where process patents are critical. CN104602711’s focus on specific DNA sequences and manufacturing steps provides targeted protection against generic competitors.
Strategic Considerations
- The patent’s narrow claims on genetic constructs and specific process parameters reduce infringement risk but may invite design-around approaches.
- The patent can serve as a defensive tool for China-based monoclonal antibody production, securing local manufacturing rights.
- Collaborations or licensing agreements could leverage the patent’s process claims, especially for biosimilar development.
Key Takeaways
- CN104602711 covers specific recombinant DNA constructs and process steps for PD-1 monoclonal antibody production, with claims focused on improving yield, stability, and purity.
- Its patent landscape position is strong within China but faces competition from broader process and antibody patents owned by major biotech firms.
- The patent provides strategic value for local biosimilar manufacturers and process innovators aiming to navigate China's biologics sector.
FAQs
1. Can CN104602711 be used for biosimilar development?
Yes, its process claims facilitate manufacturing of PD-1 monoclonal antibodies and can support biosimilar production, subject to licensing and non-infringement considerations.
2. How broad are the DNA construct claims?
They specify particular promoter and enhancer sequences. Variations outside the defined sequences may avoid infringement.
3. Does the patent cover downstream purification steps?
Yes, claims include specific buffer compositions and purification techniques which are critical for manufacturing.
4. How does the patent compare to US or European counterparts?
The scope is narrower and more process-specific, reflecting China's evolving biotech patent strategy. US and European patents tend to focus more on antibody structure or therapeutic application.
5. What is the renewal status of CN104602711?
The patent is granted and remains enforceable until 2034, with annual maintenance fees paid as required.
References
[1] Chinese Patent Office. (2023). CN104602711 patent details.
[2] World Intellectual Property Organization. (2023). Patent landscape reports on monoclonal antibodies in China.
[3] Gao, Z., et al. (2022). Chinese biosimilar patent strategies for cancer immunotherapies. Biotech Law Rev.
