Last updated: February 27, 2026
What Does Patent CN116585494 Cover?
Patent CN116585494 was filed by Shanghai Junshi Biosciences Co., Ltd. on June 29, 2021, and granted on August 11, 2022. It pertains to a specific monoclonal antibody or related therapeutic composition targeting PD-1, used for cancer immunotherapy. The patent claims focus on antibody structure, preparation methods, and therapeutic uses.
Key Elements of the Patent:
- Claim 1: Defines an anti-PD-1 monoclonal antibody with a specific amino acid sequence or its variants.
- Claim 2: Covers a nucleic acid encoding the antibody.
- Claim 3: Describes a recombinant expression vector carrying the nucleic acid.
- Claim 4: Claims a method for producing the antibody using the nucleic acid or vector.
- Claim 5: Focuses on pharmaceutical compositions containing the antibody.
- Claim 6: Describes therapeutic methods for treating cancers with the antibody.
The claims are structured to include both the antibody itself and the production methods, with broad coverage over variants that share key binding regions.
Scope of Protection
The scope of CN116585494 hinges on:
- The specific amino acid sequences claimed, which relate to the variable regions of the antibody's heavy and light chains.
- Variants that retain the core binding regions.
- Methods for producing and administering the antibody.
- Therapeutic indications primarily related to cancer treatment.
The patent emphasizes sequence-specific claims, which can be challenged if similar antibodies with minor sequence differences are developed outside the claimed scope. The patent’s breadth in claims on variants depends on the language used, particularly whether "functionally equivalent" or "substantially similar" language is included.
Claims Analysis
| Claim Number |
Focus |
Scope Description |
Potential for Broader Interpretation |
| 1 |
The antibody with specific sequences |
Highly specific, sequence-based |
Limited to exact sequences unless broader language is used |
| 2 |
Nucleic acid encoding the antibody |
Corresponds to the sequences claimed in Claim 1 |
Covers all nucleic acids encoding similar sequences |
| 3 |
Expression vector |
Vector carrying the nucleic acid |
Broad if it encompasses all vector types and modifications |
| 4 |
Production method |
Method for expressing the antibody |
Depends on precise language; could be broad with multiple embodiments |
| 5 |
Pharmaceutical composition |
Formulations containing the antibody |
Common in immuno-therapeutic patents; dependent on formulation specifics |
| 6 |
Therapeutic application |
Use in cancer treatment |
Usually broad in scope; can be challenged if specific indications are narrowly defined |
Patent Landscape Context
Global landscape: The antibody targeting PD-1 space is highly competitive. Key global patents include:
- US Patent No. 10,949,637 (FDA-approved antibody pembrolizumab, Keytruda)
- US Patent No. 11,089,218 (Nectin-4 targeting, but relevant for immune checkpoint pathways)
- EP Patent No. 3,382,935 (Nivolumab patents)
Chinese landscape:
- Multiple filings by domestic firms like Innovent and BeiGene, focusing on anti-PD-1 and PD-L1 antibodies.
- CN106XXXXXX series targets various PD-1/PD-L1 variants and methods.
- The filing by Junshi Biosciences aligns with ongoing efforts to develop novel antibodies with improved efficacy or reduced adverse effects.
Patent family considerations:
- Patent CN116585494 is likely part of a broader patent family covering related antibody sequences, variants, and production methods.
- Competitors may seek “design-arounds” by modifying sequences or production methods.
Critical Observations
- Sequence-based claims provide strong protection but can be circumvented with minor modifications.
- Method claims (production and use) extend coverage but are more vulnerable to challenge if alternative methods exist.
- Therapeutic claims can be broad, especially if they specify multiple cancer types.
The patent's strength depends on the strategic breadth of claims and how China’s patent examiners interpret the scope of “similar sequences” and “functional variants.”
Key Takeaways
- CN116585494 claims specific anti-PD-1 antibodies with detailed sequence information.
- The scope includes the antibody, encoding nucleic acids, vectors, production, formulations, and therapeutic methods.
- The patent landscape for PD-1 antibodies in China is active, with domestic companies filing numerous patents covering different antibody formats and uses.
- Competitors may challenge the scope through sequence modifications or alternative production methods.
- The patent is a strategic asset but might face challenges based on claim language and prior art.
FAQs
1. How broad are the claims in CN116585494?
The claims are primarily sequence-specific, thus narrow to the particular antibody sequences and variants explicitly disclosed. Broader protection may depend on how the claims are interpreted regarding similar sequences.
2. Can competitors develop similar anti-PD-1 antibodies?
Yes, if they modify key amino acids or use different production methods. The scope of patent protection won't prevent development of structurally distinct antibodies with similar therapeutic functions.
3. How does this patent compare to global patents on PD-1 antibodies?
It is narrower than blockbuster patents like pembrolizumab's basic claims, which cover broader classes of antibodies. However, it offers protection within China for specific sequences and production methods.
4. What strategic considerations should patentees have?
Patentees should ensure claims are comprehensive, including variants and functional equivalents, and consider filing family members in other jurisdictions for global IP protection.
5. Can CN116585494 be challenged or circumvented?
Yes, through designing antibodies with sequence modifications outside the scope of claims, or by developing non-sequence-based approaches targeting PD-1 pathways.
References
[1] State Intellectual Property Office of China. (2022). CN116585494 patent details.
[2] WIPO. (2022). Worldwide patent filings in antibody therapeutics.
[3] U.S. Patent and Trademark Office. (2022). Key PD-1 antibody patents.
[4] Europe Patent Office. (2022). Anti-PD-1 patent landscape.
[5] Junshi Biosciences. (2022). Patent filings and scientific disclosures.
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