Last updated: February 21, 2026
What does the patent CN107108559 cover?
Patent CN107108559, filed by BeiGene Beijing Co., Ltd., was granted on May 7, 2019, and relates to a method for treating tumors using a novel anti-PD-1 antibody. The patent primarily claims the antibody's structure, its application in specific tumor treatments, and related pharmaceutical compositions.
Core Claims Overview
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Antibody Composition: The patent claims an anti-PD-1 monoclonal antibody with specific amino acid sequences, notably with particular variable regions optimized for binding efficacy.
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Pharmacological Application: The claims include methods for treating tumors, notably non-small cell lung cancer (NSCLC), melanoma, and other solid tumors, through administering the antibody.
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Dosage and Administration: The patent specifies dosage ranges and administration schedules suitable for therapeutic use.
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Pharmaceutical Composition: Claims extend to compositions comprising the antibody and excipients, suitable for injection or infusion.
Scope Boundaries
The patent's claims focus on the antibody's amino acid sequences, with specific sequences listed for the heavy and light chains, and their variants. Claims extend to methods of treatment using the antibody, encompassing certain dosage ranges and administration routes, mainly intravenous infusion.
The claims are specific enough to protect the antibody's particular sequence and its therapeutic use but are limited to antibody molecules with the mentioned sequences or highly similar variants.
How does this patent compare within the landscape?
Similarities with Other Antibody Patents
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It falls within the domain of anti-PD-1 monoclonal antibodies, like pembrolizumab (Keytruda) and nivolumab (Opdivo), which target PD-1 receptor pathways to activate immune responses against tumors.
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The patent's claims on specific antibody sequences contrast with broader claims of immune checkpoint inhibitors. It emphasizes particular variable regions and sequence modifications.
Innovations over Existing Patents
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The patent claims unique amino acid sequences not disclosed in prior patents or publications, potentially providing a competitive edge in China.
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It emphasizes specific methods of treatment, including dosing schedules tailored for Chinese patient populations, which might differ from international standards.
Patent Coverage in Major Jurisdictions
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Similar patents or patent applications have been filed in the US (e.g., US patent applications related to anti-PD-1 antibodies in the same molecule class), with coverage focusing on sequence patents and therapeutics.
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European and Japanese filings tend to have broader claims but lack the detailed sequence specificity seen here.
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The Chinese patent appears to fill a gap by protecting specific sequences and treatment methods optimized for the Chinese market.
Patent Landscape and Market Context
| Patent Type |
Geographical Coverage |
Focus |
Filing Date |
Status |
Notes |
| Sequence patents |
China, US, Europe, Japan |
Anti-PD-1 antibody sequences |
CN: 2017; US: Approx. 2016-2017 |
Granted in CN; Pending in US/EU |
Sequence-specific claims with therapeutic methods |
| Composition patents |
Multiple jurisdictions |
Pharmaceutical formulations |
Filed between 2017-2018 |
Pending/Granted |
Focus on formulations suitable for Chinese markets |
| Method patents |
US, EU, CN |
Tumor treatment protocols |
2018-2019 |
Pending |
Dosing schedules specific to regional protocols |
Major Players and Competitive Positions
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BeiGene, owner of CN107108559, holds a strategic position in China’s immuno-oncology space, focusing on proprietary antibodies versus external foreign competitors.
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Biotech & Pharma Giants like Merck, BMS, and AstraZeneca hold broader anti-PD-1/PD-L1 patents, with some overlapping claims but less sequence specificity in their Chinese filings.
Implications for R&D and Market Strategy
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The patent provides BeiGene with a targeted patent barrier around specific antibody sequences, giving potential exclusivity in China for these molecules.
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The claims covering specific treatment methods, especially with dosing regimens aligned with Chinese regulatory standards, strengthen regional market protection.
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The sequence claims may face challenges if prior art exists but are likely defensible due to the unique amino acid configurations listed.
Key Takeaways
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CN107108559 delivers protection on specific anti-PD-1 antibody sequences and related tumor treatment methods.
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It complements broader immuno-oncology patent portfolios, allowing for regional differentiation.
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The patent landscape in China for anti-PD-1 therapies is active, with BeiGene securing a competitive position through sequence specificity.
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The patent’s focus on specific amino acid sequences and dosing methods positions it as a strategic asset for BeiGene's product development in China.
FAQs
1. How strong are the sequence claims in CN107108559?
Sequence claims are defined by specific amino acid sequences and their close variants, making them potentially strong if they do not overlap with prior art. Variations outside claimed sequences may not be covered.
2. Does this patent prevent other companies from developing anti-PD-1 antibodies in China?
It restricts development of antibodies with the exact sequences claimed and methods of treatment. Alternatives with different sequences may not infringe.
3. How does the patent impact BeiGene’s commercialization plans?
It provides legal protection for the specific antibodies and treatment protocols, supporting exclusivity in China markets.
4. Are there likely to be challenges against these claims?
Yes, especially around the sequence claims, if prior art shows similar amino acid configurations. Patent validity could depend on the novelty and non-obviousness of sequences.
5. How does this patent fit into BeiGene's global patent strategy?
It complements broader international filings by securing region-specific claims, especially for sequences optimized for Chinese patients and regulatory standards.
References
[1] Chinese Patent CN107108559 B. (2019). Anti-PD-1 antibody and its application in tumor therapy.
[2] US Patent Application US20170049778A1. (2017). Anti-PD-1 antibodies and therapeutic uses.
[3] European Patent EP3108431A1. (2017). Anti-PD-1 antibody compositions and methods of use.
