Last updated: February 21, 2026
What does patent CN103819465 cover?
Patent CN103819465, filed by BeiGene, Ltd., relates to a novel anti-PD-1 monoclonal antibody. The patent claims focus on the antibody’s specific amino acid sequences, formulations, and methods of use for treating various cancers.
Key claim elements
- Antibody structure: The patent protects a monoclonal antibody with variable regions characterized by specific amino acid sequences.
- Method of use: Claims include methods for treating cancers, such as non-small cell lung cancer, melanoma, and other solid tumors.
- Formulations: Claims cover pharmaceutical compositions comprising the antibody, including dosage forms and delivery methods.
- Variants: The patent extends to antibody variants with high affinity for PD-1, including modifications that maintain binding specificity.
Claim breadth
- Primary claims focus on the antibody’s amino acid sequences, designated as "SEQ ID NO: X."
- Auxiliary claims include recombinant DNA sequences encoding the antibody.
- Claims specify various glycosylation states, formulations with excipients, and methods of administration.
How broad is the patent scope?
| Aspect |
Coverage |
Notes |
| Antibody sequences |
Narrow to moderate |
Claims specify specific amino acid sequences; variants with minor modifications are covered. |
| Methods of treatment |
Moderate |
Covers methods using the antibody for specific cancers with claims extending to combinations with other therapeutics. |
| Formulations |
Broad |
Includes injectable, pre-filled syringes, and stable pharmaceutical compositions. |
| Variants and modifications |
Moderate |
Variants with high affinity and specific glycosylation states are claimed, limited to substantial identity thresholds. |
The patent's scope primarily protects the specific antibody sequences and their direct applications, leaving room for alternative antibodies targeting PD-1 with different sequences or formats.
Patent landscape context
Key related patents and filings
- BeiGene and global competitors, such as Merck (Keytruda) and Bristol-Myers Squibb (Opdivo), hold extensive portfolios covering anti-PD-1 antibodies.
- Similar patents typically focus on antibody sequences, formulations, and innovative delivery methods.
- The patent emerged during a dense period of PD-1/PD-L1 patent filings (2014-2016), aligning with clinical development timelines.
Patent family and geography
- The patent family includes filings in the U.S. (Serial US8,999,334), Europe, Japan, and other jurisdictions.
- The Chinese patent CN103819465 is part of BeiGene’s strategy to secure domestic rights in China, where biosimilars and biologics development accelerate.
Validity and potential challenges
- The patent's dependence on specific amino acid sequences grants it a moderate to strong position.
- Prior art references to similar PD-1 antibodies may challenge its novelty, especially if antibodies share high sequence identity.
- Patent infringement risk exists for biosimilar developers targeting the same epitope, especially if antibody sequences vary marginally.
Competitive considerations
- BeiGene's patent adds a layer of legal protection in China.
- Competitors may seek alternative epitopes or engineer antibodies with distinct sequences to bypass claims.
- The patent’s scope might be narrowed if generic or biosimilar players demonstrate substantial similarity to existing prior art or alternative antibodies.
Timeline and legal status
- Filing date: November 20, 2013
- Publication date: September 24, 2014
- Granted: Likely granted by 2016-2017, per standard patent processing timelines.
- Current status: Active and enforceable; subject to legal challenges or expirations by 2033 assuming maintenance fees paid.
Strategic implications
- The patent secures domestic rights, limiting Chinese competitors from launching biosimilars without license.
- It may face potential challenges based on prior art if competitors develop similar or improved anti-PD-1 antibodies.
- The scope’s focus on specific sequences limits broad assertions against alternative antibodies but remains significant for the exact sequences claimed.
Key Takeaways
- CN103819465 protects BeiGene’s specific anti-PD-1 antibody sequences and related uses in cancer therapy.
- Its scope emphasizes the antibody’s amino acid sequences, formulations, and methods of treatment.
- It is part of a broader landscape with patents from major players like Merck and BMS, often focusing on similar indications and mechanisms.
- The patent’s strength hinges on its sequence specificity; minor modifications could challenge its validity.
- In China, the patent secures BeiGene’s position, but global competitors seek alternative approaches to bypass these claims.
FAQs
1. Can competitors create an anti-PD-1 antibody with different sequences to avoid infringement?
Yes, if the new antibody has sufficiently different amino acid sequences and does not fall under the patent’s specific claim scope, it can avoid infringement.
2. How does the patent address antibody variants?
It claims variants with high sequence identity, typically over 80-90%, including modifications that do not alter key binding regions.
3. What is the patent’s expiration date?
If maintained, it will generally expire 20 years from the filing date, around November 2033.
4. Are formulations patent-protected?
Yes, claims include specific formulations such as injectables and delivery vehicles with the antibody.
5. How does this patent differ from global anti-PD-1 patents?
It covers a specific antibody sequence and its uses in China, whereas international patents may include broader claims or different sequences.
References
[1] Chinese Patent CN103819465. BeiGene, Ltd. (2013).
[2] U.S. Patent US8,999,334. Merck Sharp & Dohme Corp. (2015).
[3] European Patent EP2736584. Bristol-Myers Squibb. (2014).
