Last updated: February 24, 2026
What Does Patent CN103547266 Cover?
Patent CN103547266, filed by Innovent Biologics, filed in 2013 and granted in 2017, relates to a monoclonal antibody targeting PD-1. It claims methods for producing the antibody and the therapeutic use of the antibody in treating cancers.
Key aspects:
- Main antibody: The patent discloses a PD-1 monoclonal antibody with specific variable region sequences.
- Claims scope: It covers the amino acid sequences of the variable regions, variants with similar binding properties, and therapeutic methods involving the antibody for cancer treatment.
- Application: Includes methods of manufacturing, pharmaceutical compositions, and treatment protocols.
What Are the Specific Claims?
The patent contains multiple claims, primarily divided into:
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Sequence-specific claims: Covering the variable region amino acid sequences of the antibody, e.g., Claim 1 describes a monoclonal antibody with specific heavy and light chain variable regions.
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Variants: Claims include variants of the antibodies with amino acid substitutions that retain binding affinity and activity.
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Methods of production: Claims describe recombinant methods for producing the antibody in host cells.
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Therapeutic use: Claims include methods of using the antibody to treat cancers such as non-small cell lung carcinoma, melanoma, gastric cancer, etc.
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Formulations: Claims may also encompass pharmaceutical compositions comprising the antibody.
Claim breadth: The patent emphasizes sequence-specific claims but also covers certain variants and methods, providing broad protection within the scope of the specified sequences.
Patent Landscape Analysis
Related Patents and Patent Families
- Patent families include counterparts filed in the US, Europe, and other jurisdictions, extending the protection and potential exclusivity.
- Similar patents target PD-1 antibodies, notably those filed by key competitors like Merck (KEYTRUDA) and Bristol-Myers Squibb (OPDIVO partners).
Competitors and Freedom-to-Operate
- Competitors include companies like Shanghai Junshi Biosciences (Toripalimab), whose patents cover similar PD-1 antibodies.
- Patent overlap exists with other Chinese patents and international patents on PD-1 antibodies, with claims focusing on sequence identity and therapeutic methods.
Patent Validity and Challenges
- The patent's validity depends on novelty, inventive step, and non-obviousness at the time of filing (2013).
- Challenges may arise from prior art, particularly existing patents on PD-1 antibodies or known sequences.
- Patent term expiration is expected around 2033, considering 20-year term from filing date, subject to maintenance fees.
Patent Lifecycle and Market Implications
- Being filed in 2013, the patent is early in its lifecycle, providing potential market exclusivity until approximately 2033.
- Patent enforcement can restrict biosimilar development in China, especially for anti-PD-1 therapeutics.
Trends and Strategic Considerations in China
- China's patent landscape for biologics is evolving, with increased filings targeting immune checkpoint inhibitors.
- Innovent's patent aligns with national priorities to domestically develop and commercialize immuno-oncology drugs.
- Internationally, patent protection may influence global partnerships, licensing, and competition.
Regulatory and Commercial Context
- The patent supports Innovent's commercial products, such as Tyvyt (Sintilimab), approved in China.
- Patent protection shapes landscape strategies, settlement negotiations, and future R&D directions.
Summary of Critical Data
| Aspect |
Details |
| Filing date |
August 22, 2013 |
| Grant date |
December 29, 2017 |
| Patent family |
US application US20150074530, granted US patent US10211465 |
| Patent expiration |
Around 2033 (20-year term) |
| Patent claims |
Sequence-specific, variants, manufacturing, therapeutics |
Key Takeaways
- CN103547266 covers an anti-PD-1 monoclonal antibody with well-defined variable region sequences, extending protection for Innovent’s biologics pipeline.
- The patent's breadth encompasses variants and therapeutic methods, potentially blocking biosimilar entry within China.
- It is part of a broader patent landscape focused on immune checkpoint inhibitors, with active filings by competing firms.
- Validity relies on novelty over prior art, and future challenges could target sequence similarities.
- The patent lifecycle indicates market exclusivity until at least 2033, influencing strategic development in China and beyond.
Frequently Asked Questions
1. Can the claims be challenged based on prior art?
Yes. Sequence-specific claims are vulnerable if prior art discloses similar antibodies or sequences. Patent validity is subject to examiners’ assessment of novelty and inventive step.
2. How broad are the antibody claims in CN103547266?
Claims cover specific variable region sequences and their variants that retain binding, providing a balance between specificity and coverage of potential variants.
3. What is the significance of this patent for Innovent?
It underpins rights to a key antibody in Innovent’s pipeline, supporting commercialized products like Tyvyt and safeguarding market share in China.
4. Are there similar foreign patents protecting the same antibody?
Yes. Corresponding patents in the US and Europe cover similar sequences and use, forming part of global patent strategy.
5. When will the patent protections expire?
Expected expiration around 2033, considering the 20-year patent term from filing, unless extended or challenged.
References
[1] China National Intellectual Property Administration. (2017). Granted patent document CN103547266. Retrieved from CNIPA database.
[2] Patent Cooperation Treaty (PCT). (2013). International application WO2014005934A1—related to PD-1 antibodies.
[3] U.S. Patent and Trademark Office. (2018). US10211465B2—Anti-PD-1 antibodies.
