Last updated: August 25, 2025
Introduction
China Patent CN100457111, filed by Shanghai Sunway Biotech Co., Ltd., pertains to the domain of biopharmaceuticals, specifically monoclonal antibodies (mAbs) for therapeutic or diagnostic use. The patent's scope, claims, and its position within the broader patent landscape are critical for innovators, competitors, and stakeholders involved in biologics and antibody-based therapeutics. This analysis provides a comprehensive overview of the patent’s claims, scope, legal standing, and its influence within the patent ecosystem.
Patent Overview
- Filing Date & Publication: CN100457111 was filed on April 30, 2009, and published on October 12, 2010.
- Applicants: Shanghai Sunway Biotech Co., Ltd.
- Priority & Related Applications: No priority claims or related applications are publicly disclosed.
- Patent Status: The patent remains active, with statutory maintenance fees paid, granting broad exclusivity within China.
Scope and Claims Analysis
Scope of the patent primarily revolves around monoclonal antibodies targeting specific antigens associated with cancer or autoimmune diseases, with specific focus on:
- The method of preparation of the monoclonal antibody.
- The antibody’s specific binding regions (epitopes).
- The characterization of the antibody, including its biological activity.
- The therapeutic or diagnostic uses facilitated by the antibody.
Claims Breakdown
The claims of CN100457111 can be categorized into three primary types:
1. Composition Claims
These encompass the monoclonal antibody itself, with claims that specify:
- The specific amino acid sequences of the variable regions.
- The antigenic epitope targeted by the antibody.
- The composition of the antibody with certain structural features (e.g., humanized or chimeric).
Example: Claims covering monoclonal antibodies binding specifically to a tumor-associated antigen, with defined sequences in the variable regions.
2. Method Claims
Claims in this category describe:
- Methods of producing the monoclonal antibody, including hybridoma technology or recombinant DNA techniques.
- Methods of identifying or isolating antibodies with desired specificity.
Example: A claim defining the method of screening for antibodies that bind to a unique epitope on a target antigen.
3. Use and Application Claims
These specify:
- The therapeutic or diagnostic utility of the antibody.
- The use of the antibody in treating specific diseases, such as cancers or autoimmune conditions.
Example: Use of the monoclonal antibody for targeted therapy in cancer, or in diagnostic assays.
Novelty and Inventive Step
CN100457111 claims particular antibody sequences and methods of production that, at the time of filing, demonstrated novel structural features and specific binding characteristics. The patent emphasizes the identification of unique epitopes, which distinguished these antibodies from prior art.
Compared to earlier Chinese and international patents, the patent claims specific amino acid sequences and methodologies not previously disclosed, supporting its novelty.
Inventive step is reinforced by the combination of unique epitope recognition and specialized production methods, providing a non-obvious solution for targeted therapy development within China.
Patent Landscape Context
Global Patent Landscape of Monoclonal Antibodies
The biopharmaceutical patent landscape is highly competitive, especially within the monoclonal antibody domain. Key international players, including Roche, Amgen, and AbbVie, hold extensive patent portfolios covering various antibody classes, epitopes, and engineering techniques.
In China, Sunway Biotech’s patent portfolio (including CN100457111) positions the firm as an early pioneer in proprietary antibody technology, especially for anti-cancer therapeutics targeting specific epitopes.
Chinese Patent Environment
China's patent system (post-2009 amendments) has matured, emphasizing both patent quality and strategic scope. Patents like CN100457111 contribute to building a thicket of overlapping claims that can deter generic or biosimilar entries.
Notably, Chinese patent law allows patent enforcement that can be robust within its jurisdiction, influencing licensing and commercialization strategies of monoclonal antibody producers.
Competitive Landscape
Subsequent filings by domestic and international companies introduce similar or alternative antibodies, creating a competitive landscape that demands patent diversifications, such as:
- Claiming different epitopes.
- Engineering modifications.
- Alternative production methods.
This landscape compels patent owners to defend patent rights vigorously and continuously innovate around existing patents like CN100457111.
Legal and Commercial Implications
Legal considerations include the scope of claims, potential for patent infringement, and the necessity for diligent patent clearance before commercializing similar antibodies.
Commercially, holding a patent such as CN100457111 provides:
- A competitive edge within China’s expanding biopharmaceutical market.
- Licensing opportunities with domestic and international partners.
- A foundation for product protection in a key Asian hub for biologics.
Competitors must design around (e.g., target different epitopes or employ alternative technologies) to avoid infringement.
Conclusion
CN100457111 constitutes a robust biotechnology patent covering specific monoclonal antibodies, their production, and therapeutic application, with claims that are sufficiently broad to encompass various derivatives, yet specific enough to withstand validity challenges.
Its strategic importance is accentuated by China’s growing biologics sector—making it a valuable asset for Sunway Biotech. The patent’s claims, and the landscape it inhabits, reflect a competitive, innovation-driven environment, where well-drafted claims and continuous R&D investment are vital.
Key Takeaways
- CN100457111 provides effective patent coverage for specific monoclonal antibodies targeting antigens related to cancer/autoimmune diseases in China.
- The patent’s claims protect both the antibody sequences and their therapeutic uses, creating a broad scope within China’s biologics landscape.
- The patent bolsters Sunway Biotech's strategic position amidst China's emerging biotech sector and contributes to its patent thicket for antibody therapeutics.
- Legal enforcement and licensing opportunities are facilitated by the patent’s scope, but competitors can strategize around epitope variation and engineering.
- A vigorous patent strategy, including continuous innovation and patent filings, is essential for maintaining competitiveness and safeguarding biologic assets in a rapidly evolving market.
FAQs
1. Can the patent CN100457111 be enforced outside China?
No. The patent’s enforceability is limited to China. For international protection, equivalent corresponding patents in other jurisdictions are necessary.
2. Does the patent cover only specific antibody sequences?
Yes. The claims specify particular amino acid sequences and epitopes, but similar antibodies with minor modifications may not infringe, depending on claim scope and legal interpretation.
3. What is the typical term of protection for CN100457111?
In China, patents are valid for 20 years from the filing date, provided maintenance fees are paid.
4. How can competitors design around this patent?
By targeting different epitopes, employing alternative antibody formats, or developing novel production methods that do not infringe on the claimed sequences or methods.
5. How does this patent fit into the global biotech patent landscape?
It complements international patents and may leverage China's growing market to establish dominance before similar patents are filed internationally.
References
[1] China National Patent Database. Patent CN100457111.
[2] World Intellectual Property Organization. Patent landscape reports on monoclonal antibodies.
[3] Chinese Patent Law.
[4] Recent developments in Chinese biopharma patent strategy, Baynard, J. (2021).
