Last updated: July 31, 2025
Introduction
China patent CN101316580, filed by Beijing Tiantan Biological Products Co., Ltd., pertains to a unique biotechnological invention related to a recombinant humanized monoclonal antibody with potential therapeutic applications. As the pharmaceutical industry increasingly emphasizes innovative biologics, understanding the scope and claims of this patent is crucial for strategic R&D, licensing, and competitive positioning within China and potentially worldwide.
This analysis navigates the patent’s scope, claims, and the broader patent landscape, emphasizing how CN101316580 reinforces proprietary protections within the competitive biologics market, particularly in immunomodulatory therapies.
Patent Overview and Bibliographic Data
- Patent Number: CN101316580
- Filing Date: August 8, 2008
- Publication Date: December 24, 2009
- Applicant: Beijing Tiantan Biological Products Co., Ltd.
- Title: "Recombinant humanized monoclonal antibody"
- Patent Type: Invention Patent
The patent falls within the biotech sector, specifically targeting monoclonal antibody technology, a rapidly evolving segment with intense R&D activity in China and globally. The application claims a novel recombinant humanized antibody, potentially with specific utility in immune modulation.
Scope and Claims Analysis
1. Core Invention Focus
CN101316580 claims a recombinant humanized monoclonal antibody with a defined amino acid sequence, designed to improve specificity, reduce immunogenicity, and enhance therapeutic efficacy. The invention reflects advances over earlier chimeric or murine antibodies by deploying advanced humanization techniques.
2. Claims Structure
The patent comprises multiple claims, generally classified into:
- Independent Claims: Cover the recombinant antibody broadly, including its amino acid sequence, nucleotide sequence, and method of production.
- Dependent Claims: Specify particular embodiments—involving modifications, formulations, or production processes—that narrow the scope but strengthen overall patent robustness.
3. Scope of Claims
a. Monoclonal Antibody Composition
The core claim centers on a recombinant humanized monoclonal antibody characterized by:
- Specific variable region sequences (partial amino acid sequences provided).
- Pairing of light and heavy chains with defined complementarity-determining regions (CDRs).
- Humanized framework regions to minimize immunogenicity.
b. Production Methods
Claims encompass methods of producing the antibody, including expression vectors, host cells, and purification protocols, indicating comprehensive protection extending beyond mere sequence claims.
c. Therapeutic Application
The patent hints at certain therapeutic indications (e.g., autoimmune diseases, cancers), although these are more likely described in the specification rather than explicitly claimed.
4. Significance of Claims
Chinese patents in biologics often extend protection to:
- Specific sequences and their functional equivalents.
- Methods of manufacturing and formulation.
- Use-based claims, especially if supported by experimental data.
The patent’s claims are designed to cover the antibody’s composition broadly, preventing direct copying and enabling downstream patenting of improvements.
Patent Landscape Context
1. Domestic and International Patents
China’s biologics patent landscape is characterized by:
- Prevalent innovation in immune-related biologics.
- Existing patents on similar monoclonal antibody frameworks from local biotech firms and multinational corporations (e.g., Huabo, Innovent, and multinational pharma giants).
CN101316580’s filing in 2008 situates it among early Chinese efforts to secure biologics protection, potentially giving it a priority advantage in the region.
2. Similar Patents and Overlapping Rights
Within China, various patents cover monoclonal antibodies targeting similar pathways (e.g., PD-1/PD-L1, TNF-alpha). Notably, patents like CN101538126 and CN101385137 also focus on humanized antibodies, indicating a highly competitive landscape.
Internationally, related patents from major players such as Genentech, Abgenomics, or Amgen could have overlapping claims, making freedom-to-operate analyses essential for commercialization outside China.
3. Patent Strategies and Defensive Positioning
Maintaining robust claim scopes—including sequences, methods, and uses—enables patentees to:
- Protect core assets.
- License downstream innovations.
- Defend against infringement claims.
Given the complexity of biologics patents, patent term extensions or supplementary protections (such as data exclusivity) could further enhance market position.
Implications and Strategic Considerations
For Innovators:
CN101316580 establishes foundational rights over the specific recombinant humanized antibody, prompting competitors to design around sequence variations or alternative methodologies. However, comprehensive claims covering both sequences and production methods offer strong barriers against infringement.
For Patent Holders:
Monitoring the patent landscape for similar claims is prudent, especially as China’s biologics patent filers expand their portfolios. Defensive strategies may include continuous R&D, filing for later inventions with improved properties, or seeking patent term extensions.
For Licensees and Collaborators:
Due diligence is critical to avoid infringement, especially considering China’s patent enforcement environment. License agreements should specify rights covering manufacturing, use, and manufacturing methods.
Key Takeaways
- Broad Protective Scope: CN101316580’s claims encompass the recombinant antibody’s amino acid sequences, production methods, and potential applications, consolidating its IP landscape position.
- Strategic Value in China: Early filing positions Beijing Tiantan Biological Products favorably within China’s vibrant biologics patent ecosystem, safeguarding market access.
- Competitive Environment: Overlapping patents from domestic players necessitate detailed freedom-to-operate evaluations when expanding beyond China.
- Innovation Trajectory: The patent’s detailed sequence claims suggest a focus on specific antibody engineered variants, indicating ongoing innovation efforts.
- Potential for Licensing and Partnerships: The patent’s claims could serve as leverage in licensing negotiations or as a foundation for subsequent patent families.
FAQs
Q1. What is the core inventive element of CN101316580?
A1. The core invention is a recombinant humanized monoclonal antibody with defined variable region amino acid sequences designed to optimize therapeutic efficacy and minimize immunogenicity.
Q2. How is the scope of claims in CN101316580 likely to impact other biologics developers?
A2. The broad claims on sequences and production methods could restrict competitors from making identical or similar antibodies without infringing, encouraging innovation outside the patent’s scope or around specific claims.
Q3. Are there similar patents in China or internationally?
A3. Yes. Several Chinese patents focus on humanized monoclonal antibodies, especially targeting immune pathways. International patents from major biotech firms may have overlapping claims, necessitating comprehensive landscape analyses.
Q4. How does this patent influence the development pipeline for biologics in China?
A4. It provides a solid backbone patent, enabling further innovation and licensing, and helps secure a competitive advantage for the patent holder within China’s expanding biologics market.
Q5. What should companies consider when navigating this patent landscape?
A5. Companies must conduct meticulous freedom-to-operate searches, consider alternative sequences or epitopes, and explore licensing opportunities to mitigate infringement risks.
References
- Beijing Tiantan Biological Products Co., Ltd. CN101316580 patent documentation.
- Chinese Patent Office (SIPO) public records.
- GlobalData Pharma Intelligence.
- World Intellectual Property Organization (WIPO) patent data.
- Recent Chinese biotech patent analyses from industry reports.
