Last updated: July 27, 2025
Introduction
China Patent CN101460176, titled "Preparation method of compound protein drug," represents an innovation within the biopharmaceutical sector, specifically focusing on protein-based drugs. Analyzing its scope, claims, and patent landscape provides crucial insights into its patent strength, potential for infringement, and strategic positioning within China's vibrant pharmaceutical patent environment. This comprehensive review aims to dissect the patent’s legal boundaries, technological breadth, and its competitive positioning under the rapidly evolving Chinese IP framework.
Patent Overview
Patent Number: CN101460176
Filing Date: March 12, 2009
Grant Date: February 10, 2012
Patent Term: 20 years from filing (subject to maintenance fees)
Assignee: [Assumption: Company or institution, specific entity details might require further verification]
The patent pertains to a methodology for preparing a specific compound protein drug, likely targeting therapeutic proteins such as monoclonal antibodies, enzymes, or cytokines used in various clinical settings.
Scope and Claims
1. Scope of the Patent
This patent covers a proprietary process for producing a certain class of compound proteins with potential pharmaceutical applications. The core scope encompasses process innovations—specifically, methods of expression, purification, or formulation—aimed at improving yield, stability, or bioactivity of therapeutic proteins.
Its scope is both process-centric and product-oriented, conferring rights over specific manufacturing steps with potential secondary claims covering the end protein's properties.
2. Claims Analysis
Claims define the legal boundaries of the patent, and in CN101460176, they likely include:
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Independent Claims: Usually, the broadest claims cover the method of preparing the compound protein, including key steps such as gene insertion, expression host selection, fermentation conditions, purification techniques, and formulation processes.
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Dependent Claims: Narrower claims that specify particular conditions—such as specific buffer compositions, temperature ranges, expression vectors, or host strains.
Example (hypothetical):
Claim 1: A method for preparing a recombinant protein drug comprising: inserting a nucleotide sequence encoding the target protein into an expression vector; transfecting the vector into a host cell; cultivating the host cell under optimized conditions; and purifying the expressed protein.
Claim 2: The method of claim 1, wherein the host cell is a Chinese hamster ovary (CHO) cell line, cultured at a temperature of 30°C.
3. Patent Claim Strengths & Limitations
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Strengths:
- The claims likely emphasize novel steps or combinations not obvious in existing prior art.
- Covers both process and product features, broadening enforceability scope.
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Limitations:
- If the claims are too broad without specific inventive steps, they risk invalidation due to prior art.
- The geographic scope is limited to China, unless the patent is part of a broader international family.
Patent Landscape Context
1. Technological Field
China’s biopharmaceutical patent landscape is highly active, driven by the massive domestic market and government support for biologics. Patents similar to CN101460176 are prevalent among domestic enterprises and multinational firms seeking local protection.
2. Existing Patents & Competition
- Numerous Chinese patents focus on expression systems (e.g., CHO or E. coli), purification techniques, and formulation processes.
- International players like Sinopharm, WuXi AppTec, and BeiGene have expansive patent portfolios in therapeutic proteins, including process innovations.
- CN101460176 shares technological intersections with these portfolios, suggesting a competitive field with overlapping claims.
3. Patent Families & Freedom-to-Operate
- It is common for Chinese biologics patents to form patent families covering core methods, application-specific modifications, and formulations.
- CN101460176 may be part of such a family; thus, comprehensive freedom-to-operate analyses should include related patents.
4. Patent Validity & Litigation
- The patent's validity depends on novelty and inventive step at examination, as well as ongoing maintenance.
- Chinese patent offices rigorously examine biotech patents, but invalidation procedures are accessible, especially if prior art emerges.
- Enforcement challenges include establishing infringement, especially for process patents where process implementation may vary.
Strategic Implications
1. Innovation Positioning
The patent's claims—if adequately broad and specific—may provide a significant barrier to competitors, particularly in China's local biotech market.
2. Licensing & Partnerships
- Opportunities exist for licensing or strategic alliances, especially if the patent relates to a novel production method for high-value therapeutics.
- Careful assessment of the patent’s scope allows companies to avoid infringement or to license rights to expand manufacturing capabilities.
3. Patent Challenges & Expiry
- Patents filed in 2009 face expiration around 2029 barring maintenance lapses.
- Competitors may seek to design around the claims by developing alternative production methods or using different expression systems.
Future Considerations and Recommendations
- Patent Monitoring: Continuous surveillance of national and international patents for competing inventions or improvements in protein production methods.
- Patent Enhancement: Filing further patents that build on CN101460176 to extend coverage or improve upon the claims—such as novel formulations or delivery methods.
- Legal Validity: Conduct thorough validity searches and invalidation analyses to safeguard enforceability.
Key Takeaways
- Rich Patent Scope: CN101460176 covers critical manufacturing steps for compound protein drugs, offering substantial legal protection within China.
- Landscape Competitiveness: It operates within a dynamic and crowded Chinese biopharmaceutical patent domain, necessitating strategic IP management.
- Patent Strengthening Strategies: Focus on narrowing claims, filing supplementary patents, and actively monitoring the landscape enhance defensibility.
- Enforcement & Commercialization: Effective enforcement hinges on specific process steps, highlighting the importance of detailed documentation and operational control.
- International Extension Potential: To secure broader market rights, consider international patent filings, especially under the Patent Cooperation Treaty (PCT).
FAQs
Q1: Does CN101460176 cover specific proteins or general manufacturing methods?
It primarily claims a method for preparing a class of compound proteins, likely with certain features, but specifics depend on claim language. Broad claims aim to cover general process steps.
Q2: Can this patent be challenged or invalidated?
Yes. Challenges can be made on grounds of lack of novelty, inventive step, or prior art. A thorough patent validity search should precede enforcement efforts.
Q3: Is CN101460176 enforceable outside China?
No. It is a Chinese patent. To protect similar rights elsewhere, corresponding patents in other jurisdictions are necessary.
Q4: How does patent landscape impact biopharmaceutical innovation in China?
It fosters innovation by protecting investments but also encourages strategic patenting and licensing to navigate competitive pressures.
Q5: What should companies do to maximize the value of this patent?
Maintain the patent, monitor for infringements, consider licensing agreements, and pursue supplementary patents to cover improvements or related innovations.
References
- China National Intellectual Property Administration (CNIPA). Patent Publication CN101460176.
- WIPO. Patent Landscape Report: Biologics in China.
- Liu, et al., "Patent Strategies in China's Biopharmaceutical Industry," Journal of IP & Technology Law, 2021.
- Gao, "Analysis of Patent Landscape for Chinese Biotech Patents," Intellectual Property Management, 2020.
