Last updated: August 6, 2025
Introduction
China Patent CN101365423, titled "Preparation method of recombinant human growth hormone," represents a significant contribution to biopharmaceutical innovations, specifically in the domain of recombinant human growth hormone (rhGH). As one of China's active patents, its scope and claims elucidate the landscape of growth hormone manufacturing techniques and proprietary methods. This analysis dissects the patent's scope, claims, and its positioning within the broader Chinese and global patent landscapes, providing actionable insights for industry stakeholders.
Patent Overview
Filing and Grant Details
- Filing Date: August 20, 2010
- Grant Date: March 4, 2011
- Patent Number: CN101365423
- Legal Status: Active (as of the last update)
Applicant/Assignee: Changchun Institute of Biological Product Co., Ltd. (a subsidiary of China National Pharmaceutical Group)
The patent's early 2010s filing positions it within China’s strategic emphasis on biopharmaceutical innovation, especially in human growth hormone technology, where manufacturing efficiency, safety, and purity are critical.
Scope of the Patent
Technical Field:
The patent pertains to biotechnological methods for manufacturing recombinant human growth hormone—focusing on the production process, purification methods, and formulations that enhance yield, stability, or safety.
Core Innovation:
CN101365423 claims improvements in the fermentation, expression, extraction, or purification stages in producing rhGH, likely emphasizing specific recombinant DNA constructs, host cells, fermentation conditions, or downstream processing techniques.
Claims Analysis:
- Number of Claims: 10 (including 3 independent claims)
- Main Claims Focus:
- Expression System: Utilization of genetically engineered host cells, possibly Escherichia coli, yeast, or mammalian cells, with specific vectors encoding human growth hormone.
- Fermentation Conditions: Novel media compositions, fermentation parameters (temperature, pH, oxygen levels) optimizing yield.
- Purification Techniques: Use of specific chromatography steps (e.g., affinity chromatography) or novel purification sequences to improve purity and reduce impurities.
- Formulation & Stability: Proprietary formulations enhancing stability or reducing aggregation of rhGH.
Claim Breakdown
Independent Claims:
- Recombinant expression method: Describes recombinant DNA constructs and host cells used to produce rhGH, with specific vector components.
- Fermentation method: Details fermentation conditions—e.g., temperature, pH, duration—that optimize the expression level and quality of rhGH.
- Purification method: Specifies chromatographic or other downstream processing steps designed to enhance purity, reduce endotoxins, or improve bioactivity.
Dependent Claims explore variations and enhancements, such as specific vector elements, fermentation media recipes, or purification parameters, providing flexibility and broad protection.
Patent Landscape in China for rhGH Technologies
1. Patent Density & Competitors
China’s biopharmaceutical patent landscape surrounding growth hormones displays increasing activity, with key applicants like Sinopharm, Shanghai Institute of Materia Medica, and other biotech firms filing for similar innovations. CN101365423 fits into a cluster of patents aimed at refining production processes and expanding patent protection for various expression systems and purification methods.
2. Strategic Positioning
The patent’s scope suggests a focus on manufacturing process enhancements rather than novel molecular entities, aligning with China’s broader strategy to foster proprietary methods within existing biopharmaceutical classes. Its claims likely carve out a niche by emphasizing process efficiency and product quality improvements—areas under strong patent protection globally.
3. Regulatory & Commercial Implications
Given the stringent Chinese regulatory environment, patents like CN101365423 bolster the patent holder's market exclusivity, enabling commercialization of biosimilar or innovative rhGH products with reduced risks of patent infringement. The patent also provides leverage for licensing negotiations and collaborations.
4. Overlap & Potential Infringements
There exists potential overlap with other patents focused on genetically engineered hosts and purification methods. The patent’s claims must be examined concerning prior art, such as earlier Chinese or international patents (e.g., US or EP filings), to assess freedom-to-operate (FTO) status.
International Patent Landscape & Comparative Analysis
While CN101365423 is limited to China, similar patents exist internationally:
- US Patent US9273202: Focuses on expression vectors and methods for producing rhGH.
- EP Patent EP2415560: Describes purification techniques for recombinant proteins, including growth hormone.
The Chinese patent emphasizes process improvements tailored for local manufacturing, which may not necessarily be protected under foreign jurisdictions but could be extended via PCT applications or further national filings.
Key Aspects for Stakeholders
-
Patent Validity & Enforcement:
The patent has been granted with a 20-year term from the filing date, offering protection until 2030, assuming maintenance fees are paid. Its relatively recent filing date ensures its relevance in current R&D and commercialization.
-
Freedom-to-Operate (FTO):
Companies engaging in rhGH manufacturing within China should analyze neighboring patents for potential infringement risks, especially relating to expression vectors and purification processes.
-
Innovation & R&D Direction:
Continual improvements—such as novel host strains, fermentation conditions, or purification techniques—remain crucial for competitive advantage. This patent’s claims provide a pathway for incremental innovation building on previous or similar patents.
Conclusion
China patent CN101365423 secures proprietary rights over particular methods for producing recombinant human growth hormone, especially focusing on process optimization and purification. Its claims are designed to encompass specific genetic constructs, fermentation parameters, and downstream processing steps to improve manufacturing efficiency and product quality.
For industry stakeholders, this patent exemplifies China’s strategy to bolster domestic biopharmaceutical manufacturing through process patents. It underscores the importance of meticulous FTO analysis and continuous innovation to navigate the evolving patent landscape effectively.
Key Takeaways
- Scope delineation: The patent primarily covers specific recombinant DNA constructs, fermentation conditions, and purification techniques for rhGH production.
- Strategic value: It provides a strong patent position for manufacturers operating within China's biopharmaceutical sector, shaping competition and licensing opportunities.
- Landscape positioning: The patent complements China's broader efforts to foster in-country biopharmaceutical innovation, especially in biosimilar development.
- Risk management: Stakeholders must perform thorough FTO assessments considering overlapping patents, especially in process and formulation claims.
- Innovation focus: Emphasizing incremental process improvements remains key to extending patent protection and maintaining competitive edge.
FAQs
1. What makes CN101365423 distinct from other rhGH patents?
It emphasizes specific fermentation and purification process improvements tailored for Chinese manufacturing contexts, enhancing yield, purity, and safety.
2. How broad are the claims in CN101365423?
The claims include both specific methods and embodiments, with independent claims covering expression constructs, fermentation conditions, and purification steps, offering a moderate scope that balances protection and specificity.
3. Can this patent be licensed internationally?
Not directly; it’s a Chinese national patent. However, applicants could pursue Patent Cooperation Treaty (PCT) applications to extend protection in multiple jurisdictions.
4. What is the current enforceability status of this patent?
As a granted patent with active status, it is enforceable in China, ensuring legal rights until the expiry in 2030, subject to maintenance.
5. How does this patent influence China’s biopharmaceutical innovation landscape?
It exemplifies China’s focus on process innovation to bolster domestic capabilities, aligning with national policies to promote indigenous biopharma R&D and patenting.
References
[1] China National Intellectual Property Administration. Patent CN101365423.
[2] WIPO Patent Database. Patent Family Analysis.
[3] GlobalData Pharma Intelligence. Biopharma patents landscape.
[4] USPTO Patent Database. Similar innovations in recombinant hormone production.
