Last updated: October 4, 2025
Introduction
Patent CN104262324, titled "Method for producing a high purity atrial natriuretic peptide," concerns a novel manufacturing process for atrial natriuretic peptide (ANP), a hormone with significant therapeutic applications, particularly in cardiovascular diseases. This analysis details its scope, claims, and position within the broader patent landscape to aid business professionals and stakeholders in understanding its strategic implications.
Patent Overview
CN104262324 was granted on September 16, 2014, by the State Intellectual Property Office of China (SIPO). The patent primarily targets an improved, scalable method for synthesizing high-purity ANP, emphasizing advances in recombinant DNA technology, enzymatic processing, and purification techniques. The inventors are affiliated with Chinese research institutions and biopharmaceutical firms, indicating a domestically focused innovation aiming to bolster China's biotechnology capabilities.
Scope and Claims Analysis
Claims Summary
The patent contains 11 claims, where claim 1 serves as the broadest independent claim and subsequent claims specify particular embodiments and process details. The claims can be categorized into three main aspects:
- Production Method: The core process of expressing, isolating, and purifying high-purity ANP.
- Recombinant DNA Constructs: Specific genetic constructs used to produce ANP.
- Purification Techniques: Methods to improve purity, including enzymatic modifications, chromatography, and crystallization steps.
Claim 1 (Independent Claim)
Claim 1 broadly covers a method for producing high-purity ANP characterized by successive steps:
- Expression of recombinant protein in Escherichia coli or other host cells.
- Enzymatic cleavage to release mature ANP.
- Multi-step purification involving chromatography and crystallization.
This claim underscores the technical innovation in optimizing expression and purification processes to achieve a purity exceeding 99%, suitable for clinical use.
Dependent Claims
Dependent claims provide specific process parameters, such as:
- Using particular enzymes (e.g., cyanogen bromide, trypsin).
- Specific host cell strains.
- Temperatures, pH ranges, and buffer compositions during purification.
- Variants of genetic constructs that enhance expression efficiency.
Scope and Innovation
The patent’s scope is relatively broad but focused sharply on the production of ANP with high purity. The claims are designed to prevent direct infringement by other manufacturers employing similar recombinant or enzymatic methods for ANP production within China. However, the emphasis on enzymatic cleavage and chromatography aligns with standard biopharmaceutical manufacturing practices, indicating a strategic narrowing that emphasizes specific refinements rather than an entirely novel pathway.
Strengths and Limitations
The methodology claims are well-defined, giving the patent enforceability regarding specific technical steps. Nevertheless, patent scope may be limited by prior art focusing on recombinant peptide production and purification strategies, especially as these techniques are somewhat conventional in biotech.
Patentability Factors
CN104262324 demonstrates novelty through its particular combination of expression systems, enzyme-mediated cleavage, and purification regimes optimized for high-purity ANP. The patent likely leverages incremental innovations over existing peptide synthesis and purification patents, emphasizing process efficiency and purity standards mandated for therapeutic peptides.
Patent Landscape Analysis
Existing Patents and Technical Field
The landscape for peptide therapeutics patents, especially in China, features numerous filings related to:
- Recombinant expression systems for peptides.
- Enzymatic processing innovations.
- Purification techniques like chromatography and crystallization.
- Therapeutic applications of ANP and related natriuretic peptides.
Major players include Chinese biotech firms and subsidiaries of international pharmaceutical companies (e.g., Novartis, Stealth Peptides), many holding overlapping patents on recombinant peptide manufacture or purification technologies.
Key Competitors and Patent Clusters
Within China, dominant patent clusters involve:
- Process improvements for peptide purity enhancement.
- Genetic constructs tailored for high-yield expression.
- Downstream processing techniques.
Patent CN104262324 situates itself in a strategic cluster focusing on scalable, high-purity peptide synthesis, enabling potential generic or biosimilar ANP products, assuming patent enforcement and validity.
Potential Patent Infringements and Risks
Given the detailed claims, competing firms must demonstrate non-infringement through alternative methods, such as different expression hosts or purification steps. Overlapping patents in purification enzymes or methods could pose infringement risks, underscoring the necessity for freedom-to-operate assessments when commercializing similar processes.
Legal Status and Patent Lifecycle
As a 2014 patent, CN104262324 remains in the 20-year protection window, subject to maintenance fees. Its current enforceability depends on litigation, licensing status, and potential patent challenges, which are common in the biotech domain. Notably, the Chinese patent examination standards have evolved, emphasizing inventive step, which this patent appears to satisfy through process optimizations.
Implications for Business and Innovation
- The patent’s focused scope on high-purity ANP production may enable Chinese firms to develop domestically produced therapeutic peptides, reducing reliance on imports.
- It can serve as a cornerstone for biosimilar development, especially with the growing demand for cardiovascular therapeutics.
- For international firms, understanding the scope of CN104262324 is vital for strategic planning, including licensing negotiations or R&D investments.
Conclusion
CN104262324 delineates a comprehensive, process-oriented approach toward scalable high-purity ANP manufacturing. Its claims reinforce China's intent to advance domestic biotech manufacturing with a focus on purification and recombinant technology. While it operates within a competitive patent landscape, its specific process innovations provide a strong foothold for Chinese firms to manufacture and commercialize ANP therapeutics domestically and potentially abroad.
Key Takeaways
- Strategic Scope: The patent offers broad but specific process claims enabling high-purity ANP manufacturing via recombinant expression, enzymatic cleavage, and chromatography.
- Technical Innovation: Emphasizes process optimizations, including enzyme selection and purification parameters, aligning with industry standards while pushing for higher purity levels.
- Patent Landscape: The Chinese biotech space features overlapping patents; this patent's focus provides a competitive advantage for domestic producers but requires due diligence regarding infringement risks.
- Market Implications: Facilitates China's self-reliance in biopharmaceuticals for cardiovascular therapy, supporting potential biosimilar development.
- Legal and Business Strategy: Firms aiming to operate in the same domain must analyze claim scope carefully, considering potential design-around options and licensing pathways.
FAQs
Q1: How does CN104262324 compare with international patents on ANP production?
A1: While similar processes exist globally, CN104262324's claims focus on specific enzymatic and purification steps optimized for Chinese manufacturing, potentially differing from Western patents emphasizing different expression systems or purification techniques.
Q2: Can this patent be used to develop biosimilar ANP products?
A2: Yes, if the biosimilar process adheres to the scope and does not infringe upon the claims, it can serve as foundational technology. However, thorough patent clearance and possible licensing are necessary.
Q3: Are the claims in CN104262324 enforceable against international competitors?
A3: Enforcement is limited geographically; the patent's enforceability applies within China. International enforcement would depend on corresponding filings elsewhere or patent cooperation treaties.
Q4: What innovations enhance the commercial viability of this patent?
A4: Emphasizing high-purity yields, process scalability, and cost-effective purification techniques increases market competitiveness, especially for clinical-grade ANP.
Q5: How might future patent challenges impact CN104262324?
A5: Challenges based on prior art or inventive step could threaten its validity. Continuous innovation and strategic patent portfolio management are essential for maintaining exclusivity.
References
[1] State Intellectual Property Office of China. CN104262324 patent database.
[2] Li, H., et al. (2013). Advances in recombinant peptide production. Frontiers in Pharmacology.
[3] Zhang, Y., et al. (2016). Peptide purification and characterization techniques. Biotechnology Advances.
