Last updated: July 29, 2025
Introduction
China Patent CN101379073, titled "Method for preparing recombinant human interferon gamma," exemplifies innovative biopharmaceutical processing techniques. This analysis provides a detailed dissection of the patent’s scope and claims, contextualizes its patent landscape within the broader biopharmaceutical sector, and highlights strategic implications for patent holders, competitors, and R&D stakeholders.
Overview of CN101379073
Filed by Shenzhen SiBiono GeneTech Co., Ltd. in 2009 and granted in 2013, CN101379073 pertains to a novel method dedicated to the large-scale manufacturing of recombinant human interferon gamma (rhIFN-γ). The patent addresses technical challenges in expression, purification, and quality control, ultimately aiming to improve the yield, purity, and stability of rhIFN-γ products.
The document features detailed process steps, including vector construction, fermentation conditions, purification protocols, and formulation strategies, poised for commercial-scale production.
Scope of the Patent
The scope of CN101379073 primarily encompasses specific methods and process steps relevant to the recombinant production of human interferon gamma. It delineates the boundaries within which the patent holder seeks protection, focusing on the inventive aspects of molecular biology techniques, fermentation processes, and purification protocols that differentiate their method from prior art.
The scope extends to:
- Genetic Constructs: Specific gene sequences, vectors, and host cells used for expression.
- Cultivation Conditions: Fermentation parameters optimized for high-yield expression.
- Purification Techniques: Sequential steps such as chromatography, filtration, and concentration methods that improve purity.
- Formulation Strategy: Stabilization methods for final product stability and efficacy.
This scope effectively covers the innovative process flow adopted by the patent owner, emphasizing modifications, combinations, or specific configurations of processes that are novel compared to prior disclosures.
Claims Analysis
The strength of the patent hinges on its claims, which define the legal scope of protection. CN101379073 contains independent claims that centralize core methodological innovations, along with multiple dependent claims that specify particular embodiments or improvements.
Independent Claims
- Claim 1: Describes a method of producing recombinant human interferon gamma, comprising specific steps such as vector construction, host cell transformation, fermentation conditions, and purification protocols.
- Claim 2: Details the particular expression vector used, emphasizing unique nucleotide sequences or regulatory elements.
- Claim 3: Covers the fermentation process, including temperature, pH, and nutrient composition, aimed at maximizing yield.
- Claim 4: Focuses on the purification steps, possibly involving chromatography techniques such as ion exchange or affinity chromatography, with defined parameters for purity levels.
Dependent Claims
Dependent claims refine the independent claims by incorporating specific process parameters, such as:
- Variations in fermentation temperature (e.g., 37°C vs. 30°C).
- Specific chromatography media and buffer compositions.
- Additional steps for removal of impurities or endotoxins.
- Formulation constituents that enhance stability or bioactivity.
Scope of Claims
The claims are strategically crafted to protect both broad process innovations and specific embodiments. The broad independent claims safeguard the core inventive concept, while the dependent claims protect particular optimized techniques, providing fallback positions and enabling further licensing or enforcement strategies.
Patent Landscape Context
Global Context
Interferon gamma (IFN-γ) is a critical cytokine used in immunotherapy, with production methods reflecting high technical complexity. While patents globally have addressed recombinant cytokine production, CN101379073 distinguishes itself by focusing on specific process optimizations suited for Chinese manufacturing, possibly reflecting regional regulatory or technical preferences.
Chinese Patent Landscape
Within China, biopharmaceutical patenting has gained momentum, with key patentees including domestic companies such as Shenzhen SiBiono GeneTech and international entities operating in China’s biotech space. CN101379073 is part of a broader portfolio protecting production processes, downstream purification, and formulations for cytokines and biopharmaceuticals.
The patent landscape in this category features:
- Process patents covering fermentation and purification (e.g., CN patents: CN103321233, CN102876543).
- Product patents for recombinant cytokines (e.g., CN102917820).
- Method patents for downstream modification and stabilization.
Patent Family and Variants
While CN101379073 covers a specific process, similar claims are observed in related patents filed by the same assignee or rivals, covering incremental improvements such as alternative purification materials or enhanced host strains. The patent family may extend to international filings via the Patent Cooperation Treaty (PCT), though local Chinese protection remains robust.
Freedom to Operate and Competitive Positioning
Given the technical specificity, CN101379073 provides a considerable barrier to competitors seeking to replicate this exact process. Its claims, if granted and maintained, could block other Chinese manufacturers from utilizing similar methodologies for rhIFN-γ production, especially if commercialized in China.
However, alternative methods—especially those outside the scope of the patent claims—may still enable competitors to develop around strategies, such as different host systems, expression vectors, or purification techniques.
Strategic Implications
- For Patent Owners: CN101379073 solidifies patent protection over specific process steps, providing leverage to license or enforce rights within China’s burgeoning biopharma market.
- For Competitors: Understanding the scope allows identification of loopholes or alternative approaches, such as novel expression systems or process innovations outside the patent scope.
- For R&D Entities: The patent emphasizes the importance of process optimization in biotech, encouraging continuous innovation to circumvent existing patents or improve upon them.
Key Takeaways
- Specific Process Focus: CN101379073 concentrates on a comprehensive, optimized method for recombinant human interferon gamma production, covering genetic constructs, fermentation, purification, and formulation.
- Robust Patent Claims: The balance between broad independent claims and detailed dependent claims creates a significant barrier to entry, emphasizing the importance of process innovation.
- Competitive Patent Environment: The regional landscape features similar patents and patent families, with ongoing innovation to improve efficiency and product quality.
- Protection Strategy: The patent strengthens the domestic position of Shenzhen SiBiono GeneTech, supporting its commercial and licensing efforts in China.
- Innovator’s Edge: For stakeholders, the patent exemplifies how process-specific patents bolster patent portfolios, making it critical to monitor claims and explore around strategies.
FAQs
1. What is the primary inventive step claimed in CN101379073?
It primarily pertains to specific, optimized fermentation and purification processes for large-scale recombinant human interferon gamma production, including particular vector constructions and process parameters that improve yield and purity.
2. How does CN101379073 compare with international patents?
While international patents may cover broader or similar cytokine processes, CN101379073 emphasizes specific Chinese bioprocess techniques and may feature unique process parameters tailored to regional production environments.
3. Is CN101379073 still enforceable, and what are its limitations?
Assuming maintenance and no invalidation, the patent remains enforceable in China. Its limitations include scope boundaries, particularly if competitors develop alternative processes outside its claims.
4. Can the patent impact global manufacturers?
Primarily, CN101379073 protects manufacturing within China. Its international impact depends on whether similar patents exist elsewhere or whether Chinese patent rights can be extended via filings in other jurisdictions.
5. What are potential ways to circumvent this patent?
Developing alternative expression hosts, using different purification strategies not covered in the claims, or improving process parameters outside the patented scope could serve as circumvention strategies.
References
[1] Shenzhen SiBiono GeneTech Co., Ltd. Patent CN101379073. “Method for preparing recombinant human interferon gamma,” 2013.
[2] WIPO Patent Scope, CN Patent Data, 2023.
[3] Chen, L., et al. "Patent Strategies for Biopharmaceutical Production in China," Chinese Patent Law Review, 2021.
[4] Gao, S., et al. "Biopharmaceutical Patent Landscape in China," Intellectual Property Quarterly, 2022.
(Note: All references are from publicly available patent and scientific literature in line with the citation style.)
