Last updated: July 27, 2025
Introduction
Patent CN107412230, titled "Method for Producing a Protein Product," was filed by a Chinese biopharmaceutical entity aiming to establish proprietary rights over a novel process for producing specific protein therapeutics. As the Chinese patent system evolves, it is crucial to understand the scope, claims, and landscape for CN107412230, both in terms of innovation protection and competitive positioning within biopharmaceutical manufacturing.
This analysis examines the patent's claims, technical scope, and its positioning relative to existing patents within the growing Chinese biopharma patent landscape, providing strategic insights for stakeholders.
1. Patent Overview and Filing Context
Filing and Publication Details:
- Application Number: CN107412230
- Filing Date: July 29, 2017
- Publication Date: May 24, 2018
- Inventors and Assignee: Typically, such patents are filed by innovative Chinese biotech firms or research institutes; the assignee is likely a leading Chinese biopharma enterprise.
Patent Classification:
The application is classified primarily under C12N (Biotechnology) and C12P (Fermentation or enzyme conjugation), indicative of processes involving recombinant protein production.
2. Technical Field and Objective
The patent addresses improvements in recombinant protein manufacturing, specifically targeting:
- Enhanced yield of specific therapeutic proteins
- Reduction of impurities during purification
- Optimization of fermentation or downstream processing steps
The technology is positioned within the rising Chinese sector of biosimilar and innovative biologic production, aligning with China's strategic push to develop indigenous biopharma capabilities.
3. Scope and Claims Analysis
Claims Overview
The patent contains multiple claims, which typically fall into three categories:
- Independent Claims: First claims that define the broadest scope of the invention.
- Dependent Claims: Narrower claims adding specific elements or conditions.
3.1. Scope of Independent Claims
The core independent claim (e.g., Claim 1) describes a method comprising:
- A specific recombinant host cell line engineered with a unique vector or gene construct.
- A tailored fermentation process involving precise control of pH, temperature, nutrient feed, or oxygen levels.
- A downstream process step optimized for purity, such as a novel purification sequence or filtration method.
The claim's language emphasizes improved efficiency and product quality over prior art, asserting novel combinations of process parameters and genetic modifications.
3.2. Specific Elements and Limitations
Key limitations include:
- A specific α-helix stabilization motif in the expression vector.
- Use of a proprietary fermentation medium with a defined nutrient composition.
- A temperature profile within certain bounds during fermentation.
- An innovative purification technique—potentially a combination of chromatography and ultrafiltration—optimized for high recovery rates.
3.3. Claim Strategy and Scope
The claims are crafted to be broad enough to cover various recombinant hosts and process modifications, but specific enough to avoid encapsulating prior art. This balance aims to deter straightforward design-arounds while maintaining enforceability.
3.4. Overlap with Prior Art
The claims build upon existing biotechnology patents, such as those related to Chinese and international biologics manufacturing. However, the innovative combination of genetic elements and process steps appears sufficiently distinct, potentially providing a strong foundation for enforceability.
4. Patent Landscape and Competitive Positioning
4.1. Chinese Patent Environment for Biopharmaceuticals
China’s patent landscape for biologics has expanded rapidly, driven by government policies supporting indigenous innovation. There has been a notable increase in filings covering:
- Expression vectors and host cells for protein biologics
- Downstream processing methods
- Manufacturing equipment and process control systems
4.2. Patent Landscape Analysis
CN107412230 resides within a segment characterized by:
- Active Patent Filings: Many Chinese firms patent incremental process improvements or specific genetic constructs.
- Patent Clusters: Several patents focus on recombinant Chinese hamster ovary (CHO) cell line modifications, specific fermentation conditions, or purification innovations.
- Patent Thickets: The field is witnessing densely populated patent spaces, posing potential freedom-to-operate challenges.
4.3. Strategic Positioning
This patent likely provides a competitive moat for its assignee, particularly if it successfully claims novel process parameters or genetic modifications. It may protect the process from competitors attempting to produce similar proteins via alternative methods, aligning with China's broader biotech strategy.
5. Patent Strengths and Weaknesses
Strengths:
- Well-defined claims covering both genetic and process innovations.
- Potential to cover a range of biologic production scenarios.
- Alignment with China's national emphasis on biologics independence.
Weaknesses:
- The scope's dependence on specific process parameters could be circumvented via non-infringing alternatives.
- Dependence on the novelty and inventive step evaluation—if prior publications or patents disclose similar gene constructs or process conditions, enforceability could be challenged.
6. Legal and Commercial Implications
Enforceability:
The quality of claims, combined with thorough prosecution, appears adequate to support enforcement efforts in China. However, potential challenges from prior art require ongoing monitoring.
Licensing Opportunities:
Assuming the patent offers broad protection, licensing can be pursued by biosimilar manufacturers seeking to innovate within Chinese manufacturing limits or by multinational corporations seeking local manufacturing rights.
Infringement Risks:
Foreign companies employing similar recombinant techniques or downstream processes may face infringement risks unless they design around the patent.
7. Future Outlook and Innovation Trends
Given the rapid evolution in bioprocessing, ongoing patent filings in China suggest that process optimization and genetic engineering will remain primary innovation areas. The patent landscape is expected to consolidate around:
- Enhanced cell line engineering for higher productivity
- Advanced downstream processing techniques
- Integration of digital control technology
The patent CN107412230, with its claims focused on process parameters and genetic constructs, fits squarely within this trajectory, likely maintaining relevance for several years.
Key Takeaways
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Broad but Specific Claims: CN107412230 encapsulates a method involving genetically engineered cells and optimized fermentation and purification processes, with strategic claim language to maximize scope while avoiding prior art.
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Strategic Positioning: It strengthens the patent portfolio of Chinese biologics manufacturers, aligning with national policies to bolster domestic biologics production capabilities amidst a competitive landscape.
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Intellectual Property Value: The patent's enforceability hinges on its novelty, non-obviousness, and how effectively it overlaps with existing technologies. It provides a basis for licensing or defending market share in China.
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Competitive Landscape: The Chinese biopharmaceutical patent scene remains densely populated, demanding vigilant freedom-to-operate analysis and continuous innovation.
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Future Directions: The patent landscape will likely shift toward integrating digital technologies with bioprocessing, with patents increasingly focusing on smart manufacturing methods.
5. FAQs
Q1: What distinguishes CN107412230 from other biopharmaceutical manufacturing patents in China?
A1: It claims a unique combination of genetic modifications and process conditions—such as specific fermentation parameters and purification methods—that differentiate it from prior art, providing a potentially robust barrier to imitation.
Q2: Can this patent be enforced against foreign competitors?
A2: Yes, if the foreign competitors use similar Chinese manufacturing processes infringing on its claims; however, enforcement depends on detailed infringement analysis and prior art considerations.
Q3: How does this patent impact biosimilar manufacturers in China?
A3: It may pose an obstacle to generic copying if the patent is granted and maintained competitively, necessitating design-around strategies.
Q4: What are potential challenges in defending or licensing this patent?
A4: Challenges include establishing the patent’s inventive step over prior art, ensuring the claims are sufficiently clear and supported, and monitoring for infringing innovations.
Q5: How should companies strategize around patents like CN107412230?
A5: Companies should conduct rigorous freedom-to-operate analyses, consider filing their own process patents, and innovate beyond the scope of existing patents to maintain competitive advantage.
References
- Chinese Patent Office (SIPO). Official patent documents and classifications for CN107412230.
- WIPO. Patent landscape reports on Chinese biotech innovations.
- CNIPA Patent Gazette. Recent filings and legal status updates.
- Industry Reports. Chinese biopharmaceutical patent trends and strategic analyses (e.g., Frost & Sullivan, IQVIA).
- Legal Analyses. Judicial cases and patent examination guidelines relevant to biotech patents in China.
In conclusion, CN107412230 offers a nuanced but significant patent position for its assignee, capturing key innovations in recombinant protein manufacturing within China's actively evolving biotech patent landscape. Its strategic value depends on ongoing patent prosecution, market dynamics, and the company's innovation pipeline.
