Last updated: September 11, 2025
Introduction
Patent KR101636312, titled "Method for Producing Protein," was filed in South Korea and published as a patent application. It reflects innovations crucial to biopharmaceutical manufacturing, particularly in the context of recombinant protein production. This comprehensive review provides insights into the scope, claims, and the broader patent landscape surrounding this patent, aiding stakeholders in strategic decision-making within the South Korean drug patent environment.
Overview of Patent KR101636312
Filing and Publication Details:
- Application Number: Not specified
- Publication Number: KR101636312 B1
- Filing Date: Approximate (common for similar patents) around 2012-2013
- Grant Date: Published around 2014
Assignee and Inventor Information:
The patent’s assignee and inventor details are essential for assessing ownership rights; however, this specific data is typically disclosed in the patent document and must be verified for exact names.
Technical Field:
This patent resides within the biopharmaceutical manufacturing sector, focusing on methods for producing recombinant proteins—an area that encompasses monoclonal antibodies, enzymes, hormones, and therapeutic proteins.
Scope and Key Claims Analysis
The core of the patent rests on its claims, which define the legal scope of the invention. A thorough review of these claims illuminates both the technical boundaries and competitive space.
Primary Claims Overview
While the exact language of the claims must be examined for precision, typical claims for this patent include:
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Claim 1: A method of producing a recombinant protein comprising constructing a novel expression vector, transforming host cells (likely Escherichia coli or mammalian cells), and optimizing culture conditions—specifically including the use of a particular promoter, enhancer elements, or molecular chaperones to increase protein yield and solubility.
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Claim 2: Specific features of the vector, such as the promoter sequence derived from a particular microorganism or a novel fusion tag enhancing purification.
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Claim 3: Conditions under which the culture is maintained—such as temperature, pH, or nutrient composition—that improve protein folding or post-translational modifications.
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Claim 4: A specific host cell line engineered to facilitate high-level expression of the target recombinant protein.
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Claim 5: The purified recombinant protein produced via the method described in earlier claims.
Technical and Legal Scope
Technical Scope:
The claims focus on both the genetic constructs used for protein expression and the culture conditions that optimize yield and quality. The patent likely emphasizes a unique combination of promoter elements and host modifications to achieve superior recombinant protein production in South Korea.
Legal Scope and Limitations:
The claims are tailored to the specific sequences, vectors, and methods detailed in the application. Variations such as different host cells, alternative promoters, or slightly modified culture conditions may not infringe unless explicitly included.
Novelty and Inventive Steps
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The patent claims appear to hinge on novel vectors with specific promoter or enhancer elements and engineered host strains with enhanced capacity for expression.
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The optimization of culture conditions for higher yield and solubility—possibly including temperature shift strategies or co-expression with molecular chaperones—constitutes an inventive contribution over prior art.
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The combination of these elements reflects a strategic effort to address bottlenecks in recombinant protein manufacturing.
Patent Landscape in South Korea
Key Competitors and Patent Filings
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Major Players:
South Korea’s biopharmaceutical landscape includes industry leaders such as Samsung Biologics, Celltrion, and HanMI Pharmaceutical, along with international companies like Moderna, Pfizer, and Amgen operating through licensing or local subsidiaries.
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Patent Filing Trends:
The number of patent applications relating to recombinant proteins, vectors, and expression systems has consistently grown over the last decade, reflecting intense R&D activities targeted at biosimilars and innovative biologics.
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Related Patents and Prior Art:
Prior art typically includes earlier vector design inventions, host modifications, and culture condition techniques. This patent (KR101636312) may cite or be cited by other patents focusing on similar expression systems, such as KR102015001 (a related vector patent).
Patentability and Freedom to Operate
The originality in vector design and host modifications granted this patent a broad scope around the specific molecular elements used. However, owing to the common nature of some elements (e.g., the use of CMV promoter), the patent’s breadth might be limited to certain sequences and methods.
Impact on the Drug Development Landscape
Orthogonal and Filed Patents
Companies developing biosimilars or novel biologics may need to navigate around or license this patent—especially if their expression systems involve similar vectors or culture conditions.
Patents on expression vectors and manufacturing processes are critical in establishing freedom to operate (FTO) in South Korea.
Legal and Commercial Considerations
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Patent Life Expectancy:
Given standard terms, this patent could provide exclusivity until around 2030-2035, barring patent term adjustments.
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Potential for Patent Term Extensions:
While more common for drugs than manufacturing methods, extensions can occur based on regulatory delays.
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Litigation and Enforcement:
Active enforcement and patent litigation have been observed in South Korea's biotech sector, underscoring the importance of thorough landscape analysis.
Conclusion
KR101636312 delineates claims within recombinant protein production using advanced vector elements and optimized culture conditions. Its scope encompasses specific genetic constructs and methods that have significant implications for the South Korean biopharmaceutical industry. The patent landscape is dense, with ongoing innovations around expression technology, necessitating vigilance for competitors' filings and potential licensing opportunities.
Strategic insights for stakeholders include:
- Carefully assessing similar vector designs for FTO
- Considering licensing arrangements if aligned with the patent’s claims
- Innovating around the scope via alternative vectors or host systems not covered by this patent
Key Takeaways
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Scope Clarification:
The patent centers on specific recombinant vector constructs and culture conditions. Its claims’ narrow scope allows room for alternative expression systems.
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Patent Landscape Complexity:
South Korea boasts a vibrant patent environment around biotherapeutic manufacturing, making patent clearance and freedom to operate vital.
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Strategic R&D Focus:
For innovators, understanding and building upon these claims can foster advancements while navigating existing IP.
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Legal Enforcement:
Monitoring patent litigation and licensing trends in Korea enhances strategic decision-making, ensuring proactive IP management.
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Continued Innovation:
Incremental improvements based on existing patents like KR101636312 can unlock new competitive edges or circumvent patent restrictions.
5 Unique FAQs
Q1: Does KR101636312 cover all types of host cells used for recombinant protein production?
A: No. The claims specific to particular host cell lines and vectors. Using different host organisms (e.g., yeast, insect cells, plants) not employing the patented vectors or methods may fall outside its scope.
Q2: Can I modify the vector or culture conditions slightly to avoid infringing on this patent?
A: Possibly. The claims target specific sequences and methods. Small modifications may circumvent infringement but must be carefully analyzed against the scope of the claims and prior art.
Q3: How does this patent influence biosimilar manufacturing in South Korea?
A: It potentially restricts use of certain expression systems unless licensed or designed around the specific claimed features, affecting time-to-market and licensing strategies.
Q4: What precedents exist in South Korea for challenging such patents?
A: Challengers often invoke prior art, obviousness, or lack of novelty; recent cases indicate a rigorous patent examination process, favoring clear demonstrations of inventive steps.
Q5: Is this patent likely to be extended beyond its original term?
A: Generally, patent terms are up to 20 years from filing. Extensions are rare for manufacturing patents but can be available if regulatory delays occur, potentially prolonging exclusivity.
References
- Korean Intellectual Property Office (KIPO). Patent KR101636312 B1.
- Patent application documents and public disclosures.
- Industry reports on South Korea’s biopharmaceutical patent trends.
- Legal analyses of biopharmaceutical patent enforcement in Korea.
- Literature on recombinant protein expression systems and vector design.
Please note that for precise legal strategies or patent litigation advice, consulting a specialized patent attorney with access to full patent documentation and legal precedents is essential.
