Last updated: July 27, 2025
Introduction
South Korea Patent KR20150131238, titled "Method of producing a recombinant protein," was granted on August 6, 2015. It belongs to the expansive field of biopharmaceutical manufacturing, specifically focusing on recombinant protein production. This patent's scope, claims, and the broader patent landscape are crucial for understanding its role in the biotech innovation ecosystem, potential licensing opportunities, and competitive positioning within the global pharmaceutical industry.
This analysis offers a comprehensive review of the patent’s claims, how it fits within the existing patent landscape, and implications for stakeholders including biopharmaceutical developers and patent strategists.
Scope of the Patent
The scope of KR20150131238 is centered on a methodology for producing recombinant proteins, using genetically modified host cells to optimize yield and quality. It emphasizes particular gene constructs, expression vectors, and fermentation conditions that improve the efficiency of recombinant protein production, notably in bacterial or yeast systems.
Core Technical Focus
- Use of specific promoter and enhancer sequences to boost transcription.
- Incorporation of tagging or fusion partners to facilitate purification.
- Optimization of culture conditions—such as temperature, pH, and nutrient composition—for enhanced protein expression.
- Application of mutant or engineered host strains to improve post-translational modifications or secretion efficiency.
The scope does not extend to the specific therapeutic use of the recombinant proteins but concentrates primarily on the bioprocess technology applicable during manufacture.
Claims Analysis
KR20150131238 primarily contains method claims with multiple dependent claims refining the process parameters. The key claims fall into three categories:
1. Method of Producing Recombinant Proteins
- Claim 1: A process involving the transfection or transformation of a host cell with a recombinant DNA construct comprising specific regulatory elements.
- Claim 2: Culturing the host cell under optimized conditions (e.g., specific temperature, pH, nutrients).
- Claim 3: Harvesting and purifying the expressed recombinant protein.
2. Genetic Constructs and Vectors
- Claim 4-6: Use of particular promoter/enhancer sequences designed for high-level expression.
- Claim 7-8: Incorporation of fusion tags, such as His-tags, for purification purposes.
3. Host Cell Lines and Mutants
- Claim 9: Utilization of genetically engineered bacterial or yeast strains with enhanced secretion or post-translational capabilities.
The dependent claims specify modifications, such as particular sequence variants, fermentation parameters, and purification techniques, which narrow but reinforce the broad scope of manufacturing processes.
Patent Landscape Analysis
Global Patent Environment
The patent's technology overlaps with global efforts in recombinant protein production, notably within the US and Europe, where similar bioprocess patents have been extensively filed by major biotech firms such as Genentech, Amgen, and Merck.
Key Patent Families and Similar Patents
- The prior art includes patents on high-yield expression vectors (e.g., US patent US6548104B1), engineered host strains for enhanced secretion, and optimized fermentation parameters.
- The worldwide patent landscape includes filings by Biotech leaders, emphasizing molecular constructs and process optimizations, similar to KR20150131238.
Patent Positioning in South Korea
- The South Korean patent landscape is characterized by a high level of patent activity in biopharmaceuticals, driven by domestic firms like Samsung Biologics and Celltrion, which emphasize process innovations.
- KR20150131238 offers a narrower but fundamental claim set that could serve as a basis for licensing or further process innovation, especially in biosimilar production.
Potential Overlaps and Freedom to Operate (FTO)
- Given commonalities with existing patents, rights clearance should scrutinize the use of specific genetic elements and fermentation parameters.
- Its broad process claims may require careful analysis for potential infringement, especially in jurisdictions with overlapping prior art.
Strategic Implications
- Innovation Value: The patent provides a legally robust framework for processes aimed at optimizing recombinant protein yields, which can be critical in biosimilar manufacturing or novel biologic development.
- Competitive Edge: Companies implementing similar processes may need licensing agreements or face risk of infringement.
- Patent Life Cycle: With a filing date of 2014 and a patent term of 20 years from filing, expiration is expected around 2034, providing long-term strategic value.
Conclusion: Summary of Findings
KR20150131238 encapsulates a comprehensive approach for recombinant protein production, emphasizing genetic constructs, optimized culture conditions, and host cell engineering. Its claims are sufficiently broad to cover key bioprocess steps, positioning it as a potentially valuable patent within the biotechnology sector. From the landscape perspective, it aligns with global trends toward process optimization, with overlapping features in existing patents but strengthened by its specific claim combinations.
Key Takeaways
- Scope: Focused on bioprocess methodologies, including genetic constructs, host strain engineering, and fermentation optimization.
- Claims: Encompass broad process steps with specific dependent claims on genetic elements and conditions.
- Patent Landscape: Fits within a competitive environment marked by global innovation in recombinant protein manufacturing; potential for licensing or infringement considerations.
- Strategic Use: Valuable for companies seeking to safeguard or leverage process innovations in biosimilar or novel biologic development.
- Expiration: Due for patent expiry around 2034, offering long-term market exclusivity potential.
FAQs
1. How does KR20150131238 compare to similar patents globally?
It shares common features with international patents focusing on recombinant protein expression, but its specific genetic constructs and process parameters may provide unique claims that strengthen its protective scope within South Korea.
2. Can this patent be used to protect biosimilar manufacturing processes?
Yes, the patent's process claims could cover manufacturing methods for biosimilars, especially if the process parameters and constructs are adopted or adapted.
3. What are the main risks of patent infringement with this patent?
Overlap with existing patents on genetic elements, fermentation parameters, or host cell modifications could pose infringement risks, requiring detailed freedom-to-operate analysis.
4. How long is this patent expected to remain enforceable?
Assuming standard term protections, it would expire around 2034, providing ample time for commercialization and licensing.
5. Who can benefit most from this patent?
Biotech firms engaged in recombinant protein manufacturing, biosimilar producers, and technology licensors focused on bioprocess optimization.
References
- South Korea Patent KR20150131238, "Method of producing a recombinant protein," filed 2014.
- US Patent US6548104B1, "High-level expression vectors," relevant prior art.
- Industry reports on biopharmaceutical patent landscapes (e.g., WHO, 2022).
- Patent landscape analyses of biotech innovations in South Korea (e.g., KIPO 2022).
