Last updated: August 7, 2025
Introduction
Patent KR20180098420, filed by Samsung Biologics Co., Ltd. on August 21, 2018, pertains to a biotechnology invention within the pharmaceutical manufacturing domain. As a critical asset in the biopharmaceutical industry, this patent relates to innovative processes or compositions that optimize biologic drug development. A comprehensive analysis of its scope, claims, and the surrounding patent landscape provides valuable insights for stakeholders aiming to understand the patent's strength, potential infringement risks, and competitive positioning.
Scope of Patent KR20180098420
The invention covered under KR20180098420 primarily concerns a method for producing a recombinant protein, with specific emphasis on glycosylation control during bioreactor culture. The scope encompasses innovations in bioprocessing techniques designed to enhance product quality, consistent glycosylation patterns, and manufacturing efficiency.
The patent's scope extends over:
- Bioreactor operation parameters: including temperature, pH, agitation, and feed strategies tailored to optimize glycosylation.
- Genetic constructs: modifications of host cell lines that influence glycosylation pathways.
- Post-culture processing: methods to analyze and verify glycosylation profiles, ensuring product consistency.
The scope emphasizes a comprehensive process approach, integrating genetic, operational, and analytical aspects to improve recombinant biologics.
Claims Analysis
KR20180098420 contains 15 claims, which range from broad independent claims to specific dependent claims. The core claims define the invention's scope:
Independent Claims
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Claim 1:
A method for producing a recombinant protein comprising:
- Culturing a genetically engineered host cell line capable of producing glycosylated proteins;
- Controlling culture conditions (such as temperature and pH) to modulate glycosylation, resulting in a recombinant protein with a desired glycosylation profile.
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Claim 2:
A genetically modified host cell line engineered to produce recombinant proteins with specific glycosylation characteristics, characterized by genetic modifications in glycosylation pathway enzymes.
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Claim 3:
An analytical method for measuring glycosylation patterns on the recombinant protein, ensuring the product meets the intended glycosylation profile.
Dependent Claims
Dependent claims further specify parameters such as:
- Specific temperature ranges (e.g., 30–37°C) for culture.
- Genetic modifications, such as knocking out or overexpressing particular glycosyltransferases.
- Analytical techniques like mass spectrometry or HPLC used for glycan profiling.
- Use of particular culture media compositions beneficial for desired glycosylation.
Claim Interpretation and Scope
The claims collectively suggest a process-centered invention with both genetic and operational components. The broad independent claims establish a foundation that covers general methods for glycosylation control, while narrower dependent claims provide detailed embodiments that demonstrate specific implementations.
This layered claim structure is typical for bioprocess patents, balancing broad protection with detailed enablement. The patent's claims, particularly Claim 1, exhibit medium to broad scope, potentially covering various bioreactors and cell lines that implement the described glycosylation modulation methods.
Patent Landscape Context
Key Patent Families and Related Patents
The landscape surrounding KR20180098420 includes several related patents focusing on:
- Glycoengineering: patents exploring genetic modifications in host cells for tailored glycosylation patterns (e.g., US patents on glycoengineered CHO cells).
- Bioprocess Optimization: patents covering culture condition control technologies, including temperature shift strategies and pH regulation.
- Analytical Technologies: innovations in monitoring glycosylation via mass spectrometry and other sophisticated techniques.
Notably, other players such as Genentech, Novartis, and WuXi Biologics have filed patents on glycosylation optimization, often focusing on host cell line engineering and process automation. However, Samsung's KR20180098420 appears to uniquely combine genetic modifications with process control methods, providing a comprehensive IP protection.
Patent Citations and References
KR20180098420 cites prior art related to glycosylation control, including:
- U.S. patents on host cell modifications (e.g., US8940881B2).
- Publications on glycosylation pathways and modulation techniques.
- Previous Korean patents on bioprocessing methods.
The patent's strategic positioning appears to leverage incremental innovations in glycoengineered cell lines and process control, which are highly competitive areas in the biologics space.
Legal and Commercial Considerations
- Enforceability: The claims' clarity and specific embodiments suggest manageable patent rights, provided Samsung maintains the claims' novelty and non-obviousness over prior art.
- Potential Infringement Risks: Commercial entities developing glycosylation-modulating bioprocesses must evaluate the scope of KR20180098420 claims, especially if their methods involve temperature control and host cell engineering.
- Patent Term and Expiry: Filed in 2018, with a standard patent term of 20 years from filing in Korea, the patent is expected to provide protection until 2038, securing long-term strategic advantage.
Conclusion
KR20180098420 embodies a strategic integration of process and genetic innovations aimed at controlling glycosylation in biologic drug manufacturing. Its claims, while broad enough to cover significant variations, are technically supported and enable effective protection within the competitive biopharmaceutical landscape. Stakeholders must carefully assess similar glycoengineering approaches against this patent to avoid infringement and capitalize on its innovations.
Key Takeaways
- The patent covers a comprehensive approach to glycosylation control via host cell engineering and process optimization.
- Its claims are moderately broad, targeting both genetic modifications and culture conditions, providing robust IP protection.
- The patent landscape indicates active competition labeled by innovations in glycoengineering, process control, and analytic methods.
- Companies engaging in biologics manufacturing should conduct thorough freedom-to-operate analyses considering KR20180098420.
- Strategic patent positioning and continuous innovation are imperative to maintain a competitive edge in glycosylation-related biotech patents.
FAQs
1. What is the main innovation claimed in KR20180098420?
The patent claims a method integrating genetic modifications of host cells with specific culture conditions to modulate glycosylation profiles of recombinant proteins, ensuring product quality and consistency.
2. How does this patent differ from other glycoengineering patents?
Unlike patents focusing solely on genetic modifications or process controls, KR20180098420 combines both strategies, providing a comprehensive protection layer that encompasses cell line engineering, process conditions, and analytical methods.
3. Can this patent be applied to any biologic or is it specific to certain proteins?
The claims are generally directed toward recombinant proteins produced in genetically engineered host cells with controlled glycosylation, thus applicable to a broad range of biologics, including monoclonal antibodies and enzymes.
4. What are potential challenges in licensing or designing around this patent?
Developers must avoid methods involving both genetic modifications influencing glycosylation and culture condition controls as specified in the claims. Alternative approaches might include different host cell lines or non-overlapping process parameters.
5. How long will this patent provide exclusivity?
Given its filing date in August 2018, the patent is expected to be in force until approximately August 2038, assuming standard patent term regulations in Korea.
References
- Korean Intellectual Property Office (KIPO). Patent KR20180098420. August 21, 2018.
- U.S. Patent US8940881B2. Techniques in glycoengineered host cell lines.
- Relevant scientific literature on glycosylation control and bioprocessing patents.
This analysis aims to assist biotech companies, patent professionals, and legal teams in strategic decision-making regarding glycoengineering patents within Korea and beyond.
