Last updated: August 14, 2025
Introduction
Patent KR101526625, titled "Method of Manufacturing a Pharmaceutical Composition," issued by Samsung Bioepis Co., Ltd., exemplifies South Korea's proactive stance in biopharmaceutical innovation. This patent claims a specific manufacturing method of biosimilar products, focusing on efficient processes, enhanced stability, and improved bioavailability. This analysis dissects the scope and claims, situates the patent within the broader patent landscape, and discusses strategic considerations for stakeholders in biosimilar development.
Scope and Claims of KR101526625
Overview of Patent Content
KR101526625 claims a detailed manufacturing process for biosimilar pharmaceuticals, primarily emphasizing process steps that ensure product consistency, purity, and biological activity. The patent specifically pertains to the production of recombinant protein-based biopharmaceuticals, including factors like cell culture conditions, purification steps, and formulation techniques designed to optimize yield and functionality.
Core Claims Analysis
The patent comprises multiple claims, which can be classified into independent and dependent groups. Below is a focused breakdown:
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Independent Claims:
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Claim 1: Describes a manufacturing process involving five key steps: (a) culturing genetically engineered cells under specific conditions, (b) harvesting the culture media, (c) purifying the recombinant protein utilizing particular chromatography techniques, (d) performing a residual removal step to eliminate impurities, and (e) formulating the final pharmaceutical composition.
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Claim 10: Encompasses a purified recombinant protein produced using the process defined in claims 1-9, emphasizing the biological activity and structural integrity of the end product.
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Dependent Claims:
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Cover specific parameters such as incubation times, temperature ranges (e.g., 30–37°C during cell culture), pH conditions for purification steps, and buffer compositions, which refine the manufacturing process for optimal results.
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Further claims specify the type of recombinant cells used (e.g., CHO cells), the use of particular chromatography resins, and stabilization agents in the formulation, aligning with industry standards for biosimilar manufacturing.
Scope of Claims:
The patent's scope centers on a comprehensive process for biosimilar production, reflecting an intent to prevent competitors from adopting similar manufacturing techniques. It covers both the process and the resulting biologic, thus offering broad protection over the manufacturing pathway and the product itself, provided the process steps are followed.
Key Aspects of Claim Breadth
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Process Focus: The patent emphasizes process steps rather than product molecular structure alone, aligning with regulatory trends that favor process patents in biologics.
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Specific Parameters: While some claims specify ranges for variables like pH, temperature, and times, these are sufficiently broad to capture a wide array of comparable methods, increasing the patent's enforceability.
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Product Claims: Claims related to the final recombinant protein ensure protection not only for the process but also for the biologic produced, reducing the risk of similar biosimilars circumventing patent rights via alternate methods.
Patent Landscape in South Korea for Biosimilar Manufacturing
South Korea's Biotech Patent Environment
South Korea's patent system is robust, with a particular focus on biopharmaceutical innovation supported by government incentives and a vibrant biosimilar industry. The country's patent office (KIPO) actively maintains a strategic patent landscape to foster indigenous innovation while attracting foreign investment.
Major Patent Holders and Filing Trends
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Samsung Bioepis: As one of the premier entities, Samsung Bioepis holds numerous patents related to biosimilar manufacturing processes, formulations, and specific biologic molecules, including similar patents to KR101526625.
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Celltrion: Another key player, with a focus on monoclonal antibody biosimilars (e.g., Remsima), holds extensive patents covering cell line development, fermentation, and purification processes.
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Patent Trends: South Korea exhibits increasing filings in biologics, especially in process patents, aligning with global trends favoring process over product patenting in biologics to mitigate patent expiry risks and foster innovation.
Patent Family and Cross-licensing
KR101526625 operates within a dense patent network, often forming part of patent families extending internationally, notably in the US, Europe, and China. Cross-licensing arrangements are common among Korean biotech firms to navigate patent thickets, especially for process patents like KR101526625, which protect core manufacturing methods.
Strategic Positioning and Legal Considerations
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Patent Term and Expiry: Expected patent lifespan contours into around 2034, considering 20-year terms from filing, with adjustments for patent term adjustments or extensions.
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Potential Challenges: Competitors might introduce alternative manufacturing processes or develop biosimilars via different cell lines, bypassing process claims but potentially infringing on product claims.
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Patent Validity and Enforcement: Given the specific process claims and detailed parameters, patent infringement analysis hinges on process similarity and the likelihood of each step being reproduced identically.
Implications for Industry Stakeholders
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Innovators: KR101526625 defines a strong method patent, requiring competitors to innovate around the process or wait for patent expiry.
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Generic/Biosimilar Developers: Must analyze process claims thoroughly to develop non-infringing methods, potentially focusing on alternative purification techniques or cell culture conditions.
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Regulators and Patent Offices: This patent highlights South Korea's focus on process patents in biologics, aligning with international standards, but also posing challenges for patentability of innovative process modifications.
Conclusion
KR101526625 exemplifies comprehensive Korean biosimilar process patenting, claiming a specific manufacturing method crucial to biologic production. The patent's scope effectively overlaps with the operational core of biosimilar manufacturing, providing strategic leverage for Samsung Bioepis. The broader patent landscape in South Korea continues to support process innovation, emphasizing detailed, parameter-specific claims, but also necessitating meticulous freedom-to-operate analyses due to dense patent thickets.
Key Takeaways
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Broad Process Claiming: The patent's detailed process steps encapsulate a wide scope, requiring competitors to innovate around specific stages to avoid infringement.
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Strategic Patent Position: As a core biosimilar patent, KR101526625 reinforces South Korea’s leadership position in biologics and process innovation.
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Legal Vigilance: Companies should analyze process parameters and claim language rigorously to develop non-infringing biosimilar processes.
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Ecosystem Support: The South Korean patent landscape favors process patents, ensuring protection for manufacturing innovations amid intense competition.
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Lifecycle Planning: Stakeholders must account for patent expiry timelines and consider innovation to extend market differentiation.
FAQs
Q1: What is the primary focus of patent KR101526625?
A1: It concentrates on a specific manufacturing process for biosimilar biologics, including cell culture, purification, and formulation steps.
Q2: How broad are the claims in KR101526625?
A2: The claims are process-oriented, with specific parameter ranges, offering broad yet sufficiently detailed protection over the manufacturing method.
Q3: How does this patent fit within South Korea’s biosimilar patent landscape?
A3: It exemplifies the trend toward process patents, with major Korean biotech firms owning extensive patent families covering production methods for biosimilars.
Q4: Can competitors produce similar biosimilars without infringing this patent?
A4: Yes, by innovating around the process parameters—such as changing purification techniques or cell lines—they could potentially avoid infringement.
Q5: When does the patent KR101526625 expire?
A5: Assuming standard patent term calculations from the filing date (November 2014), it would generally expire around 2034, subject to any adjustments.
References
- Korean Intellectual Property Office (KIPO). Patent KR101526625.
- Samsung Bioepis Co., Ltd. Patent filings and procedural history.
- International Patent Classification (IPC). Relevant classes for biosimilar process patents.
- South Korea Patent Law. Regulations governing patent scope and validity.
- Global Patent Trends in Biologics. Industry reports and analyses.
End of analysis.
