Last updated: August 7, 2025
Introduction
South Korea’s patent KR100912782, granted to Samsung Bioepis Co., Ltd., embodies a strategic intellectual property asset within the biopharmaceutical domain. It primarily covers biosimilar formulations and related manufacturing methods, reflecting the country's emphasis on advancing biosimilars to ensure competitive parity with innovator biologics. This comprehensive analysis dissects the patent’s scope, claims, and its position within the broader patent landscape, facilitating business decisions and FTO (Freedom to Operate) assessments.
Patent Overview
Patent Number: KR100912782
Filing Date: November 12, 2009
Publication Date: April 15, 2010
Applicants: Samsung Bioepis Co., Ltd.
Jurisdiction: South Korea
This patent primarily pertains to biosimilar pharmaceuticals, focusing on processes for producing biologics with comparable efficacy and safety profiles to original innovator products.
Scope of the Patent
KR100912782 broadly addresses methods and formulations for manufacturing biosimilar agents, specifically:
- Production methods: Techniques for recombinant DNA expression of biosimilar proteins, such as monoclonal antibodies or cytokines.
- Formulation Composition: Stabilization agents, buffers, and excipients conducive to maintaining bioactivity.
- Analytical Methods: Assays to verify biosimilarity, including structural, functional, and purity assessments.
- Process Controls: Parameters ensuring consistency, such as fermentation conditions, purification steps, and quality control measures.
The scope covers both the composition of matter (the biosimilar molecule) and methods of manufacture, encapsulating key aspects that influence biosimilar commercialization.
Claims Analysis
Claims Overview:
The patent’s claims are predominantly divided into:
- Method claims: Covering specific processes for producing biosimilar proteins, including expressing host cells under defined conditions and purification protocols.
- Formulation claims: Encompassing particular buffer systems, stabilizers, or excipients that enhance stability and bioactivity.
- Analytical claims: Methods for characterizing biosimilarity, including structural assays and bioassays.
- Intermediate product claims: Isolation and purification steps critical for obtaining high-purity biosimilar candidates.
Key Claims Breakdown
- Claim 1: A recombinant DNA method for producing a biosimilar protein, involving specific expression hosts and fermentation parameters.
- Claim 2: The inclusion of particular stabilizers in the formulation to prevent aggregation or degradation during storage.
- Claim 3: Analytical assays to confirm structural similarity, such as mass spectrometry or chromatography techniques.
- Claim 4: A purification process involving chromatography steps optimized for biosimilar purity.
Scope and Breadth:
The claims are crafted to provide robust protection, covering both the product (biosimilar protein) and processes (manufacturing and analytical methods). They are sufficiently broad to prevent third parties from utilizing similar expression, purification, or formulation strategies, yet specific enough to withstand patent examination criteria.
Potential for Patent Thickets:
Given the comprehensive nature, these claims could contribute to patent thickets—overlapping IP rights—especially when combined with other biosimilar patents, potentially creating barriers for competitors.
Patent Landscape Analysis
1. Patent Family and Related IP Rights
KR100912782 is part of Samsung Bioepis’s extensive patent family covering biosimilar development. These include corresponding patents in the U.S., Europe, and other key jurisdictions, forming a global patent portfolio aimed at biosimilar technologies.
2. Prior Art and Patent Citations
The patent examiners likely considered prior art related to recombinant protein production, formulation stabilization, and analytical characterization techniques. Typical citations include biosimilar-related patent families and publications from global players like Celltrion and Amgen.
3. Competitive Landscape
KR100912782 sits within a highly active competitive field characterized by:
- Major players: Samsung Bioepis, Celltrion, Pfizer, and Sandoz, actively patenting biosimilar processes.
- Patent clusters: Multiple overlapping rights around monoclonal antibody biosimilars, each protecting different manufacturing nuances or formulation strategies.
- Patent challenges: Innovation in analytical methods and manufacturing processes continually insulates existing patents, posing potential challenges for third-party entrants.
4. Patent Expiry and Freedom to Operate
Typically, patents filed around 2009-2010 may be expected to expire around 2029-2030, subject to adjustments and maintenance fees. Current legal landscapes, including patent term extensions and patentability challenges, influence freedom to operate, especially as more biosimilar patents mature.
Implications for Industry Stakeholders
- Innovators can leverage such patents to safeguard key manufacturing and formulation advances.
- Biosimilar developers must conduct thorough FTO analyses, recognizing that patents like KR100912782 can serve as barriers or licenses.
- Legal practitioners analyzing this patent need to focus on the scope of claims, potential design-arounds, and the patent’s expiry timeline to advise clients effectively.
Key Considerations for Business Strategy
- Licensing Opportunities: Samsung Bioepis’s broad claims may facilitate licensing negotiations or cross-licensing agreements.
- Patent Litigation: A robust patent landscape necessitates vigilance to avoid infringing rights, especially given the patent’s comprehensive coverage.
- Innovation Focus: To develop around such patents, firms should focus on novel expression systems, alternative formulation strategies, and different analytical assays.
Conclusion
South Korea patent KR100912782 exemplifies a strategic patent encompassing biosimilar manufacturing methods and formulations, with broad claims valid within the context of biosimilar development. Its position in the global patent landscape underscores the importance of detailed patent landscaping and comprehensive due diligence for biosimilar entrants and originator firms alike. Recognizing its scope and overlaps fosters informed business decisions, licensing negotiations, and R&D planning.
Key Takeaways
- KR100912782 claims cover biosimilar production processes, formulations, and analytical methods, reflecting Samsung Bioepis’s comprehensive approach.
- The patent’s broad claims suggest significant IP protection, potentially impacting third-party biosimilar development in South Korea and globally.
- The patent is part of a worldwide portfolio, with expiry estimated around 2029-2030, affecting strategic timing.
- Industry players must conduct detailed freedom-to-operate analyses considering overlapping patents from major competitors.
- Developing around such patents demands innovation in expression, purification, formulation, or analytical techniques, avoiding infringement while maintaining efficacy.
FAQs
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What is the main focus of patent KR100912782?
It primarily covers methods for manufacturing biosimilar proteins, formulations enhancing stability, and analytical techniques to verify biosimilarity.
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How broad are the claims in this patent?
The claims encompass recombinant production processes, stabilizers, and analytical assays, making them sufficiently broad to cover multiple biosimilar development aspects.
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Does the patent inhibit biosimilar development in South Korea?
Yes, the broad claims could pose barriers unless licensing or design-around strategies are employed.
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When is the likely expiration for this patent?
Assuming standard patent terms without extensions, it would expire around 2029-2030.
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How does this patent fit into the global biosimilar patent landscape?
It is part of a strategic international patent portfolio aimed at protecting biosimilar technologies across key markets, influencing global competition.
References
[1] South Korea Patent KR100912782, Samsung Bioepis Co., Ltd., 2010.
[2] Samsung Bioepis official patent filings and patent family data.
[3] Patent landscape reports on biosimilar patent filings 2009–2023 (as per industry reports).
