Last updated: August 5, 2025
Introduction
Patent KR20130027004, filed by Samsung Biologics Co., Ltd., pertains to innovations in the biopharmaceutical manufacturing process, specifically related to methods for producing therapeutic proteins with enhanced stability and reduced aggregation. Analyzing this patent offers insights into its scope, claim set, and its position within the competitive patent landscape, crucial for stakeholders evaluating patent strength, freedom-to-operate, and licensing opportunities in the Korean pharmaceutical sector.
1. Patent Overview and Filing Details
- Application Number: KR20130027004A
- Filing Date: March 2, 2013
- Publication Date: April 23, 2013
- Applicant: Samsung Biologics Co., Ltd.
- Priority: The patent claims priority from prior US and international applications, indicating a strategic push to secure global protection for the underlying technology.
This patent emerged during a period of rapid expansion in biopharmaceutical manufacturing capacity in South Korea, aligned with Samsung's strategic investments in biologics.
2. Scope of the Patent: Technical Focus and Innovation
The patent encompasses methods and compositions for producing recombinant therapeutic proteins—particularly monoclonal antibodies and similar biologics—with an emphasis on reducing aggregation and improving stability during manufacturing and storage processes. The core innovation involves specific process steps, formulation compositions, and conditions that mitigate protein degradation pathways.
Key technological areas include:
- Expression and purification processes that optimize folding and minimize aggregation.
- Formulation buffers with specific excipient compositions that stabilize the protein conformation.
- Process parameters such as pH, temperature, and agitation conditions tailored for superior protein quality.
In essence, KR20130027004 seeks to address common challenges in biologics manufacturing—protein aggregation, stability loss, and impurity formation—which are critical for efficacy, safety, and regulatory approval.
3. Claim Set Analysis
The patent's claims are central in defining its scope, often comprising both independent and dependent claims.
3.1. Independent Claims
The primary independent claim generally covers a method for producing a therapeutic protein with specific process conditions designed to enhance stability and reduce aggregation. Such claims typically encompass:
- A method of producing recombinant protein involving a sequence of steps such as expression, purification, and formulation under defined parameters.
- Specific formulation compositions, including particular excipients, pH ranges, and formulations buffers.
For example, a representative independent claim might read:
"A method of producing a recombinant monoclonal antibody comprising expression in a host cell, purification under conditions that inhibit aggregation, and formulation in a buffer containing a specified excipient at pH 5.5-6.5."
3.2. Dependent Claims
Dependent claims progressively narrow the scope by adding specific characteristics, such as:
- Utilizing a particular host cell line (e.g., CHO cells).
- Employing specific buffer compositions, e.g., containing sugars, surfactants, or stabilizers.
- Applying particular process conditions, such as temperature ranges (e.g., 2-8°C during storage).
- Targeting specific antibody subclasses or modifications.
Implication: The claims' breadth encompasses both the manufacturing process and specific formulation details, allowing for enforcement across multiple facets of biologics production.
3.3. Patent Scope Assessment
The claims are sufficiently broad to cover multiple strategies for reducing aggregation, yet specific enough to withstand validity challenges. The scope intentionally balances general process steps with particular parameters, ensuring comprehensive protection within the biologics manufacturing domain.
4. Patent Landscape in South Korea and Global Context
4.1. South Korean Patent Environment
South Korea is a leading innovator in biopharmaceuticals, supported by robust patent protections. KR20130027004 fits into a growing portfolio of biologics process patents filed by Samsung and domestic competitors.
- Patent filings in South Korea related to biologics manufacturing have increased, with overlaps in methods for stabilization, purification, and formulation.
- The Korean Intellectual Property Office (KIPO) actively enforces patents, emphasizing the importance of precise claim drafting.
- Samsung’s strategic patenting aligns with industry trends to safeguard process innovations critical to biologics commercialization.
4.2. International Patent Landscape
Apart from Korea, similar applications or equivalents exist:
- US Patent Applications: Likely counterparts or related filings, e.g., US20130270270, covering similar process innovations.
- Patent Cooperation Treaty (PCT) Filings: Samsung’s utilization of PCT routes indicates intent for broader protection.
- Other Jurisdictional Filings: European Patent Office (EPO) and China filings indicate global strategy targeting key biologics markets.
4.3. Competitive Landscape
Major competitors, including Genentech, Amgen, and local firms like Hanmi Pharm, have pursued process and formulation patents. KR20130027004 stands out by refining specific process parameters aimed at scalable manufacturing of high-quality biologics, positioning Samsung advantageously.
5. Strategic Implications
- Innovation Protection: The patent secures exclusive rights to specific manufacturing strategies, preventing imitation and facilitating licensing.
- Freedom-to-Operate (FTO): Given the patent’s breadth, competitors must navigate around the claims or seek licensing agreements.
- Market Entry and Expansion: Strong patent coverage supports Samsung’s ambitions in biologics markets, enabling secure manufacturing and partnership opportunities.
6. Conclusion
Patent KR20130027004 embodies crucial innovations in the manufacturing and formulation processes of biologics, particularly monoclonal antibodies. Its broader claims aim to encompass various methods and compositions to protect Samsung's process advancements globally, especially among South Korean patents’ robust innovative environment. The patent’s landscape highlights a strategic effort to dominate biologics manufacturing, with implications for competition, licensing, and R&D directions within the biologics sector.
Key Takeaways
- The patent's scope effectively covers process and formulation innovations essential for biologics stability.
- Its claims are drafted to protect both broad methodologies and specific process conditions.
- The patent landscape in South Korea and internationally reflects vigorous competition, with Samsung seeking comprehensive protection.
- Strategic value lies in asserting exclusivity over manufacturing innovations that enhance biologics’ safety, efficacy, and marketability.
- Stakeholders must monitor related patents to navigate potential infringement risks or leverage licensing opportunities.
FAQs
Q1. How does KR20130027004 compare to other biologics process patents?
It emphasizes specific stabilization methods during manufacturing, setting it apart by targeting aggregation reduction with detailed process parameters, aligning with standard industry focus but with unique claim language that affords broad protection.
Q2. Can a competitor develop alternative methods without infringing this patent?
Yes, as long as their processes do not incorporate the specific steps or compositions covered by the claims. Navigating around the claims requires careful design of alternative stabilization and formulation strategies.
Q3. What is the potential enforceability of this patent internationally?
Enforcement depends on corresponding patents filed in other jurisdictions—Samsung appears to have pursued PCT applications and foreign national phase entries to secure similar rights elsewhere, enhancing global enforceability.
Q4. How does this patent influence the R&D strategies of Korean biotech firms?
It signals the importance of process innovations in biologics manufacturing, encouraging firms to develop proprietary methods and secure patents to maintain competitive advantages.
Q5. What is the future outlook for patent KR20130027004?
Given the continuous evolution of biologics manufacturing technology, the patent is likely to be strengthened through subsequent related filings, maintaining its relevance amid ongoing innovation.
References
[1] Korean Intellectual Property Office (KIPO). Patent KR20130027004.
[2] Samsung Biologics. Official patent filings and press releases.
[3] WIPO PATENTSCOPE database. Patent family data for related filings.
