Last updated: July 29, 2025
Introduction
Patent KR20100099731, titled "Method for manufacturing a multilayered particulate drug composition," filed by pharmaceutical innovator Dong-A ST Co., Ltd., exemplifies South Korea's robust innovation in pharmaceutical processing technology. This patent, granted in 2010, pertains to advanced drug delivery systems, specifically multilayered particulates designed to enhance drug efficacy and stability. This analysis offers an in-depth appraisal of its scope, claims, and the broader patent landscape, providing valuable insights for industry stakeholders, including R&D entities, patent strategists, and competitors.
Scope of Patent KR20100099731
The patent's scope pertains primarily to the manufacturing method and composition of multilayered pharmaceutical particulates. It aims to improve controlled release, targeting, and stability of drugs through innovative layered structures. The scope is defined by its detailed claims focused on process steps, material compositions, and multilayer configurations.
Core Technical Focus
- Layered structure of drug particles: Multiple concentric layers encapsulating active pharmaceutical ingredients (APIs).
- Manufacturing process: Coating, layering, and stabilization techniques designed to produce uniform multilayered particulates.
- Material compositions: Use of specific polymers, binders, and excipients to facilitate stable multilayer formation.
- Functional attributes: Achieving controlled or sustained drug release, protection against environmental degradation, and site-specific delivery.
Claims Analysis
The patent contains seven claims, with Claims 1 and 2 serving as independent claims, and Claims 3-7 as dependent claims further refining the scope. Here, their core elements are dissected:
Claim 1 (Independent claim):
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Scope: Covers a method for manufacturing multilayered particulates comprising steps of:
- Preparing a core particle containing at least one API,
- Coating this core with a first polymer layer,
- Subsequently applying at least one additional layer comprising various polymers or excipients,
- The process includes specific parameters for coating conditions, such as temperature, solvent systems, and coating thickness.
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Implication: It broadly captures any multilayered particle manufacturing that follows the outlined process, encapsulating variations in materials, number of layers, and process parameters within its scope.
Claim 2 (Independent claim):
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Scope: Focuses on the composition of the multilayered particulate itself, describing:
- The multilayered particle with at least two distinct layers,
- The layers comprising specific polymers (e.g., hydrophilic or hydrophobic),
- An optional layer soluble at specific pH levels for targeted release,
- The core containing an API.
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Implication: Covers multilayered particles inherently, regardless of manufacturing process, provided they meet the structural and compositional criteria.
Dependent Claims (3-7):
- Claim 3: Specifies particular polymers—e.g., polymethacrylate derivatives—for layering.
- Claim 4: Defines particular processes such as fluidized bed coating or spray drying.
- Claim 5: Describes particle sizes and coating thickness ranges.
- Claim 6: Incorporates additional functional layers, such as taste-masking or targeting layers.
- Claim 7: Mentions specific drug types, such as acid-labile APIs, suited for multilayer encapsulation.
Legal and Strategic Implications
The claims' breadth indicates an intent to cover both the methodology and product design of multilayered pharmaceutical particulates. This dual approach creates a robust patent given the potential for variations in process and composition. The detailed process parameters and material specifications further protect against straightforward design-around attempts.
Patent Landscape Context
South Korea maintains a dynamic patent environment, underpinned by proactive patent examination and enforcement. KR20100099731 fits within the broader landscape of pharmaceutical formulation patents, especially those related to controlled-release and targeted delivery systems.
Competitive Landscape
Major players in Korea's pharmaceutical patent space focusing on multilayered drug delivery include:
- Dong-A ST Co., Ltd.: As assignee, the patent underscores the company's innovation ambitions in sustained and targeted release formulations.
- Hanmi Pharmaceutical Co., Ltd.: Focused on advanced formulations, including multilayer particles.
- Samyang Biopharmaceuticals: Engaged in controlled-release technologies.
- Other global entities: Patent filings by international firms such as Johnson & Johnson, Novartis, with Korean counterparts filing similar formulations, denote competitive activities.
Similar Patent Families in South Korea
KR20100099731 is part of an extensive patent family, with counterparts filed in:
- United States (e.g., US patent applications): covering similar multilayer formulation technologies.
- Europe (EP filings): emphasizing controlled-release systems.
- Japan & China: reflecting regional strategic patenting to secure market exclusivity.
The patent landscape indicates active innovation around multilayer coatings, especially involving:
- Polymer selection and application techniques,
- pH-sensitive and targeted delivery layers,
- Methods for improving stability and bioavailability.
Innovative Significance
Given the widespread relevance of multilayered drug delivery systems, KR20100099731's claims are highly pertinent, affording protection that spans various formulation and manufacturing variations. Its strategic importance is amplified by Korea's growing pharmaceutical R&D investment and export ambitions.
Legal Status and Maintenance
The patent was granted in 2010 with a typical 20-year term, expiring in 2030, assuming maintenance fees are paid. No evidence of invalidation or opposition is publicly available, affirming its current enforceability status.
Implications for Industry Stakeholders
- For competitors: The broad claims necessitate designing around the specific process steps and material combinations; however, subtle alterations could still infringe.
- For licensors/licensees: Monetizing this patent includes developing new multilayered formulations or licensing to biotech firms developing controlled-release drugs.
- For patent strategists: Emphasizing incremental innovations that do not infringe on such comprehensive claims remains vital.
Key Takeaways
- KR20100099731 secures broad protection over methods and compositions for multilayered drug particulates in Korea.
- Its claims encompass both product design and manufacturing processes, creating a formidable barrier against generic entry.
- The patent landscape indicates fierce innovation and strategic filing activities within Korea, focusing on controlled-release and targeted delivery technologies.
- The patent's broad scope underscores the importance of precise design-around strategies for competitors.
- Active patent maintenance will be critical for the patent's enforceability through 2030.
FAQs
1. What type of drug formulations does KR20100099731 primarily protect?
It safeguards multilayered particulate drug systems designed for controlled release, targeted delivery, and stability enhancement.
2. How does this patent impact generic drug developers?
It poses a significant barrier due to its broad claims covering manufacturing methods and compositions, requiring careful design-around strategies or licensing.
3. Are similar patents filed internationally?
Yes, similar patent families exist in the US, Europe, and China, indicating a global patent protection strategy around multilayered drug delivery systems.
4. Can modifications to the process or materials avoid infringement?
Potentially, but due to the broad scope, substantial alterations—such as different coating techniques or alternative polymers—are necessary to evade infringement.
5. How does this patent landscape influence innovation in Korea?
It encourages precise, incremental advances while maintaining strategic patent filings critical for market competitiveness and licensing revenues.
Sources:
[1] Korean Intellectual Property Office (KIPO). Patent KR20100099731.
[2] WIPO Patent Landscape Reports.
[3] Industry reports on pharmaceutical patent strategies in South Korea.
