Last updated: July 27, 2025
Introduction
South Korean patent KR101796300, assigned to Hanmi Pharmaceutical Co., Ltd., pertains to innovative drug delivery systems. As South Korea advances as a powerhouse in biopharmaceutical innovation, understanding the scope and claims of such patents is critical for stakeholders—pharmaceutical companies, research institutions, and investors—aiming to navigate the intellectual property landscape effectively. This analysis provides a comprehensive review of KR101796300, focusing on the claims' scope, technological significance, and its position within South Korea's broader patent environment.
Overview of KR101796300
Patent KR101796300, filed and granted in 2015, relates to a novel drug delivery platform for peptide and protein therapeutics. The patent emphasizes enhanced stability and bioavailability of biologic drugs via specific formulation and delivery mechanisms.
Key Technical Aspects
- Type of Innovation: Delivery system for biologics, particularly peptides and proteins.
- Main Features: Stabilizing agents, specialized carriers, and controlled-release formulations.
- Intended Benefits: Improved pharmacokinetics, reduced immunogenicity, and extended dosing intervals.
Scope and Claims Analysis
Claims Breakdown
The patent comprises independent claims and dependent claims structured to define the scope precisely. The primary claims focus on:
- Delivery Composition: An innovative formulation comprising a biologic agent, a stabilizing excipient, and a controlled-release carrier.
- Method of Preparation: Specific methods for preparing the formulation to preserve biological activity.
- Administration Method: Particular routes of administration that maximize stability and efficacy.
Independent Claims
The broadest independent claim (Claim 1) broadly covers:
A pharmaceutical composition comprising a peptide or protein therapeutic, combined with a stabilizing agent and a controlled-release carrier, configured to enhance stability and prolong pharmacodynamic effects.
This claim’s scope encompasses variations in the biologic agent, stabilizing components, and carrier systems, provided the core principles are met.
Dependent Claims
Dependent claims further specify parameters such as:
- The type of stabilizers used (e.g., sugars, amino acids).
- The nature of carriers (e.g., liposomes, biodegradable polymers).
- Specific ranges for formulation concentrations.
- Methods of manufacturing and administration.
Scope Evaluation
Strengths:
- Broad Coverage: The independent claim generalizes across biologics, making it adaptable to various peptides/proteins.
- Versatility: Claims accommodate diverse stabilizers and carriers, expanding potential licensing opportunities.
Limitations:
- Specificity in Dependent Claims: While adding scope, the dependent claims are specific, which could limit infringement to particular embodiments.
- Potential Overlap: Similar drug delivery patents exist in the broader biologics space, possibly leading to patent thickets.
Claim Interpretation
Legal and technical interpretations suggest that the patent protects a flexible platform approach rather than a narrowly defined formulation. This broad scope provides advantageous defensibility and licensing potential but warrants review against prior art to identify potential overlaps.
Patent Landscape Context
South Korea's IP environment for biologics delivery systems is highly active, with numerous patents filed by domestic and international players.
Major Players & Patent Trends
- Hanmi Pharmaceutical Co., Ltd.: A leader in biologic innovation, actively filing in delivery systems.
- Global Competitors: Companies such as Samsung Biologics and LG Chem filing complementary patents — indicating a vibrant ecosystem.
- Patent Filing Trends: An upward trajectory from 2010 to 2020 in biologics delivery systems, focusing on stability, controlled release, and form factor innovations (Source: KIPO patent statistics).
Prior Art & Patent Family Analysis
KR101796300 falls within a crowded space. Comparable patents include:
- US patents (e.g., US20140235161) covering peptide stabilization and delivery.
- EP patents with similar formulation strategies.
The patent family related to KR101796300 indicates that Hanmi has pursued international protection through PCT applications, particularly targeting markets in the U.S. and Europe.
Legal and Competitive Implications
- Freedom to Operate (FTO): The broad claims necessitate thorough FTO analysis, especially in jurisdictions with overlapping patents.
- Patent Strength: The combination of formulation and method claims suggests robust protection, potentially limiting competitors from developing similar delivery systems without infringing.
Strategic Implications for Stakeholders
- For Innovators: KR101796300 exemplifies a flexible delivery platform, underscoring the importance of broad claim drafting.
- For Patent Holders: Continuous patent filings around peptide stability and delivery mechanisms are vital to maintain competitive edge.
- For Licensees: Licensing opportunities may involve customized formulations targeting proprietary carriers or stabilizers claimed in the patent.
Regulatory & Commercial Outlook
South Korea’s strong IP environment supports the commercialization of biologic delivery systems, with regulatory pathways favoring innovative formulations. The presence of extensive patent protection, including KR101796300, can influence licensing strategies and drug development timelines.
Conclusion
KR101796300 represents a significant strategic patent within South Korea’s biologics delivery landscape, emphasizing a versatile platform for peptide and protein therapeutics. Its broad scope encompasses various formulation components and methods, offering patent holders competitive leverage. Stakeholders must carefully analyze overlapping patents to ensure freedom to operate while leveraging this patent’s claims to strengthen their portfolios.
Key Takeaways
- KR101796300’s claims broadly cover biologic delivery compositions, focusing on stability and controlled release.
- The patent landscape in South Korea is highly active, with similar patents emphasizing peptide stabilization and delivery methods.
- The broad claims provide strategic advantages but require vigilant FTO analysis.
- International filings suggest Hanmi’s intention to secure global protection, highlighting the patent’s potential impact on the international market.
- Innovative delivery system patents like KR101796300 are critical assets driving South Korea’s leadership in biologic drug development.
FAQs
Q1: How does KR101796300 compare to international patents in biologic delivery systems?
A1: It aligns with global trends emphasizing stability and controlled-release formulations. While similar patents exist internationally, KR101796300’s broad claims confer competitive differentiation within South Korea and potentially abroad through continued patent family expansion.
Q2: Can competitors develop similar formulations without infringing on KR101796300?
A2: Possibly, if their formulations differ significantly in carrier types, stabilizers, or methods—however, due diligence through technical and legal FTO analyses is essential to avoid infringement.
Q3: What are the strategic benefits of this patent for Hanmi Pharmaceutical?
A3: It provides exclusive rights to a versatile delivery platform, enabling licensing, collaborations, or exclusive market entry, reinforcing Hanmi’s position in biologic therapeutics.
Q4: How might this patent influence the future of biologic drug delivery research in South Korea?
A4: It encourages innovation around stability and controlled release, potentially spurring further patent filings and research in this domain.
Q5: Are there any potential challenges to the enforceability of KR101796300?
A5: As with all patents, challenges may arise over prior art or claim interpretation. Ongoing patent examination and possible legal disputes could impact enforceability, making strategic legal counsel vital.
References
- Korean Intellectual Property Office (KIPO). Patent KR101796300 Patent Document.
- WIPO Patent Scope. Biologics Delivery Patent Families.
- KIPO Patent Statistics. Trends in Biologics and Delivery Systems (2010-2020).
