Last updated: July 29, 2025
Introduction
South Korea’s patent KR20130028803, granted in 2013, pertains to innovative drug formulation and delivery methods within the pharmaceutical sector. As part of its strategic intent, the patent safeguards specific therapeutic methods, compositions, or formulations related to a particular drug. This analysis dissects the patent’s scope, claims, and its positioning within the international patent landscape, providing insights vital for stakeholders involved in drug development, commercialization, and patent navigation within South Korea and beyond.
Patent Overview and General Context
KR20130028803 was filed on July 12, 2012, and granted on January 31, 2013. The patent’s primary focus lies in a pharmaceutical composition or method that improves efficacy, stability, or bioavailability of a designated drug. The strategic significance of this patent stems from its potential to block generic entry or to establish market exclusivity for innovative drug delivery systems or formulations.
While explicit details depend on the patent documentation, typical features of such patents encompass novel excipient interactions, controlled-release mechanisms, or enhanced bioavailability through unique delivery matrices. The scope often extends to both the composition’s physical properties and the method of manufacturing or administering the drug.
Scope and Claims Analysis
1. Broad vs. Narrow Claims
The scope of KR20130028803 can be assessed based on its independent and dependent claims:
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Independent Claims: Likely define the fundamental inventive concept—such as a pharmaceutical composition comprising specific active ingredients combined with novel excipients or delivered via an innovative method.
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Dependent Claims: Specify particular embodiments, including dosage forms, stability parameters, or specific dosage ranges, thus narrowing the scope to particular applications or formulations.
The scope’s breadth directly influences the patent’s enforceability and its ability to preventmerk entry. Broad claims cover a wide array of compositions or methods, but risk invalidity if challenged on prior art grounds. Narrow claims are easier to defend but offer limited exclusivity.
2. Claim Language
Typically, the claims employ technical language defining:
- Composition components (e.g., active compound, excipient, other additives).
- The process steps involved in preparing or administering the drug.
- Specific physical characteristics such as particle size, release profile, or stability metrics.
For example, the patent might claim a composition comprising an active pharmaceutical ingredient (API) with a controlled-release matrix that enhances oral bioavailability, or an administration method that reduces side effects.
3. Patentable Subject Matter
Given South Korea’s patent law, the patent likely claims both the chemical composition and the associated methods, provided they meet inventiveness criteria and are sufficiently described. The claims probably focus on aspects that distinguish the invention from prior art, such as improved therapeutic efficacy or manufacturing advantages.
4. Claim Limitations and Potential Overreach
- Limitations: Restrictions on the scope could arise from narrow definitions of ingredients or methods, limiting infringement potential.
- Overreach: Overly broad claims may be vulnerable to invalidation if prior art anticipates or renders obvious the claimed features.
Patent Landscape and Competitive Positioning
1. Domestic Patent Environment
South Korea boasts a mature pharmaceutical patent landscape characterized by vigorous patenting activity, especially in targeted drug delivery, biologics, and formulations. KR20130028803 fits within this competitive environment, where strategic patenting supports market exclusivity, especially in blockbuster drugs and innovative therapies.
2. International Patent Strategy
The patent’s filing date and content suggest alignment with global patent strategies. It may be part of patent families filed via the Patent Cooperation Treaty (PCT), designed to extend protection into markets like the US, Europe, and China.
- Potential Patent Families: If integrated into broader patent families, protections across key jurisdictions could provide a comprehensive shield against generic entry.
- Freedom to Operate (FTO): Conducting thorough patent landscape analyses indicates that similar formulations or delivery methods exist, requiring vigilant monitoring to avoid infringement.
3. Key Competitors and Patent Overlaps
- Patents filed in South Korea by multinational pharmaceutical companies (e.g., Roche, Novartis) related to similar formulations.
- Patent applications focusing on controlled-release systems, nanotechnology-facilitated delivery, or specific excipient combinations.
- Overlapping claims within the same subclass could lead to patent invalidation or licensing opportunities.
4. Patent Life and Expiry
Given the filing date (2012) and standard patent term (20 years from filing), the patent is expected to expire around 2032, unless extensions or supplementary protection certificates apply.
Implications for Stakeholders
For Developers and Innovators:
- Infringement Risks: New entrants seeking to develop similar formulations must analyze claim scope carefully.
- Design Around Strategies: Narrow claims necessitate innovative approaches to avoid infringement.
- Patent Lifespan: The remaining patent term provides a window for commercialization before generics can enter.
For Patent Holders:
- Enforcement Opportunities: The patent affords grounds to litigate unauthorized manufacturing or marketing.
- Licensing: Broad claims can be licensed to other entities, generating revenue streams.
For Regulators and Policymakers:
- Ensuring patient access post-expiry while incentivizing innovation.
- Balancing patent protection with promotion of generic competition.
Legal and Technical Challenges
- Invalidity Risks: Prior art in the form of publicly disclosed formulations, methods, or compositions could challenge the patent.
- Patentability of Improvements: Subsequent innovations must demonstrate inventive step over this patent.
- Navigating Patent Thickets: Multiple overlapping patents may complicate freedom to operate.
Conclusion
KR20130028803 represents a strategic patent within South Korea's pharmaceutical landscape, designed to protect novel drug formulations or delivery methods. Its scope hinges on the specific language of its claims—broad enough to secure significant market exclusivity yet narrow enough to withstand legal scrutiny. Stakeholders must meticulously analyze the claims' language and the surrounding patent landscape to optimize their strategic positions.
Key Takeaways
- The patent’s claims primarily cover specific pharmaceutical compositions or methods, emphasizing stability or bioavailability enhancements.
- A careful review of claim language is essential to assess infringement risks and freedom-to-operate.
- The patent landscape is competitive, with overlapping patents requiring vigilance to avoid infringement and identify licensing opportunities.
- The patent's remaining lifespan offers a crucial window for commercial exploitation, with expiration anticipated in 2032.
- Ongoing patent monitoring and landscape analysis are vital to maintain competitive advantage and adapt to evolving legal standards.
FAQs
1. How broad are the claims of KR20130028803?
The claims likely span specific formulations or delivery methods, with the breadth dependent on claim language. Broad claims cover more ground but are more susceptible to challenge.
2. Does this patent affect generic drug entry in South Korea?
Yes, granted patents serve as barriers to generic approval until expiration or invalidation, delaying biosimilar or generic launches.
3. Are similar patents filed internationally?
Most likely, yes. Developers typically file patent families to extend protection to key markets, leveraging PCT applications.
4. Can the patent be challenged or invalidated?
Yes, prior art could be introduced to challenge validity, especially if similar formulations or methods existed before filing.
5. How does this patent influence R&D strategies?
It encourages careful claim drafting, strategic filing, and ongoing patent landscape analysis to protect innovations and avoid infringement.
Sources
[1] Korean Intellectual Property Office (KIPO) patent database.
[2] Patent documents associated with KR20130028803.
[3] South Korea’s patent law regulations and guidelines.
