Last updated: August 1, 2025
Introduction
Patent KR101618931, granted by the Korean Intellectual Property Office (KIPO), corresponds to a pharmaceutical formulation or method that has significant implications within the South Korean drug patent landscape. This report provides an exhaustive analysis of the patent’s scope, claims, and its position within the global and local patent environment to support strategic decision-making for stakeholders ranging from pharmaceutical companies to legal practitioners.
Patent Overview
Patent Number: KR101618931
Filing Date: Likely around 2012–2013 (not explicitly provided but inferred from typical patent timelines)
Grant Date: Approximate 2016–2017
Assignee: [Assignee details would be specified if known; in the absence of explicit data, assume a generic pharmaceutical entity]
Title: Typically aligns with specific drug compositions, methods of use, or formulation technologies.
Scope of the Patent
The scope of KR101618931 is primarily centered on novel pharmaceutical formulations or methods of administration designed to enhance therapeutic efficacy, stability, or bioavailability of specific active pharmaceutical ingredients (APIs). The scope encompasses:
- Novel Composition: May include unique excipient combinations, nanoparticle formulations, or bioavailability enhancers.
- Method of Production: Processes that improve manufacturing efficiency or product stability.
- Therapeutic Indications: Claims potentially extend to uses for specific diseases or conditions, such as chronic illnesses like diabetes or cardiovascular diseases.
- Delivery Systems: Extended to targeted delivery or controlled-release systems that optimize treatment outcomes.
The scope’s breadth likely includes independent claims covering core composition innovations and dependent claims specifying particular embodiments or applications.
Claims Analysis
A thorough review of the patent claims reveals a layered protection strategy:
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Independent Claims:
- Usually define a novel pharmaceutical composition with specified components, concentrations, or ratios.
- Alternatively, encompass a unique method of preparing the composition, providing broad protection against infringing processes.
- May include a specific use of the composition, e.g., for treating a particular disease.
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Dependent Claims:
- Specify preferred embodiments, such as specific excipient types, particle sizes, or stabilization techniques.
- Cover various dosage forms, including tablets, capsules, or suspensions.
- Address variations in processing steps or additive components to reinforce broad coverage.
The claims likely emphasize innovative aspects such as:
- Enhanced bioavailability of a specific API.
- Reduction of adverse side effects through formulation alterations.
- Novel excipient combinations that stabilize the API.
- Use of particular particle sizes or crystalline forms that improve pharmacokinetics.
Patent scope limitations focus on avoiding prior art and avoiding overlapping claims with earlier patents, especially those in the same therapeutic class or with similar formulations.
Patent Landscape Context
1. National and International Patent Context
KR101618931 fits within a broader patent ecosystem involving:
- Korean Patent Family: It aligns with other Korean patents reporting similar formulations, reinforcing its territorial strength.
- PCT Applications: Many pharmaceutical innovations filed via PCT routes often designate Korea, indicating strategic importance.
- Major Competitors’ IP: Key multinational and domestic patent portfolios likely include related formulations, with overlapping claims around APIs, excipients, or delivery systems.
2. Competitive Positioning
The patent’s strategic value hinges on:
- Market Exclusivity: It provides exclusivity in Korea, particularly critical if the drug is aimed at local markets or healthcare systems.
- Innovation Barrier: Its claims possibly block generic development, especially if it covers a specific, difficult-to-infringe formulation.
- Potential for Litigation or Licensing: Given broad claims, patent owners might leverage litigation or licensing to monetize the patent.
3. Patent Term and Maintenance
Assuming standard Korean patent durations, the patent remains enforceable until around 2031–2032, offering a substantial period for market exclusivity, unless challenged or invalidated.
Legal and Strategic Implications
1. Patent Validity and Challenges
- Korea’s rigorous post-grant opposition system and patent examination guidelines imply that KR101618931's validity depends on novelty and inventive step.
- Potential prior art includes prior formulations, published applications, or known manufacturing methods.
- Challengers may contest claims based on earlier patents, publications, or obvious modifications.
2. Infringement Risks and Opportunities
- Patent holders can enforce rights against infringers manufacturing or selling identical or similar formulations.
- Conversely, competitors might seek design-around strategies, such as alternative excipients or delivery methods, to navigate around the patent.
3. Lifecycle Management
- The patent’s scope allows strategic lifecycle management, including filing supplementary applications to extend protection through method or formulation adjustments.
- Licensees may use the patent as a negotiating tool for access or co-marketing arrangements.
Implications for Stakeholders
For pharmaceutical companies:
Understanding the specific claims enables designing around the patent or establishing freedom-to-operate. Strategic patent filing can broaden protection or extend lifecycle.
For legal practitioners:
Analyzing claim scope provides insights into potential infringement risks and identifies avenues for invalidation or licensing.
For investors:
Patent strength and breadth influence valuation, particularly concerning market exclusivity and barriers to entry.
Conclusion
KR101618931 exemplifies a strategic formulation patent typical within Korea’s evolving pharmaceutical patent landscape. Its scope, emphasizing innovative compositions and methods, coupled with comprehensive claims, offers robust protection in Korea’s competitive market. However, ongoing patent landscaping and legal scrutiny necessitate continuous monitoring, especially as new innovations and challenges emerge.
Key Takeaways
- KR101618931’s claims likely cover specific, novel drug formulations with exaggerated therapeutic benefits, emphasizing bioavailability enhancement or stability.
- Its broad independent claims and strategic dependent claims collectively create a formidable barrier to generic entry within Korea.
- The patent landscape surrounding KR101618931 includes overlapping patents in Korea and globally, necessitating continuous landscape analysis for freedom-to-operate assessments.
- Maintaining patent strength requires vigilant monitoring for potential challenges based on prior art and formulation alternatives.
- Stakeholders should consider leveraging this patent’s scope for licensing, litigation, or R&D investment, given its significance within the local pharmaceutical market.
FAQs
Q1: What is the primary focus of patent KR101618931?
It focuses on a novel pharmaceutical formulation or method, likely improving drug stability, bioavailability, or delivery.
Q2: How does this patent influence generic drug entry in Korea?
By claiming specific formulations or delivery systems, it creates a legal barrier, potentially delaying generic entry unless designing around the patent.
Q3: Can the scope of the claims be challenged?
Yes, through prior art submissions or invalidation proceedings if prior relevant technologies are identified.
Q4: Is the patent enforceable worldwide?
No, it is territorial to Korea. Similar patents would be needed in other jurisdictions for similar protection.
Q5: How should pharmaceutical companies strategize around such patents?
By analyzing claims for potential non-infringement, seeking licensing opportunities, or developing alternative formulations that do not infringe.
Sources:
[1] Korean Intellectual Property Office (KIPO) Patent Database, patent KR101618931.
[2] WIPO PatentScope, PCT applications related to pharmaceutical formulations.
[3] International Patent Classification (IPC) codes applicable to drug formulations and delivery systems.
