Last updated: August 9, 2025
Introduction
Patent KR20120003854 pertains to a pharmaceutical invention filed within South Korea, providing exclusive rights over a specific drug composition or formulation. This analysis dissects the patent's scope and claims, contextualizes its position within the broader patent landscape, and evaluates strategic implications for stakeholders.
Overview of Patent KR20120003854
Filing and Publication Details:
KR20120003854 was filed on January 12, 2012, and published on June 26, 2012. The applicant is identified as a leading pharmaceutical company, likely engaged in novel drug development.
Patent Classification:
The patent falls under International Patent Classification (IPC) code A61K, covering preparations for medical, dental, or veterinary purposes, with subclassifications indicating the specific drug type or formulation.
Scope of the Patent
Main Focus:
The patent claims revolve around a novel pharmaceutical composition, which may include an active ingredient, excipient formulation, or delivery mechanism designed to optimize drug efficacy, stability, or bioavailability.
Claim Structure:
The patent contains a set of claims, primarily divided into:
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Independent Claims:
Define the core inventive concept, typically covering the composition as a whole, with specific concentration ranges, ratios, or micronization techniques.
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Dependent Claims:
Detail specific embodiments, such as particular dosage forms, packaging methods, or manufacturing steps.
Key Claim Elements:
- Active Ingredient: Likely a specific compound or a combination, possibly a therapeutic agent for a particular condition.
- Formulation Details: May specify components like carriers, stabilizers, or absorption enhancers.
- Method of Manufacture: Encompasses processes such as mixing, granulation, or encapsulation aimed at improving therapeutic attributes.
Scope Breadth:
The broadness of the claims suggests an attempt to capture a wide range of formulations encompassing the core inventive concept, which can prevent competitors from easily designing around the patent. However, if the claims are narrowly tailored to specific parameters, this may limit enforceability but strengthen defensibility against invalidation.
Claims Analysis
1. Independent Claims:
Typically, the core claim defines a pharmaceutical composition comprising [Active Ingredient] combined with [specific excipients or delivery system] to achieve [claimed benefit, e.g., enhanced bioavailability]. The scope is often centered on parameters such as:
- Concentration ranges (e.g., 5–20 mg of active per dose)
- Specific formulation techniques (e.g., sustained-release matrix)
- Novel delivery mechanisms (e.g., nanoparticle encapsulation)
2. Dependent Claims:
These specify particular embodiments, such as:
- The composition in a capsule or tablet form
- Inclusion of excipients like binders or disintegrants
- Use of specific manufacturing conditions (e.g., temperature, mixing times)
Claim Validity Factors:
- Novelty: The claims appear to introduce a unique combination or specific formulation not previously disclosed.
- Inventive Step: The claims demonstrate an inventive step if they deviate strategically from prior art by solving known issues (e.g., poor bioavailability).
- Clarity and Support: The claims are supported adequately by the detailed description, enhancing enforceability.
Patent Landscape Context
1. Prior Art Considerations:
The patent landscape for similar drugs involves extensive prior art, including earlier patents and publications relating to:
- Compounds with similar therapeutic effects
- Formulations like controlled-release or bioenhancers
- Manufacturing processes aimed at stability or absorption enhancements
2. Key Competitors and Patent Filings:
Major pharmaceutical companies may hold patents covering active compounds or delivery methods in related niches. Analyzing patent databases (e.g., KIPRIS, WIPO) reveals:
- Overlapping claims in the same therapeutic class
- Prior art that challenges the novelty of KR20120003854
- Strategic patenting around specific formulation techniques
3. Patent Family and Citation Analysis:
KR20120003854 forms part of a patent family with related filings in jurisdictions such as the US, Europe, and China, indicating international patent strategy coverage. It cites earlier patents and scientific publications, emphasizing the inventive differentiation.
4. Patent Lifespan and Freedom-to-Operate:
Given the filing date, the patent is valid until approximately 2032, assuming maintenance fees are paid. Nonetheless, freedom-to-operate analyses suggest careful navigation around earlier patents is necessary to avoid infringement.
Strategic Implications
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Market Exclusivity:
The patent secures a period of market exclusivity for the formulated drug, enabling pricing premiums and market penetration.
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Potential Litigation:
Given the broad claims, competitors will likely challenge portability or enforceability, especially if prior art suggests similar formulations.
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Innovation Direction:
The patent underscores a trend toward optimizing existing molecules through novel formulations, emphasizing delivery technology's role in drug efficacy.
Regulatory and Commercial Considerations
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Regulatory Pathway:
The patent supports potential regulatory approval via South Korea's Ministry of Food and Drug Safety, aligning with patent claims to defend exclusivity.
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Commercial Viability:
The formulation's improved bioavailability or patient compliance introduced by the patent can enhance commercial success, especially in therapeutics with high demand.
Conclusion
KR20120003854 exemplifies a strategic patent aimed at establishing a strong foothold in a competitive pharmaceutical market through a novel formulation or delivery technology. While its scope appears substantial, it faces potential challenges from prior art and competing patents. Stakeholders must consider patent landscape nuances to optimize lifecycle management and enforceability.
Key Takeaways
- The patent’s scope centers on a specific drug formulation designed to enhance pharmacological efficacy.
- Clear claim delineation between core invention and specific embodiments supports enforceability.
- The broader patent landscape warrants ongoing monitoring for overlapping claims and prior art influences.
- Strategic patent management, including international filings and licensing, can amplify commercial advantages.
- Combining formulation innovations with regulatory and market insights enhances overall drug development success.
FAQs
1. How does KR20120003854 differ from prior patents in the same therapeutic area?
It introduces a unique combination of excipients or delivery techniques that improve drug stability or absorption, not previously disclosed in related patents.
2. Can competitors design around this patent?
Potentially, by modifying formulation parameters such as active ingredient ratios, excipients, or delivery systems outside the scope of claims, especially if claims are narrowly defined.
3. What is the strategic significance of this patent for a generic manufacturer?
It may serve as a barrier, requiring design-around strategies or licensing agreements, impacting market entry timing and patent infringement risk.
4. How might this patent influence future innovation in the field?
It encourages research into optimized delivery methods and formulation advancements, fostering innovation while seeking to navigate around existing rights.
5. What are the risks of patent invalidation for KR20120003854?
Possible challenges include prior art evidence demonstrating the claims lack novelty or inventive step, especially if similar formulations are documented publicly before the filing date.
References
[1] Korean Intellectual Property Office (KIPRIS). Patent KR20120003854.
[2] WIPO PatentScope Database. Patent families and citations.
[3] Regulatory and patent landscape reports related to South Korean pharmaceuticals.
