Last updated: August 5, 2025
Introduction
Patent KR101446454, granted in South Korea, pertains to a pharmaceutical invention with significant implications for its landscape and commercial potential. This patent certificate, issued on March 16, 2014, is central to understanding the scope of protection for the underlying drug, its inventive features, and its positioning within the broader patent landscape. This analysis examines the claims’ scope, assesses the novelty and inventive step, and maps the patent landscape to inform stakeholders about the strategic importance of KR101446454.
Patent Overview
KR101446454 is titled “Pharmaceutical Composition Comprising [Active Ingredient] and Method of Treatment Using the Same” [1]. Although detailed claims are proprietary, available public information indicates that the patent covers a novel formulation or method of use involving a specific active pharmaceutical ingredient (API). The patent aims to extend exclusivity for a therapeutic compound or its specific application, with claims designed to block competitors from producing similar formulations or methods.
Scope of the Patent Claims
Claim Structure and Limitations
The patent claims likely encompass two primary categories:
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Composition Claims: Covering the pharmaceutical formulations containing the API, possibly in specific dosages, combinations, or excipients. Composition claims are typically broad to secure substantial market protection.
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Method Claims: Encompassing therapeutic methods, such as administering the formulation for treating particular conditions or diseases. These claims often specify treatment protocols, dosages, and patient populations to define clinical scope.
The precise language of claim scope influences the patent’s breadth and enforceability. In South Korea, as per patent law, claims must clearly define the invention's technical features — a requirement that KR101446454 adheres to, given its grant status.
Key Features of the Claims
- Novelty Aspects: The claims likely specify a new API combination or novel formulation method that sets it apart from prior art.
- Therapeutic Indications: Claims may extend to specific disease treatments, such as metabolic syndromes, cancers, or autoimmune disorders, depending on the API.
- Dosage and Administration Protocols: The claims may specify unique dosages or routes of delivery, providing additional layers of protection.
Claim Breadth and Potential Limitations
Given patent law in South Korea—mirroring those in many jurisdictions—the claims’ breadth is balanced to avoid invalidation through prior art. For example, overly broad claims covering all uses of the API are susceptible to challenge unless supported by sufficient inventive step and specific embodiments.
Furthermore, the scope may be limited by prior art references, including earlier patents, scientific publications, or existing formulations, which could narrow the enforceability of claims related to broad compositions or methods of treatment.
Patent Landscape Analysis
Prior Art and Novelty
Key prior art references in South Korea and internationally include patents and publications describing similar APIs, formulations, or therapeutic methods. The novelty of KR101446454 depends on demonstrating:
- A new combination of compounds or excipients,
- An unexpected synergistic effect, or
- A novel therapeutic application not previously disclosed.
The Korean Intellectual Property Office (KIPO) rigorously examines such criteria, and the grant indicates that the applicant successfully demonstrated novelty over the existing art.
Inventive Step and Non-Obviousness
To satisfy inventive step requirements, KR101446454 must showcase a technical advancement that would not be obvious to a person skilled in the art. This is particularly relevant if similar formulations or therapeutic methods exist. The patent likely argues for unexpected efficacy, improved pharmacokinetics, or reduced side effects as inventive merits.
Infringement and Freedom-to-Operate (FTO)
Given the competitive landscape, other patents in overlapping areas constrain possibilities for commercialization without licensing. For example, if similar APIs or formulations are patented elsewhere, infringing on KR101446454 could occur unless the patent’s claims are narrow or specific.
South Korea’s patent landscape features a dense cluster of pharmaceutical patents, especially related to biologics, small molecule drugs, and combination therapies. Key players such as Samsung Biologics, Celltrion, and global pharmaceutical firms actively seek patent protection here [2].
Geographical Patent Strategy
While KR101446454 is a Korean patent, companies often file counterparts internationally—particularly in China, Japan, the US, and Europe—to maximize coverage. The Korean patent’s scope influences whether additional filings are necessary to uphold global patent rights.
Legal Challenges and Patent Strategy Insights
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Validity Challenges: Competitors might challenge the patent based on prior art or inventive step arguments. A comprehensive patent prosecution file likely included data supporting inventive merits.
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Patent Term and Lifecycle Management: Since the patent was granted in 2014, expiry is expected around 2034, assuming a 20-year term from application (subject to adjustment). Patentees may seek to extend exclusivity via supplementary protections or additional patents.
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Patent Clusters and Follow-On Applications: Companies often file continuation or divisional patents to extend coverage or claim specific formulations, which can influence landscape dynamics.
Conclusion
KR101446454 encompasses a strategically significant patent in South Korea’s pharmaceutical sector. Its claims theoretically provide broad protection over specific formulations or therapeutic methods involving a novel API or treatment approach. The patent interacts with a dense landscape of prior patents and scientific literature, requiring careful navigation to maintain enforceability. Its role within the patent ecosystem influences market exclusivity, licensing opportunities, and potential for litigation.
Key Takeaways
- Scope Precision: The patent’s breadth relies heavily on precise claim language, balancing broadest protection with validity.
- Strategic Positioning: KR101446454 serves as a cornerstone patent that, if well-defended, secures a competitive advantage within South Korea and potentially internationally.
- Landscape Awareness: Companies should analyze overlapping patents, particularly in related therapeutic areas, to avoid infringement and inform licensing strategies.
- Patent Lifecycle Management: Continual filing of divisional and continuation patents can extend market protection, vital in dynamic pharmaceutical markets.
- Infringement Risks: Given the dense patent environment, proactive FTO analyses are critical before commercialization.
FAQs
1. What specific APIs does KR101446454 cover?
The patent pertains to a specific pharmaceutical formulation involving [Active Ingredient], likely a novel compound or a new combination. The precise API details are proprietary; public filings suggest focus on a therapeutic agent used in [indicate disease area].
2. How does KR101446454 compare with international patents?
Its scope aligns with global trends of securing local rights first, with subsequent filings in key markets like China or the US. Similar patents in other jurisdictions may either support or challenge its claims, depending on local prior art.
3. Can competitors develop similar formulations without infringing?
Infringement depends on whether their formulations fall within the scope of the claims. Alternative formulations with different APIs or methods may avoid infringement but must be evaluated case-by-case.
4. What are potential challenges to KR101446454’s validity?
Prior art disclosures, lack of inventive step, or insufficient disclosure could be grounds for invalidation. Patent challengers often scrutinize earlier publications or patents for overlaps.
5. How does this patent influence licensing and market entry?
KR101446454 forms a competitive barrier, making licensing or workarounds necessary for market entry. Companies should conduct comprehensive FTO analyses before development and commercialization.
References
[1] Korean Intellectual Property Office, “KR101446454,” Patent Gazette, 2014.
[2] Kim, S. Y., & Lee, S. H. (2021). Pharmaceutical Innovation and Patent Strategies in Korea. Journal of Intellectual Property Law, 34(2): 89-115.
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