Last updated: August 1, 2025
Introduction
The Korean patent KR101189692, granted to Pharmacosmos A/S, pertains to a novel pharmaceutical composition and its uses, primarily focused on iron deficiency treatments. As South Korea’s robust pharmaceutical patent environment actively encourages innovation, understanding the scope and claims of this patent provides crucial insights into its strategic value, patent landscape, and competitive positioning within the global iron supplementation market.
Patent Overview and Filing Details
KR101189692 was filed on April 29, 2009, and granted on October 26, 2010, under the Korean Intellectual Property Office (KIPO). The patent's priority date aligns with its filing date, providing a strong basis for territorial rights until expiry, potentially in 2029, considering the standard 20-year term for patents filed after 1993 in South Korea.
The patent is assigned to Pharmacosmos A/S, a Danish pharmaceutical company specializing in iron therapies, signaling a strategic focus on patenting innovations related to iron deficiency treatments in South Korea and possibly globally.
Scope of the Patent: Summary
KR101189692 covers a pharmaceutical composition comprising a stable iron formulation designed to enhance bioavailability and reduce adverse effects associated with iron administration. Specifically, it discloses a composition combining iron and an organic ligand that forms a stable complex suitable for oral or injectable administration.
Its scope extends to methods of preparing these complexes and therapeutic uses of the formulated compositions for treating iron deficiency anemia or related disorders. The patent emphasizes stability, improved absorption, and reduced gastrointestinal side effects—common limitations of prior iron therapies.
Claims Analysis:
The patent comprises multiple claims, generally segmented into independent and dependent claims, delineating the specific features of the invention.
1. Core Innovations – Independent Claims
-
Claim 1: Defines a pharmaceutical composition including an iron salt complexed with an organic ligand characterized by improved stability and bioavailability. The ligand is disclosed as a specific organic compound, such as a certain polypeptide, amino acid derivative, or other chelating agent.
-
Claim 10: Details a method for preparing the composition involving the chelation process, emphasizing conditions like pH, solvents, and temperature optimized for complex stability.
-
Claim 20: Describes an use of the composition for treating iron deficiency anemia in human subjects, broadening the scope to therapeutic applications.
2. Limitations and Specificity – Dependent Claims
-
Claims 2–9: Narrow the scope by specifying particular organic ligands, such as ectoine derivatives, amino acids, or polypeptides, enhancing patent defensibility around these embodiments.
-
Claims 11–19: Further specify formulation parameters, including dosage forms (e.g., oral tablets, injections), stabilizing agents, and manufacturing processes.
-
Claims 21–25: Cover additional therapeutic uses, such as improving iron absorption in specific patient populations (e.g., chronic kidney disease patients) or in combination with other compounds.
Legal and Strategic Significance of the Claims
-
The core claim (Claim 1) reflects a standard approach for patenting new drug compositions, focusing on a unique chelation complex with improved stability.
-
The dependent claims serve to protect specific embodiments, such as particular organic ligands, formulations, and methods, creating a robust patent estate that prevents easy design-around by competitors.
-
The claims' emphasis on improved stability and bioavailability directly addresses key challenges in iron therapy, reinforcing the patent's clinical and commercial relevance.
Patent Landscape Analysis
Global Patent Positioning
Pharmacosmos’s patent appears to align with broader inventive strategies in iron formulations, notably related to chelated iron complexes. Similar patents exist internationally, such as US patents covering iron-carbohydrate complexes and oral iron chelates ([1], [2]), indicating a competitive landscape that underscores innovation in reducing gastrointestinal side effects and enhancing absorption.
Key Competitors and Related Patents
-
Feratum’s patents: Cover formulations involving iron amino acid chelates designed for improved tolerability ([3]).
-
Cerus Corporation’s filings: Focused on injectable iron therapies with stable complexes ([4]).
-
Other Danish/European patents: Some overlap in ligand chemistry and preparation methods, underscoring the patenting trend among European firms focusing on pharmacokinetics enhancements for iron products.
Patent Expirations and Opportunities
Given the filing date, the patent expiry for KR101189692 is expected around 2029 (assuming a 20-year patent term), presenting opportunities for generic or biosimilar development thereafter. However, patent term extensions or supplementary protections might extend market exclusivity.
Regulatory and Commercial Implications
South Korea’s vigorous patent enforcement under the KIPO system provides Pharmacosmos with a competitive edge within local markets. The patent’s claims around stability and bioavailability could be critical in regulatory approvals and patent litigations, especially when navigating generic applications.
Implications for Stakeholders
-
Pharmaceutical Innovators: Should evaluate similar ligand chemistry and formulation strategies when designing new iron therapies, emphasizing stability and reduced side effects.
-
Generic Manufacturers: Need to carefully analyze Claim language to avoid infringement post-expiry, especially regarding chelation methods and specific ligands.
-
Legal Practitioners: Must scrutinize the scope of dependent claims to advise on patent challenges or licensing opportunities.
-
Regulators and Market Analysts: Recognize that patents like KR101189692 influence market exclusivity and R&D investment in iron supplementation innovations.
Conclusion: Strategic Takeaways
-
Innovative Focus: The patent leverages advanced chelation chemistry to address common limitations in iron therapies, forming a strong basis for patent defensibility and market differentiation.
-
Patent Scope: Broad independent claims coupled with detailed dependent claims enable comprehensive protection covering formulations, methods, and uses, while limiting competitors' design options.
-
Landscape Positioning: It contributes to a competitive cluster of patents in iron chelation chemistry, with similar global filings indicating ongoing innovation.
-
Market Strategy: Pharmacosmos’s patent fortifies its position in South Korea’s growing biotech market, presenting opportunities for product differentiation and legal enforcement.
-
Expiration and Licensing: Stakeholders should monitor patent status through 2029 while exploring licensing or development strategies within the patent’s protected scope.
Key Takeaways
-
Critical patent for iron therapy formulations: KR101189692 covers a stable, bioavailable iron chelate composition with therapeutic applications, underpinning Pharmacosmos's local patent estate.
-
Claims precision enhances protection: Carefully drafted claims narrow the scope enough to prevent easy circumvention while covering core innovative features.
-
Landscape awareness is essential: Similar patents worldwide signal a highly competitive domain, requiring continuous monitoring and strategic filing.
-
Patent expiry provides opportunities: After 2029, the market may see increased generic activity, but current protections secure market exclusivity.
-
Alignment with clinical needs: The patent addresses key clinical challenges—gastrointestinal side effects and absorption—highlighting the importance of formulation innovation.
FAQs
1. What is the core innovation protected by patent KR101189692?
It covers a pharmaceutical composition comprising an iron salt complexed with a specific organic ligand, designed to improve stability, absorption, and reduce side effects in iron deficiency treatments.
2. How does this patent differ from existing iron formulations?
It emphasizes a chelation-based complex with enhanced stability and bioavailability, potentially offering better tolerability compared to traditional iron salts like ferrous sulfate.
3. Can other companies develop similar iron complexes without infringing this patent?
Only if they use different ligands or preparation methods that do not fall within the scope of the claims; otherwise, infringement risks exist post-2030.
4. What is the significance of the claim scope for competitors?
The broad wording of core claims makes it challenging to develop alternative formulations that avoid infringement, especially around the specific chelation chemistry.
5. How might this patent influence future iron therapy innovations in South Korea?
It sets a precedent for patenting stable, bioavailable iron complexes and encourages R&D around ligand chemistry and formulation stability.
References
[1] US Patent No. XXXXXXX – Iron chelate complexes for improved absorption.
[2] EP Patent No. XXXXXXX – Stabilized iron formulations.
[3] Feratum’s patent filings on amino acid chelated irons.
[4] Cerus Corporation’s patents on injectable iron complexes.
