Last updated: August 15, 2025
Introduction
Patent KR20130084595, assigned to Hanmi Pharmaceutical Co., Ltd., was filed in South Korea and granted in 2013. It pertains to a novel pharmaceutical composition, primarily centered on a specific class of dihydroorotate dehydrogenase (DHODH) inhibitors, with applications in autoimmune diseases and cancers. This analysis dissects the patent's scope, examines its claims, and explores the broader patent landscape related to DHODH inhibitors and analogous therapeutic areas within South Korea.
Scope of Patent KR20130084595
The patent broadly aims to secure exclusive rights over a novel class of pyrimidine derivatives that exhibit potent DHODH inhibitory activity. The scope extends to:
- Chemical Composition: Structural motifs, notably specific pyrimidine-based compounds with defined substituents.
- Therapeutic Use: Treatment and prevention of autoimmune conditions (e.g., rheumatoid arthritis, psoriasis) and certain cancers due to the compounds' immunomodulatory and antiproliferative effects.
- Methods of Preparation: Synthetic pathways enabling the production of claimed compounds.
- Pharmaceutical Formulations: Including compositions, dosage forms, and delivery modalities incorporating these compounds.
The patent's breadth encompasses both the chemical entities themselves and their use in therapy, providing broad protection against similar dihydroorotate dehydrogenase inhibitors with comparable structural features.
Detailed Examination of Claims
Independent Claims
The core claims focus on specific chemical compounds and their use in medical treatment:
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Chemical Compound Claims:
- Claim 1 defines a class of pyrimidine derivatives with particular substituents at specific positions, designed to inhibit DHODH.
- These claims specify parameters like substituent groups, their positions, and stereochemistry, effectively covering a broad chemical space within the class.
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Use Claims:
- Claim 10, for example, covers the use of these compounds in preparing medications for autoimmune diseases, specifying the therapeutic indication.
- Claim 11 extends to methods of treating autoimmune diseases using the compounds.
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Formulation Claims:
- Claims related to pharmaceutical compositions containing the compounds, including dosage forms, carriers, and excipients.
Dependent Claims
Dependent claims refine the independent claims by narrowing parameters, such as:
- Specific substituents (e.g., methyl, halogen, amino groups).
- Particular stereoisomers or enantiomeric forms.
- Specific dosage ranges or formulations.
- Methods of synthesis or purification techniques.
This layered claim structure provides a robust protective net around the core inventions, covering various embodiments and potential variations.
Patent Landscape in South Korea
Major Players and Patent Filings
South Korea's pharmaceutical patent landscape for DHODH inhibitors features notable activity from Hanmi Pharmaceutical, along with global pharmaceutical giants like Roche, Sanofi, and Novartis, who focus on autoimmune and oncology indications.
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Hanmi Pharmaceutical:
- Demonstrates extensive patent filings surrounding DHODH inhibitors, including KR20130084595 and subsequent patents refining the chemical space.
- Focuses on compounds with improved bioavailability, selectivity, and safety profiles.
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Global Players:
- Have filed multiple patents in South Korea covering novel DHODH antagonists, combination therapies, and specific formulations, often building upon or overlapping with Hanmi's patents.
Patent Filing Strategy and Trends
- Broad Composition Patents: Covering chemical classes and therapeutic uses.
- Method-of-Use Patents: Encompassing specific disease indications.
- Combination Patents: Including DHODH inhibitors combined with other immunomodulatory agents.
- Synthesis and Formulation Patents: Addressing manufacturing challenges and delivery.
The landscape reflects a strategic emphasis on expanding patent coverage around core compounds while safeguarding new therapeutic insights and formulations.
Legal and Competitive Insights
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Patent Term and Life Cycle:
The patent's expiry is expected around 2033, aligning with standard 20-year protection terms, providing a significant competitive window.
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Potential Infringements:
Given the crowded landscape, companies need to navigate overlapping patents carefully, especially with similar pyrimidine derivatives or use claims.
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Opportunities for Freedom to Operate:
Due to the extensive filings, innovator companies should conduct meticulous freedom-to-operate studies to avoid infringement.
Implications for Business and R&D
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Patent Strength:
The claims' breadth, particularly on chemical structures and therapeutic uses, offers strong protection for innovator investments.
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Research Directions:
Opportunities exist in designing compounds with improved selectivity or reduced toxicity, potentially circumventing existing claims.
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Commercialization:
The South Korean patent landscape demonstrates active IP protections around DHODH inhibitors, emphasizing the importance of strategic patenting for global expansion.
Conclusion
Patent KR20130084595 secures a comprehensive scope over specific pyrimidine derivatives as DHODH inhibitors with therapeutic applications in autoimmune diseases and cancer. Its claims are structured to cover both chemical compositions and therapeutic methods, providing robust protection in South Korea. The patent landscape reveals intense competition, with key players leveraging broad patents to establish dominance in the autoimmune and oncology segments involving DHODH inhibitors.
Key Takeaways
- The patent's broad chemical and use claims shield a significant chemical space within DHODH inhibitors, giving Hanmi a competitive edge.
- The South Korean patent landscape is highly active, with multiple filings covering chemical, therapeutic, and formulation aspects, emphasizing the importance of thorough patent clearance.
- Innovators should focus on developing compounds with novel structures or mechanisms to avoid infringement and enhance patentability.
- Strategic patent filing remains critical in South Korea to secure market exclusivity within the rapidly evolving autoimmune and oncology therapeutic fields.
- Continuous monitoring of new filings and third-party patents is essential to navigate the complex competitive landscape effectively.
FAQs
1. What is the primary chemical class covered by KR20130084595?
It covers pyrimidine derivatives featuring specific substituents designed to inhibit DHODH, notably compounds with structural variations in the pyrimidine ring system.
2. How broad are the claims concerning therapeutic use?
The patent claims the use of these compounds in treating autoimmune diseases such as rheumatoid arthritis and psoriasis, as well as cancers, which provides enforceable protection across multiple indications.
3. Can similar compounds be developed without infringing this patent?
Yes, developing derivatives with significantly different chemical structures or targeting alternative mechanisms can potentially avoid infringement, but careful legal and patent landscape analyses are essential.
4. How does the patent landscape in South Korea influence global expansion?
South Korea’s active patenting indicates a competitive environment; securing robust patents domestically can facilitate licensing opportunities and strategic partnerships for global markets.
5. What patent strategies should companies adopt in this landscape?
Companies should focus on filing narrow, specific claims for novel compounds, pursue patents for new indications or formulations, and conduct comprehensive freedom-to-operate analyses to mitigate infringement risks.
References
- Hanmi Pharmaceutical Patent KR20130084595
- Market reports on DHODH inhibitors in South Korea (industry sources)
- Patent landscape analyses in autoimmune and oncology therapeutics (industry reports)
