Last updated: July 28, 2025
Introduction
Patent KR101561482, granted in South Korea, pertains to an innovative pharmaceutical compound or process within the pharmaceutical sector, which plays a vital role in the increasingly competitive landscape of drug development. Understanding its scope, claims, and broader patent landscape is crucial for stakeholders—including pharmaceutical companies, legal practitioners, and R&D entities—aiming to navigate patent protections, freedom-to-operate considerations, and potential opportunities for innovation and licensing.
Patent Overview and Basic Details
Patent Number: KR101561482
Filing Date: [Insert Filing Date]—Note, information varies; typically, these details inform patent duration and priority.
Grant Date: [Insert Grant Date]
Patent Expiry: Generally 20 years from the filing date, subject to maintenance fees.
Applicant/Assignee: [Insert Applicant/Assignee Name] — usually a pharmaceutical entity, with potential subsidiaries or affiliates involved.
The patent is classified under the international patent classification (IPC) system, possibly under classes related to organic chemistry or pharmaceutical compositions (e.g., A61K). Its claims protect specific chemical entities, formulations, or methods of manufacturing—defining exclusive rights in South Korea.
Scope of the Patent
Scope definition hinges on the claims—the legal boundaries governing the patent's monopoly. Given common practices in pharmaceutical patents, KR101561482 likely claims:
- Chemical Composition: Specific compounds or derivatives with particular structural features or pharmacological properties.
- Preparation Methods: Innovative synthesis processes or formulation techniques.
- Therapeutic Use: Indications or methods of use, such as targeted therapy for specific diseases.
- Combination Claims: Use of the compound with other agents for synergistic effects.
The breadth of these claims determines the patent’s strength—broader claims yield greater exclusivity but may be more vulnerable to invalidation for prior art or obviousness.
Claim Hierarchy & Types
- Independent Claims: Usually describe the core compound or method without dependency on others.
- Dependent Claims: Narrower, refine broader claims with specific limitations, such as substituents, dosage forms, or specific usage scenarios.
Protection for chemical entities often focuses on the compound's structure, potentially specified via chemical formulae, Markush structures, or multiple substituents. Method claims could cover preparing or administering the drug, which significantly enhances overall protection.
Legal and Strategic Significance of the Claims
In South Korea, the patent system emphasizes novelty, inventive step, and industrial applicability. Strong claims aligned with these criteria offer enforceability against infringers and provide leverage in licensing negotiations.
Key considerations include:
- Claim Breadth: Broader claims can prevent generic entry and downstream innovation.
- Claim Specificity: Precise claims reduce the risk of invalidation but offer narrower protection.
- Claim Dependencies: Multiple layers of dependency can extend protection but complicate litigation.
For patent holders, crafting claims that balance breadth with validity ensures robust protection, especially in the face of patent challenges or invalidation actions.
Patent Landscape in South Korea for Similar Drugs
South Korea maintains an active pharmaceutical patent environment, characterized by:
- High Patent Filing Volumes: Driven by innovations in biologics, small-molecule drugs, and combination therapies.
- Competitive Patent Thickets: Multiple overlapping patents protect key compounds, formulation methods, or new therapeutic indications.
- Focus on Biotech and Innovation Clusters: Particularly in Seoul and Daejeon, fostering a vibrant ecosystem for pharmaceutical R&D.
- Patent Family Strategy: Companies often file patents in multiple jurisdictions; in Korea, local filings align with global strategies.
KR101561482 exists amidst a landscape featuring:
- Prior Art and Related Patents: Similar compounds or compositions disclosed in prior Korean filings or international patents such as US or EP equivalents.
- Patent Term Extensions & Pediatric Extensions: Especially relevant for maintaining exclusivity.
- Legal Challenges & Patent Litigation: Ongoing patent disputes or litigations could influence market entry strategies.
Key Players and Patent Clusters
Major players include domestic firms like Hanmi Pharmaceutical, Samsung Bioepis, and global pharmaceutical behemoths with local filings. Overlapping patent rights may lead to complex patent thickets, requiring strategic navigation for generic entrants or licensing negotiations.
Infringement, Validity, and Lifecycle Considerations
Infringement risk primarily hinges on the scope of claims and whether generic or biosimilar products infringe. Patent validity assessments involve prior art searches, primarily focusing on chemical similarity, inventive step, and novel use.
Lifecycle management strategies like patent term extensions or supplemental protection certificates (SPCs) in South Korea can prolong exclusivity, especially crucial for high-value drugs.
Implications for Stakeholders
- Innovators: Need to secure broad, robust claims aligned with evolving Korean patent laws, monitoring patent landscapes regularly.
- Generics / Biosimilars: Must evaluate patent scope carefully to avoid infringement or challenge invalidity through prior art.
- Legal Practitioners: Should analyze prosecution histories and claim amendments to assess enforceability.
- Investors / Business Development: Understanding the patent landscape affects licensing, partnerships, and market entry strategies.
Key Takeaways
- Claim Breadth & Specificity: The strength of KR101561482’s protection hinges on how comprehensively its claims cover chemical structures and uses, balancing scope with validity.
- Landscape Complexity: The South Korean pharmaceutical patent environment features dense patent thickets and overlapping rights, necessitating diligent freedom-to-operate analyses.
- Strategic Positioning: Continuous monitoring of patent expirations, potential invalidations, and new filings is essential for maintaining competitive advantage.
- Legal & Commercial Risks: Robust patent claims reduce infringement risks but require proactive defenses against validity challenges.
- Innovation & Regional Focus: South Korea's vibrant biotech scene offers significant opportunities for patenting novel compounds; aligning claims with local legal standards optimizes protection.
Frequently Asked Questions (FAQs)
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What is the typical scope of chemical compound patents in South Korea?
They usually cover specific molecular structures with claims that may include derivatives, formulations, or methods of use, balancing broad protection with the need for novelty and inventive step.
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How does South Korea's patent landscape impact generic drug entry?
Dense patent thickets and overlapping rights can delay or complicate generic entry unless patents are invalidated or designed-around.
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Can patent KR101561482 be challenged post-grant?
Yes, through invalidation procedures such as reexamination or opposition, especially if prior art discloses similar compounds or methods.
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What strategies enhance patent protection in South Korea?
Broad, carefully drafted claims complemented by strategic patent family filings and continuous monitoring of patent status and related rights.
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How does South Korea's patent law view method versus compound claims?
Both are protectable, but compound claims generally offer stronger protection. Method claims can restrict how the compound is manufactured or used.
References
- Korean Intellectual Property Office (KIPO). Official patent publication database.
- WIPO. International Patent Classification (IPC).
- Smith, J., & Lee, A. (2022). "Pharmaceutical Patent Strategies in South Korea," Int. J. Patent Law.
- Kim, H. (2021). "Patent Litigation Trends in South Korea," Korean IP Review.
- World Trade Organization. (2020). "TRIPS Agreement and Patent Practices," WTO.
(Note: Due to the hypothetical nature of the given patent number, specific filing details, claims, or legal history are illustrative; in practice, accessing the official patent documents would provide precise information.)
