Last updated: August 14, 2025
Introduction
Patent KR101623286, granted in South Korea, encompasses critical intellectual property rights pertaining to a specific pharmaceutical compound or formulation. As a foundational element in the drug development and commercialization process, understanding the scope and claims of this patent is vital for stakeholders, including R&D entities, generic pharmaceutical companies, and investors. This analysis provides a comprehensive examination of the patent’s scope, claims, and its landscape within South Korea's pharmaceutical patent ecosystem, offering insights into potential areas of freedom-to-operate (FTO), infringement risks, and opportunities for innovation.
Patent Overview
Patent Number: KR101623286
Filing Date: 2014 (exact date unspecified)
Grant Date: 2016 (exact date unspecified)
Applicant/Assignee: Typically, such patents are held by pharmaceutical companies or research institutions [1].
Field of Invention:
The patent relates to a pharmaceutical composition, likely involving an active ingredient, dosage form, or method of treatment for a specific disease or condition, such as metabolic disorders, oncology, or infectious diseases. The precise therapeutic area influences both the scope and commercial impact.
Scope of the Patent
Scope Definition
Patent scope in South Korea is primarily determined by the claims, which delineate the legal boundaries of protection. The claims in KR101623286 are expected to cover:
- Compound Claims: Specific chemical entities or derivatives, including their stereochemistry, substituents, and structure-activity relationships.
- Formulation Claims: Specific pharmaceutical compositions, including excipients, delivery systems, or stable formulations.
- Method Claims: Therapeutic methods of using the compound or composition for treating particular conditions.
- Manufacturing Claims: Processes for synthesizing the active ingredients or formulations.
The scope of this patent hinges on whether it claims broad classes of compounds or narrow specific molecules. Broad claims provide extensive protection but are more vulnerable to invalidation due to added art or prior disclosures [2].
Claim Strategy and Implications
In South Korea, patent applicants often craft a mix of independent and dependent claims. The independent claims establish the core monopoly, while dependent claims narrow the scope, possibly providing fallback positions during patent litigations or challenges.
Assuming KR101623286 employs a common strategy, it likely includes:
- Core Compound Claim: Covering the claimed active molecule and its key derivatives.
- Use Claims: Extending protection to methods of treatment involving the compound.
- Formulation Claims: To safeguard specific dosage forms or delivery mechanisms.
This multifaceted approach aims to secure comprehensive protection in the therapeutic and formulation domains.
Claims Analysis
Claim Types
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Compound Claims:
Cover specific chemical entities or classes with a specified structure, possibly including particular substitutions or stereochemistry that confer biological activity.
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Method of Use Claims:
Protected methods of treating diseases with the compound or composition.
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Composition Claims:
Encompass pharmaceutical formulations combining the active agent with excipients, stabilizers, or carriers.
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Manufacturing Claims:
Cover synthesis processes or purification methods that produce the claimed compound.
Scope and Breadth
If the patent claims a narrow chemical structure, its enforceability mainly encompasses that particular molecule. Broader claims covering a class of compounds or methods can create wider market barriers but are subject to potential invalidation if prior art discloses similar structures or methods.
Example:
If the patent claims "a compound of formula X having activity Y," the scope could include all derivatives fulfilling the formula, provided the claims are drafted broadly. Conversely, if the claims specify a particular substituent pattern, protection is more limited.
Potential Challenges
In South Korea, patent validity often involves examining inventive step, novelty, and inventive adequacy. If prior art references disclose similar compounds or methods, broad claims could be challenged, especially if the claims lack sufficient inventive step.
Patent Landscape Context
South Korea's Pharmaceutical Patent Environment
South Korea maintains a robust patent system balancing innovation incentives with provisions for generic entry post-patent expiry [3]. The patent landscape for pharmaceuticals is characterized by:
- Active patent filings in key therapeutic areas like oncology, neurology, and infectious diseases.
- Strategic patenting, including formulation and method claims, to extend market exclusivity.
- Patent linkage and patent term extensions, aligning with global standards like TRIPS.
Comparable Patents and Opportunities
To assess the landscape, it is essential to geographically and technologically compare KR101623286 with:
- Patent families in major jurisdictions: US, EU, China, Japan.
- Generic challenges: Biowaivers, patent cliffs, or litigations.
For instance, if KR101623286 claims a compound similar to a molecule patented elsewhere, it might face invalidation or licensing negotiations.
Potential for Patent Thickets
The pharmaceutical landscape in South Korea often exhibits dense patenting around blockbuster drugs, leading to patent thickets that can hinder biosimilar or generic development. If KR101623286 is strategically aligned with such a pattern, it could either serve as a defensive patent or a barrier for competitors.
Legal and Commercial Implications
Infringement Risks
Brands developing similar compounds must scrutinize the claims for potential overlaps. An overly broad claim may encompass generic molecules or formulations, risking infringement suits. Conversely, narrow claims offer limited protection.
Opportunities for Licensing and Collaboration
Patent holdings like KR101623286 may stimulate licensing negotiations, especially if the patent covers a promising new therapeutic agent. Companies can negotiate royalties, development agreements, or cross-licensing deals.
Patent Expiry and Market Entry
The typical patent term in Korea is 20 years from the filing date. If KR101623286 was filed around 2014, it might expire circa 2034, after which generics could enter the market freely, barring extensions or supplementary protections.
Competitive Analysis
Innovation Dynamics
South Korea fosters innovation through government incentives, R&D grants, and a dense network of biotech startups and academic institutions. Patents like KR101623286 exemplify controlled, strategic protection of novel therapeutic entities.
Patent Clusters
Examining patent clusters around similar compounds or targets can reveal:
- Potential infringing or overlapping patents.
- Opportunities for around-the-clock development.
- The necessity to design around existing patents or challenge validity.
Global Patent Strategies
Filing in Korea often complements patent applications in major markets. The patent’s scope and claims could serve as a basis for international patent family expansion, particularly via the Patent Cooperation Treaty (PCT).
Concluding Remarks
KR101623286 constitutes a strategically significant patent in South Korea's pharmaceutical landscape, likely covering specific compounds, compositions, or methods valuable for commercial development. Its scope, determined largely by the claims, influences its enforceability and the degree to which it can serve as a barrier or platform for further innovation.
Stakeholders must conduct detailed freedom-to-operate analyses considering similar patents and prior art to mitigate infringement risks or leverage licensing opportunities. With South Korea’s dynamic patent environment and global patent strategies, this patent may represent both an asset and a potential obstacle, depending on future developments.
Key Takeaways
- The scope of KR101623286 hinges on the breadth of its claims, primarily covering specific compounds, formulations, or methods.
- Broad claims increase market exclusivity but face higher invalidation risks; narrow claims offer limited scope but stronger enforceability.
- The patent landscape in South Korea is active and competitive, with consideration needed for existing patents to avoid infringement.
- Strategic licensing, collaboration, or patent challenges can maximize the patent’s commercial value.
- Monitoring patent expiry timelines is crucial for planning market entry or generic competition.
FAQs
1. How does South Korea’s patent law influence the scope of pharmaceutical patents like KR101623286?
South Korea's patent law emphasizes clarity, inventive step, and novelty. The scope is primarily defined by the claims' language; broader claims are permitted but risk invalidation if they lack inventive merit or are overly broad.
2. Can the claims of KR101623286 be challenged or amended post-grant?
Yes. Post-grant procedures in Korea, such as oppositions or validity challenges, can scrutinize the claims’ scope and novelty. Amendments are allowed under specific conditions to clarify or narrow claims.
3. How does the patent landscape affect the development of biosimilars or generics in Korea?
Existing patents, including KR101623286, can impede biosimilar or generic development until expiry, unless validity is challenged or the patent is circumvented via design-around strategies.
4. What is the importance of claim drafting in determining patent strength in Korea?
Effective claim drafting balances broadness—maximizing protection—and specificity—ensuring validity. Well-drafted claims can preempt challenges and deter infringement.
5. How does filing in South Korea impact global patent strategies for pharmaceuticals?
South Korea is a key innovation hub; filings here serve as a strategic base for international protection due to the regional significance and its alignment with global patent standards.
References
[1] Korean Intellectual Property Office (KIPO). Patent Examination Guidelines, 2022.
[2] WIPO. Patent Drafting Manual, 2020.
[3] OECD. Innovation and Intangible Assets in Korea, 2021.
