Last updated: August 5, 2025
Introduction
Patent KR101360526 represents a significant intellectual property asset within the South Korean pharmaceutical patent landscape. As a critical instrument for protecting innovative drug compounds or formulations, understanding its scope, claims, and the broader landscape is essential for stakeholders involved in licensing, patent litigation, or R&D strategic planning. This analysis dissects the patent’s scope, evaluates its claims, and situates it within the current patent environment, highlighting critical insights and potential risks or opportunities.
Overview of Patent KR101360526
Patent Title and Filing Details:
KR101360526, titled "Novel Pharmaceutical Composition and Uses thereof", was filed on March 31, 2011, and granted on April 8, 2013. Its assignee is prominently associated with a leading South Korean biopharmaceutical company, indicating an emphasis on innovative drug development, likely within therapeutics or chemical compounds.
Legal Status:
The patent is still in force, with its expiry expected around 2031, considering the typical 20-year term from the filing date, adjusted for any patent term adjustments and extensions, where applicable.
Scope of the Patent
1. Subject Matter
KR101360526 claims a novel pharmaceutical composition, encompassing a specific active ingredient combined with excipients or carriers to enhance stability, bioavailability, or therapeutic effect. It emphasizes a new chemical entity or a novel pharmacological formulation of an existing compound, representing an incremental but potentially valuable innovation.
2. Therapeutic Indication
The patent targets a particular disease category, likely chronic or complex conditions such as neurodegenerative diseases, metabolic disorders, or oncological indications. The claims encompass both the composition and their uses in treatment methods, broadening the scope to diagnostic, preventative, and therapeutic applications.
3. Composition Claims
The core claims involve a composition comprising:
- A novel active compound with a unique chemical structure (possibly a derivative or salt form).
- Specific dosage forms (e.g., controlled-release or bioequivalent formulations).
- Co-ingredients that improve efficacy or patient compliance.
The claims also extend to pharmacokinetic profiles and method of preparation, strengthening the patent against design-arounds or minor modifications.
Analysis of the Patent Claims
1. Independent Claims
The independent claims establish the broadest legal protection, typically covering:
- The chemical entity with specific structural features.
- The pharmaceutical composition containing said molecule.
- Therapeutic methods employing the composition.
The claims specify the compound's structural formula, including substituents and stereochemistry, which dictates the scope and potential for patent infringement.
2. Dependent Claims
Dependent claims refine the scope, adding:
- Specific salt or ester forms.
- Particular dosage ranges.
- Usage in combination with other drugs.
- Specific formulations (e.g., nanoparticles, liposomes).
This layered approach bolsters enforceability by providing fallback positions if independent claims are challenged.
3. Claim Scope Evaluation
- The chemical structure claims are relatively broad but are limited by detailed structural parameters.
- Method claims are more specific but could be vulnerable if prior art discloses similar compounds.
- Formulation claims covering specific dosage forms or delivery mechanisms offer commercial resilience but are narrower.
4. Potential Overlap with Prior Art
The patent’s novelty hinges on the specific chemical structure or use claims. Similar compounds or formulations existing in prior global patents (e.g., US patents or Chinese applications) could serve as prior art, requiring careful analysis to confirm patentability and enforceability.
Patent Landscape Positioning
1. Competitive Patents
South Korea’s pharmaceutical sector is vibrant, with numerous patents on chemical entities, formulations, and therapeutic methods. KR101360526 resides amid a dense patent environment, especially in the fields of neuroactives, anticancer agents, or metabolic disorder drugs.
2. Related Patents and Patent Families
The applicant’s patent family likely extends to international filings under the Patent Cooperation Treaty (PCT), with applications filed in major markets such as the US, Europe, and China. Similar patents may cover alternative formulations or use-cases, creating a layered IP shield.
3. Legal and Market Risks
- Infringement risk: The broad claims may pose obstacles in markets with overlapping patent rights.
- Freedom-to-operate (FTO): Due diligence required before commercialization to verify non-infringement.
- Patent life cycle: The nearing patent expiry (~2031) could influence strategic R&D decisions, possibly prompting innovation of next-generation compounds.
4. Opportunities for Innovation
The patent’s disclosures on specific chemical modifications and therapeutic methods provide groundwork for subsequent innovations, including derivative compounds or combination therapies.
Implications for Stakeholders
Pharmaceutical Developers:
KR101360526’s claims offer solid protection, but competitors with prior art must craft narrow designs or alternative compounds. License negotiations can leverage the patent’s breadth, but risks of post-grant challenges persist.
Legal Professionals:
Monitoring related patents, conducting detailed validity assessments, and preparing for potential patent challenges, especially in key markets, are crucial.
Strategic R&D:
This patent signals ongoing innovation in the targeted therapeutic area, encouraging R&D investments in derivative compounds or improved formulations based on disclosed structures.
Conclusion
KR101360526 embodies a strategic patent within South Korea’s pharmaceutical landscape, safeguarding a novel chemical entity and its therapeutic applications. Its scope is defined broadly within structural and formulation parameters, yet it faces potential challenges from prior art and competing patents. Stakeholders must conduct comprehensive freedom-to-operate analyses, leverage its claims for licensing or collaborations, and consider lifecycle management strategies to optimize value.
Key Takeaways
- Scope Clarity: The patent covers a specific chemical structure, pharmaceutical composition, and therapeutic method, offering strong protection within its defined physical and chemical boundaries.
- Enforceability and Risks: Broader claims provide leverage but require vigilance regarding prior art that could narrow enforceability.
- Landscape Positioning: Existing patents in similar therapeutic areas necessitate thorough prior art searches to ensure freedom-to-operate.
- Innovation Opportunities: The disclosure invites derivative research, such as creating related compounds, different formulations, or combination therapies.
- Strategic Planning: R&D investments should consider the patent’s remaining lifespan (~8 years), with forward-looking patent filings for extended protection.
Frequently Asked Questions (FAQs)
1. What makes KR101360526 distinct from prior patents?
It claims a specific chemical structure and associated formulations that differ from prior art by unique substituents, stereochemistry, or delivery mechanisms, establishing its novelty under Korean patent law.
2. Can the claims be challenged or invalidated?
Yes. Invalidation can occur if prior art disclosures demonstrate that the claimed compounds or methods are known, obvious, or lack inventive step. Detailed legal and technical analyses are necessary.
3. How does this patent influence R&D strategies?
It provides a secure IP foundation for developing and commercializing drugs within its scope but incentivizes innovation to extend patent life or create improved formulations.
4. Does the patent cover international markets?
While it is a South Korean patent, its assignee likely sought or plans to seek patent protection in other jurisdictions, especially through PCT applications, to secure broader market rights.
5. What are the key considerations for licensing this patent?
Assess its legal scope, validity, remaining life, and potential infringement risks in target markets. Licensing provides an opportunity to leverage protected compounds while sharing R&D risks and costs.
References
[1] Korean Intellectual Property Office (KIPO), Patent Status Database.
[2] WIPO PATENTSCOPE, for related patent families.
[3] Patent analysis reports from industry-specific patent analytics firms.
