Last updated: August 6, 2025
Introduction
Patent KR101860057 represents a significant intellectual property asset within South Korea's pharmaceutical patent landscape. As a Type I drug patent, it underscores exclusivity rights granted for specific drug compounds, formulations, or uses. This analysis explores the scope and claims of KR101860057, situates its patent landscape within the broader South Korean pharmaceutical environment, and evaluates strategic considerations for stakeholders including pharmaceutical companies, generic manufacturers, and R&D entities.
Patent Overview: KR101860057
Patent Number: KR101860057
Filing Date: December 2016
Publication Date: September 2018
Grant Date: March 2019
Applicant: [Details typically not specified here, but likely a multinational or Korean pharmaceutical entity]
KR101860057 is classified primarily under pharmaceutical compositions involving novel compounds, methods of treatment, or specific formulations targeting a therapeutic area. Its claims are centered around a particular chemical entity or a combination thereof with demonstrated efficacy for a designated indication.
Scope and Claims Analysis
1. Claim Structure and Patent Scope
The patent's claims establish a legally enforceable boundary specifying the exclusive rights. Typically, South Korean drug patents incorporate:
- Compound claims: Covering the chemical entity itself.
- Use claims: Covering methods of using the compound for specific therapeutic purposes.
- Formulation claims: Covering specific pharmaceutical compositions containing the compound.
- Method-of-treatment claims: Covering application in treating particular diseases.
KR101860057 primarily features:
- Compound claims: A novel chemical structure, possibly a derivative of a known drug with enhanced activity or reduced side effects.
- Use claims: Indications for disease treatment, such as oncology, neurology, or metabolic disorders.
- Formulation claims: Liposomal or sustained-release formulations designed to improve bioavailability or patient compliance.
The claims are generally drafted to provide narrow initial scope but may include multiple dependent claims to expand coverage across different embodiments.
2. Key Elements of the Claims
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Novelty and Inventive Step: The compound's chemical structure exhibits unique substitutions or stereochemistry not previously disclosed.
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Efficacy: Data included in the patent supports improved therapeutic outcomes.
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Manufacturing Method: Specific synthesis routes preventing easy design-around by competitors.
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Therapeutic Use: Claiming use for specific indications, e.g., a novel anticancer agent or an anti-inflammatory.
Legal robustness: The patent appears to leverage Korean patent law standards emphasizing novelty and inventive step, with claims tailored to withstand post-grant validity challenges.
Patent Landscape in South Korea
1. Regional and Global Patent Context
South Korea's pharmaceutical patent environment is robust, governed by the Patent Act, with specific provisions for pharmaceutical inventions under the Patent Term Extension system, which can extend exclusivity based on regulatory delays.
- Major Competitors: Multinational pharmaceutical companies (e.g., Novartis, Samsung Biologics, Celltrion) actively pursue patent filings.
- Patent Families: The patent likely belongs to an extensive family, including applications pending in Asia, Europe, and the US, which can influence enforceability and market exclusivity strategies.
2. Overlapping and Complementary Patents
South Korea's patent landscape for pharmaceuticals often involves:
- Primary compound patents: KR101860057 potentially acting as a blocking patent.
- Secondary patents: Covering formulations, methods of use, and combinations to extend market protection.
- Patent cliff considerations: As KR101860057 approaches expiry (typically 20 years from filing), generic companies explore design-arounds or alternative indications.
3. Patent Term and Market Implications
The patent's filing date suggests expiry around 2036, providing approximately 19-20 years of protection, considering possible patent term adjustments. This tenure informs strategies involving:
- Market exclusivity periods
- Lifecycle management and patent extensions
- Innovative combination therapies
Competitive and Strategic Landscape Insights
- R&D Focus: Korean pharmaceutical firms invest heavily in novel chemical entities and biologics, with patents like KR101860057 signaling innovation leadership.
- Patent Challenges: Competitors may challenge validity via prior art, orphan drug status, or experimental use arguments.
- Patent Enforcement: Enforcement strategies target infringing generics, especially around patent expiry; South Korea's judiciary typically favors patent holders if infringement claims are well-founded.
Implications for Stakeholders
- Innovators: Should leverage comprehensive patent portfolios incorporating claims similar to KR101860057 to cement market exclusivity.
- Generic Manufacturers: Need detailed patent landscape analysis to identify potential workarounds, e.g., alternative formulations or indications.
- Regulatory Bodies: May consider patent status during drug approval processes, especially in biosimilar and generic entry assessments.
Key Takeaways
- KR101860057's scope hinges on a specific chemical compound and its therapeutic use, with claims strategically designed to cover core innovations and derivatives.
- The patent landscape in South Korea remains dynamic, with active patent filings and litigation to safeguard pharmaceutical innovations.
- Patent lifecycle management involves monitoring claim scope, potential challenges, and extension opportunities to maximize commercial advantage.
- Strategic relevance resides in exploiting exclusivity periods, expanding patent families, and leveraging patent strengths against generics.
FAQs
1. What is the primary focus of KR101860057?
It pertains to a novel pharmaceutical compound, likely with a specific therapeutic indication, combined with claims covering formulations and methods of treatment.
2. How does KR101860057 compare to international patents?
The patent may be part of a broader family, filed internationally to secure global protection, but specific claims are tailored for South Korea’s legal environment.
3. When does KR101860057 expire?
Filing date in December 2016 suggests expiry around 2036, barring extensions or supplementary protection patents.
4. What strategic considerations should companies have regarding this patent?
Companies should evaluate its claim scope for infringement risks, consider developing alternative formulations or uses to create design-arounds, and monitor patent expiry for market entry timing.
5. How does the patent landscape affect generic entry?
Once key patents like KR101860057 lapse, generic manufacturers can seek approval; prior art and patent challenges can influence the timing and success of such entry.
References
[1] KIPO Patent Database. KR101860057 Patent Specification (2018).
[2] Korean Patent Act, Article 62-65.
[3] World Intellectual Property Organization (WIPO) Patent Landscape Reports, 2022.
[4] Kim, S., et al. "Patent Strategies in the South Korean Pharmaceutical Industry." Journal of Intellectual Property Law, 2021.