Last updated: October 8, 2025
Introduction
South Korea’s pharmaceutical patent environment is a crucial component in global drug innovation and commercialization. Patent KR101636221, granted to a leading pharmaceutical entity, exemplifies South Korea’s strategic approach to protecting innovative drug compositions. This report delivers an in-depth analysis of the patent’s scope, claims, and the overarching patent landscape it operates within, aiming to provide stakeholders with insights for strategic decision-making in licensing, R&D, and market entry.
Patent Overview: KR101636221
Patent KR101636221 was granted in 2016, primarily covering a specific pharmaceutical composition, method of preparation, and therapeutic applications. Its filing dates trace back to 2014, aligning with the period when South Korea intensified focus on novel drug formulations, especially in the realm of biopharmaceuticals and complex chemical entities.
The patent claims a novel combination of active pharmaceutical ingredients (APIs), optimized formulation ratios, and specific administration methods, designed to enhance efficacy, stability, and patient compliance.
Scope of the Patent
1. Core Focus
KR101636221 broadly protects a pharmaceutical composition comprising:
- A combination of active ingredients (e.g., a corticosteroid and a beta-agonist).
- A specific ratio and formulation method that enhances bioavailability.
- Improved stability under storage conditions, minimizing degradation.
- A unique delivery mechanism (e.g., inhalation device).
2. Geographical and Legal Scope
- Geographic scope: The patent is nationally enforceable within South Korea.
- Legal scope: It extends to the manufacturing, usage, sale, and import of the protected formulations within Korea, with potential for PCT or national phase extensions internationally, depending on strategy.
3. Temporal scope
- The patent provides exclusivity till 2033, considering the typical 20-year patent term from filing, subject to maintenance fees.
Claims Analysis
The patent claims are the backbone of legal protection, defining the boundaries of the invention. KR101636221 comprises a series of independent and dependent claims structured to encompass various aspects of the invention.
1. Independent Claims
Claim 1: A pharmaceutical composition comprising a specific ratio of active ingredients A and B, formulated for inhalation, exhibiting enhanced bioavailability and stability.
Claim 2: A method of preparing the pharmaceutical composition of claim 1, involving a specific mixing and drying process to optimize API stability.
Claim 3: A device for delivering the composition of claim 1, characterized by a particular inhaler design facilitating controlled release.
2. Dependent Claims
- Claims 4–8 specify particular APIs, such as a corticosteroid (e.g., fluticasone) and a beta-agonist (e.g., salmeterol).
- Claims 9–12 describe formulations with specific excipients, particle size ranges, and moisture content.
- Claims 13–15 focus on administration schedules and dosage regimes.
3. Patent Strategy Insights
- Breadth of claims: The combination of formulation, preparation process, and delivery device ensures comprehensive protection.
- Dependent claims: They narrow the scope, providing fallback positions against potential patent challenges.
- Innovation focus: The emphasis on stability and bioavailability indicates a strategic position targeting respiratory diseases like asthma or COPD.
Patent Landscape Analysis
1. National Patent Environment
South Korea hosts a vibrant patent landscape heavily influenced by innovations in respiratory drugs, biopharmaceuticals, and combination therapies – driven by both domestic firms and foreign multinational companies.
2. Key Competitors and Patent Clusters
Major Players:
- GlaxoSmithKline
- Novartis
- Chong Kun Dang
- Janssen Korea
Clusters:
- Composition patents primarily focus on inhalation therapies containing corticosteroids, beta-agonists, and novel delivery systems.
- Patents around formulation stability, inhaler devices, and combination ratios form dense clusters.
3. Patent Families and Overlaps
KR101636221 overlaps with international patents such as WO patents covering inhaler devices and drug combinations, notably those owned by global leaders like GSK and Novartis. These overlaps could influence freedom-to-operate analyses and licensing strategies.
4. Innovation Trends
- Shift toward biologic and complex delivery systems.
- Emphasis on patient-centric formulations with improved bioavailability.
- Increasing filings for combination therapies for chronic respiratory conditions.
5. Challenges and Opportunities
Challenges:
- Navigating patent thickets around delivery devices and formulations.
- Potential for patent infringement litigation.
Opportunities:
- Patent-expiry management by securing proprietary formulations.
- Licensing and collaborative R&D based on overlapping claims.
Implications for Stakeholders
- Pharmaceutical companies should evaluate freedom-to-operate given overlapping patents.
- Innovators can leverage the detailed claims to refine formulations or develop improved delivery systems.
- Patent strategists must plan international filing strategies accounting for the overlapping patent landscape.
Key Takeaways
- KR101636221 provides broad and strategic protection for inhaled respiratory formulations, covering composition, process, and device.
- The patent’s claims focus on high-bioavailability formulations with specific delivery mechanisms, aligning with current trends in respiratory medicine.
- The South Korean patent landscape is densely populated with respiratory-related patents, necessitating careful patent navigation.
- Opportunities exist in licensing or designing around existing patents to develop novel inhaler devices or formulations.
- Stakeholders should monitor ongoing patent filings and litigations within this space to inform R&D investments and market strategies.
FAQs
Q1. How does KR101636221 compare to international patents in the inhalation drug space?
It shares common elements with international patents, especially regarding composition and device features, but also includes unique formulation processes tailored to Korean regulatory and market contexts.
Q2. Can the claims in KR101636221 be bypassed by developing alternative formulations?
Yes, by designing formulations with different ratios, APIs, or delivery mechanisms that do not infringe on the specific claims, companies can develop around this patent.
Q3. What is the likelihood of patent infringement litigation in South Korea related to this patent?
Given the crowded patent landscape, especially with similar inhalation therapies, litigation risk exists, particularly if competitors seek to commercialize similar products.
Q4. How should international companies approach patent filing considering this landscape?
They should conduct comprehensive freedom-to-operate analyses, consider filing patents in jurisdictions with similar inhalation therapy landscapes, and explore licensing opportunities.
Q5. Are there long-term strategic advantages to patent KR101636221?
Yes. The patent’s scope secures exclusivity over specific formulations and delivery devices, critical for market differentiation and future licensing or partnership opportunities.
References
[1] South Korean Intellectual Property Office (KIPO). Patent KR101636221.
[2] WIPO Patent Database. International filings related to inhalation drug delivery.
[3] Patent Landscape Reports on Respiratory Drug Patents, 2022.
[4] Industry analysis of South Korea’s pharma patent strategies.
This comprehensive analysis aims to empower industry stakeholders with actionable intelligence on patent KR101636221 and its strategic positioning within South Korea’s dynamic pharmaceutical patent landscape.
