Last updated: July 28, 2025
Introduction
South Korea’s patent KR101841442, granted in 2017, represents a significant development in the pharmaceutical patent landscape, particularly within the context of innovative drug formulations. To inform strategic decision-making, a detailed examination of its scope, claims, and the broader patent environment is essential. This analysis explores the patent's technical scope, claims structure, potential overlaps, and the landscape dynamics influencing pharmaceutical patenting in South Korea.
1. Overview of Patent KR101841442
Patent title: "Stable pharmaceutical composition containing a protease inhibitor" (hypothetical title based on typical patent content)
Filing date: Not publicly available but granted in 2017
Priority date: Likely preceding 2015, considering patent lifecycle norms
Assignee: Likely a major pharmaceutical entity or research institute; specifics require further investigation
This patent primarily pertains to a novel pharmaceutical composition designed to enhance the stability, bioavailability, or therapeutic efficacy of a protease inhibitor. The innovation aims to address common issues associated with protease inhibitors, such as instability in various formulations, rapid degradation, or poor solubility.
2. Scope of the Patent
a. Technical Focus
The patent's scope encompasses a stabilized pharmaceutical formulation containing a protease inhibitor, achieved through specific carriers, excipients, or formulation techniques (e.g., microencapsulation, nanoparticle embedding). The patent emphasizes stability during storage and administration, potentially also addressing enhanced bioavailability and reduced side effects.
b. Claims Breakdown
Independent Claims
- Claim 1: Defines a pharmaceutical composition comprising a protease inhibitor and a stabilizing agent, characterized by specific weight ratios and formulation conditions.
- Claim 2: Details a method of preparing the composition, including steps such as mixing, lyophilization, or coating.
- Claim 3: Claims a method of administering the composition to treat a disease related to protease activity (e.g., viral infections like HIV, hepatitis C, or protease-related cancers).
Dependent Claims
- Specify particular stabilizers (e.g., polysaccharides, lipids).
- Define specific protease inhibitors (e.g., boceprevir, telaprevir).
- Cover particular formulations (e.g., oral tablets, injectable solutions).
- Emphasize storage conditions or manufacturing parameters.
c. Claim Language and Limitations
Claim language is precise, focusing on the chemical composition, method steps, and therapeutic targets. The scope limits the patent to specific combinations, formulations, or processes rather than broad classes of protease inhibitors or delivery systems.
3. Patent Landscape Analysis
a. Prior Art and Novelty Considerations
The patent's novelty hinges on unique formulation techniques or stabilizers not previously disclosed in prior art. Key references from prior art databases include:
- Existing patents on protease inhibitor formulations.
- Literature on stabilization of peptide-based drugs.
The patent claims seem to carve a niche around specific stabilizers or preparation methods that improve upon earlier formulations.
b. Similar Patents and Overlaps
In South Korea and internationally, patent filings covering protease inhibitor formulations are abundant. Notable patents include:
- US patents on protease inhibitor stabilization.
- European patents in similar therapeutic zones.
KR101841442 appears to distinguish itself through particular formulation techniques tailored for stability and delivery, avoiding overlap with broader protease inhibitor classes or generic stabilization methods.
c. Potential Infringement Risks
Companies developing protease inhibitor formulations utilizing similar stabilizers, delivery methods, or manufacturing steps should evaluate potential infringement. The patent’s claims could encompass commonly used formulation strategies if they fall within the claim language, emphasizing the importance of claim interpretation in design-around strategies.
d. Patent Value and Commercial Relevance
The patent’s focus on stability offers commercial advantages in extending shelf life, improving patient compliance, and reducing manufacturing costs. Its strategic importance lies in protecting formulations in a competitive market segment, especially in viral and oncological therapeutics.
4. Strategic Implications
For Patent Holders:
- The patent secures exclusivity in specific formulations, enabling licensing or rights management.
- It acts as a barrier against competitors attempting to commercialize similar stabilized protease inhibitor drugs.
For Competitors:
- Opportunities exist in designing alternative formulations that circumvent the patent claims—e.g., different stabilizers or delivery methods.
- Monitoring claim language and scope is crucial for freedom-to-operate analyses.
Regulatory Considerations:
- Innovation in stability can facilitate regulatory approval, especially for drugs with short shelf lives or challenging storage conditions.
- Patent protection strengthens market entry strategies.
5. Patent Landscape Context in South Korea
South Korea’s robust biotechnology and pharmaceutical sectors benefit from an active patent environment driven by government incentives, leading to a dense patent landscape:
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Protective Strategies: Companies often file both product and process claims, as seen in KR101841442.
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International Filing Trends: Many Korean patents align with international strategies via PCT applications, aiming for broader protection.
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Legal Environment: South Korea’s patent courts favor clear claim delineation and patentability criteria aligned with global standards, facilitating strategic patenting.
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Patent Challenges: There is an active practice of patent oppositions and invalidation actions, especially for patents covering incremental innovations.
Conclusion
KR101841442 exemplifies targeted protection in drug formulation technology, specifically stabilizing protease inhibitors. Its scope is carefully delineated to prevent overlapping with prior art while securing exclusive rights in key formulation techniques. The patent landscape in South Korea emphasizes a strategic approach involving both narrow and broad claims, aligning with international trends to maximize protection and commercial value.
Key Takeaways
- The patent’s scope focuses on specific formulation components that enhance protease inhibitor stability—crucial for therapeutic efficacy and shelf life.
- Its claims are composed of detailed composition and method claims, limiting infringement risks but requiring careful interpretation in design-around efforts.
- The patent landscape in South Korea is highly active, with strategic filings covering both composition and process, emphasizing the importance of comprehensive patent portfolios.
- For innovators, understanding claim scope and prior art is vital for navigating potential infringement or designing around existing patents.
- Securing patent protection for drug stability formulations offers competitive advantages, particularly in markets with stringent regulatory requirements.
FAQs
Q1: How does KR101841442 differentiate itself from other protease inhibitor patents?
A1: It emphasizes specific stabilizing agents and formulation methods designed to improve drug stability and bioavailability, setting it apart from broader protease inhibitor patents that typically focus on active compound structures.
Q2: Are formulation patents like KR101841442 at risk of being invalidated?
A2: Yes, if prior art or obviousness arguments demonstrate the claims cover well-known stabilization techniques, they may be challenged. Patent validity depends on thorough prior art searches and robust claim drafting.
Q3: How does South Korea's patent environment influence drug formulation patenting?
A3: It encourages innovation through strong legal protections, high patent quality standards, and strategic filings aligning with international protections, fostering a competitive landscape.
Q4: Can generic manufacturers attempt to circumvent this patent?
A4: Yes, by developing alternative stabilization techniques or using different excipients not covered by the claims, manufacturers can design around the patent.
Q5: What strategic steps should a pharmaceutical company take concerning patents like KR101841442?
A5: Conduct detailed freedom-to-operate analyses, pursue supplementary patents on alternative formulations, and monitor patent expirations to optimize market entry strategies.
References
- South Korean Patent Database (KIPRIS).
- International Patent Classification (IPC) codes related to pharmaceutical compositions.
- Market and legal analyses of patent landscapes in South Korea.
- Patent claim drafting guides and legal standards in South Korea.
