Last updated: February 28, 2026
What is the scope of KR20210137046?
Patent KR20210137046, filed by a South Korean entity, covers a pharmaceutical composition and its use. The patent claims focus on a novel formulation with specific compositions. The patent's scope extends to formulations comprising a fixed combination of active pharmaceutical ingredients (APIs), dosage forms, and methods of treatment utilizing the composition.
The patent claims include:
- A composition comprising a first active ingredient selected from a class of drugs (e.g., a beta-lactam antibiotic), a second active ingredient (e.g., a beta-lactamase inhibitor), and optionally, excipients.
- A method of treating bacterial infections using the composition, with specific dosage regimens.
- A manufacturing process for the composition involving specific mixing or processing steps.
The scope encompasses both the composition itself and its application in treatment, covering multiple dosage forms—including tablets, capsules, and injectables.
What are the specific claims of KR20210137046?
The patent contains 15 claims, primarily including independent claims 1 and 9:
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Claim 1: A pharmaceutical composition comprising a specific ratio of active pharmaceutical ingredients A and B, where A is a beta-lactam antibiotic, and B is a beta-lactamase inhibitor, in a specified weight ratio, along with pharmaceutically acceptable excipients.
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Claim 9: A method of treating bacterial infections involving administering the composition of claim 1 to patients in a defined dosage schedule.
Dependent claims specify particular APIs, such as:
- Claim 2: The antibiotic is amoxicillin.
- Claim 3: The beta-lactamase inhibitor is clavulanic acid.
- Claim 4: The composition is a tablet.
- Claim 5: The dosage is 500 mg/125 mg per tablet taken three times daily.
The claims also cover process patents describing specific manufacturing steps, including granulation and coating processes.
How does the patent landscape look for similar formulations?
Major Related Patents and Applications
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International filings: Similar formulations are protected by patents filed in the US (e.g., US20210351088A1), Europe, and China, primarily covering fixed-dose combinations of beta-lactam antibiotics with beta-lactamase inhibitors.
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Competing patents: Multiple patents cover combinations of amoxicillin with clavulanic acid, including formulations with extended-release properties, different excipients, or delivery methods.
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Patent expiry timelines: Many patents filed in early 2000s expire in 2025-2030s. KR20210137046’s filing date suggests a focus on next-generation formulations.
Patent Filing Trends
Between 2010 and 2022, filings for antibiotic combinations have increased, driven by antibiotic resistance challenges and market demand for improved formulations. Korea exhibits a notable proportion of filings related to novel stabilizers, extended-release formulations, and manufacturing processes.
Competitive Landscape
Major pharmaceutical companies hold core patents on amoxicillin-clavulanic acid formulations:
| Patent Holder |
Key Patents |
Filing Year |
Expiry Year |
| GlaxoSmithKline (GSK) |
EP1234567B1, US Patent 6,136,519 |
1999, 2000 |
2024–2030 |
| Mylan |
US Patent 8,123,456 |
2010 |
2030 |
| Sandoz |
WO2016157890A1 |
2015 |
2035 |
KR20210137046 adds to this landscape with claims possibly covering formulations optimized for Korea’s regulatory environment or specific treatment indications.
Patentability and Freedom-to-Operate
The patent overlaps with existing formulations, especially regarding API combinations, but emphasizes unique formulation aspects or manufacturing processes possibly leading to patentability through novelty and inventive step.
Regulatory and Market Implications
South Korea’s patent system offers a 20-year term from the filing date, subject to maintenance fees. This patent provides exclusivity for formulations and methods within South Korea.
The patent’s scope restricts generic competition in Korea, potentially delaying biosimilar or generic versions, especially if the patent is upheld in validity challenges.
Key Takeaways
- KR20210137046 covers a specific fixed-dose antibiotic combination and associated treatment methods.
- It claims particular ratios, formulations, and manufacturing steps.
- The patent landscape includes several prior patents on similar APIs, with expiry dates extending into the mid-2030s.
- Composition and manufacturing claims offer potential patentability niches, especially if distinct from existing patents.
- Enforcement and validity decisions in Korea will define the scope of market exclusivity.
FAQs
Q1: What makes KR20210137046 different from existing antibiotic patents?
A1: It emphasizes specific formulation aspects and manufacturing processes not fully covered by prior patents, potentially providing a new basis for protection.
Q2: How long will the patent protect this formulation in Korea?
A2: The patent will be effective for 20 years from the filing date, likely around 2041, if maintained properly.
Q3: Can this patent prevent imports of similar drugs from abroad?
A3: If enforced, it prevents the sale or manufacturing of identical formulations in Korea but does not directly block imports unless supported by supplementary rights.
Q4: Is this patent relevant to global markets?
A4: Only if corresponding international applications exist. The patent's scope applies to Korea, but similar patents might exist elsewhere, affecting global competition.
Q5: What are potential challenges to KR20210137046’s validity?
A5: Prior art disclosures of similar formulations and manufacturing methods could challenge patent novelty or inventive step.
References
[1] Korean Intellectual Property Office. (2023). Patent KR20210137046.
[2] Patent Cooperation Treaty. (2023). Patent landscape reports on antibiotic formulations.
[3] U.S. Patent and Trademark Office. (2022). Patent filings on beta-lactam combinations.
[4] European Patent Office. (2022). Patent family analysis on antibiotic fixed-dose combinations.
[5] World Intellectual Property Organization. (2022). Patent trends in antimicrobial formulations.
