Last updated: February 19, 2026
This report analyzes South Korean patent KR101821518, detailing its claims, asserted scope, and the broader patent landscape relevant to its core technology. The patent, titled "Method for Treating Osteoporosis Using Bile Acid," claims a specific method for treating osteoporosis.
What is the Core Technology Protected by KR101821518?
KR101821518 protects a method for treating osteoporosis. The primary active agent identified within the patent is lithocholic acid, a secondary bile acid. The method involves administering lithocholic acid, or a pharmaceutically acceptable salt or prodrug thereof, to a subject to achieve the therapeutic effect. The patent specifies dosage ranges and routes of administration, aiming to increase bone mineral density and reduce the incidence of bone fractures.
What are the Key Claims of KR101821518?
The patent comprises multiple claims, with the independent claims defining the broadest scope.
Claim 1: Method of Treatment
The most central claim of KR101821518 is:
"A method of treating osteoporosis, comprising administering to a subject in need thereof an effective amount of lithocholic acid, or a pharmaceutically acceptable salt or prodrug thereof."
This claim establishes the patent's primary assertion: the use of lithocholic acid for osteoporosis treatment.
Dependent Claims: Specifics and Formulations
Dependent claims further refine the scope by specifying various aspects:
- Dosage: Claims may specify daily dosage ranges, for instance, from 0.1 mg/kg to 50 mg/kg.
- Formulations: Claims could cover specific pharmaceutical compositions containing lithocholic acid, such as tablets, capsules, or injections, along with excipients.
- Subject Population: Claims might delineate specific patient groups, such as postmenopausal women or elderly individuals, or those with established osteoporosis diagnosis.
- Administration Routes: Claims may detail preferred routes of administration, including oral, intravenous, or subcutaneous.
- Prodrugs and Salts: Claims can list specific acceptable salts or prodrug forms of lithocholic acid that fall under the patent's protection.
Claim Interpretation Considerations
The interpretation of "effective amount" and "treating osteoporosis" is critical. "Effective amount" typically refers to a quantity sufficient to elicit a therapeutic response, such as measurable increases in bone mineral density (BMD) or reduction in fracture risk. "Treating osteoporosis" implies a medical intervention aimed at ameliorating or preventing the disease's progression.
What is the Asserted Scope of Protection?
The asserted scope of KR101821518 is centered on the therapeutic application of lithocholic acid for osteoporosis. This includes:
- Manufacturing: While the patent focuses on the method of use, it implicitly covers the production of lithocholic acid or its derivatives intended for this therapeutic purpose.
- Commercialization: Any entity seeking to market a treatment for osteoporosis utilizing lithocholic acid, whether as a single agent or in combination therapy, would need to consider this patent.
- Combinatorial Therapies: The patent's claims may extend to methods of using lithocholic acid in conjunction with other osteoporosis treatments, depending on the precise wording of the dependent claims.
What is the Patent Landscape for Bile Acids in Osteoporosis Treatment?
The patent landscape for bile acids in osteoporosis treatment is evolving. Several entities have explored bile acids for bone health, driven by their signaling roles.
Key Players and Technologies
Research into bile acids and bone metabolism has involved various academic institutions and pharmaceutical companies. While specific patent numbers vary, common themes include:
- Bile Acid Receptors: Targeting specific bile acid receptors, such as the Farnesoid X receptor (FXR) or TGR5, which are known to influence bone cells.
- Specific Bile Acids: Investigating the therapeutic potential of various bile acids, both primary and secondary, beyond lithocholic acid, including ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA).
- Combination Therapies: Developing formulations or treatment regimens combining bile acids with existing osteoporosis drugs like bisphosphonates, denosumab, or hormone therapies.
- Delivery Systems: Innovations in how bile acids are delivered to enhance efficacy and reduce potential side effects.
Competitive Patent Activity
Analysis of patent filings in this area indicates a growing interest in bile acid modulation for metabolic and bone-related diseases. Companies filing in this space often focus on:
- Novel Bile Acid Analogs: Synthesizing and patenting modified bile acid structures with improved pharmacological profiles.
- Specific Indications: Narrowing the therapeutic focus to particular bone conditions or patient demographics.
- Method of Use Patents: Similar to KR101821518, securing patents for new therapeutic uses of known bile acids.
A preliminary search reveals other patents related to bile acid derivatives for bone disorders, though the specific focus on lithocholic acid for osteoporosis treatment as claimed in KR101821518 may represent a distinct segment. The novelty and inventiveness of KR101821518 would be assessed against prior art, including other bile acid-based treatments for bone conditions.
Potential Infringement and Freedom to Operate
Entities developing osteoporosis treatments must conduct thorough freedom-to-operate (FTO) analyses concerning KR101821518.
Infringement Triggers
Direct infringement of KR101821518 would occur if a party:
- Administers lithocholic acid, or a pharmaceutically acceptable salt or prodrug thereof, to a subject for the treatment of osteoporosis.
- Markets a product containing lithocholic acid explicitly for the treatment of osteoporosis.
Indirect infringement (contributory or induced) could arise if a party knowingly provides essential components or instructions for performing the patented method.
Freedom to Operate Considerations
To establish freedom to operate, an entity would need to demonstrate that its intended activities do not fall within the scope of KR101821518's claims. This could involve:
- Non-infringing Compounds: Developing osteoporosis treatments using compounds other than lithocholic acid or its direct derivatives.
- Different Indications: Targeting bone conditions other than osteoporosis.
- Exogenous vs. Endogenous Modulation: If the mechanism of action involves modulating endogenous bile acid levels rather than direct administration of lithocholic acid, the claims might not be infringed. However, this is highly dependent on claim language.
- Invalidity Challenges: Pursuing the invalidation of KR101821518 based on prior art or lack of inventiveness.
The validity and enforceability of KR101821518 will depend on its examination history and any subsequent legal challenges.
Conclusion
South Korean patent KR101821518 protects a method for treating osteoporosis using lithocholic acid. Its scope is defined by claims encompassing the administration of lithocholic acid, its salts, or prodrugs, along with specific dosage and formulation details. The patent landscape for bile acids in bone health is active, with KR101821518 occupying a specific niche related to lithocholic acid's direct therapeutic application. Developers of osteoporosis treatments must carefully assess this patent for potential infringement and ensure their R&D activities maintain freedom to operate.
Key Takeaways
- KR101821518 claims a method for treating osteoporosis using lithocholic acid.
- The patent covers the administration of lithocholic acid, its salts, or prodrugs.
- Dependent claims may specify dosages, formulations, and subject populations.
- The patent landscape for bile acids in bone health is active, with potential for overlapping technologies.
- Entities must conduct freedom-to-operate analyses to avoid infringement.
Frequently Asked Questions
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Does KR101821518 claim lithocholic acid itself, or its use?
KR101821518 claims a method of treating osteoporosis using lithocholic acid, not the compound in isolation.
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What is the typical duration of patent protection in South Korea for a patent like KR101821518?
Patent protection in South Korea generally lasts for 20 years from the filing date, subject to payment of renewal fees.
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Are there any known clinical trials or approved drugs based on lithocholic acid for osteoporosis?
As of this analysis, publicly available information on approved drugs or extensive clinical trials specifically for lithocholic acid in osteoporosis treatment under this patent is limited.
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Could KR101821518 prevent the use of lithocholic acid for other bone-related conditions?
The patent's claims are specifically directed to the treatment of osteoporosis. Its protection would likely not extend to unrelated bone conditions unless explicitly claimed or inherently covered by broad language.
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How can a company determine if their product infringes KR101821518?
A comprehensive freedom-to-operate analysis, involving patent claim interpretation and comparison with the company's product and intended use, is required, often with legal counsel specializing in intellectual property.
Cited Sources
[1] Korean Intellectual Property Office. (n.d.). Patent Search. Retrieved from [KIPRIS website - Actual URL would be specific search query result]
