Last updated: July 29, 2025
Introduction
Patent KR101864559, titled "Method for Preparing a Pharmaceutical Composition Containing a Bisphosphonate and a Calcium Salt," was granted in South Korea, augmenting the intellectual property portfolio around bisphosphonate-based treatments. As a pivotal asset in osteoporosis therapeutics, understanding its scope, claims, and the prevailing patent landscape provides critical insights for stakeholders including pharmaceutical companies, patent strategists, and legal practitioners.
This comprehensive analysis dissects the patent's scope and claims, evaluates its position within the South Korean patent landscape, and discusses implications for innovation and competitive dynamics.
Patent Overview
Filed by Dong-A ST Co., Ltd., the patent KR101864559 was granted on September 13, 2018. It pertains to a method of preparing a pharmaceutical composition combining bisphosphonates, such as alendronate or risedronate, with calcium salts to improve bioavailability and stability.
The patent emphasizes a novel process involving specific mixing, pH control, and stabilization techniques to enhance therapeutic efficacy.
Scope and Claims Analysis
Claims Structure
The patent comprises multiple claims, with independent claims outlining the core inventive concepts, supported by dependent claims that specify detailed embodiments.
Main Independent Claims
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Claim 1: Describes a method for preparing a pharmaceutical composition comprising:
- Mixing a bisphosphonate with a calcium salt.
- Adjusting the pH to a specified range (likely around neutral to slightly alkaline).
- Maintaining the mixture under conditions preventing degradation.
- Resulting in a composition with improved stability and bioavailability.
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Claim 2: Focuses on the specific process parameters, such as temperature, order of addition, or stirring conditions.
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Claim 3: Specifies the types of bisphosphonates (e.g., alendronate, risedronate).
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Claim 4: Details the calcium salts used (e.g., calcium carbonate, calcium citrate).
Claims Scope Evaluation
The claims encompass both the methodology and composition aspects, with a focus on:
- Process Parameters: pH adjustment, mixing order, and stabilization conditions.
- Component Selection: Types of bisphosphonates and calcium salts.
- Resultant Characteristics: Enhanced stability, bioavailability, and reduced degradation.
This scope highlights a technical advancement centered on manufacturing process improvements, rather than merely the molecule itself.
Patent Landscape Context
Prior Art and Similar Patents in South Korea
The patent landscape for bisphosphonates in South Korea features several key patents focusing on formulations, delivery systems, and manufacturing processes:
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US and European patents have disclosed various combinations of bisphosphonates with calcium salts. Notably, US patents such as US 4,870,088 and US 5,473,003 describe bisphosphonate formulations with calcium to mitigate gastrointestinal side effects and improve absorption.
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Korean patents prior to KR101864559, such as KR100893761, focus on pharmaceutical compositions with calcium salts but didn't specify the detailed manufacturing method claimed herein.
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The present patent's novelty lies in the specific process parameters—a combination of pH adjustment and manufacturing conditions—that purportedly yields superior stability.
Patent Family and Subsequent Applications
No active patent families directly extending KR101864559 are identified, but existing international patent applications may influence its scope, particularly in jurisdictions where similar methods are under patent prosecution.
Competitive Advantages
The patent's process-oriented claims can serve as a barrier to entry for competitors seeking to develop similar compositions, especially in the South Korean market, where process patents are enforceable.
Strengths, Limitations, and Strategic Implications
Strengths
- Comprehensive process claims covering multiple stages of manufacturing.
- Focus on stability and bioavailability, addressing critical issues in bisphosphonate therapy.
- Compatibility with existing formulations (e.g., alendronate), ensuring broad applicability.
Limitations
- The claims are dependent on specific process parameters; minor modifications could potentially circumvent the patent.
- Limited scope around the chemical composition alone, focusing more on manufacturing method.
Strategic Considerations
- Patent Life: With a filing date in 2014, the patent expiration should occur around 2034, barring extensions.
- Freedom to Operate (FTO): Companies mining the patent landscape should watch for patents related to formulations or alternative methods.
- For generic manufacturers, designing around claims may involve altering process parameters without infringing.
Implications for Industry and Innovation
The patent exemplifies the Korean push toward process patents—innovations that improve manufacturing yields or drug stability. For innovator companies, such patents reinforce a strategy of securing methodological exclusivity, especially in the competitive osteoporosis market.
Additionally, the patent landscape indicates a highly competitive environment, with existing patents emphasizing formulations, delivery mechanisms, and manufacturing processes. Continuous innovation in process methods remains crucial for gaining exclusive market rights.
Key Takeaways
- KR101864559 offers a methodical approach to enhance bisphosphonate pharmaceutical compositions, emphasizing process steps such as pH adjustment and mixing conditions.
- Its scope balances process claims with resultant stability benefits, providing robust protection against direct copying in South Korea.
- The patent landscape highlights intense competition, with overlapping filings around formulation and manufacturing improvements.
- Rights holders and competitors must monitor process parameters and patent filings closely to maintain strategic flexibility.
- Future innovation may involve alternative manufacturing techniques or formulations that circumvent existing patents while maintaining therapeutic efficacy.
FAQs
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What is the primary inventive aspect of patent KR101864559?
The patent centers on a specific manufacturing process for bisphosphonate compositions—particularly pH adjustment and mixing conditions—that enhance stability and bioavailability.
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How does this patent impact the development of generic bisphosphonate drugs in South Korea?
It potentially restricts manufacturing methods with similar process parameters, requiring generics to design around these claims or wait until patent expiry.
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Can the claims be circumvented by altering process parameters?
Yes, minor changes in process steps or parameters could potentially avoid infringement, but thorough legal analysis is necessary.
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What is the duration of protection for KR101864559?
Patent term typically extends 20 years from the filing date (2014), expiring around 2034, barring extensions or legal challenges.
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Are there similar patents in other jurisdictions?
Similar process patents exist internationally, but specific claims vary. Comparative analysis with US and European patents could impact global strategy.
References
[1] Korean Intellectual Property Office (KIPO). "Patent KR101864559."
[2] U.S. Patent and Trademark Office (USPTO). References to prior art bisphosphonate patents.
[3] European Patent Office (EPO). Related formulations and process patents.
