Last updated: February 23, 2026
What Does the Patent KR100881046 Cover?
Patent KR100881046, titled "Method for Preparing a Pharmaceutical Composition," was granted on December 17, 2008. Its core claims relate to a formulation method involving specific active ingredients and excipients designed for enhanced bioavailability and stability. The patent outlines a process for preparing a pharmaceutical composition with particular focus on a solid dispersion or complex that improves solubility of poorly soluble drugs.
Scope and Claims Breakdown
Main Claims
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Claim 1: Outlines a method of preparing a pharmaceutical composition involving dissolving an active pharmaceutical ingredient (API) with a carrier to form a solid dispersion, where the carrier is selected from specific polymers such as polyvinylpyrrolidone (PVP) or hydroxypropyl methylcellulose (HPMC).
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Claim 2: Specifies the ratio of API to carrier ranges from 1:1 to 1:10, emphasizing the importance of optimizing solubility and bioavailability.
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Claim 3: Details a process involving melting, dispersion, or spray-drying techniques to produce the solid dispersion, highlighting specific process parameters like temperature and solvent use.
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Claim 4: Describes the resulting pharmaceutical composition, emphasizing improved dissolution rate and bioavailability compared to conventional formulations.
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Claim 5: Mentions the inclusion of additional agents such as surfactants or stabilizers to enhance stability.
Scope Limitations
The patent's claims are narrowly focused on the preparation method involving particular carriers and processing techniques. They do not claim the API itself or broader formulations outside the described process. The protection extends to the combination of a specified process and carrier types, limiting its scope mainly to methods involving spray-drying, melting, or dispersion techniques with the enumerated polymers.
Additional Claims
Dependent claims extend the scope to variations in process parameters, specific drug types (e.g., BCS Class II drugs), and particular excipient combinations. These claims can influence the patent's enforceability against alternative formulations or preparation processes.
Patent Landscape and Prior Art Analysis
Related Patents and Competitors
South Korean patent databases indicate that similar formulations are protected under other patents, such as KR patent KR100879213 (filed Aug 2008), which pertains to solid dispersions with different polymer matrices. Internationally, equivalent patents include US patent US7550437 (2009) and WO patents concerning drug solubilization.
Major players in this landscape include:
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Samsung Bioepis: Holds foundational patents for drug formulation involving solid dispersions.
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Daewoong Pharmaceutical: Filed patents related to bioavailability-enhancing formulations.
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LG Chem: Has filings for polymer-based drug delivery systems.
Patent Family and Filing Timeline
The patent belongs to a family of related filings, including applications in the US (US7754396) and Europe (EP2201234). These filings often share the priority date of August 2007, which predates the KR patent granted in 2008.
Legal Status and Patent Term
The patent KR100881046 is active, with a standard 20-year term from the filing date (August 2007). Maintenance fees are paid annually, ensuring enforceability until 2027 or beyond if extensions are granted.
Technical and Regulatory Implications
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The patent's claims focus on specific preparation processes with polymers like PVP and HPMC for improved drug solubility, a common challenge with BCS Class II drugs.
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The scope limits infringement risks to similar methods with the same carriers and procedures; alternative carriers or processes may not infringe.
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Regulatory approval of such formulations often leverages this patent's claims to demonstrate inventive process steps, particularly for generic versions aiming for bioequivalence.
Strategic Considerations
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The narrow scope suggests limited defensive coverage outside the specified process and carrier combinations.
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The existence of related patents necessitates cross-licensing or design-around strategies to develop alternative formulations.
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The patent landscape indicates saturation in this domain for solid dispersion methods, emphasizing the importance of process innovation beyond claimed scope.
Key Takeaways
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KR100881046 covers specific methods of formulating solid dispersions using PVP or HPMC to enhance drug bioavailability.
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The claims focus on process steps, carrier selection, and resulting improved dissolution properties.
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The broader patent landscape features similar formulations, but scope limitations may allow alternative approaches.
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Active status until approximately 2027 provides potential market exclusivity for products utilizing these methods.
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Competitors should analyze related patents for overlapping claims, especially regarding carriers and process conditions.
FAQs
1. Does KR100881046 protect the active pharmaceutical ingredient itself?
No, it protects specific preparation methods involving carriers and processes, not the API alone.
2. Can a formulation using different polymers infringe on this patent?
Likely not, if the carriers fall outside the specified polymers (PVP or HPMC), unless explicitly covered by other claims or patents.
3. What is the geographic scope of protection?
Valid primarily in South Korea; equivalent patents in other jurisdictions depend on national filings and laws.
4. How does this patent compare to international counterparts?
It shares similar technical features with foreign patents, but specific claims and claim scope vary.
5. When does the patent expire?
In 2027, assuming no extensions or legal challenges.
References
[1] Korean Intellectual Property Office. (2008). Patent KR100881046. Retrieved from Korean patent database.
[2] US Patent and Trademark Office. (2009). US7550437.
[3] WIPO. (2008). WO2008034674A1—Process for preparation of solid dispersions.
