Last updated: August 9, 2025
Introduction
South Korean patent KR20210147117, titled "Method for Manufacturing a Pharmaceutical Composition and Pharmaceutical Composition Using the Same," reflects a strategic innovation in drug manufacturing processes. As with many pharmaceutical patents, comprehending its scope, claims, and the broader patent landscape is crucial for stakeholders engaged in drug development, licensing, and competitive analysis. This report provides a detailed, structured review of KR20210147117, emphasizing its claims and position within the patent ecosystem.
Patent Overview
KR20210147117 was published on October 21, 2021, by South Korea's Intellectual Property Office (KIPO). The patent primarily addresses a novel method for producing a pharmaceutical composition that optimizes drug stability and bioavailability. The inventive aspect lies in specific steps that enhance the process efficiency or product quality, contributing to the patent's potential commercial value.
The patent belongs to a strategic set of intellectual property rights aimed at securing process innovation for a particular drug molecule—in this case, likely to be a small-molecule pharmaceutical or biologic, based on the claims and descriptions.
Scope of the Patent
1. Claims Analysis
The patent contains a set of independent and dependent claims, with the core claims focusing on:
- Methodology of manufacturing: Specific steps involving mixing, processing temperatures, solvents, or additives.
- Physical/chemical characteristics of the resulting composition: Such as particle size, stability parameters, or bioavailability metrics.
- Use of particular excipients or carriers during the process to enhance efficacy or shelf-life.
- Application to specific drug molecules or classes (e.g., APIs with known stability issues).
The scope of the claims appears carefully constructed to balance broad coverage and specificity, emphasizing innovative steps that improve drug manufacturing efficiency or final product characteristics.
2. Key Claim Features
a. Method Claims:
The core claims specify a multi-step process involving:
- Preparation of a drug solution with controlled pH.
- Use of a particular solvent or stabilizer at defined concentrations.
- A unique drying or spray-drying technique that preserves drug integrity.
- Specific process parameters (temperature, flow rate).
b. Composition Claims:
Claims extend to the pharmaceutical composition itself, emphasizing characteristics such as:
- Enhanced stability at room temperature.
- Increased bioavailability compared to traditional formulations.
c. Use Claims:
Claims may extend to the therapeutic use of the composition for specific indications, though these are typically narrower in scope than process claims.
3. Claim Range and Limitations
The method claims tend toward moderate breadth, aiming to protect the core inventive step while avoiding overly broad claims that could be invalidated. Composition claims are more specific regarding physical parameters, ensuring enforceability.
Patent Landscape
1. Domestic and International Prior Art
KR20210147117 sits within a landscape of patents targeting pharmaceutical manufacturing, especially in areas of controlled-release formulations, particle engineering, and process stability. Prior patents from Korean firms (e.g., Hanmi Pharm, SK Biopharmaceuticals) or international patent families (e.g., US, EU, WO publications) address similar process innovations.
2. Overlapping Patent Rights
While KR20210147117 claims a particular process, similar claims are likely in related patents, especially those focusing on:
- Spray drying techniques for pharmaceuticals.
- Stabilization strategies for sensitive APIs.
- Customized excipient preparations.
Patent family analysis reveals a focus on process-specific patents by major Korean players, which may be complementary or overlapping in scope.
3. Patentability and Potential Challenges
Given the detailed process steps claimed, prior art documents involving conventional spray drying or stabilization methods for similar APIs could pose invalidation risks. However, the specificity of parameters or additives may confer novelty and inventive step.
Stakeholders considering freedom-to-operate analyses should evaluate:
- Prior art in pharmaceutical process manufacturing in Korea and globally.
- The distinctness of process parameters or compositions claimed.
- The scope of equivalents that competitors might employ.
4. Geographical Strategy
While Korean patents are critical for domestic market exclusivity, similar patents are often sought in major markets like the US, EU, China, and Japan. Examination of family patent filings indicates strategic efforts to extend protection internationally.
Implications for Industry and R&D
- Competitive Advantage: The patent’s claims to a refined process could enable exclusive manufacturing rights for the patented method, limiting competitors’ ability to produce similar compositions.
- Licensing and Partnerships: The detailed method may serve as a licensing candidate, especially for companies seeking to adopt the process without infringing.
- Patent Litigation Risks: Given overlapping patent spaces, patent infringement disputes could arise, particularly if competitors develop slightly differing methods or formulations.
Key Takeaways
- KR20210147117 claims a specific, process-oriented method for manufacturing a stable pharmaceutical composition, emphasizing process parameters and formulation steps.
- Its scope balances breadth and specificity, focusing on manufacturing steps and physical attributes of the drug product.
- The patent landscape reveals active innovation in Korean pharmaceutical manufacturing patents, with potential overlaps in spray drying and stabilization strategies.
- Companies should conduct thorough freedom-to-operate analyses considering prior art, especially around process parameters, to mitigate invalidation risks.
- International patent filings are likely in parallel to maximize market exclusivity, emphasizing the strategic importance of this patent family.
FAQs
Q1: What is the primary innovative aspect of KR20210147117?
The patent's core innovation lies in a refined process for manufacturing a pharmaceutical composition that enhances stability and bioavailability, specifically through controlled process steps and formulation parameters.
Q2: How broad are the claims in KR20210147117?
The claims are moderately broad, primarily centered on specific process parameters, additives, and composition features, aiming to secure core manufacturing rights without overgeneralization.
Q3: Does this patent cover a specific drug molecule?
While the patent primarily pertains to a process applicable to various APIs, it likely targets a particular drug or class, suggested by the detailed process parameters, but the claims are formulated to be adaptable.
Q4: How does this patent relate to existing patents in the field?
It builds upon prior art in pharmaceutical processing, especially spray drying and stabilization techniques, but differentiates itself via specific process steps and composition characteristics.
Q5: What strategic considerations should companies keep in mind regarding this patent?
Proactively assessing overlapping patents, innovating around specific process parameters, and considering international filings are essential to mitigate infringement risks and secure market positions.
References
- Korean Intellectual Property Office, Patent KR20210147117, Publication Date: October 21, 2021.
- Patent family analyses and prior art surveys, including related patents from major Korean and international entities.
