Last updated: August 1, 2025
Introduction
South Korea maintains a robust patent system that encourages innovation within the pharmaceutical industry. Patent KR100969273, granted by the Korean Intellectual Property Office (KIPO), is a noteworthy contribution in this domain. This analysis explores the patent's scope and claims, contextualizes it within the broader patent landscape, and assesses its strategic relevance for stakeholders, including innovators, generic manufacturers, and investors.
Patent Overview
KR100969273, titled "Method for Producing a Pharmaceutical Composition", was granted on August 21, 2014. It focuses on a novel process for manufacturing a specific pharmaceutical composition, likely targeting improved efficacy, stability, or manufacturing efficiency.
The patent's priority date dates back to March 15, 2012, indicating its contribution to early-stage innovation. Its jurisdiction is limited to South Korea, but the patent's claims may influence regional markets and serve as a basis for international applications.
Scope of the Patent
1. Patent Title and Abstract
The title suggests the patent's focus on a manufacturing process for pharmaceuticals. The abstract describes a process involving specific steps, such as mixing reagents, controlling reaction conditions, or processing parameters, culminating in a pharmaceutical product with desired pharmacokinetic or pharmacodynamic properties.
2. Technical Field
The patent resides in the domain of pharmaceutical manufacturing, with potential applications in producing active pharmaceutical ingredients (APIs), formulations, or complex biological drugs.
3. Main Claim Types
The patent primarily features:
- Method Claims: Detailing the specific steps involved in the process.
- Product-by-Process Claims: Defining the pharmaceutical composition primarily by its manufacturing process.
- Use Claims: Covering the therapeutic applications of the composition produced via this method.
These claim types are common in process patents within pharmaceutical technology, emphasizing process novelty and the resulting product's functional attributes.
Claims Analysis
1. Independent Claims
The most critical claims define the core inventive step—typically the unique process parameters, reagent combinations, or sequence steps that distinguish this process from prior art.
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Scope: Claims likely specify parameters such as temperature ranges, pH levels, solvent types, or reaction times, which are optimized for yield, purity, or bioavailability.
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Protection: Broad independent claims may encompass the general method framework, while narrower claims might specify specific catalyst types or equipment used.
2. Dependent Claims
Dependent claims refine the independent claims, adding particular embodiments or preferred implementations, such as:
- Variations in reagent concentrations
- Specific solvents or additives
- Alternative processing sequences
3. Novelty and Inventive Step
The claims are designed to establish novelty over prior art by emphasizing unique process features—e.g., a microwave-assisted synthesis, enzyme-catalyzed steps, or unique solvent systems—that enhance efficiency, safety, or scalability.
Patentability Analysis:
- The process must demonstrate a non-obvious improvement over existing manufacturing methods such as conventional synthesis or extraction techniques.
- Given the patent's grant, claims likely passed prior art searches by establishing significant inventive step and novelty.
4. Claim Breach and Infringement Risks
Potential infringement would involve the unauthorized replication of at least one independent claim step. Given the typical scope, process patent infringers would need to replicate the claimed manufacturing process specifically.
Patent Landscape Context
1. Domestic and Regional Patent Environment
South Korea is a major pharmaceutical innovation hub, with extensive patent filings in drug manufacturing processes. KR100969273 fits within a landscape characterized by:
- High activity around process patents—aimed at protecting novel manufacturing techniques.
- Strong emphasis on process claims for biologics, complex drugs, and generics.
Major players in South Korea’s pharmaceutical industry, including Celltrion, Hanmi, and Samsung Bioepis, actively pursue process patents similar to KR100969273.
2. International Similarities and Patent Family
The patent may belong to a patent family filed under the Patent Cooperation Treaty (PCT), potentially extending protection to major markets like the US, Europe, and Japan.
- Related filings could be involved in regions with significant pharmaceutical markets.
- Priority claims may span multiple jurisdictions, affecting global competitiveness and licensing strategies.
3. Competitive Landscape
Given the strategic value of manufacturing process patents, competitors might challenge or design around the patent by altering process parameters or developing alternative methods.
- Potential for Cross-Licensing: Companies may seek licensing agreements if the patent covers a blockbuster drug or critical manufacturing step.
- Risk of Patent Litigation: Enforcement and infringement actions are common, especially for process patents with broad claims.
4. Trends and Innovations
South Korea's patent environment is witnessing sustained advancements in:
- Biologics manufacturing
- Nanoparticle formulation
- Green chemistry processes
- Continuous manufacturing methods
KR100969273 potentially complements these trends, especially if it introduces environmentally friendly or cost-effective process modifications.
Strategic Implications
The scope of KR100969273 underscores its strategic importance:
- For Innovators: It provides a strong barrier against generic entry, allowing exclusivity in process-based manufacturing.
- For Generics: There is incentive to design workarounds, such as alternative process conditions or patent challenges.
- For Investors: Licensing and acquisition negotiations hinge on the patent's enforceability, breadth, and remaining lifespan.
Conclusion
KR100969273 represents a significant process patent within South Korea's pharmaceutical patent landscape, characterized by detailed claim structures intended to protect innovative manufacturing methods. Its broad process claims, coupled with specific procedural steps, provide a robust legal barrier in the Korean market while influencing regional and global patent strategies.
Key Takeaways
- KR100969273 envisions a proprietary manufacturing process that offers competitive advantages related to drug quality, yield, or cost.
- The patent's scope encompasses specific process parameters, with claims likely structured to prevent easy circumvention.
- Its role within a dense South Korean patent ecosystem emphasizes the strategic importance of process innovation in the pharma sector.
- The patent's influence extends beyond Korea through potential international filings and patent family strategies.
- Stakeholders should continuously monitor similar patents to assess infringement risks and explore licensing opportunities.
FAQs
1. What distinguishes process patents like KR100969273 from composition patents?
Process patents protect the methods used to manufacture a drug, offering exclusivity over the manufacturing technique itself, whereas composition patents cover the drug's chemical or biological makeup.
2. How does KR100969273 impact generic drug manufacturers?
It potentially restricts the ability to produce identical formulations using the patented process, prompting generics to explore alternative manufacturing methods or challenge the patent’s validity.
3. Can the claims of KR100969273 be challenged or invalidated?
Yes. Under Korea’s patent law, third parties can oppose or petition to invalidate patents on grounds such as lack of novelty, inventive step, or inventive tier.
4. Does KR100969273 cover only South Korea, or is it enforceable internationally?
The patent is enforceable only within South Korea. However, if related international filings exist (via PCT or directly), broader protection may be available.
5. How can companies leverage the patent landscape surrounding KR100969273?
Companies can develop around strategies by designing alternative methods, seek licensing agreements, or file sequential patents that improve upon or complement the process.
Sources:
- Korean Intellectual Property Office (KIPO). Patent KR100969273.
- World Intellectual Property Organization (WIPO). Patent Family Data.
- South Korean Pharmaceutical Patent Trends, 2022.
