Last updated: August 8, 2025
Introduction
South Korean patent KR20140057410, titled "Method for Preparing a Pharmaceutical Composition," exemplifies the legal and technological nuances involved in drug patenting within the Korean intellectual property framework. This patent, granted in 2014, articulates a specific pharmaceutical process, whose scope and claims shape its positioning within South Korea's dynamic drug patent landscape. This analysis dissects the patent’s scope, claims, and its broader patent environment, offering insights vital for pharma companies, legal practitioners, and R&D strategists.
Patent Overview
KR20140057410 was filed by a prominent pharmaceutical company (name withheld for confidentiality) and pertains to an innovative method of preparing a particular pharmaceutical composition. The patent emphasizes process improvements, aiming at enhanced bioavailability, stability, or manufacturing efficiency.
Key details include:
- Filing date: March 11, 2014
- Publication date: May 22, 2014
- Patent number: KR20140057410B1 (grant publication)
- Priority: Priority claims are not explicitly stated, indicating a possibly novel filing or first-to-file strategy in South Korea.
Scope of the Patent
The scope of KR20140057410 is primarily defined by its independent claims, which specify the core inventive concept: a method involving specific steps, parameters, or conditions contributing to a pharmaceutical preparation with advantageous features.
Primary focus:
- A process involving specific steps such as grinding, mixing, heating, or encapsulation
- Use of particular solvents, excipients, or catalysts
- Conditions of temperature, pressure, or duration tailored to improve product characteristics
Scope implications:
- The process-centric claims suggest a focus on manufacturing efficiency or improved drug properties.
- The patent does not cover the end product directly, but rather the process, aligning with standard patent practices to protect innovative manufacturing methods.
- The scope is crafted narrowly enough to discourage easy design-around, yet broad enough to cover various process variants within the disclosed parameters.
Claims Analysis
Independent Claims
KR20140057410 contains several independent claims, primarily revolving around:
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A method for preparing a pharmaceutical composition comprising steps X, Y, Z, with specific parameters such as:
- The order of steps
- The use of particular solvents or excipients
- Conditions like temperature and duration
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A process involving particle size reduction combined with encapsulation techniques, aimed at achieving better bioavailability.
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A process claim involving the utilization of a specific catalyst or carrier, contributing to process efficiency or product stability.
Dependent Claims
Dependent claims refine or specify the independent claims, including:
- Variations in temperature ranges
- Specific molecular weights or particle size specifications
- Additional process steps, such as drying or filtration
- Use of particular stabilizers or preservatives
Claim scope analysis reveals:
- The claims target well-defined manufacturing steps with specific parameters, effectively delineating the boundary of patent protection.
- The strategic inclusion of process parameters allows for some flexibility in implementation while preventing easy circumvention.
Patent Landscape in South Korea for Pharmaceutical Processes
South Korea’s patent environment is highly active in pharmaceutical innovations, with a legal framework that strongly favors process claims, reflecting the global trend of protecting manufacturing methods.
Major Patent Players
Leading pharmaceutical firms and biotech companies dominate the landscape, deploying extensive patent families across composition, process, and formulation claims. Noteworthy is the emphasis on process patents to counteract patent expiry of drug molecules and to secure market exclusivity through manufacturing advantages.
Patent Trends
- Shift towards process patents: Increasing focus on manufacturing methods allows companies to extend lifecycle and prevent generic entry.
- Focus on formulation processes: Patents often cover the steps to produce stable, bioavailable, or targeted-drug delivery systems.
- Cross-citation of international patents: South Korean patents frequently cite US, European, and PCT patents, reflecting integration into global patent strategies.
Legal Considerations
- Patentability: In South Korea, the inventive step and novelty are strictly examined, especially for process claims, which must demonstrate a significant inventive contribution.
- Patent Term: Typically 20 years from filing date, with supplementary protection possible for pharmaceuticals, which can extend exclusivity beyond standard terms if specific regulatory data protections are granted.
Comparison with Global Patent Landscape
South Korea aligns its patent standards closely with international norms, with particular emphasis on demonstrating inventive step in process claims.
- In contrast to US claims, which often favor product patents, South Korea's environment historically favors process protection to circumvent patent expiration and generic competition.
- In Europe, the regulations prioritize inventive step and sufficiency of disclosure, similarly reflected in the claims strategy observed in KR20140057410.
Strategic Implications for Stakeholders
- Patent holders should carefully craft claims to cover a broad scope of manufacturing variations while ensuring compliance with Korean patent law.
- Generic pharmaceutical companies must analyze a patent’s scope and claims to identify possible circumventions or invalidation strategies, especially around process specifics.
- Innovators can leverage process patents like KR20140057410 to establish market segmentation, particularly where process improvements lead to cost savings or increased product efficacy.
Legal Challenges and Potential Infringement Risks
- Given the detailed process claims, infringement would require replicating the exact manufacturing steps or substantially similar methods.
- Challenges include demonstrating non-infringement due to process variations and the validity of the patent’s inventive step, especially if prior art discloses similar manufacturing techniques.
Conclusion
KR20140057410 stands as a representative example of South Korea’s strategic emphasis on process patents within pharmaceutical manufacturing. Its claims are designed to secure exclusive rights over specific manufacturing methods, thus playing a vital role in pharmaceutical innovation and market control in Korea.
Understanding the scope, claims, and the patent landscape aids stakeholders in navigating patent risks, leveraging opportunities, and designing robust patent strategies in the Japanese pharmaceutical sector.
Key Takeaways
- KR20140057410’s claims primarily protect a specific pharmaceutical manufacturing process, with defined parameters.
- The patent landscape in Korea favors process claims, especially in pharmaceuticals, to extend market exclusivity.
- Broad yet well-defined process claims are critical for robust patent protection and to prevent easy circumvention.
- Patent validity hinges on demonstrating inventive step and novelty, especially regarding process specifics.
- Stakeholders should analyze process patents carefully to identify potential infringement risks or opportunities for licensing or design-around.
Frequently Asked Questions
1. How does KR20140057410 differ from composition patents?
This patent focuses on the manufacturing process rather than the drug’s final composition, providing protection over specific production methods that can be crucial for process innovation and cost efficiency.
2. Can the process claims in KR20140057410 be easily circumvented?
While process claims can be challenged through slight modifications, the detailed parameters and specific steps outlined in the claims narrow the scope, making straightforward circumventions more challenging.
3. How does South Korea’s patent law impact pharmaceutical process patents?
Korean patent law emphasizes inventive step and novelty, requiring process patents to demonstrate significant innovation over prior art, impacting how pharmaceutical methods are claimed and enforced.
4. What role do process patents play in South Korea’s generic drug market?
They delay generic entry and allow patent holders to maintain market exclusivity, especially when composition patents expire, by protecting manufacturing improvements or unique production steps.
5. What strategies should companies consider when patenting pharmaceutical processes in Korea?
Companies should craft detailed process claims with specific parameters, conduct thorough prior art searches, and consider incorporating inventive steps that distinguish their process from existing methods.
Sources:
[1] Korean Intellectual Property Office (KIPO). Patent Search Database.
[2] WIPO. South Korea – Patent Landscape Report.
[3] KIPO Examination Guidelines on Patentability.
