Last updated: July 29, 2025
Introduction
Patent KR20140148502, titled "Method of manufacturing a drug" (as per available information), represents a significant filing within South Korea's pharmaceutical patent landscape. This document provides an in-depth analysis of the patent's scope, claims, technical coverage, and positioning within the existing patent ecosystem, offering insights crucial for pharmaceutical companies, patent strategists, and legal professionals.
Patent Overview
KR20140148502 was filed to protect an innovative manufacturing process for a specific drug formulation, likely targeting a therapeutic area such as oncology, neurology, or infectious diseases, given prevalent patenting trends. The patent's priority and filing date, which are crucial for establishing novelty and inventive step, are assumed to be early 2014, with publication in 2014 or 2015, based on numbering conventions.
Scope and Claims Analysis
Claims set
The core of the patent's protectable scope resides in its independent claims, which define the essential features of the manufacturing process or the drug composition. While precise claim language is typically technical, these claims generally encompass:
- Method of manufacturing: Specific steps involved, such as preparation, combination, and stabilization of active pharmaceutical ingredients (APIs).
- Formulation specifics: Use of particular excipients, processing conditions, or temporal sequences.
- Device or apparatus limitations: If applicable, claims might include details about manufacturing equipment optimized for the process.
The claims likely specify the following:
- Novelty of process steps: For instance, a unique reaction condition, purification step, or encapsulation technique that improves yield, stability, or bioavailability.
- Enhanced purity or efficacy: Claims may extend to the end product, claiming improved pharmacokinetic profiles or reduced impurities.
- Commercial advantage: Scope may include claims directed at scalable manufacturing methods facilitating commercialization.
Claim construction and interpretation
The scope is constrained by specific language and terminology. For example:
- Phrases like "a method comprising," "wherein," and "consisting of" delineate the boundaries of the claims.
- Use of open terms ("comprising") suggests the possibility of additional steps or components, broadening protection.
- Conversely, restrictive language ("consisting of") limits claims narrowly.
Understanding whether claims are product-by-process, method claims, or composition claims shapes their enforceability and infringement scope.
Technical and Legal Scope
KR20140148502's claims likely aim to capture:
- A novel manufacturing process not previously disclosed in prior art.
- Specific process parameters (temperature, pH, reaction time) that yield superior drug quality.
- Unique combinations of process steps and reagents.
This broadens legal protection, but patent validity hinges on the validity of these claims over existing art, which includes prior patents, scientific publications, and industry standards.
Patentability and Validity Considerations
- Novelty: The process must differ significantly from prior art, such as prior patents for similar drugs or methods.
- Inventive step: Demonstrating non-obviousness requires showing the process yields unexpected benefits.
- Industrial applicability: The invention must be capable of practical application at an industrial scale.
In the South Korean patent landscape, patent examination emphasizes prior art search results, especially from global patent databases, including WIPO, EPO, and USPTO, given the highly interconnected pharma innovation environment.
Patent Landscape Context
Competitive landscape
South Korea is home to major biotech firms (e.g., Celltrion, Hanmi) and global pharmaceutical companies operating through local R&D and manufacturing centers. Key considerations include:
- Existing patents: There is robust patenting activity around manufacturing methods for biosimilars, small molecules, and biologics, particularly in the last decade.
- Patent families: Similar methods patented internationally may impact the scope in Korea via patent family or parallel filings.
- Patent thickets: Multiple overlapping patents often exist around process each step, requiring careful freedom-to-operate analysis.
Related patents and patent families
KR20140148502 likely forms part of a broader patent family with counterparts filed in major jurisdictions (e.g., WO/EP filings). These related patents can reinforce or limit the scope depending on their claims overlap.
- Blocking patents: Older patents may restrict the scope of current inventions.
- Synergistic patents: Complementary patents may create an ecosystem of protective IP.
Legal challenges & patent enforcement
Patent enforcement in South Korea is robust, with a developed patent judiciary. Enforcement centers on proving infringement through comparative analysis of claims, particularly process steps and manufacturing parameters.
Implications for Stakeholders
- Innovators must ensure claims are sufficiently broad yet specific, balancing defensive breadth with validity.
- Filing strategy should include international patent protection due to the global nature of pharma markets.
- Infringement risks hinge on the precise wording of claims; slight deviations in process may still bypass legal barriers if claims are overly narrow.
Future Patent Trends
Considering South Korea’s focus on biologics and biosimilars, innovations around manufacturing processes for complex molecules will likely continue to be a rich domain. Patents similar to KR20140148502 will need to address evolving process technologies, such as continuous manufacturing or single-use systems, to maintain competitive advantage.
Conclusion
Patent KR20140148502 reflects a focused effort to protect a novel manufacturing process within South Korea’s dynamic pharmaceutical landscape. Its scope hinges on specific process steps and parameters designed to demonstrate novelty and inventive step. Its strategic positioning within global patent families provides an additional layer of protection, with implications for both infringement risk and patentability trends.
Key Takeaways
- Scope is defined by detailed, process-specific claims, emphasizing innovative manufacturing steps.
- Broad claim language, including open terms, can maximize protection but must balance validity.
- Patent landscape analysis reveals an intense field with overlapping patents; thorough freedom-to-operate assessments are essential.
- International family members strengthen global rights but require tailored strategies for each jurisdiction.
- Continued innovation in manufacturing techniques (e.g., continuous processing) will shape future patent filings and landscape shifts.
FAQs
1. How does KR20140148502 compare with international patents in the same domain?
The patent likely shares core inventive concepts with international counterparts, but unique process parameters or formulation steps claim distinct protection. Cross-referencing filings in the PCT database reveals geographical scope and potential for blocking patents elsewhere.
2. Can this patent be challenged on grounds of obviousness?
Yes. If prior art demonstrates similar manufacturing steps or known methods, the patent could face invalidation procedures based on lack of inventive step. Patent validity depends on the demonstration of non-obvious enhancements.
3. What are typical infringement indicators for this type of patent?
Infringement occurs if a competitor employs substantially similar manufacturing processes or claims process steps covered by the patent claims, especially those with narrow process parameters.
4. How does patent KR20140148502 impact drug manufacturing companies in Korea?
It provides exclusivity over specific manufacturing techniques, discouraging competitors from adopting similar methods without licensing, thereby offering a competitive edge and potential licensing revenue.
5. What strategic recommendations should patent applicants consider today?
Applicants should pursue comprehensive patent family strategies, incorporate broad yet valid claims, monitor evolving process technologies, and ensure global coverage to maximize market protection.
References
- South Korea Intellectual Property Office (KIPO) Patent Database, Patent KR20140148502.
- World Intellectual Property Organization (WIPO) Patent Scope Database.
- European Patent Office (EPO) PATSTAT.
- Patent landscape reports for South Korea’s pharmaceutical sector.
- Industry analyses on process patents in biologics and small molecules.
