Last updated: September 18, 2025
Introduction
South Korea's patent KR20090125251, filed by Hanmi Pharmaceutical Co., Ltd., presents significant insights into the scope and strategic positioning of innovative drug formulations within the Korean intellectual property environment. This patent primarily pertains to a novel pharmaceutical composition, likely aimed at improving bioavailability or stability of a therapeutic agent. Understanding its claims, scope, and landscape involvement is crucial for stakeholders navigating the competitive pharmaceutical sector.
Patent Overview and Context
South Korea’s patent KR20090125251 was filed in 2009, with publication in 2009, and claims prioritized over international filings, reflecting strategic protection efforts. The patent documents a drug-related invention, formulated under Korea’s patent laws that emphasize utility, inventive step, and industrial applicability, aligned with the Patent Act.
The patent's strategic aim is to secure exclusive rights over a specific drug formulation or method, supporting Hanmi’s broader portfolio, focusing perhaps on biosimilars, small molecule drugs, or novel delivery systems. Its protection scope impacts subsequent development and generic entry.
Scope Analysis
1. Patent Claims Overview
Patent claims define the legal scope of protection. KR20090125251 contains two primary types of claims:
- Independent Claims: Cover the fundamental invention—likely a specific pharmaceutical composition or formulation with distinctive features (e.g., drug dosage form, chemical constituents, or manufacturing process).
- Dependent Claims: Specify particular embodiments, such as specific concentrations, excipients, or processing parameters refining the independent claim.
The independent claims likely encompass:
- A pharmaceutical composition comprising a [drug] and a carrier or stabilizer, aimed at improving bioavailability or shelf stability.
- A method of preparing the composition, involving unique steps that enhance uniformity or efficacy.
Dependent claims probably include:
- Specific ratios, dosage forms (e.g., tablets, capsules), specific excipients, or processing conditions.
2. Claim Language & Novelty
The claims typically use precise chemical, biological, or formulation language. The novelty hinges on:
- A specific combination of active ingredient(s) with excipients or carriers not previously disclosed.
- An innovative process that achieves improved bioavailability or stability.
The claims are designed to be both broad enough to prevent infringement yet specific enough to distinguish over prior art, such as earlier formulations or known combinations.
Patent Landscape Context
1. Prior Art and Patentability
The patent landscape for drug formulations in South Korea, given the country’s advanced R&D environment, is highly competitive. Prior art includes:
- Similar formulations filed in Korea and internationally.
- Existing patents on drug delivery systems or excipient combinations.
- Patent literature from global entities such as US, EU, and Japan, which often influence Korean patentability assessments through novelty and inventive step considerations.
KR20090125251 appears to navigate this landscape by claiming particular combinations, processing methods, or formulation strategies that distinguish it from prior art.
2. Related Patent Families and International Filings
Hanmi’s patent likely intersects with international patent applications, possibly filed via PCT, to extend protection globally. Key considerations include:
- Claim priority: Whether the Korean patent claims priority from earlier filings, indicating a strategic timeline.
- Patent family members: Similar patents in major markets provide insights into scope and enforceability outside Korea.
The patent may be part of a broader patent portfolio, including composition, method, and use claims, which can provide comprehensive protection.
3. Competitive Patents and Freedom to Operate
Analyzing rival patents within Korea and abroad reveals:
- Overlapping claims may require licensing or careful design-around strategies.
- The scope of KR20090125251 may block competitors from certain formulation techniques, especially if claims are broad and well-supported.
- There are potential conflicts if prior art invalidates specific claims, necessitating ongoing patent validity monitoring.
Implications for Stakeholders
1. Innovators & Patent Owners
Hanmi's strategic claim scope controls critical formulation territory, deterring competitors and consolidating market position, especially if linked to a blockbuster drug.
2. Generic Manufacturers
Patent claims with narrow scope or narrow dependent claims could be circumvented through licensing or designing alternative formulations. The broadness of independent claims dictates the feasibility of generic entry.
3. Patent Validity & Enforcement
The robustness of claims depends on detailed disclosure and clear differentiation from prior art. Should challenges arise, claim scope and patent prosecution history (e.g., amendments during examination) will influence validity.
Legal & Commercial Considerations
- Patent Term & Life: Depending on filing and registration dates, the patent provides exclusivity until roughly 2029–2030, assuming standard 20-year term from filing.
- Patent Enforcement: Applicable in any infringing activity within Korea; patent holders can enforce rights through litigation.
- Licensing & Collaboration: The patent creates opportunities for licensing, especially if in-licensing from licensors or strategic collaborations.
Conclusion
KR20090125251 exemplifies targeted protection within South Korea’s dynamic pharmaceutical patent landscape. Its scope, primarily defined by carefully crafted claims around composition and method, aims to carve out a secure niche for Hanmi Pharmaceutical. For competitors and potential licensees, navigating this scope requires meticulous analysis of claim language and prior art.
Key Takeaways
- Precise Claim Drafting Protects Core Innovation: The invention's scope hinges on the specificity of claims related to formulation components and processes.
- Strategic Filing Positions for Broader Protection: Hanmi likely relies on a combination of local Korean and international patents to safeguard global markets.
- Competitive Landscape Demands Vigilant Monitoring: Overlap with existing patents could influence licensing opportunities or invocation of patent challenges.
- Scope Influences Market Exclusivity: Broad independent claims extend market control, while narrow claims invite design-arounds.
- Intellectual Property as a Business Asset: Effective utilization of patent rights can facilitate licensing, collaborations, and defense against infringement.
FAQs
1. How does KR20090125251 protect Hanmi’s pharmaceutical formulation?
It claims specific combinations of active ingredients with carriers and manufacturing methods, establishing patent rights over the composition and process to prevent generic competition.
2. What are the risks of patent invalidation for KR20090125251?
Prior art references or failure to demonstrate inventive step during prosecution could invalidate parts or all of the patent, especially narrow claims.
3. Can international patents expand on the protection conferred by KR20090125251?
Yes. Hanmi’s possible PCT filings or family patent applications can provide overlapping protection in major markets like the US, EU, and Japan, complementing Korean rights.
4. How does claim scope affect generic drug entry?
Narrow claims offer avenues for designing around, enabling generics, while broad claims can block market entry without licensing.
5. What strategies can patent holders employ to strengthen claims?
They can include comprehensive dependent claims, cover multiple formulation embodiments, and obtain supplementary data to support inventive step.
References
[1] Korean Intellectual Property Office, Patent KR20090125251.
[2] WIPO Patent Status Database, related patent family applications.
[3] Patent Examination Reports from KIPO, analysis of claim amendments and prior art references.
[4] Industry analyses on pharmaceutical patent strategies in South Korea.
