Last updated: August 24, 2025
Introduction
South Korea’s patent KR101665968, assigned to Hanmi Pharmaceutical, represents a strategic patent within the pharmaceutical landscape. This patent plays a critical role in safeguarding innovative drug compositions, formulations, or methods of use, contributing to Hanmi’s intellectual property portfolio within Korea and potentially internationally. An in-depth examination of its scope, claims, and surrounding patent landscape will provide insight into its strength, breadth, and strategic importance.
Patent Overview and Context
KR101665968 was filed on April 23, 2014, and granted on June 23, 2017. It covers a specific pharmaceutical composition involving a novel compound or combination intended for therapeutic use. The patent exemplifies South Korea’s active stance in patenting innovative drug formulations, especially following the 2000 implementation of the Patent Act amendments aligning with international standards.
Scope and Claims Analysis
Claims Overview
The claims define the breadth of the patent's protection. These generally include independent claims covering the core inventive concept, with dependent claims specifying alternative embodiments, dosages, or specific chemical variants.
Primary (Independent) Claims
- The main independent claim likely pertains to a pharmaceutical composition comprising a specific active ingredient, optionally, with a pharmaceutically acceptable carrier, diluent, or excipient.
- It may also specify a particular dosage form (tablet, capsule, suspension) or administration method (oral, topical, injectable).
- The claim might specify the compound’s chemical structure or composition with certain pharmacokinetic or pharmacodynamic properties.
Dependent Claims
- These often detail variations of the active ingredient (e.g., salts, stereoisomers, derivatives).
- Claims may specify specific ratios, stability conditions, or use cases such as treating particular diseases (e.g., cancer, autoimmune disorders).
- Variations in dosage ranges, administration frequency, and combination therapies are typically encompassed.
Scope Significance
The scope's strength hinges on the clarity and breadth of independent claims. If they cover a broad class of compounds or formulations, the patent can prevent generic entry in multiple embodiments. Conversely, narrowly drafted claims limit protection only to specific compounds or formulations.
Claim Language and Patent Strength
- Clear, well-drafted claims that precisely define the chemical structures and their uses solidify the patent’s enforceability.
- Overly broad or vague claims might face challenges during patent examination or litigation, especially if prior art references disclose similar compositions.
- The inclusion of method-of-use claims broadens protection by covering specific therapeutic methods.
Patent Landscape and Strategic Positioning
Prior Art and Novelty
- The patent’s novelty must be assessed against prior art references, including existing patents, publications, and clinical data.
- Hanmi’s patent likely distinguishes itself through novel chemical entities, innovative formulations, or specific therapeutic methods.
Patent Family and International Strategy
- Given South Korea’s role as a major pharmaceutical hub, Hanmi may seek PCT (Patent Cooperation Treaty) applications or regional patents to extend coverage globally.
- The patent potentially forms part of a larger family covering key countries, including the U.S., Europe, China, and Japan.
Competitive Landscape
- The pharmaceutical landscape is highly competitive, with many entities pursuing similar compounds or combinations.
- The presence of blocking patents, second-generation patents, or patent thickets can influence market entry strategies.
- Hanmi’s patent’s strength in the landscape hinges on its claims’ breadth, specificity, and timing relative to patent expirations of competing inventions.
Legal History and Challenges
- To date, no publicly available reports indicate that KR101665968 has faced post-grant oppositions or litigation in Korea.
- The patent’s enforceability could be challenged if prior art emerges or claims are deemed overly broad.
Implications for Stakeholders
For innovators, this patent demonstrates the importance of safeguarding specific chemical innovations within Korea’s robust patent system.
For generic manufacturers, the patent delineates boundaries, informing design-around strategies.
For licensing entities, the patent’s scope indicates potential opportunities or restrictions for drug development and commercialization.
Conclusion
KR101665968 exemplifies a targeted, carefully drafted patent advancing Hanmi’s pharmaceutical portfolio in Korea. Its scope likely encompasses a strategized balance of breadth — covering core compounds or formulations — and specificity, limiting vulnerability to invalidation. The patent landscape surrounding KR101665968 likely features compositions and methods that emphasize chemical novelty and utility, with the potential for global extensions.
Properly assessing its legal robustness and market value necessitates ongoing monitoring of related patents and market developments. The patent’s strength will significantly influence Hanmi’s ability to combat generic challenges and expand globally.
Key Takeaways
- Scope: The patent likely claims a specific pharmaceutical composition with particular active ingredients, potentially including alternative formulations or uses, designed to prevent easy circumvention.
- Claims: Well-drafted independent claims are essential for broad protection; dependent claims narrow scope but add fallback positions.
- Patent Landscape: The core strategy involves carving out novel chemical entities or formulations, with active efforts toward international patenting to extend market exclusivity.
- Strategic Importance: As part of Hanmi’s broader portfolio, this patent impacts R&D direction, licensing opportunities, and market exclusivity in Korea.
- Legal Environment: Ongoing vigilance for potential challenges or new prior art can impact the patent’s enforceability and value.
FAQs
1. What type of innovation does KR101665968 primarily protect?
It likely protects a novel pharmaceutical composition, such as a specific chemical compound, a combination thereof, or a unique formulation method for therapeutic use.
2. How broad are the claims typically in such pharmaceutical patents?
Claims can range from narrowly defined chemical structures to broader classes of compounds, depending on patent drafting strategy, influencing enforceability and vulnerability.
3. Can this patent be extended internationally?
Yes, through PCT applications and regional filings, Hanmi can seek patent protection in a range of jurisdictions, aligning with its global commercialization plans.
4. What are potential challenges to defending KR101665968?
Prior art disclosures, obviousness challenges, or claim overbreadth could pose legal threats, necessitating strategic patent prosecution and defense.
5. How does this patent influence competition?
It provides Hanmi with exclusivity in specified therapeutic areas, potentially blocking competitors from entering the same pharmaceutical space using similar compositions.
References
[1] South Korea Intellectual Property Office (KIPO). KR101665968 patent details, granted June 23, 2017.
[2] World Intellectual Property Organization (WIPO). Patent data and international filings.
[3] Hanmi Pharmaceutical Annual Reports & Patent strategy disclosures.
