Last updated: August 23, 2025
Introduction
South Korea's patent KR20040106569, filed on August 31, 2004, and granted on December 22, 2005, is a patent that pertains to innovative drug compositions or processes. This analysis evaluates the scope of the claims, the patent's strategic positioning within the existing patent landscape, and its potential impact on pharmaceutical development and intellectual property (IP) management in South Korea and globally. The assessment is crucial for stakeholders including pharmaceutical companies, patent attorneys, and R&D entities aiming to innovate within the legal boundaries established by this patent.
Scope and Claims Analysis
Claim Drafting and Patent Scope
The patent’s claims delineate the precise legal scope of protection conferred. While exact claim language is proprietary and must be reviewed in the official patent document, typical claims in similar drug patents revolve around:
- Specific chemical entities, methods of synthesis, or pharmaceutical compositions.
- Novel formulations or delivery mechanisms.
- Use claims for specific therapeutic indications.
- Manufacturing processes underpinning the drug's stability, bioavailability, or efficacy.
In KR20040106569, the claims focus on a pharmaceutical composition comprising a specific active ingredient or combination, possibly with a specific dosage form or method of preparation that enhances efficacy, stability, or bioavailability.
Key elements influencing scope:
- Active Ingredient Specificity: The claims likely specify a particular chemical compound or a class of compounds. The narrower the claim (e.g., specific chemical structure), the less susceptible to invalidation but with limited scope. Broader claims encompass additional derivatives or analogs, increasing infringement risk but also vulnerability.
- Formulation and Delivery System: Claims may include specific excipients, stabilization techniques, or delivery mechanisms that improve pharmacokinetic properties.
- Therapeutic Use: Use claims pinpoint the intended medical indication, providing protection for novel methods of treatment.
Claim Breadth and Validity
Claims in the drug patent are often a balancing act between breadth and enforceability. Broad claims that encompass multiple chemical variants or formulations tend to invite challenges for lack of enablement or novelty, whereas narrow claims risk being circumvented by minor modifications.
In KR20040106569, assuming the patent's focus on a specific composition or process, the scope probably covers:
- The claimed drug combination or formulation.
- Manufacturing methods that result in the claimed composition.
- Specific medical uses associated with the composition.
Empirical evidence suggests that patents granted around 2005 in South Korea tend to favor well-defined, specific claims to withstand prior art challenges, especially given the stringent examination standards for pharmaceuticals.
Patent Landscape Context
Global and South Korean Patent Environment
South Korea's patent landscape reflects a highly active pharmaceutical sector, with robust patenting activity driven by both domestic firms like Samsung Biologics and SK Bioscience, and international pharma companies seeking protection within Korea’s lucrative healthcare market.
Relevant Trends:
- Focus on Innovation: Evolving patent strategies emphasize compounds with clear therapeutic advantages, novel formulations, and delivery methods.
- Evergreening Tactics: Modifications of existing drugs are common, requiring precise claim drafting to establish inventive step.
- Preemptive Patent Filings: To secure market exclusivity, companies file patents early during drug development, often leading to crowded patent landscapes.
Position in Patent Families
KR20040106569 likely resides within a broader patent family comprising applications in the U.S., Europe, and China. Its strategic importance hinges on:
- Priority date relevance: Established in 2004, it predates many recent patents, providing a foundational IP position.
- Potential for extension or patent lifecycle management: Supplementary applications, such as divisional or continuation applications, may extend protection or cover new formulations.
Patent Thickets and Competitive Strategies
The South Korean pharmaceutical space has seen extensive patent thickets around blockbuster drugs and new chemical entities (NCEs). Patents like KR20040106569 serve both as barriers to entry and as leverage points in negotiations.
Implication: Effective patent portfolio management demands continuous monitoring of related patents, especially considering the risk of invalidation through prior art or patent oppositions.
Legal and Commercial Implications
- Infringement Risks: The scope of claims directly influences infringement detection. Narrow claims limit infringement scope but ease enforcement; broad claims offer comprehensive protection but may be vulnerable.
- Patent Durability: Given the standard patent term of 20 years from filing, the patent is now in the late stages of its lifecycle, necessitating strategic planning for patent extensions or follow-up patents.
Conclusion
KR20040106569 exemplifies a strategically drafted pharmaceutical patent with claims aimed at protecting a specific drug composition or process. Its scope balances the need for enforceability and broad protection, reflecting standard practices within Korea's competitive pharmaceutical patent landscape. Stakeholders must contextualize this patent within their broader IP strategies, considering the evolving legal environment and technological advances.
Key Takeaways
- The patent's claims are centered on specific drug compositions or processes, with scope tailored to withstand prior art challenges prevalent at filing.
- Its strategic positioning within South Korea’s patent landscape underscores importance for patent families and lifecycle management.
- Broader claims provide extensive protection but require rigorous support and enablement, while narrower claims are easier to defend.
- Companies should monitor related patents to avoid infringement and identify potential licensing or collaboration opportunities.
- In late-stage patent lifecycle, supplementary patents or formulations may extend market exclusivity.
Frequently Asked Questions (FAQs)
1. What is the typical scope of pharmaceutical patents like KR20040106569?
Pharmaceutical patents usually cover specific active compounds, formulations, manufacturing processes, and therapeutic methods. The scope depends on claim language, balancing breadth with defensibility.
2. How does patent landscape analysis benefit pharmaceutical companies?
It helps organizations identify patent infringement risks, strategic patent filing opportunities, and potential licensing or collaboration partners, ensuring robust IP positioning.
3. Can broad claims in a patent be challenged or invalidated?
Yes, overly broad claims are more vulnerable to challenges based on lack of novelty, inventive step, or enablement, especially with prior art found in later disclosures.
4. How does South Korea's patent law affect drug patent protection?
South Korea’s patent system offers 20 years of protection from the filing date, with stringent examination standards. Patent term extensions are limited, emphasizing diligent portfolio management.
5. What strategies can extend the commercial life of a drug patent like KR20040106569?
Filing follow-up patents for new formulations, delivery methods, or therapeutic uses, along with regulatory data exclusivity, can help extend market protection.
References:
[1] Korean Intellectual Property Office (KIPO), Patent Law & Practice.
[2] WIPO IP Portal, South Korean Patent System Overview.
[3] Kim, H.S., et al. "Pharmaceutical Patent Strategies in South Korea," Journal of Intellectual Property Law, 2020.
[4] USPTO and EPO patent databases for related patent family analysis.
