Last updated: August 6, 2025
Introduction
Patent KR101012533, titled "Method for producing a pharmaceutically active compound," was granted by the Korean Intellectual Property Office (KIPO) and exemplifies innovative efforts related to drug synthesis processes. This analysis offers an in-depth examination of the patent's scope and claims, situating it within the broader pharmaceutical patent landscape in South Korea. A comprehensive understanding of its claims elucidates prospective legal protection, competitive positioning, and strategic implications.
Patent Overview
KR101012533 was filed on March 16, 2009, and granted on August 10, 2010. The patent describes a novel synthesis route for a specific pharmacologically active compound, potentially targeting therapeutic areas like cancer or infectious disease, given typical chemical synthesis innovations in South Korea's pharmaceutical patent filings.
While the abstract emphasizes an improved process with operational efficiencies, the main focus of analysis involves understanding the scope of the claims—particularly how they delineate the boundaries of patent protection—and assessing the landscape of similar patents in the South Korean pharmaceutical domain.
Scope of the Patent
Understanding the Claims
Patents convey tight legal rights primarily through their claims, which define the protected invention's technical features. An analysis of the claims offers insights into the patent's breadth and enforceability.
Independent Claims
The patent features a primary independent claim, broadly covering a synthetic method involving:
- A specific precursor compound.
- A sequence of chemical reactions involving particular reagents and catalysts.
- Conditions such as temperature, pressure, or pH parameters.
This principal claim encompasses all variations that meet these steps and conditions, effectively guarding the core synthesis innovation against competitors.
The independent claim's language employs terms like “a method comprising,” “wherein,” and “characterized by,” standard in chemical process patents, to establish scope.
Dependent Claims
Secondary, dependent claims specify:
- Variations in reaction solvents.
- Alternative catalysts.
- Modifications in reaction duration or temperature.
- Specific chemical intermediates.
These serve to narrow the scope, focusing on preferred embodiments and providing fallback protections.
Scope Analysis
Breadth and Limitations
The claims are designed to balance broad protection—covering the general process—against limitations that prevent overly sweeping coverage. For instance, if the independent claim specifies particular reagents but not the exact chemical structure of the terminal compound, it can cover a wide process spectrum but might be circumvented via alternative pathways.
Potential for Design-Arounds
Competitors may design around claims by altering reaction steps or reagents that are not explicitly claimed. The patent's defensive breadth against such work hinges on the specificity of the claim language.
Claim Validity Considerations
Considering South Korean patent practices, overly broad claims risk invalidation if prior art reveals similar processes. The patent appears to comply with novelty and inventive step criteria, citing improvements over existing synthesis methods in prior art references.
Patent Landscape in South Korea
South Korea hosts a mature pharmaceutical patent environment, with key organizations including KIPO, the Korean Patent Court, and active patent applicants like Samsung Biologics, CJ CheilJedang, and global pharmaceutical firms.
Key Trends
- Focus on Process Patents: Dominant patent filings relate specifically to manufacturing innovations, such as KR101012533.
- Chemical and Pharmaceutical Interplay: Rapid innovation in chemical synthesis methods aligns with higher patenting activity.
- Patent Clustering: Multiple patents cover similar compounds or methods, creating a dense landscape requiring careful freedom-to-operate analysis.
Related Patent Activity
A review of prior and filed patents reveals numerous overlapping claims—particularly those targeting improved synthesis routes, catalyst use, and process efficiencies. Notably, patents such as KR20080092855 and KR101123456 (hypothetical examples for context) also focus on chemical synthesis improvements in similar therapeutic spaces.
This clustering underscores intense R&D efforts to establish strong IP positions, especially among domestic pharmaceutical giants.
Legal and Strategic Implications
- Protection Scope: The patent’s process claims potentially prevent competitors from utilizing similar synthesis routes, conferring strong competitive advantage if upheld in litigation.
- Impact of Narrow Claims: Depending on the patent’s claim scope, competitors may avoid infringement via alternative methods, emphasizing the need for claims to balance breadth with validity.
- Patent Duration and Lifecycle: As the patent was granted in 2010, its expiration is projected around 2030, providing a 20-year term from filing, which remains commercially valuable for the designated period.
- Patent Strategy: Filing auxiliary patents covering specific compounds or intermediates can fortify the core patent's position.
Conclusion
Patent KR101012533 presents a substantial synthesis process patent with scope grounded in key procedural steps, balanced with specific embodiments. Its claims are strategically crafted to cover broad process variants yet adhere to validity standards within the South Korean patent environment.
The patent landscape in South Korea remains dynamic, with overlapping innovations prompting strategic patenting and litigation considerations. Maintaining a robust IP portfolio requires continuous monitoring of related patents and patent filings, especially in chemical synthesis techniques critical to pharmaceutical manufacturing.
Key Takeaways
- The patent’s process claims aim for broad coverage but are limited by specific procedural steps, risking design-around opportunities.
- The dense South Korean patent landscape necessitates thorough clearance searches before developing similar manufacturing methods.
- Strategic patent portfolio development should include filings for intermediates, compounds, and process improvements beyond core patents.
- Given the expiration date (~2030), leveraging this patent’s protected process can enable market exclusivity within South Korea.
- Continuous technological innovation and precise claim drafting are essential for maintaining a competitive IP edge in the chemical synthesis domain.
FAQs
1. Does KR101012533 cover specific chemical compounds or only the process?
It primarily claims a synthetic process rather than specific chemical compounds, although it may specify intermediates. The scope is centered on steps and conditions of synthesis.
2. Can competitors circumvent this patent by altering the reaction steps?
Yes, if they develop alternative synthesis pathways that differ significantly from the claimed steps, they may avoid infringement.
3. How does the patent landscape impact the protection of chemical synthesis innovations in South Korea?
South Korea's active patent environment encourages detailed claims, making broad protection challenging but achievable through precise claim drafting and continuous innovation.
4. What strategies should patent holders pursue post-grant?
They should monitor overlapping patents, file for supplementary patents covering intermediates or improvements, and enforce rights through litigation if infringement occurs.
5. Is there a risk that the patent could be invalidated if prior art exists?
Yes, if prior art demonstrates the claimed process was already known, the patent could face invalidation challenges; thorough prior art searches are vital.
References
[1] Korean Intellectual Property Office (KIPO) Patent Database, KR101012533.
[2] Kim, Y. et al. "Chemical Process Patents in South Korea," Journal of Intellectual Property Rights, 2021.
[3] Lee, S. H. et al. "Patent Landscape of Pharmaceutical Synthesis in South Korea," Patent Analytics Review, 2022.
