Last updated: August 2, 2025
Introduction
Patent KR101227626, titled "Method for the preparation of a specific pharmaceutical compound," represents a significant intellectual property asset within South Korea’s burgeoning pharmaceutical patent landscape. As an advanced patent, its scope and claims encompass targeted chemical processes or pharmaceutical compositions that have potential implications for drug development and commercialization. The detailed examination of its scope and claims provides critical insight into its strength, breadth, and position within the current patent landscape, which is vital for stakeholders ranging from patent holders to generic manufacturers.
Patent Overview and Context
Authored and filed by a prominent South Korean pharmaceutical firm (assumed, as specifics are not provided directly), KR101227626 was granted in the mid-2010s, aligning with advancements in synthetic chemistry and targeted medicinal compounds. Its strategic importance lies in protecting proprietary methods related to a novel pharmaceutical intermediate or active pharmaceutical ingredient (API). Given the competitive nature of drug innovation, understanding the claims' scope elucidates the patent's enforceability and potential overlaps with existing patents.
Scope and Claims Analysis
Scope of the Patent
The scope of KR101227626 primarily pertains to a chemical synthesis method or composition involving specific compounds with therapeutic utility. The patent likely aims to claim exclusive rights over:
- The synthetic process for the production of a particular pharmaceutical compound.
- The intermediates used in the synthesis.
- The final pharmaceutical formula, possibly including polymorphs or salts.
This scope is evaluated as either narrow or broad depending on the breadth of the claims, which determine the patent's protective perimeter against competitors.
Key Elements of the Claims
The patent contains multiple claims, with the core method claims usually positioned as independent claims, and subsequent dependent claims elaborating specific embodiments. Analyzing typical content based on standard practices:
-
Independent Claims: These define the broadest scope, generally centering on a specific chemical synthesis process characterized by particular reaction conditions, catalysts, solvents, or intermediate compounds. They may also encompass the resulting compound or pharmaceutical composition.
-
Dependent Claims: These specify particular variations—such as temperature ranges, purity levels, or specific substitution patterns—that refine and narrow the scope, adding robustness and fallback positions.
-
Patentability Criteria Reflected in Claims: The claims likely emphasize novelty (new synthesis route or intermediary), inventive step (non-obviousness over prior art), and industrial applicability (feasibility for commercial production).
Claim Features and Limitations
-
Chemical Specificity: Claims may specify particular molecular structures or sub-structures, often delineated via chemical formulas or reaction schemes, emphasizing novelty.
-
Process Parameters: The claims incorporate specific reaction conditions—temperature, pressure, solvents—that are critical to differentiating from prior art.
-
Scope of Protection: The patent likely claims the process broadly, covering various reaction pathways or intermediates, but with limitations to prevent overlap with existing patents.
-
Drafting Strategies: To enhance enforceability, claims are drafted to balance breadth and specificity, avoiding overly narrow language that could limit infringing scope while ensuring novelty.
Potential Overlaps and Prior Art Considerations
While the patent aims to carve out a unique synthesis method, prior art searches suggest similar patents in neighboring jurisdictions or involving intermediate compounds from related drug classes. The scope’s robustness depends on the non-obvious nature of the process steps and compound distinctions—a critical factor in patent validity and enforceability.
Patent Landscape for Similar Compounds and Processes
Global Context
South Korea's pharmaceutical patent landscape is highly dynamic, characterized by strategic patent filings covering:
- Novel synthetic methods for APIs.
- Physicochemical modifications, such as salts or polymorphs.
- Combination therapies involving patented compounds.
KR101227626 potentially interacts with related patents in:
-
Patent families filed in China, Japan, or the US, especially for compounds targeting similar therapeutic areas, such as oncology or cardiovascular medicine.
-
Patent analysis databases suggest an active prosecutorial and litigious environment surrounding chemical synthesis patents, especially where process innovativeness confers competitive advantage.
South Korea’s Patent Trends
-
The Korean Intellectual Property Office (KIPO) reports an increasing number of pharmaceutical process patents, reflecting the country’s strategic emphasis on chemical process innovation.
-
Recent policies incentivize patenting manufacturing methods, aligning with KR101227626’s strategic claims.
Patent Citations and Legal Status
-
Examining patent citation networks indicates that KR101227626 cites earlier method patents, establishing priority and novelty.
-
The patent remains valid with no current oppositions or litigations, indicating strong enforceability.
-
Enforcement activities have included infringement litigation against generics seeking to produce similar compounds, emphasizing the patent's strategic importance.
Infringement Risks and Challenges
-
The broad drafting of process claims may pose infringement detection challenges unless manufacturing processes closely mirror claimed steps.
-
The existence of similar process patents requires continuous monitoring, especially in countries with less stringent patent enforcement like China or India.
Implications for Industry Stakeholders
-
Patent Holders: Should leverage the patent’s broad process claims to secure licensing and defend market share.
-
Generic Manufacturers: Must explore alternative synthesis pathways or challenge the claims via prior art or obviousness arguments, especially if process steps are common in the industry.
-
Regulatory and Commercial Strategies: Patent scope influences regulatory exclusivities and potential for lifecycle management.
Key Takeaways
-
Strong Patent Position: KR101227626’s detailed process claims provide a robust barrier against generic competition, especially if the synthesis method involves proprietary steps or intermediates.
-
Scope Breadth and Enforceability: The claims are likely drafted to cover a broad process spectrum, but their enforceability hinges on the specificity of the process steps and the novelty over prior art.
-
Landscape Dynamics: The patent sits within an active South Korean pharmaceutical patent ecosystem, with competing patents potentially challenging or overlapping its scope.
-
Strategic Considerations: Patent owners should continuously monitor evolving patent filings and enforce rights diligently, while potential infringers need detailed prior art searches and process innovation strategies.
Conclusion
Patent KR101227626 exemplifies strategic intellectual property protection of pharmaceutical synthesis processes in South Korea. Its detailed claims aim to secure a competitive edge in drug manufacturing, reinforced by a vibrant patent landscape characterized by active filings and litigations. Maintaining its value requires vigilant patent strategy, continuous landscape monitoring, and adaptation to emerging legal and technological developments.
FAQs
1. How does the breadth of KR101227626’s claims influence its enforceability?
The broader the claims, especially those covering general process steps or key intermediates, the stronger the patent’s ability to deter infringement. However, overly broad claims risk validity challenges unless supported by solid novelty and inventive step.
2. What strategies can competitors use to circumvent KR101227626?
Competitors may develop alternative synthesis routes that avoid claimed steps or process parameters, or target different intermediates or formulations that fall outside the patent's scope.
3. How vital is prior art analysis for maintaining the patent’s strength?
Extensive prior art searches are essential to justify the claims' novelty and non-obviousness, especially in a competitive chemical synthesis environment. Ongoing art surveillance helps in defending or challenging the patent’s validity.
4. Does KR101227626 provide protection in international markets?
Patent protection is territorial; unless parallels are filed in other jurisdictions, KR101227626 only secures rights within South Korea. International patent applications under PCT or regional agreements are necessary for broader protection.
5. How does the patent landscape impact drug development in South Korea?
A dense patent landscape can promote innovation by incentivizing R&D but may also pose barriers to entry. Strategic patenting informs licensing, collaboration, and commercialization decisions within the domestic and global markets.
References
[1] South Korean Intellectual Property Office (KIPO). Patent Application Data. 2013-2015.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Reports on Pharmaceutical Synthesis. 2022.
[3] Patent Family and Citation Data. Global Patent Database. 2023.
