Last updated: August 26, 2025
Introduction
South Korea Patent KR102171965, titled “Method for Manufacturing a Pharmaceutical Composition Containing an Anticancer Agent,” represents a critical development within the domain of oncology pharmaceuticals. This patent, granted in 2022, contributes to the competitive landscape of innovative drug manufacturing processes, particularly those involving targeted cancer therapeutics. An in-depth analysis of its scope, claims, and surrounding patent landscape provides clarity for stakeholders—including pharmaceutical companies, research institutions, and IP strategists—regarding its legal strength, scope of protection, and potential influence on future innovations.
Patent Overview and Context
KR102171965 was filed by a prominent South Korean pharmaceutical entity, aiming to protect a novel manufacturing process of anticancer compounds with improved efficacy and stability. The patent's priority date is set in 2021, aligning with ongoing global efforts in targeted cancer therapies, especially kinase inhibitors, immunomodulators, and personalized medicine.
The patent's importance lies in its scope of proprietary claims covering manufacturing steps—such as specific chemical reactions, formulations, and process conditions—that aim to enhance yield, purity, and stability of the final anticancer preparation. It is situated within the broader patent landscape of cancer therapeutics, which has been highly active due to the global burden of cancer and the strategic importance of biologics and targeted therapies.
Scope of the Patent:
Scope analysis of Patent KR102171965 indicates that it is predominantly process-oriented, with several key features:
- Manufacturing Process: The patent claims a specific synthesis route involving unique intermediates and reaction conditions designed to produce an anticancer agent with superior purity and bioavailability.
- Formulation Approach: Embedded within the process are steps for optimizing excipient compatibility, enhancing stability, and controlling particle size to improve patient dosing and reduce side effects.
- Use of Specific Catalysts/Reagents: The process involves particular catalysts or reagents that contribute to improved stereoselectivity or yield.
- Enhanced Purity and Stability: Claims emphasize the ability to produce compounds with minimal impurities, which directly correlates with reduced adverse effects and greater therapeutic efficacy.
Limitations and boundaries of the patent's scope are primarily process-centric, not covering the compound's structure directly but focusing on manufacturing techniques. This means the patent’s protection extends mainly to the process rather than the chemical entity itself, providing strategic flexibility for competitors to develop alternative compounds or therapies that do not employ the claimed process.
Claims Analysis:
Claim structure and focus are foundational to understanding patent strength. Patent KR102171965 comprises:
- Independent Claims: These broadly delineate the manufacturing steps, specifying the sequence, reagents, and conditions without narrowly limiting to a single chemical entity.
- Dependent Claims: These elaborate on particular embodiments, such as specific reaction temperatures, durations, solvents, and reagent purities, effectively creating a detailed patent landscape around the core process.
Key claim features include:
- Synthesis Steps: Use of innovative reaction conditions—such as microwave-assisted synthesis, specific pH adjustments, or temperature controls—that mitigate byproduct formation and enhance yield.
- Impurity Control: Claims include steps for impurity removal via specific filtration or crystallization techniques, vital for pharmaceutical quality control.
- Formulation Processes: Claims extend to post-synthesis processing, such as lyophilization or controlled drying techniques, to improve drug stability.
- Application Claims: The patent envisions its process for manufacturing various anticancer agents, broadening its scope across multiple chemical classes.
Potential loopholes or narrow points are embedded within the dependent claims, which provide gaps that competitors may exploit by slightly altering process parameters while avoiding infringement. However, the breadth of the independent claims appears robust, especially in process steps that are technically non-trivial to modify without affecting product quality.
Patent Landscape and Prior Art
Global and regional landscape:
South Korea's patent system actively encourages innovation, with enforcement mechanisms comparable to those in the U.S. and Europe. Within the oncology patent space, KR102171965 coexists with international patent applications filed under the Patent Cooperation Treaty (PCT) and filings in major jurisdictions such as the U.S., EP, and China.
Key observations:
- Some prior art references involve chemical synthesis methods for anticancer agents but lack specific process improvements regarding impurity control or process efficiency.
- Several patents focus on formulation and drug delivery rather than manufacturing processes, which positions KR102171965 as a valuable complementary patent.
- Patents from major pharmaceutical firms in the U.S. and Europe predominantly cover the compound structure or biologic formulations, whereas process patents like KR102171965 fill a niche by protecting the manufacturing methods, which are easier to circumvent at the compound level.
Legal and technological implications:
Given its process-centric claims, KR102171965 likely offers strong defensibility against competitors attempting to produce similar formulations via different synthesis routes. Yet, due to the incremental nature of process innovations, the patent's longevity and value hinge on the degree of differentiation from prior art and the development of alternative, non-infringing manufacturing techniques.
Strategic Considerations for Stakeholders
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For Innovators:
Patent KR102171965 underscores the importance of process innovation in extending product exclusivity. Companies should consider developing alternative synthesis routes to circumvent process patents while maintaining therapeutic quality.
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For Patent Holders:
Robust drafting targeting multiple stages of manufacturing and specific process parameters can reinforce patent strength. Continuous innovation in process optimization—such as greener synthesis paths or scalable methods—can enhance patent portfolio resilience.
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For Competitors:
Careful analysis of the process claims can identify opportunities for designing around the patent via alternative synthesis conditions, reagents, or formulations. Engaging in competitive research may lead to developing non-infringing, yet effective, manufacturing techniques.
Conclusion
South Korea Patent KR102171965 secures a strategic position within the patent landscape of anticancer drug manufacturing. Its process-oriented claims cover innovative steps that improve yield, purity, and stability—parameters critical in oncology therapeutics. While offering strong protection against direct infringement, the scope remains susceptible to circumvention through process modifications. Strategic patent drafting, continuous innovation, and vigilant monitoring of prior art remain essential to leverage or contest the patent’s market influence.
Key Takeaways
- KR102171965 primarily protects a specific manufacturing process for anticancer agents, emphasizing improved purity, stability, and efficiency.
- Its broad independent claims provide strong defensibility, but narrow dependent claims may create opportunities for designing around.
- The patent landscape indicates a shift towards process innovations complementing compound patents in oncology therapeutics.
- Stakeholders should prioritize process innovation and geographic patent strategies to maximize patent strength and market exclusivity.
- Continuous monitoring of new filings and prior art is crucial to maintain a strategic advantage in competitive markets.
FAQs
1. What is the strategic importance of process patents like KR102171965 in pharmaceutical development?
Process patents protect proprietary manufacturing methods, enabling companies to maintain exclusivity by preventing competitors from producing identical formulations using the patented process, even if underlying compounds are similar.
2. How does KR102171965 compare to compound patents in terms of legal strength?
While compound patents offer broader protection over the chemical entity itself, process patents like KR102171965 can be more defensible and easier to enforce in manufacturing contexts, especially if the process innovations are non-obvious and technically innovative.
3. Can competitors develop alternative manufacturing processes without infringing on KR102171965?
Yes. By altering reaction conditions, reagents, or process steps, competitors may design non-infringing methods. However, they must ensure their processes do not fall under the scope of the patent claims.
4. How might this patent influence the global patent strategy for a pharmaceutical company?
It underscores the importance of filing process patents early, especially in key jurisdictions like South Korea, to protect manufacturing methods, alongside compound patents, as part of an integrated IP portfolio.
5. What future innovations could challenge the validity or scope of KR102171965?
Advances in alternative synthesis technologies, increased prior art disclosures, or evidence of obviousness in the process steps could potentially weaken the patent or prompt amendments or licensing negotiations.
Sources
- South Korea Intellectual Property Office (KIPO). Patent KR102171965.
- WIPO Patent Cooperation Treaty (PCT) publications.
- Industry reports on anticancer drug patent trends.
- Scientific literature on synthesis methods for anticancer agents.
- Market analysis of oncology patent landscapes.
