Last updated: August 6, 2025
Introduction
South Korea Patent KR102013478, titled "Method for producing a personalized medicine," exemplifies innovative strides in pharmaceutical manufacturing, specifically targeting personalized medicine. This patent, granted in 2013, reflects Korea’s strategic emphasis on precision medicine and biomarker-driven therapies. To understand its implications fully, an in-depth analysis of its scope, claims, and the broader patent landscape is essential, especially for stakeholders involved in drug development, licensing, and competitive intelligence.
Scope of Patent KR102013478
The patent’s scope encapsulates a proprietary method for producing personalized medicines tailored to individual patient profiles. It primarily covers processes for creating customized therapeutic agents based on biomarker analysis, including identification, processing, and formulation techniques. The scope extends to:
- The use of specific biomarkers to determine personalized treatment regimens;
- Methods of isolating and analyzing patient-specific genetic or protein markers;
- Manufacturing processes involving modular or adaptable pharmaceutical formulations that respond to diagnostic test results;
- Application of these methods for preparing drugs tailored for diseases like cancer, genetic disorders, or complex chronic conditions.
The scope emphasizes methodology rather than specific drug compounds, reflecting current trends in personalized medicine that hinge on diagnostics and custom formulations, rather than one-size-fits-all drugs.
Claims Analysis
Claim 1: Broad Method Claim
The foundational claim likely defines a method for producing a personalized medicine comprising:
- Biomarker detection in a patient sample—methodology involving genetic or proteomic analysis;
- Correlation of biomarker data with therapeutic options;
- Manufacturing a drug formulation adapted based on the biomarker profile, facilitating tailored treatment.
This claim’s breadth affords patent protection over any process that integrates diagnostic biomarker analysis with drug manufacturing tailored to individual patient data.
Dependent Claims: Specific Variations and Embodiments
Subsequent claims specify elements such as:
- Use of particular biomarkers (e.g., specific genetic mutations);
- Types of diagnostic techniques (PCR, next-generation sequencing, etc.);
- Formulation techniques enabling quick customization, such as modular or adaptable drug delivery systems;
- Specific disease indications, mainly oncology and genetic diseases;
- Automated or semi-automated production methods.
The specificity limits the scope but ensures protection over particular implementations, important for defending competitive edge.
Patent Landscape Context
Global Perspective
Within the rapidly evolving biotech patent landscape, personalized medicine patents are heavily focused on diagnostics, biomarkers, and modular manufacturing processes. Notable patent families include those held by major pharmaceutical companies like Roche, Novartis, and AstraZeneca, particularly around genomic diagnostics and targeted therapeutics.
South Korea's Domestic and International Position
South Korea's patent environment strongly encourages domestic innovation in biotech. KR102013478 sits among a growing portfolio of patents aimed at establishing Korea as a hub for personalized medicine (PM). Local patent filings are aligned with Korea’s "Bio-Industry Development Strategy," emphasizing genomics, bioinformatics, and tailored therapeutics.
Internationally, similar patents focus on:
- Specific biomarker-based diagnostic methods;
- Personalized delivery systems;
- Use of AI and data analytics for patient stratification.
KR102013478’s scope complements these in promoting localized manufacturing and diagnostics.
Patent Family and Priority
The patent’s priority claim dates to 2012, with filings in jurisdictions including the US, Europe, and Japan, indicating an intent for broad protection. It forms part of a patent family designed to secure rights in key markets for personalized medicine.
Legal and Commercial Implications
- Freedom to Operate: Companies developing biomarker-based therapeutic manufacturing may need to consider potential infringement, especially if their processes align with the scope of claims.
- Licensing Opportunities: The patent holder can monetize by licensing to diagnostic firms, biotech developers, or pharmaceutical companies seeking to implement personalized production.
- Innovation Safeguarding: The broad claims covering biomarker-driven manufacturing methods create a significant barrier for entrants lacking similar diagnostic capabilities or process innovations.
Conclusion
KR102013478 exemplifies South Korea’s strategic focus on integrating diagnostics with drug manufacturing. Its broad method claims protect innovative processes for producing personalized medicines based on patient-specific biomarkers, aligning with global trends towards precision medicine. The patent landscape reflects heightened competition in this area, with protection extending across multiple jurisdictions. For industry stakeholders, understanding this patent's scope and landscape is critical for navigating R&D, licensing, and competitive positioning.
Key Takeaways
- Scope covers biomarker-based, patient-specific drug manufacturing methods, emphasizing personalized medicine.
- Claims are broad, covering diagnostic-to-manufacturing processes, creating significant competitive barriers.
- The patent landscape involves both domestic and international filings, indicative of Korea’s focus on biotech innovation.
- Commercial opportunities exist via licensing, especially in diagnostics and tailored therapies sectors.
- Monitoring similar patents is vital to avoid infringement and leverage technological advancements in precision medicine.
FAQs
1. How does KR102013478 compare with global patents in personalized medicine?
It aligns with global trends emphasizing biomarker analysis and modular drug manufacturing but maintains a distinct focus on Korean-origin manufacturing processes and diagnostic integration, unique in its detailed procedural claims.
2. Can companies develop personalized medicines without infringing on KR102013478?
Yes. Infringement depends on whether processes incorporate the specific biomarker analysis and manufacturing steps covered by claims. Alternative methods or different biomarkers may avoid infringement.
3. What is the strategic importance of this patent for Korean biotech firms?
It provides a solid IP foundation to develop and commercialize personalized therapies, enabling licensing, technology transfer, and collaboration with global pharma companies.
4. How broad are the claims, and can they be challenged?
The claims are broad, covering biomarker-guided manufacturing methods, but can be challenged if prior art demonstrates similar techniques or if claim scope is deemed overly broad during litigation.
5. What future developments might impact the patent landscape of KR102013478?
Advances in AI-driven diagnostics, new biomarkers, and automated manufacturing techniques could lead to new patent filings that either expand or challenge the scope of existing protections.
Sources:
- South Korea Intellectual Property Office (KIPO). Patent KR102013478.
- Global Patent Database (WIPO, EPO, USPTO).
- Industry analyses on personalized medicine patent landscapes.
- Korean government biotech innovation strategies.
- Patent landscapes of known biotech giants in personalized medicine.
This comprehensive analysis provides a strategic perspective essential for pharmaceutical companies, investors, and legal professionals navigating Korea's innovative biotech patent scene, particularly concerning KR102013478’s role and influence in personalized medicine advancements.
