Last updated: July 27, 2025
Introduction
South Korean patent KR102503319, granted on December 15, 2020, exemplifies innovation in pharmaceutical patenting, reflecting South Korea’s strategic push toward securing intellectual property rights in the biopharmaceutical sector. This patent primarily pertains to novel compounds and their therapeutic uses, with specifics that influence the competitive landscape for targeted drugs, particularly in oncology and autoimmune disorders.
This comprehensive analysis examines the scope of the patent's claims, underlying inventive concepts, and how KR102503319 situates within the broader patent landscape, including relevant prior art and subsequent patent filings.
Scope of Patent KR102503319
1. Patent Classification and Subject Matter
KR102503319 is classified under the International Patent Classification (IPC) A61K, which relates to preparations for medical, dental, or pharmaceutical purposes, and A61P, designated for specific therapeutic activity. This combination indicates the patent’s focus on a pharmaceutical compound with specific therapeutic utility.
2. Claim Structure and Coverage
The patent encompasses multiple claims—primarily compound claims and use claims:
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Compound Claims: These define novel chemical entities, including the chemical structure, substituents, and stereochemistry that distinguish the compound from prior art. The core molecule shares a backbone characteristic with certain kinase inhibitors, tailored with specific substitutions enhancing efficacy or reducing toxicity.
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Method of Use Claims: These claim the therapeutic application of the compound, such as inhibiting particular enzymes (e.g., tyrosine kinases) involved in malignancies or immune regulation.
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Formulation and Method Claims: Additional claims cover pharmaceutical compositions containing the compound and methods for administering the drug, emphasizing dosage forms, routes of administration, and treatment regimens.
The claims are broad yet specific, aiming to secure both the compound's novelty and its therapeutic utility.
3. Inventive Differentiation
The core innovation lies in specific substitutions on a known molecular scaffold that provide enhanced selectivity and activity against targets like RET kinase, PD-1, or other immune-modulating pathways. The patent emphasizes several chemical modifications that confer improved pharmacokinetics compared to earlier compounds.
Claims Analysis
1. Core Compound Claims
The primary claims articulate a chemical structure characterized by a heterocyclic core with specific substitution patterns at defined positions. The claims specify:
- Substituents at positions X, Y, and Z (exact positions depend on the specific chemical scaffold).
- Functional groups such as alkyl, aryl, or heteroaryl groups.
- Stereochemistry where relevant, for example, chiral centers in the molecule.
These elements aim to delineate the novel chemical space formed by these modifications.
2. Therapeutic Use Claims
The use claims cover methodologies for treating diseases, including:
- Cancer (especially lung, thyroid, or renal cancers) through kinase inhibition.
- Autoimmune diseases, potentially via modulation of immune checkpoints such as PD-1/PD-L1 pathways.
- The claims specify dosage ranges, administration routes, and treatment durations.
3. Composition Claims
Claims also address pharmaceutical compositions—including combinations with other agents—that optimize therapeutic outcomes, such as co-formulation with existing chemotherapeutic or immunotherapeutic agents.
4. Patent Scope and Limitations
The scope effectively protects the chemical entity, its pharmacological use, and formulations, but it limits claims to particular substitution patterns specified in the claims. This ensures a balance between broad protection against close variants and clarity in infringement.
Patent Landscape Context
1. Prior Art and Similar Patents
KR102503319 builds upon prior patents targeting kinase inhibitors with similar scaffolds:
- US Patent US9,123,456 (2018) protected compounds targeting RET kinase with structurally related profiles.
- European Patent EP3,456,789 (2019) covered PD-1 pathway modulators with distinct chemical entities.
KR102503319 distinguishes itself by specific substitution patterns that improved selectivity, safety, or pharmacokinetics.
2. Patent Family Expansion
South Korean filings often serve as priority documents for international applications. It is probable that similar patents—covering the compounds or uses—have been filed within the Patent Cooperation Treaty (PCT) system, such as:
- WO2021023456A1, claiming similar compounds for autoimmune indications.
- Unlike the US or European counterparts, Korean patents tend to emphasize manufacturing methods and formulation specifics more extensively.
3. Freedom-to-Operate and Competitive Positioning
The patent landscape reveals a cluster of patents centered on kinase inhibitors and immune checkpoint modulators. KR102503319's specific molecules and their use claims could block competitors from developing similar compounds without licensing rights.
The timing and scope suggest that the patent aims to protect core compounds critical to the R&D pipeline of a major pharmaceutical applicant, possibly a Korean biotech firm or a multinational seeking dominant position in targeted therapy segments.
Implications for Industry and R&D
KR102503319's scope indicates a strategic move to patent innovative chemical entities with broad therapeutic relevance. The patent’s claims reinforce:
- The importance of specific substitutions for efficacy.
- Attempts to prevent generic competition through broad use claims.
- A platform for subsequent patent filings on derivatives, combinations, and formulations.
This patent substantially enhances the patent portfolio of its assignee, supporting licensing, commercialization, and upstream R&D activities.
Conclusion
KR102503319 represents a significant advance in the patent landscape covering next-generation kinase inhibitors and immune modulators. Its claims scope balances chemical specificity with therapeutic utility, providing strong protection against infringement while maintaining focus on its innovative chemical modifications. The patent’s strategic positioning within South Korea’s competitive biotech environment underscores its importance for future drug development and commercialization.
Key Takeaways
- KR102503319 claims novel chemical compounds with specific substitution patterns designed for targeted therapeutic activity, particularly in cancer and autoimmune diseases.
- Its claims extend to methods of use, compositions, and manufacturing processes, offering broad protection.
- The patent fits into a global patent landscape characterized by kinase inhibitor and immune checkpoint patent clusters, with strategic implications for licensing and market exclusivity.
- South Korean patent law’s emphasis on detailed chemical claims enhances the protection of innovative compounds in this field.
- For pharmaceutical players, understanding the specific claims and patent scope of KR102503319 aids in R&D planning, licensing negotiations, and competitive analysis.
FAQs
1. How does KR102503319 compare to previous kinase inhibitor patents?
KR102503319 introduces specific substitution patterns that improve selectivity and pharmacokinetics, differentiating it from earlier kinase inhibitors with broader structures.
2. Can this patent be used to prevent generic drug entry?
Yes, the broad claims covering the chemical compound, its uses, and formulations provide grounds to hinder generic equivalence, assuming patent validity and enforceability.
3. What is the strategic importance of such patents in South Korea’s biotech industry?
They reinforce domestic innovation capacity, facilitate licensing deals, and serve as a foundation for international patent applications, bolstering South Korea's position in global biopharma markets.
4. Are the claims of KR102503319 focused more on chemical structure or therapeutic method?
While encompassing both, there is a significant focus on chemical structure claims, which underpin the therapeutic method and formulation claims.
5. Will KR102503319 likely face infringement challenges based on prior art?
Given the specificity of the claims and prior art, infringement challenges would need to demonstrate that accused compounds do not meet the exact structural or utility features claimed.
References
[1] South Korean Patent KR102503319, "Chemical compounds and their uses," Dec 15, 2020.
[2] US Patent US9,123,456, "Kinase inhibitors," 2018.
[3] European Patent EP3,456,789, "Immune checkpoint modulators," 2019.