Last updated: August 13, 2025
Introduction
The patent KR102135601 pertains to a pharmaceutical invention granted in South Korea, affiliated with Zydus Cadila’s extensive patent portfolio. As the Korean national patent system privileges strategic patenting, understanding the scope, claims, and landscape for KR102135601 is critical for stakeholders involved in generic entry, licensing, and R&D investments. This analysis offers an in-depth review of this patent’s claims, its technological scope, and broader patenting trends within the South Korean pharmaceutical patent landscape.
Patent Overview and Bibliographic Details
- Patent Number: KR102135601 B1
- Filing Date: August 22, 2016
- Registration Date: December 11, 2018
- Applicant: Zydus Cadila
- Legal Status: Granted and in force
- International Classification: Typically falls under classes related to pharmaceuticals and chemical compositions, most likely A61K (preparations for medical, dental, or veterinary use) and C07K (peptides), depending on the exact application scope.
This patent builds upon prior filings and possibly relates to formulations, methods of synthesis, or specific therapeutic ingredients, aligning with Zydus’s strategic focus on novel drug delivery systems.
Scope and Claims Analysis
1. Core Technology and Claim Set
The primary claims in KR102135601 encompass:
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Chemical Composition Claims:
These define specific molecular entities, possibly novel compounds, salts, or derivatives with therapeutic relevance. Any claims centered on chemical structures are aimed at covering the compound itself, its salts, esters, or prodrugs.
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Method of Manufacturing or Use Claims:
These include procedures for synthesis, purification, or administration routes, securing broad protection over the commercial handling of the core compounds.
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Formulation Claims:
If the patent protects specific formulations (e.g., sustained-release, fixed-dose combinations), the claims specify ratios, excipients, or delivery mechanisms.
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Therapeutic Use Claims:
These claims delineate specific indications, such as certain diseases or conditions, likely targeting areas like diabetes, cancer, or infectious diseases, consistent with Zydus’s patent strategy.
Note: The scope of claims, especially in pharmaceuticals, hinges on structural specificity, therapeutic utility, or process innovation. Broad, composition-of-matter claims are most valuable but also more vulnerable to patent invalidation through prior art.
2. Claim Hierarchy and Strength
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Independent claims tend to be broad, emphasizing novel compounds or methods, serving as the primary patent defenses.
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Dependent claims specify particular embodiments, such as dosage forms, administration routes, or specific chemical substitutions, narrowing scope but offering fallback positions during litigation.
The breadth of the core claims suggests an intent to prevent generic manufacturers from producing similar compounds or formulations. Yet, the patent’s strength will depend on the degree of structural or functional uniqueness over prior art.
Patent Landscape Context
1. Competitive Patent Environment in South Korea
South Korea's pharmaceutical patent landscape is characterized by:
- High-density patenting, with a focus on chemical, biological, and formulation innovations.
- Strong patent filings by domestic and international pharma companies, especially in generics, biologics, and novel drug delivery systems.
- Rigorous patent examination, emphasizing inventive step and novelty, with a significant body of prior art from both Korean and international sources.
In this context, KR102135601 fits into Zydus Cadila’s strategic pursuit of protecting particular therapeutic compounds and their formulations, aligned with their broader pipeline in anti-infectives, oncology, and chronic disease.
2. Patent Family and Related Patents
KR102135601 likely belongs to a serial family, with counterparts filed in:
- International Patent Applications (PCT filings)
- Other jurisdictions such as India, USA, Europe, possibly China
This multi-jurisdiction strategy ensures comprehensive patent coverage, especially given South Korea's prominence in pharmaceutical innovation and manufacturing.
3. Potential Challenges and Patentability Concerns
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Prior Art Risks:
Chemical compounds or formulations similar to those claimed might exist in patent databases, scientific literature, or existing patents, potentially narrowing the scope or jeopardizing validity.
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Obviousness and Inventive Step:
If the molecule or process is a straightforward modification of prior art, patent strength could be questioned.
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Compulsory Licensing and Patent Life:
As patents expire or face compulsory licensing pressures, generic manufacturers might challenge the patent’s validity or design-around claims.
Innovative Aspects and Commercial Implications
The inventive core likely resides in:
- A specific chemical modification enhancing bioavailability, stability, or efficacy.
- A novel route of synthesis reducing costs or impurities.
- An optimized formulation providing sustained release or improved patient compliance.
Commercially, KR102135601 grants Zydus Cadila exclusive rights to market, license, or defend these innovations within South Korea. Its strategic importance grows if linked to high-value therapeutic areas such as oncology or chronic disease management.
Regulatory and Licensing Considerations
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Patent Term Extension:
South Korean patent law offers limited extensions; thus, timely commercialization is critical.
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Generic Entry:
Patent expiration, or potential judicial invalidation, provides opportunities for generics.
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Patent Litigation Risks:
Ongoing patent validity disputes or opposition proceedings can impact enforceability.
Key Takeaways
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Scope:
KR102135601 primarily covers specific chemical compounds, their synthesis, formulations, and therapeutic applications, with a focus on protecting novel molecules and delivery methods.
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Claims:
A mix of broad independent claims and narrower dependent claims embed protections against competitors, emphasizing structural novelty and industrial applicability.
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Patent Landscape:
This patent is part of a rigorous South Korean pharmaceutical patent environment, implying high thresholds for patentability but also significant strategic value for Zydus Cadila.
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Implications for Stakeholders:
Generics manufacturers must analyze the patent’s claims closely to identify potential workarounds. Innovators should continue to monitor related filings and opposition proceedings to secure enforceability and extend market exclusivity.
FAQs
1. What is the primary innovation protected by KR102135601?
The patent primarily protects a specific chemical entity, its derivatives, formulations, or methods of synthesis, aimed at therapeutic use. The novelty lies in structural modifications or formulation strategies that improve efficacy or manufacturability.
2. How does the scope of claims influence patent validity?
Broader claims provide extensive protection but require strong novelty and inventive step. Narrower claims are easier to defend but offer limited market control. The patent’s enforceability depends on the specificity of these claims vis-à-vis prior art.
3. How does KR102135601 compare to similar patents internationally?
It likely aligns with global filings in the same therapeutic area but varies in claim scope based on regional patent laws. A comprehensive freedom-to-operate analysis must consider this, particularly in markets like India, Europe, and the US.
4. Can competitors develop similar compounds without infringing this patent?
Potentially, if they design around the structural aspects covered by the claims or focus on different chemical classes or formulations, avoiding infringement.
5. What strategies should patent holders employ in South Korea?
Active monitoring of potential patent challenges, timely enforcement against infringers, and pursuing patent term extensions or new filings to maintain market exclusivity.
References
- South Korean Patent Office (KIPO): Official patent document and legal status.
- Patent Families and Filing Data: International patent databases.
- Zydus Cadila IP Portfolio: Public disclosures and company filings.
- South Korea Patent Law: Regulations on patentability, infringement, and extensions.
- Global Patent Classifications: CPC and IPC codes related to pharmaceuticals.
In conclusion, KR102135601 exemplifies a strategic patent positioning by Zydus Cadila, protecting specific innovations within South Korea’s competitive pharmaceutical landscape. Its scope directs future research, licensing, and litigation efforts, emphasizing the importance of comprehensive patent analysis in the dynamic biopharmaceutical sector.
