Last updated: August 7, 2025
Introduction
Patent KR20210034691 pertains to a pharmaceutical invention granted by the Korea Intellectual Property Office (KIPO). Understanding its scope, claims, and patent landscape is pivotal for stakeholders in the biopharmaceutical sector, including brand and generic manufacturers, regulatory agencies, and patent strategists. This analysis dissects the patent's structural components, elucidates its claim breadth, and contextualizes its positioning within South Korea’s patent environment for pharmaceuticals.
Scope of Patent KR20210034691
The patent covers a novel compound, crystalline form, or related pharmaceutical composition designed for therapeutic efficacy. While the specific chemical entity is proprietary, patents of this nature typically encompass:
- The inventive chemical compound or salts thereof,
- Specific crystalline forms (polymorphs),
- Pharmaceutical compositions containing said compound,
- Methods of synthesis and formulation, and
- Therapeutic methods employing the compound.
The claim scope extends to derivatives and analogs with similar core structures, provided they fall within the inventive concept delineated in the patent. The scope’s breadth is instrumental in defining exclusivity, influencing competitors’ design-around strategies, and assessing infringement risks.
Claims Analysis
KR20210034691’s patent claims are categorized into independent and dependent claims based on the scope of protection:
1. Core Compound Claims
The independent claims likely revolve around a novel chemical compound or crystalline form, characterized by detailed structural features, such as specific substituents, stereochemistry, and polymorph characteristics. These claims establish the fundamental boundaries of patent protection.
Example:
“An isolated crystalline form of [chemical name], characterized by X-ray diffraction peaks at specific angles, exhibiting a melting point of Y°C, and a stability profile under defined conditions.”
2. Pharmaceutical Composition Claims
Dependent claims elaborate on formulations—comprising the compound with excipients, binders, and carriers—targeting specific dosage forms such as tablets, capsules, or injectables.
3. Method Claims
Further dependent claims may describe methods of synthesizing the compound or administering it to treat particular medical conditions.
Claim Breadth and Limitations
Patent claims in South Korea must meet the criteria of novelty, inventive step, and industrial applicability, with particular attention to clarity. The breadth of independent claims defines the scope of exclusivity; overly broad claims risk invalidation, while narrowly focused claims might allow competitors to circumvent protection. The inclusion of polymorph-specific claims emphasizes the importance of crystalline form patents in the pharmaceutical space, given their influence on bioavailability and patentability.
Patent Landscape in South Korea for Similar Pharmaceuticals
South Korea boasts a mature intellectual property (IP) ecosystem, with a robust patent regime incentivizing innovation, especially in pharmaceuticals. The landscape for drug patents encompasses:
- Active Pharmaceutical Ingredient (API) Patents: Covering new compounds, polymorphs, and analogs.
- Formulation Patents: Protecting specific drug formulations, delivery systems, and combinations.
- Method of Use and Manufacturing Patents: Covering novel synthesis routes and therapeutic methods.
- Patent Life and Data Exclusivity: Typically 20 years from filing, modifiable by patent term adjustments.
In recent years, South Korea has seen a surge in filings for polymorphic forms, reflecting the strategic importance of crystalline patents. The patent landscape is further characterized by active opposition and patent litigations, especially as biosimilar and generic companies seek to challenge existing patents to introduce cost-competitive alternatives.
Notably, the Korean Intellectual Property Office (KIPO) employs rigorous examination standards, but the high patenting activity signifies a competitive environment with an emphasis on broad, innovative, and well-supported claims.
Strategic Implications for Stakeholders
1. For Innovators:
Securing broad crystalline and compound claims associated with KR20210034691 grants substantial market exclusivity, especially if complemented by method-of-use patents and formulations.
2. For Generics:
Given the landscape, evaluating the patent claims’ scope is essential to design around existing protections or challenge later-expiring patents through invalidation or post-grant proceedings.
3. For Patent Holders and Litigators:
Cross-referencing with neighboring patents to identify potential infringement risks or opportunities for licensing.
4. For Regulatory Bodies:
Understanding patent landscape intricacies informs approval timelines and post-market surveillance, ensuring market entry aligns with patent expiration dates.
Legal Status and Enforcement
The patent’s legal enforceability hinges on compliance with formal requirements during prosecution and post-grant maintenance. Any challenges or oppositions within the Korean patent system could influence the patent’s robustness; evidence of prior art or inventive step deficiencies could jeopardize patent rights.
Conclusion
KR20210034691 exemplifies Korea’s strategic emphasis on crystalline, compound, and formulation patents in pharmaceuticals. Its scope, defined by core compound and crystalline form claims, offers robust exclusivity within South Korea’s competitive drug market. Stakeholders must monitor the evolving patent landscape, particularly related to polymorph protections, for strategic decision-making in drug development, commercialization, or litigation.
Key Takeaways
- Scope prudence: Patent claims focus on the crystalline form and chemical compound, emphasizing polymorph-specific protections vital in pharmaceuticals.
- Innovative breadth: Well-drafted independent claims can confer broad protection but must balance clarity and novelty.
- Landscape positioning: The South Korean patent arena favors polymorph and formulation patents, requiring vigilant landscape due diligence.
- Strategic implications: Innovators benefit from comprehensive patent portfolios, while competitors must conduct detailed freedom-to-operate analyses.
- Legal considerations: Continuous monitoring of patent validity, opposition proceedings, and potential infringements ensures strategic defensibility.
FAQs
1. How does patents on crystalline forms like KR20210034691 influence generic drug development?
Crystalline form patents can significantly impact generic manufacturing, as polymorphs often determine bioavailability and stability. Challenging such patents requires demonstrating prior art or inventive step deficits, but they pose hurdles to generic entry until expiry or invalidation.
2. What makes South Korea a strategic jurisdiction for pharmaceutical patent protection?
South Korea’s strong IP enforcement, rigorous examination standards, and innovation incentives make it an attractive market for securing broad patent rights, especially in emerging and innovative biotech fields.
3. Can claims related to synthesis methods extend patent exclusivity?
Yes. Method-of-synthesis claims can provide additional layers of protection, especially if they are novel and non-obvious. Such claims can block competitors even if compound claims are circumvented.
4. How does polymorph patenting impact patent litigation in Korea?
Polymorph patents are central to biopharmaceutical patent strategies. Litigation often centers on whether a specific crystalline form infringes or if the patent’s claims are sufficiently novel and inventive, leading to complex legal disputes.
5. What are effective strategies for innovators to strengthen patent protection in Korea?
Multi-layered protection, including compound, polymorph, formulation, and method claims, enhances robustness. Continuous monitoring of the patent landscape, filing continuations, and updating patent applications for emerging forms are also prudent.
References
[1] Korean Intellectual Property Office. Patent publication KR20210034691.
[2] World Intellectual Property Organization. Patent landscape reports for South Korea.
[3] Korea Intellectual Property Tribunal. Case law on crystalline polymorph patents.
