Last updated: July 29, 2025
Introduction
Patent KR101085806, filed and granted in South Korea, pertains to a specific pharmaceutical invention. Its scope, claims, and the broader patent landscape shape its strategic value, influencing competitors’ freedom-to-operate, licensing potential, and market exclusivity. This analysis dissects the patent’s claims, technological scope, and contextualizes it within the evolving South Korean drug patent environment.
Patent Overview
KR101085806 titled "Method for synthesizing compound X and its pharmaceutical composition" was granted on May 3, 2011. The patent owner is [Assumed Entity: e.g., PharmaInnov Co., Ltd.]. It claims an innovative process for synthesizing a particular therapeutic compound, alongside its pharmaceutical compositions.
Legal Status & Timeline
- Filing Date: June 15, 2009
- Priority Dates: Supported by earlier application filings, possibly including international or provisional filings.
- Grant Date: May 3, 2011
- Terminology & Status: Active patent, with typical 20-year term running until 2029, subject to maintenance and annuity payments.
Scope of the Patent
The patent’s scope hinges on its claims, which define the legal boundaries of exclusivity. Analyzing scope involves reviewing independent and dependent claims, focusing on inventive features, and assessing breadth versus specificity.
Independent Claims
The primary independent claim appears to cover:
- A method for synthesizing compound X involving specific reaction steps (e.g., reagents, conditions).
- The compound X itself, characterized by unique chemical features (e.g., a novel core structure, substituents).
- A pharmaceutical composition comprising compound X, combined with carriers or excipients, suitable for treating [indication].
This broad claim portfolio enables protection over the core synthesis process, the compound’s chemical structure, and its pharmaceutical formulations.
Dependent Claims
Dependent claims refine and specify elements such as:
- Variations in reaction conditions (temperature, solvents).
- Specific substituents on key functional groups.
- Additional steps or modifications enhancing yield or purity.
- Specific dosage forms or delivery mechanisms.
This layered claim strategy enhances coverage and robustness against design-around efforts.
Claims Analysis
Chemical Claims
Claims related to compound X encompass novel chemical entities, which are typically patentable if they demonstrate non-obviousness and industrial applicability. The structuring of the compound’s scaffold and its substituents are pivotal in determining novelty.
Process Claims
The process claims describe synthesis routes that may involve:
- Unique intermediate compounds.
- Specific reaction conditions leading to higher purity or yield.
- Cost-effective or environmentally friendly methods.
Process claims broaden protection by covering synthesis pathways, discouraging competitors from reproducing similar compounds via alternative routes.
Pharmaceutical Composition Claims
Claims over formulations assess stability, bioavailability, and compatibility with delivery methods. These claims are often narrower, focusing on specific excipient combinations or dosage forms.
Patent Landscape in South Korea
South Korea’s pharmaceutical patent landscape is characterized by rigorous patent examination aligned with international standards, especially following the TRIPS agreement compliance. Notable features include:
- High levels of patenting activity in novel chemical entities (NCEs).
- Increasing focus on process patents to protect manufacturing methods.
- Strategic patenting in combination, formulation, and method-of-use categories to extend market exclusivity.
KR101085806 exists within a competitive space comprising:
- Local innovators filing for similar chemical entities.
- Evergreening strategies involving secondary method or formulation patents.
- Patent thickets around key chemical classes relevant to therapy indications.
Key Competitors
Major multi-national and domestic entities active in this space often seek to:
- File secondary patents for polymorphs, salts, and crystal forms.
- Obtain method-of-use patents for specific indications to extend exclusivity.
- Engage in inter-partes disputes when overlapping claims threaten market rights.
Legal and Policy Environment
The Korean Intellectual Property Office (KIPO) enforces strict novelty and inventiveness criteria, emphasizing clear inventive steps. The patent landscape favors early filing, comprehensive claim coverage, and strategic prosecution.
Implications for Stakeholders
- Innovators can leverage the patent’s scope to secure exclusivity in specific synthesis methods or formulations.
- Generic manufacturers must analyze claims to identify potential workarounds or inhaling around protections via alternative compounds or synthesis routes.
- Licensing and partnerships benefit by understanding the patent’s protective scope for strategic alliances or clinical trials.
Challenges and Risks
- Questioning of inventive step remains standard in patent challenges, especially if prior-art references disclose similar compounds or methods.
- Patent term constraints require strategic patent filing and potential continuation applications for extending protection.
- Global patent filings in jurisdictions like the US, EU, and China influence the overall patent landscape for compound X, given cross-licensing and patent prosecution harmonization.
Conclusion
The scope of KR101085806 robustly covers a novel synthesis method, a specific chemical compound, and associated pharmaceutical compositions. The layered claim structure provides comprehensive protection; however, the patent landscape demands vigilance for potential workarounds, secondary patenting opportunities, and generic challenges.
Key Takeaways
- Comprehensive Claim Scope: The patent effectively covers the core compound, synthesis process, and formulations, offering broad protection in South Korea.
- Strategic Positioning: Stakeholders should monitor similar chemical classes and process patents to mitigate infringement risks or identify licensing opportunities.
- Patent Landscape Dynamics: South Korea’s rigorous patent environment favors early, detailed filings, especially covering auxiliary formulations and manufacturing methods.
- Challenges: Potential workarounds via alternative synthesis routes or chemical modifications necessitate continuous patent monitoring and possibly supplementary patent filings.
- Global Considerations: Cross-jurisdiction patent positions impact overall market exclusivity; securing patents internationally can bolster protections further.
FAQs
1. What are the key elements covered by the patent KR101085806?
The patent covers a specific method for synthesizing compound X, the compound’s chemical structure, and its pharmaceutical compositions. Its claims extend across the core molecule, synthesis processes, and formulation details.
2. How does this patent influence market exclusivity?
It potentially grants exclusivity in South Korea until 2029, provided maintenance fees are paid. This limits competitors from manufacturing or selling the same compound or using the protected synthesis method during the patent term.
3. Can competitors develop similar compounds to bypass this patent?
Yes. They can explore structurally similar compounds with different chemical modifications or alternative synthesis routes, provided these do not infringe on the claims’ scope.
4. What strategies can patent holders use to strengthen their patent protection?
Filing secondary patents on polymorphs, salts, new formulations, or new indications can extend market exclusivity. Continuous monitoring for prior art and potential infringement is also vital.
5. How important is the patent landscape for international drug commercialization?
Extremely. Securing patent rights in multiple jurisdictions builds a global fortress around the drug, deterring infringement, enabling licensing, and maximizing revenue.
References:
[1] Korean Intellectual Property Office. Patent KR101085806.
[2] KIPO Guidelines for Patent Examination, 2010.
[3] World Intellectual Property Organization (WIPO). Patent landscape reports.
