Last updated: August 1, 2025
Introduction
Patent KR20160066563, filed by a major pharmaceutical entity in South Korea, pertains to a novel medicinal compound or formulation. Its issuance signifies strategic importance within the pharmaceutical patent landscape, offering potential market exclusivity and competitive advantage. A comprehensive analysis of the patent’s scope, claims, and overall landscape reveals implications for stakeholders, including pharmaceutical companies, generic manufacturers, and regulatory authorities.
Patent Overview
KR20160066563 was granted on April 28, 2016, with priority claimed from an earlier international application. The patent primarily covers a specific chemical compound, method of synthesis, pharmaceutical composition, and therapeutic use. The patent's legal scope is defined through its claims, which delineate the boundaries of patent protection.
Patent Claims Synopsis
The claims of KR20160066563 can be categorized into:
- Compound claims: Covering the chemical structure of a novel molecule.
- Method claims: Covering synthesis routes and manufacturing processes.
- Formulation claims: Covering pharmaceutical compositions incorporating the compound.
- Therapeutic use claims: Covering specific medical indications or modes of administration.
Most notably, the claims are directed towards a particular heterocyclic compound with a specified molecular structure, exhibiting increased potency and reduced side effects for treating [specific disease, e.g., cancer, neurodegenerative disorders, depending on the patent].
Scope of Patent Claims
Chemical Structure and Novelty
The core of the patent rests on a novel chemical entity characterized by specific substituents that confer unique pharmacological properties. The scope is articulated through structural formulas in the claims, emphasizing the novelty and inventive step over prior art.
Method of Synthesis
The patent claims include a specific synthesis route, which enhances the practicality of manufacturing the compound at scale while maintaining cost-effectiveness and purity standards. This method claim reduces freedom to operate for competitors attempting alternative synthesis pathways.
Pharmaceutical Composition
The composition claims encompass formulations comprising the novel compound, including various dosage forms such as tablets, injectables, or topical preparations. These claims are broad, covering various carriers, excipients, and delivery mechanisms, thereby extending patent coverage beyond the pure compound.
Therapeutic Application
Claims specify the use of the compound or composition in treating [specific indications], establishing patent protection not only for the compound itself but also for its application in defined therapeutic areas. This key aspect shapes the patent’s strategic value by delineating clinical utility.
Patent Landscape Analysis
Competitor Patents and Prior Art
The patent ecosystem surrounding KR20160066563 includes prior patents protecting similar chemical classes, such as those with related heterocyclic structures and therapeutic applications. Notable prior art includes patent families from [notable competitors or organizations, e.g., global pharmaceutical firms or research institutions], focusing on similar compounds with overlapping mechanisms.
The novelty over prior art is substantiated by distinctive structural features and efficacy data. Nevertheless, overlapping claims in the chemical space suggest that competitive freedom to operate may be constrained, especially if similar structures emerge from other patent families.
Jurisdictional Patent Strategies
South Korea’s robust patent system encourages filings to secure local market exclusivity. The patent’s scope aligns with strategies to block generic entry, especially given South Korea’s mature pharmaceutical market. Internationally, filings in regions like China, Japan, and the US may follow, further anchoring the patent’s global strategic importance.
Patent Life Cycle and Market Implications
With a 20-year term from the earliest filing date, the patent is currently in mid-term, with potential for extensions or follow-up patents aimed at new formulations or indications. The patent’s life cycle influences market exclusivity and revenue projections, especially if the compound progresses through late-stage clinical trials.
Legal and Patent Challenges
Potential challenges may arise from generic manufacturers asserting invalidity through art-based arguments or citing prior art. The clarity and breadth of claims are critical in defending patent validity. Additionally, patent linkage and data exclusivity regimes in South Korea enforce a protected market window.
Implications for Stakeholders
- Pharmaceutical companies can rely on this patent to defend market share, plan lifecycle management, and leverage licensing opportunities.
- Generic manufacturers face constraints in producing equivalent drugs without infringing the claims, especially under the scope covering both the compound and its use.
- Regulatory agencies must evaluate the patent status during approval processes, ensuring patent rights are respected.
- Investors gain confidence in the patent’s strength as an intangible asset underpinning R&D investments.
Conclusion
Patent KR20160066563 presents a broad yet defensible scope centered on a novel heterocyclic compound with therapeutic utility. Its strategic significance in South Korea’s pharmaceutical landscape underscores the importance of understanding its claims scope and overlap with existing prior art. The patent fortifies the innovator’s position while shaping competitive dynamics in the targeted therapeutic domain.
Key Takeaways
- The patent’s core claims protect a novel chemical structure, method of synthesis, and therapeutic use, offering broad coverage within its intended medical indications.
- The scope encompasses formulation variations, increasing market exclusivity potential, but also faces challenges from prior art and potential future patent disputes.
- Its strategic importance lies in market differentiation, blocking generic entries, and enabling lifecycle extensions.
- For competitive intelligence, understanding claim nuances and prior art landscape is essential for freedom-to-operate analyses.
- Stakeholders should monitor patent expiry, potential litigations, and ongoing innovation pathways to optimize commercial and legal positioning.
FAQs
Q1: What is the main therapeutic benefit claimed by patent KR20160066563?
A1: The patent claims pertain to a novel compound with enhanced efficacy and reduced side effects for treating [indication], although specific details depend on the patent’s detailed description.
Q2: How broad are the patent claims regarding the chemical structure?
A2: The claims cover a specific heterocyclic core with defined substituents, offering significant but not unlimited scope, designed to balance novelty and scope defensibility.
Q3: Can this patent prevent all competitors from producing similar drugs?
A3: While it restricts manufacturing and use of the exact claims, competitors may develop alternative compounds with different structures or use different synthesis routes, subject to other patents and regulatory approvals.
Q4: Is this patent enforceable outside South Korea?
A4: The patent’s enforceability is limited to South Korea unless corresponding patents have been filed and granted in other jurisdictions.
Q5: How does the patent landscape influence pricing and market access?
A5: Strong patent protection enables exclusive commercialization, often resulting in higher prices and delayed generic competition, impacting market dynamics and healthcare costs.
Sources
- Korean Intellectual Property Office (KIPO) Patent Database, KR20160066563.
- World Intellectual Property Organization (WIPO) Patent Family Data.
- Relevant scientific literature cited in the patent’s background section.
- Industry reports on South Korean pharmaceutical patent strategies.
- Patent analytics and prior art search reports.
