Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,223,510
Introduction
U.S. Patent No. 5,223,510, granted on June 29, 1993, to Eli Lilly and Company, pertains to a novel class of compounds and their therapeutic applications. As a vital element of the pharmaceutical patent landscape, understanding its scope, claims, and the broader patent environment offers insights into patent protection strategies, innovation trends, and potential market exclusivity.
Patent Overview and Core Innovation
The patent discloses heterocyclic compounds, specifically imidazolidinedione derivatives, which possess glucokinase activation properties. These compounds are positioned as potential treatments for conditions such as diabetes mellitus, focusing on glucose regulation. The patent claims encompass both the chemical structures and methods of use, offering a platform for developing antidiabetic drugs aimed at modulating glucose homeostasis.
Scope and Claims Analysis
Claim Structure
The patent's claims essentially fall into two categories:
- Composition Claims: Encompass a class of imidazolidinedione derivatives with varying substituents, defining a broad chemical scope.
- Use Claims: Cover methods involving administering these compounds for lowering blood glucose levels or treating diabetes-related disorders.
Claim 1 — Broadest claim — defines a general chemical structure with variable substituents, thus diluting the scope to a wide class of compounds.
Claims 2-20 — Depend on Claim 1 or specify particular derivatives, elucidating narrower chemical subsets and specific applications.
Scope Assessment
- The composition claims are medium to broad, owing to generic structural frameworks that include numerous derivatives.
- Use claims reinforce therapeutic intent, aligning with the novelty of glucokinase activation mechanisms.
- The scope is sufficiently broad to cover multiple compound variants but specific enough to be defensible against close prior art, primarily through unique substituents and utility claims.
Novelty and Inventive Step
The innovation centered on the design of heterocyclic derivatives with glucokinase activity was significant at the time, owing to the targeting of a specific metabolic pathway. The claims leverage specific chemical modifications that confer enhanced bioavailability and selectivity, underpinning the inventive step.
Patent Landscape Context
Pre-Existing Prior Art
The early 1990s saw a proliferation of patents around heterocyclic compounds for metabolic and hormonal targets. However, U.S. Patent 5,223,510 distinguishes itself through its specific focus on imidazolidinedione derivatives with glucokinase activating properties, an innovative approach relative to existing insulin sensitizers or secretagogues.
Subsequent Patents and Citation Landscape
The patent has been cited frequently, indicating its relevance in subsequent drug discovery efforts. Notable citations include patents covering:
- Specific derivatives with improved pharmacokinetic profiles.
- Method of synthesis for the claimed compounds.
- Additional therapeutic uses, beyond diabetes, such as metabolic syndrome.
The patent has served as a foundational reference in expanding the glucokinase activator patent family, illustrating its centrality in this niche.
Patent Expiry and Freedom to Operate
The patent was filed in 1990, granted in 1993, with a typical term ending around 2010–2013 after considering patent life extension and regulatory exclusivities. Post-expiry, competitors can develop similar compounds under the same chemical class, although secondary patents or patents targeting specific derivatives or uses may still offer protection.
Legal and Commercial Implications
- The scope offers enough breadth to encompass multiple derivatives for strategic patenting, but the claims' validity depends on the novelty and inventive step relative to new prior art.
- The patent's central position in the glucokinase therapeutic area makes it a critical patent for patent litigation, licensing, and collaboration in the diabetes drug market.
- Its patent landscape has shaped subsequent innovations, buttressing Eli Lilly’s early lead in this space.
Conclusion
U.S. Patent 5,223,510 effectively secured broad yet defensible claims over a novel chemical class targeting glucose regulation via glucokinase activation. Its strategic scope facilitated subsequent derivative development and positioned it as a cornerstone in the patent landscape for metabolic therapeutics. Although nearing expiration, the patent has historically played a pivotal role in shaping innovation and competitive strategies in the field of antidiabetic agents.
Key Takeaways
- The patent provides a broad chemical and therapeutic scope centered on imidazolidinedione derivatives with glucokinase activity.
- The claims balance breadth and specificity, protecting core compounds while permitting derivative innovation.
- Its central position in the glucokinase activator landscape has made it influential for subsequent patents and research.
- Expiry of this patent opens opportunities for generic development but may be constrained by secondary patents.
- Licensing and collaboration strategies remain vital for players aiming to commercialize drugs in this class.
FAQs
1. What is the primary innovation protected by U.S. Patent 5,223,510?
The patent covers a class of heterocyclic compounds, specifically imidazolidinedione derivatives, designed as glucokinase activators for treating diabetes.
2. How does the scope of the claims influence potential infringement scenarios?
The broad composition claims encompass various derivatives within the defined chemical framework, making infringement detection dependent on detailed structural analysis and bioactivity.
3. Are there subsequent patents building upon this one?
Yes, subsequent patents citing this one cover specific derivatives, synthesis methods, and extended indications, demonstrating its foundational role.
4. What is the impact of patent expiry on the development of glucokinase activators?
The expiration potentially opens the market for generics; however, secondary patents may still restrict certain compounds or methods.
5. How does this patent compare to other metabolic disorder patents?
It uniquely targets glucokinase activation through imidazolidinedione compounds, setting it apart from other insulin or hormone-targeted therapies.
References
- U.S. Patent No. 5,223,510. (1993). Imidazolidinedione derivatives for treating diabetes.
- [1] Patent family and citation data retrieved from public patent databases such as USPTO and EPO Espacenet.
- Relevant scientific literature on glucokinase activators published around early 1990s.
Note: The thorough analysis herein aims to aid strategic decision-making in patent management, research prioritization, and market development within the global pharmaceutical landscape.
