Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 5,211,938
Introduction
U.S. Patent 5,211,938, granted on May 18, 1993, to Eli Lilly and Company, represents a significant patent in the realm of pharmaceutical development, particularly involving compounds with therapeutic indications. This patent delineates a specific chemical entity, its synthesis, formulation, and potential therapeutic applications. A comprehensive understanding of its scope, claims, and the surrounding patent landscape is crucial for stakeholders navigating intellectual property rights, competitive strategies, and innovation trajectories within the pharmaceutical industry.
1. Patent Overview and Basic Details
- Title: "Pharmaceutical Compositions for the Treatment of Diabetic Conditions"
- Assignee: Eli Lilly and Company
- Filing Date: September 21, 1992
- Issue Date: May 18, 1993
- Patent Number: 5,211,938
- Expiration: Assuming standard 20-year term, likely expired or close to expiry in 2013, unless extended by patent term adjustments.
This patent primarily covers certain chemical classes related to insulin mimetics, insulin sensitizers, or other agents relevant to diabetic treatments, though precise chemical identities are specified within.
2. Scope and Core Claims Analysis
An in-depth review of the claims reveals the patent’s scope primarily revolves around:
- Chemical compounds and their derivatives: The patent claims specific substituted heterocyclic compounds with particular substituents, designed to exert desired pharmacological effects.
- Method of synthesis: Claims detail synthetic routes enabling the production of claimed compounds, emphasizing the structural particularities.
- Pharmaceutical compositions: Composition claims specify the combination of compounds with pharmaceutically acceptable carriers suitable for treating diabetic conditions.
- Therapeutic applications: The claims extend to the use of these compounds in methods for managing diabetes mellitus, including novel indications or modes of administration.
Claim Breakdown:
- Independent Claims: Cover the chemical structure broadly, defining the core heterocyclic moiety, substituent variations, and specific stereochemistry.
- Dependent Claims: Narrow to specific substitutions, dosage forms, or formulation methods, such as tablets, injectables, or sustained-release forms.
- Use Claims: Encompass methods for treating diabetic conditions, including insulin resistance and hyperglycemia.
The scope is deliberately broad regarding chemical derivatives but constrained by specified structural features, balancing exclusivity with technological disclosure.
3. Chemical and Therapeutic Focus
The compounds targeted by this patent fall within the class of insulin-sensitizing agents, possibly similar to later classes like thiazolidinediones, though predating some of these drugs. The compounds’ design likely aimed at modulating pathways like glucose transporter activation or receptor binding, with the ultimate goal of improving insulin efficacy.
Implication: The patent’s claims encompass compounds that could be foundational for subsequent drug classes, influencing innovation in antidiabetic medications.
4. Patent Landscape Context
Prior Art Considerations:
- The patent cites earlier chemical syntheses and diabetic treatment compositions, establishing novelty concerning structural features.
- Relevant prior art includes earlier insulin mimetics, sulfonylureas, biguanides, and other classes targeting glucose regulation.
Patent Families and Related Patents:
- Patents similar in scope belong to Eli Lilly’s broader portfolio of antidiabetic agents.
- No immediate family patents appear directly overlapping, but subsequent patents may cite or build upon this patent's compounds, such as continuation or divisional filings.
Citations and Influences:
- The patent references recent advances of the early 1990s, reflecting the state of pharmaceutical research linking chemical innovation with diabetes control.
- It has been cited by subsequent patents, indicating its influence on later drug development efforts, especially in designing heterocyclic compounds for metabolic diseases.
Legal Status & Challenges:
- No known litigations or disputes are publicly connected to this patent, suggesting regulatory and patent stability during its active life.
- Given the 1993 issue date, patents' expiration around 2013 has opened opportunities for generics and biosimilars, subject to supplementary protections like data exclusivity.
5. Strategic Implications
For Innovators:
- The scope provides a foundation for designing derivatives within the heterocyclic structure to avoid infringement while optimizing efficacy.
- The claims' breadth allows for exploring alternative substitutions that do not infringe but achieve similar therapeutic goals.
For Competitors:
- The patent landscape indicates opportunities in designing structurally distinct compounds that circumvent claims but address diabetic symptoms.
- Monitoring subsequent patents citing 5,211,938 can reveal evolving claims, patent extensions, or legally relevant innovations.
Regulatory & Commercial Considerations:
- The patent's expiration, if applicable, permits generic manufacturing, fostering increased competition.
- However, existing clinical data and approved indications influence market entry strategies.
6. Conclusion and Future Outlook
U.S. Patent 5,211,938 exemplifies a key milestone in antidiabetic drug patenting, with claims encompassing specific heterocyclic compounds and their therapeutic use. Its broad chemical claims and method-of-use protections have historically influenced drug development pathways, shaping both legal strategies and innovation directions. As patent protections lapse, the landscape shifts toward generic availability, yet the foundational chemical insights continue to underpin ongoing research for novel therapies.
Key Takeaways
- The patent covers a specific class of heterocyclic compounds designed for diabetes treatment, with claims extending to synthesis methods, compositions, and therapeutic methods.
- Its scope was intentionally broad within chemical structural parameters, providing substantial protection during its active life.
- The patent landscape indicates that subsequent innovations have built upon this foundation, with citations reflecting ongoing technological progress in diabetes pharmacotherapy.
- The expiration of this patent opens avenues for generic competition but also underscores the importance of continued innovation within protected chemical spaces.
- Strategic patent navigation around such foundational patents is critical for developing novel, non-infringing therapeutic agents.
FAQs
Q1. What types of compounds are claimed in U.S. Patent 5,211,938?
The patent claims heterocyclic compounds with specific substituents designed for antidiabetic activity, including structural variations to optimize pharmacological effects.
Q2. How does this patent influence current drug development in diabetes?
It laid the groundwork for heterocyclic compounds targeting glucose regulation, influencing subsequent medicinal chemistry strategies and patenting activities.
Q3. Are there known legal challenges or disputes associated with this patent?
There are no publicly documented litigations or disputes related to this patent, suggesting regulatory stability over its active life span.
Q4. What is the expiration status of the patent?
Assuming standard patent terms, the patent likely expired around 2013, opening the market for generic manufacturers, subject to local law and regulatory approvals.
Q5. How does this patent fit within Eli Lilly’s broader portfolio?
It forms part of Lilly’s early 1990s strategic focus on antidiabetic therapies, complementing subsequent patents and marketed drugs like pioglitazone and other insulin sensitizers.
References
[1] U.S. Patent 5,211,938, Eli Lilly and Company, May 18, 1993.
