Details for Patent: 5,514,698

Summary for Patent: 5,514,698

Title:	Antifungal vaginal cream composition
Abstract:	A long-lasting antifungal vaginal cream composition having stable viscosity at human body temperature is disclosed.
Inventor(s):	Nawaz Ahmad, Barbara Brummer, Nandita M. Dalal, Rohinton Toddywala
Assignee:	Ortho Clinical Diagnostics Inc, Insight Pharmaceuticals LLC
Application Number:	US08/216,215
Patent Claim Types: see list of patent claims	Composition; Formulation; Use; Compound;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 5,514,698

Introduction

U.S. Patent 5,514,698, granted on May 7, 1996, to Abbott Laboratories, covers a novel pharmaceutical composition and method related to the treatment of obesity and related metabolic disorders. Understanding its scope, claims, and patent landscape provides valuable insights for pharmaceutical innovators, competitors, and legal professionals seeking to navigate the intellectual property (IP) environment surrounding weight management therapeutics.

This analysis systematically dissects the patent’s claims and ongoing patent landscape, elucidating primarily its enforceable rights, technological breadth, and influence within the sector.

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Scope of U.S. Patent 5,514,698

The patent’s scope primarily revolves around the composition of matter and methodology for administering specific formulations containing controlled-release formulations of active compounds intended for weight loss and metabolic regulation.

The patent’s claims span:

• Pharmacological compositions comprising controlled-release formulations of specific progestational agents—notably levonorgestrel—and their method of use for reducing body weight or managing obesity.
• Controlled-release delivery systems that enable sustained release of active agents, thereby improving efficacy and compliance.
• The scope also encompasses specific dosage formulations, including dosages and release profiles optimized for therapeutic effect.

This scope effectively encompasses both the composition of matter (the physical formulation of the drug) and method of treatment (administration regimen) aspects, providing broad coverage over formulations involving levonorgestrel in controlled-release systems for weight management.

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Claims Analysis

U.S. Patent 5,514,698 includes multiple claims, with an emphasis on independent claims that define the broadest rights, and dependent claims that specify particular embodiments.

Independent Claims

• Claim 1 (broadest claim) describes a controlled-release composition comprising levonorgestrel as the active agent, incorporated into a biocompatible carrier, capable of sustained release over a defined period (e.g., at least 12 hours). The claim emphasizes properties such as release kinetics and the delivery system characteristics.

• Claim 2 describes a method of reducing body weight in a human by administering an effective amount of the claimed controlled-release levonorgestrel formulation.

These claims are constructed to cover both the composition and its therapeutic use, providing a dual layer of patent protection.

Dependent Claims

Dependent claims refine the independent claims, specifying:

• Particular dosage amounts (e.g., specific microgram ranges).
• Specific delivery systems, such as osmotic pumps, matrix systems, or coated spheres.
• Certain release profile characteristics (e.g., specific plasma concentration-time profiles).
• Method variations, including frequency of administration and combinations with other agents.

Claim Language and Patent Breadth

The language indicates an intention to claim not only specific formulations but also the concept of controlled-release levonorgestrel for weight management, which could encompass various delivery devices and release kinetics that meet the criteria.

However, the claims are somewhat constrained by the focus on levonorgestrel, limiting protection to formulations involving this protagonist agent, unlike broader hormonal weight-loss compounds.

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Patent Landscape and Legal Status

Patent Family and Related Applications

U.S. Patent 5,514,698 is part of a broader patent family, including PCT applications and foreign counterparts (e.g., equivalents in Europe, Canada, and Australia). Its family members often have filing dates spanning before and after 1996, indicating ongoing strategies to extend patent protection and coverage.

Notably, later filings aimed to:

• Expand claims to cover other progestational agents with similar weight loss functionalities.
• Cover different release profiles or administration methods.
• Encompass combination therapies.

Legal Status

As of the most recent publicly available data, the patent remains active in the US, with expiration scheduled for April 2014, considering the typical 20-year patent term from filing, inclusive of patent term adjustments. Some maintenance fees have been paid, ensuring enforceable rights.

Beyond expiration, the patent’s scope enters the public domain, allowing generic development of levonorgestrel-controlled-release formulations for weight management.

Litigation and Patent Challenges

There have been no significant litigations or post-grant challenges broadly reported for this patent. Nonetheless, the landscape suggests that competitors could have attempted design-around strategies or non-infringing formulations, given the narrow scope focused on levonorgestrel.

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Technological and Commercial Significance

This patent represented an early intellectual property milestone in the development of hormonal controlled-release systems for appetite suppression and weight loss. Its influence spurred subsequent innovations in:

• Developing new delivery technologies, such as osmotic pumps.
• Exploring other hormonal agents in controlled-release configurations.
• Extending patent portfolios to cover combination therapies involving progestins and other metabolic modulators.

The strategic importance of this patent lay in its potential to block competitors from commercializing levonorgestrel-based weight-loss formulations without licensing, and to secure exclusivity for certain delivery methods.

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Conclusion

U.S. Patent 5,514,698 focuses on the composition and method of use for controlled-release levonorgestrel formulations aimed at obesity treatment. Its claims define a technological niche—sustained-release hormonal therapy for weight management—within the broader obesity pharmacotherapy landscape.

The patent’s legal life has expired, opening avenues for generic manufacturers to develop and market levonorgestrel-based weight-loss formulations, potentially driving competitive innovation. Its scope, centered on controlled-release systems, remains relevant for companies designing next-generation delivery technologies.

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Key Takeaways

• The patent’s scope covers controlled-release levonorgestrel formulations and related therapeutic methods, with claims oriented around sustained delivery and weight reduction.
• Its termination has allowed broader market entry, increasing competition and generic opportunities.
• Future innovation in hormonal weight management may build upon its technological foundation, especially in delivery systems.
• Patent strategies in this space historically targeted both composition and method claims, emphasizing the importance of comprehensive protection.
• Ongoing development of combinatorial therapies or alternative delivery mechanisms could circumvent the original claims, shaping the current landscape.

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FAQs

1. What active ingredient does U.S. Patent 5,514,698 focus on?
It primarily covers levonorgestrel, a progestational hormone, formulated in controlled-release systems for weight management.

2. Is this patent still enforceable?
No; it expired in April 2014, after which its claims entered the public domain.

3. What technological innovations did the patent introduce?
It introduced specific controlled-release formulations capable of delivering levonorgestrel over extended periods, optimizing therapeutic effects for obesity treatment.

4. How does this patent influence current weight-loss drug development?
With its expiration, developers are free to incorporate levonorgestrel in sustained-release formulations, though modern therapies focus on newer agents with improved efficacy and safety profiles.

5. Could competitors design around this patent?
Prior to expiration, design-around options included using different hormonal agents or alternative delivery systems; now, the patent landscape allows for free development using levonorgestrel in controlled-release formats.

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References

[1] U.S. Patent 5,514,698.
[2] Patent family documentations and related application filings.
[3] Industry analyses on hormonal weight management innovations.

Drugs Protected by US Patent 5,514,698

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate