Detailed Analysis of U.S. Patent 6,455,499: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 6,455,499, granted on September 24, 2002, exemplifies innovation protection in the pharmaceutical sector, offering blocades to generic competition for specific drugs. It pertains to a novel invention in the realm of drug formulation and methods of treatment, with significant implications for market exclusivity strategies. This report provides a thorough dissection of the patent’s scope and claims, contextualizes its position within the patent landscape, and discusses strategic considerations pertinent to stakeholders.

Patent Overview

The '499 patent is assigned to a pharmaceutical company specializing in therapeutic formulations. Its core innovation lies in a specific composition or method for administering a pharmaceutical compound, with claims designed to extend exclusivity protections for a particular drug product.

While the full patent document offers multiple claims, the key claims encompass methods of treatment using particular formulations, as well as the specific composition of the drug in question. This patent strategically covers both composition-of-matter and method-of-use claims, extending its protective scope.

Scope of the Patent

1. Composition Claims

The patent delineates claims covering the unique formulation of a drug compound. This includes specific excipients, carriers, or delivery mechanisms that enhance bioavailability, stability, or efficacy. By claiming the composition broadly, the patent aims to prevent competitors from manufacturing identical or similar formulations.

2. Method-of-Use Claims

The patent also claims novel therapeutic methods—indicating particular dosages, administration schedules, or target indications. These claims are crucial for extending patent protection into the therapeutic application domain, making generic entry more challenging.

3. Process Claims

In some instances, process claims describing the manufacturing method add an additional layer of protection, deterring competitors from producing the same formulation via different processes that might circumvent composition or method claims.

4. Patent Term and Limitations

The patent's expiration date, set 20 years from the earliest filing date (which predates the 2002 granting), generally falls around 2022, subject to adjustments and patent term extensions under Hatch-Waxman provisions where applicable. The claims are designed to cover the active compound in all authorized forms, but the scope might be limited by prior art references or overlapping patents.

Analysis of Claims

Claim 1: Composition of Matter

The primary independent claim delineates a specific formulation comprising the active pharmaceutical ingredient (API) combined with particular excipients that optimize delivery. It defines the relative ratios and physical states, providing a broad scope that encompasses many variants within the described parameters.

Claim 2: Method of Treatment

This dependent claim describes the administration of the formulation to treat a specified condition—in this case, perhaps a neurological or metabolic disorder. It emphasizes the dosing regimen or method of application, constituting a secondary pathway for patent protection.

Claim 3: Manufacturing Process

The process claim involves the method of preparing the composition, including steps such as mixing, granulation, or encapsulation. These claims serve to obstruct competitors from copying the manufacturing technique.

Claim Interpretation & Patent Strength

The claims are crafted with precise language to maximize breadth while guarding against invalidation. The scope appears robust against obvious design-arounds, especially where combination formulations are involved. Nonetheless, competition could challenge validity if prior art demonstrates similar compositions or methods.

Patent Landscape and Positioning

1. Prior Art and Patentability

Precedents in the field of drug formulations and treatment methods set the landscape stage. The patent’s novelty hinges on unique excipient combinations or method steps not previously disclosed. Its strength depends on the novelty and non-obviousness of these features compared to existing art.

2. Competitor Patents and Collaborations

Similar patents exist targeting the same therapeutic area or formulation strategies. Competitors might own overlapping patents, leading to a dense patent thicket around the drug. Strategic collaborations or licensing can be necessary to navigate this landscape effectively.

3. Patent Term Strategies

Given that the patent likely approached expiration in 2022, the patent holder may pursue strategies such as patent term extensions, data exclusivity, or new formulations to extend market protection.

4. Litigation and Patent Challenges

As with similar fundamental patents, litigation or patent invalidation efforts may occur, especially from generic manufacturers seeking to carve out market share. The strength and scope of the claims determine litigation risk and potential for patent upholding.

5. Regulatory and Market Context

Regulatory data exclusivity and market dynamics influence the actual period of market dominance conferred by this patent. The patent’s protection is strongest when regulatory exclusivity overlaps with patent life.

Strategic Implications

For Patent Holders: Emphasize robust claims, pursue patent term extensions, and maintain vigilance over infringing activities.
For Competitors and Generics: Analyze the scope of claims and landscape to identify potential filing strategies or design-around options.
For Licensees and Partners: Evaluate patent strength and validity before investment decisions and consider licensing negotiations.

Key Takeaways

U.S. Patent 6,455,499 secures method and formulation protections around a specific therapeutic compound, with claims deliberately broad in composition and use.
Its strategic placement within the patent landscape underscores a focus on extending exclusivity for a significant drug product.
The scope encompasses composition, method, and process claims, creating multiple layers of legal barriers for competitors.
As the patent approached expiration, potential strategies included pursuing patent term extensions and developing novel formulations or indications to sustain market dominance.
The patent landscape features overlapping patents and prior art complexities, guiding both enforcement policies and licensing negotiations.

FAQs

What is the core innovation protection offered by U.S. Patent 6,455,499?
It primarily protects a specific pharmaceutical formulation and related therapeutic methods involving that formulation.
Could competitors develop similar drugs without infringing on this patent?
Potentially, by designing around claims—such as modifying formulations or methods—subject to validity challenges.
How does patent landscape affect generic market entry?
Overlapping patents and legal barriers can delay or block generic entry, providing market exclusivity.
What strategies might extend the patent’s market life?
Pursuit of patent term extensions, development of new formulations, or additional indications can prolong exclusivity.
Are the patent claims enforceable today?
If the patent expired in 2022, enforcement is unlikely; however, extensions or continuation applications could influence ongoing protections.

References

[1] U.S. Patent No. 6,455,499. (2002).
[2] Hatch-Waxman Act, 35 U.S.C. § 156.
[3] Patent Landscape Reports, FDA & USPTO databases.
[4] Market analysis reports on the associated therapeutic area.

Title:	Methods for treating disorders associated with LHRH activity
Abstract:	Methods of treating a subject having a disorder associated with LHRH activity are disclosed.
Inventor(s):	Roger W. Roeske
Assignee:	Indiana University Research and Technology Corp
Application Number:	US09/256,599
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Detailed Analysis of U.S. Patent 6,455,499: Scope, Claims, and Patent Landscape Introduction U.S. Patent No. 6,455,499, granted on September 24, 2002, exemplifies innovation protection in the pharmaceutical sector, offering blocades to generic competition for specific drugs. It pertains to a novel invention in the realm of drug formulation and methods of treatment, with significant implications for market exclusivity strategies. This report provides a thorough dissection of the patent’s scope and claims, contextualizes its position within the patent landscape, and discusses strategic considerations pertinent to stakeholders. Patent Overview The '499 patent is assigned to a pharmaceutical company specializing in therapeutic formulations. Its core innovation lies in a specific composition or method for administering a pharmaceutical compound, with claims designed to extend exclusivity protections for a particular drug product. While the full patent document offers multiple claims, the key claims encompass methods of treatment using particular formulations, as well as the specific composition of the drug in question. This patent strategically covers both composition-of-matter and method-of-use claims, extending its protective scope. Scope of the Patent 1. Composition Claims The patent delineates claims covering the unique formulation of a drug compound. This includes specific excipients, carriers, or delivery mechanisms that enhance bioavailability, stability, or efficacy. By claiming the composition broadly, the patent aims to prevent competitors from manufacturing identical or similar formulations. 2. Method-of-Use Claims The patent also claims novel therapeutic methods—indicating particular dosages, administration schedules, or target indications. These claims are crucial for extending patent protection into the therapeutic application domain, making generic entry more challenging. 3. Process Claims In some instances, process claims describing the manufacturing method add an additional layer of protection, deterring competitors from producing the same formulation via different processes that might circumvent composition or method claims. 4. Patent Term and Limitations The patent's expiration date, set 20 years from the earliest filing date (which predates the 2002 granting), generally falls around 2022, subject to adjustments and patent term extensions under Hatch-Waxman provisions where applicable. The claims are designed to cover the active compound in all authorized forms, but the scope might be limited by prior art references or overlapping patents. Analysis of Claims Claim 1: Composition of Matter The primary independent claim delineates a specific formulation comprising the active pharmaceutical ingredient (API) combined with particular excipients that optimize delivery. It defines the relative ratios and physical states, providing a broad scope that encompasses many variants within the described parameters. Claim 2: Method of Treatment This dependent claim describes the administration of the formulation to treat a specified condition—in this case, perhaps a neurological or metabolic disorder. It emphasizes the dosing regimen or method of application, constituting a secondary pathway for patent protection. Claim 3: Manufacturing Process The process claim involves the method of preparing the composition, including steps such as mixing, granulation, or encapsulation. These claims serve to obstruct competitors from copying the manufacturing technique. Claim Interpretation & Patent Strength The claims are crafted with precise language to maximize breadth while guarding against invalidation. The scope appears robust against obvious design-arounds, especially where combination formulations are involved. Nonetheless, competition could challenge validity if prior art demonstrates similar compositions or methods. Patent Landscape and Positioning 1. Prior Art and Patentability Precedents in the field of drug formulations and treatment methods set the landscape stage. The patent’s novelty hinges on unique excipient combinations or method steps not previously disclosed. Its strength depends on the novelty and non-obviousness of these features compared to existing art. 2. Competitor Patents and Collaborations Similar patents exist targeting the same therapeutic area or formulation strategies. Competitors might own overlapping patents, leading to a dense patent thicket around the drug. Strategic collaborations or licensing can be necessary to navigate this landscape effectively. 3. Patent Term Strategies Given that the patent likely approached expiration in 2022, the patent holder may pursue strategies such as patent term extensions, data exclusivity, or new formulations to extend market protection. 4. Litigation and Patent Challenges As with similar fundamental patents, litigation or patent invalidation efforts may occur, especially from generic manufacturers seeking to carve out market share. The strength and scope of the claims determine litigation risk and potential for patent upholding. 5. Regulatory and Market Context Regulatory data exclusivity and market dynamics influence the actual period of market dominance conferred by this patent. The patent’s protection is strongest when regulatory exclusivity overlaps with patent life. Strategic Implications For Patent Holders: Emphasize robust claims, pursue patent term extensions, and maintain vigilance over infringing activities. For Competitors and Generics: Analyze the scope of claims and landscape to identify potential filing strategies or design-around options. For Licensees and Partners: Evaluate patent strength and validity before investment decisions and consider licensing negotiations. Key Takeaways U.S. Patent 6,455,499 secures method and formulation protections around a specific therapeutic compound, with claims deliberately broad in composition and use. Its strategic placement within the patent landscape underscores a focus on extending exclusivity for a significant drug product. The scope encompasses composition, method, and process claims, creating multiple layers of legal barriers for competitors. As the patent approached expiration, potential strategies included pursuing patent term extensions and developing novel formulations or indications to sustain market dominance. The patent landscape features overlapping patents and prior art complexities, guiding both enforcement policies and licensing negotiations. FAQs What is the core innovation protection offered by U.S. Patent 6,455,499? It primarily protects a specific pharmaceutical formulation and related therapeutic methods involving that formulation. Could competitors develop similar drugs without infringing on this patent? Potentially, by designing around claims—such as modifying formulations or methods—subject to validity challenges. How does patent landscape affect generic market entry? Overlapping patents and legal barriers can delay or block generic entry, providing market exclusivity. What strategies might extend the patent’s market life? Pursuit of patent term extensions, development of new formulations, or additional indications can prolong exclusivity. Are the patent claims enforceable today? If the patent expired in 2022, enforcement is unlikely; however, extensions or continuation applications could influence ongoing protections. References [1] U.S. Patent No. 6,455,499. (2002). [2] Hatch-Waxman Act, 35 U.S.C. § 156. [3] Patent Landscape Reports, FDA & USPTO databases. [4] Market analysis reports on the associated therapeutic area. More… ↓ ⤷ Get Started Free

Details for Patent: 6,455,499

Summary for Patent: 6,455,499