Analysis of U.S. Patent 5,562,925: Scope, Claims, and Patent Landscape

Introduction

United States Patent 5,562,925, granted on October 8, 1996, to Merck & Co., Inc., pertains to pharmaceutical formulations and methods related to the treatment of disease. This patent exemplifies significant advancements in drug formulation technology, with particular emphasis on compound delivery systems. Understanding its scope, claims, and place within the broader patent landscape provides insights into its influence on subsequent innovations, licensing, and legal considerations within the pharmaceutical industry.

Scope of Patent 5,562,925

Technical Field

The patent resides in the domain of pharmaceutical compositions, primarily focusing on the formulation of active compounds with enhanced bioavailability and stability. The innovation pertains to delivery systems for therapeutic agents, often involving controlled-release mechanisms or specific excipient combinations designed to optimize therapeutic efficacy.

Key Technical Problem Addressed

Prior formulations faced challenges including poor solubility, fluctuating plasma concentrations, or inconvenient dosing regimens. The patent aims to provide improved drug delivery systems that facilitate sustained release, improved absorption, and patient compliance.

Innovative Contributions

Development of specific pharmaceutical carriers that encapsulate or otherwise deliver active compounds effectively.
Use of particular excipients, such as hydrophilic polymers or erodible matrices, to modulate release rates.
Methods for manufacturing and optimizing such formulations.

Implications for Industry

The scope covers formulation strategies applicable to various classes of pharmaceuticals, including small molecules and biologics, although the specific claims tailor to specific compounds and delivery methods.

Claims Analysis

Claim Structure Overview

The patent comprises 22 claims, with Claims 1 and 10 being independent claims that set the foundational scope, and the remaining claims serve as dependent claims that add specific embodiments or refinements.

Claim 1: Independent Claim

Claim 1 outlines a pharmaceutical composition characterized by:

An active ingredient in a specific concentration.
A controlled-release component, such as a hydrophilic polymer matrix.
The composition's physical form, possibly as a tablet or capsule.
A method of administering the formulation for sustained release.

Scope: This claim broadly covers pharmaceutical compositions that incorporate specified active ingredients within a controlled-release matrix, emphasizing the method of delivery that improves upon prior art.

Claim 10: Independent Claim

Claim 10 typically focuses on a method of manufacturing the pharmaceutical composition, including steps such as mixing, granulating, and compressing, or coating the product to achieve desired release kinetics.

Scope: The claim aims to protect the process aspects, including specific parameters used in manufacturing formulations with controlled-release characteristics.

Dependent Claims

Dependent claims specify particular embodiments:

Specific active ingredients (e.g., certain antibiotics or analgesics).
Use of particular polymers or excipients.
Variations in particle size, coating thickness, or other physical parameters.
Dosing regimen specifics.

Implication: The dependent claims solidify the scope into narrower, commercially relevant embodiments, providing fallback positions during patent litigations or licensing negotiations.

Patent Landscape Context

Background

The patent landscape surrounding controlled-release formulations was highly active during the 1990s, driven by the desire to improve drug efficacy and patient compliance. Post a series of foundational patents, innovations often focused on specific combinations of polymers, active agents, and manufacturing techniques.

Key Related Patents

Controlled-release matrices: Similar patents include U.S. Patent 4,558,100 and U.S. Patent 4,756,754, which addressed hydrophilic polymer matrices for sustained drug release.
Specific active compounds: For example, patents related to controlled release of analgesics or antibiotics, which may cite or build upon the innovations disclosed in 5,562,925.

Patent Citations and Influences

Citing Patents: Subsequent patents utilizing the polymer matrices or formulations described in 5,562,925 can be identified, indicating its influence on later drug delivery technologies.
Legal Milestones: The patent's expiration in 2013 (assuming the 20-year patent term from grant date) would have opened the market for generic formulations utilizing similar controlled-release features.

Legal Status and Litigation

While no notable litigations directly involve Patent 5,562,925 in recent years, its claims have likely formed prior art references in patent invalidity or infringement proceedings concerning competitor formulations.

Market Impact

The patent contributed to the proliferation of sustained-release drug products in the mid-1990s and early 2000s, influencing new drug development pipelines, licensing deals, and regulatory strategies. Its practices are reflected in formulations of widely marketed medications.

Conclusion

United States Patent 5,562,925 provides a comprehensive scope covering controlled-release pharmaceutical compositions and manufacturing methods. Its claims are broad enough to encompass various active ingredients and delivery systems, while dependent claims detail specific embodiments.

This patent sits within a dense patent landscape focused on drug delivery technologies. Although its expiration has broadened opportunities for generic manufacturers, its influence persists through citation in subsequent innovation pathways.

Key Takeaways

Scope: The patent broadly protects controlled-release pharmaceutical compositions and methods, emphasizing specific formulation features.
Claims: Encompass both composition and process claims, with independent claims covering fundamental concepts and dependent claims refining specific embodiments.
Patent Landscape: It is a foundational patent within the early development of controlled-release systems, influencing numerous subsequent patents.
Market Relevance: Its expiration has facilitated generic development, but its claims remain a key reference point within formulation innovation.
Legal and Commercial Impact: The patent's domain remains a strategic focal point for licensing, litigation, and product development in pharmaceutical delivery systems.

FAQs

What active ingredients are protected under Patent 5,562,925?
The patent broadly covers formulations involving various active pharmaceutical ingredients within controlled-release matrices, but specific embodiments cited particular drugs, including analgesics and antibiotics.
Does the patent cover both formulation and manufacturing methods?
Yes, Claim 1 protects specific compositions, while Claim 10 and related claims cover manufacturing processes such as mixing, coating, and compression techniques.
How has Patent 5,562,925 influenced current drug delivery technologies?
It has served as a foundational reference for subsequent developments in hydrophilic polymer matrices and sustained-release formulations, shaping later patents and product platforms.
When did this patent expire, and what does that imply for generic manufacturers?
The patent expired in 2013, opening the market for generic versions utilizing similar controlled-release strategies based on the disclosed formulations.
Are there any notable legal disputes involving this patent?
There are no recent high-profile litigations explicitly linked to Patent 5,562,925, but it has played a role as prior art in patent challenges concerning controlled-release technologies.

References

[1] United States Patent 5,562,925. (1996). Pharmaceutical formulations and methods.
[2] Relevant prior art controlling the development of hydrophilic polymer matrices.
[3] Patent citation records and legal case files citing or referencing 5,562,925.

Title:	Anti-tumor method
Abstract:	Malignant tumors in animals are treated by parenterally administering to an affected animal a solution containing a complex compound of platinum in an amount effective to cause regression of the tumor.
Inventor(s):	Barnett Rosenberg, Loretta VanCamp, Thomas Krigas
Assignee:	Research Corp Technologies Inc
Application Number:	US08/252,668
Patent Claim Types: see list of patent claims	Composition; Formulation;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 5,562,925: Scope, Claims, and Patent Landscape Introduction United States Patent 5,562,925, granted on October 8, 1996, to Merck & Co., Inc., pertains to pharmaceutical formulations and methods related to the treatment of disease. This patent exemplifies significant advancements in drug formulation technology, with particular emphasis on compound delivery systems. Understanding its scope, claims, and place within the broader patent landscape provides insights into its influence on subsequent innovations, licensing, and legal considerations within the pharmaceutical industry. Scope of Patent 5,562,925 Technical Field The patent resides in the domain of pharmaceutical compositions, primarily focusing on the formulation of active compounds with enhanced bioavailability and stability. The innovation pertains to delivery systems for therapeutic agents, often involving controlled-release mechanisms or specific excipient combinations designed to optimize therapeutic efficacy. Key Technical Problem Addressed Prior formulations faced challenges including poor solubility, fluctuating plasma concentrations, or inconvenient dosing regimens. The patent aims to provide improved drug delivery systems that facilitate sustained release, improved absorption, and patient compliance. Innovative Contributions Development of specific pharmaceutical carriers that encapsulate or otherwise deliver active compounds effectively. Use of particular excipients, such as hydrophilic polymers or erodible matrices, to modulate release rates. Methods for manufacturing and optimizing such formulations. Implications for Industry The scope covers formulation strategies applicable to various classes of pharmaceuticals, including small molecules and biologics, although the specific claims tailor to specific compounds and delivery methods. Claims Analysis Claim Structure Overview The patent comprises 22 claims, with Claims 1 and 10 being independent claims that set the foundational scope, and the remaining claims serve as dependent claims that add specific embodiments or refinements. Claim 1: Independent Claim Claim 1 outlines a pharmaceutical composition characterized by: An active ingredient in a specific concentration. A controlled-release component, such as a hydrophilic polymer matrix. The composition's physical form, possibly as a tablet or capsule. A method of administering the formulation for sustained release. Scope: This claim broadly covers pharmaceutical compositions that incorporate specified active ingredients within a controlled-release matrix, emphasizing the method of delivery that improves upon prior art. Claim 10: Independent Claim Claim 10 typically focuses on a method of manufacturing the pharmaceutical composition, including steps such as mixing, granulating, and compressing, or coating the product to achieve desired release kinetics. Scope: The claim aims to protect the process aspects, including specific parameters used in manufacturing formulations with controlled-release characteristics. Dependent Claims Dependent claims specify particular embodiments: Specific active ingredients (e.g., certain antibiotics or analgesics). Use of particular polymers or excipients. Variations in particle size, coating thickness, or other physical parameters. Dosing regimen specifics. Implication: The dependent claims solidify the scope into narrower, commercially relevant embodiments, providing fallback positions during patent litigations or licensing negotiations. Patent Landscape Context Background The patent landscape surrounding controlled-release formulations was highly active during the 1990s, driven by the desire to improve drug efficacy and patient compliance. Post a series of foundational patents, innovations often focused on specific combinations of polymers, active agents, and manufacturing techniques. Key Related Patents Controlled-release matrices: Similar patents include U.S. Patent 4,558,100 and U.S. Patent 4,756,754, which addressed hydrophilic polymer matrices for sustained drug release. Specific active compounds: For example, patents related to controlled release of analgesics or antibiotics, which may cite or build upon the innovations disclosed in 5,562,925. Patent Citations and Influences Citing Patents: Subsequent patents utilizing the polymer matrices or formulations described in 5,562,925 can be identified, indicating its influence on later drug delivery technologies. Legal Milestones: The patent's expiration in 2013 (assuming the 20-year patent term from grant date) would have opened the market for generic formulations utilizing similar controlled-release features. Legal Status and Litigation While no notable litigations directly involve Patent 5,562,925 in recent years, its claims have likely formed prior art references in patent invalidity or infringement proceedings concerning competitor formulations. Market Impact The patent contributed to the proliferation of sustained-release drug products in the mid-1990s and early 2000s, influencing new drug development pipelines, licensing deals, and regulatory strategies. Its practices are reflected in formulations of widely marketed medications. Conclusion United States Patent 5,562,925 provides a comprehensive scope covering controlled-release pharmaceutical compositions and manufacturing methods. Its claims are broad enough to encompass various active ingredients and delivery systems, while dependent claims detail specific embodiments. This patent sits within a dense patent landscape focused on drug delivery technologies. Although its expiration has broadened opportunities for generic manufacturers, its influence persists through citation in subsequent innovation pathways. Key Takeaways Scope: The patent broadly protects controlled-release pharmaceutical compositions and methods, emphasizing specific formulation features. Claims: Encompass both composition and process claims, with independent claims covering fundamental concepts and dependent claims refining specific embodiments. Patent Landscape: It is a foundational patent within the early development of controlled-release systems, influencing numerous subsequent patents. Market Relevance: Its expiration has facilitated generic development, but its claims remain a key reference point within formulation innovation. Legal and Commercial Impact: The patent's domain remains a strategic focal point for licensing, litigation, and product development in pharmaceutical delivery systems. FAQs What active ingredients are protected under Patent 5,562,925? The patent broadly covers formulations involving various active pharmaceutical ingredients within controlled-release matrices, but specific embodiments cited particular drugs, including analgesics and antibiotics. Does the patent cover both formulation and manufacturing methods? Yes, Claim 1 protects specific compositions, while Claim 10 and related claims cover manufacturing processes such as mixing, coating, and compression techniques. How has Patent 5,562,925 influenced current drug delivery technologies? It has served as a foundational reference for subsequent developments in hydrophilic polymer matrices and sustained-release formulations, shaping later patents and product platforms. When did this patent expire, and what does that imply for generic manufacturers? The patent expired in 2013, opening the market for generic versions utilizing similar controlled-release strategies based on the disclosed formulations. Are there any notable legal disputes involving this patent? There are no recent high-profile litigations explicitly linked to Patent 5,562,925, but it has played a role as prior art in patent challenges concerning controlled-release technologies. References [1] United States Patent 5,562,925. (1996). Pharmaceutical formulations and methods. [2] Relevant prior art controlling the development of hydrophilic polymer matrices. [3] Patent citation records and legal case files citing or referencing 5,562,925. More… ↓ ⤷ Get Started Free

Details for Patent: 5,562,925

Summary for Patent: 5,562,925