United States Patent 4,060,084: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,060,084, titled "Method and therapeutic system for providing chemotherapy transdermally," is a significant innovation in the field of medical science, particularly in drug delivery systems. This patent, granted in 1977, introduces a method and a therapeutic system designed for the transdermal administration of chemotherapy.
Background and Context
The patent addresses a critical need in medical treatment by providing a method for delivering chemotherapy directly through the skin, avoiding the traditional oral or intravenous routes. This approach aims to maintain a steady-state systemic concentration of the drug, enhancing efficacy and reducing side effects.
Scope of the Patent
Method of Administration
The patent describes a method for providing chemotherapy transdermally over a predetermined prolonged period. This method involves using a therapeutic system in the form of a bandage specifically designed to administer the drug in two phases: an initial priming dose phase followed by a constant rate administration phase[5].
Therapeutic System
The therapeutic system is a bandage that includes several key components:
- Backing: Provides structural support.
- Drug Reservoir: Contains the chemotherapy drug.
- Microporous Membrane: Regulates the release of the drug.
- Contact Adhesive Layer: Ensures the bandage adheres to the skin and contains drug in specific proportions[5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Primary Claims
- The method for providing chemotherapy transdermally involves a bandage with a drug reservoir, a microporous membrane, and a contact adhesive layer.
- The drug is administered in two phases: an initial priming dose followed by a constant rate administration[5].
Dependent Claims
- The bandage is designed to maintain a steady-state systemic concentration of the drug.
- The drug is present in specific proportions in both the contact adhesive layer and the reservoir.
- The microporous membrane ensures a controlled release of the drug through the skin[5].
Patent Landscape
Prior Art
Prior to this patent, drug delivery systems were often limited by their inability to maintain a constant release rate over extended periods. This invention overcomes such limitations by introducing a two-phase administration method and using a microporous membrane to regulate drug release[5].
Related Patents
Other patents in the field of drug delivery systems include those related to controlled release devices, such as the one described in US Patent 4,220,152. This patent involves the use of a porous material with hydrogel to achieve controlled and predictable release rates of drugs, particularly in ruminants[1].
Classification and Categories
The patent is classified under various categories in the International Patent Classification (IPC) system, including:
- A61K9/703: Transdermal patches and similar drug-containing composite devices.
- A61K9/7092: Transdermal patches having multiple drug layers or reservoirs[5].
Impact and Innovations
Clinical Significance
The transdermal delivery system described in this patent offers several clinical advantages, including reduced side effects, improved patient compliance, and the ability to maintain a steady-state systemic concentration of the drug[5].
Technological Innovations
The use of a microporous membrane and a two-phase administration method represents a significant technological innovation in drug delivery. This design ensures a controlled and sustained release of the drug, which is crucial for chemotherapy treatments.
Economic and Legal Implications
Patent Scope and Quality
The scope of this patent is well-defined, with clear claims that distinguish it from prior art. The patent's scope is narrower compared to some other patents, which can reduce the likelihood of litigation and increase its validity[3].
Licensing and Litigation
Given its specific and well-defined claims, this patent is less likely to be involved in licensing and litigation issues related to overly broad or unclear claims. This clarity enhances its economic value and encourages further innovation in the field.
Future Developments and Trends
Advancements in Drug Delivery
The technology described in this patent has paved the way for further advancements in transdermal drug delivery systems. Future developments may include more sophisticated membrane materials, multi-drug reservoirs, and personalized medicine approaches.
Regulatory Environment
The regulatory environment for medical devices and drug delivery systems continues to evolve. Future patents in this field will need to comply with increasingly stringent regulations and guidelines to ensure safety and efficacy.
Key Takeaways
- Method and System: The patent introduces a method and therapeutic system for transdermal chemotherapy administration.
- Components: The system includes a backing, drug reservoir, microporous membrane, and contact adhesive layer.
- Two-Phase Administration: The drug is administered in an initial priming dose phase followed by a constant rate administration phase.
- Clinical Significance: The system offers reduced side effects, improved compliance, and steady-state systemic drug concentration.
- Technological Innovations: The use of a microporous membrane and two-phase administration is a significant technological advancement.
- Economic and Legal Implications: The patent's clear scope reduces the likelihood of litigation and enhances its economic value.
FAQs
What is the primary innovation of United States Patent 4,060,084?
The primary innovation is the method and therapeutic system for providing chemotherapy transdermally using a bandage with a drug reservoir, microporous membrane, and contact adhesive layer.
How does the two-phase administration method work?
The two-phase method involves an initial priming dose phase followed by a constant rate administration phase to maintain a steady-state systemic concentration of the drug.
What are the key components of the therapeutic system described in the patent?
The key components include a backing, drug reservoir, microporous membrane, and contact adhesive layer.
How does this patent differ from prior art in drug delivery systems?
This patent differs by introducing a controlled release system using a microporous membrane and a two-phase administration method, overcoming the limitations of prior art devices.
What are the potential future developments in transdermal drug delivery systems?
Future developments may include more sophisticated membrane materials, multi-drug reservoirs, and personalized medicine approaches.
Cited Sources
- US4220152A - Delivery system - Google Patents
- Patent Claims Research Dataset - USPTO
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- EP0238554A4 - Liposome transdermal drug ... - Google Patents
- US4060084A - Method and therapeutic system for ... - Google Patents
