Analyzing the Scope and Claims of United States Patent 4,994,267
Introduction
United States Patent 4,994,267, titled "Transdermal Drug Delivery Device," is a significant patent in the field of pharmaceuticals and medical devices. This patent, granted in 1991, pertains to the development of transdermal drug delivery systems, which have revolutionized the way medications are administered. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent was filed by inventors Robert E. Sablotsky and others, and it was assigned to Alza Corporation, a company known for its innovations in drug delivery systems. The patent describes a transdermal drug delivery device designed to release a therapeutic agent through the skin over an extended period.
Scope of the Patent
The scope of the patent encompasses the design, materials, and functionality of the transdermal drug delivery device. Here are some key aspects:
Device Design
The patent describes a device that includes a backing layer, an adhesive layer, a drug reservoir, and a rate-controlling membrane. This design ensures controlled release of the drug through the skin, providing a steady and consistent dosage over time[4].
Materials Used
The device uses specific materials for each layer, such as polyisobutylene for the adhesive layer and cellulose acetate for the rate-controlling membrane. These materials are chosen for their compatibility with the skin and their ability to control the drug release rate[4].
Functionality
The device is designed to be applied to the skin, where it adheres and releases the therapeutic agent. The rate-controlling membrane ensures that the drug is released at a predetermined rate, which can be adjusted based on the specific needs of the patient[4].
Claims of the Patent
The claims of the patent are critical as they define the legal boundaries of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the overall device, including the backing layer, adhesive layer, drug reservoir, and rate-controlling membrane.
- Claim 2 specifies the materials used for each layer, such as polyisobutylene and cellulose acetate[4].
Dependent Claims
- These claims further detail specific aspects of the device, such as the thickness of the layers, the type of adhesive used, and the method of manufacturing the device[4].
Patent Landscape
Understanding the patent landscape is crucial for assessing the impact and uniqueness of the invention.
Prior Art
The patent cites several prior art references, including earlier patents related to transdermal drug delivery systems. For example, U.S. Patent Numbers 4,814,168 and 5,006,108 are mentioned as related inventions[4].
International Patents
Similar patents exist in other countries, such as the Canadian Patents Database, which lists patents with similar claims and descriptions. For instance, Canadian Patent 2245366 also pertains to transdermal patches and shares some similarities with U.S. Patent 4,994,267[4].
Global Dossier
Using tools like the Global Dossier provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This helps in understanding the global patent family and any office actions related to similar inventions[1].
Economic and Market Impact
The economic and market impact of this patent has been significant.
Market Dominance
Alza Corporation, the assignee of the patent, has been a leader in the transdermal drug delivery market. The patent has enabled the company to develop and market several successful products, contributing to its market dominance.
Research and Development
The patent has also spurred further research and development in the field. The detailed information on claims from U.S. patents, such as those provided in the Patent Claims Research Dataset by the USPTO, helps researchers and inventors understand the scope and trends in patent claims, including those related to transdermal drug delivery systems[3].
Legal and Regulatory Aspects
Understanding the legal and regulatory environment is essential for navigating the patent landscape.
Patent Expiration
The patent has expired, which means that the technology is now in the public domain. This allows other companies to develop similar products without infringing on the original patent.
Regulatory Compliance
Companies developing transdermal drug delivery systems must comply with regulatory requirements, such as those set by the FDA. The patent provides a baseline for understanding the regulatory standards and compliance requirements in this field.
Conclusion
United States Patent 4,994,267 has played a pivotal role in the development of transdermal drug delivery systems. The detailed analysis of its scope, claims, and the broader patent landscape highlights its significance and impact on the pharmaceutical and medical device industries.
Key Takeaways
- Device Design: The patent describes a transdermal drug delivery device with specific layers and materials.
- Claims: The patent includes independent and dependent claims that define the invention and its components.
- Patent Landscape: The patent is part of a larger global patent family, with similar patents in other countries.
- Economic Impact: The patent has contributed to market dominance and spurred further research and development.
- Legal and Regulatory: The patent has expired, and companies must comply with regulatory requirements when developing similar products.
FAQs
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What is the main invention described in U.S. Patent 4,994,267?
- The main invention is a transdermal drug delivery device designed to release a therapeutic agent through the skin over an extended period.
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Who were the inventors of this patent?
- The inventors were Robert E. Sablotsky and others.
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What materials are used in the device described in the patent?
- The device uses materials such as polyisobutylene for the adhesive layer and cellulose acetate for the rate-controlling membrane.
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Has the patent expired?
- Yes, the patent has expired, which means the technology is now in the public domain.
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How does the Global Dossier help in understanding the patent landscape?
- The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users understand the global patent family and any office actions related to similar inventions.
Sources
- USPTO - Search for patents
- Google Patents - EP1586512A1
- USPTO - Patent Claims Research Dataset
- Canadian Patents Database - Patent 2245366 Summary
