United States Patent 5,252,334: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,252,334, titled "Transdermal Delivery of a Steroid Using an Adhesive Matrix Patch," is a significant patent in the field of pharmaceuticals, particularly in the area of transdermal drug delivery systems. This patent, assigned to Chiang et al., was granted on October 12, 1993. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent pertains to the development of transdermal delivery systems for steroid drugs, specifically using an adhesive matrix patch. This technology is crucial for the administration of hormones and other steroid-based medications through the skin, bypassing traditional oral or injectable routes.
Scope of the Patent
Invention Overview
The patent describes a method and apparatus for the transdermal delivery of steroid drugs, such as estradiol, using an adhesive matrix patch. The patch consists of an acrylate adhesive, the steroid drug, and optionally, a permeation enhancer and water-soluble polymers[4].
Key Components
- Adhesive Matrix: The patch is made from a biocompatible polymeric adhesive, typically an acrylate adhesive, which is intimately admixed with the steroid drug.
- Permeation Enhancer: The inclusion of permeation enhancers is optional but can significantly improve the drug's penetration through the skin.
- Water-Soluble Polymers: These polymers can be added to enhance the stability and delivery characteristics of the patch.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core aspects of the invention:
- Claim 1 describes the adhesive matrix patch comprising an acrylate adhesive and the steroid drug.
- Claim 2 specifies the optional inclusion of a permeation enhancer.
- Claim 3 details the use of water-soluble polymers in the patch[4].
Dependent Claims
Dependent claims further elaborate on the specifics of the invention, such as the types of steroid drugs that can be used (e.g., estradiol), the composition of the adhesive, and the method of preparing the patch.
Patent Landscape
Related Patents
Several other patents are relevant to the landscape of transdermal drug delivery systems:
- U.S. Patent No. 5,232,703: This patent by Blank describes an uncrosslinked, water-insoluble vinylpyrrolidone copolymer matrix for delivering estradiol through the skin[4].
- U.S. Patent No. 5,079,008: Sinnreich et al. disclose a polyisobutylene matrix for drug delivery in combination with penetration promoters[4].
- U.S. Patent No. 5,023,084: Chien's patent describes a transdermal progestin/estrogen matrix patch for fertility control[4].
Global Patent System
The patent landscape extends beyond the U.S., with similar technologies being developed and patented in other countries. For instance, the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO) provide access to international patent databases that can be searched to identify similar inventions globally[1].
Search and Analysis Tools
To conduct a comprehensive analysis of the patent landscape, several tools and resources are available:
- Patent Public Search: The USPTO's Patent Public Search tool allows for enhanced access to prior art and can be used to identify related patents and applications[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping to identify the patent family and related applications[1].
- Common Citation Document (CCD): This application consolidates prior art cited by multiple offices, facilitating a more integrated view of the global patent landscape[1].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Impact and Applications
The technology described in U.S. Patent 5,252,334 has significant implications for the treatment of hormonal insufficiencies, inflammation, and other conditions. The transdermal delivery system offers a convenient and effective method for administering steroid drugs, improving patient compliance and reducing side effects associated with other delivery methods.
Future Developments
The field of transdermal drug delivery continues to evolve, with ongoing research into new materials, enhancers, and delivery systems. Future patents in this area are likely to focus on improving the efficacy, stability, and patient comfort of these systems.
Key Takeaways
- Invention Details: U.S. Patent 5,252,334 describes a transdermal delivery system using an adhesive matrix patch for steroid drugs.
- Key Components: The patch includes an acrylate adhesive, the steroid drug, and optional permeation enhancers and water-soluble polymers.
- Related Patents: Several other patents exist in the field of transdermal drug delivery, highlighting the complexity and innovation in this area.
- Global Landscape: The patent landscape is global, with tools like the Global Dossier and CCD facilitating international searches.
- Metrics for Scope: Metrics such as claim length and count can help assess the breadth and clarity of patent claims.
FAQs
What is the main invention described in U.S. Patent 5,252,334?
The main invention is a transdermal delivery system for steroid drugs using an adhesive matrix patch.
What are the key components of the adhesive matrix patch?
The key components include an acrylate adhesive, the steroid drug, and optionally, a permeation enhancer and water-soluble polymers.
How does the patent landscape look for transdermal drug delivery systems?
The landscape is complex, with multiple patents from various inventors and countries, indicating significant innovation and competition in this field.
What tools can be used to analyze the patent landscape?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are useful for analyzing the patent landscape.
What are some metrics used to measure the scope of a patent?
Metrics include independent claim length and independent claim count, which can indicate the breadth and clarity of the patent claims.
How does the technology described in U.S. Patent 5,252,334 impact patient care?
The technology offers a convenient and effective method for administering steroid drugs, improving patient compliance and reducing side effects associated with other delivery methods.
