United States Patent 5,223,261: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,223,261, titled "Transdermal Estradiol Delivery System," was granted to its inventors for a innovative method of delivering estradiol through the skin. This patent is a significant contribution to the field of pharmaceuticals and dermatology. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent, numbered US5223261A, was issued by the United States Patent and Trademark Office (USPTO) and is categorized under the utility patent type[4].
Prior Art and Background
The invention builds upon prior art in the field of transdermal drug delivery systems. For instance, U.S. Patent No. 4,460,372 and GB Application 2158355 are cited as relevant prior art, highlighting earlier developments in transdermal devices and dosage forms[4].
Legal Status
As of the current date, the patent has expired, marking the end of its lifetime protection.
Scope of the Patent
Invention Description
The patent describes a pressure-sensitive adhesive sheet material designed for delivering estradiol to the skin. The sheet material includes a backing with a layer of a pressure-sensitive adhesive containing estradiol. This system is engineered to enhance skin penetration and provide a controlled release of the therapeutic agent[4].
Claims
The patent includes several claims that define the scope of the invention. These claims are crucial as they outline what is protected under the patent. Here are some key claims:
- Claim 1: A transdermal estradiol delivery system comprising a backing and a layer of a pressure-sensitive adhesive containing estradiol.
- Claim 2: The system of claim 1, wherein the adhesive layer further contains a percutaneous absorption enhancer.
- Claim 3: The system of claim 1, wherein the backing is a flexible material[4].
Claim Analysis
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth of a patent. For US5223261A, the independent claims are relatively concise, indicating a focused scope. The number of independent claims is also limited, suggesting that the inventors were precise in defining their invention[3].
Claim Dependency
The dependency between claims is another important aspect. In this patent, the dependent claims build upon the independent claims, providing additional details and limitations that further define the invention. This structure helps in narrowing down the scope and ensuring clarity in what is protected[2].
Patent Landscape
Related Patents and Applications
The patent landscape for transdermal drug delivery systems is extensive. Patents like U.S. Patent No. 4,460,372 and GB Application 2158355, as mentioned earlier, are part of this landscape. These patents and applications collectively contribute to the evolution of transdermal delivery technologies.
Global Dossier and IP5 Offices
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service can be useful in understanding the global patent landscape for similar inventions[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by all participating IP5 Offices for the family members of a patent application. This tool can help in identifying overlapping prior art and understanding how different offices evaluate similar inventions[1].
Economic and Innovation Impact
Patent Scope and Quality
The scope of a patent, as measured by metrics like independent claim length and count, can influence its quality and the innovation it fosters. Narrower claims, as seen in US5223261A, are often associated with a higher probability of grant and shorter examination processes, which can encourage more focused and meaningful innovations[3].
Forward Citations and Maintenance Payments
Forward citations, which indicate how often a patent is cited by later patents, and maintenance payments can be indicators of a patent's impact. While specific data for US5223261A is not provided here, these metrics are generally used to assess the significance and influence of a patent in its field[3].
Practical Applications and Impact
Clinical Use
The transdermal estradiol delivery system patented in US5223261A has significant clinical applications, particularly in hormone replacement therapy. This method of delivery offers advantages such as controlled release, improved patient compliance, and reduced side effects compared to oral or injectable forms.
Market and Competition
In the market for transdermal drug delivery systems, patents like US5223261A play a crucial role in protecting intellectual property and driving innovation. Companies that hold such patents can leverage them to develop new products and maintain a competitive edge.
Key Takeaways
- Patent Scope: The patent's scope is defined by its claims, which are focused and concise, indicating a well-defined invention.
- Claim Analysis: Independent claim length and count metrics suggest a narrow and clear scope.
- Patent Landscape: The patent is part of a broader landscape of transdermal drug delivery systems, with related patents and applications contributing to the field's evolution.
- Economic Impact: The patent's scope and quality can influence innovation and economic outcomes, such as shorter examination processes and higher grant probabilities.
- Practical Applications: The invention has significant clinical applications in hormone replacement therapy and other medical fields.
FAQs
What is the main invention described in US5223261A?
The main invention is a transdermal estradiol delivery system using a pressure-sensitive adhesive sheet material.
How does the patent protect the invention?
The patent protects the invention through several claims that define the scope of the transdermal delivery system, including the composition and structure of the adhesive layer and the backing.
What is the significance of independent claim length and count in patent scope analysis?
Independent claim length and count are metrics used to measure patent scope. They indicate the breadth and clarity of the patent, with narrower claims often associated with higher grant probabilities and shorter examination processes.
How does the Global Dossier service relate to US5223261A?
The Global Dossier service allows users to view related applications filed at participating IP Offices, providing a global perspective on the patent family and prior art relevant to US5223261A.
What are the clinical applications of the transdermal estradiol delivery system?
The system is primarily used in hormone replacement therapy, offering advantages such as controlled release and improved patient compliance.
Sources
- USPTO - Search for Patents: https://www.uspto.gov/patents/search
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents - US5223261A: https://patents.google.com/patent/US5223261A/en
- USPTO - Nonprovisional (Utility) Patent Application Filing Guide: https://www.uspto.gov/patents/basics/apply/utility-patent
