United States Patent 4,201,211: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,201,211, titled "Therapeutic system for administering clonidine transdermally," is a significant patent in the field of transdermal drug delivery systems. This patent, issued in 1980, describes a therapeutic system designed to administer clonidine through intact skin to treat hypertension. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
Clonidine is a medication used to treat hypertension (high blood pressure) and other conditions. The patent in question introduces a novel method for administering clonidine transdermally, which is a significant advancement in drug delivery technology. This method allows for continuous and controlled release of the drug through the skin, providing a more convenient and potentially more effective treatment option compared to traditional oral or parenteral administration[4].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific elements and functionalities of the therapeutic system.
Key Components
- Backing Layer: The system includes a backing layer that is substantially impermeable to clonidine. This layer forms the top of the patch and ensures that the drug is released only through the skin[4].
- Drug Reservoir: Adjacent to the backing layer is a clonidine reservoir that contains the drug dispersed in a carrier material permeable to clonidine. This reservoir holds an amount of clonidine sufficient for the desired treatment period[4].
- Microporous Membrane: A microporous membrane layer controls the release rate of clonidine from the reservoir. This membrane is crucial for maintaining a consistent and controlled release of the drug[4].
- Contact Adhesive Layer: The system includes a contact adhesive layer that attaches the patch to the skin. This layer must be permeable to clonidine to allow the drug to pass through and be absorbed by the skin[4].
Claims Analysis
The patent includes several claims that define the invention's scope and distinguish it from prior art.
Independent Claims
- The primary independent claim describes the therapeutic system as a whole, including the backing layer, drug reservoir, microporous membrane, and contact adhesive layer. This claim sets the foundation for the entire invention[4].
- Subsequent claims detail specific aspects of the system, such as the composition of the drug reservoir, the properties of the microporous membrane, and the characteristics of the contact adhesive layer.
Dependent Claims
- Dependent claims further specify the materials and methods used in the therapeutic system. For example, they describe the use of specific polymers and the process of preparing the drug reservoir and adhesive layers[4].
Patent Landscape
To understand the significance and positioning of this patent within the broader patent landscape, it is essential to consider related patents and technological advancements.
Prior Art
- Patents such as U.S. Pat. No. 3,742,951 and U.S. Pat. No. 3,797,494 describe earlier transdermal delivery systems. These patents laid the groundwork for the development of more sophisticated systems like the one described in U.S. Pat. 4,201,211[4].
International and Global Context
- The development of transdermal drug delivery systems is a global effort. Patents from other countries, such as those available through the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), also contribute to this field. Tools like the Global Dossier and Common Citation Document (CCD) help in navigating the international patent landscape and identifying related inventions[1].
Impact and Innovations
The patent for the transdermal clonidine system has had a significant impact on the field of pharmaceuticals.
Clinical Significance
- The ability to administer clonidine transdermally offers several clinical advantages, including improved patient compliance and reduced side effects compared to oral or injectable forms of the drug[4].
Technological Advancements
- This patent has paved the way for further innovations in transdermal drug delivery. Later patents, such as those describing systems with multiple material matrix layers, have built upon the foundational work presented here[2].
Litigation and Licensing
Patents like U.S. Pat. 4,201,211 can be subject to litigation and licensing agreements.
Patent Quality and Scope
- The scope and quality of patents are critical in determining their validity and enforceability. Metrics such as independent claim length and count can be used to assess patent scope and quality, as discussed in research papers on the topic[3].
Licensing and Collaboration
- Companies often license patents to other entities to facilitate the development and commercialization of new products. The licensing of U.S. Pat. 4,201,211 could have enabled other companies to develop similar or improved transdermal delivery systems.
Conclusion
United States Patent 4,201,211 represents a significant milestone in the development of transdermal drug delivery systems. The detailed analysis of its scope, claims, and the broader patent landscape highlights its importance and impact on the pharmaceutical industry.
Key Takeaways
- Transdermal Delivery System: The patent describes a novel system for administering clonidine through the skin, which has improved treatment options for hypertension.
- Key Components: The system includes a backing layer, drug reservoir, microporous membrane, and contact adhesive layer.
- Claims Analysis: The patent's claims define the invention's scope and distinguish it from prior art.
- Patent Landscape: The patent is part of a larger global effort in transdermal drug delivery, with related patents and international databases contributing to the field.
- Impact and Innovations: The patent has had a significant impact on clinical practice and has paved the way for further technological advancements.
FAQs
Q: What is the main innovation described in U.S. Pat. 4,201,211?
A: The main innovation is a therapeutic system for administering clonidine transdermally through intact skin.
Q: What are the key components of the transdermal delivery system described in the patent?
A: The key components include a backing layer, a drug reservoir, a microporous membrane, and a contact adhesive layer.
Q: How does the microporous membrane function in the system?
A: The microporous membrane controls the release rate of clonidine from the reservoir, ensuring a consistent and controlled delivery of the drug.
Q: What are some of the clinical advantages of transdermal clonidine administration?
A: Transdermal administration offers improved patient compliance and reduced side effects compared to oral or injectable forms of the drug.
Q: How can one search for related patents and understand the broader patent landscape?
A: Tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to search for related patents and understand the international patent landscape[1].
Sources
- USPTO: Search for patents - USPTO
- Google Patents: DE60311449T2 - TRANSDERMAL THERAPEUTIC SYSTEM WITH TWO MATERIAL MATRIX LAYERS PROVIDING DIFFERENT AFFINITY TO THE INGREDIENT SUBSTANCE
- SSRN: Patent Claims and Patent Scope
- Google Patents: US4201211A - Therapeutic system for administering clonidine transdermally
