United States Patent 8,591,941: A Comprehensive Analysis of Scope and Claims
Introduction
The United States Patent 8,591,941, titled "Transdermal drug delivery device including an occlusive backing," is a significant innovation in the field of pharmaceuticals, particularly in transdermal drug delivery systems. This patent, assigned to an unspecified entity, outlines a sophisticated design for delivering active agents through the skin over an extended period.
Background of Transdermal Drug Delivery
Transdermal drug delivery systems have been a focus of pharmaceutical research for decades due to their ability to provide steady and controlled drug release, bypassing first-pass metabolism, and enhancing patient compliance. These systems typically consist of multiple layers, each serving a specific function such as drug reservoir, adhesive layer, and protective backing[1].
Patent Overview
Invention Description
The patent describes a transdermal drug delivery system designed for the topical application of one or more active agents. This system includes one or more polymeric and/or adhesive carrier layers that contain the active agents. These carrier layers are positioned proximate to a non-drug containing polymeric backing layer. The backing layer can be processed separately from the carrier layers to prevent loss of drug or system components and combined prior to application[1].
Key Components
- Polymeric and/or Adhesive Carrier Layers: These layers contain the active agents and are designed to release the drug at a controlled rate.
- Non-Drug Containing Polymeric Backing Layer: This layer is crucial for preventing the loss of drug and other system components. It can be manufactured separately or together with the carrier layers.
- Drug Release Rate Controlling Layer: This layer ensures that the drug diffuses at a known rate, maintaining a consistent therapeutic effect[1].
Scope of the Patent
Claim Language and Scope
The patent claims are detailed and specific, focusing on the unique aspects of the transdermal drug delivery system. The scope includes:
- The composition of the polymeric and/or adhesive carrier layers.
- The design and function of the non-drug containing polymeric backing layer.
- The method of manufacturing and combining the different layers.
- The control of drug release profiles over extended periods, up to seven days or longer[1].
Metrics for Measuring Patent Scope
Research on patent scope often involves metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For US Patent 8,591,941, the claims are narrowly defined to ensure specificity and clarity, which is crucial for maintaining the integrity of the invention and avoiding potential litigation[3].
Claims and Their Significance
Independent Claims
The independent claims of the patent are critical as they define the core invention. These claims include:
- The structure and composition of the transdermal drug delivery system.
- The method of preparing and applying the system.
- The specific characteristics of the polymeric backing layer that control drug release[1].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and variations of the invention. These claims may include specific types of active agents, solvents, and co-solvents used in the carrier layers, as well as different manufacturing processes[1].
Patent Landscape
Related Patents and Applications
The patent landscape for transdermal drug delivery systems is extensive, with numerous patents and applications addressing various aspects of these systems. For example:
- U.S. Pat. No. 4,559,222 describes a multi-layer non-adhesive matrix-type device.
- U.S. Pat. No. 5,762,952 discusses a system with a self-crosslinking acrylate adhesive.
- Recent applications, such as those related to amphetamine transdermal delivery systems, highlight the ongoing innovation in this field[1][4].
Industry Impact
The invention described in US Patent 8,591,941 has significant implications for the pharmaceutical industry. It offers a reliable and efficient method for delivering drugs transdermally, which can improve patient outcomes and compliance. The controlled release profile and extended duration of action make it particularly valuable for managing chronic conditions.
Technical and Scientific Aspects
Materials and Manufacturing
The patent details the use of non-aqueous solvents and co-solvents that are non-toxic and pharmaceutically acceptable. These solvents are crucial for maintaining the adhesive properties and solubility of the active agents. The manufacturing process involves combining the carrier layers with the backing layer, ensuring minimal loss of drug or system components[1].
Drug Release Mechanism
The drug release mechanism is controlled by the characteristics of the polymeric backing layer. This layer can be adjusted to achieve the desired drug release profile, ensuring a consistent therapeutic effect over an extended period.
Economic and Legal Considerations
Patent Maintenance and Litigation
The clarity and specificity of the patent claims are crucial for avoiding litigation and ensuring the patent's validity. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process[3].
Market and Competitive Landscape
The transdermal drug delivery market is competitive, with several companies and research institutions actively developing new technologies. The unique features of US Patent 8,591,941 position it as a valuable asset in this market, offering a competitive edge in terms of drug delivery efficiency and patient compliance.
Conclusion
US Patent 8,591,941 represents a significant advancement in transdermal drug delivery technology. The detailed claims and specific design elements ensure a controlled and efficient drug release profile, making it a valuable innovation in the pharmaceutical industry.
Key Takeaways
- Transdermal Drug Delivery System: The patent describes a system with polymeric and/or adhesive carrier layers and a non-drug containing polymeric backing layer.
- Controlled Drug Release: The system is designed to release drugs over an extended period, up to seven days or longer.
- Manufacturing Process: The backing layer can be processed separately or together with the carrier layers to prevent drug loss.
- Patent Scope: The claims are narrowly defined to ensure specificity and clarity.
- Industry Impact: The invention improves patient outcomes and compliance, offering a competitive edge in the transdermal drug delivery market.
FAQs
What is the main innovation of US Patent 8,591,941?
The main innovation is a transdermal drug delivery system with a non-drug containing polymeric backing layer that ensures controlled drug release over an extended period.
How does the patent control drug release?
The drug release is controlled by the characteristics of the polymeric backing layer, which can be adjusted to achieve the desired release profile.
What are the key components of the transdermal drug delivery system?
The key components include polymeric and/or adhesive carrier layers containing the active agents and a non-drug containing polymeric backing layer.
How does the manufacturing process prevent drug loss?
The backing layer can be processed separately from the carrier layers to prevent loss of drug or system components.
What is the significance of the patent in the pharmaceutical industry?
The patent offers a reliable and efficient method for delivering drugs transdermally, improving patient outcomes and compliance, and providing a competitive edge in the market.
Sources
- US Patent 8,591,941 B2 - Transdermal drug delivery device including an occlusive backing.
- DrugPatentWatch - Details for Patent: 8598181.
- SSRN - Patent Claims and Patent Scope.
- Justia Patents - US Patent Application for AMPHETAMINE CARBAMATE.
- USPTO - Patent Claims Research Dataset.
