United States Patent 4,379,454: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 4,379,454, titled "Dosage for coadministering drug and percutaneous absorption enhancer," is a significant patent in the field of medical and pharmaceutical technology. This patent, issued on April 12, 1983, pertains to a unit dosage form and method for coadministering a drug and a percutaneous absorption enhancer to a predetermined area of unbroken skin. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a method and device for the controlled percutaneous administration of a drug, enhanced by a percutaneous absorption enhancer. The device consists of several layers, including a backing layer, a drug reservoir layer, a microporous membrane layer, and a contact adhesive layer. The rate of drug administration is controlled by the rate at which the drug diffuses through the microporous membrane[4].
Key Components
- Drug Reservoir Layer: Contains the drug to be administered.
- Microporous Membrane Layer: Controls the rate of drug diffusion.
- Contact Adhesive Layer: Ensures the device adheres to the skin.
- Backing Layer: Provides structural support to the device.
Scope of the Patent
Patent 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.
- Claim 1: A unit dosage form for coadministering a drug and a percutaneous absorption enhancer to a predetermined area of unbroken skin.
- Subsequent Claims: Detail the specific layers and their functions, such as the microporous membrane layer and the contact adhesive layer[4].
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be metrics for measuring patent scope. In this case, the patent has a focused set of claims that define a specific method and device, indicating a relatively narrow scope[3].
Claims Analysis
Claim Construction
The claims are constructed to ensure that the invention is clearly defined and distinguishable from prior art. For example, the claim specifying the microporous membrane layer highlights its critical role in controlling drug diffusion[4].
Prior Art Considerations
The patent references prior art, such as U.S. Pat. No. 4,031,894 and U.S. Pat. No. 3,797,494, which also describe methods and devices for percutaneous drug administration. However, the current patent introduces specific improvements, such as the use of a microporous membrane to control drug diffusion[4].
Patent Landscape
Related Patents
The patent landscape in this field is rich with similar inventions aimed at improving drug delivery through the skin.
- U.S. Pat. No. 4,031,894: Describes the pre- or coadministration of percutaneous absorption enhancers with controlled percutaneous administration of scopolamine.
- U.S. Pat. No. 3,797,494: Describes bandages for administering drugs percutaneously, using a transport agent to enhance skin penetration[4].
International Patent Offices
Similar patents can be found in international databases, such as the European Patent Office (EPO) and the Japan Patent Office (JPO), which provide access to machine translations and full-text searches of published international patent applications[1].
Search and Analysis Tools
USPTO Resources
For conducting a thorough search and analysis of patents like U.S. Patent 4,379,454, the United States Patent and Trademark Office (USPTO) offers several resources:
- Patent Public Search: A modern interface for searching prior art and accessing enhanced patent search capabilities.
- Global Dossier: Provides access to file histories of related applications from participating IP Offices.
- Patent and Trademark Resource Centers (PTRCs): Local resources for training in patent search techniques[1].
International Databases
Databases such as esp@cenet from the EPO, PATENTSCOPE from WIPO, and KIPRIS from Korea provide comprehensive access to international patent collections, facilitating global patent searches[1].
Impact and Relevance
Innovation and Licensing
The patent's focus on controlled drug delivery through the skin has significant implications for medical innovation. It addresses the need for precise and efficient drug administration, which can enhance patient outcomes and reduce side effects.
Litigation and Validity
The clarity and specificity of the claims in this patent are crucial for avoiding litigation and ensuring the validity of the patent. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Citation and Prior Art
"The rate of drug administration is controlled by the rate at which drug diffuses from the reservoir through the microporous membrane"[4].
This quote highlights the innovative aspect of the patent, which differentiates it from prior art.
Statistics and Industry Insights
- Patent Maintenance Payments: Patents with narrower claims, like U.S. Patent 4,379,454, tend to have lower maintenance payments, indicating a more focused and valuable invention[3].
- Forward Citations: The number of forward citations can indicate the impact of a patent on subsequent innovations. A patent with significant forward citations suggests it has contributed substantially to the field[3].
Expert Opinions
Industry experts often emphasize the importance of clear and specific claims in patents. For example:
"Clear and specific claims are essential for protecting the inventor's rights while also providing a clear roadmap for future innovators to build upon or around the existing patent"[3].
## Key Takeaways
- **Specific Claims**: The patent's claims are specific and focused, defining a clear method and device for drug administration.
- **Controlled Drug Delivery**: The use of a microporous membrane to control drug diffusion is a key innovation.
- **Prior Art**: The patent references and builds upon prior art, introducing specific improvements.
- **Global Patent Landscape**: Similar patents exist in international databases, highlighting the global nature of medical innovation.
- **Impact on Innovation**: The patent's clarity and specificity contribute to its relevance and impact in the medical field.
## FAQs
### **What is the main innovation of U.S. Patent 4,379,454?**
The main innovation is the use of a microporous membrane to control the rate of drug diffusion in a percutaneous drug delivery system.
### **How does the patent differ from prior art?**
The patent differs by introducing a specific method of controlling drug diffusion through a microporous membrane, which is not described in the referenced prior art.
### **What resources can be used to search for similar patents?**
Resources include the USPTO's Patent Public Search, Global Dossier, and international databases like esp@cenet and PATENTSCOPE.
### **Why are clear and specific claims important in patents?**
Clear and specific claims are essential for protecting the inventor's rights, avoiding litigation, and providing a clear roadmap for future innovators.
### **How does the patent impact medical innovation?**
The patent contributes to medical innovation by providing a precise and efficient method for drug administration, which can enhance patient outcomes and reduce side effects.
## Sources
1. **USPTO - Search for patents**. Retrieved from https://www.uspto.gov/patents/search
2. **Justia - US Patent for Dosage for coadministering drug and percutaneous absorption enhancer**. Retrieved from https://patents.justia.com/patent/4379454
3. **SSRN - Patent Claims and Patent Scope**. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
4. **Google Patents - US4379454A - Dosage for coadministering drug and percutaneous absorption enhancer**. Retrieved from https://patents.google.com/patent/US4379454A/en
5. **Google Patents - EP0427741B1 - Dispositif de distribution**. Retrieved from https://patents.google.com/patent/EP0427741B1/fr
