Understanding the Scope and Claims of United States Patent 4,867,982: A Detailed Analysis
Introduction
United States Patent 4,867,982, titled "Transdermal drug delivery device," is a significant invention in the field of medical devices, particularly for the delivery of active agents through the skin. This patent, granted to inventors, outlines a novel approach to transdermal drug delivery, which has been a crucial area of research and development in pharmaceuticals.
Background of the Patent
The patent was granted on September 19, 1989, and it describes a medical device designed for the transdermal delivery of an active agent through intact skin. This technology was innovative at the time, as it provided a new method for administering drugs that avoided the need for oral or injectable routes, which can have various drawbacks such as gastrointestinal side effects or the need for medical professionals to administer the drug.
Key Components of the Patent
Device Description
The patent details a device that consists of several key components:
- Backing Layer: This layer provides structural support to the device.
- Adhesive Layer: This layer ensures the device adheres to the skin.
- Drug Reservoir: This is where the active agent is stored.
- Rate-Controlling Membrane: This membrane regulates the release of the active agent through the skin[4].
Functionality
The device is designed to deliver the active agent at a controlled rate, ensuring consistent and effective drug delivery. The rate-controlling membrane is crucial as it prevents the drug from being released too quickly or too slowly, which could affect the efficacy and safety of the treatment.
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some of the key claims:
Claim 1
This claim describes the overall device, including the backing layer, adhesive layer, drug reservoir, and rate-controlling membrane. It specifies that the device is designed for transdermal delivery of an active agent[4].
Claim 2-5
These claims provide more detailed descriptions of the components, such as the material composition of the backing layer and the adhesive layer, and the characteristics of the rate-controlling membrane[4].
Claim 6-10
These claims focus on the method of using the device, including the application of the device to the skin and the controlled release of the active agent[4].
Patent Landscape and Impact
Innovation in Drug Delivery
The invention represented a significant innovation in drug delivery technology. Transdermal delivery systems offer several advantages, including improved patient compliance, reduced side effects, and the ability to maintain a steady drug concentration in the bloodstream[2].
Commercial and Clinical Impact
The commercial impact of this patent has been substantial. Transdermal drug delivery devices have become common in treating various conditions, such as pain management, hypertension, and nicotine addiction. Clinically, these devices have improved treatment outcomes by providing a more consistent and controlled release of medications.
Challenges and Criticisms
Patent Quality and Clarity
The clarity and quality of patent applications, including those for medical devices like the one described in US 4,867,982, are critical. The USPTO has faced challenges in ensuring that patent applications meet statutory requirements for clarity and novelty. For instance, a GAO report highlighted that nearly 90% of patent examiners encountered broadly worded patent applications, which made thorough examinations difficult[1].
Legal and Regulatory Considerations
The legal landscape surrounding patents, especially in the medical field, is complex. Issues such as patentability, infringement, and the need for a small claims patent court have been subjects of ongoing discussions. For example, the Administrative Conference of the United States (ACUS) has studied the feasibility of a small claims patent court to address disputes more efficiently[5].
Economic and Statistical Insights
Costs Associated with Patenting
The process of obtaining and maintaining a patent, especially for complex inventions like medical devices, can be costly. The cost of drafting and filing a U.S. non-provisional patent application can range from $8,000 to $20,000, with additional costs incurred during the patent prosecution process[2].
Data on Patent Claims
The USPTO's Patent Claims Research Dataset provides insights into the scope and complexity of patent claims. This dataset, which includes claims from U.S. patents granted between 1976 and 2014, helps in understanding the trends and measurements of patent scope, which can be relevant for analyzing the impact of patents like US 4,867,982[3].
Key Takeaways
- Innovative Technology: US Patent 4,867,982 introduced a novel transdermal drug delivery device that has significantly impacted the pharmaceutical industry.
- Complex Patent Landscape: The patent's claims and descriptions highlight the complexity of patent applications in the medical device sector.
- Economic and Clinical Impact: The device has had substantial commercial and clinical impacts, improving treatment outcomes and patient compliance.
- Challenges in Patent Quality: Ensuring the clarity and quality of patent applications remains a challenge for the USPTO.
- Legal Considerations: The patent's validity and enforcement involve complex legal and regulatory considerations.
FAQs
What is the main innovation of US Patent 4,867,982?
The main innovation is a transdermal drug delivery device that delivers active agents through intact skin at a controlled rate.
What are the key components of the device described in the patent?
The key components include a backing layer, adhesive layer, drug reservoir, and rate-controlling membrane.
How does the device improve drug delivery?
The device improves drug delivery by providing a consistent and controlled release of the active agent, enhancing patient compliance and reducing side effects.
What are the costs associated with obtaining and maintaining a patent like US 4,867,982?
The costs can range from $8,000 to $20,000 for drafting and filing, with additional costs during the patent prosecution process.
Why is patent clarity important, and how does it relate to US 4,867,982?
Patent clarity is crucial for ensuring that the patent meets statutory requirements and can be thoroughly examined. Broadly worded patent applications, like those encountered by nearly 90% of examiners, can complicate the examination process.
Sources
- GAO Report: "Intellectual Property: Patent Office Should Define Quality, Reassess Time Allotted for Examination" (June 2016).
- KU Office of Research: "Intellectual Property Protection".
- USPTO: "Patent Claims Research Dataset".
- PubChem: "Transdermal drug delivery device - Patent US-4867982-A".
- ACUS: "U.S. Patent Small Claims Court".
