United States Patent 4,588,580: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,588,580, titled "Transdermal administration of fentanyl and device therefor," was granted on May 13, 1986, to inventors Robert M. Gale, Victor Goetz, Eun S. Lee, Lina T. Taskovich, and Su I. Yum, assigned to Alza Corporation. This patent is significant in the field of pharmaceuticals, particularly in the development of transdermal delivery systems for potent analgesics like fentanyl.
Background of the Invention
The invention pertains to the administration of fentanyl, a highly potent opioid analgesic, and its derivatives through intact skin over an extended period at a substantially constant rate. Fentanyl and its derivatives have long been recognized for their effectiveness in pain management, but their administration has been challenging due to their potency and the need for controlled release[4].
Scope of the Invention
The patent covers a method and device for transdermal administration of fentanyl. The device includes several key components:
- A contact adhesive layer
- A rate-controlling membrane
- A backing member
- An aqueous gel containing the drug
These components work together to ensure a steady release of fentanyl through the skin, maintaining therapeutic levels over an extended period[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the transdermal delivery device comprising a backing member, a rate-controlling membrane, an adhesive layer, and an aqueous gel containing fentanyl.
- Claim 2 specifies the method of administering fentanyl through the skin using the described device.
Dependent Claims
- Claims 3-10 detail various aspects of the device, including the composition of the rate-controlling membrane, the adhesive layer, and the aqueous gel.
- Claims 11-14 describe the process of manufacturing the device, including the steps of forming the adhesive layer, laminating the rate-controlling membrane, and sealing the pouches[4].
Patent Landscape
Related Patents
Several other patents are related to the transdermal administration of drugs and share similarities with US 4,588,580:
- US 4666441A: This patent, granted to Ciba-Geigy Corporation, describes multicompartmentalized transdermal patches, which also aim to provide controlled drug release[2].
- US 4671953A: This patent, granted to the University of Utah Research Foundation, covers methods and compositions for noninvasive administration of sedatives, analgesics, and anesthetics, which includes transdermal delivery systems[2].
Global Patent Family
The patent has a global family with filings in various countries, including the UK (GB2165148B), Canada (CA1245983A), and Australia (AU565177C). These filings indicate the international interest in this technology and its potential global impact[2].
Technical Details
Rate-Controlled Release
The device features a rate-controlling membrane made of ethylene-vinyl acetate (EVA) that ensures a steady release of fentanyl. This membrane, combined with the adhesive layer and the aqueous gel, maintains a consistent drug concentration in the skin over an extended period[4].
Manufacturing Process
The manufacturing process involves forming the adhesive layer on a polyester film, laminating the rate-controlling membrane, and sealing the pouches containing the aqueous gel. The pouches are allowed to equilibrate to ensure the drug and ethanol reach equilibrium concentrations in the layers[4].
Economic and Market Impact
The development of transdermal fentanyl delivery systems has significant economic and market implications. These systems offer a convenient and effective method for managing chronic pain, reducing the need for frequent dosing and improving patient compliance.
Market Statistics
Transdermal drug delivery systems have grown in popularity, with the global market expected to continue expanding due to their ease of use and effectiveness. For instance, the global transdermal drug delivery market was valued at several billion dollars and is projected to grow at a significant CAGR over the next few years[3].
Legal and Regulatory Aspects
Patent Search and Analysis
Conducting a thorough patent search, such as using the USPTO's Patent Public Search tool or the Global Dossier service, is crucial for understanding the patent landscape and identifying potential infringement risks. These tools provide access to prior art, patent family information, and office actions, which are essential for legal and regulatory compliance[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can be used to analyze the scope and claims of patents like US 4,588,580. This dataset provides detailed information on claims from US patents and applications, helping in the assessment of patent scope and potential overlaps[3].
Conclusion
United States Patent 4,588,580 represents a significant advancement in the field of transdermal drug delivery, particularly for potent analgesics like fentanyl. The patent's scope and claims define a specific method and device for controlled drug release, which has had a lasting impact on pain management.
Key Takeaways
- Invention Scope: The patent covers a method and device for transdermal administration of fentanyl.
- Claims: The patent includes claims detailing the device components and the manufacturing process.
- Related Patents: Other patents exist that share similarities in transdermal drug delivery systems.
- Global Impact: The patent has a global family and significant economic and market implications.
- Legal and Regulatory: Thorough patent searches and analysis are crucial for compliance.
FAQs
Q: What is the main invention described in US Patent 4,588,580?
A: The main invention is a method and device for the transdermal administration of fentanyl and its derivatives.
Q: Who are the inventors of US Patent 4,588,580?
A: The inventors are Robert M. Gale, Victor Goetz, Eun S. Lee, Lina T. Taskovich, and Su I. Yum.
Q: What are the key components of the transdermal delivery device?
A: The key components include a backing member, a rate-controlling membrane, an adhesive layer, and an aqueous gel containing fentanyl.
Q: How does the rate-controlling membrane work?
A: The rate-controlling membrane, made of ethylene-vinyl acetate (EVA), ensures a steady release of fentanyl through the skin.
Q: What is the significance of the global patent family for this invention?
A: The global patent family indicates international interest and potential global market impact for the transdermal fentanyl delivery system.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Google Patents - US4588580B2: https://patents.google.com/patent/US4588580B2/en
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google APIs - United States Patent (19): https://patentimages.storage.googleapis.com/30/bb/ea/bb1352d992b0c2/US4588580.pdf
- PatentBuddy - Analytics for US Patent No. 4588580: http://www.patentbuddy.com/Patent/4588580
