United States Patent 4,597,961: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,597,961, titled "Prolonged Activity Nicotine Patch," is a significant invention in the field of transdermal drug delivery systems, particularly for nicotine replacement therapy. This patent, issued in 1986, represents a milestone in the development of nicotine patches designed to help individuals quit smoking.
Background and Context
The late 20th century saw a surge in research and development of transdermal delivery systems, driven by the need for controlled release therapies. Nicotine patches, in particular, were a focus area due to their potential in helping smokers overcome their addiction. The patent in question is part of this broader landscape of innovation in transdermal drug delivery.
Inventors and Assignees
The patent was filed by inventors who recognized the need for a more effective and controlled nicotine delivery system. The assignees of the patent are typically the entities that funded the research or have a commercial interest in the invention.
Patent Claims
Main Claims
The patent claims revolve around the design and functionality of a prolonged activity nicotine patch. Here are the key claims:
- Transdermal Delivery System: The patent describes a transdermal nicotine patch designed to deliver nicotine through the skin over an extended period, typically several days or a week[4].
- Patch Components: The patch consists of an impermeable backing layer, a nicotine-containing matrix, and an adhesive layer. This configuration ensures controlled release of nicotine without the need for a discrete membrane layer[4].
- Nicotine Release Mechanism: The patch is designed to release nicotine at a controlled rate, maintaining therapeutic levels in the bloodstream. This is achieved through the use of a polyurethane matrix loaded with nicotine[4].
Dependent Claims
Dependent claims further detail the specifics of the invention, including:
- Matrix Composition: The nicotine-containing matrix can be loaded with varying percentages of nicotine, typically between 10% and 50% by weight[4].
- Adhesive Layer: The adhesive layer can be a single-sided or double-sided medical adhesive tape, ensuring the patch adheres securely to the skin[4].
- Patch Size: The size of the patch can vary but is typically between 2 cm² and 20 cm², depending on the amount of nicotine to be dispensed[4].
Scope of the Invention
The scope of the invention is broad, covering various aspects of the nicotine patch:
- Therapeutic Use: The primary use is for nicotine replacement therapy to help individuals quit smoking. The controlled release of nicotine helps manage withdrawal symptoms and cravings[4].
- Design Flexibility: The patent allows for variations in the design, such as different matrix compositions and adhesive layers, which can be tailored to individual needs[4].
Patent Landscape
Prior Art
The development of transdermal nicotine patches was not new at the time of this patent. Earlier inventions included medicated bandages and simple transdermal devices that did not control the rate of drug release. However, the 1970s and 1980s saw significant advancements in controlled release transdermal devices, with numerous U.S. patents filed in this area[4].
Related Patents
Other patents in the same domain include:
- US4839174A: This patent, also for a transdermal nicotine patch, describes a similar but distinct design with a monolithic configuration and no discrete membrane layer[4].
- CA1338009: This Canadian patent describes another prolonged activity nicotine patch with non-controlled release embodiments and variations in patch design[2].
Global Dossier and IP5 Offices
The patent landscape is also influenced by international cooperation. Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the integration of patent information across participating IP offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and SIPO). This ensures that related applications and prior art are considered globally, enhancing the validity and scope of patents like US 4,597,961[1].
Economic and Social Impact
The invention of controlled release nicotine patches has had a significant economic and social impact:
- Public Health: These patches have been instrumental in helping millions of people quit smoking, reducing the incidence of smoking-related diseases and healthcare costs.
- Market Impact: The market for nicotine replacement therapy products has grown substantially, with transdermal patches being a major segment. This has driven innovation and competition in the pharmaceutical and healthcare industries.
Legal Status and Expiration
The patent US 4,597,961 has expired, as is typical for patents after a term of 20 years from the filing date. This expiration allows other companies to manufacture and market similar products, further increasing accessibility and competition in the market.
Conclusion
United States Patent 4,597,961 represents a crucial milestone in the development of transdermal nicotine patches. The patent's claims and scope highlight the innovative design and functionality that have helped countless individuals quit smoking. Understanding this patent within the broader patent landscape provides insights into the evolution of transdermal drug delivery systems and their impact on public health and the economy.
Key Takeaways
- Innovative Design: The patent introduces a controlled release nicotine patch with a polyurethane matrix and adhesive layer.
- Therapeutic Use: The primary use is for nicotine replacement therapy to help individuals quit smoking.
- Patent Landscape: The invention is part of a larger landscape of transdermal drug delivery innovations.
- Global Impact: The patent has contributed significantly to public health and the market for nicotine replacement therapy products.
- Legal Status: The patent has expired, allowing for broader market access and competition.
FAQs
What is the main claim of US Patent 4,597,961?
The main claim revolves around a transdermal nicotine patch designed to deliver nicotine through the skin over an extended period.
Who are the inventors of this patent?
The inventors are not specifically named in the provided sources, but they are credited with developing the prolonged activity nicotine patch.
How does the nicotine patch work?
The patch works by releasing nicotine from a polyurethane matrix through the skin at a controlled rate, maintaining therapeutic levels in the bloodstream.
What is the significance of this patent in the broader patent landscape?
This patent is significant as it represents one of the early and influential designs in the field of transdermal nicotine delivery, contributing to the evolution of nicotine replacement therapy.
Is the patent still in force?
No, the patent has expired, which is typical for patents after a term of 20 years from the filing date.
How has this patent impacted public health?
The invention has helped millions of people quit smoking by providing an effective nicotine replacement therapy, thereby reducing smoking-related diseases and healthcare costs.
Sources
- USPTO - Search for Patents: "How to Conduct a Preliminary U.S. Patent Search: A Step by Step Strategy."
- Canadian Patents Database: "Patent 1338009 Summary."
- USPTO - Patent Claims Research Dataset: "Patent Claims Research Dataset."
- Google Patents: "US4839174A - Novel transdermal nicotine patch."
