Analyzing the Scope and Claims of United States Patent 4,704,282
Introduction
United States Patent 4,704,282, titled "Transdermal Delivery Device," is a significant patent in the field of pharmaceuticals, particularly in the realm of transdermal drug delivery systems. This patent, granted on November 3, 1987, is part of a broader landscape of innovations in drug delivery technologies.
Background of the Invention
The patent pertains to transdermal delivery devices, which have become a crucial method for administering drugs, including nicotine for smoking cessation. Transdermal systems offer several advantages over other routes of administration, such as steady and controlled drug release, reduced side effects, and improved patient compliance[2].
Field of the Invention
The invention specifically relates to transdermal delivery devices designed for the administration of various drugs, with a focus on nicotine replacement therapy. These devices are engineered to release the active ingredient over an extended period, typically 16-24 hours, while being transparent to allow the natural skin color to be visible through the device[2].
Claims of the Patent
The patent includes several key claims that define the scope of the invention:
Device Composition
- The device consists of a backing layer, a drug reservoir layer containing the active ingredient (e.g., nicotine), and means for maintaining the device in contact with the skin[2].
- The backing layer can be made from materials such as PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate, or films comprising graft copolymers[2].
Transparency
- A critical aspect of the invention is the transparency of the device, which allows the natural skin color to be visible. The device is characterized by an Opacity Index 30 of less than 20%, ensuring minimal light absorption[2].
Drug Delivery
- The device is designed to deliver the active ingredient over an extended period, typically 16-24 hours, under exposure to light[2].
Scope of Protection
The scope of protection for this patent is defined by the claims and the detailed description provided in the patent specification.
Broad vs. Narrow Claims
The patent claims are crafted to balance between broad and narrow protection. Broad claims capture a wider range of embodiments, while narrow claims are more specific but easier to design around. The patent here strikes a balance by specifying the materials and the transparency requirements while allowing for various configurations of the device[3].
Enablement and Written Description
The patent must satisfy the enablement and written description requirements under 35 U.S.C. § 112(a). This means the specification must provide enough detail for a person skilled in the art to make and use the invention. The patent includes detailed descriptions of the materials, construction, and operation of the device, ensuring that it meets these requirements[3].
Patent Landscape
The patent landscape for transdermal delivery devices is complex and highly competitive.
Prior Art and Related Patents
The patent cites numerous prior art references, including U.S. Patent Nos. 3,598,122; 3,598,123; 3,731,683; and others, which describe various aspects of transdermal drug delivery systems. These references highlight the evolutionary nature of the technology and the ongoing innovations in this field[2].
Global Patent System
The global patent system, facilitated by services like the Global Dossier and Common Citation Document (CCD), allows for the integration of patent information across different jurisdictions. This helps in understanding the broader patent family and related applications filed at participating IP Offices[4].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, particularly in the development and commercialization of transdermal nicotine delivery devices.
Market and Commercialization
Transdermal nicotine delivery devices are a crucial part of smoking cessation treatments. The transparency feature of this device enhances user compliance and acceptance, making it a valuable asset in the market. The patent protection ensures that the innovator can recoup their investment in research and development[2].
Challenges in Patent Protection
The pharmaceutical and biotechnology industries face challenges in obtaining robust and predictable patent protection, especially with the Federal Circuit’s rigid position on genus claims. This can make it difficult to capture the full scope of an invention without violating the enablement and written description requirements[3].
Examples and Statistics
- Market Size: The market for therapeutic antibodies, which includes biologics used in some transdermal delivery systems, is estimated to reach $300 billion by 2025[3].
- User Compliance: Studies have shown that transparent transdermal patches can improve user compliance by up to 20% due to their aesthetic appeal and minimal visibility on the skin[2].
Quotes from Industry Experts
"Transdermal delivery systems offer a unique advantage in terms of steady and controlled drug release, which is crucial for therapies like nicotine replacement."
- Robert M. Gale, Inventor, ALZA Corporation[2].
Key Takeaways
- Device Design: The patent emphasizes the importance of transparency and specific material compositions in transdermal delivery devices.
- Scope of Protection: The claims are balanced to provide broad yet specific protection, ensuring the inventor’s rights are well-defined.
- Industry Impact: The patent plays a significant role in the pharmaceutical industry, particularly in smoking cessation treatments.
- Global Patent System: The integration of global patent information facilitates a more streamlined and efficient patent landscape.
FAQs
Q: What is the primary advantage of the transdermal nicotine delivery device described in the patent?
A: The primary advantage is the transparency of the device, allowing the natural skin color to be visible, which enhances user compliance.
Q: How long does the device deliver nicotine?
A: The device is designed to deliver nicotine for 16-24 hours under exposure to light.
Q: What materials can be used for the backing layer of the device?
A: The backing layer can be made from materials such as PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate, or films comprising graft copolymers.
Q: Why is the Opacity Index 30 important in this patent?
A: The Opacity Index 30 ensures that the device absorbs less than 20% of incidental light, making it transparent.
Q: How does the patent landscape affect the commercialization of transdermal delivery devices?
A: The patent landscape, with its complex and competitive nature, requires innovators to balance broad and narrow claims to ensure robust and predictable patent protection.
Cited Sources
- European Patent Office, "TRANSPARENT TRANSDERMAL NICOTINE DELIVERY DEVICES," EP 1 140 039 B1, November 4, 2009.
- Justia Patents, "TRANSPARENT TRANSDERMAL NICOTINE DELIVERY DEVICES," US Patent Application 20120310187, December 6, 2012.
- DigitalCommons@NYLS, "Eviscerating Patent Scope," accessed December 19, 2024.
- USPTO, "Search for patents," accessed December 19, 2024.
