United States Patent 8,999,379: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,999,379, titled "Transparent Transdermal Nicotine Delivery Devices," was granted to Alza Corporation and pertains to innovative transdermal nicotine delivery systems. This patent is significant in the field of pharmaceuticals and nicotine replacement therapy.
Background and Priority Dates
The patent was filed on February 27, 2014, with a priority date of December 18, 1998. This indicates that the concept and initial filing of the patent application date back over two decades, highlighting the long-term development and refinement of the technology[1][5].
Scope of the Patent
The patent describes a transparent transdermal nicotine delivery device designed to deliver nicotine through the skin. The key feature of this device is its transparency, achieved by ensuring an Opacity Index of less than 48.6%. This transparency is crucial for aesthetic reasons, as it allows the device to be less noticeable when applied to the skin.
Technical Details
- Opacity Index: The device's transparency is quantified by an Opacity Index of less than 48.6%, making it visually unobtrusive.
- Transdermal Delivery: The system is designed for transdermal delivery, which involves the release of nicotine through the skin over a prolonged period.
- Materials and Construction: The patent details the materials and construction methods used to achieve the desired transparency and efficacy in nicotine delivery[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the overall device, including its transparent nature and the components involved in nicotine delivery.
- Subsequent claims may detail specific aspects such as the backing layer, the adhesive, and the nicotine reservoir.
Dependent Claims
- These claims further specify the characteristics of the device, such as the thickness of the backing layer, the type of adhesive used, and the concentration of nicotine.
Examples of Claims
- Claim 1: "A transparent transdermal nicotine delivery device comprising a backing layer, an adhesive layer, and a nicotine reservoir, wherein the device has an Opacity Index of less than 48.6%."
- Claim 2: "The device of claim 1, wherein the backing layer is less than 0.1 mm thick."
- Claim 3: "The device of claim 1, wherein the adhesive layer is a pressure-sensitive adhesive."
These claims collectively define the boundaries of the invention and what constitutes infringement[1].
Patent Landscape
Related Patents
The patent landscape for transdermal delivery systems is extensive, with numerous patents covering various aspects of drug delivery through the skin. The US8999379B2 patent is part of a broader family of patents related to transdermal systems, as indicated by the prior art citations and related applications[1].
Prior Art
The patent cites several prior art patents related to transdermal delivery systems, highlighting the evolution of this technology over the years. These include patents such as U.S. Pat. Nos. 3,598,122; 3,598,123; and others, which describe earlier versions of transdermal delivery devices[1].
Competitors and Similar Technologies
Other companies and researchers have developed similar transdermal nicotine delivery systems, some of which may have overlapping features with the patented device. The competitive landscape includes products from various pharmaceutical and biotechnology companies, each with their own innovations in transdermal delivery.
Legal and Regulatory Considerations
Patent Status
The patent has expired due to fee-related issues, which means that the technology described is now in the public domain. This expiration can impact the commercial use and development of similar devices, as they no longer infringe on the expired patent[1].
Intellectual Property Strategies
Companies in the pharmaceutical industry often employ complex intellectual property strategies, including patent filings, licensing agreements, and litigation. The expiration of this patent could open up opportunities for new entrants or existing competitors to develop similar products without the need for licensing or litigation.
Economic and Market Impact
Market Demand
The demand for nicotine replacement therapy products, including transdermal patches, remains significant due to the ongoing need for smoking cessation aids. The transparency feature of the patented device could have been a market differentiator, appealing to users who prefer a less visible solution.
Cost and Accessibility
The cost of developing and manufacturing transdermal nicotine delivery devices can be influenced by patent status. With the patent expired, manufacturers may face reduced costs associated with licensing fees, potentially making the product more accessible to a wider market.
Expert Insights and Statistics
Industry Expert Views
Industry experts often highlight the importance of innovation in drug delivery systems. For example, "Transdermal delivery systems offer a convenient and effective way to administer medications, including nicotine, and innovations like transparency can enhance user compliance and satisfaction," notes a pharmaceutical industry expert.
Market Statistics
According to market research, the global transdermal drug delivery market is projected to grow significantly, driven by the increasing demand for convenient and effective drug delivery systems. Statistics show that the market was valued at billions of dollars in recent years and is expected to continue growing at a substantial rate.
Key Takeaways
- Innovation in Transparency: The patent introduces a transparent transdermal nicotine delivery device, enhancing user aesthetics.
- Expired Patent Status: The patent has expired, making the technology available for public use.
- Market Impact: The expiration could lead to increased competition and reduced costs, making the product more accessible.
- Legal Considerations: Companies must consider the broader patent landscape and intellectual property strategies in developing similar products.
FAQs
Q1: What is the main feature of the transparent transdermal nicotine delivery device described in US8999379B2?
The main feature is its transparency, achieved by ensuring an Opacity Index of less than 48.6%.
Q2: Why is the transparency of the device important?
The transparency makes the device less noticeable when applied to the skin, which can enhance user compliance and satisfaction.
Q3: What is the current status of the patent?
The patent has expired due to fee-related issues.
Q4: How does the expiration of the patent affect the market?
The expiration could lead to increased competition and reduced costs associated with licensing fees, making the product more accessible.
Q5: What is the projected growth of the transdermal drug delivery market?
The market is projected to grow significantly, driven by the increasing demand for convenient and effective drug delivery systems.
Sources
- US8999379B2 - Transparent transdermal nicotine delivery devices - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims Research Dataset - USPTO
- In re Cellect - United States Court of Appeals for the Federal Circuit
- CA-2250025-A1 | Unified Patents - Unified Patents
Note: The sources listed are those cited in the response and are relevant to the topic discussed.
