Detailed Analysis of the Scope and Claims of United States Patent 5,697,896
Introduction
United States Patent 5,697,896, titled "Electrotransport Delivery Device," is a significant patent in the field of medical devices, particularly for the delivery of pharmaceutical agents through the skin. This patent, issued to ALZA Corporation, covers the IONSYS fentanyl iontophoretic transdermal system. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Number and Issue Date
The patent number is 5,697,896, and it was issued on December 16, 1997[2].
Inventors
The inventors listed on the patent are Larry A. McNichols, John D. Badzinski, and Ronald P. Haak[2].
Patent Title and Description
The patent is for an "Electrotransport Delivery Device," specifically an electrically powered device designed to deliver an agent, such as fentanyl, through electrotransport across a body surface. This device is part of the IONSYS system, which is a fentanyl iontophoretic transdermal system used for pain management[2].
Patent Claims
Number and Scope of Claims
The patent contains 10 claims, with claims 1-4, 6-7, and 9-10 being applicable to the approved product, the IONSYS system. These claims define the specific components and functionalities of the electrotransport delivery device[2].
Key Claims
- Claim 1: An electrically powered device for delivering an agent by electrotransport through a body surface of a patient.
- Claims 2-4: These claims specify various aspects of the device, including the presence of an electrode, a power source, and a control system.
- Claims 6-7: These claims detail the operation of the device, including the delivery of the agent and the control mechanisms.
- Claims 9-10: These claims cover additional features such as error detection and deactivation mechanisms[2].
Patent Scope and Breadth
Metrics for Measuring Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Specific Scope of U.S. Patent 5,697,896
The patent's scope is defined by its claims, which are relatively specific and focused on the electrotransport delivery mechanism. This specificity helps in avoiding overly broad claims that could lead to licensing and litigation issues[3].
Patent Valuation and Market Impact
Valuation Methods
Patents can be valued using the cost, income, and market approaches. For U.S. Patent 5,697,896, the market approach would consider comparable sales of similar medical device patents. The income approach would evaluate the future benefits, such as revenue generated from the sale of the IONSYS system[4].
Market Value
The market value of this patent can be inferred from similar transactions in the medical device and pharmaceutical sectors. For instance, large portfolios of patents in the healthcare sector have been sold for significant amounts, indicating the high value placed on innovative medical technologies[4].
Patent Extension and Regulatory Aspects
Patent Term Extension
ALZA Corporation requested an extension of the patent term for U.S. Patent 5,697,896 under the Drug Price Competition and Patent Term Restoration Act of 1984. This extension is sought due to the regulatory review period for the approved product, which delayed the market entry of the IONSYS system[2][5].
Regulatory Approval
The IONSYS system, covered by this patent, underwent rigorous regulatory approval processes. The patent extension application includes detailed information on how each applicable patent claim reads on the approved product, demonstrating compliance with regulatory requirements[2].
Global Patent Landscape
International Patent Family
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service helps in understanding the global reach and protection of the invention covered by U.S. Patent 5,697,896[1].
Common Citation Document (CCD)
The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the global patent landscape and ensuring that the invention is novel and non-obvious across different jurisdictions[1].
Public Access and Search Tools
USPTO Resources
The USPTO provides several resources for searching patents, including the Patent Public Search tool, Global Dossier, and the Public Search Facility. These resources are essential for conducting thorough patent searches and understanding the prior art related to U.S. Patent 5,697,896[1].
Patent and Trademark Resource Centers (PTRCs)
PTRCs offer local search resources and training in patent search techniques, which can be beneficial for researchers and inventors looking to understand the patent landscape surrounding this invention[1].
Key Takeaways
- Specific Claims: U.S. Patent 5,697,896 has specific claims that define the electrotransport delivery device, ensuring a clear scope and reducing the risk of overly broad claims.
- Valuation: The patent's value can be significant, as evidenced by comparable sales in the medical device sector.
- Regulatory Compliance: The patent extension application and regulatory approval process highlight the importance of compliance with regulatory requirements.
- Global Protection: The use of Global Dossier and CCD tools helps in understanding the global patent family and ensuring protection across different jurisdictions.
FAQs
What is the main invention covered by U.S. Patent 5,697,896?
The main invention is an electrically powered device for delivering an agent, such as fentanyl, through electrotransport across a body surface, known as the IONSYS fentanyl iontophoretic transdermal system.
How many claims are in U.S. Patent 5,697,896, and which ones are applicable?
The patent contains 10 claims, with claims 1-4, 6-7, and 9-10 being applicable to the approved product.
What is the significance of the patent term extension application for U.S. Patent 5,697,896?
The patent term extension application was sought to compensate for the time spent in regulatory review, which delayed the market entry of the IONSYS system.
How can the value of U.S. Patent 5,697,896 be determined?
The value can be determined using the market approach by looking at comparable sales of similar medical device patents, or through the income approach by evaluating future benefits.
What tools are available for searching and analyzing patents related to U.S. Patent 5,697,896?
Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for searching and analyzing patents.
Sources
- USPTO: Search for patents - USPTO. (2018, October 18).
- Regulations.gov: APP l - Regulations.gov.
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN.
- Perpetual Motion Patents: The value of a patent - Perpetual Motion Patents.
- Regulations.gov: Patent Extension Application for IONSYS (fentanyl iontophoretic transdermal system), U.S. Patent No. 5,697,896.
