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Last Updated: December 22, 2024

Details for Patent: 8,428,708


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Which drugs does patent 8,428,708 protect, and when does it expire?

Patent 8,428,708 protects IONSYS and is included in one NDA.

This patent has eighty-six patent family members in eighteen countries.

Summary for Patent: 8,428,708
Title:Self-test for analgesic product
Abstract: Electrotransport drug delivery devices, system and methods of using configured to determine if a current is present between the anode and cathode when drug is not intended to be delivered by the device. These devices/systems may include an off-current module to determine that any current (e.g., which may be inferred by measuring potential difference between the anode and cathode of the device) flowing between the anode and cathode is below a threshold value when the device is not supposed to be delivering drug, thereby preventing unintended delivery of drug and/or alerting a user that unintended delivery of drug may occur.
Inventor(s): White; Bradley E. (Mason, OH), Lemke; John (Pleasanton, CA), Hayter; Paul (Mountain View, CA), Chen; Corinna X. (Oakland, CA), Read; Brian W. (Brier, WA), Dougherty; Jason E. (Seattle, WA)
Assignee: Incline Therapeutics, Inc. (Redwood City, CA) Alza Corporation (Vacaville, CA)
Application Number:13/476,960
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 8,428,708

Introduction

United States Patent 8,428,708, titled "Self-test for analgesic product," is a patent that describes an innovative approach to ensuring the proper functioning of electrotransport drug delivery devices. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Overview of the Patent

Publication Details

  • Publication Number: US8428708B1
  • Authority: United States
  • Prior Art Date: The patent was filed on June 29, 2011, and granted on April 23, 2013[4].

Invention Summary

The patent pertains to an electrotransport drug delivery system designed to deliver analgesic products. The system includes a reservoir module with an anode, a cathode, and a source of the drug, along with an electrical module that applies current between the anode and cathode to deliver the drug. A key feature is the off-current module, which periodically checks for any unwanted current flow between the anode and cathode when the device is in the off state, preventing unintended drug delivery[4].

Scope of the Patent

Technical Details

The patent describes a self-test mechanism integrated into the electrotransport drug delivery system. Here are the key technical aspects:

  • Reservoir Module: Includes an anode, a cathode, and a source of the drug.
  • Electrical Module: Contains an activation circuit that applies current to deliver the drug when the device is in the on state.
  • Off-Current Module: Automatically and periodically checks for current flow between the anode and cathode when the device is in the off state. If current is detected above a predetermined threshold, it triggers an indicator or shuts down the device[4].

Applications

The invention is primarily aimed at ensuring the safety and reliability of electrotransport drug delivery systems. By preventing unintended drug delivery, it enhances patient safety and the overall efficacy of the treatment.

Claims of the Patent

Independent Claims

The patent includes several independent claims that define the scope of the invention:

  • Claim 1: Describes the electrotransport drug delivery device with a reservoir module, an electrical module, and an off-current module.
  • Claim 10: Focuses on the method of automatically determining if there is a current flowing between the anode and cathode when the device is in the off state[4].

Dependent Claims

Dependent claims further specify the details of the invention, such as the configuration of the off-current module, the threshold values for current detection, and the actions taken when unwanted current is detected.

Patent Landscape

Related Patents and Applications

The patent landscape for electrotransport drug delivery systems is rich with various inventions and improvements. Here are a few relevant points:

  • Global Patent Family: The patent is part of a larger family of patents filed in different jurisdictions, reflecting its global significance.
  • Citation Data: The Common Citation Document (CCD) application by the USPTO consolidates prior art citations from participating IP offices, which can be useful in understanding the broader context of this patent[1].

Industry Impact

The invention has significant implications for the medical device industry, particularly in the field of pain management and drug delivery systems. It addresses critical safety concerns and enhances the reliability of electrotransport devices.

Legal and Regulatory Aspects

Patent Office Actions

The patent has undergone various office actions during its prosecution. The Global Dossier service provided by the USPTO allows users to access the file histories of related applications, including office actions and citations[1].

Expiration and Maintenance

The patent has expired due to fee-related issues. However, understanding the legal status and maintenance requirements is crucial for similar patents to ensure they remain in force[4].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to medical devices. This dataset can be used to analyze trends and scope measurements in patent claims, offering insights into the economic and research implications of such inventions[3].

Expert Opinions and Studies

Small Claims Patent Court Study

While not directly related to this specific patent, studies on small claims patent courts highlight the need for efficient and cost-effective dispute resolution mechanisms in the patent landscape. This could impact how future patents, including those in the medical device sector, are litigated and enforced[5].

Key Takeaways

  • Safety Mechanism: The patent introduces a critical safety mechanism to prevent unintended drug delivery in electrotransport systems.
  • Technical Scope: The invention includes a reservoir module, an electrical module, and an off-current module.
  • Industry Impact: It enhances patient safety and the reliability of drug delivery systems.
  • Legal and Regulatory: Understanding office actions, patent family, and legal status is essential for maintaining and enforcing similar patents.
  • Economic and Research: The patent claims dataset and economic studies provide valuable insights into the broader patent landscape.

FAQs

Q: What is the primary purpose of the off-current module in the patent? A: The off-current module is designed to periodically check for any unwanted current flow between the anode and cathode when the device is in the off state, preventing unintended drug delivery.

Q: How does the Common Citation Document (CCD) application relate to this patent? A: The CCD application consolidates prior art citations from participating IP offices, providing a single point of access to citation data related to the patent family.

Q: What is the current legal status of the patent? A: The patent has expired due to fee-related issues.

Q: How can the Patent Claims Research Dataset be useful for analyzing this patent? A: The dataset provides detailed information on claims from U.S. patents, allowing for the analysis of trends and scope measurements in patent claims.

Q: What is the significance of the Global Dossier service in relation to this patent? A: The Global Dossier service allows users to access the file histories of related applications, including office actions and citations, from participating IP offices.

More… ↓

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Drugs Protected by US Patent 8,428,708

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,428,708

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012238095 ⤷  Subscribe
Australia 2012238096 ⤷  Subscribe
Australia 2013266914 ⤷  Subscribe
Australia 2013274873 ⤷  Subscribe
Australia 2015271708 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.