Analyzing the Scope and Claims of United States Patent 6,385,488
Introduction
United States Patent 6,385,488, assigned to Vyteris Inc., is a significant patent in the field of iontophoretic drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Title: Locking and Disfiguring Mechanism for an Iontophoretic System
Patent Number: US 6,385,488
Issue Date: September 10, 2002
Assignee: Vyteris Inc.
Claims and Scope
The patent focuses on a locking and disfiguring mechanism designed for an iontophoretic system. Here are the key aspects of the claims:
Independent Claims
- Claim 1 describes a locking mechanism for securing the iontophoretic system to the skin, ensuring proper contact and preventing accidental dislodgment.
- Claim 2 details a disfiguring mechanism that prevents the reuse of the iontophoretic system, enhancing safety and compliance with single-use protocols.
Dependent Claims
- These claims elaborate on the specific components and functionalities of the locking and disfiguring mechanisms, including the materials used, the design of the locking elements, and the process of disfiguring the device after use.
Technical Description
The patent specifies a system that includes an electrode assembly and a reservoir containing the drug to be delivered. The locking mechanism ensures that the electrode assembly is securely attached to the skin, while the disfiguring mechanism renders the device unusable after a single application. This is crucial for maintaining the integrity of the drug delivery process and preventing potential misuse.
Patent Landscape Analysis
Geographical Spread and Saturation
The patent landscape for iontophoretic drug delivery systems is relatively saturated, with numerous patents filed by various companies. However, Vyteris Inc.'s patents, including US 6,385,488, hold a significant position due to their innovative locking and disfiguring mechanisms[3].
Competitors and New Entrants
Key competitors in this space include other pharmaceutical and medical device companies that have developed similar iontophoretic systems. New entrants are continually evaluating the patent landscape to identify opportunities for innovation and market entry. The saturation level in this technology area necessitates a comprehensive patent landscape analysis to uncover strategic insights and potential niches[3].
Time-Slicing and Historical Context
The patent was issued in 2002, and since then, there have been significant advancements in iontophoretic technology. Time-slicing analysis would show that while this patent was innovative at the time of its issuance, subsequent patents have built upon or circumvented its claims. Understanding the historical context and the evolution of technology in this field is essential for strategic decision-making[3].
Exclusivity and Patent Expiry
Patent Expiry
The patent US 6,385,488 expired in September 2013, which is 11 years after its issue date. This expiry has opened up opportunities for generic or similar products to enter the market[2].
Global Patent Protection
While the patent protection in the United States has expired, it is crucial to examine the broader global patent landscape. Patents in multiple countries may still be in effect, influencing the timing and strategy for market entry in different regions[2].
Impact on Market Entry
The expiry of this patent, along with other related patents held by Vyteris Inc., has facilitated the entry of generic products. Companies considering market entry must analyze the remaining patent protection, if any, and the competitive landscape to strategize their launch effectively[2].
Strategic Insights
Identifying Niche Areas
A comprehensive patent landscape analysis can help identify underappreciated niche areas within the iontophoretic drug delivery system technology. This could involve focusing on specific improvements or innovations that are not heavily patented, allowing for new market opportunities[3].
Evaluating Competitor Activity
Understanding the patent activities of competitors, including filings, grants, and expiries, provides valuable insights into their strategic directions. This information can guide R&D and business decisions, helping companies to pivot or invest in areas with less patent saturation[3].
Key Takeaways
- Patent Scope and Claims: US 6,385,488 covers a locking and disfiguring mechanism for iontophoretic systems, ensuring secure and single-use operation.
- Patent Landscape: The iontophoretic drug delivery system space is saturated, but there are opportunities for innovation and niche market entry.
- Exclusivity and Expiry: The patent has expired, but global patent protection and competitor activities must be considered for market strategy.
- Strategic Insights: Comprehensive patent landscape analysis is crucial for identifying opportunities and making informed R&D and business decisions.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of US Patent 6,385,488?
A: The primary focus is on a locking and disfiguring mechanism for an iontophoretic system to ensure secure and single-use operation.
Q: When did the patent expire?
A: The patent expired in September 2013, 11 years after its issue date.
Q: How does the expiry of this patent affect market entry?
A: The expiry has opened up opportunities for generic or similar products to enter the market, but companies must still consider global patent protection and competitor activities.
Q: What is the significance of patent landscape analysis in this context?
A: Patent landscape analysis helps identify niche areas, evaluate competitor activity, and guide R&D and business decisions in a saturated technology space.
Q: Are there other patents related to this technology that are still in effect?
A: Yes, while US 6,385,488 has expired, other related patents may still be in effect globally, influencing market entry strategies.
Sources:
- The Analysis of the Temporary Patent Application System in the US - Clausius Press.
- Lidosite Topical System Kit patent expiration - Pharsight.
- Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP.
- USPTO Issues New Guidance on Patent Subject Matter Eligibility for AI Inventions - GT Law.
- Patents Assigned to Vyteris, Inc. - Justia.
