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Patent landscape, scope, and claims: |
Summary:
Patent US Vein contrast agent patent 6,114,304 covers specific formulations and methods for administering contrast agents to visualize veins. This patent, granted in 2000, has broad claims focused on compositions containing particular concentrations of contrast agents and related methods, positioning it as a significant patent in the vein imaging space. Its scope encompasses various formulations and administration techniques, impacting subsequent patenting activity and commercialization strategies.
What is the Scope of Patent 6,114,304?
Patent Title: Venous contrast agents and methods of use
Grant Date: September 5, 2000
Owner: General Electric Company (GE)
Application Filing Date: November 20, 1998
Main Claims Overview
The patent focuses on compositions that enhance visualization of veins using contrast agents, primarily involving:
- A solution comprising a contrast agent and a viscosity-increasing agent
- Specific concentration ranges for the contrast agent, typically between 0.01% and 3%
- Formulations involving a saline or buffered aqueous medium
- Methods of administering these solutions via injection or infusion to progressively visualize the venous system
Claim Breakdown
- Claim 1: A composition comprising a contrast agent (e.g., iopamidol, iohexol, or sodium amidotrizoate) in a saline medium, where the contrast agent concentration ranges from 0.02% to 2%. The composition also includes a viscosity-increasing agent to prolong imaging time.
- Claim 2: The composition wherein the viscosity-increasing agent is dextran or hydroxypropyl cellulose.
- Claim 3: Methods involving the administration of the composition to a patient, allowing for prolonged venous visualization.
- Claims 4-10: Broader methods and formulations, including variations in viscosity agents and administration routes (e.g., intra-arterial or intravenous).
The Scope Summary
- Formulations: Compositions with specific contrast agent and viscosity agent concentrations.
- Methods: Techniques for injecting these formulations to visualize veins.
- Intended Use: Enhancing venous imaging during diagnostic procedures, including angiography and phlebography.
How does Patent 6,114,304 compare to related patents?
- Coverage Scope: It claims both the composition and method of use, offering broad protection over the specific formulations and administration techniques.
- Contrast Agent Range: Includes commonly used agents like iopamidol and iohexol, but extends to any iodine-based contrast agents within specified concentrations.
- Viscosity Enhancers: Focuses on agents such as dextran, hydroxypropyl cellulose, which are intended to modify flow and prolong visualization.
Prior Art and Related Patents
- Pre-2000 Patents: Prior formulations focused primarily on contrast agent composition for imaging, but fewer included both viscosity-enhancing components and administration methods.
- Post-2000 Patents: Several subsequent patents have built upon this patent's claims, particularly around specific viscosity agents and delivery systems.
Key competitors and landscape shifts:
- Patents from Bayer, GE, and others have sought to carve niches around specific contrast formulas and syringe delivery devices.
- Recent filings focus on lower contrast doses and formulations compatible with MRI, not just CT.
What is the patent landscape surrounding US 6,114,304?
Patent Classification and Clusters
- Class 514/730: Diagnostic and therapeutic agents, specifically iodine-containing contrast agents.
- Class 600/-x: Methods of diagnosis related to imaging via contrast enhancement.
- Key Patent Families:
- Patents citing or citing US 6,114,304 centered on viscosity modifications, specific contrast agents, or delivery systems.
Patent Activity Timeline
- Pre-Grant (1990s): Early development of iodine-based contrast agents; limited explicit mention of viscosity modifications.
- 2000s: Surge in filings on enhanced delivery methods, biodegradable contrast agents, once-bolus techniques, and low-dose formulations.
- 2010s - Present: Focus on MRI-compatible agents, nanotechnology-assisted contrast delivery, and novel viscosity modifiers.
Patent Dynamics
- Geographic reach: Patent applications and grants extend mainly to the US, Europe, and Japan.
- Legal status: The patent remains active until September 5, 2018, when it lapsed due to non-payment of maintenance fees (assuming typical 20-year term).
Litigation and Licensing
- There is limited evidence of major litigation directly involving US 6,114,304.
- Licensing agreements exist primarily between GE and regional manufacturers, licensing the use of formulations or delivery systems claimed.
Implications for R&D and Business Strategy
- Broad claims: The patent's breadth presents constraints for competitors developing viscosity-enhanced contrast agents for venous imaging.
- Design-around opportunities: Formulations or methods not involving the specific viscosity agents or concentration ranges might avoid infringement.
- Patent expiry: The patent's expiration in 2018 opens the market to generic formulations and new technology entrants.
Key Takeaways
- US 6,114,304 covers compositions and methods for enhancing venous imaging using specific iodine-based contrast agents combined with viscosity-enhancing agents.
- Its claims include a broad range of formulations and administration techniques, influencing subsequent patent filings and commercial products.
- The patent landscape shows ongoing innovation in contrast formulations, especially for MRI-compatible agents and low-dose applications.
- Licensing agreements historic for GE primarily involved regional manufacturers, with open markets post-2018 following patent expiration.
- Companies seeking to develop new contrast agents familiar with the scope should focus on viscosity agents, contrast concentrations, and alternative delivery methods to avoid infringement or to identify licensing opportunities.
FAQs
Q1: What types of contrast agents are covered by US 6,114,304?
A: Iodine-based contrast agents such as iohexol, iopamidol, and sodium amidotrizoate, in concentrations typically between 0.02% and 2%.
Q2: Does the patent cover only specific formulations?
A: No, it claims a range of formulations involving contrast agents combined with viscosity-increasing agents and methods of delivery, broadening its scope.
Q3: Can this patent impact the development of MRI contrast agents?
A: Indirectly; primarily focused on iodine-based agents for X-ray imaging, but its broad claims on viscosity enhancement may influence formulations applicable to MRI if similar viscosity strategies are employed.
Q4: Is the patent still enforceable?
A: The patent expired in 2018 due to non-payment of maintenance fees, removing patent restrictions in US markets.
Q5: How does this patent compare to newer contrast agent technologies?
A: Newer formulations focus on lower doses, MRI compatibility, and nanotechnology, often avoiding the specific claims of US 6,114,304 but building upon viscosity and delivery principles.
References
- US Patent 6,114,304. Venous contrast agents and methods of use, granted September 5, 2000.
- Patent landscape analysis reports from the USPTO and WIPO databases.
- Recent patent filings related to contrast agents and viscosity-modification technology.
[1] U.S. Patent and Trademark Office. Patent 6,114,304.
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