Detailed Analysis of the Scope and Claims of United States Patent 4,001,323
Introduction
United States Patent 4,001,323, issued on January 4, 1977, is a significant patent that describes the preparation of water-soluble, non-ionizing hydroxy-containing amide derivatives of 2,4,6-triiodo-3-acetamido benzoic acid. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent in question pertains to a chemical process and the resulting compounds used primarily in medical imaging, particularly in radiography. The invention involves the synthesis of specific amide derivatives, which are crucial for their water-solubility and non-ionizing properties, making them suitable for medical use[5].
Scope of the Patent
The scope of the patent is defined by the claims, which outline the specific processes and compounds protected under the patent.
Claims
The patent includes several claims that cover:
- Process Claims: These claims describe the specific steps and conditions for synthesizing the amide derivatives. For example, the reaction of dimethyl 5-nitroisophthalate with other reagents under specific conditions to produce the desired compounds[4].
- Compound Claims: These claims protect the specific chemical structures of the amide derivatives produced through the described process. This includes the water-soluble, non-ionizing hydroxy-containing amide derivatives of 2,4,6-triiodo-3-acetamido benzoic acid[5].
Patent Landscape
To understand the position of this patent within the broader patent landscape, it is essential to analyze the following aspects:
Prior Art
The patent references prior art, such as British Patent 1,548,594, which described a similar process but with lower yields and longer reaction times. The current patent improves upon this prior art by achieving higher yields (96.9-99.6%) and shorter reaction times (five hours compared to 44 hours)[4].
Competing Patents
The patent landscape in the field of medical imaging and radiography is dense with various patents covering different aspects of contrast agents and their synthesis. For instance, other patents might cover alternative synthesis methods or different types of contrast agents. The unique process and compounds described in U.S. Patent 4,001,323 differentiate it from these competing patents.
Patent Analytics
To fully understand the coverage and gaps in the patent portfolio related to this invention, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to identify areas of protection and potential gaps. For example, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property and where opportunities or gaps exist[3].
Regulatory Considerations
While the patent itself does not deal directly with regulatory approvals, it is crucial to consider the regulatory environment in which such medical imaging agents are used. Patents in this field may be subject to extensions under the Hatch-Waxman Act, which compensates for the time lost during FDA approval processes. However, such extensions are subject to specific limitations and calculations, as seen in the context of other pharmaceutical patents[1][2].
Economic and Market Impact
The economic and market impact of U.S. Patent 4,001,323 can be significant, given the importance of contrast agents in medical imaging. The improved yield and shorter reaction times described in the patent can lead to cost savings and increased efficiency in production, making the product more competitive in the market.
Expiration and Extension
The original term of the patent would have been 17 years from the date of issuance. However, considering the changes in patent law, such as those introduced by the Uruguay Round Agreements Act (URAA), the patent term might have been adjusted to 20 years from the filing date. Any potential extensions under the Hatch-Waxman Act would have been calculated based on these adjusted terms[1][2].
Key Takeaways
- Process and Compound Innovation: The patent introduces an improved process for synthesizing water-soluble, non-ionizing hydroxy-containing amide derivatives with higher yields and shorter reaction times.
- Patent Landscape: The patent is part of a dense landscape in medical imaging and radiography, with unique claims that differentiate it from prior art and competing patents.
- Regulatory Considerations: While not directly related to regulatory approvals, the patent's term and potential extensions are influenced by regulatory frameworks.
- Economic Impact: The improved process can lead to cost savings and increased market competitiveness.
FAQs
Q: What is the main innovation described in U.S. Patent 4,001,323?
A: The main innovation is an improved process for synthesizing water-soluble, non-ionizing hydroxy-containing amide derivatives with higher yields and shorter reaction times.
Q: How does this patent differ from prior art?
A: The patent improves upon prior art by achieving higher yields (96.9-99.6%) and shorter reaction times (five hours compared to 44 hours).
Q: What tools can be used to analyze the patent landscape related to this invention?
A: Patent analytics tools, such as Claim Coverage Matrix and ClaimScape® software, can be used to categorize patents by claims and scope concepts, identifying areas of protection and gaps.
Q: Are there any regulatory considerations for patents in this field?
A: Yes, patents in this field may be subject to extensions under the Hatch-Waxman Act, which compensates for the time lost during FDA approval processes.
Q: What is the potential economic impact of this patent?
A: The improved process can lead to cost savings and increased efficiency in production, making the product more competitive in the market.
Sources
- Merck & Co., Inc., and Msd Technology, L.p., Plaintiffs ... - Justia Law
- Extension Under 35 U.S.C. 156(e)(1) - OG Date: 29 July 2003
- Patent Analytics | Intellectual Property Law
- EP1131280B1 - Preparation of 5-amino-isophthalamides
- US-5705692-A - Unified Patents Portal
