Detailed Analysis of the Scope and Claims of United States Patent 6,949,527
Introduction
United States Patent 6,949,527, titled "6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block," is a significant patent in the field of pharmaceuticals, particularly in the area of neuromuscular blockade reversal. Here, we will delve into the scope, claims, and patent landscape of this invention.
Background
Neuromuscular blocking agents are commonly used in surgical procedures to facilitate muscle relaxation. However, reversing these blocks is crucial to restore normal muscle function post-surgery. The patent in question addresses this need by introducing 6-mercapto-cyclodextrin derivatives as effective reversal agents.
Scope of the Invention
Overview of 6-Mercapto-Cyclodextrin Derivatives
The patent describes the synthesis and use of 6-mercapto-cyclodextrin derivatives as reversal agents for drug-induced neuromuscular block. These derivatives are modified cyclodextrins, which are cyclic oligosaccharides known for their ability to form inclusion complexes with various molecules[1][2].
Application in Neuromuscular Blockade Reversal
The primary application of these derivatives is in the reversal of neuromuscular blockade induced by drugs such as mivacurium, pancuronium, and atracurium. The 6-mercapto-cyclodextrin derivatives act by binding to the neuromuscular blocking agents, thereby reducing their effectiveness and allowing muscle function to return[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The 6-mercapto-cyclodextrin derivatives themselves, including their chemical structure and synthesis methods.
- The use of these derivatives as reversal agents for drug-induced neuromuscular block.
- Pharmaceutical compositions containing these derivatives and methods for their administration[1].
Dependent Claims
Dependent claims further specify the scope by detailing:
- Specific types of cyclodextrins, such as gamma-cyclodextrin, and their derivatives.
- Various salts and esters of the 6-mercapto-cyclodextrin derivatives.
- Methods for preparing and purifying these compounds.
- Dosage forms and administration routes, including injections and infusions[1][2].
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding US 6,949,527 includes other patents related to cyclodextrin derivatives and their applications. For example, patents like WO2001040316A1 also describe the use of 6-mercapto-cyclodextrin derivatives as reversal agents, highlighting the broader interest in this technology[2].
Competing Technologies
Other reversal agents and methods exist, but the use of 6-mercapto-cyclodextrin derivatives offers a unique approach due to their high specificity and efficacy in reversing neuromuscular block. This differentiates the invention from other reversal agents that may have different mechanisms of action or side effect profiles[1].
Patent Analytics and Claim Coverage
To fully understand the protection and coverage provided by this patent, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape. For instance, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to 6-mercapto-cyclodextrin derivatives[3].
Manufacturing and Preparation
Synthesis Methods
The patent details various methods for synthesizing the 6-mercapto-cyclodextrin derivatives, including the use of organic bases and specific reaction conditions. These methods are crucial for ensuring the purity and efficacy of the final product[1].
Purification and Characterization
The invention also includes methods for purifying and characterizing the derivatives, such as using electrospray ionization mass spectrometry and liquid chromatography mass spectrometry. These techniques are essential for ensuring the quality and consistency of the reversal agents[1].
Clinical and Preclinical Studies
In Vivo Studies
The patent references in vivo studies where the 6-mercapto-cyclodextrin derivatives were tested for their efficacy in reversing neuromuscular block. These studies involved continuous infusion of a neuromuscular blocking agent and subsequent administration of the reversal agent to measure muscle contraction force[1][2].
Safety and Efficacy
The data from these studies indicate that the 6-mercapto-cyclodextrin derivatives are highly effective and safe for use in clinical settings. The reversal of neuromuscular block was achieved rapidly and without significant side effects, making these derivatives a valuable addition to surgical protocols[1].
Regulatory and Legal Status
Patent Expiration
The patent has expired, which means that the intellectual property protection for the 6-mercapto-cyclodextrin derivatives as described in this patent is no longer in effect. This opens up the possibility for other companies to develop and market similar products without infringing on the original patent[1].
Global Implications
The expiration of this patent has global implications, as it allows for the widespread use and development of 6-mercapto-cyclodextrin derivatives without the need for licensing or royalties. This can lead to increased accessibility and potentially lower costs for these reversal agents[1].
Conclusion
United States Patent 6,949,527 has played a significant role in the development of reversal agents for drug-induced neuromuscular block. The 6-mercapto-cyclodextrin derivatives described in this patent offer a highly effective and safe solution for reversing neuromuscular blockade, which is crucial in surgical procedures.
Key Takeaways
- Effective Reversal Agents: 6-Mercapto-cyclodextrin derivatives are highly effective in reversing drug-induced neuromuscular block.
- Synthesis and Purification: Specific methods for synthesizing and purifying these derivatives are detailed in the patent.
- Clinical Efficacy: In vivo studies have demonstrated the safety and efficacy of these reversal agents.
- Patent Expiration: The patent has expired, allowing for broader use and development of these derivatives.
- Global Implications: The expiration of the patent has global implications, potentially increasing accessibility and reducing costs.
FAQs
Q: What are 6-mercapto-cyclodextrin derivatives used for?
A: These derivatives are used as reversal agents for drug-induced neuromuscular block, helping to restore muscle function after surgical procedures.
Q: How do 6-mercapto-cyclodextrin derivatives work?
A: They work by binding to the neuromuscular blocking agents, thereby reducing their effectiveness and allowing muscle function to return.
Q: What is the significance of the patent expiration for US 6,949,527?
A: The expiration of the patent means that the intellectual property protection for the 6-mercapto-cyclodextrin derivatives is no longer in effect, allowing other companies to develop and market similar products without infringing on the original patent.
Q: Are 6-mercapto-cyclodextrin derivatives safe for clinical use?
A: Yes, in vivo studies have shown that these derivatives are safe and effective for use in clinical settings, with minimal side effects.
Q: How are 6-mercapto-cyclodextrin derivatives synthesized and purified?
A: The patent details specific synthesis methods using organic bases and purification techniques such as electrospray ionization mass spectrometry and liquid chromatography mass spectrometry.
Sources
- US6949527B2 - 6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block - Google Patents
- WO2001040316A1 - 6-mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block - Google Patents
- Patent Analytics | Intellectual Property Law - SLWIP
- US20220096664A1 - Stabilized formulations containing iodinated contrast agents and cyclodextrins - Google Patents
- 6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block - PubChem