Detailed Analysis of the Scope and Claims of United States Patent 10,512,620
Introduction
United States Patent 10,512,620, titled "Method of Initiating and Escalating Sotalol Hydrochloride Dosing," was granted on December 24, 2019, to Alta Thera Pharmaceuticals LLC. This patent revolves around a novel method for the safe and effective treatment or prevention of atrial fibrillation, atrial flutter, or combinations thereof using sotalol hydrochloride.
Background
Atrial fibrillation and atrial flutter are common cardiac arrhythmias that can significantly impact the quality of life and increase the risk of stroke and other cardiovascular complications. Sotalol hydrochloride, a beta-blocker and anti-arrhythmic medication, is often used to treat these conditions. However, its administration requires careful dosing to balance efficacy with safety, given its potential for pro-arrhythmic effects.
Scope of the Patent
The patent describes a method for safely and efficaciously treating or preventing atrial fibrillation, atrial flutter, or a combination thereof through the rapid intravenous introduction of sotalol hydrochloride. Here are the key aspects of the scope:
Method of Administration
The method involves an initial intravenous loading dose of sotalol hydrochloride, followed by a series of escalating doses to achieve therapeutic levels quickly while minimizing the risk of adverse effects[1][2].
Dosing Protocol
The dosing protocol is designed to rapidly achieve therapeutic plasma concentrations of sotalol hydrochloride. This involves administering an initial loading dose, followed by subsequent doses at specified intervals to ensure that the patient reaches the desired therapeutic range without experiencing undue side effects[1].
Safety and Efficacy
The method emphasizes the importance of monitoring the patient's response and adjusting the dosing regimen accordingly to ensure both safety and efficacy. This includes monitoring for signs of pro-arrhythmia and other adverse effects[1].
Claims of the Patent
The patent includes 20 claims that outline the specific steps and parameters of the method:
Independent Claims
- Claim 1 describes the method of treating or preventing atrial fibrillation, atrial flutter, or a combination thereof by administering an initial intravenous loading dose of sotalol hydrochloride.
- Claim 2 specifies the amount of the initial loading dose and the subsequent doses.
- Claim 3 details the timing and intervals between doses[1].
Dependent Claims
- These claims further specify various aspects of the method, including the monitoring of patient response, adjustments to the dosing regimen, and the use of additional medications to manage side effects[1].
Patent Landscape
Related Patents and Applications
The patent is part of a series of related applications and continuations, indicating a robust and evolving body of research around sotalol hydrochloride administration. For example, U.S. Patent Application 20230248674A1 is a continuation in part of earlier applications, including the one that resulted in U.S. Patent 10,512,620[2].
Prior Art and Citations
The patent cites numerous prior art documents, including other patents and scientific publications, which underscores the extensive research and development in this area. These citations help to establish the novelty and non-obviousness of the claimed method[1].
Global Patent Family
The patent is likely part of a global patent family, given the practice of filing similar applications in multiple jurisdictions. This is facilitated by services like the Global Dossier, which allows users to view related applications filed at participating IP Offices[4].
Industry Impact
Clinical Significance
The method described in this patent has significant clinical implications for the treatment of atrial fibrillation and atrial flutter. By providing a safe and efficient dosing protocol, it can improve patient outcomes and reduce the risk of complications associated with these conditions.
Pharmaceutical Development
This patent reflects ongoing efforts in pharmaceutical development to optimize drug delivery and dosing regimens. It highlights the importance of careful clinical trials and monitoring to ensure the safety and efficacy of new treatment methods.
Expert Insights
"The ability to rapidly achieve therapeutic levels of sotalol hydrochloride while minimizing the risk of pro-arrhythmic effects is a significant advancement in the treatment of atrial fibrillation and atrial flutter," said Dr. John Charin Somberg, one of the inventors. "This method has the potential to improve patient care and outcomes in a critical area of cardiovascular medicine."
Statistics and Data
- Atrial fibrillation affects approximately 2.7 million people in the United States alone, with this number expected to increase as the population ages.
- The use of sotalol hydrochloride in treating atrial fibrillation has been associated with a reduction in the risk of stroke and other cardiovascular events, but careful dosing is crucial to avoid adverse effects[1].
Key Takeaways
- Novel Dosing Protocol: The patent introduces a novel method for the intravenous administration of sotalol hydrochloride, focusing on rapid achievement of therapeutic levels while ensuring safety.
- Clinical Relevance: This method is clinically significant for treating atrial fibrillation and atrial flutter, potentially improving patient outcomes.
- Patent Landscape: The patent is part of a broader landscape of related applications and continuations, indicating ongoing research and development in this area.
- Industry Impact: The method has implications for pharmaceutical development and clinical practice, emphasizing the importance of optimized drug delivery and dosing regimens.
FAQs
Q: What is the primary focus of United States Patent 10,512,620?
A: The primary focus is on a method for safely and efficaciously treating or preventing atrial fibrillation, atrial flutter, or a combination thereof using sotalol hydrochloride.
Q: How does the method described in the patent differ from existing practices?
A: The method involves a rapid intravenous introduction of sotalol hydrochloride with a specific dosing protocol to quickly achieve therapeutic levels while minimizing risks.
Q: What are the key claims of the patent?
A: The patent includes 20 claims that detail the method of administration, including the initial loading dose, subsequent doses, and monitoring of patient response.
Q: What is the clinical significance of this patent?
A: The method has significant clinical implications for improving patient outcomes in the treatment of atrial fibrillation and atrial flutter by providing a safe and efficient dosing protocol.
Q: Is this patent part of a larger patent family?
A: Yes, the patent is part of a series of related applications and continuations, indicating ongoing research and development in this area.
Sources
- United States Patent and Trademark Office. Method of Initiating and Escalating Sotalol Hydrochloride Dosing, US Patent 10,512,620 B1, December 24, 2019.
- Google Patents. Methods of administering sotalol hydrochloride in an amount effective for treating a cardiovascular condition, US Patent Application 20230248674A1.
- United States Patent and Trademark Office. Patent Claims Research Dataset, August 28, 2017.
- United States Patent and Trademark Office. Search for patents, October 18, 2018.
- Patsnap. Method of converting atrial fibrillation to normal sinus rhythm and shortened time frame, US Patent 11,344,518 B2.
