United States Patent 8,568,793: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,568,793, titled "Sodium nitrite-containing pharmaceutical compositions," is a significant patent in the field of pharmaceuticals, particularly focusing on the use and production of sodium nitrite for medical treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Craig Sherman, Anthony James Lepine, Catherine Marie Smith, Kevin Robert Wirtz, and Erich Schulze, and is assigned to Hope Medical Enterprises, Inc.[2][4].
Issue Date and Expiration
The patent was issued on October 29, 2013, and is set to expire on December 24, 2031[2].
Scope of the Patent
Pharmaceutical Compositions
The patent provides detailed descriptions of pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. These compositions are designed to meet stringent quality standards, including specific limits on impurities such as methanol and non-volatile organic carbon (NVOC)[4].
Methods of Production
The patent outlines methods for producing sodium nitrite that adhere to pharmaceutical grade standards. This includes processes for determining the total non-volatile organic carbon in sodium nitrite-containing samples, ensuring the purity and safety of the final product[4].
Methods of Treatment
The invention also encompasses methods of treatment involving the administration of pharmaceutically acceptable sodium nitrite. Sodium nitrite has been identified as an effective vasodilator, making it potentially useful for treating conditions such as heart attacks and strokes[4].
Claims
The patent includes several key claims that define the scope of the invention:
Composition Claims
- Claims related to the composition of sodium nitrite, including specifications on the levels of impurities such as methanol and NVOC. For example, the patent specifies that the sodium nitrite should contain no greater than about 10 ppm, 100 ppm, 500 ppm, 1000 ppm, or 3000 ppm of methanol[4].
Process Claims
- Claims detailing the methods for producing sodium nitrite, including the determination of total non-volatile organic carbon. These processes ensure that the final product meets pharmaceutical grade standards[4].
Use Claims
- Claims related to the use of sodium nitrite in medical treatments. These include the administration of sodium nitrite as a vasodilator for various medical conditions[4].
Patent Landscape
Related Patents
The inventors and assignee of this patent have also been involved in other related patents, such as:
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Sodium Thiosulfate-Containing Pharmaceutical Compositions: Patents like US 10,479,686 and US 9,345,724 focus on similar themes of producing and using sodium thiosulfate in pharmaceutical compositions[2].
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Other Pharmaceutical Compositions: Patents like US 8,496,973 and US 9,944,524 also deal with the production and use of other pharmaceutical agents, highlighting the broader research and development efforts of Hope Medical Enterprises, Inc.[2].
Process Intensity
The rise of process claims, as documented in recent studies, is relevant here. Patents with higher process intensity, such as this one, are more valuable and often more cited. This trend reflects the increasing importance of detailed process descriptions in pharmaceutical patents[3].
Regulatory Compliance
The patent emphasizes compliance with Good Manufacturing Practices (GMP) and other regulatory standards mandated by the FDA. This includes adherence to the Food, Drug, and Cosmetic Act of 1938, ensuring that the pharmaceutical products meet applicable quality specifications[1].
Industrial and Medical Significance
Sodium nitrite, as a vasodilator, has significant potential in treating cardiovascular conditions. The patent's focus on ensuring the purity and safety of sodium nitrite compositions underscores its importance in medical treatments.
Economic and Legal Implications
The expiration date of December 24, 2031, marks a critical point for the patent's legal status. After this date, the technology and methods described in the patent will enter the public domain, potentially impacting the market and competition in the pharmaceutical industry.
Key Takeaways
- Pharmaceutical Compositions: The patent details specific compositions of sodium nitrite with strict impurity limits.
- Production Methods: It outlines methods for producing and purifying sodium nitrite to pharmaceutical grade standards.
- Medical Use: The invention includes methods for treating medical conditions using sodium nitrite as a vasodilator.
- Regulatory Compliance: The patent adheres to FDA regulations and GMP standards.
- Patent Landscape: It is part of a broader portfolio of patents related to pharmaceutical compositions and production methods.
FAQs
Q: What is the primary focus of United States Patent 8,568,793?
A: The primary focus is on sodium nitrite-containing pharmaceutical compositions, including their production and medical use.
Q: Who are the inventors of this patent?
A: The inventors are Craig Sherman, Anthony James Lepine, Catherine Marie Smith, Kevin Robert Wirtz, and Erich Schulze.
Q: What is the expiration date of this patent?
A: The patent is set to expire on December 24, 2031.
Q: What are the key claims of this patent?
A: The key claims include composition, process, and use claims related to sodium nitrite in pharmaceutical compositions.
Q: How does this patent comply with regulatory standards?
A: The patent complies with FDA regulations and Good Manufacturing Practices (GMP) standards.
Cited Sources
- United States Patent and Trademark Office, "Sodium thiosulfate-containing pharmaceutical compositions," US 10,479,686 B2.
- Drugs.com, "Generic Nithiodote Availability."
- Econstor, "The rise of process claims: Evidence from a century of U.S. patents."
- Google Patents, "Sodium nitrite-containing pharmaceutical compositions," US 8,568,793 B2.
