Understanding the Scope and Claims of United States Patent 8,496,973: Sodium Thiosulfate-Containing Pharmaceutical Compositions
Introduction
United States Patent 8,496,973, titled "Sodium Thiosulfate-Containing Pharmaceutical Compositions," is a significant patent in the pharmaceutical industry, particularly in the context of treating acute cyanide poisoning. This patent, issued to Hope Medical Enterprises, Inc., covers various aspects of sodium thiosulfate formulations and their applications.
Background
Sodium thiosulfate is a crucial component in the treatment of cyanide poisoning, often used in conjunction with sodium nitrite. The patent in question addresses the development, formulation, and use of sodium thiosulfate in pharmaceutical compositions.
Patent Overview
Issuance and Expiration
The patent was issued on July 30, 2013, and is set to expire on March 29, 2031[5].
Inventors and Assignee
The inventors listed on the patent are Sherman Craig, Smith Catherine Marie, Wirtz Kevin Robert, and Schulze Erich. The assignee is Hope Medical Enterprises, Inc.[5].
Claims and Scope
Pharmaceutical Compositions
The patent covers pharmaceutically acceptable sodium thiosulfate and various pharmaceutical compositions thereof. These compositions are designed to be safe and effective for medical use, particularly in the treatment of acute cyanide poisoning[4].
Methods of Production
The patent includes methods for producing pharmaceutically acceptable sodium thiosulfate. This involves detailed processes to ensure the purity and stability of the sodium thiosulfate, which is critical for its therapeutic efficacy[4].
Methods of Treatment
The patent describes methods of treatment that involve the administration of sodium thiosulfate. This includes protocols for dosing and administration, which are essential for the effective treatment of cyanide poisoning[4].
Analytical Methods
Additionally, the patent provides methods for determining the total non-purgable organic carbon in a sodium thiosulfate-containing sample. This analytical aspect is vital for quality control and ensuring the pharmaceutical grade of the sodium thiosulfate[4].
Patent Landscape
Related Patents
The patent is part of a series of patents related to sodium thiosulfate-containing pharmaceutical compositions. Other patents, such as U.S. Patent Nos. 9,345,724, 9,585,912, 10,479,686, and 11,753,301, also cover various aspects of these compositions and their applications[2].
Patent Infringement
The patent is listed in the Orange Book in conjunction with Hope’s New Drug Application (NDA) product, indicating its importance in protecting the intellectual property related to these pharmaceutical compositions. There have been legal actions taken to prevent generic versions of these compositions from being manufactured or sold before the patent expiration dates[2].
Measuring Patent Scope
Claim Length and Scope
The scope of a patent can be measured by the length of its claims. Generally, longer claims are more specific and narrower in scope, making it harder for competitors to design around them. In the case of U.S. Patent 8,496,973, the claims are detailed and specific, indicating a narrower but more robust protection against infringement[3].
Number of Claims and Patent Classes
While the number of claims and patent classes can provide some insight into the scope of a patent, research suggests that these metrics are not as predictive as the length of the claims. The patent in question includes multiple claims that collectively define the scope of protection for the sodium thiosulfate compositions[3].
Impact on the Pharmaceutical Industry
Treatment of Cyanide Poisoning
The patent plays a critical role in the treatment of acute cyanide poisoning by ensuring the availability of high-quality sodium thiosulfate formulations. This is a life-saving intervention, and the patent protects the intellectual property behind these formulations, encouraging innovation and investment in this area[1].
Generic Versions and Competition
The expiration of this patent in 2031 will open the door for generic versions of sodium thiosulfate-containing pharmaceutical compositions. However, until then, the patent holder, Hope Medical Enterprises, Inc., retains exclusive rights to manufacture, sell, and distribute these compositions, limiting competition in this specific market segment[5].
Legal and Regulatory Aspects
FDA Approval and Orange Book Listing
The patent is listed in the FDA's Orange Book, which is a critical step in ensuring that generic versions of the drug cannot be approved until the patent expires. This listing also underscores the regulatory approval process that these pharmaceutical compositions have undergone[2].
Patent Infringement Litigation
There have been legal actions taken by Hope Medical Enterprises, Inc. to protect their patent rights against potential infringers. These actions highlight the importance of patent protection in the pharmaceutical industry and the measures companies take to enforce their intellectual property rights[2].
Key Takeaways
- Patent Coverage: U.S. Patent 8,496,973 covers sodium thiosulfate-containing pharmaceutical compositions, methods of production, and methods of treatment.
- Expiration Date: The patent is set to expire on March 29, 2031.
- Scope and Claims: The patent includes detailed claims that define a narrow but robust scope of protection.
- Impact on Industry: The patent is crucial for the treatment of acute cyanide poisoning and affects the availability of generic versions of sodium thiosulfate formulations.
- Legal and Regulatory: The patent is listed in the FDA's Orange Book and has been the subject of patent infringement litigation.
FAQs
What is the primary use of sodium thiosulfate in the context of this patent?
Sodium thiosulfate is primarily used in the treatment of acute cyanide poisoning, often in conjunction with sodium nitrite.
Who is the assignee of U.S. Patent 8,496,973?
The assignee of U.S. Patent 8,496,973 is Hope Medical Enterprises, Inc.
What is the significance of the patent being listed in the FDA's Orange Book?
Listing in the FDA's Orange Book indicates that the patent has been approved and protects the intellectual property rights of the patent holder until the patent expires, preventing generic versions from being approved during this period.
How is the scope of a patent typically measured?
The scope of a patent is typically measured by the length of its claims, with longer claims indicating a narrower scope.
When is the patent set to expire?
The patent is set to expire on March 29, 2031.
Sources
- DrugBank: Thiosulfuric acid: Uses, Interactions, Mechanism of Action.
- Insight.RPXCorp: Case 1:22-cv-00978-RGA-JLH Document 62 Filed 09/14/23.
- Boston University Law: The Ways We've been Measuring Patent Scope are Wrong.
- Google Patents: Sodium thiosulfate-containing pharmaceutical compositions.
- Drugs.com: Generic Nithiodote Availability.
