United States Patent 11,491,166: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 11,491,166, titled "Spironolactone aqueous compositions," discloses a stable, ready-to-use liquid formulation of spironolactone and its method of use. This patent is crucial in the pharmaceutical industry, particularly in the development of medical preparations.
Patent Details
Publication Number and Authority
The patent is identified by the publication number US11,491,166B2 and is granted by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Classification
The patent is classified under various categories within the International Patent Classification (IPC) system:
- A61K31/00: Medicinal preparations containing organic active ingredients.
- A61K31/56: Compounds containing cyclopenta[a]hydrophenanthrene ring systems; derivatives thereof, e.g., steroids.
- A61K47/00: Medicinal preparations characterized by the non-active ingredients used, e.g., carriers or inert additives[4].
Prior Art Keywords
Key terms associated with this patent include "spironolactone," "composition," "buffer," "liquid formulation," and "ready-to-use"[4].
Scope of the Patent
Description of the Invention
The patent describes a stable aqueous composition of spironolactone, which is a steroid used in various medical treatments. The composition includes spironolactone as the active ingredient, along with a buffer to maintain the stability of the formulation. The buffer can include components like citric acid, benzoic acid, or their salts. Additionally, preservatives such as methylparaben, propylparaben, or sorbic acid and its salts are included to ensure the formulation remains effective and safe for use[4].
Method of Use
The method of use involves preparing the liquid formulation by dissolving spironolactone in an aqueous solution with the appropriate buffer and preservatives. This ready-to-use formulation is designed to be stable and effective for medical applications.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition itself, the method of preparing the composition, and the use of the composition in medical treatments.
Dependent Claims
Dependent claims further specify the details of the composition, such as the concentration of spironolactone, the types of buffers and preservatives used, and the method of preparation. For example, the amount of sorbic acid can range from 0.025% w/v to 0.050% w/v, while the amount of sorbate salt can range from 0.10% w/v to 0.20% w/v[4].
Patent Landscape
Related Patents and Applications
To understand the broader patent landscape, it is essential to search for related patents and applications. Tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) can be used to identify similar inventions and prior art cited by various patent offices[1].
International Patent Offices
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can help in identifying global patent families related to spironolactone formulations[1].
Patent Families
The Global Dossier service allows users to view the patent family for a specific application, including all related applications filed at participating IP offices. This helps in understanding the global reach and variations of the patent[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceutical compositions. This dataset can be used to analyze trends and scope measurements in patent claims, offering insights into the economic and research implications of such patents[3].
Industry Impact
The development of stable, ready-to-use liquid formulations of spironolactone can significantly impact the pharmaceutical industry. It can lead to improved patient compliance, reduced production costs, and enhanced product stability, thereby influencing market dynamics and competition.
Legal Status and Expiration
Current Status
The patent is currently active, but its legal status is subject to change based on various factors, including maintenance fees and potential legal challenges[4].
Expiration Date
The expiration date of the patent will depend on the filing date and the term of the patent, which is typically 20 years from the earliest filing date.
Key Takeaways
- Stable Formulation: The patent describes a stable aqueous composition of spironolactone, which is crucial for medical applications.
- Method of Use: The method involves preparing the liquid formulation with specific buffers and preservatives.
- Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: Understanding related patents and global patent families is essential for navigating the intellectual property landscape.
- Economic Implications: The patent can have significant economic and research implications, influencing the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 11,491,166?
The main subject is a stable, ready-to-use liquid formulation of spironolactone.
What are the key components of the spironolactone formulation?
The formulation includes spironolactone, a buffer, and preservatives such as sorbic acid and its salts.
How can one search for related patents and applications?
Tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) can be used.
What is the significance of the Global Dossier service?
It allows users to view the patent family for a specific application, including all related applications filed at participating IP offices.
Where can one find detailed information on patent claims?
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents.
What is the current legal status of the patent?
The patent is currently active, but its status is subject to change.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) - USAGov: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- US11491166B2 - Spironolactone aqueous compositions - Google Patents: https://patents.google.com/patent/US11491166
