United States Patent 8,088,398: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,088,398, titled "Pharmaceutical compositions comprising fesoterodine," is a significant patent in the pharmaceutical industry, particularly in the field of urinary system disorders. This patent, granted to pharmaceutical companies, outlines specific formulations and methods for preparing fesoterodine, a medication used to treat overactive bladder.
Background of Fesoterodine
Fesoterodine is a muscarinic receptor antagonist marketed under the trade name TOVIAZ® in the United States. It is used to treat symptoms of overactive bladder, such as urgency, frequency, and incontinence[5].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include fesoterodine or its pharmaceutically acceptable salts or solvates. These compositions are characterized by the inclusion of specific stabilizers and excipients that enhance the stability and efficacy of the medication. The preferred stabilizers include sugar alcohols such as xylitol, sorbitol, polydextrose, isomalt, and dextrose[4].
Granulate Formation
A key aspect of the patent is the method of forming a granulate of fesoterodine and a stabilizer. This process involves granulating fesoterodine or its salt/solvate with a stabilizer, followed by mixing or combining the granulate with at least one type of hydroxypropyl methylcellulose and optionally other excipients. The resultant composition can then be pressed into tablets and coated[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- A pharmaceutical composition comprising fesoterodine or its pharmaceutically acceptable salt or solvate and a stabilizer selected from a group of sugar alcohols.
- A granulate comprising fesoterodine or its salt/solvate and a stabilizer, which is then mixed with hydroxypropyl methylcellulose and other excipients.
- A method for producing the pharmaceutical composition involving the granulation and mixing steps[4].
Dependent Claims
Dependent claims further specify the details of the composition and the method of production. For example, they detail the preferred types of stabilizers, the ratio of fesoterodine to stabilizer, and the additional excipients that can be included in the composition[4].
Patent Landscape
International Patent Family
The patent is part of an international patent family, with corresponding applications filed in various countries. This is evident from the Global Dossier service provided by the USPTO, which allows users to see the patent family for a specific application, including all related applications filed at participating IP Offices[1].
Prior Art and Citations
The patent cites prior art related to pharmaceutical compositions and stabilizers. The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of this patent application, providing a comprehensive view of the prior art landscape[1].
Expiration and Legal Status
The patent is currently active but has an expiration date. The legal status is subject to change based on various factors, including maintenance fees and potential legal challenges[4].
Classification and Industry Impact
Classification
The patent is classified under several categories in the International Patent Classification (IPC) system, including A61K (Preparations for medical, dental, or toilet purposes) and A61P (Specific therapeutic activity of chemical compounds or medicinal preparations)[4].
Industry Impact
This patent has significant implications for the pharmaceutical industry, particularly in the development and manufacturing of medications for urinary system disorders. The specific formulations and methods described in the patent can influence the quality and efficacy of fesoterodine products, thereby impacting patient outcomes and market competition.
Search and Analysis Tools
USPTO Resources
To conduct a thorough analysis of this patent, one can use various resources provided by the USPTO, such as the Patent Public Search tool, which offers enhanced access to prior art and related patent documentation. The Global Dossier and Common Citation Document services are also invaluable for understanding the international patent landscape and prior art citations[1].
International Databases
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can provide a broader perspective on the global patent landscape related to fesoterodine and similar pharmaceutical compositions[1].
Conclusion
United States Patent 8,088,398 is a critical patent in the pharmaceutical industry, detailing specific formulations and methods for preparing fesoterodine. Understanding the scope, claims, and patent landscape of this invention is essential for pharmaceutical companies involved in the development and manufacturing of medications for urinary system disorders.
Key Takeaways
- The patent describes pharmaceutical compositions of fesoterodine with specific stabilizers and excipients.
- The method of forming a granulate and mixing it with hydroxypropyl methylcellulose is a key aspect of the patent.
- The patent is part of an international patent family and has significant implications for the pharmaceutical industry.
- Various USPTO and international resources can be used to analyze the patent and its landscape.
FAQs
What is the main subject of United States Patent 8,088,398?
The main subject is pharmaceutical compositions comprising fesoterodine, a medication used to treat overactive bladder.
What are the preferred stabilizers mentioned in the patent?
The preferred stabilizers include sugar alcohols such as xylitol, sorbitol, polydextrose, isomalt, and dextrose.
How is the granulate formed according to the patent?
The granulate is formed by granulating fesoterodine or its salt/solvate with a stabilizer, followed by mixing or combining the granulate with at least one type of hydroxypropyl methylcellulose and optionally other excipients.
What is the classification of this patent in the IPC system?
The patent is classified under A61K and A61P categories in the International Patent Classification (IPC) system.
Where can one find more information about the international patent family of this patent?
One can use the Global Dossier service provided by the USPTO to see the patent family for this specific application.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Pharmacompass - US Patent 8088398: https://www.pharmacompass.com/us-patent-8088398
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8088398B2: https://patents.google.com/patent/US8088398B2/en
- Google Patents - US20150182629A1: https://patents.google.com/patent/US20150182629A1/de
