United States Patent 5,401,741: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,401,741, titled "Topical preparation for treating otopathy," is a significant patent in the field of pharmaceuticals, particularly in the treatment of ear diseases. This patent, granted on March 28, 1995, is an example of how intellectual property can protect innovative medical treatments.
Background of the Patent
The patent was filed on April 12, 1993, by the assignee, and it is based on an earlier Japanese patent application filed on April 8, 1988[4].
Scope of the Patent
The patent describes a topical preparation for treating otopathy, which is a condition affecting the ear. The preparation contains ofloxacin or a salt thereof as the active ingredient. Ofloxacin is an antibiotic known for its efficacy in treating various bacterial infections.
Active Ingredient and Composition
The patent specifies that the topical preparation includes ofloxacin, which is dissolved in a solution suitable for application directly into the ear. This solution can be administered to treat conditions such as otitis externa or other bacterial infections of the ear[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the topical preparation containing ofloxacin or its salt.
- Subsequent claims may detail specific concentrations of ofloxacin, the method of preparation, and the application method.
Dependent Claims
- These claims further specify the composition, such as the presence of additional ingredients like solvents or preservatives, and the method of administration.
Patent Family and Related Applications
The patent is part of a larger patent family that includes related applications filed in different jurisdictions. For example, there is a corresponding Japanese patent application (JP63086378A) filed in 1988, which is part of the same patent family[4].
Prior Art and Citations
The patent cites several prior art references, including other patents related to external preparations and treatments for otopathy. For instance, it references US Patent 4,260,416 and Japanese Patent JPS638333A[4].
Legal Status and Expiration
The patent has expired, as indicated by its legal status. Patents typically have a lifetime of 20 years from the filing date of the earliest non-provisional application, assuming all maintenance fees are paid[4].
Patent Landscape and Industry Impact
The patent landscape in the field of otopathy treatments is complex, with multiple patents covering various aspects of ear disease treatments.
Competing Patents
Other patents in this field may cover different active ingredients, formulations, or methods of treatment. For example, patents related to other antibiotics or therapeutic agents used in ear treatments could be considered part of the competitive landscape.
Regulatory Environment
The regulatory environment plays a crucial role in the patent landscape. Patents must comply with FDA regulations and other health authority guidelines to ensure the safety and efficacy of the treatments. The approval process for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) is stringent and can impact the validity and enforcement of patents[5].
Economic and Research Implications
The economic implications of this patent are significant, as it protected a novel treatment for otopathy, allowing the assignee to recoup investment in research and development.
Research Datasets
Research datasets, such as those provided by the USPTO, can offer insights into patent claims and scope. For instance, the Patent Claims Research Dataset provides detailed information on claims from US patents, which can be used to analyze trends and patterns in patenting activities[3].
Accessing and Utilizing Patent Information
To access and utilize patent information effectively, tools like the USPTO's Global Dossier and Common Citation Document (CCD) are invaluable. These services provide a single point of access to citation data and file histories of related applications, facilitating a more comprehensive understanding of the patent landscape[1].
Public Search Facilities and Resources
The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer public access to patent and trademark information. These resources are crucial for conducting thorough patent searches and understanding the scope of existing patents[1].
Key Takeaways
- Patent Scope: The patent covers a topical preparation containing ofloxacin for treating otopathy.
- Claims: The patent includes independent and dependent claims defining the composition and method of application.
- Patent Family: Part of a larger patent family with related applications in different jurisdictions.
- Legal Status: The patent has expired.
- Industry Impact: Significant in protecting a novel treatment for otopathy, influencing the competitive landscape and regulatory environment.
- Economic Implications: Protected investment in research and development, contributing to the economic viability of the treatment.
Frequently Asked Questions (FAQs)
1. What is the main active ingredient in the topical preparation described in US Patent 5,401,741?
The main active ingredient is ofloxacin or a salt thereof.
2. What is the purpose of the topical preparation described in the patent?
The preparation is designed to treat otopathy, a condition affecting the ear.
3. Has the patent expired?
Yes, the patent has expired.
4. How can one access detailed information about this patent and related applications?
One can use the USPTO's Global Dossier and Common Citation Document (CCD) services to access detailed information about the patent and related applications.
5. What resources are available for conducting thorough patent searches?
Resources include the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online databases like the USPTO's Electronic Official Gazette.
Sources:
- USPTO - Search for patents.
- USA.gov - U.S. Patent and Trademark Office (USPTO).
- USPTO - Patent Claims Research Dataset.
- Google Patents - US5401741A - Topical preparation for treating otopathy.
- CAFC - ASTELLAS PHARMA, INC. v. SANDOZ INC..
