United States Patent 5,164,402: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,164,402, titled "Trovafloxacin mesylate and its preparation," is a significant patent in the pharmaceutical industry, particularly in the field of antibiotics. This patent, granted to Pfizer Inc., protects the human drug product trovafloxacin mesylate, a fluoroquinolone antibiotic. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
Invention Overview
The patent 5,164,402 describes trovafloxacin mesylate, a salt form of the antibiotic trovafloxacin, and its method of preparation. Trovafloxacin is used to treat various bacterial infections due to its broad-spectrum antibacterial activity[5].
Grant and Eligibility
The patent was granted on November 17, 1992, and it is eligible for patent term extension under 35 U.S.C. ยง 156, which allows for the extension of the patent term to compensate for delays in the regulatory approval process[2].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims cover:
- Composition of Matter: The patent claims the compound trovafloxacin mesylate itself, emphasizing its purity and stability.
- Method of Preparation: The claims also include the methods for preparing trovafloxacin mesylate, which involve specific chemical processes to ensure the desired purity and form of the compound.
- Pharmaceutical Compositions: Claims extend to pharmaceutical compositions containing trovafloxacin mesylate, which are formulated for various routes of administration, such as oral or parenteral use[5].
Prior Art and References
The patent references prior art related to the synthesis of azabicyclohexane intermediates and methods for treating infections with similar compounds. For example, it incorporates references to U.S. Patents 5,475,116 and 5,256,791, which describe intermediates useful in the synthesis of alatrofloxacin and trovafloxacin[4].
Claims Analysis
Independent Claims
The independent claims are crucial as they define the broadest scope of the invention. For instance, Claim 1 might describe the compound trovafloxacin mesylate in its pure form, while subsequent claims might narrow down to specific methods of preparation or pharmaceutical formulations.
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or limitations. These claims help to further define the invention and can include specific aspects such as the purity of the compound, the process steps involved in its preparation, or the formulation of the pharmaceutical composition.
Patent Landscape
Related Patents and Applications
The patent landscape surrounding 5,164,402 includes other patents and applications related to fluoroquinolone antibiotics. For example, U.S. Patent Application 08/764,655 refers to methods of treating Helicobacter pylori infections with alatrofloxacin and trovafloxacin, indicating a broader research and development effort in this therapeutic area[4].
International Patent Family
The patent is part of an international patent family, with corresponding applications and grants in other countries. This is evident from the use of tools like the Global Dossier, which provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA)[1].
Citation Data
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool helps in visualizing the search results for the same invention produced by several offices on a single page, providing a comprehensive view of the patent landscape[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 inventions like 5,164,402. This dataset helps in analyzing patent scope and trends, offering insights into the strategic use of patent claims in the pharmaceutical industry[3].
Market Impact
The protection afforded by this patent has significant market implications. It allows Pfizer Inc. to maintain exclusivity over the production and sale of trovafloxacin mesylate, influencing the competitive landscape in the antibiotic market.
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. Additionally, the Public Search Facility and Patent and Trademark Resource Centers (PTRCs) provide trained staff and local search resources to assist in patent search techniques[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), is crucial for understanding the global patent landscape related to this invention[1].
Key Takeaways
- Patent Scope: The patent covers the compound trovafloxacin mesylate, its method of preparation, and pharmaceutical compositions containing it.
- Claims Analysis: Independent and dependent claims define the invention's scope, with a focus on purity, preparation methods, and pharmaceutical formulations.
- Patent Landscape: The patent is part of an international family with related applications and grants, and it is supported by various international patent databases and tools.
- Economic Implications: The patent's protection influences the market exclusivity and competitive landscape in the antibiotic sector.
- Research and Analysis: Tools like the USPTO's Patent Claims Research Dataset and international patent databases are essential for a comprehensive analysis.
FAQs
What is the main subject of United States Patent 5,164,402?
The main subject of United States Patent 5,164,402 is trovafloxacin mesylate, a fluoroquinolone antibiotic, including its preparation and pharmaceutical compositions.
How can one search for related patents internationally?
One can use databases such as the European Patent Office's esp@cenet, Japan Patent Office's database, and the World Intellectual Property Organization's PATENTSCOPE to search for related patents internationally[1].
What is the significance of the Global Dossier in patent searching?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related data such as classification and citation data[1].
How does the USPTO's Patent Claims Research Dataset help in analyzing patents?
The dataset provides detailed information on claims from U.S. patents, including claim-level statistics and document-level statistics, helping in the analysis of patent scope and trends[3].
What are the economic implications of patent 5,164,402?
The patent's protection allows Pfizer Inc. to maintain market exclusivity over trovafloxacin mesylate, influencing the competitive landscape in the antibiotic market.
