United States Patent 5,536,743: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,536,743, titled "Vaginal Pharmaceutical Compositions and Methods for Preparing Them," is a significant patent in the field of pharmaceuticals, particularly focusing on vaginal treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, issued on July 16, 1996, pertains to vaginal pharmaceutical compositions containing antimicrobial agents, such as metronidazole, used for treating various vaginal infections. The invention includes both the compositions and the methods for preparing them.
Scope of the Patent
Overview
The scope of the patent encompasses vaginal pharmaceutical compositions designed to deliver therapeutic agents effectively. The primary focus is on metronidazole, an antimicrobial imidazole, which is used to treat infections such as bacterial vaginosis and trichomoniasis.
Key Components
- Active Pharmaceutical Agent: The patent highlights the use of metronidazole as the active ingredient. This compound is known for its efficacy in treating microbial infections[4].
- Formulation: The compositions can be in various forms, including gels, creams, and suppositories, each designed to optimize the delivery of the active agent.
- Buffer System: The inclusion of a buffer system is crucial to maintain the pH level of the vagina, ensuring the stability and effectiveness of the metronidazole[5].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core aspects of the invention:
- Claim 1: This claim describes the vaginal pharmaceutical composition containing metronidazole, a buffer system, and other excipients to maintain the therapeutic efficacy of the active agent.
- Claim 2: This claim outlines the method for preparing the composition, including the steps of mixing the active ingredient with the buffer and other components.
Dependent Claims
Dependent claims further specify the details of the composition and the method:
- Claim 3: This claim specifies the concentration of metronidazole and the type of buffer used.
- Claim 4: This claim describes the formulation of the composition, such as a gel or cream.
Patent Landscape
Prior Art
The patent landscape for vaginal pharmaceutical compositions was already populated with various treatments, but this patent introduced a novel approach by focusing on a specific antimicrobial agent and a buffer system to enhance efficacy. Prior art included other antimicrobial agents and different delivery systems, but the combination and formulation described in this patent were innovative at the time of filing[5].
International Patent Offices
Similar patents and applications can be found in other international patent offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO). These offices provide access to global patent databases, which can be searched to identify related inventions and prior art[1].
Related Patents
Other patents in the same field include those related to vaginal treatments and antimicrobial compositions. For example, US Patent 7,456,207 (B2) also deals with vaginal pharmaceutical compositions but focuses on different active agents and formulations[4].
Search and Analysis Tools
To conduct a thorough analysis of the patent landscape, several tools and resources are available:
- Patent Public Search: This tool provided by the USPTO allows for comprehensive searches of prior art and related patents[1].
- Global Dossier: This service provides access to file histories of related applications from participating IP offices, helping to identify the patent family and related citations[1].
- Common Citation Document (CCD): This application consolidates citation data from multiple IP offices, facilitating a more integrated view of the global patent landscape[1].
Importance of Clear Claim Definitions
The clarity and specificity of claim terms are crucial in patent drafting. As seen in the case of CoolIT Sys., Inc. v. Vidal, ambiguous claim terms can lead to disputes and unexpected claim constructions. Therefore, patent drafters should ensure that terms like "matingly engaged" are clearly defined in the specification to avoid future ambiguities[2].
Economic and Research Implications
The Patent Claims Research Dataset provided by the USPTO offers detailed information on claims from US patents, including those related to pharmaceutical compositions. This dataset can be used to analyze trends and the scope of patents in this field, providing valuable insights for researchers and economists[3].
Key Takeaways
- Innovative Formulation: The patent introduces a novel formulation for vaginal pharmaceutical compositions using metronidazole and a buffer system.
- Comprehensive Claims: The claims are detailed and specify both the composition and the method of preparation.
- Global Patent Landscape: The patent is part of a broader global landscape of similar inventions, which can be analyzed using various search and analysis tools.
- Importance of Clear Definitions: Clear definitions of claim terms are essential to avoid ambiguities and ensure the patent's validity.
FAQs
Q: What is the primary active ingredient in the vaginal pharmaceutical compositions described in US Patent 5,536,743?
A: The primary active ingredient is metronidazole, an antimicrobial imidazole.
Q: What is the role of the buffer system in the patent?
A: The buffer system is used to maintain the pH level of the vagina, ensuring the stability and effectiveness of the metronidazole.
Q: How can one search for related patents in the global patent landscape?
A: Tools such as the Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used to search for related patents and analyze the global patent landscape.
Q: Why is it important to have clear definitions of claim terms in a patent?
A: Clear definitions of claim terms are crucial to avoid ambiguities and ensure the patent's validity, as seen in cases like CoolIT Sys., Inc. v. Vidal.
Q: Where can one find detailed information on claims from US patents for research purposes?
A: The Patent Claims Research Dataset provided by the USPTO offers detailed information on claims from US patents, which can be used for research and analysis.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Crowell - Patent Counsel: Do Your Patents Claim Engagement of Components as Intended?: https://www.crowell.com/en/insights/client-alerts/patent-counsel-do-your-patents-claim-engagement-of-components-as-intended
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Vaginal pharmaceutical compositions and methods for preparing them: https://patents.google.com/patent/US7456207B2/en
- Google APIs - United States Patent (19): https://patentimages.storage.googleapis.com/1d/6c/99/fbd18a69c4f64e/US5536743.pdf
