Understanding the Scope and Claims of United States Patent 9,198,858
Introduction
United States Patent 9,198,858, titled "Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations," is a significant patent in the field of pharmaceuticals, particularly in the treatment of bacterial vaginosis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent, issued to Bausch Health Ireland Ltd., describes novel mucoadhesive aqueous-based gel formulations of metronidazole designed for the treatment of bacterial vaginosis. Here are the key aspects of the patent:
Invention Description
The patent details methods for treating bacterial vaginosis using specific aqueous-based gel formulations of metronidazole. These formulations are designed to be mucoadhesive, ensuring prolonged contact with the vaginal mucosa, thereby enhancing the efficacy of the treatment[4].
Key Components
- Solvent System: The patent specifies a solvent system that includes lower aliphatic diols, lower polyoxyalkylenes, and lower aromatic alcohols. For example, the solvent system may comprise benzyl alcohol, propylene glycol, and polyethylene glycol (PEG 400)[4].
- Concentration: The solvent system is tailored to achieve a specific concentration of metronidazole, ensuring high solubility and stability[4].
Claims Analysis
The patent includes several claims that define the scope of the invention.
Independent Claims
- Claim 1 typically defines the broadest scope of the invention, including the composition of the aqueous-based gel formulation and its method of use.
- Subsequent claims narrow down the scope by specifying particular components, concentrations, and methods of preparation[4].
Dependent Claims
- These claims build upon the independent claims, adding additional limitations such as specific solvent ratios, pH ranges, and viscosity requirements.
- Dependent claims help to further define the invention and provide a clearer understanding of what is protected under the patent[4].
Patent Scope
The scope of the patent is crucial in determining what is protected and what might infringe upon the patent.
Patent Scope Measurements
Research datasets, such as those provided by the USPTO, can help in understanding patent scope. For instance, the Patent Claims Research Dataset includes detailed information on claims from US patents, which can be used to analyze the scope and dependency relationships between claims[3].
Prior Art
The patent's prior art section lists previous patents and publications that are relevant to the invention. This helps in understanding how the current patent differs from existing technologies and ensures that the invention is novel and non-obvious[4].
Patent Landscape
The patent landscape surrounding US 9,198,858 involves several key aspects:
Related Patents
- Other patents related to metronidazole formulations and treatments for bacterial vaginosis are part of the broader patent landscape. These patents may include variations in formulation, delivery methods, or specific applications[4].
- For example, patents like US9198858B2 and others mentioned in the prior art section of US 9,198,858 are part of this landscape.
Global Dossier
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global reach and related filings of the patent[1].
Litigation and Infringement
Patents like US 9,198,858 can be involved in litigation, especially when generic versions of the patented product are introduced. For instance, the complaint filed by Chemo Research SL and Bausch Health Ireland Ltd. against Encube Ethicals Private Ltd. highlights the importance of patent protection and the potential for infringement claims[2].
Search and Analysis Tools
Several tools are available for searching and analyzing patents, which can be useful in understanding the scope and claims of US 9,198,858.
Patent Public Search
The USPTO's Patent Public Search tool provides enhanced access to prior art and allows for a comprehensive search of patent documents, including those related to US 9,198,858[1].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP Offices, enabling a single-point access to citation data related to the patent family. This can be particularly useful in identifying prior art and understanding the patent's position within the broader patent landscape[1].
Practical Implications
Understanding the scope and claims of US 9,198,858 has significant practical implications:
Innovation and Development
Companies developing similar products must ensure that their formulations do not infringe on the claims of US 9,198,858. This requires a thorough analysis of the patent's scope and claims[4].
Litigation and Enforcement
For patent holders, understanding the scope and claims is crucial for enforcing their rights and defending against potential infringement. This involves monitoring generic versions and ensuring that any challenges to the patent's validity are addressed[2].
Conclusion
United States Patent 9,198,858 is a critical patent in the treatment of bacterial vaginosis, and its scope and claims are meticulously defined. Understanding these aspects is essential for both innovators and patent holders to navigate the complex landscape of pharmaceutical patents.
Key Takeaways
- Patent Scope: The patent covers specific aqueous-based metronidazole gel formulations and their methods of use.
- Claims Analysis: Independent and dependent claims define the invention's scope, including components, concentrations, and preparation methods.
- Patent Landscape: The patent is part of a broader landscape involving related patents, global dossier services, and potential litigation.
- Search and Analysis Tools: Tools like Patent Public Search and CCD are essential for comprehensive patent analysis.
- Practical Implications: Understanding the patent's scope and claims is vital for innovation, development, and litigation.
FAQs
Q: What is the main invention described in US 9,198,858?
A: The main invention is a method of treating bacterial vaginosis using mucoadhesive aqueous-based gel formulations of metronidazole.
Q: What are the key components of the solvent system in US 9,198,858?
A: The solvent system includes lower aliphatic diols, lower polyoxyalkylenes, and lower aromatic alcohols, such as benzyl alcohol, propylene glycol, and polyethylene glycol (PEG 400).
Q: How can one search for related patents to US 9,198,858?
A: Using tools like the USPTO's Patent Public Search and the Common Citation Document (CCD) application can help in identifying related patents.
Q: What is the significance of the Global Dossier service in relation to US 9,198,858?
A: The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices, providing a global perspective on the patent.
Q: Why is understanding the scope and claims of US 9,198,858 important for pharmaceutical companies?
A: Understanding the scope and claims helps companies avoid infringement, ensure compliance with patent laws, and defend their own patents against challenges.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE: https://insight.rpxcorp.com/litigation_documents/14816007
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations - Google Patents: https://patents.google.com/patent/US9198858B2/en
- U.S. Patent Small Claims Court - ACUS: https://www.acus.gov/research-projects/us-patent-small-claims-court
