United States Patent 10,596,155: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,596,155, assigned to Chemo Research SL, is a significant patent in the pharmaceutical sector, particularly relating to aqueous-based metronidazole gel formulations. This article provides a comprehensive analysis of the patent's scope, claims, and the broader patent landscape in which it operates.
Patent Overview
Title and Assignees
The patent, titled "Aqueous-based Metronidazole Gel Formulations," is assigned to Chemo Research SL, a company known for its innovative pharmaceutical products. The priority date for this patent is June 28, 2011, indicating the initial filing date of the patent application[5].
Scope of the Patent
Technical Field
The patent pertains to the field of pharmaceutical formulations, specifically focusing on aqueous-based gels containing metronidazole. Metronidazole is an antibiotic and antiprotozoal medication used to treat various infections.
Background of the Invention
The background section of the patent highlights the need for improved metronidazole formulations, particularly those that are stable, effective, and easy to administer. Traditional formulations often faced issues such as instability, poor bioavailability, or unpleasant textures, which the inventors aimed to address[5].
Claims of the Patent
Independent and Dependent Claims
The patent includes several claims, both independent and dependent, that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding additional features.
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Independent Claim 1: This claim usually describes the general composition of the aqueous-based metronidazole gel, including the active ingredient, excipients, and any specific characteristics such as pH range or viscosity[5].
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Dependent Claims: These claims build upon the independent claims by specifying particular aspects, such as the concentration of metronidazole, the type of excipients used, or the method of preparation. For example, a dependent claim might specify a gel formulation with a particular viscosity or a specific pH range that enhances stability and efficacy.
Patent Landscape
Related Patents
The patent landscape for metronidazole gel formulations is complex, with multiple patents held by various entities. For instance, other patents held by Chemo Research SL and Bausch Health Ireland Ltd. (as seen in the litigation documents) cover similar but distinct aspects of metronidazole formulations[2].
Litigation and Infringement
The patent has been involved in litigation, as evidenced by a complaint filed against Encube Ethicals Private Ltd. for alleged patent infringement. The complaint alleges that Encube's generic version of a metronidazole gel product infringes on the claims of U.S. Patent 10,596,155, among other patents[2].
Search and Analysis Tools
USPTO Resources
To conduct a thorough analysis of this patent and its landscape, several tools provided by the United States Patent and Trademark Office (USPTO) are invaluable:
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Patent Public Search: This tool allows for comprehensive searching of U.S. patents and published patent applications, including full-text searching and access to prior art[4].
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Global Dossier: This service provides access to the file histories of related applications from participating IP offices, helping to identify patent families and related applications[4].
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Common Citation Document (CCD): This application consolidates prior art cited by multiple offices for the family members of a patent application, facilitating a more integrated view of the global patent landscape[4].
International Patent Databases
Access to Global Patents
The patent landscape extends beyond U.S. borders, and accessing international patent databases is crucial:
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European Patent Office (EPO): The esp@cenet network provides access to European patent databases and includes machine translation for some languages[4].
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World Intellectual Property Organization (WIPO): The PATENTSCOPE database offers full-text searching of international patent applications and machine translations for some documents[1].
Economic and Statistical Analysis
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014 and published applications between 2001 and 2014. This dataset can be used to analyze trends and scope measurements of patents, including those related to pharmaceutical formulations[3].
Practical Implications
Commercial and Regulatory Aspects
The patent's commercial implications are significant, as it protects a specific formulation of metronidazole gel that is used in products like NUVESSA®. Regulatory aspects, such as the approval process for generic versions, are also critical. The litigation against Encube highlights the importance of ensuring that generic products do not infringe on existing patents[2].
Key Takeaways
- Patent Scope: U.S. Patent 10,596,155 covers aqueous-based metronidazole gel formulations with specific characteristics.
- Claims: The patent includes independent and dependent claims that define the invention's scope.
- Litigation: The patent has been involved in infringement litigation, emphasizing its commercial importance.
- International Landscape: Access to global patent databases is essential for a comprehensive analysis.
- Economic Analysis: The USPTO's Patent Claims Research Dataset provides valuable insights into patent trends and scope.
FAQs
Q: What is the primary focus of U.S. Patent 10,596,155?
A: The primary focus is on aqueous-based metronidazole gel formulations.
Q: Who is the assignee of this patent?
A: The assignee is Chemo Research SL.
Q: What tools can be used to analyze the patent landscape for this invention?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are useful.
Q: Why is this patent significant in the pharmaceutical industry?
A: It protects a specific and improved formulation of metronidazole gel, which is commercially important and subject to regulatory scrutiny.
Q: How can one access international patent databases related to this invention?
A: Databases such as the EPO's esp@cenet and WIPO's PATENTSCOPE provide access to international patent information.
Sources
- Clemson University Libraries: Research and Course Guides: Patent Searching, Advanced.
- United States District Court for the District of Delaware: Complaint for Patent Infringement.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- Unified Patents: FR-2899475-A1 | Unified Patents.
