Analyzing the Scope and Claims of United States Patent 8,658,678
Introduction
United States Patent 8,658,678, hereafter referred to as the '678 Patent, is a significant intellectual property asset in the pharmaceutical industry. To understand its impact and the landscape it operates within, it is crucial to delve into its scope, claims, and the broader patent landscape.
Patent Overview
The '678 Patent, titled "Aqueous-based Metronidazole Gel Formulations," was issued by the United States Patent and Trademark Office (USPTO) on February 25, 2014. This patent is owned by Chemo Research SL and Bausch Health Ireland, Ltd., and it pertains to specific formulations of metronidazole, a common antibiotic used in various medical treatments, including the treatment of bacterial vaginosis.
Scope of the Patent
The '678 Patent covers aqueous-based metronidazole gel formulations, which are designed for topical application. The scope includes the composition of the gel, the method of preparation, and the therapeutic uses of the formulation.
- Composition: The patent describes a gel formulation that includes metronidazole as the active ingredient, along with various excipients and stabilizers to enhance the stability and efficacy of the gel[5].
- Method of Preparation: The patent outlines the steps involved in preparing the gel formulation, ensuring that the final product maintains its therapeutic properties[5].
- Therapeutic Uses: The primary therapeutic use of the formulation is the treatment of bacterial vaginosis, a common vaginal infection[5].
Claims of the Patent
The claims of the '678 Patent are critical as they define the legal boundaries of the invention. Here are some key aspects:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the general composition of the aqueous-based metronidazole gel formulation[5].
- Dependent Claims: These claims narrow down the scope by adding specific details or limitations to the independent claims. For instance, a dependent claim might specify the concentration of metronidazole or the type of excipients used[5].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights associated with the '678 Patent.
Related Patents
The '678 Patent is part of a family of patents related to metronidazole formulations. Other patents in this family include U.S. Patent Nos. 7,893,097, 8,877,792, 8,946,276, 9,198,858, 10,238,634, and 10,596,155. These patents collectively cover various aspects of metronidazole formulations, including different compositions, methods of preparation, and therapeutic applications[5].
Exclusivity and Expiration
The '678 Patent is listed in the FDA's Orange Book, which provides information on drug patents and exclusivity. The patent is set to expire on June 28, 2032, as indicated in the Orange Book[5].
Litigation and Infringement
The '678 Patent has been involved in litigation, particularly in cases related to generic versions of the metronidazole gel formulation. For example, Chemo Research SL and Bausch Health Ireland, Ltd. have filed complaints against Encube Ethicals Private, Ltd. for patent infringement related to the submission of an Abbreviated New Drug Application (ANDA) for a generic version of the product[5].
Patent Analytics and Claim Coverage
To fully understand the protective scope of the '678 Patent, patent analytics tools can be employed.
- Claim Coverage Matrix: This tool helps in identifying which patents and claims are actively protecting the intellectual property. It categorizes patents by claims and scope concepts, making it easier to analyze large numbers of patent claims[3].
- Claim Charts: These charts, generated by software like ClaimScape®, facilitate the review of patent coverage with technical experts. They help in determining gaps in current coverage and highlighting future design opportunities[3].
Public Search and Access
For researchers and practitioners, accessing the details of the '678 Patent is facilitated through various tools provided by the USPTO.
- Patent Public Search: This tool allows users to search for patents, including the '678 Patent, using modern interfaces that enhance access to prior art[1].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, which can be useful for understanding the global patent family and citation data related to the '678 Patent[1].
Conclusion
The '678 Patent is a significant asset in the pharmaceutical industry, particularly in the treatment of bacterial vaginosis. Understanding its scope, claims, and the broader patent landscape is crucial for both the owners of the patent and potential competitors. The use of patent analytics tools and access to public search facilities can help in navigating the complex intellectual property landscape associated with this patent.
Key Takeaways
- Scope and Claims: The '678 Patent covers aqueous-based metronidazole gel formulations, including composition, method of preparation, and therapeutic uses.
- Patent Landscape: The patent is part of a family of related patents and is listed in the FDA's Orange Book with an expiration date of June 28, 2032.
- Litigation: The patent has been involved in infringement cases related to generic versions of the product.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing the protective scope of the patent.
- Public Access: The USPTO provides various tools for searching and accessing patent information.
FAQs
Q: What is the primary therapeutic use of the '678 Patent?
A: The primary therapeutic use of the '678 Patent is the treatment of bacterial vaginosis.
Q: When is the '678 Patent set to expire?
A: The '678 Patent is set to expire on June 28, 2032.
Q: What tools can be used to analyze the claims of the '678 Patent?
A: Tools such as Claim Coverage Matrix and Claim Charts, generated by software like ClaimScape®, can be used to analyze the claims.
Q: How can one access the details of the '678 Patent?
A: The details of the '678 Patent can be accessed through the USPTO's Patent Public Search tool and the Global Dossier service.
Q: Is the '678 Patent involved in any litigation?
A: Yes, the '678 Patent has been involved in litigation related to patent infringement by generic manufacturers.
