United States Patent 8,946,276: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,946,276, titled "High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis," is a significant patent in the field of pharmaceuticals, particularly for the treatment of bacterial vaginosis. This patent, issued to Chemo Research SL and assigned to Bausch Health Ireland, Ltd., covers innovative formulations and methods for delivering metronidazole, a commonly used antibiotic.
Background
Bacterial vaginosis is a common vaginal infection caused by an imbalance of naturally occurring bacterial flora. Metronidazole, an antibiotic, is a standard treatment for this condition. However, traditional formulations often have limitations such as low bioavailability and patient compliance issues. The patent in question addresses these challenges by introducing high dosage mucoadhesive aqueous-based gel formulations of metronidazole.
Scope of the Patent
The patent's scope is broad and encompasses several key aspects:
Mucoadhesive Gel Formulations
The patent describes the development of mucoadhesive gel formulations containing high doses of metronidazole. These formulations are designed to adhere to the mucosal surfaces of the vagina, ensuring prolonged release of the antibiotic and enhanced bioavailability[5].
Treatment of Bacterial Vaginosis
The primary use of these formulations is for the treatment of bacterial vaginosis. The patent outlines methods and compositions that improve the efficacy of metronidazole in treating this condition by ensuring a sustained release of the drug at the site of infection[5].
Aqueous-Based Formulations
The patent emphasizes the use of aqueous-based gel formulations, which are more patient-friendly compared to traditional formulations. These aqueous gels are easier to apply and less likely to cause irritation, improving patient compliance[5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Composition
Claim 1 specifies the composition of the mucoadhesive gel formulation, including a high dose of metronidazole (typically 1.3%) and various excipients that enhance mucoadhesion and stability[5].
Claim 2: Method of Preparation
This claim details the method of preparing the gel formulation, including the steps involved in mixing the ingredients and ensuring the desired consistency and mucoadhesive properties[5].
Claim 3: Use in Treatment
Claim 3 pertains to the use of the gel formulation for treating bacterial vaginosis, highlighting the therapeutic benefits and the improved efficacy of the treatment[5].
Patent Landscape
Related Patents
The patent is part of a series of related patents held by Chemo Research SL and Bausch Health Ireland, Ltd. These include patents such as U.S. Patent Nos. 7,893,097, 8,658,678, 8,877,792, and 9,198,858, which collectively cover various aspects of metronidazole formulations and their use in treating genital and sexual disorders[2].
Litigation and Enforcement
The patent has been involved in litigation, with Chemo Research SL and Bausch Health Ireland, Ltd. filing a complaint against Encube Ethicals Private, Ltd. for patent infringement. The lawsuit alleges that Encube's generic gel product infringes on the claims of the '276 Patent[2].
Expiration Date
The '276 Patent is listed in the FDA's Orange Book with an expiration date of June 28, 2032. This indicates that the patent will remain in force for several years, protecting the proprietary rights of the holders[2].
Impact on the Pharmaceutical Industry
Innovation in Drug Delivery
The patent represents a significant innovation in drug delivery systems, particularly for vaginal infections. The mucoadhesive gel formulation enhances the efficacy and patient compliance of metronidazole treatment, setting a new standard in the field[5].
Competitive Advantage
The exclusive rights granted by this patent provide a competitive advantage to the holders, allowing them to dominate the market for bacterial vaginosis treatments using metronidazole gel formulations[2].
Generic Challenges
The patent's validity and infringement claims are being challenged by generic manufacturers like Encube Ethicals Private, Ltd. These challenges highlight the ongoing battle between innovator companies and generic manufacturers in the pharmaceutical industry[2].
Key Takeaways
- Innovative Formulation: The patent introduces a high dosage mucoadhesive aqueous-based gel formulation of metronidazole, enhancing the treatment of bacterial vaginosis.
- Broad Scope: The patent covers the composition, method of preparation, and use of the gel formulation.
- Litigation: The patent is involved in litigation with generic manufacturers, highlighting the importance of patent enforcement.
- Expiration Date: The patent expires on June 28, 2032, providing a significant period of exclusivity.
- Industry Impact: The patent sets a new standard in drug delivery for vaginal infections and provides a competitive advantage to the holders.
FAQs
Q: What is the primary use of the mucoadhesive gel formulation described in U.S. Patent 8,946,276?
A: The primary use is for the treatment of bacterial vaginosis.
Q: What is unique about the gel formulation described in this patent?
A: The formulation is aqueous-based, mucoadhesive, and contains a high dose of metronidazole, ensuring prolonged release and enhanced bioavailability.
Q: Who are the holders of U.S. Patent 8,946,276?
A: The patent is held by Chemo Research SL and assigned to Bausch Health Ireland, Ltd.
Q: What is the expiration date of U.S. Patent 8,946,276?
A: The patent expires on June 28, 2032.
Q: Is the patent involved in any litigation?
A: Yes, the patent is involved in litigation with Encube Ethicals Private, Ltd. for alleged patent infringement.
Sources
- US8946276B2 - High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE CHEMO RESEARCH SL, AND BAUSCH HEALTH IRELAND, LTD., Plaintiffs, v. ENCUBE ETHICALS PRIVATE, LTD., Defendant - Insight.RPXCorp
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- (12) United States Patent (10) Patent No.: US 8,946,276 B2 - Patent Images Storage Googleapis
