United States Patent 7,820,186: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 7,820,186, titled "Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt," is a significant patent in the field of dermatology, particularly for the treatment of acne. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Patent Holder and Assignee
The patent is assigned to Galderma Research & Development, a company known for its innovative dermatological and cosmetic products. This assignment indicates that Galderma holds the exclusive rights to the proprietary formulation described in the patent[4].
Patent Expiration Date
The patent is set to expire on November 23, 2025. This expiration date is crucial as it marks the end of the exclusive rights granted to Galderma, after which the formulation can be used by other companies to develop generic versions[2][4].
Scope of the Patent
Combination of Active Ingredients
The patent covers a gel composition that combines two active ingredients: adapalene and benzoyl peroxide. Adapalene is a retinoid, and benzoyl peroxide is an antibacterial agent. This combination is specifically designed for the once-daily treatment of common acne, addressing cell differentiation, proliferation, and keratinization disorders[4].
Therapeutic Use
The primary therapeutic use of this gel composition is the treatment of acne lesions. The combination of adapalene and benzoyl peroxide works synergistically to prevent or treat conditions related to cell differentiation and keratinization, which are key factors in the development of acne[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, the method of preparation, and the therapeutic use of the gel.
- Composition Claims: These claims specify the exact formulation of the gel, including the percentages of adapalene and benzoyl peroxide, and other components such as gelling agents and preservatives[4].
- Method of Preparation Claims: These claims outline the process of preparing the gel composition, ensuring that the manufacturing process is consistent and reproducible[4].
- Therapeutic Use Claims: These claims define the intended use of the gel composition, which is the treatment of acne and related skin disorders[4].
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations or specifications. For example, dependent claims might specify particular concentrations of the active ingredients or additional components that enhance the stability or efficacy of the gel[4].
Patent Landscape
Related Patents
The patent landscape surrounding US 7,820,186 includes several other patents related to the combination of adapalene and benzoyl peroxide. These patents, such as US 7,964,202, US 8,071,644, and US 8,129,362, cover various aspects of the formulation, manufacturing process, and therapeutic uses. These patents are also held by Galderma and are part of the broader intellectual property portfolio protecting the Epiduo brand[1][2].
Patent Exclusivity
In addition to the patent protection, the FDA has granted exclusivity periods for certain drugs. For the generic version of Epiduo, which is based on this patent, Actavis Mid Atlantic LLC was granted 180 days of generic drug exclusivity. This exclusivity period begins from the date of commercial marketing and is provided under section 505(j)(5)(B)(iv) of the FD&C Act[1].
Litigation and Certifications
The approval of generic versions of Epiduo involved litigation related to the validity and enforceability of the patents. Actavis Mid Atlantic LLC submitted paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the FD&C Act, stating that the patents were invalid, unenforceable, or would not be infringed by their manufacture, use, or sale of the generic product. This led to litigation in the United States District Court for the Northern District of Texas, which was eventually dismissed[1].
Impact on the Market
The expiration of the patent and the subsequent approval of generic versions will significantly impact the market for acne treatments. Generic versions of Epiduo, such as the Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%, will become more widely available, potentially reducing costs for consumers and increasing competition in the dermatological market[2].
Key Takeaways
- Patent Scope: The patent covers a specific gel composition combining adapalene and benzoyl peroxide for treating acne.
- Expiration Date: The patent expires on November 23, 2025.
- Claims: The patent includes claims related to the composition, method of preparation, and therapeutic use.
- Related Patents: Several other patents protect various aspects of the Epiduo formulation and manufacturing process.
- Exclusivity: Actavis Mid Atlantic LLC has been granted 180 days of generic drug exclusivity.
- Litigation: Litigation related to patent validity and enforceability has been resolved.
FAQs
What is the primary use of the gel composition described in US 7,820,186?
The primary use is the once-daily treatment of common acne, addressing cell differentiation, proliferation, and keratinization disorders.
Who is the assignee of US 7,820,186?
The assignee is Galderma Research & Development.
When does the patent expire?
The patent expires on November 23, 2025.
What are the active ingredients in the gel composition?
The active ingredients are adapalene and benzoyl peroxide.
Has a generic version of Epiduo been approved?
Yes, a generic version of Epiduo has been approved by the FDA.
What is the significance of the 180-day exclusivity period for Actavis Mid Atlantic LLC?
This period grants Actavis exclusive marketing rights for the generic version of Epiduo, starting from the date of commercial marketing.
Sources
- FDA Approval Letter: Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% - FDA.
- Drugs.com: Generic Epiduo Availability - Drugs.com.
- SSRN Paper: Patent Claims and Patent Scope - SSRN.
- Google Patents: US7820186B2 - Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt - Google Patents.
- Google Patents: (12) United States Patent - googleapis.com.
