United States Patent 7,179,475: An In-Depth Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,179,475, titled "Anhydrous Topical Skin Preparations," is a significant patent in the field of dermatology and pharmaceuticals. This patent, granted to address the delivery of medicaments through topical skin preparations, provides a comprehensive framework for the formulation and application of anhydrous compositions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Prior Art
Before the invention described in US Patent 7,179,475, topical skin preparations often faced challenges related to the effective delivery of medicaments. The prior art included various formulations, but they were not always efficient in penetrating the skin or maintaining stability. This patent aimed to overcome these limitations by introducing anhydrous compositions that enhance the delivery and efficacy of topical treatments[1].
Scope of the Invention
The patent covers anhydrous compositions designed for the topical delivery of medicaments. These compositions are characterized by several key components:
- Penetration Enhancer/Solvent: Selected from the group consisting of alcohol, propylene glycol, or a combination thereof.
- Humectant/Solvent: Selected from the group consisting of polyethylene glycol, glycerin, sorbitol, xylitol, or any combination of these.
- Anhydrous Vehicle: This component ensures the formulation remains anhydrous, which is crucial for stability and effectiveness.
- Medicaments: The patent includes a wide range of medicaments such as antifungals (e.g., ketoconazole), antibiotics (e.g., erythromycin), and steroids (e.g., desonide)[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: An anhydrous topical skin preparation comprising a penetration enhancer/solvent, a humectant/solvent, an anhydrous vehicle, and one or more medicaments.
- Claim 2: The preparation of Claim 1, where the penetration enhancer/solvent is selected from alcohol, propylene glycol, or a combination thereof.
- Claim 3: The preparation of Claim 1, where the humectant/solvent is selected from polyethylene glycol, glycerin, sorbitol, xylitol, or any combination thereof.
- Claim 4: The preparation of Claim 1, where the medicament is an antifungal agent, such as ketoconazole[1].
Key Components and Their Roles
Penetration Enhancer/Solvent
These components, such as alcohol and propylene glycol, facilitate the penetration of the medicament through the skin, enhancing the efficacy of the treatment[1].
Humectant/Solvent
Humectants like polyethylene glycol, glycerin, sorbitol, and xylitol help retain moisture in the skin, ensuring the formulation remains stable and effective[1].
Anhydrous Vehicle
The anhydrous vehicle is crucial as it prevents the inclusion of water, which can degrade the medicament or reduce the stability of the formulation[1].
Medicaments
The patent covers a broad range of medicaments, including antifungals like ketoconazole, which is particularly effective against fungal skin infections such as seborrheic dermatitis[4].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of topical skin preparations is extensive. Other patents and technologies focus on different aspects such as emollients, chelating agents, pH adjusters, antioxidants, gelling agents, viscosifiers, colorants, fragrances, UV stabilizers, and sunscreens. These components can be combined with the anhydrous compositions described in US Patent 7,179,475 to enhance their functionality[1].
Patent Analytics and Claim Coverage
To understand the full scope of protection and potential gaps, patent analytics tools are essential. These tools help in categorizing patents by claims and scope concepts, making it easier to identify areas of coverage and opportunities for future development. For instance, Claim Coverage Matrix and Claim Charts can be used to review patent coverage and determine if there are gaps in current coverage[3].
Industry Impact and Applications
Clinical Use
The anhydrous topical skin preparations described in this patent have significant clinical applications. For example, ketoconazole, a broad-spectrum antifungal, is used to treat seborrheic dermatitis and other fungal skin infections. The formulation ensures effective delivery and stability of the medicament, improving treatment outcomes[4].
Market and Competitive Landscape
The market for topical skin preparations is competitive, with numerous products available. However, the unique formulation described in US Patent 7,179,475 offers a competitive edge due to its enhanced penetration and stability. This can lead to better patient compliance and treatment efficacy, making it a valuable asset in the pharmaceutical industry.
Future Directions and Opportunities
Research and Development
Continued research and development in this area can focus on integrating other medicaments and components to expand the range of treatments. For instance, combining antifungal agents with other types of medicaments could create multifunctional topical preparations.
Patent Strategy
Companies holding this patent can use patent analytics to identify gaps in their current coverage and future design opportunities. This involves categorizing patents by claims and scope concepts to ensure comprehensive protection of their intellectual property[3].
Regulatory Considerations
Terminal Disclaimers and Double Patenting
Recent proposals by the USPTO regarding terminal disclaimers in response to obviousness type double patenting rejections could impact the prosecution and litigation strategies related to this patent. Ensuring that the terminally disclaimed patent is enforceable only if not tied to a patent with finally held unpatentable or invalid claims is crucial for maintaining the validity of the patent[5].
Key Takeaways
- Anhydrous Compositions: The patent introduces anhydrous topical skin preparations that enhance the delivery and stability of medicaments.
- Key Components: Penetration enhancers, humectants, anhydrous vehicles, and medicaments are critical components of the formulation.
- Clinical Applications: The formulations are particularly useful for treating fungal skin infections and other dermatological conditions.
- Patent Landscape: The patent is part of a broader landscape that includes various related technologies and components.
- Future Directions: Continued R&D and strategic patent management are essential for maximizing the value of this invention.
FAQs
What is the primary purpose of the anhydrous vehicle in the topical skin preparations described in US Patent 7,179,475?
The primary purpose of the anhydrous vehicle is to prevent the inclusion of water, which can degrade the medicament or reduce the stability of the formulation.
Which antifungal agent is specifically mentioned in the patent as a preferred medicament?
Ketoconazole is mentioned as a preferred antifungal agent in the patent.
How do penetration enhancers/solvents contribute to the efficacy of the topical skin preparations?
Penetration enhancers/solvents, such as alcohol and propylene glycol, facilitate the penetration of the medicament through the skin, enhancing the efficacy of the treatment.
What role do humectants play in the anhydrous topical skin preparations?
Humectants help retain moisture in the skin, ensuring the formulation remains stable and effective.
How can patent analytics tools be used to manage the intellectual property related to this patent?
Patent analytics tools can be used to categorize patents by claims and scope concepts, helping to identify areas of coverage and potential gaps, and to determine future design opportunities.
Sources
- US Patent 7,179,475: Anhydrous topical skin preparations.
- Patent and patent application Claims data: USPTO Chief Economist.
- Patent Analytics: Schwegman, Lundberg & Woessner, P.A.
- Ketoconazole: DrugBank.
- United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice: Sterne, Kessler, Goldstein & Fox P.L.L.C.
