United States Patent 8,460,641: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,460,641, titled "Microemulsion process and composition," is a patent that describes an oil-in-water microemulsion or sub-micron emulsion composition designed for the dermal delivery of at least one pharmaceutically active ingredient. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent was granted on June 11, 2013, and is classified under various categories, including the International Patent Classification (IPC) and the United States Patent Classification (USPC) systems. Understanding the context in which this patent was filed and granted is crucial for appreciating its significance and impact.
Scope of the Invention
Microemulsion Composition
The patent describes a microemulsion composition that is specifically designed for dermal delivery. Microemulsions are stable, isotropic mixtures of oil, water, and surfactants, which are particularly useful for delivering active pharmaceutical ingredients (APIs) through the skin. The composition includes a pharmaceutically active ingredient, an oil phase, a water phase, and one or more surfactants[4].
Key Components
- Pharmaceutically Active Ingredient: This can be any drug or therapeutic agent intended for dermal delivery.
- Oil Phase: This component is crucial for solubilizing the active ingredient and enhancing its delivery.
- Water Phase: The water phase helps in stabilizing the microemulsion and facilitating the delivery of the active ingredient.
- Surfactants: These are critical for reducing the interfacial tension between the oil and water phases, thereby stabilizing the microemulsion.
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the microemulsion composition comprising a pharmaceutically active ingredient, an oil phase, a water phase, and one or more surfactants.
- Claim 2 specifies the types of surfactants that can be used, such as non-ionic surfactants.
- Claim 3 details the concentration ranges of the various components in the microemulsion[4].
Dependent Claims
- These claims further specify the characteristics of the microemulsion, such as the particle size, the type of pharmaceutically active ingredient, and the method of preparation.
Patent Landscape
Related Patents and Prior Art
The patent landscape for microemulsion compositions is extensive. Prior art includes various patents and publications related to microemulsions and their applications in pharmaceutical delivery. For instance, other patents may describe similar compositions but with different surfactants or methods of preparation.
Classification and Categorization
The patent is classified under several categories, including:
- International Patent Classification (IPC): A61K8/06, A61K8/34, etc.
- United States Patent Classification (USPC): 424/401, 514/944, etc.
These classifications help in identifying similar patents and understanding the broader technological field[1][3].
Economic and Market Impact
Pharmaceutical Industry
The invention has significant implications for the pharmaceutical industry, particularly in the development of topical formulations. Microemulsions offer improved bioavailability and stability for many drugs, enhancing their therapeutic efficacy.
Market Trends
The demand for advanced drug delivery systems is increasing, driven by the need for more effective and patient-friendly treatments. This patent contributes to this trend by providing a novel composition that can be tailored for various pharmaceutical applications.
Legal and Regulatory Considerations
Patent Validity and Enforcement
The validity of the patent is subject to legal scrutiny, including challenges based on prior art, obviousness, and the written description requirement. The patent must comply with statutory requirements such as those outlined in 35 U.S.C. § 112 and § 251 for reissue patents[5].
Regulatory Approvals
For the microemulsion composition to be used in pharmaceutical products, it must undergo rigorous regulatory approvals, including clinical trials and FDA clearance.
Future Developments and Challenges
Research and Development
Continued research is necessary to optimize the microemulsion composition for different pharmaceutical active ingredients and to explore new applications in dermatology and other fields.
Competitive Landscape
The competitive landscape in the field of pharmaceutical delivery systems is highly dynamic. Other companies and researchers are continually developing new formulations and delivery methods, which could potentially challenge the market position of this patent.
Key Takeaways
- Innovative Composition: The patent describes a novel microemulsion composition for dermal delivery of pharmaceutical active ingredients.
- Broad Applications: The invention has wide-ranging applications in the pharmaceutical industry, particularly in topical formulations.
- Regulatory and Legal Considerations: The patent must comply with statutory and regulatory requirements to ensure its validity and enforcement.
- Market Impact: The invention contributes to the growing demand for advanced drug delivery systems.
FAQs
What is the primary use of the microemulsion composition described in US Patent 8,460,641?
The primary use is for the dermal delivery of at least one pharmaceutically active ingredient.
What are the key components of the microemulsion composition?
The key components include a pharmaceutically active ingredient, an oil phase, a water phase, and one or more surfactants.
How does the patent classify under the IPC and USPC systems?
The patent is classified under various categories such as A61K8/06 and 424/401, respectively.
What are the regulatory requirements for the microemulsion composition to be used in pharmaceutical products?
The composition must undergo clinical trials and obtain FDA clearance before it can be used in pharmaceutical products.
How does this patent impact the pharmaceutical industry?
The patent contributes to the development of advanced drug delivery systems, enhancing the bioavailability and stability of pharmaceutical active ingredients.
Cited Sources
- PatentsView: Data Download Tables - PatentsView[1]
- Administrative Conference of the United States: U.S. Patent Small Claims Court[2]
- United States Patent and Trademark Office: Patent Claims Research Dataset[3]
- Google Patents: US8460641B2 - Microemulsion process and composition[4]
- Court of Appeals for the Federal Circuit: In Re FLOAT'N'GRILL LLC[5]
