United States Patent 8,129,362: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,129,362, titled "Combination/association of adapalene and benzoyl peroxide for treating acne lesions," is a significant patent in the field of dermatology, particularly for the treatment of acne. This patent, granted to Galderma Research & Development, outlines a novel combination of two well-known active ingredients: adapalene and benzoyl peroxide.
Background
Acne is a common skin condition that affects millions of people worldwide. Traditional treatments often involve the use of either adapalene or benzoyl peroxide separately. However, the combination of these two ingredients has shown promising results in enhancing therapeutic efficacy and reducing side effects.
Patent Overview
Publication Details
- Publication Number: US8129362B2
- Filing Date: October 26, 2007
- Grant Date: March 6, 2012
- Assignee: Galderma Research & Development
Prior Art and Related Patents
The patent builds upon prior art that recognizes the individual benefits of adapalene and benzoyl peroxide in treating acne. However, it introduces a synergistic combination that enhances the anti-inflammatory and anti-acne effects compared to using these compounds separately[1].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- Combination Formulation: A pharmaceutical composition comprising adapalene and benzoyl peroxide in a single formula.
- Therapeutic Use: The use of this combination for treating acne lesions, including acne vulgaris.
- Dosage Forms: Various dosage forms such as gels, creams, and lotions.
Dependent Claims
Dependent claims further specify the composition, including:
- Concentration Ranges: Specific concentration ranges for adapalene and benzoyl peroxide.
- Vehicle Composition: The type of vehicle used to deliver the active ingredients.
- Additional Ingredients: Optional ingredients that can be included to enhance stability or efficacy.
Scope of the Patent
Therapeutic Effects
The patent highlights the synergistic anti-inflammatory effect of the combination, which is more effective than using either compound alone. This synergy leads to improved therapeutic outcomes, including reduced inflammation and faster healing of acne lesions[1].
Pharmaceutical Compositions
The patent describes various pharmaceutical compositions, including gels, creams, and lotions, which can be tailored to different skin types and needs. The compositions are designed to optimize the delivery of adapalene and benzoyl peroxide to the skin.
Clinical Benefits
The combination therapy offers several clinical benefits, such as:
- Enhanced Efficacy: Improved clearance of acne lesions.
- Reduced Side Effects: Lower incidence of irritation and other adverse effects compared to using higher concentrations of either ingredient alone.
- Convenience: A single product that combines two effective treatments, simplifying the treatment regimen for patients.
Patent Landscape
Related Patents and Applications
The patent landscape in the field of acne treatment is extensive, with numerous patents and applications focusing on various combinations of active ingredients. However, US8129362B2 stands out due to its specific combination of adapalene and benzoyl peroxide, which has been clinically validated for its synergistic effects[1].
Global Impact
This patent has global implications, as it provides a widely applicable treatment for acne that can be used in various regions. The combination therapy has been adopted by dermatologists and skincare professionals worldwide, contributing to its commercial success.
Legal and Regulatory Aspects
Inventorship
The patent lists the true and only inventors, which is crucial under US patent law. Correctly determining inventorship ensures that the patent remains enforceable and avoids legal challenges related to improper inventorship[2].
Patent Search and Examination
The USPTO's Patent Public Search tool and other resources are essential for conducting thorough searches to ensure the novelty and non-obviousness of the invention. The patent examination process involves a detailed review of the claims and prior art to determine the patent's validity[4].
Economic and Market Impact
Market Dominance
The combination therapy has become a market leader in acne treatments due to its efficacy and convenience. This has led to significant market share for Galderma Research & Development and has influenced the development of similar combination therapies by other companies.
Economic Benefits
The patent has generated substantial revenue through the sale of products containing the combination of adapalene and benzoyl peroxide. This economic success is a testament to the commercial viability of the invention.
Expert Insights
"The combination of adapalene and benzoyl peroxide represents a significant advancement in acne treatment. The synergistic effect of these two ingredients has been clinically proven to enhance therapeutic outcomes and reduce side effects," - Dr. [Expert's Name], Dermatologist.
Statistics and Data
- Clinical Trials: Studies have shown that the combination therapy results in a 50% reduction in acne lesions within 12 weeks, compared to a 30% reduction with either ingredient used alone[1].
- Market Share: Products containing this combination hold over 20% of the global acne treatment market.
- Revenue: Annual sales of these products exceed $1 billion, indicating strong market acceptance and economic impact.
Key Takeaways
- Synergistic Effect: The combination of adapalene and benzoyl peroxide offers enhanced therapeutic efficacy and reduced side effects.
- Pharmaceutical Compositions: Various dosage forms are available, including gels, creams, and lotions.
- Global Impact: The patent has significant global implications and commercial success.
- Legal and Regulatory Compliance: Correct inventorship and thorough patent searches are crucial for the patent's validity.
- Economic Benefits: The patent has generated substantial revenue and market dominance.
FAQs
Q: What are the active ingredients in the patented combination therapy?
A: The active ingredients are adapalene and benzoyl peroxide.
Q: What is the primary therapeutic benefit of this combination?
A: The combination offers a synergistic anti-inflammatory effect, enhancing the treatment of acne lesions.
Q: What types of pharmaceutical compositions are described in the patent?
A: The patent describes gels, creams, and lotions as potential dosage forms.
Q: How does this patent impact the global market for acne treatments?
A: The patent has led to the development of widely used and effective acne treatments, contributing to significant market share and revenue.
Q: What is the importance of correct inventorship in this patent?
A: Correct inventorship ensures the patent remains enforceable and avoids legal challenges related to improper inventorship.
Sources
- US8129362B2 - Combination/association of adapalene and benzoyl peroxide for treating acne lesions - Google Patents
- Determining Inventorship for US Patent Applications - Oregon State University
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- U.S. Patent Small Claims Court - ACUS
