United States Patent 8,222,270: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,222,270, titled "2×2×2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod," is a significant patent in the field of dermatology. This patent, granted to Sharon F. Levy, outlines a specific treatment regimen for actinic keratosis, a common skin condition. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Actinic Keratosis
Actinic keratosis is a precancerous skin condition caused by prolonged exposure to UV radiation. It is characterized by small, rough patches on the skin and can progress to squamous cell carcinoma if left untreated. The treatment typically involves topical creams, photodynamic therapy, or surgical removal[4].
Patent Overview
Publication and Grant Details
- Publication Number: US8222270B2
- Grant Date: July 17, 2012
- Application Number: US13/179,315
- Priority Date: June 30, 2011[4].
Inventor and Assignee
The patent was granted to Sharon F. Levy, with the assignee being the original applicant or their designated entity.
Scope of the Patent
The patent describes a specific treatment regimen for actinic keratosis using a pharmaceutical composition containing 2.5% imiquimod. Here are the key aspects of the scope:
Treatment Regimen
The patent outlines a "2×2×2 week treatment regimen," which involves applying the imiquimod cream for two weeks, followed by a two-week rest period, and then another two weeks of treatment. This cyclic approach is designed to maximize efficacy while minimizing side effects[4].
Pharmaceutical Composition
The composition includes 2.5% imiquimod, along with various excipients such as methylparaben, propylparaben, ethyl acetate, and glycerine. These components help in stabilizing the formulation and enhancing its application properties[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the treatment regimen involving the application of 2.5% imiquimod cream for two weeks, followed by a two-week rest period, and then another two weeks of treatment.
- Claim 2 specifies the pharmaceutical composition, including the active ingredient imiquimod and various excipients[4].
Dependent Claims
These claims further detail the components of the pharmaceutical composition, such as the concentration of imiquimod, the types of excipients used, and the method of application.
Patent Landscape
Prior Art and Related Patents
The patent landscape for actinic keratosis treatments is extensive, with numerous patents covering various aspects of treatment regimens and pharmaceutical compositions. For instance, other patents may cover different concentrations of imiquimod or alternative treatment schedules. The USPTO's Patent Public Search tool and international databases like the European Patent Office's esp@cenet can be used to identify prior art and related patents[1].
Global Dossier and International Filings
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the global patent landscape for similar inventions[1].
Competitive Analysis
Competitors in the field of dermatology treatments for actinic keratosis include other pharmaceutical companies with their own patented treatment regimens. Analyzing these patents through tools like the Patent Examination Data System (PEDS) can provide insights into the competitive landscape and potential areas for innovation[1].
Economic and Market Impact
Market Demand
The demand for effective treatments for actinic keratosis is significant due to the prevalence of the condition. Patents like US8222270B2 play a crucial role in driving innovation and ensuring that patients have access to proven treatment regimens.
Expiration and Generic Competition
The patent's expiration date is crucial for understanding when generic versions of the treatment can enter the market. According to PharmaCompass, the patent's expiration can affect the market dynamics, allowing for generic competition and potentially reducing treatment costs[5].
Legal and Regulatory Aspects
Patent Enforcement
The legal status of the patent is active, but it is important to note that legal analyses and representations regarding the status are not provided by databases like Google Patents. Patent holders must ensure compliance with all regulatory requirements and enforce their patents to protect their intellectual property[4].
Regulatory Approvals
The treatment regimen described in the patent would have undergone regulatory approvals, such as those from the FDA, before being marketed. The FDA Orange Book lists patents related to approved drugs, including this treatment regimen[5].
Conclusion
United States Patent 8,222,270 is a significant contribution to the treatment of actinic keratosis, offering a specific and effective treatment regimen using 2.5% imiquimod. Understanding the scope, claims, and broader patent landscape is essential for innovators, competitors, and regulatory bodies. This patent highlights the importance of intellectual property in driving medical innovation and ensuring patient access to effective treatments.
Key Takeaways
- Specific Treatment Regimen: The patent describes a "2×2×2 week treatment regimen" using 2.5% imiquimod cream.
- Pharmaceutical Composition: The composition includes imiquimod and various excipients to enhance stability and application.
- Claims: The patent includes independent and dependent claims defining the treatment regimen and pharmaceutical composition.
- Patent Landscape: The patent is part of a broader landscape of actinic keratosis treatments, with global filings and competitive analysis being crucial.
- Economic and Market Impact: The patent affects market demand and competition, with its expiration influencing generic competition.
- Legal and Regulatory Aspects: The patent is subject to regulatory approvals and enforcement to protect intellectual property.
FAQs
What is the main claim of US Patent 8,222,270?
The main claim describes a "2×2×2 week treatment regimen" for treating actinic keratosis using a pharmaceutical composition containing 2.5% imiquimod.
Who is the inventor of US Patent 8,222,270?
The inventor is Sharon F. Levy.
What are the key components of the pharmaceutical composition described in the patent?
The composition includes 2.5% imiquimod, along with excipients such as methylparaben, propylparaben, ethyl acetate, and glycerine.
How does the Global Dossier service relate to this patent?
The Global Dossier service allows users to view the patent family for this application, including related applications filed at participating IP Offices.
What is the significance of the patent's expiration date?
The expiration date affects when generic versions of the treatment can enter the market, potentially reducing treatment costs and increasing competition.
How can one search for related patents in the field of actinic keratosis treatments?
One can use the USPTO's Patent Public Search tool, international databases like esp@cenet, and services like the Global Dossier to search for related patents.
