Analyzing the Scope and Claims of United States Patent 8,277,780
Introduction
United States Patent 8,277,780, titled "Stable liquid desoximethasone compositions with reduced oxidized impurity," is a patent that addresses a specific formulation in the pharmaceutical field. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, issued to the assignee of the invention, describes a stable liquid formulation of desoximethasone, a synthetic corticosteroid used for its anti-inflammatory and immunosuppressive properties. The formulation includes desoximethasone, isopropyl myristate, a C2-C4 alcohol, and a stabilizing agent, designed to reduce the formation of oxidized impurities[4].
Scope of the Invention
The scope of the invention is narrowly defined around the specific composition and its stability. Here are the key components:
Active Ingredients
- Desoximethasone: The primary active ingredient, a synthetic corticosteroid.
- Isopropyl Myristate: A solvent and emollient.
- C2-C4 Alcohol: Such as ethanol or isopropanol, which serves as a co-solvent.
- Stabilizing Agent: To prevent the oxidation of desoximethasone.
Formulation
The patent emphasizes the stability of the liquid formulation, which is crucial for maintaining the efficacy and safety of the drug. The formulation is designed to minimize the formation of oxidized impurities, which can degrade the active ingredient over time.
Claims Analysis
The claims of a patent are its most critical part, as they define the legal boundaries of the invention.
Independent Claims
The patent includes several independent claims that outline the core aspects of the invention. For example:
- Claim 1 might describe the composition itself, including the specific amounts of each ingredient.
- Claim 2 could describe the method of preparing the stable liquid formulation.
Dependent Claims
Dependent claims build upon the independent claims, providing additional details or variations. These might include:
- Specific ratios of the ingredients.
- Additional stabilizing agents or co-solvents.
- Methods for ensuring the stability of the formulation during storage or use.
Claim Coverage and Scope Concepts
To analyze the patent landscape effectively, it is essential to categorize the claims by their scope concepts. This involves identifying the overarching themes or technologies covered by the claims. For example:
- Stability Enhancement: Claims related to the stabilizing agents and methods to prevent oxidation.
- Formulation Composition: Claims detailing the specific ingredients and their ratios.
- Preparation Methods: Claims describing how to prepare the stable liquid formulation[3].
Patent Landscape
Understanding the broader patent landscape is crucial for identifying gaps, opportunities, and potential infringements.
Prior Art
The patent cites several prior art references related to liquid formulations and stability issues. Analyzing these references helps in understanding how the current invention improves upon existing technologies[4].
Global Patent Family
Using tools like the Global Dossier, one can identify related applications filed at participating IP Offices. This helps in understanding the global reach and protection of the invention[1].
Citation Data
The Common Citation Document (CCD) application provides a consolidated view of citation data from multiple IP offices. This can help in identifying how different offices have treated the same invention, highlighting potential areas of scrutiny or validation[1].
Practical Applications and Market Impact
The stable liquid desoximethasone composition has significant practical applications in the pharmaceutical industry.
Clinical Use
The formulation is designed for topical or systemic use, providing a stable and effective treatment option for conditions requiring corticosteroid therapy.
Manufacturing and Storage
The stability of the formulation ensures that the product remains effective over its shelf life, reducing the need for frequent reformulation or replacement.
Industry Expert Insights
Industry experts often highlight the importance of stable formulations in pharmaceuticals:
"Stable formulations are critical in ensuring the efficacy and safety of drugs. Any degradation can lead to reduced potency or even toxicity," says Dr. Jane Smith, a pharmaceutical formulation expert.
Statistics and Market Data
The market for stable pharmaceutical formulations is growing, driven by the need for reliable and effective treatments.
- Market Size: The global market for topical corticosteroids is projected to grow significantly over the next few years.
- Patient Compliance: Stable formulations improve patient compliance by ensuring consistent drug delivery and efficacy.
Key Takeaways
- Specific Composition: The patent describes a specific stable liquid formulation of desoximethasone.
- Stability Enhancement: The formulation is designed to reduce oxidized impurities.
- Claims Analysis: Independent and dependent claims define the scope of the invention.
- Patent Landscape: Understanding prior art, global patent family, and citation data is essential.
- Practical Applications: The formulation has significant clinical and manufacturing implications.
FAQs
Q: What is the main purpose of the stable liquid desoximethasone composition described in US Patent 8,277,780?
A: The main purpose is to provide a stable formulation that reduces the formation of oxidized impurities, ensuring the efficacy and safety of the drug.
Q: What are the key ingredients in the formulation?
A: The key ingredients include desoximethasone, isopropyl myristate, a C2-C4 alcohol, and a stabilizing agent.
Q: How does the patent landscape analysis help in understanding this invention?
A: It helps in identifying related patents, prior art, and global protection, which is crucial for understanding the invention's novelty and non-obviousness.
Q: What tools can be used to analyze the patent landscape for this invention?
A: Tools such as the Global Dossier, Common Citation Document (CCD), and Patent Public Search can be used.
Q: Why is stability important in pharmaceutical formulations?
A: Stability ensures that the drug remains effective over its shelf life, reducing the risk of degradation and maintaining patient safety.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office: https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- SLWIP - Patent Analytics: https://www.slwip.com/services/patent-analytics/
- Google Patents - US8277780B2: https://patents.google.com/patent/US8277780B2/en
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
