United States Patent 7,431,943: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,431,943, titled "Controlled release and taste masking oral compositions," is a significant patent in the pharmaceutical field. This patent addresses the formulation of oral medications with specific release and taste-masking properties. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent, issued on October 7, 2008, pertains to medicinal preparations characterized by special physical forms, specifically pills, tablets, and other oral compositions. The invention focuses on creating a three-component matrix structure to control the release of active ingredients and mask unpleasant tastes[1].
Scope of the Patent
Physical Form and Composition
The patent describes medicinal preparations in the form of pills, tablets, discs, or rods. These preparations are characterized by a special physical form, particularly a three-component matrix structure. This structure includes:
- Active Ingredient: The therapeutic component of the medication.
- Hydrophilic Component: A water-soluble part that helps in the controlled release of the active ingredient.
- Amphiphilic Component: A component that has both hydrophilic and hydrophobic properties, aiding in the taste-masking and controlled release[1].
Controlled Release and Taste Masking
The primary objective of this patent is to achieve controlled release of the active ingredient and to mask the unpleasant taste of the medication. The three-component matrix ensures that the active ingredient is released in a controlled manner, enhancing the efficacy and patient compliance of the medication.
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key claims:
Claim 1
This claim describes the composition of the medicinal preparation, including the three-component matrix structure and the active ingredient inglobated within it[1].
Claim 2
This claim specifies the types of hydrophilic and amphiphilic components that can be used in the matrix structure. It includes details about the materials and their proportions[1].
Claim 3
This claim outlines the method of preparing the medicinal composition, including the steps involved in creating the three-component matrix[1].
Patent Classification
The patent is classified under various categories of the International Patent Classification (IPC) and the Cooperative Patent Classification (CPC):
- A61K9/00: Medicinal preparations characterized by special physical form.
- A61K9/20: Pills, tablets, discs, rods.
- A61K9/2072: Pills, tablets, discs, rods characterized by shape, structure or size.
- A61K9/2086: Layered tablets, e.g., bilayer tablets[1].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of controlled release and taste-masking oral compositions is extensive. Other patents and technologies focus on similar aspects, such as:
- Layered Tablets: Patents that describe layered tablets with different release profiles and taste-masking capabilities[1].
- Coated Pills or Tablets: Patents that involve coating materials to achieve controlled release and taste masking[1].
Industry Trends and Challenges
The pharmaceutical industry is continually evolving, with a focus on improving drug delivery systems. Challenges include ensuring the stability of the active ingredient, achieving the desired release profile, and maintaining patient compliance. This patent addresses some of these challenges by providing a novel matrix structure for controlled release and taste masking.
Legal and Regulatory Aspects
Inventorship and Patent Ownership
The correct identification of inventors is crucial for the validity of a patent. Errors in inventorship can lead to the patent being unenforceable, especially if there is deceptive intent involved[2].
Patent Eligibility and Scope
The scope of a patent is often a subject of debate, particularly in terms of patent eligibility under 35 U.S.C. § 101. Patents must define their claims clearly and narrowly to avoid issues of overbreadth and lack of clarity[3][5].
Metrics for Measuring Patent Scope
To evaluate the scope of this patent, metrics such as independent claim length (ICL) and independent claim count (ICC) can be used. These metrics help in assessing the breadth and clarity of the patent claims, which are critical for determining patent quality and enforceability[3].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry:
- Improved Drug Delivery: The controlled release and taste-masking capabilities enhance the efficacy and patient compliance of oral medications.
- Innovation: The novel matrix structure encourages further innovation in drug delivery systems, driving advancements in pharmaceutical technology.
Key Takeaways
- Controlled Release and Taste Masking: The patent provides a three-component matrix structure for achieving controlled release and taste masking of active ingredients.
- Patent Classification: Classified under A61K9/00, A61K9/20, and other relevant categories.
- Legal and Regulatory: Correct inventorship and clear claim definitions are essential for patent validity and enforceability.
- Industry Impact: Enhances drug delivery systems, improving efficacy and patient compliance.
FAQs
Q: What is the primary focus of United States Patent 7,431,943?
A: The primary focus is on creating oral compositions with controlled release and taste-masking properties using a three-component matrix structure.
Q: What are the key components of the matrix structure described in the patent?
A: The matrix includes an active ingredient, a hydrophilic component, and an amphiphilic component.
Q: How is the scope of this patent measured?
A: Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure the scope and clarity of the patent claims.
Q: What are the implications of incorrect inventorship in patent applications?
A: Incorrect inventorship, especially with deceptive intent, can render the patent unenforceable.
Q: How does this patent impact the pharmaceutical industry?
A: It enhances drug delivery systems by providing controlled release and taste-masking capabilities, improving efficacy and patient compliance.
Sources
- US7431943B1 - Controlled release and taste masking oral compositions containing one or more active principles inglobated in a three-component matrix structure.
- Determining Inventorship for US Patent Applications.
- Patent Claims and Patent Scope - Hoover Institution.
- Research and Course Guides: Patent Searching, Advanced: Overview.
- Electric Power Group, LLC v. Alstom S.A..
