Understanding the Scope and Claims of United States Patent 11,896,719
Introduction
United States Patent 11,896,719, titled "Pharmaceutical compositions," is a patent that focuses on the development of specific pharmaceutical formulations, particularly for the treatment of IgA nephropathy. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape it operates within.
Patent Overview
The patent in question, US11896719B2, describes a pharmaceutically acceptable composition intended to treat IgA nephropathy. This composition includes budesonide, a corticosteroid, and one or more pharmaceutically acceptable excipients[1].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically outline the essential components and characteristics of the pharmaceutical composition.
- Claim 1: This claim usually sets the broadest scope of the invention, specifying the composition that includes budesonide and at least one excipient.
- Claim 2-5: These claims may narrow down the scope by specifying particular types of excipients, the dosage form (e.g., tablets, capsules), or the method of administration.
Dependent Claims
Dependent claims build upon the independent claims, adding additional limitations to further define the invention. For example:
- Claim 6: This might specify a particular ratio of budesonide to excipient or a specific release profile.
- Claim 7-10: These could detail specific excipients, such as fillers, binders, or disintegrants, and their proportions.
Scope of the Invention
The scope of the patent is defined by the claims and the description provided in the specification.
Active Ingredient
The patent centers around budesonide, a corticosteroid known for its anti-inflammatory properties. The use of budesonide in treating IgA nephropathy is a key aspect of the invention.
Excipients
Excipients play a crucial role in the formulation, affecting the release profile, stability, and bioavailability of budesonide. The patent may specify certain excipients that enhance these properties.
Release Profile
The patent might describe a specific release profile, such as immediate or sustained release, which is critical for the effective treatment of IgA nephropathy.
Patent Landscape
Related Patents
Other patents related to pharmaceutical compositions, especially those involving corticosteroids, provide context to the landscape.
- US8491932B2: This patent deals with compositions for the oral delivery of corticosteroids, specifically for treating inflammatory diseases of the gastrointestinal tract. While it is not directly related to IgA nephropathy, it shares similarities in the use of corticosteroids and oral delivery systems[4].
Patent Scope Metrics
Research on patent scope metrics can provide insights into how the claims of US11896719B2 compare to other patents. Metrics such as independent claim length and independent claim count can indicate the breadth and clarity of the patent claims. Narrower claims, as seen in some studies, are often associated with a higher probability of grant and a shorter examination process[3].
Legal and Regulatory Considerations
Patent Validity
The validity of the patent claims is crucial. Challenges to patent validity, such as those seen in the DDR Holdings case, often involve arguments about the patent's subject matter, indefiniteness, and obviousness. Ensuring that the claims are clear, specific, and not overly broad is essential to maintaining the patent's validity[2].
Small Claims Patent Court
The concept of a small claims patent court, as studied by the Administrative Conference of the United States (ACUS), could impact the enforcement and litigation landscape for patents like US11896719B2. Such a court could provide a more streamlined and cost-effective way to resolve patent disputes, which is particularly relevant for smaller entities or inventors[5].
Practical Implications
Treatment of IgA Nephropathy
The practical implication of this patent is the development of an effective treatment for IgA nephropathy, a kidney disease characterized by the deposition of IgA antibodies in the kidneys. The specific formulation described in the patent aims to improve the therapeutic outcomes for patients with this condition.
Pharmaceutical Development
For pharmaceutical companies, this patent highlights the importance of precise formulation and the role of excipients in drug delivery. It also underscores the need for rigorous testing and clinical trials to ensure the efficacy and safety of the treatment.
Key Takeaways
- Specific Composition: The patent describes a specific pharmaceutical composition for treating IgA nephropathy using budesonide and various excipients.
- Claims Analysis: The claims define the scope of the invention, with independent claims setting the broad scope and dependent claims adding specific limitations.
- Patent Landscape: The patent operates within a broader landscape of pharmaceutical compositions, with related patents and metrics providing context.
- Legal Considerations: Ensuring the validity and enforceability of the patent claims is crucial, and the concept of a small claims patent court could impact future disputes.
- Practical Implications: The patent has significant implications for the treatment of IgA nephropathy and pharmaceutical development.
FAQs
Q1: What is the main active ingredient in the pharmaceutical composition described in US11896719B2?
A1: The main active ingredient is budesonide, a corticosteroid.
Q2: What is the primary use of the pharmaceutical composition described in this patent?
A2: The primary use is for the treatment of IgA nephropathy.
Q3: How do excipients affect the pharmaceutical composition?
A3: Excipients affect the release profile, stability, and bioavailability of budesonide.
Q4: What metrics can be used to measure the scope of patent claims?
A4: Metrics such as independent claim length and independent claim count can be used to measure the scope of patent claims.
Q5: Why is the concept of a small claims patent court relevant to this patent?
A5: The concept of a small claims patent court could provide a more streamlined and cost-effective way to resolve patent disputes related to this and similar patents.
Sources
- US11896719B2 - Pharmaceutical compositions - Google Patents
- DDR Holdings - United States Court of Appeals for the Federal Circuit
- Patent Claims and Patent Scope - SSRN
- US8491932B2 - Compositions for the oral delivery of corticosteroids - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States (ACUS)
