United States Patent 11,278,622: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 11,278,622, titled "Ceftolozane antibiotic compositions," is a significant patent in the pharmaceutical sector, particularly in the field of antibiotics. This patent, issued to address the growing need for effective antibacterial treatments, involves compositions of ceftolozane, often used in combination with tazobactam.
Background of Ceftolozane
Ceftolozane is a cephalosporin antibiotic known for its broad-spectrum activity against Gram-negative bacteria, including multi-drug resistant strains. It is commonly used in combination with tazobactam, a beta-lactamase inhibitor, to enhance its efficacy against bacteria that produce beta-lactamase enzymes[1].
Scope of the Patent
Pharmaceutical Compositions
The patent primarily focuses on pharmaceutical compositions that include ceftolozane, either alone or in combination with tazobactam. These compositions are designed to be administered intravenously and are formulated to ensure stability and efficacy.
Active Ingredients
- Ceftolozane: The primary active ingredient, a cephalosporin antibiotic.
- Tazobactam: A beta-lactamase inhibitor used to enhance the antibacterial activity of ceftolozane.
Inert Ingredients
The patent also details various inert ingredients such as sodium chloride, which are used to stabilize the composition and ensure its compatibility with intravenous administration[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- Pharmaceutical Compositions: Specific formulations of ceftolozane and tazobactam.
- Methods of Preparation: Detailed processes for preparing these pharmaceutical compositions.
- Methods of Use: Clinical applications of these compositions, including treatment of bacterial infections.
Dependent Claims
Dependent claims further specify the independent claims by detailing:
- Concentration Ranges: Specific concentrations of ceftolozane and tazobactam in the compositions.
- Formulation Variants: Different formulations, such as solutions or suspensions, and their respective preparation methods.
- Administration Routes: Methods of administering the compositions, including intravenous infusion.
Patent Landscape
Classification
The patent is classified under various categories within the International Patent Classification (IPC) system:
- A61K31/431: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, such as penicillins and cephalosporins.
- A61K31/546: Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, specifically cephalosporins[1].
Related Patents
The patent landscape includes other patents related to cephalosporin antibiotics and their combinations with beta-lactamase inhibitors. These patents often overlap in their claims regarding pharmaceutical compositions and methods of use.
Global Dossier
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This includes classification, citation data, and office actions related to the patent family of US11278622B2[4].
Claim Coverage and Scope Concepts
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents by claims and scope concepts, helping to identify gaps or opportunities in the patent landscape. For example, it can show which claims cover the specific technology intended to be protected and highlight areas where additional claim coverage might be needed[3].
Interactive Claim Charts
Interactive claim charts generated by ClaimScape® software can be used to review patent coverage with technical experts. These charts help determine whether specific scope concepts are applicable to target products or methods, making it easier to spot gaps in current coverage and identify future design opportunities[3].
Inventorship and Ownership
Determining Inventorship
The patent lists the inventors who conceived the idea and reduced it to practice. Proper inventorship is crucial, as errors in naming inventors can lead to patent invalidity if done with deceptive intent. The conception step, which involves forming a definite and permanent idea of the invention, is key in determining who should be listed as an inventor[2].
Assignment and Licensing
The patent may be assigned or licensed to other entities, which can impact its enforcement and use. Correct identification and documentation of inventorship and ownership are essential to maintain the enforceability of the patent.
Practical Implications
Clinical Use
The compositions described in the patent are used in clinical settings to treat various bacterial infections. Understanding the scope and claims of the patent is crucial for healthcare providers and pharmaceutical companies to ensure compliance and effective treatment.
Regulatory Compliance
Compliance with regulatory requirements is essential. The patent's claims and scope must align with FDA approvals and other regulatory standards to ensure the safe and effective use of the antibiotic compositions.
Key Takeaways
- Ceftolozane and Tazobactam Compositions: The patent focuses on pharmaceutical compositions of ceftolozane, often combined with tazobactam.
- Scope and Claims: The patent includes claims on pharmaceutical compositions, methods of preparation, and methods of use.
- Patent Landscape: Classified under specific IPC categories, the patent is part of a broader landscape of cephalosporin antibiotics.
- Inventorship and Ownership: Proper identification of inventors and documentation of ownership are critical for patent enforceability.
- Practical Implications: The patent has significant implications for clinical use and regulatory compliance.
FAQs
What is the primary active ingredient in the patent US11278622B2?
The primary active ingredient is ceftolozane, a cephalosporin antibiotic.
What is the role of tazobactam in the patent?
Tazobactam is a beta-lactamase inhibitor used to enhance the antibacterial activity of ceftolozane.
How are the pharmaceutical compositions administered?
The compositions are designed for intravenous administration.
What is the significance of proper inventorship in patent law?
Proper inventorship is crucial to ensure the patent's enforceability; errors with deceptive intent can render the patent invalid.
How can the scope and claims of the patent be analyzed effectively?
Using tools like Claim Coverage Matrix and interactive claim charts can help analyze the scope and claims of the patent effectively.
Sources
- US11278622B2 - Ceftolozane antibiotic compositions - Google Patents
- Determining Inventorship for US Patent Applications - Oregon State University
- Patent Analytics - Schwegman Lundberg & Woessner, P.A.
- Search for patents - USPTO - United States Patent and Trademark Office
