United States Patent 5,955,488: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 5,955,488, titled "Pharmaceutical Composition Containing a 5-HT3 Receptor Antagonist," is a significant patent in the pharmaceutical industry, particularly in the field of antiemetic drugs. This patent, granted on September 21, 1999, is part of a broader landscape of intellectual property related to 5-HT3 receptor antagonists.
Background
5-HT3 receptor antagonists are a class of drugs used primarily to prevent nausea and vomiting, especially in patients undergoing chemotherapy or surgery. The patent in question involves the use of specific compounds within this class for therapeutic purposes.
Scope of the Patent
The patent 5,955,488 focuses on the preparation and use of pharmaceutical compositions containing 5-HT3 receptor antagonists. Here are the key aspects of its scope:
Active Ingredients
The patent specifies the use of substances such as ondansetron, tropisetron, granisetron, dolasetron, and other related compounds. These substances are characterized by their indole-containing chemical structure, which is derived from 5-hydroxytryptamine (5-HT)[1].
Pharmaceutical Compositions
The patent describes the formulation of these active ingredients into various pharmaceutical compositions. These compositions can include one or more pharmaceutically acceptable carriers, diluents, or excipients. The formulations can be adapted for different modes of administration, such as oral, topical, parenteral, or inhalation routes[1].
Dosage and Administration
The patent provides dosing recommendations and guidelines for adjusting doses based on patient groups. This ensures that the prescriber can anticipate and make necessary dose adjustments to avoid prescribing the wrong drug to the wrong patients at the wrong dose[1].
Claims of the Patent
The claims of the patent are crucial as they define the legal boundaries of the invention. Here are some key claims:
Claim 1: Pharmaceutical Composition
The first claim typically defines the pharmaceutical composition containing a 5-HT3 receptor antagonist and a pharmaceutically acceptable carrier or diluent[1].
Claim 2: Specific Compounds
Subsequent claims often specify the use of particular compounds such as ondansetron, tropisetron, and granisetron, and their variants obtainable through chemical modifications[1].
Claim 3: Formulations
Claims may also cover various formulations, including tablets, capsules, suppositories, solutions, and suspensions, tailored to different administration routes[1].
Claim 4: Dosage Regimens
Claims can include specific dosage regimens and guidelines for adjusting doses based on patient characteristics, such as genetic variations affecting drug metabolism[1].
Patent Landscape
The patent landscape surrounding 5,955,488 is complex and involves several related patents and applications.
Related Patents
The patent 5,955,488 is part of a series of patents related to 5-HT3 receptor antagonists. Other relevant patents include US patents 4,695,578, 4,753,789, 5,578,628, 6,063,802, and others cited in the patent documentation[1].
Global Patent Family
The patent is likely part of a global patent family, with corresponding patents and applications filed in other jurisdictions. Tools like the Global Dossier provided by the USPTO can help track the patent family and related applications across different IP offices[4].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry:
Therapeutic Applications
The patent enables the efficient treatment and prevention of nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. This improves patient outcomes and quality of life[1].
Market Competition
The patent protects the intellectual property of the inventors and assigns, giving them a competitive edge in the market. This can influence the development and marketing of similar drugs by other companies[1].
Legal and Regulatory Considerations
The patent is subject to various legal and regulatory frameworks:
Patent Enforcement
The USPTO and other IP offices play a crucial role in enforcing patent rights. Tools like the Patent Public Search and Global Dossier help in monitoring and enforcing patent claims[4].
Patent Litigation
In cases of infringement, the patent holder may engage in litigation to protect their rights. The study on a potential small claims patent court highlights the complexities and considerations involved in such legal proceedings[5].
Key Takeaways
- Active Ingredients: The patent involves 5-HT3 receptor antagonists like ondansetron, tropisetron, and granisetron.
- Pharmaceutical Compositions: Various formulations for different administration routes are described.
- Dosage and Administration: Specific dosing recommendations and guidelines for adjustments are provided.
- Claims: The patent claims cover the pharmaceutical composition, specific compounds, formulations, and dosage regimens.
- Patent Landscape: The patent is part of a broader landscape of related patents and global patent families.
- Impact: Significant therapeutic applications and market implications.
FAQs
Q: What are the primary active ingredients covered by this patent?
A: The primary active ingredients are 5-HT3 receptor antagonists such as ondansetron, tropisetron, granisetron, and dolasetron.
Q: How are the pharmaceutical compositions formulated?
A: The compositions can be formulated into various forms like tablets, capsules, suppositories, solutions, and suspensions, using pharmaceutically acceptable carriers or diluents.
Q: What is the significance of genetic variations in the patent?
A: The patent considers genetic variations affecting drug metabolism, particularly the presence of less than three copies of a polynucleotide encoding a functional CYP2D6 polypeptide.
Q: How does this patent impact the pharmaceutical industry?
A: It protects the intellectual property related to 5-HT3 receptor antagonists, influencing market competition and therapeutic applications.
Q: What tools are available for tracking related patents and applications?
A: Tools like the Global Dossier and Patent Public Search provided by the USPTO can be used to track related patents and applications across different IP offices.
Sources
- WO2003100091A1 - Moyens et methodes de ... - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- U.S. Patent Small Claims Court
