United States Patent 6,743,441: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,743,441, titled "Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy," is a significant patent in the pharmaceutical field, particularly for the treatment of overactive bladder. This patent, assigned to Watson Pharmaceuticals, Inc., addresses a critical issue in medication by reducing the adverse effects associated with oxybutynin, a commonly used drug for this condition.
Background of Oxybutynin
Oxybutynin is a medication widely prescribed for the treatment of overactive bladder and its associated symptoms such as urinary frequency, urgency, and incontinence. However, it is known to cause several adverse effects, including dry mouth, constipation, and drowsiness, which can significantly impact the quality of life for patients.
Patent Overview
Inventors and Assignee
The patent was invented by Steven W. Sanders and Charles D. Ebert, both from Salt Lake City, UT, and is assigned to Watson Pharmaceuticals, Inc., based in Corona, CA[1][2].
Patent Claims
The patent claims cover compositions and methods designed to minimize the incidence and severity of adverse drug experiences associated with oxybutynin therapy. Here are the key aspects of the claims:
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Compositions: The patent includes compositions that provide a lower plasma concentration of oxybutynin metabolites, such as N-desethyloxybutynin, which are believed to contribute to the adverse effects. These compositions maintain sufficient oxybutynin plasma concentration to ensure therapeutic efficacy[1][2].
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Methods: The methods described involve administering oxybutynin in a way that reduces the formation of metabolites responsible for adverse effects. This can include specific formulations or delivery systems that optimize the therapeutic profile of oxybutynin[1][2].
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Isomers: The patent also covers isomers of oxybutynin and its metabolites that meet the criteria of minimizing adverse effects while maintaining therapeutic efficacy[1][2].
Scope of the Patent
Therapeutic Benefits
The primary scope of the patent is to provide therapeutic benefits to patients with overactive bladder by reducing the adverse effects associated with oxybutynin. This is achieved through innovative compositions and methods that ensure the drug's efficacy while minimizing its side effects.
Pharmaceutical Formulations
The patent encompasses various pharmaceutical formulations, including extended-release formulations, transdermal patches, and other delivery systems that can help in reducing the metabolite levels responsible for adverse effects.
Claims Analysis
Composition Claims
The composition claims are focused on the development of formulations that reduce the plasma concentration of oxybutynin metabolites. For example, the patent describes formulations that use specific excipients or delivery systems to slow down the release of oxybutynin, thereby reducing the peak plasma levels of its metabolites[1][2].
Method Claims
The method claims include procedures for administering oxybutynin in a manner that minimizes adverse effects. This could involve specific dosing regimens, administration routes (e.g., oral, transdermal), and monitoring protocols to ensure optimal therapeutic outcomes[1][2].
Patent Landscape
International Protection
The patent has international protection, with filings in several countries including Austria, Australia, and others. This ensures that the inventions covered by the patent are protected globally, preventing unauthorized use or manufacture of the compositions and methods described[1][5].
Expiration and Supplementary Protection
The patent's expiration dates vary by country, but generally, it is set to expire around the mid-2020s, depending on the jurisdiction and any supplementary protection certificates (SPCs) that may have been granted[1].
Related Patents and Applications
The patent is part of a broader landscape of intellectual property related to oxybutynin and its therapeutic applications. Other patents and applications may cover different aspects of oxybutynin therapy, such as new formulations, combination therapies, or novel delivery systems.
Impact on the Pharmaceutical Industry
Innovation in Drug Delivery
This patent represents a significant innovation in drug delivery systems, particularly for drugs with known adverse effects. By reducing the incidence and severity of these effects, the patent contributes to improved patient compliance and overall therapeutic outcomes.
Competitive Advantage
For Watson Pharmaceuticals, Inc., this patent provides a competitive advantage in the market for overactive bladder treatments. The ability to offer a version of oxybutynin with reduced side effects can attract more patients and healthcare providers, enhancing market share.
Legal and Regulatory Aspects
Patent Enforcement
The enforcement of this patent involves ensuring that other companies do not infringe on the protected compositions and methods. This includes monitoring for unauthorized use and taking legal action when necessary.
Regulatory Approvals
The patent's validity and enforceability are also dependent on regulatory approvals. The compositions and methods described must comply with regulatory standards and guidelines set by health authorities such as the FDA.
Conclusion
United States Patent 6,743,441 is a pivotal patent in the field of pharmaceuticals, especially for the treatment of overactive bladder. By minimizing the adverse effects associated with oxybutynin, this patent enhances patient care and compliance. The scope of the patent, including its composition and method claims, provides a comprehensive approach to improving therapeutic outcomes.
Key Takeaways
- Innovation in Drug Delivery: The patent introduces innovative compositions and methods to reduce adverse effects of oxybutynin.
- Global Protection: The patent has international protection, ensuring global enforcement of its claims.
- Therapeutic Benefits: The primary focus is on improving patient care by minimizing side effects while maintaining therapeutic efficacy.
- Competitive Advantage: The patent provides a competitive edge for Watson Pharmaceuticals, Inc., in the market for overactive bladder treatments.
- Regulatory Compliance: The patent's validity is dependent on compliance with regulatory standards.
FAQs
Q: What is the main purpose of United States Patent 6,743,441?
A: The main purpose is to provide compositions and methods for administering oxybutynin while minimizing the incidence and severity of adverse drug experiences.
Q: Who are the inventors of this patent?
A: The inventors are Steven W. Sanders and Charles D. Ebert.
Q: Which company is assigned this patent?
A: The patent is assigned to Watson Pharmaceuticals, Inc.
Q: What are the key claims of this patent?
A: The key claims include compositions and methods that reduce the plasma concentration of oxybutynin metabolites and maintain sufficient oxybutynin plasma concentration for therapeutic efficacy.
Q: Does this patent have international protection?
A: Yes, the patent has international protection with filings in several countries.
Sources
- Drug Patent Watch: Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy.
- Unified Patents Portal: US-6743441-B2.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- Unified Patents Portal: AT-488233-T.
