United States Patent 4,857,330: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,857,330, titled "Chlorpheniramine Therapy," is an invention related to an osmotic dosage form designed for delivering chlorpheniramine, a common antihistamine. This patent, granted in 1989, is a significant contribution to the field of pharmaceuticals, particularly in the area of controlled drug delivery systems.
Background and Context
Chlorpheniramine is widely used to treat allergic reactions, and the development of an osmotic dosage form was a breakthrough in ensuring consistent and controlled release of the medication. This innovation addressed the need for a more efficient and patient-friendly delivery method compared to traditional immediate-release formulations.
Scope of the Patent
The scope of the patent revolves around the design and functionality of an osmotic dosage form. Here are the key aspects:
Osmotic Dosage Form
The patent describes an osmotic dosage form that uses osmotic pressure to deliver chlorpheniramine at a controlled rate. This system typically includes a core containing the active ingredient, a semipermeable membrane, and an osmotic agent that helps in the release of the drug[2].
Components and Structure
- Core: The core contains chlorpheniramine, which is the active ingredient.
- Semipermeable Membrane: This membrane surrounds the core and allows water to enter while preventing the drug from escaping.
- Osmotic Agent: The osmotic agent helps in creating osmotic pressure that drives the release of the drug through a small orifice in the membrane[2].
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:
Independent Claims
- The patent claims an osmotic dosage form comprising a core containing chlorpheniramine, a semipermeable membrane surrounding the core, and an osmotic agent that facilitates the release of the drug[2].
Dependent Claims
- Dependent claims include variations of the osmotic dosage form, such as different types of semipermeable membranes, various osmotic agents, and different configurations of the core and membrane[2].
Patent Landscape
Understanding the patent landscape is essential to grasp the broader context and potential impacts of this invention.
Prior Art and Related Patents
- The patent landscape includes other inventions related to controlled drug delivery systems. For example, patents like USP 4,576,604 and USP 4,449,983 describe similar osmotic dosage forms but with different designs and components[4].
- The European Patent Office (EPO) and other international patent offices also have similar patents, indicating a global interest in this technology[1].
Global Dossier and International Patent Offices
- The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service is useful for understanding the global reach and variations of similar patents[1].
Common Citation Document (CCD)
- The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].
Impact on Pharmaceutical Industry
The invention described in US Patent 4,857,330 has had a significant impact on the pharmaceutical industry:
Controlled Drug Delivery
- The osmotic dosage form ensures a consistent and controlled release of chlorpheniramine, which improves patient compliance and reduces side effects associated with peak and trough drug levels.
Innovation and Competition
- This patent has spurred further innovation in controlled drug delivery systems. Other pharmaceutical companies have developed similar or improved versions, contributing to a competitive market that benefits patients.
Legal and Regulatory Aspects
Understanding the legal and regulatory environment is crucial for navigating the patent landscape.
Patent Assignment and Ownership
- The Patent Assignment Search website provided by the USPTO allows users to search for patent assignments and changes in ownership, which is important for tracking the legal status of the patent[1].
Office Actions and Examination Data
- The Patent Examination Data System (PEDS) provides public users with the ability to search, view, and download bibliographic data for all publicly available patent applications. This includes office actions, which are critical for understanding the patent's legal status and any challenges it may have faced during the examination process[1].
Conclusion
United States Patent 4,857,330 represents a significant advancement in the field of pharmaceuticals, particularly in controlled drug delivery systems. The scope and claims of the patent define a specific osmotic dosage form for delivering chlorpheniramine, while the patent landscape highlights its place within a broader context of similar inventions globally.
Key Takeaways
- Osmotic Dosage Form: The patent describes an osmotic dosage form for controlled release of chlorpheniramine.
- Components: The system includes a core, semipermeable membrane, and osmotic agent.
- Claims: The patent claims various configurations of the osmotic dosage form.
- Patent Landscape: The invention is part of a global landscape of controlled drug delivery systems.
- Impact: The patent has improved patient compliance and spurred further innovation in the pharmaceutical industry.
- Legal and Regulatory: Understanding patent assignments, office actions, and examination data is crucial for navigating the legal environment.
FAQs
Q: What is the main innovation described in US Patent 4,857,330?
A: The main innovation is an osmotic dosage form designed for the controlled release of chlorpheniramine.
Q: How does the osmotic dosage form work?
A: The form uses osmotic pressure to deliver the drug at a controlled rate through a semipermeable membrane and an osmotic agent.
Q: What are the key components of the osmotic dosage form?
A: The key components include a core containing chlorpheniramine, a semipermeable membrane, and an osmotic agent.
Q: How does this patent impact the pharmaceutical industry?
A: It improves patient compliance and has spurred further innovation in controlled drug delivery systems.
Q: Where can I find more information about related patents globally?
A: You can use services like the Global Dossier and Common Citation Document (CCD) provided by the USPTO and other international patent offices[1].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents - US-4857330-A: https://portal.unifiedpatents.com/patents/patent/US-4857330-A
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - CN101500543A: https://patents.google.com/patent/CN101500543A/en
