Analyzing the Scope and Claims of United States Patent 4,366,310: A Comprehensive Overview
Introduction
United States Patent 4,366,310, titled "Controlled Release Pharmaceutical Compositions," was granted on December 28, 1982, to inventors associated with Alpharma Pharmaceuticals LLC. This patent is significant in the field of pharmaceuticals, particularly for its innovations in controlled-release formulations.
Background and Context
The patent is part of a broader landscape of pharmaceutical innovations aimed at improving drug delivery systems. Controlled-release formulations are designed to release the active ingredient over a prolonged period, enhancing patient compliance and therapeutic efficacy.
Inventors and Assignee
The patent was invented by Leslie et al. and assigned to Alpharma Pharmaceuticals LLC, a company known for its contributions to pharmaceutical technology[1].
Scope of the Patent
Controlled Release Mechanism
The patent describes a controlled-release pharmaceutical composition that utilizes a unique matrix system. This system involves embedding the active ingredient within a polymer matrix, which slowly releases the drug as the matrix erodes or dissolves. This mechanism ensures a steady and prolonged release of the medication, reducing the need for frequent dosing[1].
Key Components
- Active Ingredient: The patent specifies various active ingredients that can be used, including opioids and other therapeutic agents.
- Polymer Matrix: The matrix is composed of biodegradable or non-biodegradable polymers, which can be tailored to achieve the desired release profile.
- Excipients: Additional components such as fillers, binders, and lubricants are included to enhance the formulation's stability and manufacturability[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core aspects of the invention:
- Claim 1: Describes the controlled-release composition comprising an active ingredient dispersed within a polymer matrix.
- Claim 5: Specifies the method of preparing the composition, including the steps of mixing the active ingredient with the polymer and forming the desired dosage form[1].
Dependent Claims
Dependent claims further detail specific aspects of the invention, such as:
- Claim 2: Describes the use of specific polymers, such as cellulose derivatives or polyvinylpyrrolidone.
- Claim 6: Outlines the various dosage forms that can be produced, including tablets, capsules, and pellets[1].
Patent Landscape Analysis
Technological Domain
The patent falls within the technological domain of controlled-release pharmaceuticals, a field that has seen significant advancements over the years. This domain includes various types of drug delivery systems, such as sustained-release, extended-release, and targeted-release formulations[5].
Competitors and Related Patents
Several other patents and companies have contributed to this domain:
- Purdue Pharma: Known for its abuse-resistant opioid formulations, as described in patents like US 9,084,729 B2[4].
- Other Innovators: Companies like Alpharma and individual inventors have filed numerous patents related to controlled-release technologies, creating a complex and competitive landscape[1][4].
Market Developments
The patent landscape in this domain is dynamic, with ongoing research and development aimed at improving drug delivery systems. This includes mergers and acquisitions, in/out-licensing agreements, and litigation activities that shape the market[5].
Legal Status and Expiry Dates
As of the current date, the patent has expired, given its grant date in 1982. However, the technology and concepts described in this patent continue to influence modern pharmaceutical formulations. Understanding the legal status and expiry dates of such patents is crucial for companies to navigate the intellectual property landscape and identify opportunities for innovation[5].
Impact on the Pharmaceutical Industry
Enhanced Patient Compliance
Controlled-release formulations, as described in this patent, have significantly improved patient compliance by reducing the frequency of dosing. This has led to better therapeutic outcomes and improved quality of life for patients.
Abuse Deterrence
Innovations in controlled-release systems have also been crucial in the development of abuse-resistant opioid formulations. These formulations are designed to prevent tampering and misuse, addressing a critical public health issue[4].
Key Takeaways
- Controlled Release Technology: The patent introduces a novel matrix system for controlled-release pharmaceuticals.
- Polymer Matrix: The use of biodegradable or non-biodegradable polymers is central to the invention.
- Market Impact: The technology has improved patient compliance and contributed to the development of abuse-resistant formulations.
- Patent Landscape: The patent is part of a complex landscape involving multiple innovators and ongoing market developments.
FAQs
What is the main innovation described in US Patent 4,366,310?
The main innovation is a controlled-release pharmaceutical composition using a polymer matrix to slowly release the active ingredient.
Who are the inventors and assignee of the patent?
The inventors are Leslie et al., and the assignee is Alpharma Pharmaceuticals LLC.
What are the key components of the controlled-release composition?
The key components include the active ingredient, a polymer matrix, and excipients such as fillers, binders, and lubricants.
How does the patent impact patient compliance?
The controlled-release formulation reduces the need for frequent dosing, enhancing patient compliance and therapeutic efficacy.
Is the patent still in force?
No, the patent has expired given its grant date in 1982.
How does this patent relate to abuse-resistant opioid formulations?
The technology described in this patent has contributed to the development of abuse-resistant opioid formulations by providing a framework for controlled-release systems that can be adapted to prevent tampering and misuse.
Sources
- United States Patent and Trademark Office. (1982). Controlled Release Pharmaceutical Compositions. US Patent 4,366,310.
- Unified Patents. (n.d.). Time Release Protein. US Patent 5,055,300.
- Schwegman Lundberg & Woessner. (n.d.). Patent Analytics.
- United States Patent and Trademark Office. (2015). Abuse-Resistant Controlled-Release Opioid Dosage Form. US Patent 9,084,729 B2.
- Sagacious Research. (n.d.). Navigating Technological Domains with Patent Landscape Analysis.
