United States Patent 6,254,887: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,254,887, titled "Controlled Release Tramadol," is a significant patent in the pharmaceutical industry, particularly in the field of pain management. This patent, issued to various assignees over time, outlines a controlled release preparation for oral administration of tramadol. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Status
The patent, numbered US6254887B1, was published on July 3, 2001, and has since expired due to the completion of its lifetime[4].
Inventors and Assignees
The patent was granted to the inventors who developed the controlled release formulation of tramadol. Over time, the patent rights may have been assigned to different pharmaceutical companies.
Scope of the Invention
Controlled Release Preparation
The patent describes a controlled release preparation for oral administration of tramadol or its pharmaceutically acceptable salts. This preparation is designed to release the active ingredient over an extended period, providing sustained pain relief[4].
Key Components
- Active Ingredient: Tramadol or its pharmaceutically acceptable salts.
- Release Control Component: Water-soluble or insoluble fusible materials, such as hydrophobic materials.
- Additional Ingredients: Conventional pharmaceutical excipients like diluents, lubricants, binders, granulating aids, colorants, flavorants, surfactants, pH adjusters, anti-adherents, and glidants[4].
Preparation Method
The preparation involves forming a mixture of the active ingredient and fusible release control materials, which are then mechanically worked in a high-speed mixer to form particles. These particles are sieved to achieve a specific size range (0.1 to 3.0 mm) and can be further processed into dosage forms like tablets or capsules[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The controlled release preparation itself.
- The process for preparing the controlled release particles.
- The specific composition of the preparation, including the active ingredient and release control components[4].
Dependent Claims
Dependent claims further specify various aspects of the independent claims, such as the size range of the particles, the use of specific excipients, and the method of film coating the particles[4].
Patent Landscape
Prior Art and Citations
The patent cites several prior art documents related to controlled release formulations and pharmaceutical preparations. The Common Citation Document (CCD) application, which consolidates prior art cited by multiple patent offices, would be useful in understanding the global citation landscape for this patent[1].
Related Patents and Applications
Other patents and applications related to controlled release formulations, especially those involving tramadol or similar analgesics, form part of the broader patent landscape. These may include patents from other countries, accessible through databases like the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO)[1].
Patent Analytics and Claim Coverage
To fully understand the protection and gaps in the patent landscape, patent analytics tools can be employed. A Claim Coverage Matrix and interactive claim charts, such as those provided by Schwegman’s ClaimScape® software, can help categorize patents by claims and scope concepts, identifying areas of coverage and potential gaps[3].
Impact on the Pharmaceutical Industry
Market Significance
The controlled release formulation of tramadol has significant market implications, particularly in the management of chronic pain. This formulation allows for sustained release of the medication, enhancing patient compliance and reducing the need for frequent dosing.
Competitive Landscape
The expiration of the patent opens up opportunities for generic manufacturers to develop similar controlled release formulations of tramadol. This can lead to increased competition in the market, potentially driving down prices and expanding access to the medication.
Legal and Regulatory Considerations
Patent Litigation
The patent has been involved in litigation, as seen in court documents related to its enforcement and validity. Understanding the legal status and any litigation history is crucial for companies looking to develop similar products[5].
Regulatory Compliance
Any new or generic versions of the controlled release tramadol must comply with regulatory requirements set by bodies like the FDA. This includes ensuring the formulation meets safety and efficacy standards.
Key Takeaways
- Controlled Release Formulation: The patent describes a specific method for preparing a controlled release formulation of tramadol.
- Claims and Scope: The patent includes detailed claims that define the composition, preparation method, and dosage forms of the controlled release preparation.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and applications, both domestically and internationally.
- Impact on Industry: The expiration of the patent has significant implications for the pharmaceutical industry, including increased competition and potential market expansion.
- Legal and Regulatory: Understanding the legal and regulatory environment is crucial for companies looking to develop or manufacture similar products.
FAQs
What is the main invention described in US Patent 6,254,887?
The main invention is a controlled release preparation for oral administration of tramadol or its pharmaceutically acceptable salts.
What are the key components of the controlled release preparation?
The key components include tramadol or its salts, release control materials (such as hydrophobic fusible materials), and conventional pharmaceutical excipients.
How is the controlled release preparation manufactured?
The preparation involves mixing the active ingredient with fusible release control materials, mechanically working the mixture, and sieving the particles to achieve a specific size range.
What is the significance of the patent's expiration?
The expiration of the patent allows generic manufacturers to develop similar controlled release formulations, potentially increasing competition and reducing prices.
How can companies ensure compliance with regulatory requirements for similar products?
Companies must ensure their formulations meet safety and efficacy standards set by regulatory bodies like the FDA and comply with all relevant regulations.
What tools can be used to analyze the patent landscape for this invention?
Tools such as the Common Citation Document (CCD) application and patent analytics software like Schwegman’s ClaimScape® can be used to analyze the patent landscape and identify gaps or opportunities.
Sources
- USPTO: Search for patents - USPTO
- Justia Patents: US Patent for Controlled release tramadol
- SLWIP: Patent Analytics | Intellectual Property Law
- Google Patents: US6254887B1 - Controlled release tramadol
- Insight.RPXCorp: IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT...
