United States Patent 6,099,859: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,099,859, titled "Controlled Release Oral Tablet Having a Unitary Core," is a significant patent in the pharmaceutical industry, particularly in the realm of controlled release formulations. This patent, assigned to Sciele Pharma, Inc., pertains to a specific type of oral tablet designed for the controlled release of antihyperglycemic drugs, such as metformin hydrochloride.
Background
The patent was granted on August 8, 2000, and it falls under the category of pharmaceutical formulations, specifically those related to diabetes treatment. The invention described in this patent is crucial for managing Type 2 diabetes by providing a stable and controlled release of the active ingredient over an extended period.
Scope of the Patent
Invention Overview
The patent describes a controlled release oral tablet with a unitary core that contains an antihyperglycemic drug. This core is designed to release the drug in a controlled manner, ensuring a consistent therapeutic effect without the need for an expanding polymer, which was a common component in earlier controlled release formulations[5].
Key Components
- Unitary Core: The core of the tablet is composed of the antihyperglycemic drug, along with other excipients that facilitate controlled release.
- Controlled Release Mechanism: The mechanism ensures that the drug is released at a predetermined rate, providing a steady therapeutic effect over time.
- Absence of Expanding Polymer: Unlike other formulations, this tablet does not contain an expanding polymer, which simplifies the manufacturing process and enhances patient compliance[5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the controlled release oral tablet with a unitary core containing the antihyperglycemic drug.
- Claim 2 specifies the composition of the core, including the drug and other excipients.
- Claim 3 details the controlled release mechanism and the absence of an expanding polymer[5].
Dependent Claims
- These claims further elaborate on the specific components, their proportions, and the manufacturing process of the tablet.
Patent Landscape
Related Patents and Applications
The patent landscape surrounding U.S. Patent 6,099,859 includes other patents related to controlled release formulations and antihyperglycemic drugs. For example, U.S. Patent 6,866,866, also assigned to Sciele Pharma, Inc., pertains to similar formulations and is often cited in conjunction with this patent[2].
International Patent Family
To understand the global reach of this invention, one must look at the international patent family. Tools like the Global Dossier provided by the USPTO allow users to see related applications filed at participating IP Offices, including the IP5 Offices (the United States, Europe, Japan, Korea, and China)[1].
Litigation and Enforcement
This patent has been involved in several legal disputes. For instance, in the case of Sciele Pharma, Inc. v. Lupin Ltd., the court addressed issues related to the infringement of this and other related patents by generic manufacturers[2].
Search and Analysis Tools
USPTO Resources
To conduct a thorough analysis of this patent, one can use various resources provided by the USPTO, such as the Patent Public Search tool, which offers enhanced access to prior art and related patents. The Common Citation Document (CCD) application is also useful for consolidating citation data from multiple offices[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to this invention. This dataset can help in understanding the scope and trends of patent claims in the pharmaceutical sector[3].
Impact on the Pharmaceutical Industry
Innovation and Competition
The controlled release oral tablet described in this patent has contributed significantly to the management of Type 2 diabetes. It has set a standard for innovative formulations that enhance patient compliance and therapeutic efficacy.
Economic Implications
The economic impact of this patent is substantial, given the widespread use of metformin hydrochloride and other antihyperglycemic drugs. The patent has allowed Sciele Pharma, Inc. to maintain a competitive edge in the market while also driving innovation in pharmaceutical formulations.
Conclusion
United States Patent 6,099,859 is a pivotal patent in the field of pharmaceuticals, particularly for controlled release formulations. Its scope and claims define a specific and innovative approach to managing Type 2 diabetes. Understanding this patent and its place within the broader patent landscape is crucial for both industry professionals and researchers.
Key Takeaways
- Innovative Formulation: The patent describes a controlled release oral tablet without an expanding polymer.
- Therapeutic Impact: It enhances the management of Type 2 diabetes by providing a consistent therapeutic effect.
- Patent Landscape: The patent is part of a larger family of related patents and has been involved in legal disputes.
- Industry Impact: It has driven innovation and competition in the pharmaceutical industry.
- Search and Analysis Tools: Various USPTO resources and datasets are available for detailed analysis.
FAQs
Q: What is the main innovation described in U.S. Patent 6,099,859?
A: The main innovation is a controlled release oral tablet with a unitary core that does not contain an expanding polymer.
Q: How does this patent impact the management of Type 2 diabetes?
A: It provides a stable and controlled release of the antihyperglycemic drug, enhancing patient compliance and therapeutic efficacy.
Q: What tools can be used to analyze this patent and its related family?
A: Tools such as the USPTO's Patent Public Search, Global Dossier, and the Patent Claims Research Dataset are useful for analysis.
Q: Has this patent been involved in any legal disputes?
A: Yes, it has been involved in several legal disputes, including the case of Sciele Pharma, Inc. v. Lupin Ltd.
Q: How does this patent contribute to the pharmaceutical industry?
A: It sets a standard for innovative formulations, drives competition, and maintains a competitive edge for the patent holder in the market.
