United States Patent 6,228,398: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,228,398, titled "Multiparticulate modified release composition," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This patent, issued to various inventors, describes a novel method for delivering active ingredients in a pulsed or bimodal manner. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes a multiparticulate modified release composition designed to deliver an active ingredient in a controlled manner. This composition is engineered to release the active ingredient in two distinct phases, often referred to as a "pulsed" or "bimodal" release. This technology is crucial for achieving specific therapeutic effects, such as maintaining optimal drug levels in the bloodstream over an extended period[2].
Scope of the Invention
The scope of the invention is defined by its ability to deliver active ingredients in a manner that is both controlled and tailored to specific therapeutic needs. The multiparticulate composition can be formulated to release the active ingredient at different times, ensuring that the drug levels remain within the therapeutic window. This is particularly useful for drugs that require a specific dosing regimen to be effective and to minimize side effects[2].
Claims of the Patent
The claims of the patent are the heart of the invention, outlining what is protected by the patent. Here are some key aspects of the claims:
- Active Ingredient Delivery: The patent claims cover compositions that deliver an active ingredient in a pulsed or bimodal manner. This includes the specific formulation and the timing of the releases[2].
- Component Structure: The claims detail the structure of the multiparticulate composition, including the types of components and how they are combined to achieve the desired release profile[2].
- Therapeutic Application: The patent claims also cover the therapeutic applications of the composition, including the treatment of various conditions where controlled drug release is beneficial[4].
Claim Construction and Interpretation
Claim construction is a critical aspect of patent law, as it determines the scope of protection. In the case of U.S. Patent 6,228,398, the claims have been subject to judicial interpretation. For instance, in a court order related to this patent, the term "following oral delivery to a subject" was construed to mean the delivery of the active ingredient to the general class of persons to whom the patented compositions are directed, rather than individual patients[5].
Patent Landscape
The patent landscape surrounding U.S. Patent 6,228,398 is complex and involves several related patents and technologies.
- Related Patents: Other patents, such as U.S. Patent 6,902,742, also deal with similar drug delivery systems and have been involved in litigation alongside the '398 patent. These patents collectively form a network of intellectual property that protects various aspects of controlled release technologies[5].
- Global Patent Family: The invention is part of a global patent family, with corresponding patents filed in other jurisdictions. For example, the Canadian patent CA 2570916 covers a similar pulsed release dosage form of a proton pump inhibitor (PPI)[4].
- Competing Technologies: The landscape also includes competing technologies and patents from other companies and inventors, which may offer alternative solutions for controlled drug release. This competition drives innovation and ensures that the field remains dynamic[3].
Patent Analytics and Claim Coverage
To fully understand the value and coverage of U.S. Patent 6,228,398, patent analytics tools are essential. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities.
- Claim Coverage Matrix: A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to this invention. This matrix helps in identifying where gaps or opportunities exist in the current patent portfolio[3].
- Scope Concepts: The use of scope concepts to categorize patents allows for a more efficient analysis of large numbers of patent claims. This method is particularly useful for determining whether a particular scope concept is applicable to a target product or method[3].
Practical Applications and Benefits
The practical applications of U.S. Patent 6,228,398 are significant in the pharmaceutical industry.
- Therapeutic Efficacy: The controlled release profile ensures that the drug levels remain within the therapeutic window, enhancing the efficacy of the treatment and reducing side effects[2].
- Patient Compliance: The pulsed release mechanism can improve patient compliance by reducing the frequency of dosing, making it easier for patients to adhere to their treatment regimen[4].
Legal and Regulatory Aspects
The patent has been subject to various legal and regulatory processes.
- Litigation: The patent has been involved in litigation, with court orders construing the terms of the claims. This highlights the importance of clear claim construction in patent law[5].
- Maintenance and Renewal: The patent requires periodic maintenance fees to remain in force. The history of these payments and any changes in ownership or status are publicly available[4].
Conclusion
U.S. Patent 6,228,398 represents a significant advancement in drug delivery technology, offering a controlled and tailored approach to releasing active ingredients. Understanding the scope, claims, and patent landscape surrounding this invention is crucial for both legal and strategic purposes. The use of patent analytics and claim coverage matrices further enhances the ability to manage and leverage this intellectual property effectively.
Key Takeaways
- Controlled Release Technology: The patent describes a multiparticulate composition that delivers active ingredients in a pulsed or bimodal manner.
- Claim Construction: Judicial interpretations of the claims have clarified the scope of protection.
- Global Patent Family: The invention is part of a global patent family with corresponding patents in other jurisdictions.
- Patent Analytics: Tools like Claim Coverage Matrix and scope concepts are essential for managing and leveraging the patent portfolio.
- Therapeutic Benefits: The technology enhances therapeutic efficacy and improves patient compliance.
FAQs
Q: What is the main innovation of U.S. Patent 6,228,398?
A: The main innovation is a multiparticulate modified release composition that delivers an active ingredient in a pulsed or bimodal manner.
Q: How does the patent protect the invention?
A: The patent protects the invention through specific claims that outline the composition, its components, and the therapeutic applications.
Q: What is the significance of claim construction in this patent?
A: Claim construction is crucial as it determines the scope of protection. Judicial interpretations have clarified the meaning of key terms in the claims.
Q: How does this patent fit into the global patent landscape?
A: The patent is part of a global patent family with corresponding patents filed in other jurisdictions, such as Canada.
Q: What are the practical benefits of this technology?
A: The technology enhances therapeutic efficacy, reduces side effects, and improves patient compliance by reducing the frequency of dosing.
Sources
- USPTO - How to Conduct a Preliminary U.S. Patent Search
- Google Patents - US6228398B1
- SLWIP - Patent Analytics
- Canadian Patents Database - CA 2570916
- Justia - ORDER Construing the terms of U.S. Patent Nos. 6,228,398 and 6,902,742
