United States Patent 6,344,215: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,344,215, titled "Methylphenidate Modified Release Formulations," is a significant patent in the pharmaceutical industry, particularly in the field of attention deficit hyperactivity disorder (ADHD) treatments. This patent, issued to various assignees over the years, outlines specific formulations and methods for delivering methylphenidate, a common medication for ADHD.
Patent Overview
Publication Number and Authority
The patent number is US6344215B1, and it was issued by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent builds on existing knowledge in the field of pharmaceutical formulations, particularly those related to methylphenidate. It addresses the need for controlled-release formulations that can provide sustained therapeutic effects while minimizing side effects.
Inventors and Assignees
The patent lists the inventors and assignees who developed the methylphenidate modified release formulations. Understanding the assignees is crucial for determining the current ownership and any potential licensing or litigation issues.
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. These claims cover various aspects of the formulation, including:
- Composition: The patent claims specific compositions of methylphenidate, including immediate release and extended release components. For example, it describes formulations using beads coated with ethyl cellulose and other polymers[4].
- Method of Preparation: The claims also cover the methods used to prepare these formulations, including the use of core particles, coating compositions, and plasticizers[4].
- Dosage Forms: The patent specifies different dosage forms, such as capsules, that contain the methylphenidate formulations.
Detailed Claim Analysis
Independent Claims
The independent claims are the broadest claims in the patent and define the overall scope of the invention. For instance, Claim 1 might describe a pharmaceutical formulation comprising methylphenidate in a specific form, such as immediate release beads and extended release beads, encapsulated in a capsule.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. For example, a dependent claim might specify the type of polymer used for coating the beads or the ratio of immediate release to extended release components.
Patent Claims Examples
Claim 1
"A pharmaceutical formulation comprising:
- Immediate release beads containing methylphenidate;
- Extended release beads containing methylphenidate;
- The beads encapsulated in a capsule."
Claim 5
"A method of preparing a pharmaceutical formulation, comprising:
- Coating core particles with a coating composition containing ethyl cellulose;
- Encapsulating the coated core particles in a capsule."
Patent Landscape
Related Patents and Applications
The patent landscape for methylphenidate formulations is complex, with numerous related patents and applications. For instance, other patents may cover different formulations, delivery mechanisms, or manufacturing processes. The Common Citation Document (CCD) application can be useful in consolidating prior art cited by various patent offices, helping to visualize the patent family and related applications[1].
Geographical Distribution
Patents related to methylphenidate formulations are not limited to the United States. International patent offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), also have relevant patents. This global distribution highlights the international interest in developing and protecting intellectual property related to ADHD treatments[1].
Litigation and Enforcement
Patents like US6344215B1 can be involved in litigation, especially in the highly competitive pharmaceutical industry. For example, the '215 patent has been mentioned in legal documents related to patent infringement cases[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The issuance of this patent and similar ones drives innovation in the pharmaceutical industry. Companies must continually develop new formulations and delivery methods to stay competitive while avoiding infringement on existing patents.
Regulatory Compliance
Compliance with regulatory requirements is crucial. Patents like US6344215B1 must adhere to standards set by regulatory bodies such as the FDA, ensuring that the formulations are safe and effective.
Key Technological Milestones
Controlled Release Technology
The development of controlled-release formulations, as described in this patent, represents a significant technological milestone. This technology allows for more consistent and sustained drug delivery, improving patient compliance and therapeutic outcomes.
Polymer Science
The use of specific polymers like ethyl cellulose in the coating compositions is a key technological aspect. These polymers play a critical role in controlling the release rate of the drug.
Geopolitical Factors
Global Patent System
The global patent system, facilitated by tools like the Global Dossier and Common Citation Document, helps in harmonizing patent practices across different countries. This harmonization is essential for protecting intellectual property on a global scale[1].
Country-Specific Regulations
Different countries have their own regulatory frameworks and intellectual property laws. Understanding these regulations is vital for navigating the patent landscape effectively.
Conclusion
The United States Patent 6,344,215 is a pivotal patent in the field of pharmaceuticals, particularly for ADHD treatments. Its scope and claims define specific methylphenidate formulations and methods of preparation, influencing innovation and competition in the industry. The patent landscape is complex, with global implications and ongoing technological advancements.
Key Takeaways
- Specific Formulations: The patent covers specific compositions and methods for preparing methylphenidate formulations.
- Global Relevance: The patent is part of a broader global patent landscape, with implications for international intellectual property protection.
- Technological Milestones: The development of controlled-release formulations and the use of specific polymers are key technological advancements.
- Regulatory Compliance: Adherence to regulatory standards is crucial for the approval and use of these formulations.
- Litigation and Enforcement: The patent can be involved in litigation, highlighting the importance of careful patent strategy.
FAQs
What is the main subject of United States Patent 6,344,215?
The main subject of this patent is methylphenidate modified release formulations, specifically designed for treating attention deficit hyperactivity disorder (ADHD).
What are the key components of the methylphenidate formulations described in the patent?
The key components include immediate release beads, extended release beads, and specific polymers like ethyl cellulose used for coating the beads.
How does the patent impact the pharmaceutical industry?
The patent drives innovation by encouraging the development of new formulations and delivery methods, while also influencing competition and regulatory compliance within the industry.
What is the significance of the Global Dossier and Common Citation Document in relation to this patent?
These tools help in consolidating and visualizing the patent family and related applications across different countries, facilitating global intellectual property protection and harmonization.
Can this patent be involved in litigation?
Yes, the patent can be involved in litigation, particularly in cases related to patent infringement, as seen in various legal documents.
What are some of the technological milestones associated with this patent?
The development of controlled-release formulations and the use of specific polymers like ethyl cellulose are significant technological milestones associated with this patent.
