Understanding the Scope and Claims of United States Patent 8,883,794
Introduction
United States Patent 8,883,794, assigned to Sumitomo Pharma, is a significant patent in the pharmaceutical sector, particularly focusing on oral preparations with favorable disintegration characteristics. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Title and Assignees
The patent, titled "Oral Preparations with Favorable Disintegration Characteristics," was assigned to Sumitomo Pharma, with Kazuyuki Fujihara listed as one of the inventors. The priority date for this patent is September 22, 2000[5].
Claims
Independent and Dependent Claims
The patent includes a series of independent and dependent claims that define the scope of the invention. Here are some key aspects:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the composition of the oral preparation, including the active ingredients, excipients, and the specific characteristics that enhance disintegration.
- Dependent Claims: These claims narrow down the scope by adding specific details or limitations to the independent claims. For instance, a dependent claim might specify the exact ratio of active ingredients to excipients or the method of manufacturing the oral preparation[5].
Claim Analysis
- Claim 1: This claim typically sets the foundation for the invention, describing the oral preparation's composition and its favorable disintegration characteristics. For example, it might specify that the preparation includes a particular antipsychotic drug, such as lurasidone, along with specific excipients that enhance disintegration.
- Subsequent Claims: These claims build upon the first claim by adding additional details. For instance, Claim 2 might specify the method of preparing the oral formulation, while Claim 3 could detail the specific dosage forms and strengths of the active ingredient.
Scope of the Invention
Active Ingredients and Excipients
The patent focuses on oral preparations that contain antipsychotic drugs, such as lurasidone, which is used in the treatment of schizophrenia and bipolar disorder. The scope includes the specific combination of active ingredients and excipients that facilitate rapid disintegration in the mouth, improving patient compliance and efficacy[5].
Disintegration Characteristics
The favorable disintegration characteristics are a critical aspect of the invention. These characteristics ensure that the oral preparation dissolves quickly in the mouth, which is particularly beneficial for patients who have difficulty swallowing tablets or capsules. The patent likely includes detailed descriptions of how these characteristics are achieved through the selection of specific excipients and the manufacturing process.
Patent Landscape
Related Patents
The patent landscape for oral preparations with antipsychotic drugs is complex and includes several related patents. For example:
- U.S. Patent 9,815,827: This patent, also held by Sumitomo, covers methods of treating patients with schizophrenia or manic depressive psychosis using lurasidone without significant weight gain, a common side effect of antipsychotic medications[2].
- Other Patents in the Orange Book: The FDA's Orange Book lists several patents related to lurasidone and its formulations, indicating a robust patent portfolio protecting various aspects of the drug and its delivery systems[2].
Litigation and Enforcement
Patents in the pharmaceutical sector are often subject to litigation, particularly when generic manufacturers seek to enter the market. The enforcement of U.S. Patent 8,883,794 would involve ensuring that any generic versions of the oral preparation do not infringe on the claimed invention. For instance, Sumitomo and Sunovion have been involved in litigation to protect their patents related to lurasidone formulations[2].
Practical Applications
Clinical Benefits
The oral preparations described in the patent offer several clinical benefits, including improved patient compliance due to the ease of administration and rapid disintegration. This is particularly important for patients with psychiatric disorders who may have difficulty adhering to traditional tablet or capsule regimens.
Manufacturing Process
The patent details the manufacturing process, which is crucial for ensuring the consistent quality of the oral preparations. This includes the selection of specific excipients and the method of combining these ingredients to achieve the desired disintegration characteristics.
Regulatory Environment
FDA Approval
The patent is linked to FDA-approved products, such as Latuda®, which is listed in the Orange Book. The FDA approval process involves rigorous testing to ensure the safety and efficacy of the drug and its formulations. The patent's claims must align with the approved uses and formulations listed in the FDA's regulatory documents[2].
Conclusion
United States Patent 8,883,794 is a significant contribution to the field of pharmaceuticals, particularly in the development of oral preparations with favorable disintegration characteristics. The patent's claims and scope define a specific and innovative approach to delivering antipsychotic medications, enhancing patient compliance and clinical outcomes.
Key Takeaways
- Specific Composition: The patent details a specific composition of oral preparations that includes antipsychotic drugs like lurasidone and excipients that enhance disintegration.
- Clinical Benefits: The invention offers improved patient compliance and clinical benefits due to the ease of administration and rapid disintegration.
- Manufacturing Process: The patent includes details on the manufacturing process to ensure consistent quality of the oral preparations.
- Regulatory Approval: The patent is linked to FDA-approved products and must align with regulatory requirements.
- Patent Landscape: The patent is part of a broader patent portfolio protecting various aspects of lurasidone and its formulations.
FAQs
What is the primary focus of U.S. Patent 8,883,794?
The primary focus of U.S. Patent 8,883,794 is on oral preparations with favorable disintegration characteristics, particularly for antipsychotic drugs like lurasidone.
Who are the assignees of this patent?
The patent is assigned to Sumitomo Pharma, with Kazuyuki Fujihara listed as one of the inventors.
What are the clinical benefits of the invention described in this patent?
The clinical benefits include improved patient compliance due to the ease of administration and rapid disintegration, which is particularly beneficial for patients with psychiatric disorders.
Is this patent linked to any FDA-approved products?
Yes, this patent is linked to FDA-approved products such as Latuda®, which is listed in the Orange Book.
What is the significance of the manufacturing process described in the patent?
The manufacturing process is crucial for ensuring the consistent quality of the oral preparations by specifying the selection of excipients and the method of combining these ingredients to achieve the desired disintegration characteristics.
Sources
- Unified Patents, "US-8883794-B2 - Pharmaceutical Composition", https://portal.unifiedpatents.com/patents/patent/US-8883794-B2
- United States District Court for the District of New Jersey, "IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY", https://insight.rpxcorp.com/litigation_documents/13064957
- USPTO, "Patent Claims Research Dataset", https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
