Understanding the Scope and Claims of United States Patent 9,358,207
Introduction
The United States Patent 9,358,207, hereafter referred to as the '207 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent, issued on April 12, 2020, pertains to specific formulations and methods related to pharmaceuticals. Here, we will delve into the details of its scope, claims, and the broader patent landscape it inhabits.
Background of the Patent
The '207 patent is associated with Aripiprazole, a medication used in the treatment of various psychiatric conditions, including schizophrenia, bipolar disorder, and major depressive disorder. The patent is held by Otsuka Pharmaceutical Co., Ltd., a company well-known for its innovative pharmaceutical products.
Scope of the Patent
The scope of the '207 patent revolves around specific formulations and methods of using Aripiprazole. Here are some key aspects:
Formulation
The patent describes particular formulations of Aripiprazole, including orally disintegrating tablets. These formulations are designed to enhance the drug's efficacy, stability, and patient compliance. The granules or tablets may include one or more medicaments, along with other excipients and ingredients that facilitate rapid disintegration in the mouth[2].
Method of Use
The patent also covers the methods of using these formulations, particularly in the treatment of psychiatric disorders. This includes specific dosages, administration routes, and any additional therapeutic benefits these formulations provide over existing treatments.
Claims of the Patent
The claims of the '207 patent are crucial as they define the legal boundaries of what is protected under the patent.
Independent Claims
Independent claims typically define the broadest scope of the invention. For the '207 patent, these might include claims related to the composition of the orally disintegrating tablets, the method of preparing these tablets, and the specific therapeutic uses of these formulations.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These could include specific ratios of ingredients, particular manufacturing processes, or detailed methods of administration.
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property environment surrounding the '207 patent.
Related Patents
The '207 patent is part of a larger family of patents related to Aripiprazole. Other patents in this family include those covering different formulations, methods of use, and even method-of-use patents that do not claim the same indications as the '207 patent[2].
Litigation and Certifications
The '207 patent has been involved in litigation, particularly with generic pharmaceutical companies seeking to manufacture and market their own versions of Aripiprazole. These companies often file paragraph IV certifications under the FD&C Act, stating that the patents are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of the generic drug[2].
Implications for Innovators and Practitioners
For innovators and patent practitioners, the '207 patent offers several key takeaways:
Patent Eligibility
The patent eligibility of formulations and methods related to pharmaceuticals can be complex. The '207 patent demonstrates how specific formulations and methods can be patented by showing a practical application and a concrete technological improvement. This aligns with recent USPTO guidance updates, which emphasize the integration of judicial exceptions into practical applications to ensure patent eligibility[1].
Compliance with Regulatory Requirements
The patent highlights the importance of complying with regulatory requirements, such as those under the FD&C Act. Generic manufacturers must navigate these regulations carefully to avoid infringement and ensure their products are approved by regulatory bodies[2].
Real-World Applications
The '207 patent has real-world applications that extend beyond the legal and regulatory aspects.
Patient Compliance
The orally disintegrating tablets covered by the patent are designed to improve patient compliance, especially in populations that have difficulty swallowing traditional tablets. This formulation can enhance the overall efficacy of the treatment by ensuring that patients take their medication as prescribed.
Therapeutic Benefits
The specific formulations and methods described in the patent can provide therapeutic benefits, such as improved stability and bioavailability of the drug. These benefits can lead to better treatment outcomes for patients suffering from psychiatric disorders.
Key Takeaways
- Specific Formulations: The '207 patent covers specific formulations of Aripiprazole, including orally disintegrating tablets.
- Method of Use: The patent includes methods of using these formulations in the treatment of psychiatric disorders.
- Patent Landscape: The patent is part of a larger family of patents related to Aripiprazole and has been involved in litigation with generic manufacturers.
- Regulatory Compliance: Compliance with regulatory requirements is crucial for both innovators and generic manufacturers.
- Real-World Applications: The patent has significant real-world applications, including improved patient compliance and therapeutic benefits.
FAQs
Q: What is the primary focus of the '207 patent?
A: The primary focus of the '207 patent is on specific formulations and methods of using Aripiprazole, particularly orally disintegrating tablets.
Q: How does the '207 patent fit into the broader patent landscape?
A: The '207 patent is part of a larger family of patents related to Aripiprazole and has been involved in litigation with generic manufacturers.
Q: What are the implications of the '207 patent for generic manufacturers?
A: Generic manufacturers must navigate regulatory requirements carefully and may need to file paragraph IV certifications to avoid infringement.
Q: How does the '207 patent impact patient compliance?
A: The orally disintegrating tablets covered by the patent are designed to improve patient compliance, especially in populations that have difficulty swallowing traditional tablets.
Q: What are the therapeutic benefits of the formulations described in the '207 patent?
A: The specific formulations and methods described in the patent can provide improved stability and bioavailability of the drug, leading to better treatment outcomes.
Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- ANDA 090165 ANDA APPROVAL Zydus Pharmaceuticals (USA) - FDA
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- Flashmelt oral dosage formulation - Patent US-9358207-B2 - PubChem
