Understanding the Scope and Claims of United States Patent 8,580,796
Introduction
The United States Patent 8,580,796, titled "Low hygroscopic aripiprazole drug substance and processes for the preparation thereof," is a significant patent in the pharmaceutical industry. This patent, assigned to Otsuka Pharmaceutical Co., Ltd., addresses the formulation and preparation of aripiprazole, a medication used to treat various psychiatric conditions. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Background of Aripiprazole
Aripiprazole is an atypical antipsychotic medication used to treat conditions such as schizophrenia, bipolar disorder, and major depressive disorder. The drug's stability and formulation are critical for its efficacy and shelf life.
Patent Overview
The patent 8,580,796 focuses on developing low hygroscopic forms of aripiprazole. Hygroscopic substances absorb moisture from the air, which can lead to degradation and loss of potency. The invention described in this patent aims to prevent this issue by creating stable, anhydrous forms of aripiprazole.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: This claim describes the low hygroscopic aripiprazole drug substance, specifying its crystalline form and the process for its preparation. It emphasizes the anhydrous nature of the substance, which is crucial for maintaining its stability[4].
Dependent Claims
- Claims 2-10: These claims further detail the specific conditions and steps involved in preparing the low hygroscopic aripiprazole. They include aspects such as the crystallization process, the use of specific solvents, and the control of moisture levels during the preparation[4].
Scope of the Patent
The scope of the patent is defined by the claims and the detailed description provided in the patent document.
Crystalline Forms
The patent describes various crystalline forms of aripiprazole that are resistant to moisture absorption. These forms are achieved through specific crystallization processes and the use of particular solvents[4].
Preparation Processes
The patent outlines detailed processes for preparing the low hygroscopic aripiprazole. This includes steps such as dissolving aripiprazole in a solvent, controlling the temperature and humidity, and crystallizing the substance under specific conditions[4].
Patent Landscape
The patent landscape surrounding US 8,580,796 involves several related patents and legal disputes.
Related Patents
- U.S. Patent Nos. 8,017,615, 8,642,600, 8,642,760, and 8,759,350: These patents, also related to aripiprazole formulations and processes, are part of the broader intellectual property portfolio of Otsuka Pharmaceutical Co., Ltd.[5].
Legal Disputes
- Otsuka Pharm. Co. v. Zydus Pharms. U.S. & Cadila Healthcare Ltd.: This case involves disputes over the infringement of Otsuka's patents, including the '796 patent, by generic drug manufacturers. The court decisions in such cases help define the boundaries of patent protection and the scope of infringement[5].
Impact on the Pharmaceutical Industry
The patent 8,580,796 has significant implications for the pharmaceutical industry:
Stability and Efficacy
- The development of low hygroscopic forms of aripiprazole ensures the stability and efficacy of the drug, which is crucial for patient treatment outcomes.
Manufacturing Processes
- The detailed processes outlined in the patent provide a roadmap for manufacturers to produce high-quality aripiprazole formulations.
Intellectual Property Protection
- The patent protects Otsuka's innovation, preventing other companies from using the same processes and formulations without permission, thus safeguarding their investment in research and development.
Key Takeaways
- Stability of Aripiprazole: The patent focuses on creating stable, anhydrous forms of aripiprazole to prevent degradation due to moisture absorption.
- Detailed Preparation Processes: The patent outlines specific steps and conditions for preparing the low hygroscopic aripiprazole.
- Patent Protection: The patent is part of a broader intellectual property strategy by Otsuka Pharmaceutical Co., Ltd., to protect their innovations in aripiprazole formulations.
- Legal Implications: The patent has been involved in legal disputes over infringement, highlighting the importance of patent protection in the pharmaceutical industry.
FAQs
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What is the main focus of the US 8,580,796 patent?
- The main focus is on developing low hygroscopic forms of aripiprazole to ensure the drug's stability and efficacy.
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Why is the anhydrous form of aripiprazole important?
- The anhydrous form prevents the drug from absorbing moisture, which can lead to degradation and loss of potency.
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What are the key claims of the patent?
- The key claims describe the low hygroscopic aripiprazole drug substance and the specific processes for its preparation.
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How does this patent impact the pharmaceutical industry?
- It ensures the stability and efficacy of aripiprazole, provides detailed manufacturing processes, and protects Otsuka's intellectual property.
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Are there any related legal disputes involving this patent?
- Yes, there have been legal disputes over the infringement of this and related patents by generic drug manufacturers.
Sources
- US8580796B2 - Low hygroscopic aripiprazole drug substance and processes for the preparation thereof - Google Patents
- Otsuka Pharm. Co. v. Zydus Pharms. U.S. & Cadila Healthcare Ltd. - Casetext
- ANDA 090165 ANDA APPROVAL Zydus Pharmaceuticals (USA Inc.) - FDA[2][4][5]
