United States Patent 9,089,567: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,089,567, hereafter referred to as the '567 patent, is a significant patent in the pharmaceutical sector, particularly related to the treatment of cognitive impairments and schizophrenia. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '567 patent, titled "Method of treating cognitive impairments and schizophrenias," is associated with Otsuka Pharmaceutical Co., Ltd. and was granted on July 28, 2015. It pertains to methods of treating central nervous system disorders, specifically those related to the 5-HT 1A receptor[1].
Scope of the Patent
Relevance to Cognitive Impairments and Schizophrenia
The patent focuses on therapeutic methods targeting the 5-HT 1A receptor, which is crucial in the treatment of cognitive impairments and schizophrenia. This receptor plays a significant role in the serotonin system, which is often implicated in psychiatric disorders[1].
Specific Claims
The '567 patent includes specific claims related to the use of certain compounds as agonists or antagonists of the 5-HT 1A receptor. These claims are detailed and specify the chemical structures and therapeutic applications of these compounds. The patent also covers various formulations and dosages, ensuring a comprehensive approach to treatment[1].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations or features. For the '567 patent, the independent claims outline the general method of treatment using 5-HT 1A receptor agonists or antagonists, while dependent claims specify particular compounds, dosages, and administration methods[1].
Claim Language and Scope
The claim language is critical in defining the patent's scope. The '567 patent uses precise language to describe the chemical compounds and their therapeutic uses, ensuring clarity and specificity. This precision helps in distinguishing the invention from prior art and other related patents[3].
Patent Landscape
Related Patents
The '567 patent is part of a larger portfolio of patents related to aripiprazole, a drug used in treating various psychiatric conditions. Other patents, such as the '600, '760, '350, and '939 patents, also owned by Otsuka Pharmaceutical Co., Ltd., cover different aspects of aripiprazole, including its formulation, preparation, and additional therapeutic uses[5].
Litigation and Legal Status
The '567 patent has been involved in litigation, particularly in the context of generic drug approvals. For instance, Otsuka Pharmaceutical Co., Ltd. has initiated legal actions against companies like Zydus Pharmaceuticals USA Inc. for alleged infringement of this and other related patents. These cases have been dismissed, but they highlight the patent's significance in protecting intellectual property in the pharmaceutical industry[5].
Expiration and Pediatric Exclusivity
The '567 patent expired on January 28, 2022. However, some related patents, such as the '939 and '182 patents, have pediatric exclusivity added, extending their protection until later dates[5].
Impact on Pharmaceutical Industry
Innovation and Competition
The '567 patent, along with other related patents, has significant implications for innovation and competition in the pharmaceutical industry. By protecting specific methods of treatment and formulations, these patents can influence the development of new drugs and the entry of generic competitors into the market[3].
Regulatory Compliance
Companies seeking to develop generic versions of drugs covered by these patents must comply with regulatory requirements, including submitting ANDAs (Abbreviated New Drug Applications) and addressing patent certifications. The FDA's guidelines and the Generic Drug User Fee Amendments play crucial roles in this process[2][5].
Key Takeaways
- Therapeutic Focus: The '567 patent is centered on treating cognitive impairments and schizophrenia through the 5-HT 1A receptor.
- Specific Claims: The patent includes detailed claims on the use of specific compounds as agonists or antagonists of the 5-HT 1A receptor.
- Patent Landscape: It is part of a broader portfolio of patents related to aripiprazole and has been involved in litigation to protect intellectual property.
- Expiration and Exclusivity: The patent expired on January 28, 2022, but related patents have extended protection due to pediatric exclusivity.
- Industry Impact: The patent influences innovation, competition, and regulatory compliance in the pharmaceutical industry.
FAQs
What is the main focus of the '567 patent?
The '567 patent focuses on methods of treating cognitive impairments and schizophrenia through the use of compounds that act as agonists or antagonists of the 5-HT 1A receptor.
Who is the owner of the '567 patent?
The '567 patent is owned by Otsuka Pharmaceutical Co., Ltd.
What is the current legal status of the '567 patent?
The '567 patent expired on January 28, 2022.
How does the '567 patent impact the pharmaceutical industry?
The patent protects specific methods of treatment and formulations, influencing innovation, competition, and the entry of generic competitors into the market.
Are there related patents to the '567 patent?
Yes, there are several related patents owned by Otsuka Pharmaceutical Co., Ltd., including the '600, '760, '350, and '939 patents, which cover different aspects of aripiprazole.
Sources
- US Patent and Trademark Office. Method of treating cognitive impairments and schizophrenias. US9089567B2.
- FDA. Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg. December 16, 2024.
- Hoover Institution. Patent Claims and Patent Scope. August 2016.
- Encyclopedia MDPI. Digital Pills with Ingestible Sensors. September 1, 2022.
- FDA. ANDA 090165 ANDA APPROVAL Zydus Pharmaceuticals (USA). March 2, 2018.
