United States Patent 9,839,637: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,839,637, titled "Piperazine-substituted benzothiophenes for treatment of mental disorders," is a significant patent in the pharmaceutical industry, particularly in the treatment of mental health disorders. This patent, assigned to Otsuka Pharmaceutical Co., Ltd., involves the development of novel compounds with a wide treatment spectrum and improved safety profiles.
Background and Inventors
The patent was granted on December 12, 2017, to a team of inventors from Otsuka Pharmaceutical Co., Ltd., including Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, and others. The inventors are based in Tokushima, Japan, and their work focuses on developing heterocyclic compounds for therapeutic use[1][4].
Scope of the Patent
The patent covers a class of piperazine-substituted benzothiophenes designed to treat various mental disorders, including central nervous system disorders. These compounds are characterized by their general formula, which includes specific structural elements that contribute to their therapeutic efficacy and safety profile[1][4].
Therapeutic Applications
The compounds described in the patent have a wide treatment spectrum, including but not limited to:
- Major depressive disorder
- Schizophrenia
- Other central nervous system disorders
These compounds are noted for their excellent tolerability, fewer side effects, and high safety profile, making them promising candidates for treating mental health conditions[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. These claims are critical in determining the boundaries of the patent owner’s rights.
Independent Claims
The patent includes independent claims that describe the general structure of the piperazine-substituted benzothiophenes. These claims specify the chemical groups and substituents that are essential for the compounds' therapeutic activity[1][4].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular embodiments of the compounds, including specific substituents and their positions on the benzothiophene ring. These claims help in protecting specific aspects of the invention while allowing for some variability[1][4].
Patent Landscape and Related Patents
The patent landscape surrounding US 9,839,637 is complex, with several related patents and ongoing litigation.
Related Patents
The patent is part of a larger family of patents related to piperazine-substituted benzothiophenes. Other patents in this family include US 8,349,840, US 8,618,109, and US 10,307,419. These patents collectively cover various aspects of the compounds, including their synthesis, formulation, and therapeutic uses[2][5].
Litigation and Patent Infringement
The patent has been involved in several litigation cases, particularly related to generic drug manufacturers seeking FDA approval through Abbreviated New Drug Applications (ANDAs). For example, Otsuka Pharmaceutical Co., Ltd. has filed lawsuits against companies like Teva and Zenara Pharma for alleged patent infringement[2][5].
Genus Claims and Patent Scope
The scope of the patent claims is crucial in defining the inventor's rights. Genus claims, which cover a broad class of compounds, are common in pharmaceutical patents. However, these claims must be balanced to avoid being too broad or too narrow. If the claims are too broad, they may be invalidated for not being commensurate with the invention described in the patent application. Conversely, if the claims are too narrow, they can be easily designed around, reducing the patent's protective value[3].
Drafting Patent Claims
The process of drafting patent claims for pharmaceutical inventions like US 9,839,637 involves careful consideration of the breadth and specificity of the claims. The claims must capture the essence of the invention while providing enough detail to distinguish the invention from prior art. This balance is critical in ensuring the patent's enforceability and value[3].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, particularly in the development and commercialization of antipsychotic and antidepressant drugs. The compounds covered by this patent offer a promising alternative to existing treatments, with their improved safety and efficacy profiles.
Market Competition
The involvement of this patent in litigation highlights the competitive nature of the pharmaceutical market. Generic drug manufacturers often challenge patents to enter the market earlier, while innovator companies like Otsuka Pharmaceutical Co., Ltd. seek to protect their intellectual property to recoup their investment in research and development[2][5].
Key Takeaways
- Therapeutic Applications: The patent covers compounds for treating mental disorders, including major depressive disorder and schizophrenia.
- Chemical Structure: The compounds are piperazine-substituted benzothiophenes with specific structural elements.
- Safety and Efficacy: These compounds are noted for their excellent tolerability and high safety profile.
- Patent Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Related Patents and Litigation: The patent is part of a larger family of patents and has been involved in several litigation cases.
- Impact on Industry: The patent has significant implications for the development and commercialization of antipsychotic and antidepressant drugs.
FAQs
What is the main focus of United States Patent 9,839,637?
The main focus of this patent is the development of piperazine-substituted benzothiophenes for the treatment of mental disorders, including central nervous system disorders.
Who are the inventors of this patent?
The inventors include Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, and several others from Otsuka Pharmaceutical Co., Ltd.
What are the therapeutic applications of the compounds described in this patent?
The compounds are designed to treat various mental health conditions, including major depressive disorder, schizophrenia, and other central nervous system disorders.
Why is the scope of patent claims important?
The scope of patent claims is crucial as it defines the boundaries of the patent owner’s rights and determines what exactly the inventor is claiming as their invention.
Is this patent involved in any litigation?
Yes, this patent has been involved in several litigation cases related to patent infringement by generic drug manufacturers seeking FDA approval through ANDAs.
Cited Sources
- United States Reissued Patent US RE48,059 E - "Piperazine-substituted benzothiophenes for treatment of mental disorders."
- RPX Insight - "Case 1:19-cv-01955-UNA Document 1 Filed 10/15/19."
- DigitalCommons@NYLS - "Eviscerating Patent Scope."
- Google Patents - "US9839637B1 - Piperazine-substituted benzothiophenes for treatment of mental disorders."
- RPX Insight - "in the united states district court."
