United States Patent 8,618,109: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,618,109, 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., highlights a novel class of compounds with potential therapeutic benefits.
Background and Inventors
The patent was issued on December 31, 2013, and is the work of several inventors from Otsuka Pharmaceutical Co., Ltd., including Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, and others based in Tokushima, Japan[4].
Scope of the Patent
Therapeutic Applications
The patent covers a wide treatment spectrum for mental disorders, including central nervous system disorders. The compounds described have shown promise in treating various mental health conditions with minimal side effects and high safety profiles[1][4].
Chemical Structure
The patent details heterocyclic compounds represented by a specific general formula, which includes piperazine-substituted benzothiophenes. These compounds are designed to interact with specific biological targets, thereby providing therapeutic effects[4].
Claims of the Patent
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims specify the chemical structure of the compounds, their synthesis methods, and their therapeutic uses. The independent claims are crucial as they set the boundaries of what is protected under the patent[4].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the compounds, such as specific substituents, dosages, and administration methods. These claims build upon the independent claims and provide additional protection for specific embodiments of the invention[4].
Patent Landscape
Related Patents
The patent is part of a broader portfolio of patents related to mental health treatments. Other patents, such as U.S. Patent Nos. 7,888,362, 8,349,840, 9,839,637, and 10,307,419, are also relevant in this landscape and often cited together in legal and scientific contexts[2].
Litigation and Enforcement
The patent has been involved in litigation, particularly in cases related to generic drug manufacturers. For example, Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have filed complaints against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for alleged patent infringement related to the filing of Abbreviated New Drug Applications (ANDAs)[2].
Patent Scope Metrics
Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent likely involved significant scrutiny to ensure the claims were clear, novel, and non-obvious. The changes during the examination process would have narrowed the scope of the patent claims to ensure they were enforceable and valid[3].
Safety and Efficacy
Clinical Significance
The compounds described in the patent have been noted for their high safety profile and efficacy in treating mental disorders. This is a critical aspect, as it differentiates these compounds from other treatments that may have significant side effects[1][4].
IC50 Values
The patent includes data on IC50 values, which are calculated from concentration-dependent reactions using non-linear analysis programs. These values are important in understanding the potency of the compounds[4].
International Patent Coverage
The patent is part of an international patent family, with corresponding patents in other jurisdictions. This ensures global protection for the invention, which is crucial for pharmaceutical companies operating internationally[5].
Reissue and Updates
The patent has been reissued as US RE48,059 E, indicating that there have been updates or corrections to the original patent. This reissue maintains the original claims and scope while addressing any issues that arose post-issuance[4].
Industry Impact
Innovation and Competition
The issuance of this patent has significant implications for innovation in the pharmaceutical industry. It sets a benchmark for new treatments and encourages further research into similar compounds. However, it also creates barriers for generic manufacturers, which can impact competition and drug prices[2].
Licensing and Litigation Costs
The patent's scope and enforcement can influence licensing and litigation costs. Broader patents can lead to increased costs due to licensing fees and potential litigation, which can deter innovation if not managed carefully[3].
Key Takeaways
- Therapeutic Applications: The patent covers a wide range of mental health disorders with minimal side effects.
- Chemical Structure: The compounds are piperazine-substituted benzothiophenes with specific therapeutic targets.
- Claims and Scope: The patent includes multiple independent and dependent claims defining the invention's boundaries.
- Litigation and Enforcement: The patent has been involved in significant litigation related to generic drug applications.
- Safety and Efficacy: The compounds are noted for their high safety profile and efficacy.
- International Coverage: The patent is part of an international patent family ensuring global protection.
Frequently Asked Questions
What is the main therapeutic application of the compounds described in US Patent 8,618,109?
The main therapeutic application is the treatment of mental disorders, including central nervous system disorders.
Who are the inventors of US Patent 8,618,109?
The inventors include Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, and others from Otsuka Pharmaceutical Co., Ltd.
What is the significance of the IC50 values mentioned in the patent?
IC50 values indicate the potency of the compounds and are calculated from concentration-dependent reactions using non-linear analysis programs.
Has US Patent 8,618,109 been involved in any litigation?
Yes, it has been involved in litigation related to generic drug manufacturers, such as Teva Pharmaceuticals.
What is the impact of this patent on the pharmaceutical industry?
The patent sets a benchmark for new treatments, encourages further research, but also creates barriers for generic manufacturers, affecting competition and drug prices.
Cited Sources
- US8618109B2 - Piperazine-substituted benzothiophenes for treatment of mental disorders - Google Patents
- Case 1:19-cv-01955-UNA Document 1 Filed 10/15/19 - RPX Insight
- Patent Claims and Patent Scope - Hoover Institution
- (19) United States (12) Reissued Patent - googleapis.com
- Drugs covered by patent 8,618,109 - Drug Patent Watch
