United States Patent RE48059: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Reissue Patent RE48059, 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, held by Otsuka Pharmaceutical Co., Ltd., and H. Lundbeck A/S, has been the subject of several legal battles and is crucial for understanding the patent landscape in this field.
Background and Inventors
The patent was originally issued on February 15, 2011, as Patent No. 7,888,362, and was reissued on June 23, 2020, as RE48059. The inventors include Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, Kunio Oshima, Jun Matsubara, Hideaki Kuroda, Haruka Takahashi, Satoshi Shimizu, Tatsuyoshi Tanaka, and Yasuo Oshiro, all from Tokushima, Japan[1][4].
Scope of the Patent
The patent covers a class of heterocyclic compounds, specifically piperazine-substituted benzothiophenes, which have a broad treatment spectrum for mental disorders, including central nervous system disorders. These compounds are noted for their high safety profile and lack of side effects[1][4].
Claims of the Patent
The RE48059 patent includes 15 claims that define the scope of the invention. These claims are detailed and specify the chemical structure of the compounds, their synthesis, and their therapeutic applications. The claims are categorized into different types, including composition claims, method claims, and use claims, ensuring comprehensive protection for the inventors' work[1][4].
Chemical Structure and Synthesis
The compounds covered by this patent are characterized by their piperazine-substituted benzothiophene structure. The general formula includes various substituents such as alkyl groups, alkenylene groups, and other functional groups that contribute to the therapeutic efficacy of the compounds. The synthesis methods described involve substitution reactions and other chemical processes to produce these complex molecules[1][4].
Therapeutic Applications
The piperazine-substituted benzothiophenes are designed to treat a wide range of mental disorders, including schizophrenia, bipolar disorder, and other central nervous system disorders. The patent highlights the compounds' high safety profile and lack of side effects, which are critical factors in the development of psychiatric medications[1][4].
Patent Infringement Litigation
The RE48059 patent has been at the center of several patent infringement lawsuits. Otsuka Pharmaceutical Co., Ltd., and H. Lundbeck A/S have filed complaints against various generic pharmaceutical companies, including Zenara Pharma Private Ltd., Biophore India Pharmaceuticals Private Ltd., and Alkem Laboratories Ltd., alleging infringement through the submission of Abbreviated New Drug Applications (ANDAs) to the FDA. These lawsuits claim that the generic companies' products would infringe on the claims of the RE48059 patent if approved and marketed before the patent's expiration date[2][5].
Claim Coverage and Patent Landscape
To understand the patent landscape, it is essential to analyze the claim coverage of the RE48059 patent. This involves categorizing the claims by scope concepts, which helps in identifying gaps or opportunities in the patent protection. Tools like Claim Coverage Matrix and Claim Charts are useful in this analysis, allowing companies to filter, search, and accurately analyze large numbers of patent claims concurrently. This method helps in determining whether a particular scope concept is applicable to a target product or method and highlights future design opportunities[3].
Legal Status and Expiration
The RE48059 patent is currently active, but its expiration date is crucial for understanding the timeline of patent protection. The patent's legal status and any terminal disclaimers must be considered when assessing its impact on the pharmaceutical market[4].
Impact on the Pharmaceutical Industry
The RE48059 patent significantly influences the development and marketing of psychiatric medications. The protection it offers ensures that Otsuka Pharmaceutical Co., Ltd., and H. Lundbeck A/S maintain exclusivity over the piperazine-substituted benzothiophenes, preventing generic competition until the patent expires. This exclusivity is critical for the companies' revenue and for the continued research and development in this therapeutic area[2][5].
Conclusion
The United States Reissue Patent RE48059 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of mental health disorders. Its comprehensive claims and robust patent landscape analysis underscore its importance in protecting intellectual property and driving innovation in psychiatric medications.
Key Takeaways
- The RE48059 patent covers piperazine-substituted benzothiophenes for treating mental disorders.
- The patent includes 15 detailed claims specifying the chemical structure, synthesis, and therapeutic applications.
- The compounds have a high safety profile and lack of side effects.
- The patent has been involved in several infringement lawsuits against generic pharmaceutical companies.
- Claim coverage analysis is crucial for understanding the patent landscape and identifying gaps or opportunities.
- The patent's legal status and expiration date are vital for assessing its impact on the pharmaceutical market.
Frequently Asked Questions (FAQs)
Q: What is the main subject of the RE48059 patent?
A: The RE48059 patent covers piperazine-substituted benzothiophenes for the treatment of mental disorders.
Q: Who are the inventors of the RE48059 patent?
A: The inventors include Hiroshi Yamashita, Nobuaki Ito, Shin Miyamura, and others from Tokushima, Japan.
Q: What is the significance of the RE48059 patent in the pharmaceutical industry?
A: The patent ensures exclusivity over a class of psychiatric medications, preventing generic competition and driving innovation in this therapeutic area.
Q: What legal actions have been taken regarding the RE48059 patent?
A: Otsuka Pharmaceutical Co., Ltd., and H. Lundbeck A/S have filed patent infringement lawsuits against several generic pharmaceutical companies.
Q: How does the claim coverage analysis help in understanding the patent landscape?
A: Claim coverage analysis helps in categorizing claims by scope concepts, identifying gaps or opportunities, and determining the applicability of claims to target products or methods.
Cited Sources:
- United States Reissue Patent RE48059 - Piperazine-substituted benzothiophenes for treatment of mental disorders[1].
- Complaint for Patent Infringement - Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S vs. Zenara Pharma Private Ltd. and Biophore India Pharmaceuticals Private Ltd.[2].
- Patent Analytics - Schwegman’s process for analyzing patent claims and scope concepts[3].
- Google Patents - USRE48059E1 - Piperazine-substituted benzothiophenes for treatment of mental disorders[4].
- Complaint for Patent Infringement - Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S vs. Alkem Laboratories Ltd.[5].
