Detailed Analysis of the Scope and Claims of United States Patent 6,821,975
Introduction
United States Patent 6,821,975, titled "Beta-carboline drug products," is a significant patent in the fields of pharmaceutical and organic chemistry. This patent, which has since expired, pertains to the development and use of β-carboline compounds, particularly for the treatment of various medical conditions.
Patent Overview
The patent was granted on November 30, 2004, and it expired due to the natural lifetime of the patent term. Here is a brief overview of the key aspects:
- Publication Number: US6821975B1
- Prior Art Date: The patent builds on earlier research and developments in the field of β-carboline compounds[1].
Scope of the Patent
The scope of the patent is broad and encompasses several key areas:
β-Carboline Compounds
The patent focuses on β-carboline compounds, which are a class of indole alkaloids. These compounds are known for their potential therapeutic benefits, including the treatment of sexual dysfunction, such as erectile dysfunction and female sexual arousal disorder[1].
Pharmaceutical Formulations
The patent describes various pharmaceutical formulations of β-carboline compounds, including solid particulate forms, compressed tablets, and other dosage forms. These formulations can include a range of pharmaceutical excipients, such as binders, fillers, lubricants, and disintegrants[1].
Particle Size and Distribution
The patent emphasizes the importance of particle size and distribution in the formulation of these compounds. It describes methods for achieving specific particle sizes and distributions, which can affect the bioavailability and efficacy of the drug[1].
Therapeutic Uses
The therapeutic uses of the β-carboline compounds covered by this patent include the treatment of sexual dysfunction. Specifically, it mentions erectile dysfunction, impotence, and female sexual arousal disorders[1].
Claims of the Patent
The claims of the patent are detailed and cover several aspects of the β-carboline drug products:
Compound Claims
The patent claims cover the β-carboline compounds themselves, including their chemical structure and various salts and solvates. These claims are specific to the molecular structure and the methods of synthesizing these compounds[1].
Formulation Claims
The patent includes claims related to the pharmaceutical formulations of these compounds. This includes solid particulate forms, compressed tablets, and other dosage forms. The claims also cover the use of various pharmaceutical excipients and the methods of manufacturing these formulations[1].
Particle Size and Distribution Claims
The claims specify the particle size and distribution of the solid particulate forms of the β-carboline compounds. This includes methods for achieving a bimodal particle size distribution, which can enhance the drug's performance[1].
Therapeutic Claims
The patent claims also cover the therapeutic uses of these compounds, including their application in treating sexual dysfunction. These claims are supported by clinical data and studies that demonstrate the efficacy of these compounds in treating these conditions[1].
Patent Landscape
The patent landscape surrounding US 6,821,975 is complex and involves several related patents and developments:
Related Patents
Other patents, such as US 20070098804 A1, also deal with similar pharmaceutical formulations, particularly focusing on tadalafil, another compound used for treating erectile dysfunction. These patents often overlap in terms of the methods and formulations described, highlighting the competitive and innovative environment in this field[2].
Crystalline Molecular Complexes
Patents like WO 2010/099323 A1 describe crystalline molecular complexes of tadalafil, which are related to the β-carboline compounds in terms of their therapeutic applications. These patents show the ongoing research and development in creating new and more effective pharmaceutical formulations[4].
Patent Scope and Quality
The debate over patent scope and quality is relevant here. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This indicates that the scope of US 6,821,975, while broad, was likely refined during the examination process to ensure clarity and validity[3].
Impact and Legacy
Despite its expiration, US 6,821,975 has had a significant impact on the development of pharmaceuticals for treating sexual dysfunction:
Therapeutic Advances
The patent contributed to the advancement of treatments for sexual dysfunction by providing new formulations and methods of delivery for β-carboline compounds. These advancements have improved patient outcomes and expanded treatment options[1].
Industry Influence
The patent has influenced subsequent research and development in the pharmaceutical industry. It has set a precedent for the formulation and therapeutic use of similar compounds, driving innovation in this field[2][4].
Key Takeaways
- β-Carboline Compounds: The patent focuses on β-carboline compounds and their therapeutic applications, particularly in treating sexual dysfunction.
- Pharmaceutical Formulations: It describes various formulations, including solid particulate forms and compressed tablets, and the importance of particle size and distribution.
- Therapeutic Uses: The patent covers the treatment of erectile dysfunction, impotence, and female sexual arousal disorders.
- Patent Landscape: The patent is part of a broader landscape involving related patents on tadalafil and other compounds used for similar therapeutic purposes.
- Impact and Legacy: Despite its expiration, the patent has contributed significantly to the advancement of treatments for sexual dysfunction and continues to influence pharmaceutical research and development.
FAQs
What is the main focus of US Patent 6,821,975?
The main focus of US Patent 6,821,975 is on β-carboline compounds and their use in treating sexual dysfunction, including erectile dysfunction and female sexual arousal disorders.
What types of pharmaceutical formulations are described in the patent?
The patent describes various pharmaceutical formulations, including solid particulate forms, compressed tablets, and other dosage forms, along with the use of pharmaceutical excipients.
Why is particle size and distribution important in this patent?
Particle size and distribution are crucial for the bioavailability and efficacy of the drug. The patent specifies methods for achieving specific particle sizes and distributions, such as a bimodal particle size distribution.
What is the therapeutic application of the β-carboline compounds covered by this patent?
The therapeutic application includes the treatment of sexual dysfunction, specifically erectile dysfunction, impotence, and female sexual arousal disorders.
How does this patent fit into the broader patent landscape?
This patent is part of a broader landscape involving related patents on tadalafil and other compounds used for similar therapeutic purposes, highlighting ongoing research and development in pharmaceutical formulations.
What is the current status of US Patent 6,821,975?
US Patent 6,821,975 has expired due to the natural lifetime of the patent term.
Sources
- US Patent 6,821,975 B1 - Beta-carboline drug products[1].
- US Patent Application 20070098804 A1 - Solid particulate tadalafil having a bimodal particle size distribution[2].
- SSRN Paper - Patent Claims and Patent Scope[3].
- WO 2010/099323 A1 - Crystalline molecular complexes of tadalafil[4].
