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Last Updated: December 22, 2024

Details for Patent: 8,658,663


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Which drugs does patent 8,658,663 protect, and when does it expire?

Patent 8,658,663 protects BRISDELLE and is included in one NDA.

This patent has forty-four patent family members in twenty-six countries.

Summary for Patent: 8,658,663
Title:Method of treating thermoregulatory disfunction with paroxetine
Abstract: The present invention relates to a method for treating a patient suffering from a thermoregulatory dysfunction, especially hot flashes and flushes associated with hormonal changes due to naturally occurring menopause (whether male or female) or due to chemically or surgically induced menopause. The method is also applicable to treating the hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation of body temperature.
Inventor(s): Richards; Patricia Allison Tewes (Scarsdale, NY)
Assignee: Noven Therapeutics, LLC (Miami, FL)
Application Number:12/292,960
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,658,663
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 8,658,663: A Detailed Analysis

Introduction

United States Patent 8,658,663, titled "Method of treating thermoregulatory dysfunction with paroxetine," is a patent that addresses a specific medical treatment method. To fully comprehend the implications and landscape of this patent, it is crucial to delve into its claims, the patent's scope, and the broader patent landscape in the relevant field.

Patent Overview

Title and Abstract

The patent titled "Method of treating thermoregulatory dysfunction with paroxetine" describes a method for treating conditions such as hot flashes, hot flushes, or night sweats associated with disease states that disrupt normal hormonal regulation. This method involves the use of paroxetine, a selective serotonin reuptake inhibitor (SSRI), to alleviate these symptoms[2].

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 invention by adding additional limitations.

  • Independent Claim 1: This claim typically outlines the core method of treating thermoregulatory dysfunction using paroxetine.
  • Dependent Claims: These claims build upon the independent claim by specifying additional details such as dosage, administration methods, and specific conditions treated.

Claim Construction

The claims in this patent are constructed to ensure they meet the criteria for patent eligibility under 35 U.S.C. ยง 101. This involves demonstrating that the method is a practical application rather than an abstract idea. For instance, the claims must show how the use of paroxetine provides a concrete benefit in treating thermoregulatory dysfunction, such as reducing the frequency and severity of hot flashes.

Patent Eligibility

Subject Matter Eligibility

The patent eligibility of this invention hinges on whether the claims integrate a judicial exception into a practical application. The USPTO's 2024 guidance update on AI and software-related technologies, although not directly applicable to pharmaceutical methods, emphasizes the importance of showing concrete technological improvements. In this context, the method must demonstrate significant and meaningful limits on the exception (the use of paroxetine) to transform it into patent-eligible subject matter[1].

Patent Landscape Analysis

Geographical Spread and Saturation

To understand the patent landscape surrounding this invention, it is essential to analyze the geographical spread and saturation of similar patents.

  • Geographical Spread: This involves identifying where similar patents are being filed and granted. For pharmaceuticals, this often includes major markets like the United States, Europe, and Japan.
  • Saturation: Determining how saturated the patent space is for thermoregulatory dysfunction treatments helps in assessing the potential for new inventions and the competitive landscape. A highly saturated space may indicate that new entrants need to innovate significantly to secure patent protection[3].

Competitors and New Entrants

Identifying key competitors and new entrants in the patent space is crucial.

  • Known Competitors: Analyzing the patent portfolios of known competitors in the field of thermoregulatory dysfunction treatments can reveal trends and areas of focus.
  • New Entrants: Identifying new entrants can highlight emerging technologies or approaches that might challenge existing patents or create new opportunities[3].

Time-Slicing and Trends

Analyzing the patent landscape over time can reveal trends and changes in the technology area.

  • Time-Slicing: This involves looking at the patent filings and grants over different time periods to see how the technology has evolved.
  • Trends: Identifying trends can help in understanding whether the focus is shifting towards new treatments or if there is a resurgence in interest in existing methods like the use of paroxetine[3].

Niche Patent Areas

Identifying underappreciated niche patent areas can provide opportunities for innovation.

  • Niche Technologies: For example, if there is a lack of patents focusing on specific types of thermoregulatory dysfunctions or particular patient populations, this could be an area for further research and development[3].

Patentability Search vs. Patent Landscape Analysis

While a patentability search focuses on specific prior art related to the claims of a new filing, a comprehensive patent landscape analysis provides a broader view of the entire technology area.

  • Patentability Search: This is essential for ensuring that the claims of the patent do not infringe on existing prior art.
  • Patent Landscape Analysis: This helps in making strategic decisions about entering a new technology space and identifying potential risks and opportunities[3].

Tools and Resources for Analysis

Several tools and resources are available for conducting a thorough patent landscape analysis.

  • USPTO Public Search Facility: This facility provides access to patent and trademark information in various formats.
  • Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques.
  • Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, which can be useful for international patent landscape analysis[4].

International Patent Landscape

Given the global nature of pharmaceutical research, it is important to consider the international patent landscape.

  • International Patent Offices: Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) offer valuable resources for searching international patents[4].

Key Takeaways

  • Claims Construction: The claims must demonstrate a practical application of the method to treat thermoregulatory dysfunction.
  • Patent Eligibility: The method must integrate the use of paroxetine into a practical application that provides concrete benefits.
  • Patent Landscape: Understanding the geographical spread, saturation, and trends in the patent space is crucial for strategic decision-making.
  • Tools and Resources: Utilizing various tools and resources available from the USPTO and international patent offices can enhance the analysis.

FAQs

What is the main focus of United States Patent 8,658,663?

The main focus of this patent is a method for treating thermoregulatory dysfunction using paroxetine.

How does the patent ensure it meets the criteria for patent eligibility?

The patent ensures it meets the criteria by demonstrating that the method is a practical application that provides concrete benefits in treating thermoregulatory dysfunction.

What is the importance of patent landscape analysis in this context?

Patent landscape analysis helps in understanding the competitive landscape, identifying trends, and making strategic decisions about entering or innovating within the technology space.

What tools are available for conducting a patent landscape analysis?

Tools such as the USPTO Public Search Facility, PTRCs, Global Dossier, and international patent office databases are available for conducting a comprehensive patent landscape analysis.

Why is international patent landscape analysis important for pharmaceutical patents?

International patent landscape analysis is crucial because pharmaceutical research and development are global endeavors, and understanding the international patent landscape helps in navigating potential risks and opportunities.

Cited Sources:

  1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
  2. Method of treating thermoregulatory disfunction with paroxetine - PubChem
  3. Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP
  4. Search for patents - USPTO - USPTO

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Drugs Protected by US Patent 8,658,663

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 AB RX Yes Yes 8,658,663 ⤷  Subscribe Y Y TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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