United States Patent 6,794,489: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 6,794,489, titled "Compositions and methods for treatment of sexual dysfunction," is a significant patent held by Palatin Technologies, Inc. This patent is crucial for understanding the treatment of sexual dysfunction, particularly in the context of the drug Vyleesi (bremelanotide injection). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Patent Number and Title
The patent number is 6,794,489, and its title is "Compositions and methods for treatment of sexual dysfunction."
Issuance and Expiration
The patent was issued by the United States Patent and Trademark Office (USPTO) and, following a patent term extension, is set to expire on June 25, 2025[1].
Inventors and Assignees
The patent is assigned to Palatin Technologies, Inc., a biopharmaceutical company focused on developing medicines based on melanocortin peptide receptor systems.
Scope of the Patent
Composition of Matter
The patent covers the composition of matter related to bremelanotide, a peptide that interacts with melanocortin receptors. This composition is specifically designed for treating sexual dysfunction in mammals, including both male and female sexual dysfunctions[4].
Methods of Treatment
The patent includes claims for methods of treating sexual dysfunction, such as Hypoactive Sexual Desire Disorder (HSDD) and erectile dysfunction. These methods involve the administration of bremelanotide, which stimulates sexual response[4].
Claims of the Patent
Independent Claims
The patent contains independent claims that define the scope of the invention. These claims include:
- The composition of bremelanotide and its salts.
- Methods for administering bremelanotide to stimulate sexual response.
- Specific formulations and delivery methods, such as injections and sprays[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, including the dosage forms, administration routes, and the effects of the treatment on sexual response.
Patent Landscape
Related Patents
In addition to U.S. Patent 6,794,489, Palatin Technologies holds other patents related to the treatment of sexual dysfunction with Vyleesi. These include U.S. patents 10,286,034, 9,700,592, and 9,352,013, which cover methods of treatment and have terms extending until November 2033[1].
Patent Term Extension
The patent term extension for U.S. Patent 6,794,489 was granted under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This extension compensates for the time lost during drug development and FDA regulatory review, allowing the patent to expire on June 25, 2025, instead of the original date of June 25, 2020[1].
Patent Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can indicate the breadth and clarity of a patent. Narrower claims, as seen in the examination process, are associated with a higher probability of grant and a shorter examination process. This implies that the claims in U.S. Patent 6,794,489, which have been refined during the examination process, are likely to be clear and specific[3].
Impact on Innovation
Licensing and Litigation
The clarity and specificity of the claims in U.S. Patent 6,794,489 can influence licensing and litigation costs. Clear and valid patents reduce the likelihood of costly legal disputes and make it easier for other companies to understand what is protected, thereby promoting innovation in the field of sexual dysfunction treatments[3].
Industry Expert Insights
Industry experts often emphasize the importance of well-defined patent claims for fostering innovation. For example, "Clear and valid patents are essential for encouraging investment in research and development. They provide a clear roadmap for what is protected and what is not, reducing the risk of litigation and facilitating collaboration," notes a patent law expert.
Statistics and Examples
- Patent Term Extension: The five-year extension granted to U.S. Patent 6,794,489 is a significant example of how the Hatch-Waxman Amendments can impact the patent landscape, allowing companies to recoup time lost during regulatory processes[1].
- Market Impact: Vyleesi, the drug covered by this patent, has been approved by the FDA for the treatment of HSDD in premenopausal women, demonstrating the practical application and market impact of this patent[1].
Global Patent System
Global Dossier and Common Citation Document
Tools like the Global Dossier and the Common Citation Document (CCD) facilitate the integration of global patent systems. These resources allow users to access file histories and citation data for related applications across different IP offices, enhancing the efficiency of patent searches and ensuring consistency in patent examination processes[5].
Public Search Resources
USPTO Public Search Facility
The USPTO provides various resources for public patent searches, including the Patent Public Search tool, which replaced legacy search tools like PubEast and PubWest. These resources enable comprehensive searches of prior art and related patent documentation[5].
Key Takeaways
- Patent Scope: U.S. Patent 6,794,489 covers the composition of bremelanotide and methods for treating sexual dysfunction.
- Claims: The patent includes claims for the composition of matter and methods of treatment.
- Patent Term Extension: The patent term has been extended to June 25, 2025, under the Hatch-Waxman Amendments.
- Related Patents: Other patents held by Palatin Technologies extend the protection for Vyleesi until November 2033.
- Impact on Innovation: Clear and valid patents reduce licensing and litigation costs, promoting innovation.
FAQs
What is the main subject of U.S. Patent 6,794,489?
The main subject of U.S. Patent 6,794,489 is the composition of bremelanotide and methods for treating sexual dysfunction.
Who is the assignee of U.S. Patent 6,794,489?
The assignee of U.S. Patent 6,794,489 is Palatin Technologies, Inc.
What is the expiration date of U.S. Patent 6,794,489 after the extension?
The expiration date of U.S. Patent 6,794,489 after the extension is June 25, 2025.
What other patents does Palatin Technologies hold related to Vyleesi?
Palatin Technologies holds other patents, including U.S. patents 10,286,034, 9,700,592, and 9,352,013, which cover methods of treatment and have terms extending until November 2033.
How does the Hatch-Waxman Amendments impact the patent term?
The Hatch-Waxman Amendments allow for a patent term extension of up to five years to compensate for time lost during drug development and FDA regulatory review.
Sources
- Palatin Announces U.S. Patent Term Extension for Vyleesi (bremelanotide injection) - PR Newswire
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims and Patent Scope - Hoover Institution
- US6794489B2 - Compositions and methods for treatment of sexual dysfunction - Google Patents
- Search for patents - USPTO
