United States Patent 9,352,013: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,352,013, titled "Uses of bremelanotide in therapy for female sexual dysfunction," is a significant patent that addresses a critical area in women's health. This patent, granted to Palatin Technologies, Inc., focuses on the therapeutic use of bremelanotide, a peptide melanocortin receptor agonist, for treating female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).
Background on Female Sexual Dysfunction
Female sexual dysfunction, including FSAD and HSDD, affects a substantial portion of the female population. Approximately 43% of adult women in the United States experience some form of these disorders, highlighting the need for effective treatments[1].
Patent Overview
Patent Number and Classification
The patent number is US9352013B2, classified under the United States Patent and Trademark Office (USPTO) system. It falls under the category of utility patents, which are the most common type of patent application filed with the USPTO[2].
Filing and Grant Date
The patent was filed as a non-provisional application, which is a complete patent application that includes all the necessary documents, drawings, and fees. The filing date and grant date are crucial for determining the patent term, which is generally 20 years from the filing date of the non-provisional application[2].
Inventor and Assignee
The patent is assigned to Palatin Technologies, Inc., a company that has been at the forefront of developing treatments for sexual dysfunction. The inventors listed on the patent are key researchers who have contributed to the development of bremelanotide as a therapeutic agent.
Scope of the Patent
Claims
The claims in a patent application are essential as they define the scope of the patent's protection. For US9352013B2, the claims include various methods and compositions related to the use of bremelanotide for treating female sexual dysfunction. These claims specify the dosage, administration routes (such as subcutaneous injection), and the therapeutic effects of bremelanotide on FSAD and HSDD[1].
Therapeutic Use
The patent details the therapeutic use of bremelanotide, emphasizing its role in enhancing sexual arousal and desire in women. It includes data on the efficacy and safety of bremelanotide, which is crucial for regulatory approval and clinical use.
Claims Analysis
Method Claims
The method claims outline the specific procedures for administering bremelanotide, including the dosage regimen and the timing of administration. These claims are critical for ensuring that the patented method is distinct from existing treatments and provides a novel approach to treating female sexual dysfunction[1].
Composition Claims
The composition claims describe the formulation of bremelanotide, including the active ingredient, excipients, and any other components. These claims ensure that the patented composition is unique and not anticipated by prior art[1].
Patent Landscape
Prior Art
To secure a patent, the invention must be novel, non-obvious, and useful. The prior art search, which involves reviewing existing patents and publications, is a crucial step in the patent application process. For US9352013B2, the prior art search would have included examining existing treatments for female sexual dysfunction and ensuring that bremelanotide's use as described in the patent is not anticipated by earlier disclosures[2].
Related Patents
The patent landscape includes other patents related to the treatment of female sexual dysfunction. These may include patents on other therapeutic agents or methods that could potentially compete with or complement bremelanotide. Understanding this landscape is essential for strategic planning and potential collaborations or licensing agreements[4].
Economic and Regulatory Impact
Market Potential
The patent on bremelanotide has significant market potential given the prevalence of female sexual dysfunction. The approval and commercialization of this treatment could provide a substantial revenue stream for Palatin Technologies, Inc., and improve the quality of life for millions of women[1].
Regulatory Approval
The patent's claims and data support regulatory approval processes. Regulatory bodies such as the FDA review the efficacy, safety, and manufacturing process of the drug before granting approval. The patent's detailed claims and supporting data are crucial for this process[2].
Legal and Intellectual Property Considerations
Patent Term
The patent term for US9352013B2 is 20 years from the filing date of the non-provisional application. During this period, Palatin Technologies, Inc. has the exclusive right to make, use, offer for sale, sell, or import the invention in the United States[2].
Enforcement and Litigation
The patent holder must enforce the patent to prevent infringement. This involves monitoring for unauthorized use and taking legal action if necessary. The claims defined in the patent are the basis for any infringement claims and are crucial for defending the patent in litigation[2].
Conclusion
United States Patent 9,352,013 represents a significant advancement in the treatment of female sexual dysfunction. The patent's scope, defined by its claims, ensures that Palatin Technologies, Inc. has exclusive rights to the therapeutic use of bremelanotide for FSAD and HSDD. Understanding the patent landscape, regulatory environment, and economic potential is essential for maximizing the value of this patent.
Key Takeaways
- Therapeutic Use: The patent focuses on the use of bremelanotide for treating female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).
- Claims: The patent includes method and composition claims that define the scope of protection.
- Patent Landscape: The patent is part of a broader landscape of treatments for female sexual dysfunction.
- Regulatory Impact: The patent supports regulatory approval processes and has significant market potential.
- Legal Considerations: The patent term is 20 years, and enforcement is crucial to prevent infringement.
FAQs
Q: What is the primary focus of United States Patent 9,352,013?
A: The primary focus is the therapeutic use of bremelanotide for treating female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).
Q: Who is the assignee of the patent?
A: The patent is assigned to Palatin Technologies, Inc.
Q: What is the significance of the claims in the patent?
A: The claims define the scope of the patent's protection and ensure that the patented method and composition are distinct from existing treatments.
Q: How long is the patent term for US9352013B2?
A: The patent term is 20 years from the filing date of the non-provisional application.
Q: What is the importance of prior art search in the patent application process?
A: The prior art search ensures that the invention is novel, non-obvious, and not anticipated by earlier disclosures.
Sources
- US9352013B2 - Uses of bremelanotide in therapy for female sexual dysfunction - Google Patents
- Patents | The Maryland People's Law Library
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
