Detailed Analysis of the Scope and Claims of United States Patent 7,151,103
Introduction
United States Patent 7,151,103, titled "Method of treating female hypoactive sexual desire disorder with flibanserin," is a significant patent in the field of pharmaceuticals, particularly for the treatment of female sexual dysfunction. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes the use of flibanserin, or its pharmaceutically acceptable acid addition salts, for the treatment of female hypoactive sexual desire disorder (HSDD). Flibanserin is known by its brand name Addyi and is the first FDA-approved medication for this condition[4].
Prior Art and Background
The invention builds upon previous research and patents related to flibanserin and its applications. The patent cites various prior art documents, including earlier patents and scientific studies, to establish the novelty and non-obviousness of the claimed method[4].
Scope of the Patent
Claims Analysis
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Independent Claims: The patent has several independent claims that outline the method of treating HSDD using flibanserin. For example, Claim 1 specifies the administration of flibanserin or its acid addition salts to treat HSDD in premenopausal women[4].
- Dependent Claims: Dependent claims further specify the dosage, mode of administration, and other aspects of the treatment method. These claims provide additional details that narrow down the scope but are still encompassed within the broader independent claims[4].
Claim Metrics
To understand the patent scope, metrics such as independent claim length (ICL) and independent claim count (ICC) can be useful. These metrics indicate the complexity and breadth of the patent claims. For US7151103B2, the independent claims are relatively detailed, reflecting a specific method of treatment rather than a broad, generic approach[3].
Patent Claims and Scope
Independent Claim Length
The independent claims in this patent are moderately lengthy, indicating a clear and specific description of the method. This length suggests that the patent is focused on a particular application of flibanserin rather than a broad range of uses[3].
Independent Claim Count
The patent includes multiple independent claims, each focusing on different aspects of the treatment method. This multiplicity indicates a comprehensive approach to covering various scenarios and ensuring broad protection for the invention[4].
Patent Landscape
Related Patents
Several patents are related to the use of flibanserin, each covering different aspects such as the stable polymorph of flibanserin, methods of treating sexual desire disorders, and other specific applications.
- US7420057: This patent, which has expired, covered the stable polymorph of flibanserin. The expiration of this patent does not directly impact the validity of US7151103B2 but indicates that certain aspects of flibanserin's formulation are no longer under patent protection[2].
- US8227471 and US9468639: These patents, which have also expired, were related to treating sexual desire disorders with flibanserin. Their expiration suggests that while some methods of treatment may no longer be patented, the specific method described in US7151103B2 remains protected[2].
Patent Expiration Dates
The patent US7151103B2 is set to expire on May 9, 2028. This expiration date is crucial for understanding when generic versions of Addyi might become available. Currently, there is no generic version of Addyi approved in the United States[5].
Generic Availability
As of now, there is no therapeutically equivalent generic version of Addyi available in the U.S. market. The expiration of the patent in 2028 will likely pave the way for generic manufacturers to develop and market their own versions of flibanserin[5].
Impact on Innovation and Competition
Patent Quality and Scope
The debate around patent quality often centers on the breadth and clarity of patent claims. Narrower claims, like those in US7151103B2, are generally associated with higher patent quality and a shorter examination process. This specificity helps in reducing litigation costs and encourages innovation by providing clear boundaries for what is protected[3].
Litigation and Licensing
The specific and well-defined claims in this patent reduce the likelihood of costly litigation and licensing disputes. This clarity is beneficial for both the patent holder and potential competitors, as it sets clear expectations for what is protected and what is not[3].
Key Takeaways
- Specific Method of Treatment: The patent protects a specific method of treating female hypoactive sexual desire disorder using flibanserin.
- Expiration Date: The patent is set to expire on May 9, 2028, after which generic versions may become available.
- Related Patents: Other patents related to flibanserin have expired, but they do not impact the validity of US7151103B2.
- Patent Quality: The patent's specific claims contribute to higher patent quality and reduce the likelihood of litigation.
FAQs
What is the main subject of United States Patent 7,151,103?
The main subject is the method of treating female hypoactive sexual desire disorder (HSDD) using flibanserin.
When is the patent set to expire?
The patent is set to expire on May 9, 2028.
Are there any generic versions of Addyi available?
No, there are currently no therapeutically equivalent generic versions of Addyi available in the United States.
How does the specificity of the patent claims impact innovation?
The specificity of the claims reduces the likelihood of costly litigation and licensing disputes, encouraging innovation by providing clear boundaries for what is protected.
What are the implications of related patents expiring?
The expiration of related patents does not directly impact the validity of US7151103B2 but indicates that certain aspects of flibanserin's formulation or other methods of treatment may no longer be under patent protection.
Sources
- United States Patent and Trademark Office. Diagnosis of Hypoactive Sexual Desire Disorder in Women, US10874668B2.
- Pharsight. Addyi patent expiration, https://pharsight.greyb.com/drug/addyi-patent-expiration.
- Hoover Institution. Patent Claims and Patent Scope, https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf.
- Google Patents. Method of treating female hypoactive sexual desire disorder with flibanserin, US7151103B2.
- Drugs.com. Generic Addyi Availability, https://www.drugs.com/availability/generic-addyi.html.
