United States Patent 10,617,696: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,617,696, titled "Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same," was granted to Clarus Therapeutics in April 2020. This patent is significant in the field of pharmaceuticals, particularly for the treatment of testosterone deficiency. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Details
- Publication Number: US10617696B2
- Grant Date: April 2020
- Assignee: Clarus Therapeutics
- Prior Art Date: Reflects the earliest filing date of the patent application, which is crucial for determining the patent's validity and scope[2].
Scope of the Patent
The patent covers oral testosterone ester formulations and methods for treating testosterone deficiency. Here are the key aspects of the scope:
Formulations
- The patent describes specific formulations of testosterone undecanoate, which is an oral testosterone ester. These formulations are designed to improve the bioavailability and efficacy of testosterone when administered orally[2].
Methods of Treatment
- The methods outlined in the patent involve the use of these oral formulations to treat symptoms associated with testosterone deficiency. This includes improving serum testosterone levels, which is essential for various physiological functions[2].
Claims of the Patent
The claims section is critical as it defines the legal boundaries of the invention.
Independent Claims
- The patent includes several independent claims that describe the composition of the oral testosterone ester formulations and the methods of using these formulations to treat testosterone deficiency. For example, Claim 1 might describe a specific formulation of testosterone undecanoate in a particular carrier oil[2].
Dependent Claims
- Dependent claims further specify the independent claims, often detailing specific aspects such as dosage, administration routes, and additional components of the formulation. These claims help to narrow down the scope and provide additional protection for the invention[2].
Classification and Categorization
The patent is classified under various categories within the International Patent Classification (IPC) system.
IPC Classification
- The patent falls under the A61K category, which pertains to "Preparations for medical, dental, or toilet purposes." More specifically, it is classified under A61K31/568, which includes compounds containing cyclopenta[a]hydrophenanthrene ring systems, such as steroids[2].
Patent Landscape
Understanding the patent landscape is essential for assessing the novelty, non-obviousness, and potential impact of the invention.
Global Patent Family
- The patent is part of a global patent family, which can be accessed through services like the Global Dossier provided by the USPTO. This allows users to see related applications filed at participating IP Offices, including the dossier, classification, and citation data[1].
Prior Art and Citations
- The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].
Competing Patents
- The patent landscape in the field of testosterone treatments is quite active. Other patents and patent applications related to testosterone formulations and treatments need to be considered to understand the competitive environment. Tools like PatentsView and patent landscape reports from WIPO can provide insights into the state of the art in this field[4].
Search and Analysis Tools
Several tools and resources are available for searching and analyzing patents, which are crucial for understanding the patent landscape.
USPTO Resources
- The USPTO offers the Patent Public Search tool, which provides enhanced access to prior art. Additionally, resources like the Patent and Trademark Resource Centers (PTRCs) and the Public Search Facility in Alexandria, VA, offer trained staff and various search resources[1].
International Databases
- Databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), provide access to global patent collections. These resources are essential for a comprehensive patent search[1].
Economic and Research Implications
The patent claims and scope can have significant economic and research implications.
Patent Claims Research Dataset
- The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents and patent applications. This dataset can be used to analyze trends in patent scope and claims, which is valuable for researchers and economists[3].
Market Impact
- The grant of this patent can influence the market for testosterone treatments by providing a new oral formulation that may offer advantages over existing treatments. This can lead to increased competition and innovation in the pharmaceutical industry.
Key Takeaways
- Patent Scope: The patent covers specific oral testosterone ester formulations and methods for treating testosterone deficiency.
- Claims: The claims define the composition and methods of use, with both independent and dependent claims providing detailed protection.
- Classification: Classified under A61K, particularly A61K31/568, within the IPC system.
- Patent Landscape: Part of a global patent family with prior art and citations consolidated through tools like the Global Dossier and CCD.
- Search and Analysis: Utilize USPTO resources and international databases for comprehensive patent searches.
- Economic and Research Implications: Significant for market competition and innovation, with datasets available for analyzing patent trends.
FAQs
What is the main subject of United States Patent 10,617,696?
The main subject is oral testosterone ester formulations and methods for treating testosterone deficiency.
Who is the assignee of this patent?
The assignee is Clarus Therapeutics.
How can one access the global patent family for this patent?
Through the Global Dossier service provided by the USPTO.
What classification does this patent fall under in the IPC system?
It falls under A61K, specifically A61K31/568.
What tools are available for searching and analyzing patents related to this invention?
Tools include the USPTO's Patent Public Search, PTRCs, and international databases like those from the EPO, JPO, and WIPO.
How does this patent impact the market for testosterone treatments?
It can increase competition and innovation by providing a new oral formulation with potential advantages over existing treatments.
Sources
- USPTO - Search for patents
- Google Patents - US10617696B2
- USPTO - Patent Claims Research Dataset
- Brown University Library Guides - Patents
