United States Patent 8,546,367: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,546,367, titled "Compositions Comprising Deoxycholic Acid and Salts Thereof Suitable for Use in Treating Fat Deposits," is a significant patent in the pharmaceutical industry, particularly in the field of cosmetic and medical treatments for fat reduction. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Description
The patent, issued on October 1, 2013, pertains to compositions containing deoxycholic acid and its salts, which are used for treating fat deposits. Deoxycholic acid is a bile acid that has been used in medical and cosmetic procedures to dissolve fat cells[2].
Assignee and Ownership
The patent is assigned to Allergan Sales, LLC, which is the owner of all rights, title, and interest in the patent. This assignment indicates that Allergan has full control over the patent's enforcement and licensing[2].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Composition Claims: These claims describe the specific compositions of deoxycholic acid and its salts, along with any additional components that may be included in the formulation[2].
- Use Claims: These claims specify the intended use of the compositions, which is for treating fat deposits. This includes methods of administration and the therapeutic effects expected[2].
Examples of Claims
For instance, claim 1 of the patent might describe a composition comprising deoxycholic acid or a salt thereof, while claim 2 might specify the method of using this composition to treat submental fat (double chin)[2].
Patent Claims and Scope
Detailed Analysis of Claims
The claims of the patent are crucial as they define the legal boundaries of the invention. Here’s a breakdown:
- Independent Claims: These are the main claims that stand alone and define the core invention. For example, claim 1 might describe the composition itself.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, claim 2 might depend on claim 1 and specify a particular method of use[3].
Patent Scope Measurements
The scope of the patent can be measured using various metrics, such as those provided by the USPTO's Patent Claims Research Dataset. This dataset includes detailed information on claims from U.S. patents and can help in understanding the breadth and depth of the patent claims[3].
Patent Landscape
Related Patents
The patent 8,546,367 is part of a larger family of patents related to deoxycholic acid and its applications. Other patents in this family include U.S. Patent Nos. 8,367,649, 8,653,058, and others, which collectively cover various aspects of formulations, compositions, and methods of use[2].
Global Dossier and Patent Family
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This service helps in understanding the global patent family for a specific application, including the dossier, classification, and citation data for these applications[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by all participating offices for the family members of a patent application. This tool is useful for visualizing the search results for the same invention produced by several offices on a single page, which can be particularly relevant for understanding the broader patent landscape surrounding U.S. Patent 8,546,367[1].
Litigation and Enforcement
Patent Infringement Litigation
The patent has been involved in several litigation cases, particularly with generic drug manufacturers. For example, Slayback Pharma Inc. submitted an Abbreviated New Drug Application (ANDA) that included a Paragraph IV Certification, alleging that the patent was invalid, unenforceable, or would not be infringed by their product. This led to legal disputes where the validity and enforceability of the patent were challenged[2].
Office Actions and Patent Quality
The USPTO's Enhanced Patent Quality Initiative plays a crucial role in ensuring the quality of patents like 8,546,367. This initiative includes measures such as consistent definitions of patent quality, reassessment of examination time, and analysis of incentives on patent quality. These efforts help in maintaining the integrity and enforceability of patents[4].
Economic and Market Impact
Market Domination
Patents like 8,546,367 can significantly impact the market by granting exclusive rights to the patent holder. In this case, Allergan's control over the patent for deoxycholic acid compositions allows them to dominate the market for treatments like Kybella®, which is used for reducing submental fat[2].
Economic Research
The USPTO's economic research datasets provide insights into the economic impact of patents. For instance, the Patent Claims Research Dataset can help in analyzing the scope and breadth of patent claims and their impact on innovation and competition[3].
Key Takeaways
- Patent Scope and Claims: The patent 8,546,367 has specific claims that define its scope, including composition and use claims.
- Patent Landscape: It is part of a larger family of patents related to deoxycholic acid and is influenced by global patent systems and tools like the Global Dossier and CCD.
- Litigation and Enforcement: The patent has been involved in litigation, particularly with generic drug manufacturers, and its validity and enforceability have been challenged.
- Market Impact: The patent grants Allergan exclusive rights, allowing them to dominate the market for treatments like Kybella®.
FAQs
What is the main subject of U.S. Patent 8,546,367?
The main subject of U.S. Patent 8,546,367 is compositions comprising deoxycholic acid and its salts, used for treating fat deposits.
Who is the assignee of the patent?
The assignee of the patent is Allergan Sales, LLC.
What are some of the key claims in the patent?
The key claims include composition claims and use claims, specifying the formulation and the method of using deoxycholic acid to treat fat deposits.
How does the Global Dossier service relate to this patent?
The Global Dossier service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family.
What is the significance of the Common Citation Document (CCD) in this context?
The CCD consolidates prior art cited by all participating offices for the family members of a patent application, helping to visualize search results on a single page.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Insight.rpxcorp.com - Litigation documents: https://insight.rpxcorp.com/litigation_documents/13303628
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- GAO - Intellectual Property: Patent Office Should Define Quality, Reassess ...: https://www.gao.gov/products/gao-16-490
