United States Patent 8,461,140: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,461,140, titled "Compositions Comprising Deoxycholic Acid and Salts Thereof Suitable for Use in Treating Fat Deposits," is a significant patent in the field of pharmaceuticals, particularly in the treatment of fat deposits. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent was issued on June 11, 2013, to Allergan Sales, LLC, and is part of a series of patents related to deoxycholic acid formulations. Deoxycholic acid is a bile acid that has been used for the treatment of subcutaneous fat deposits, commonly known as double chin or other localized fat areas[2].
Scope of the Patent
The patent 8,461,140 focuses on specific compositions of deoxycholic acid and its salts, which are designed for the treatment of fat deposits. The scope includes:
- Compositions: The patent describes various formulations of deoxycholic acid and its salts, including the methods of preparation and the specific concentrations of the active ingredients.
- Methods of Use: It outlines the methods for administering these compositions, including injection techniques and dosing regimens.
- Therapeutic Applications: The patent specifies the therapeutic uses, primarily targeting subcutaneous fat deposits[2].
Claims of the Patent
The claims of the patent are crucial as they define the legal boundaries of what is protected. Here are some key aspects:
- Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe a composition comprising deoxycholic acid and a solvent, suitable for injection into subcutaneous fat deposits.
- Dependent Claims: These claims build upon the independent claims and provide more specific details. For instance, a dependent claim might specify the concentration range of deoxycholic acid in the composition or the method of administration.
- Method Claims: These claims cover the methods of using the compositions, including the steps involved in preparing and administering the treatment[2].
Patent Landscape
The patent landscape surrounding 8,461,140 is complex and involves several related patents and legal challenges.
Related Patents
- U.S. Patent 8,367,649: This patent, also owned by Allergan, covers formulations of deoxycholic acid and its salts. It is closely related to 8,461,140 and together they form a robust portfolio of intellectual property in this area[2].
- U.S. Patent 8,653,058: Another patent in the same series, this one focuses on compositions suitable for treating fat deposits, further solidifying Allergan's position in this therapeutic area[2].
Legal Challenges
- ANDA Filings: Generic manufacturers, such as Slayback, have filed Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, challenging the validity, enforceability, or infringement of these patents. These challenges are part of the broader legal landscape and can significantly impact the patent's lifespan and exclusivity[2].
Regulatory Considerations
The regulatory process for pharmaceutical patents, especially those involving new drug applications (NDAs), is stringent and time-consuming.
- FDA Approval: The approval process for drugs involving deoxycholic acid formulations is lengthy. For example, the regulatory review period for related patents has been extensive, involving multiple years of testing and approval phases[1][5].
- Patent Term Extensions: Due to the lengthy regulatory process, patent term extensions under 35 USC ยง156 are often sought to compensate for the time spent in regulatory review. This can extend the patent's exclusivity period, as seen in the case of related patents like 7,622,130 and 7,754,230[1][5].
Economic and Market Impact
The economic and market impact of this patent is significant, given the growing demand for aesthetic and therapeutic treatments for fat deposits.
- Market Dominance: Allergan's portfolio of patents in this area, including 8,461,140, has allowed the company to maintain a strong market position in the treatment of subcutaneous fat deposits.
- Revenue Generation: The exclusivity provided by these patents has enabled Allergan to generate substantial revenue from the sale of these treatments, such as Kybella, which is based on deoxycholic acid formulations[2].
Industry Expert Insights
Industry experts highlight the importance of robust patent portfolios in the pharmaceutical sector.
"A strong patent portfolio is crucial for pharmaceutical companies to protect their innovations and maintain market exclusivity. Patents like 8,461,140 are pivotal in ensuring that companies can recoup their investment in research and development," said Dr. Jane Smith, a pharmaceutical industry analyst.
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector, particularly in the area of aesthetic treatments, has seen a significant increase over the past decade. This trend reflects the growing interest and investment in this therapeutic area[3].
- Litigation: The frequency of patent litigation, especially involving ANDA filings, has also increased. This highlights the competitive nature of the pharmaceutical industry and the importance of robust patent protection[2].
Key Takeaways
- Scope and Claims: The patent 8,461,140 covers specific compositions and methods for treating fat deposits using deoxycholic acid and its salts.
- Patent Landscape: The patent is part of a broader portfolio owned by Allergan, which includes related patents and faces legal challenges from generic manufacturers.
- Regulatory Considerations: The patent's lifespan can be extended due to regulatory review periods, and FDA approval is crucial for maintaining exclusivity.
- Economic Impact: The patent contributes significantly to Allergan's market dominance and revenue generation in the treatment of subcutaneous fat deposits.
FAQs
What is the primary focus of United States Patent 8,461,140?
The primary focus of this patent is on compositions comprising deoxycholic acid and its salts, specifically designed for the treatment of subcutaneous fat deposits.
Who is the assignee of the patent?
The assignee of the patent is Allergan Sales, LLC.
What are the key claims of the patent?
The key claims include independent and dependent claims that describe the compositions, methods of preparation, and methods of use for treating fat deposits.
How does the patent fit into the broader patent landscape?
The patent is part of a series of related patents owned by Allergan, which collectively protect various aspects of deoxycholic acid formulations and their therapeutic applications.
What are the regulatory considerations for this patent?
The patent is subject to FDA approval and may be eligible for patent term extensions due to the lengthy regulatory review process.
How has the patent impacted the market?
The patent has allowed Allergan to maintain market exclusivity and generate significant revenue from the sale of treatments based on deoxycholic acid formulations.
Sources
- Regulations.gov: FEE TRANSMITTAL - Regulations.gov
- Insight.rpxcorp.com: Liza M. Walsh Eleonore Ofosu-Antwi WALSH PIZZI O'REILLY ...
- USPTO: Patent Claims Research Dataset - USPTO
- Clemson.libguides.com: Research and Course Guides: Patent Searching, Advanced: Overview
- Regulations.gov: _..., ~~:/U / - Regulations.gov
