United States Patent 7,754,230: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,754,230, titled "Methods and Related Compositions for Reduction of Fat," was issued on July 13, 2010, to inventors Michael S. Kolodney and Adam M. Rotunda. This patent is significant in the medical and pharmaceutical fields, particularly for the treatment of submental fat. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Title and Inventors
The patent, titled "Methods and Related Compositions for Reduction of Fat," was invented by Michael S. Kolodney and Adam M. Rotunda. It is associated with the product KYBELLA®, a drug used for the reduction of moderate to severe submental fat (double chin)[2].
Issue and Expiration Dates
The patent was issued on July 13, 2010, and is set to expire on December 10, 2027. An application for a patent term extension was submitted under 35 USC §156, which could potentially extend the patent term by 506 days[1].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Key claims include methods for using deoxycholic acid to reduce fat, as well as compositions containing deoxycholic acid for this purpose. Claims 1 and 2 are particularly significant as they read on the approved product, KYBELLA®[1].
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth and clarity of patents. While specific details on the length and count of independent claims for this patent are not provided, these metrics are crucial in assessing the patent's scope and potential for litigation or licensing issues[3].
Regulatory Review and Patent Term Extension
Regulatory Review Period
The regulatory review period for this patent began on December 5, 2007, with the full approval of the Investigational New Drug (IND) application and ended with the filing of the New Drug Application (NDA) on May 12, 2014. The approval phase started on May 13, 2014, and concluded with the NDA approval on April 29, 2015. This period is critical for determining the patent term extension[1].
Patent Term Extension Application
The applicant submitted an application for a patent term extension under 35 USC §156, citing the regulatory review period and the diligence of the marketing applicant during this time. The requested extension is 506 days, calculated based on the testing and approval phases[1].
Patent Landscape
Technological Classification
The patent falls under the classification related to pharmaceutical and medical treatments, specifically within the realm of dermatological and cosmetic procedures. It is classified under relevant International Patent Classification (IPC) technical fields, which help in understanding its technological context[4].
Industry Trends
In the broader context, patents related to pharmaceuticals and medical treatments have seen significant growth. The U.S. Patent and Trademark Office (USPTO) has granted a substantial number of patents in these fields, reflecting the ongoing innovation in healthcare and medical sciences. The role of information and communication technologies (ICT) is also evident in the increasing number of patents in related fields[4].
Impact on Innovation
Patent Quality and Scope
The debate over patent quality and scope is relevant here. Patents with narrower claims tend to have a higher probability of grant and shorter examination processes, which can foster innovation by reducing litigation and licensing costs. The scope of this patent, defined by its claims, is crucial in determining its impact on the market and the incentives for further innovation[3].
Market and Commercial Significance
KYBELLA®
KYBELLA®, the product associated with this patent, has been approved by the FDA for the reduction of submental fat. This approval and the subsequent market presence of KYBELLA® underscore the commercial significance of the patent. The product's success can be attributed to the innovative method and composition described in the patent[2].
Legal and Regulatory Aspects
Patent Term Extension
The application for a patent term extension highlights the regulatory and legal complexities surrounding patents. The extension, if granted, would allow the patent holder to maintain exclusive rights for a longer period, which can impact market competition and innovation in the field[1].
Key Takeaways
- Patent Scope and Claims: The patent includes specific claims related to methods and compositions for fat reduction, with claims 1 and 2 being particularly significant.
- Regulatory Review: The regulatory review period and the diligence of the applicant during this period are crucial for the patent term extension application.
- Technological Classification: The patent is classified under relevant IPC technical fields, reflecting its technological context.
- Industry Trends: The patent is part of a larger trend in pharmaceutical and medical innovation.
- Impact on Innovation: The scope and quality of the patent influence its impact on market incentives and innovation.
FAQs
What is the main subject of United States Patent 7,754,230?
The main subject of United States Patent 7,754,230 is methods and related compositions for the reduction of fat, specifically submental fat.
Who are the inventors of this patent?
The inventors of this patent are Michael S. Kolodney and Adam M. Rotunda.
What product is associated with this patent?
The product associated with this patent is KYBELLA®, a drug approved by the FDA for reducing submental fat.
Why was a patent term extension application submitted for this patent?
A patent term extension application was submitted to account for the time spent in regulatory review, which could extend the patent term by 506 days.
How does the scope of this patent impact innovation?
The scope of this patent, defined by its claims, can influence innovation by affecting licensing and litigation costs. Narrower claims generally lead to higher probabilities of grant and shorter examination processes, fostering innovation.
