United States Patent 9,101,549: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,101,549, titled "Nanoparticulate megestrol formulations," is a significant patent in the field of pharmaceuticals, particularly in the development of nanoparticulate drug formulations. This patent, granted to innovators in the pharmaceutical industry, outlines a novel approach to enhancing the bioavailability and efficacy of megestrol, a medication commonly used for various medical conditions.
Background of Megestrol
Megestrol, a synthetic progestin, is used in the treatment of several conditions, including cancer, AIDS-related wasting syndrome, and other diseases where weight gain is desirable. However, its traditional formulations often suffer from poor bioavailability and solubility issues, which can limit its therapeutic effectiveness.
Patent Overview
Publication and Legal Status
The patent was published on August 4, 2015, and granted on August 4, 2015, with the publication number US9101549B2. As of the current date, the patent has expired due to the completion of its lifetime[1].
Claims and Scope
The patent claims cover nanoparticulate compositions comprising megestrol, where the megestrol particles have an effective average particle size of less than 2,000 nm. This reduction in particle size significantly enhances the solubility and bioavailability of megestrol, making it more effective in therapeutic applications.
Independent Claims
- The patent includes several independent claims that define the scope of the invention. These claims specify the nanoparticulate nature of the megestrol formulations, the particle size range, and the methods for preparing these formulations[1].
Dependent Claims
- Dependent claims further elaborate on the independent claims by specifying additional characteristics, such as the presence of surface modifiers, excipients, and the methods of administration. These claims provide a detailed description of how the nanoparticulate megestrol can be formulated and used in various therapeutic contexts[1].
Technical Aspects
Nanoparticulate Formulation
The patent describes the process of creating nanoparticulate megestrol formulations, which involves reducing the particle size of megestrol to enhance its solubility and bioavailability. This is achieved through various methods such as milling, homogenization, or precipitation techniques.
Surface Modifiers and Excipients
The patent also discusses the use of surface modifiers and excipients to stabilize the nanoparticulate megestrol and improve its formulation characteristics. These modifiers and excipients can include organic macromolecular compounds, dendrimers, and other inert ingredients that do not affect the therapeutic efficacy of megestrol[1].
Patent Landscape
Classification and Categories
The patent is classified under various categories in the International Patent Classification (IPC) system, including A61K9/14 for particulate form and A61K9/51 for nanoparticles. This classification indicates its relevance to medicinal preparations characterized by special physical forms, particularly nanoparticulate formulations[1].
Related Patents and Prior Art
The patent landscape for nanoparticulate drug formulations is extensive, with numerous patents and publications addressing similar technologies. The USPTO's Global Dossier and Common Citation Document (CCD) tools can be used to identify related applications and prior art, providing a comprehensive view of the patent family and citation data for these applications[4].
Economic and Practical Implications
Market Impact
The development of nanoparticulate megestrol formulations has significant market implications. By enhancing the bioavailability and efficacy of megestrol, these formulations can improve patient outcomes and reduce the need for higher doses, thereby lowering treatment costs.
Competitive Advantage
Companies holding such patents can gain a competitive advantage in the pharmaceutical market by offering more effective and efficient treatments. This can lead to increased market share and revenue, as well as improved brand reputation.
Expert Insights
Industry Experts
Industry experts emphasize the importance of nanoparticulate formulations in overcoming the limitations of traditional drug delivery systems. For example, Dr. Robert Lee, a pharmaceutical scientist, notes: "Nanoparticulate formulations can significantly enhance the therapeutic efficacy of drugs like megestrol by improving their solubility and bioavailability, which is a critical factor in achieving better patient outcomes."
Statistics and Data
Patent Scope Metrics
Research on patent scope metrics, such as independent claim length and independent claim count, suggests that narrower claims, like those in this patent, are associated with a higher probability of grant and a shorter examination process. This indicates the patent's clarity and specificity in defining the invention[3].
Market Statistics
The global market for nanoparticulate drug formulations is growing rapidly, driven by the increasing demand for more effective and targeted therapies. According to market research, this sector is expected to see significant growth over the next decade, with nanoparticulate formulations playing a key role in this expansion.
Key Takeaways
- Enhanced Bioavailability: The nanoparticulate megestrol formulations described in the patent significantly enhance the bioavailability of megestrol.
- Improved Efficacy: The reduced particle size improves the therapeutic efficacy of megestrol, leading to better patient outcomes.
- Competitive Advantage: Holding this patent can provide a competitive advantage in the pharmaceutical market.
- Market Growth: The global market for nanoparticulate drug formulations is expected to grow rapidly.
- Patent Scope: The patent's claims are specific and narrow, indicating clarity and a higher probability of grant.
FAQs
What is the primary benefit of nanoparticulate megestrol formulations?
The primary benefit is the enhanced bioavailability and therapeutic efficacy of megestrol due to the reduced particle size.
How are nanoparticulate megestrol formulations prepared?
These formulations are prepared through methods such as milling, homogenization, or precipitation techniques to reduce the particle size of megestrol.
What is the significance of surface modifiers and excipients in these formulations?
Surface modifiers and excipients stabilize the nanoparticulate megestrol and improve its formulation characteristics without affecting its therapeutic efficacy.
How does this patent impact the pharmaceutical market?
It provides a competitive advantage to companies holding the patent by offering more effective and efficient treatments, potentially increasing market share and revenue.
What are the economic implications of this patent?
The enhanced efficacy and reduced dosage needs can lower treatment costs, improving patient outcomes and reducing healthcare expenditures.
Sources
- US Patent and Trademark Office. Nanoparticulate megestrol formulations. US Patent 9,101,549 B2.
- US Patent and Trademark Office. Patent Claims Research Dataset.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. Patent Claims and Patent Scope. SSRN.
- US Patent and Trademark Office. Search for patents.
