United States Patent 8,846,100: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,846,100, titled "Controlled Dose Drug Delivery System," was issued on September 30, 2014, to Shojaei et al. and is owned by Shire LLC. This patent is crucial in the field of pharmaceuticals, particularly for the delivery of amphetamine salts. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
The patent describes a controlled dose drug delivery system designed for the administration of pharmaceutically active amphetamine salts. This system is engineered to provide a sustained release of the drug, which is particularly beneficial for treating conditions such as Attention Deficit Hyperactivity Disorder (ADHD)[2].
Key Components
- The system includes a core containing the amphetamine salt, which is then coated with a release-controlling layer.
- The coating is designed to regulate the release of the drug over a specified period, ensuring a consistent therapeutic effect.
- The patent also covers various modifications to the pharmaceutical composition to achieve the desired release profile[5].
Claims of the Patent
The patent includes 31 claims that define the scope of the invention. Here are some key aspects:
Independent Claims
- Claim 1 describes the basic structure of the controlled dose drug delivery system, including the core and the release-controlling layer.
- Dependent claims (2-4, 13-21, and 31) detail specific modifications and variations to the composition and the coating layer to achieve different release profiles[1].
Anticipation and Obviousness
The patent has faced challenges regarding its validity, particularly in the context of prior art. For instance, the '819 patent (U.S. Patent No. 6,322,819) has been cited as potentially anticipating several claims of the '100 patent. The '819 patent discloses similar elements of a controlled release system, which could render some claims of the '100 patent unpatentable[1].
Patent Landscape Analysis
Understanding the patent landscape is crucial for navigating the complexities of intellectual property in the pharmaceutical sector.
Saturation of the Patent Space
The area of controlled dose drug delivery systems is highly saturated with numerous patents and ongoing research. A comprehensive patent landscape analysis reveals a dense field with many existing and pending patents, making it challenging to secure new claims without infringing on prior art[3].
Competitor Analysis
Companies like Shire LLC, Teva Pharmaceuticals, and Purdue Pharma are key players in this space. Shire LLC, in particular, has a significant portfolio related to ADHD treatments and controlled release systems. Teva Pharmaceuticals, with its extensive generics business, also poses a significant competitive threat in this arena[2].
Strategic Insights
A thorough patent landscape analysis helps in identifying opportunities and risks. For instance, it can reveal areas where the technology is mature and highly patented, suggesting the need to pivot to newer inventive spaces. This analysis also highlights competitors' focus areas and potential gaps in the market that can be exploited[3].
Litigation and Enforcement
The '100 patent has been involved in several legal disputes, particularly regarding patent infringement.
Shire LLC vs. Teva Pharmaceuticals
Shire LLC has filed complaints against Teva Pharmaceuticals and its affiliates for alleged infringement of the '100 patent, along with other related patents. These lawsuits underscore the importance of protecting intellectual property in a competitive market[2].
Impact on Pharmaceutical Development
The '100 patent and similar inventions have a significant impact on the development of pharmaceutical products.
Innovation and Competition
Patents like the '100 patent drive innovation by protecting the intellectual property of companies, allowing them to invest in research and development. However, they also create barriers to entry for generic manufacturers, which can affect the availability and affordability of drugs[3].
Regulatory Considerations
The FDA's approval process and the listing of patents in the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) are critical for the commercialization of these products. The '100 patent is listed in the FDA's publication, which affects the ability of generic manufacturers to enter the market[2].
Conclusion
The United States Patent 8,846,100 is a pivotal invention in the field of controlled dose drug delivery systems, particularly for ADHD treatments. Understanding its scope, claims, and the broader patent landscape is essential for navigating the complex intellectual property landscape in pharmaceuticals.
Key Takeaways
- The patent describes a controlled dose drug delivery system for amphetamine salts.
- It includes 31 claims that define the scope of the invention.
- The patent has faced challenges regarding its validity due to prior art.
- The patent landscape is highly saturated, making it challenging to secure new claims.
- Litigation and enforcement are critical for protecting intellectual property.
- The patent has a significant impact on pharmaceutical development and innovation.
FAQs
What is the main purpose of the United States Patent 8,846,100?
The main purpose of the patent is to describe a controlled dose drug delivery system designed for the administration of pharmaceutically active amphetamine salts, particularly for treating ADHD.
Which companies are involved in the litigation related to this patent?
Shire LLC and Teva Pharmaceuticals are key companies involved in the litigation related to this patent.
How does the patent landscape analysis impact the development of new pharmaceutical products?
A patent landscape analysis helps in identifying highly saturated areas, guiding companies to pivot to newer inventive spaces, and revealing competitors' focus areas and potential market gaps.
What is the significance of the FDA's Orange Book in relation to this patent?
The FDA's Orange Book lists approved drug products with their associated patents. The inclusion of the '100 patent in this book affects the ability of generic manufacturers to enter the market.
How does the '819 patent impact the validity of the '100 patent?
The '819 patent has been cited as potentially anticipating several claims of the '100 patent, which could render some claims of the '100 patent unpatentable.
