United States Patent 6,322,819: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,322,819, titled "Oral pulsed dose drug delivery system," is a significant patent in the pharmaceutical industry, particularly in the realm of drug delivery systems. This patent, held by Shire LLC, pertains to a multiple pulsed dose drug delivery system designed for pharmaceutically active amphetamine salts. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes a drug delivery system that combines immediate-release and delayed-release components. This system is designed to deliver pharmaceutically active amphetamine salts in a controlled manner, ensuring both immediate and delayed release of the drug. The invention includes a core seed coated with layers of the active drug, a protective layer, and an enteric coating layer[1][4].
Key Components of the Invention
Immediate-Release Component
The immediate-release component ensures that a portion of the drug is released quickly upon ingestion, providing an initial therapeutic effect.
Delayed-Release Component
The delayed-release component, facilitated by an enteric coating, delays the release of the drug until it reaches the intestines. This coating can be of varying thickness and may include a protective layer between the drug and the enteric coating to control the release timing[1][4].
Protective Layer
A protective layer is often applied between the drug and the enteric coating or over the enteric coating to further control the drug release profile. This layer is crucial in ensuring the drug is not released prematurely in the stomach[1][4].
Patent Claims
The patent includes several claims that define the scope of the invention:
Claim Structure
- The claims outline the composition of the drug delivery system, including the core seed, the layers of pharmaceutically active amphetamine salts, the protective layer, and the enteric coating layer.
- Specific claims detail the method of applying these layers and the resulting drug release profile[1][4].
Claim Scope
The claims are constructed to cover various aspects of the drug delivery system:
- The composition of the drug delivery system.
- The method of manufacturing the system.
- The specific layers and their functions.
- The timing and manner of drug release[1][4].
Patent Infringement and Litigation
The patent has been at the center of several infringement cases, notably involving generic drug manufacturers.
Shire LLC v. Sandoz, Inc.
In this case, Shire LLC alleged that Sandoz, Inc.'s submissions to the FDA for approval of their ANDA (Abbreviated New Drug Application) products infringed upon the '819 and '300 patents. Shire claimed that Sandoz's products literally infringed the '300 patent and infringed the '819 patent under the doctrine of equivalents[2][4].
Claim Construction and Prosecution History
The court's analysis involved determining the scope and meaning of the patent claims and comparing them to the allegedly infringing device. The prosecution history played a crucial role in understanding how the inventor and the PTO understood the patent claims. Statements made during the prosecution, such as the distinction between enteric and sustained release coatings, were critical in defining the claim scope[2][4].
Patent Landscape and Industry Impact
Patent Quality and Scope
The debate over patent quality and scope is relevant here. The patent's claims and their construction have been subject to scrutiny, with discussions on whether the claims are overly broad or narrowly defined. Metrics such as independent claim length and count can provide insights into patent scope, and the examination process often narrows the scope of patent claims[3].
Competitive Landscape
The pharmaceutical industry is highly competitive, and patents like the '819 play a significant role in protecting intellectual property. Companies like Shire LLC invest heavily in research and development, and patents are crucial for recouping these investments and maintaining market exclusivity[5].
Industry Expert Insights
Industry experts emphasize the importance of clear and well-defined patent claims to avoid litigation and ensure innovation. For example, the use of specific terms like "enteric release coating" and the distinction from "sustained release coatings" are critical in defining the scope of the invention[4].
Statistics and Data
- The patent has been involved in multiple litigation cases, highlighting its significance in the pharmaceutical industry.
- The use of enteric coatings in drug delivery systems has increased, reflecting the importance of controlled drug release in therapeutic efficacy[5].
Key Takeaways
- Complex Drug Delivery System: The patent describes a sophisticated drug delivery system with immediate and delayed release components.
- Critical Layers: The protective layer and enteric coating layer are essential for controlling the drug release profile.
- Litigation and Infringement: The patent has been central to several infringement cases, emphasizing its importance in protecting intellectual property.
- Patent Scope and Quality: The claims and their construction are crucial in defining the scope of the invention and avoiding overly broad or narrow claims.
- Industry Impact: The patent influences the competitive landscape in the pharmaceutical industry, particularly in the development of controlled drug delivery systems.
FAQs
Q: What is the main purpose of the United States Patent 6,322,819?
A: The main purpose is to describe an oral pulsed dose drug delivery system for pharmaceutically active amphetamine salts, ensuring both immediate and delayed release of the drug.
Q: What are the key components of the drug delivery system described in the patent?
A: The key components include an immediate-release component, a delayed-release component facilitated by an enteric coating, and a protective layer.
Q: Why is the protective layer important in the drug delivery system?
A: The protective layer is crucial for controlling the drug release profile by preventing premature release in the stomach and ensuring the drug reaches the intestines before being released.
Q: What was the outcome of the Shire LLC v. Sandoz, Inc. case?
A: The case involved allegations of patent infringement by Sandoz, Inc., with Shire LLC claiming that Sandoz's products infringed upon their patents. The specifics of the outcome depend on the court's rulings on claim construction and infringement.
Q: How does the patent landscape impact the pharmaceutical industry?
A: The patent landscape, including patents like the '819, significantly influences the competitive dynamics by protecting intellectual property and encouraging innovation in drug delivery systems.
Sources
- US6322819B1 - Oral pulsed dose drug delivery system - Google Patents
- Shire LLC v. Sandoz, Inc. - Casetext
- Patent Claims and Patent Scope - Hoover Institution
- United States District Court, D. Colorado. SHIRE LLC v. SANDOZ - IP Mall
- Shire Sues Barr, Impax Again Over Adderall Patents - Law360
