United States Patent 9,173,857: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,173,857, titled "Controlled Dose Drug Delivery System," is a significant patent in the pharmaceutical industry, particularly for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This patent, approved by the U.S. Food and Drug Administration (FDA), involves a sophisticated drug delivery system for amphetamine salts.
Background and Context
The patent focuses on a multiple pulsed dose drug delivery system designed to release pharmaceutically active amphetamine salts in a controlled manner. This system is crucial for maintaining therapeutic levels of the drug over an extended period, which is essential for the effective management of ADHD[4].
Scope of the Patent
Claim Overview
The patent claims cover a specific drug delivery system that includes several key components:
- Pharmaceutically Active Amphetamine Salts: The system is designed to deliver amphetamine salts, which are commonly used in ADHD treatments.
- Multiple Pulsed Dose Delivery: The system releases the drug in multiple pulses, ensuring a sustained therapeutic effect.
- Controlled Release Mechanism: The delivery system includes immediate and delayed release components, ensuring that the drug is released in a controlled and predictable manner[4].
Claim Construction
The claims are constructed to define the specific components and their functions within the drug delivery system. For example:
- Immediate Release Component: Designed to release the drug immediately upon administration.
- Delayed Release Components: These components release the drug at predetermined intervals, maintaining therapeutic levels over time.
- Discrete Components: The claims specify that these components can be discrete beads or other forms of dosage, which may be present on the same or separate cores[1].
Key Claims and Their Significance
Independent Claims
The independent claims define the core aspects of the drug delivery system, including the composition and the release mechanism. For instance:
- Claim 1 describes the overall system comprising immediate and delayed release components.
- Claim 2 specifies the types of amphetamine salts used and their formulations.
Dependent Claims
Dependent claims provide additional details and limitations to the independent claims. For example:
- Dependent claims may specify the exact formulation ratios or the timing of the delayed releases.
- These claims help in narrowing down the scope and ensuring that the patent covers specific embodiments of the invention[1].
Patent Landscape Analysis
Competing Patents and Technologies
The patent landscape for controlled drug delivery systems is complex, with several patents covering similar technologies. For instance:
- Other patents may cover different types of sustained release formulations or alternative drug delivery mechanisms.
- The landscape includes patents from various pharmaceutical companies, each with their own unique approaches to drug delivery[3].
Claim Coverage Matrix
To understand the patent landscape better, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify gaps or opportunities in the existing patent coverage. For the US 9,173,857 patent, this matrix would highlight:
- The specific scope concepts related to controlled release mechanisms and amphetamine salts.
- How these claims intersect with other patents in the field, indicating areas of overlap or innovation[3].
Prosecution History and Litigation
Prosecution History
The prosecution history of the patent provides valuable insights into the interactions between the patent applicant and the examiner. This history can include discussions on prior art, claim constructions, and the reasons for allowance. For example:
- The examiner's reasons for allowance might highlight the novelty and non-obviousness of the claimed invention.
- Statements made during prosecution can influence the interpretation of the claims and their scope[1].
Litigation and Settlements
Patents like US 9,173,857 can be involved in litigation, particularly in the context of Abbreviated New Drug Applications (ANDAs). Litigation often revolves around claim construction, infringement, and validity. Settlements in such cases can impact the patent landscape by defining the boundaries of what is considered infringing or non-infringing[2].
Impact on the Pharmaceutical Industry
Treatment of ADHD
The controlled dose drug delivery system patented in US 9,173,857 is crucial for the effective treatment of ADHD. By ensuring a sustained release of amphetamine salts, this system helps in maintaining therapeutic drug levels, which is essential for managing ADHD symptoms[4].
Innovation and Competition
This patent contributes to the innovation in drug delivery systems, encouraging further research and development in the field. It also sets a benchmark for competitors, who must navigate around the claimed inventions to develop their own products.
Future Directions and Opportunities
Design Opportunities
The patent analytics tools, such as ClaimScape®, can help in identifying future design opportunities. By analyzing the scope concepts and claim coverage, companies can determine areas where they can innovate without infringing existing patents[3].
Gaps in Coverage
Identifying gaps in the current patent coverage can highlight areas where new patents can be filed, ensuring comprehensive protection of intellectual property. This is particularly important in a rapidly evolving field like pharmaceuticals.
Key Takeaways
- The US 9,173,857 patent covers a sophisticated drug delivery system for amphetamine salts used in ADHD treatment.
- The claims define immediate and delayed release components, ensuring sustained therapeutic drug levels.
- The patent landscape is complex, with competing patents and technologies requiring careful analysis.
- Prosecution history and litigation can significantly impact the interpretation and enforcement of the patent.
- The patent contributes to innovation in drug delivery systems and sets a benchmark for competitors.
FAQs
What is the main focus of the US 9,173,857 patent?
The main focus of the US 9,173,857 patent is a controlled dose drug delivery system for pharmaceutically active amphetamine salts, particularly for the treatment of ADHD.
How does the drug delivery system work?
The system includes immediate and delayed release components that ensure a sustained release of the drug, maintaining therapeutic levels over time.
What is the significance of the prosecution history in patent litigation?
The prosecution history provides insights into the interactions between the patent applicant and the examiner, influencing the interpretation of claims and their scope.
How can patent analytics tools help in managing intellectual property?
Patent analytics tools, such as ClaimScape®, help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in existing patent coverage, and determining the value of patent claims.
What are the potential future directions for innovation based on this patent?
Future directions include identifying design opportunities and gaps in current patent coverage, allowing companies to innovate while ensuring comprehensive protection of their intellectual property.
Cited Sources:
- District of Delaware. 17-1696.pdf. January 23, 2019.
- JD Supra. ANDA Litigation Settlements - Winter 2020. January 31, 2020.
- Schwegman Lundberg & Woessner. Patent Analytics. Accessed December 22, 2024.
- Google Patents. US9173857B2 - Controlled dose drug delivery system. Accessed December 22, 2024.
