Understanding the Scope and Claims of United States Patent 10,905,652
Introduction
United States Patent 10,905,652, titled "Compositions for treatment of attention deficit hyperactivity disorder," is a significant patent in the pharmaceutical sector, particularly in the treatment of ADHD. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity. The treatment often involves medications, and one of the most commonly used is methylphenidate. The patent in question focuses on a novel formulation of methylphenidate designed to provide a delayed and extended release.
Patent Overview
The patent describes therapeutic compositions that deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. This formulation is designed to improve the efficacy and compliance of ADHD treatment by providing a more controlled release of the active ingredient over an extended period.
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key aspects:
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Claim 1: This claim describes the composition comprising a therapeutic amount of methylphenidate in a delayed and extended release formulation. The formulation includes a lag time before the release of methylphenidate, ensuring that the drug is released in a controlled manner over a specified period[2].
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Claim 2: This claim specifies the dosage form and the release profile, including the amount of methylphenidate released at different time intervals. It emphasizes the extended release nature of the formulation, which is crucial for maintaining therapeutic levels of the drug throughout the day[2].
Dependent Claims
Dependent claims further refine the scope of the independent claims by adding additional limitations. For example:
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Claim 3: This claim specifies the type of excipients used in the formulation, such as polymers and fillers, which are essential for controlling the release rate of methylphenidate[2].
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Claim 4: This claim details the manufacturing process of the composition, including the steps involved in preparing the delayed and extended release formulation[2].
Subject Matter Eligibility
Given the recent updates in patent law, particularly the 2024 USPTO guidance on AI and software-related patents, it is important to assess whether the claims of this patent meet the criteria for subject matter eligibility.
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Practical Applications: The claims in this patent clearly integrate the abstract idea of a drug formulation into a practical application. The specified use of methylphenidate in a delayed and extended release formulation provides tangible benefits, such as improved efficacy and patient compliance, which are crucial in the treatment of ADHD[1].
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Meaningful Limits: The claims impose meaningful limits on the judicial exceptions by specifying the exact formulation and release profile. This ensures that the invention is not merely an abstract idea but a concrete technological improvement in the field of pharmaceuticals[1].
Patent Landscape
Prior Art and Related Patents
The patent landscape for ADHD treatments is extensive, with numerous patents covering various formulations and delivery systems. For instance:
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Other Formulations: There are patents for different types of methylphenidate formulations, such as immediate release and sustained release formulations. However, the unique aspect of this patent is the delayed and extended release profile, which distinguishes it from existing formulations[5].
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International Patents: The global patent landscape includes similar inventions from other countries. For example, the European Patent Office and other international intellectual property offices have patents related to ADHD treatments, which may share similarities but also have distinct differences in formulation and delivery mechanisms[4].
Competitive Analysis
The competitive landscape for ADHD treatments is highly competitive, with several pharmaceutical companies developing innovative formulations to improve treatment outcomes. This patent provides a competitive edge by offering a formulation that enhances patient compliance and efficacy.
Economic and Market Impact
The economic impact of this patent can be significant, given the high prevalence of ADHD and the continuous demand for effective treatments. Here are some key points:
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Market Demand: The market for ADHD medications is substantial, and a novel formulation that offers improved efficacy and compliance can capture a significant share of this market.
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Cost Savings: By providing a delayed and extended release formulation, this patent can help reduce the frequency of dosing, potentially leading to cost savings for both patients and healthcare systems.
Future Developments and Challenges
Regulatory Environment
The regulatory environment for pharmaceutical patents is stringent and evolving. Future developments may include updates in regulatory guidelines that could affect the scope and validity of this patent.
Technological Advancements
Advancements in drug delivery technologies and formulation science could lead to new innovations that might challenge or complement this patent. For instance, the use of AI in drug development, as highlighted in the 2024 USPTO guidance, could lead to more sophisticated formulations in the future[1].
Key Takeaways
- Novel Formulation: The patent describes a novel delayed and extended release formulation of methylphenidate, which enhances the treatment of ADHD.
- Practical Applications: The claims integrate the abstract idea of a drug formulation into practical applications, ensuring subject matter eligibility.
- Competitive Edge: The patent provides a competitive edge in the ADHD treatment market by improving efficacy and patient compliance.
- Economic Impact: The patent has significant economic potential due to the high demand for effective ADHD treatments.
FAQs
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What is the main innovation of United States Patent 10,905,652?
- The main innovation is a delayed and extended release formulation of methylphenidate for the treatment of ADHD.
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How does this patent meet the criteria for subject matter eligibility?
- The patent meets the criteria by specifying a practical application of the drug formulation, imposing meaningful limits on judicial exceptions, and providing tangible benefits such as improved efficacy and patient compliance.
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What is the competitive landscape for ADHD treatments like?
- The competitive landscape is highly competitive with several pharmaceutical companies developing innovative formulations. This patent offers a unique delayed and extended release profile that distinguishes it from existing formulations.
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How could future technological advancements affect this patent?
- Future advancements in drug delivery technologies and the use of AI in drug development could lead to new innovations that might challenge or complement this patent.
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What are the potential economic benefits of this patent?
- The patent could lead to significant economic benefits by capturing a substantial share of the ADHD treatment market, reducing dosing frequency, and potentially leading to cost savings for patients and healthcare systems.
Cited Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz.
- Compositions for treatment of attention deficit hyperactivity disorder - Google Patents.
- Patent Claims Research Dataset - USPTO.
- Search for patents - USPTO - USPTO.
- Sustained released delivery of amphetamine salts - PubChem.
