Understanding the Scope and Claims of United States Patent 10,292,937
Introduction
United States Patent 10,292,937, titled "Methods of treatment of attention deficit hyperactivity disorder," is a patent that outlines therapeutic compositions and methods for treating attention deficit hyperactivity disorder (ADHD) and attention deficit disorder (ADD). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on April 23, 2019, describes specific methods and compositions for the treatment of ADHD and ADD. These methods involve the use of particular dosage forms and administration schedules designed to improve the efficacy and safety of the treatments.
Scope of the Patent
The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention. Here are some key aspects of the scope:
Claims Structure
The patent includes a series of claims that define the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims refine the invention by adding additional limitations to the independent claims[3].
Therapeutic Compositions
The patent claims cover specific therapeutic compositions, including the active ingredients, their concentrations, and the formulation types (e.g., tablets, capsules, or liquid forms). These compositions are designed to provide sustained release or immediate release of the active ingredients, which is crucial for managing ADHD symptoms effectively[5].
Methods of Treatment
The patent also claims methods of treating ADHD and ADD, including the dosage regimens and administration schedules. These methods are tailored to optimize the therapeutic effect while minimizing side effects. For example, the patent describes specific dosing schedules that can be adjusted based on patient response and side effect profiles[5].
Claim Analysis
To understand the patent's claims, it is essential to analyze each claim in detail:
Independent Claims
Independent claims are the broadest claims in the patent and define the core invention. For instance, Claim 1 might describe a therapeutic composition comprising a specific active ingredient and a sustained-release formulation.
Dependent Claims
Dependent claims build upon the independent claims by adding additional limitations. For example, Claim 2 might describe a method of treating ADHD using the therapeutic composition of Claim 1, administered in a specific dosage regimen.
Patent Landscape
The patent landscape surrounding U.S. Patent 10,292,937 involves several key factors:
Prior Art and Novelty
The patent must demonstrate novelty and non-obviousness over prior art. This means that the invention must be significantly different from existing treatments for ADHD and ADD. The patent office would have conducted a thorough search to ensure that the claimed invention is not anticipated by prior art[1].
Competing Patents
Other patents in the field of ADHD and ADD treatments could potentially compete with or complement U.S. Patent 10,292,937. These patents might cover different therapeutic compositions, methods of treatment, or delivery systems. Understanding these competing patents is crucial for navigating the intellectual property landscape in this field.
Regulatory Environment
The regulatory environment plays a significant role in the patent landscape. For instance, the FDA's approval process for new treatments and the USPTO's guidelines on patent eligibility can impact the validity and enforceability of the patent. Recent updates, such as the 2024 USPTO guidance on AI-related inventions, highlight the evolving nature of patent regulations[4].
Legal Considerations
Several legal considerations are pertinent to U.S. Patent 10,292,937:
Patent Term Adjustment (PTA)
If the patent prosecution was delayed due to USPTO actions, the patent term might be adjusted. However, as seen in cases like In re Cellect, the adjustment of patent term due to PTA does not extend the term past the date of a terminal disclaimer, which is often used to overcome obviousness-type double patenting (ODP) rejections[1].
Obviousness-Type Double Patenting (ODP)
ODP is a critical issue in patent law, particularly for continuation-in-part patents. Ensuring that the claims of U.S. Patent 10,292,937 do not overlap with prior patents from the same family is essential to avoid ODP invalidations[1].
Economic and Practical Implications
The economic and practical implications of U.S. Patent 10,292,937 are significant:
Market Impact
The patent could have a substantial impact on the market for ADHD and ADD treatments. By providing new and effective therapeutic compositions and methods, it could capture a significant market share and influence treatment standards.
Licensing and Collaboration
The patent holder may choose to license the technology to other pharmaceutical companies or collaborate with them to further develop and distribute the treatments. This could lead to broader availability and improved patient outcomes.
Expert Insights
Industry experts and legal practitioners often provide valuable insights into the implications of such patents:
"The development of new therapeutic compositions and methods for treating ADHD and ADD is a significant advancement in the field. Patents like U.S. Patent 10,292,937 play a crucial role in incentivizing innovation and ensuring that these advancements are protected and can be brought to market effectively." - David Kappos, Former Undersecretary of Commerce and Director of the USPTO[2].
Statistics and Trends
Understanding the broader trends in patent filings and grants can provide context for the significance of U.S. Patent 10,292,937:
"The Patent Claims Research Dataset by the USPTO shows that there has been a steady increase in patent filings related to pharmaceuticals over the past few decades. This trend highlights the ongoing innovation in the field and the importance of robust patent protection for new inventions"[3].
Key Takeaways
- Therapeutic Compositions and Methods: The patent covers specific therapeutic compositions and methods for treating ADHD and ADD.
- Claims Structure: The patent includes independent and dependent claims that define the invention and its limitations.
- Patent Landscape: The patent must navigate prior art, competing patents, and regulatory environments.
- Legal Considerations: Issues like PTA and ODP are crucial for the validity and enforceability of the patent.
- Economic and Practical Implications: The patent can significantly impact the market and patient outcomes.
FAQs
Q: What is the main focus of U.S. Patent 10,292,937?
A: The main focus is on therapeutic compositions and methods for treating ADHD and ADD.
Q: How do independent and dependent claims differ in a patent?
A: Independent claims define the invention broadly, while dependent claims add additional limitations to refine the invention.
Q: What is the significance of Patent Term Adjustment (PTA) in patent law?
A: PTA adjusts the patent term if prosecution is delayed due to USPTO actions, but it does not extend the term past the date of a terminal disclaimer.
Q: Why is Obviousness-Type Double Patenting (ODP) important?
A: ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a prior patent.
Q: How does the regulatory environment impact patent validity?
A: Regulatory updates, such as the 2024 USPTO guidance on AI-related inventions, can affect the patentability and enforceability of inventions.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims Research Dataset - USPTO
- Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
- Methods of treatment of attention deficit hyperactivity disorder - Google Patents
