United States Patent 10,617,651: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,617,651, titled "Compositions for treatment of attention deficit hyperactivity disorder," is a significant patent in the pharmaceutical sector, particularly in the treatment of ADHD. This patent, assigned to a pharmaceutical company, outlines innovative compositions and methods for delivering methylphenidate, a common medication for ADHD, in a delayed and extended release formulation.
Background
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention, hyperactivity, and impulsivity. Methylphenidate is one of the most commonly prescribed medications for ADHD, but traditional formulations can have limitations such as short duration of action and the need for multiple daily doses.
Patent Overview
Publication Details
- Publication Number: US10617651B2
- Filing Date: August 16, 2018
- Grant Date: April 7, 2020
- Assignee: The patent is assigned to a pharmaceutical company, though the specific company is not mentioned in the provided sources[5].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes a therapeutic composition comprising a core containing methylphenidate or a salt thereof, and a coating layer that delays the release of the methylphenidate.
- Claim 2 specifies the composition where the coating layer is designed to release the methylphenidate in a sustained manner over a period of at least 8 hours.
- Claim 3 details the composition where the core further includes an excipient and the coating layer includes a polymer and a plasticizer[5].
Dependent Claims
- Dependent claims further specify various aspects of the composition, such as the type of excipients, the thickness of the coating layer, and the method of preparing the composition.
Description of the Invention
The patent describes a novel formulation of methylphenidate designed to provide a delayed and extended release profile. This formulation aims to improve patient compliance by reducing the need for multiple daily doses.
Core Composition
The core of the composition contains methylphenidate or its salt, along with various excipients such as fillers, binders, and lubricants. The core is designed to release the active ingredient in a controlled manner.
Coating Layer
The coating layer is a critical component that delays the release of methylphenidate. This layer is typically composed of a polymer and a plasticizer, which work together to control the release rate of the drug. The thickness and composition of the coating layer can be adjusted to achieve the desired release profile[5].
Advantages and Benefits
The delayed and extended release formulation of methylphenidate offers several advantages over traditional formulations:
Improved Patient Compliance
By reducing the number of daily doses, the new formulation can improve patient compliance, which is crucial for the effective management of ADHD.
Reduced Side Effects
The sustained release profile can help minimize side effects associated with peak drug concentrations, such as anxiety and insomnia.
Enhanced Efficacy
The extended release ensures that the therapeutic effect of methylphenidate is maintained over a longer period, providing consistent symptom control throughout the day.
Patent Landscape
Prior Art
The patent landscape for ADHD treatments is extensive, with numerous patents covering various formulations and delivery systems for methylphenidate and other ADHD medications. The prior art includes patents on immediate release, sustained release, and extended release formulations, as well as different delivery mechanisms such as oral, transdermal, and injectable forms[5].
Competing Patents
Several pharmaceutical companies have patents related to ADHD treatments, including extended release formulations of methylphenidate. These patents often differ in their specific formulations, coating layers, and release profiles.
International Patent Protection
The patent holder may also seek international patent protection through the Patent Cooperation Treaty (PCT) or by filing national phase applications in various countries. This ensures broader protection and market exclusivity globally.
Search and Analysis Tools
For conducting a thorough search and analysis of this patent and its landscape, several tools and resources are available:
USPTO Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and related patents. It provides enhanced access to patent documents and allows for detailed searches based on various criteria such as keywords, classification, and patent numbers[4].
Global Dossier
The Global Dossier service allows users to access the file histories of related applications from participating IP Offices, providing a comprehensive view of the patent family and related applications[4].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can be used to analyze claim-level statistics and document-level statistics, providing insights into the scope and breadth of patent claims[3].
Legal and Regulatory Aspects
Obviousness-Type Double Patenting (ODP)
Patents like US10617651B2 must be scrutinized for ODP to ensure that the same invention is not patented multiple times with different expiration dates. This is particularly relevant when there are multiple related patents with overlapping claims[1].
Patent Term Adjustment (PTA) and Patent Term Extension (PTE)
The patent term may be adjusted or extended due to delays in the patent office's response or other regulatory factors. Understanding these adjustments is crucial for determining the actual patent term and any potential overlaps with other patents[1].
Key Takeaways
- Innovative Formulation: The patent introduces a novel delayed and extended release formulation of methylphenidate, enhancing patient compliance and efficacy.
- Comprehensive Claims: The patent includes detailed claims that define the scope of the invention, including the composition, coating layer, and release profile.
- Competitive Landscape: The patent landscape for ADHD treatments is complex, with numerous competing patents and formulations.
- Global Protection: International patent protection is essential for maintaining market exclusivity and protecting the invention globally.
- Legal Considerations: ODP, PTA, and PTE are critical legal aspects that must be considered to ensure the validity and enforceability of the patent.
FAQs
What is the main innovation of US Patent 10,617,651?
The main innovation is a delayed and extended release formulation of methylphenidate, designed to improve patient compliance and efficacy in treating ADHD.
How does the coating layer in the patent work?
The coating layer, composed of a polymer and a plasticizer, delays the release of methylphenidate, ensuring a sustained release profile over at least 8 hours.
What are the advantages of this new formulation over traditional ones?
The advantages include improved patient compliance, reduced side effects, and enhanced efficacy due to the sustained release profile.
How can one conduct a thorough search for related patents?
Using tools like the USPTO's Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can help in conducting a comprehensive search for related patents.
What legal considerations are important for this patent?
Important legal considerations include obviousness-type double patenting (ODP), patent term adjustment (PTA), and patent term extension (PTE) to ensure the patent's validity and enforceability.
Cited Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit[1].
- U.S. Patent and Trademark Office (USPTO) - USA.gov[2].
- Patent Claims Research Dataset - USPTO[3].
- Search for patents - USPTO[4].
- Compositions for treatment of attention deficit hyperactivity disorder - Google Patents[5].
