Detailed Analysis of the Scope and Claims of United States Patent 10,857,143
Introduction
United States Patent 10,857,143, titled "Methylphenidate extended release chewable tablet," is a significant innovation in the field of pharmaceuticals, particularly for the treatment of attention deficit hyperactivity disorder (ADHD). This patent, issued to a pharmaceutical company, outlines a novel formulation for an oral methylphenidate extended release tablet that can be scored and still retain its extended release profile.
Overview of the Patent
Publication Details
- Publication Number: US10857143B2
- Authority: United States
- Prior Art Date: The patent builds upon existing knowledge in the field of methylphenidate formulations, incorporating new methods to achieve an extended release profile in a chewable tablet form[4].
Scope of the Patent
Problem Addressed
The patent addresses the need for a methylphenidate formulation that is both extended release and chewable. Traditional extended release formulations often come in non-chewable forms, which can be inconvenient for certain patients, especially children or those with difficulty swallowing tablets.
Solution Provided
The invention describes a methylphenidate extended release chewable tablet that maintains its extended release profile even when scored. This is achieved through a specific formulation that includes a combination of immediate-release and sustained-release components.
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of the invention:
- Claim 1: The patent claims a chewable tablet comprising methylphenidate, where the tablet is scored and retains its extended release profile upon scoring[4].
- Claim 2: The tablet includes a mixture of immediate-release and sustained-release formulations to achieve the desired release profile.
- Claim 3: The tablet may include various excipients such as coating agents, polymers, and stabilizers to enhance the release characteristics and stability of the methylphenidate.
Detailed Claim Analysis
Immediate-Release and Sustained-Release Components
The patent specifies that the tablet contains both immediate-release and sustained-release components. The immediate-release component provides an initial dose of methylphenidate, while the sustained-release component ensures a prolonged release of the drug over time. This dual-release mechanism is crucial for maintaining therapeutic levels of the drug throughout the day[4].
Coating and Excipients
The claims also detail the use of various coating agents and excipients such as polyvinyl acetate, ethyl cellulose, and cation exchange resins. These components help in controlling the release rate of methylphenidate and ensuring the tablet's stability and integrity even when scored[4].
Scoring Feature
The scoring feature of the tablet is a significant aspect of the patent. The tablet is designed to be scored, allowing for flexibility in dosing without compromising the extended release profile. This is particularly useful for patients who may require different doses or for those who have difficulty swallowing whole tablets[4].
Patent Landscape
Prior Art and Related Patents
The patent landscape for methylphenidate formulations is extensive, with numerous patents covering various aspects of drug delivery and formulation. However, the specific combination of an extended release and chewable tablet with a scoring feature sets this patent apart from prior art.
Global Dossier and International Patent Offices
To understand the global patent landscape, one can use resources like the Global Dossier provided by the USPTO, which allows access to file histories of related applications from participating IP Offices. This can help in identifying similar patents filed in other countries and understanding the international scope of protection for this invention[1].
Patent Analytics
Patent analytics tools can be used to track patents by claims and scope concepts, helping to identify gaps or opportunities in the intellectual property landscape. For instance, a Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to methylphenidate formulations, and where potential gaps or future design opportunities exist[3].
Practical Applications
Clinical Significance
The methylphenidate extended release chewable tablet has significant clinical implications, particularly for patients with ADHD. The convenience of a chewable tablet that can be scored makes it easier for patients to adhere to their medication regimen, which is crucial for the effective management of ADHD.
Market Impact
This patent could have a substantial market impact by offering a unique and patient-friendly formulation that addresses the needs of a specific patient population. Pharmaceutical companies can leverage this innovation to differentiate their products and capture a larger market share in the ADHD treatment segment.
Legal and Regulatory Considerations
Patent Protection
The patent provides legal protection for the specific formulation and design of the methylphenidate extended release chewable tablet. This protection prevents other companies from manufacturing or selling similar products without permission, thereby safeguarding the inventor's rights and investment.
Regulatory Compliance
The development and marketing of this product must comply with regulatory requirements set by agencies such as the FDA. The patent documentation includes details on the testing methods and data that support the safety and efficacy of the formulation, which are critical for regulatory approval[4].
Conclusion
United States Patent 10,857,143 represents a significant advancement in the field of pharmaceuticals, particularly for ADHD treatment. The detailed analysis of its scope and claims highlights the innovative aspects of the methylphenidate extended release chewable tablet, including its scoring feature and dual-release mechanism. Understanding the patent landscape and leveraging patent analytics can help companies navigate the intellectual property environment and identify opportunities for further innovation.
Key Takeaways
- Innovative Formulation: The patent describes a novel methylphenidate extended release chewable tablet that can be scored without losing its extended release profile.
- Clinical Significance: This formulation is particularly beneficial for patients with ADHD, offering a convenient and adherence-friendly treatment option.
- Market Impact: The unique features of this product can help pharmaceutical companies differentiate their offerings and capture a larger market share.
- Legal and Regulatory Considerations: The patent provides legal protection, and compliance with regulatory requirements is essential for the development and marketing of this product.
FAQs
Q1: What is the main innovation of United States Patent 10,857,143?
The main innovation is the development of a methylphenidate extended release chewable tablet that retains its extended release profile even when scored.
Q2: How does the scoring feature of the tablet benefit patients?
The scoring feature allows for flexibility in dosing, making it easier for patients to take the correct dose and improving adherence to their medication regimen.
Q3: What are the key components of the tablet formulation?
The tablet includes a mixture of immediate-release and sustained-release formulations, along with various excipients such as coating agents, polymers, and stabilizers.
Q4: How can companies use patent analytics to understand the intellectual property landscape for this invention?
Companies can use patent analytics tools to track patents by claims and scope concepts, identifying gaps or opportunities in the intellectual property landscape related to methylphenidate formulations.
Q5: What regulatory considerations must be addressed for this product?
The development and marketing of this product must comply with regulatory requirements set by agencies such as the FDA, including providing data on safety and efficacy.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- SLWIP - Patent Analytics: https://www.slwip.com/services/patent-analytics/
- Google Patents - US10857143B2: https://patents.google.com/patent/US10857143B2/en
- Unified Patents Portal - US-20140072645-A1: https://portal.unifiedpatents.com/patents/patent/US-20140072645-A1
