Understanding the Scope and Claims of United States Patent 10,759,778: A Detailed Analysis
Introduction
United States Patent 10,759,778, titled "Methylphenidate-prodrugs, processes of making and using the same," is a patent that delves into the realm of pharmaceuticals, specifically focusing on methylphenidate, a medication commonly used to treat attention deficit hyperactivity disorder (ADHD) and certain cases of narcolepsy. This article will provide a comprehensive analysis of the scope, claims, and the broader patent landscape surrounding this invention.
Background of Methylphenidate
Methylphenidate, known by its brand name Ritalin among others, is a central nervous system stimulant. It has been widely used for decades to manage symptoms of ADHD and narcolepsy. However, its use is often limited by its side effects and the need for controlled release formulations to maintain therapeutic efficacy while minimizing adverse effects.
Overview of the Patent
Publication Details
- Publication Number: US10759778B2
- Authority: United States
- Prior Art Date: The patent builds upon earlier research and developments in the field of methylphenidate formulations[4].
Invention Summary
The patent describes compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate. These compositions are designed to improve the delivery and efficacy of methylphenidate, potentially reducing side effects and enhancing patient compliance.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the following aspects:
- Composition Claims: These claims describe the specific compositions of methylphenidate-prodrugs, including the types of conjugates and the ratios of conjugated to unconjugated methylphenidate[4].
- Process Claims: These claims outline the methods for making the methylphenidate-prodrugs, including the synthesis steps and conditions[4].
- Use Claims: These claims specify the therapeutic uses of the compositions, such as the treatment of ADHD and narcolepsy[4].
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations. For example, they might specify particular types of conjugates, specific dosages, or particular methods of administration.
Scope of the Patent
Technical Scope
The technical scope of the patent is focused on the chemical and pharmaceutical aspects of methylphenidate-prodrugs. It includes:
- Chemical Structures: The patent details the chemical structures of the conjugates and how they are synthesized.
- Pharmacokinetics: The invention aims to improve the pharmacokinetic profile of methylphenidate, ensuring a more controlled and sustained release of the active ingredient[4].
Commercial Scope
The commercial scope involves the potential market and applications of the invention. This includes:
- Therapeutic Applications: The patent targets the treatment of ADHD and narcolepsy, which are significant markets in the pharmaceutical industry.
- Competitive Landscape: The invention competes with existing methylphenidate formulations, offering potential advantages in terms of efficacy, safety, and patient compliance.
Patent Landscape
Related Patents
The patent landscape for methylphenidate formulations is extensive, with numerous patents covering various aspects of methylphenidate chemistry, formulation, and use. For instance:
- Prior Art: Earlier patents have addressed different formulations and delivery systems for methylphenidate, such as extended-release formulations and transdermal patches.
- Competing Patents: Other patents may cover similar conjugate technologies or alternative approaches to improving methylphenidate delivery.
Global Dossier
Using tools like the Global Dossier provided by the USPTO, one can track the patent family for this specific application, including related applications filed at participating IP Offices. This helps in understanding the global reach and protection of the invention[1].
Legal and Regulatory Considerations
Patent Litigation
Patent litigation is a critical aspect of the patent landscape. For example, cases like Provisur Technologies, Inc. v. Weber, Inc. highlight the importance of patent infringement and willfulness determinations, which can significantly impact the commercial viability of a patented invention[2].
Small Claims Patent Court
There have been discussions and studies on the feasibility of a small claims patent court, which could potentially simplify and reduce the costs associated with patent litigation for smaller entities. This could affect how future disputes related to this patent might be handled[5].
Economic Impact
Market Potential
The economic impact of this patent is significant, given the large market for ADHD and narcolepsy treatments. Improved formulations can capture a substantial share of this market, leading to considerable revenue.
Research and Development
The development of new pharmaceutical formulations often involves substantial investment in research and development. Patents like US10759778B2 protect these investments, encouraging further innovation in the field.
Key Takeaways
- Innovation in Formulations: The patent represents an innovative approach to improving methylphenidate delivery, potentially enhancing therapeutic outcomes.
- Market Significance: The invention targets a large and growing market, making it commercially significant.
- Legal and Regulatory Environment: The patent's validity and enforcement are influenced by the broader legal and regulatory landscape, including potential litigation and the structure of patent courts.
- Global Protection: The use of tools like the Global Dossier helps in managing and protecting the patent globally.
FAQs
What is the main focus of United States Patent 10,759,778?
The main focus of this patent is on compositions comprising d-threo-methylphenidate conjugates and unconjugated methylphenidate, aimed at improving the delivery and efficacy of methylphenidate.
How does this patent differ from existing methylphenidate formulations?
This patent differs by introducing specific conjugate technologies designed to enhance the pharmacokinetic profile of methylphenidate, potentially reducing side effects and improving patient compliance.
What are the therapeutic applications of this invention?
The invention is primarily aimed at treating attention deficit hyperactivity disorder (ADHD) and narcolepsy.
How does the Global Dossier help in managing this patent?
The Global Dossier allows users to track the patent family for this specific application, including related applications filed at participating IP Offices, providing access to file histories, classification, and citation data.
What is the potential economic impact of this patent?
The patent has significant economic potential due to its target market size and the potential to capture a substantial share of the ADHD and narcolepsy treatment market.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Provisur - United States Court of Appeals for the Federal Circuit: https://cafc.uscourts.gov/opinions-orders/23-1438.OPINION.10-2-2024_2394588.pdf
- Patent Claims Research Dataset - USPTO: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Methylphenidate-prodrugs, processes of making and using the same - Google Patents: https://patents.google.com/patent/US10759778B2/en
- U.S. Patent Small Claims Court - ACUS: https://www.acus.gov/research-projects/us-patent-small-claims-court
