United States Patent 10,376,590: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,376,590, titled "Sustained delivery formulations of risperidone compound," is a significant patent in the field of pharmaceuticals, particularly in the treatment of psychiatric conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Status
The patent, US10376590B2, was granted on August 13, 2019, and is currently active. It was filed on October 27, 2017, under the application number US15/858,525[5].
Inventors and Assignees
The patent is assigned to Alkermes Pharma Ireland Limited, a company known for its innovative pharmaceutical products, especially in the area of sustained release formulations.
Background of the Invention
Risperidone is a well-known antipsychotic medication used to treat various psychiatric conditions, including schizophrenia, bipolar disorder, and irritability associated with autism. However, traditional formulations of risperidone often require frequent dosing, which can lead to compliance issues. The invention described in this patent aims to address this by providing sustained release formulations of risperidone.
Scope of the Invention
The scope of the invention is centered around the development of sustained release formulations of risperidone. These formulations are designed to provide a steady and prolonged release of the active ingredient, thereby improving patient compliance and therapeutic efficacy.
Key Components
- Active Ingredient: Risperidone, an antipsychotic compound.
- Delivery System: The patent describes various sustained release delivery systems, including injectable formulations and implants.
- Excipients and Carriers: The formulations may include various excipients and carriers to facilitate the sustained release of risperidone[5].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes a sustained release formulation comprising risperidone and a biodegradable polymer.
- Claim 5 details an injectable sustained release formulation of risperidone.
- Claim 9 describes a method for treating a psychiatric condition using the sustained release formulation of risperidone[5].
Dependent Claims
- These claims further specify the composition, method of preparation, and the therapeutic uses of the sustained release formulations.
Patent Landscape
Prior Art and Related Patents
The patent landscape for sustained release formulations of antipsychotic compounds is rich with prior art. For example, another patent, EP4404913A1, describes a long-acting injectable sustained release composition for antipsychotic drugs, which shares similarities with the current patent but differs in specific components and delivery mechanisms[4].
Global Dossier and IP5 Offices
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service is crucial for understanding the global patent landscape and potential overlaps or conflicts with other patents[1].
Technical and Legal Aspects
Patent Scope Metrics
Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics can help in assessing the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Office Actions and Examination Process
The Patent Examination Data System (PEDS) and the Common Citation Document (CCD) application are valuable tools for understanding the examination process and prior art citations related to the patent. These tools can help in identifying potential issues and strengthening the patent application[1].
Therapeutic Applications
The sustained release formulations of risperidone described in this patent are designed to treat a range of psychiatric conditions, including:
- Schizophrenia: A chronic mental health disorder characterized by disruptions in thought processes, perceptions, and social interactions.
- Bipolar Disorder: A condition that causes extreme mood swings, including manic highs and depressive lows.
- Autism Spectrum Disorder: A developmental disorder that affects communication and behavior[5].
Market Impact
The introduction of sustained release formulations of risperidone can significantly impact the market by:
- Improving Patient Compliance: By reducing the frequency of dosing, these formulations can enhance patient adherence to treatment regimens.
- Enhancing Therapeutic Efficacy: Sustained release formulations can provide a more consistent and stable therapeutic effect, leading to better outcomes for patients.
- Competitive Advantage: For the assignee, Alkermes Pharma Ireland Limited, this patent can provide a competitive edge in the pharmaceutical market by offering a unique and innovative treatment option.
Key Takeaways
- Innovative Formulation: The patent describes a novel sustained release formulation of risperidone, addressing compliance issues associated with traditional formulations.
- Broad Therapeutic Applications: The formulations are designed to treat a range of psychiatric conditions.
- Strong Patent Position: The patent includes multiple claims that define the scope of the invention, providing a robust legal foundation.
- Global Patent Landscape: The use of tools like Global Dossier and CCD helps in understanding the global patent landscape and potential overlaps.
FAQs
Q: What is the main purpose of the sustained release formulations of risperidone described in US Patent 10,376,590?
A: The main purpose is to improve patient compliance and therapeutic efficacy by providing a steady and prolonged release of the active ingredient.
Q: Who is the assignee of this patent?
A: The patent is assigned to Alkermes Pharma Ireland Limited.
Q: What are some of the key components of the sustained release formulations described in the patent?
A: The formulations include risperidone as the active ingredient and various biodegradable polymers and excipients.
Q: How can the Global Dossier service be useful in understanding this patent?
A: The Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices, which helps in understanding the global patent landscape.
Q: What metrics can be used to measure the scope of a patent like US10376590B2?
A: Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of the patent claims.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- Patent Claims and Patent Scope - Search eLibrary :: SSRN. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- EP4404913A1 - Antipsychotic injectable extended ... - Google Patents. Retrieved from https://patents.google.com/patent/EP4404913A1/en
- US10376590B2 - Sustained delivery formulations of risperidone ... - Google Patents. Retrieved from https://patents.google.com/patent/US10376590B2/en
