Detailed Analysis of the Scope and Claims of United States Patent 10,143,693
Introduction
United States Patent 10,143,693, titled "Dosing regimen for missed doses for long-acting injectable paliperidone esters," is a significant patent in the field of psychiatric treatment, particularly for patients receiving long-acting injectable medications. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent addresses a critical issue in psychiatric care: the management of missed doses for long-acting injectable paliperidone esters. Paliperidone esters are used to treat schizophrenia and other psychiatric disorders. The invention provides a dosing regimen to ensure therapeutic efficacy and safety when doses are missed.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected.
Claims Overview
The patent includes multiple claims that describe the method for treating patients who have missed doses of long-acting injectable paliperidone esters. Here are some key aspects:
- Independent Claims: These claims define the core of the invention. For example, Claim 1 describes a method for treating a patient in need of psychiatric treatment, involving the administration of a specific dose of paliperidone ester after a missed dose[4].
- Dependent Claims: These claims build upon the independent claims, providing additional details or variations. For instance, dependent claims might specify different dosing schedules or patient populations.
Claim Language and Scope
The claim language is crucial in defining the patent's scope. Here are some metrics and considerations:
Independent Claim Length (ICL)
The length of the shortest independent claim can indicate the complexity and specificity of the invention. Shorter claims often suggest narrower and more focused protection, while longer claims may indicate broader but more detailed protection[3].
Independent Claim Count (ICC)
The total number of independent claims can also reflect the breadth of the invention. More independent claims may suggest a wider scope of protection, but each claim must be distinct and not overly broad to avoid patent office rejections[3].
Patent Claims and Patent Scope
The patent scope is a critical aspect of patent quality and can impact innovation and litigation.
Patent Quality Concerns
Patent scope has been a subject of debate, with concerns over overly broad claims and unclear disclosures. The USPTO and legal scholars have emphasized the importance of clear and narrow claims to avoid litigation and ensure innovation incentives[3].
Examination Process
The examination process at the USPTO tends to narrow the scope of patent claims, both in terms of claim length and count. This process ensures that granted patents have well-defined and valid claims, which is crucial for maintaining patent quality[3].
Specific Claims of US10143693B2
Dosing Regimen
The patent describes a method for reinitiating treatment with long-acting injectable paliperidone esters after a missed dose. This includes specific dosing schedules and administration protocols to maintain therapeutic levels of the drug[4].
Patient Population
The claims specify the patient population, including those with psychiatric diseases such as schizophrenia, schizoaffective disorder, and mood disorders. The method ensures that these patients receive appropriate treatment even after missing a dose[4].
Prior Art and Novelty
The patent must demonstrate novelty and non-obviousness over prior art. The dosing regimen described is novel in that it provides a specific and safe method for managing missed doses, which was not previously disclosed in the prior art[4].
Litigation and Enforcement
The patent has been involved in litigation, as seen in the case filed in 2021, which relates to the infringement of this patent. This highlights the importance of the invention and the need for clear and enforceable claims[5].
Broader Patent Landscape
Psychiatric Treatment Patents
The patent landscape in psychiatric treatment is complex, with numerous patents covering various aspects of drug delivery, dosing regimens, and therapeutic compounds. This patent fits into a broader ecosystem of innovations aimed at improving psychiatric care[4].
Pharmaceutical Patents
Pharmaceutical patents, especially those involving long-acting injectables, are subject to stringent regulatory and patent office scrutiny. The scope and claims of these patents must be carefully crafted to ensure validity and enforceability[3].
Industry Impact
Therapeutic Efficacy
The dosing regimen described in the patent ensures that patients receive consistent and effective treatment, even when doses are missed. This is crucial for maintaining therapeutic efficacy and patient safety[4].
Market Competition
The patent provides a competitive advantage to the holder, allowing them to offer a unique and valuable treatment option in the psychiatric care market. This can influence market dynamics and innovation strategies of competitors[5].
Key Takeaways
- Specific Dosing Regimen: The patent provides a detailed method for managing missed doses of long-acting injectable paliperidone esters.
- Patent Scope: The claims are designed to be clear and narrow, ensuring validity and enforceability.
- Litigation: The patent has been involved in litigation, highlighting its importance and the need for robust claims.
- Industry Impact: The invention enhances therapeutic efficacy and safety, providing a competitive advantage in the psychiatric care market.
FAQs
What is the main focus of United States Patent 10,143,693?
The main focus is on a dosing regimen for managing missed doses of long-acting injectable paliperidone esters in psychiatric treatment.
How does the patent ensure therapeutic efficacy?
The patent ensures therapeutic efficacy by providing a specific dosing schedule to maintain therapeutic levels of the drug even after a missed dose.
What are the key metrics for measuring patent scope?
Key metrics include independent claim length (ICL) and independent claim count (ICC), which help in assessing the breadth and clarity of the patent claims[3].
Why is patent scope important?
Patent scope is crucial for ensuring innovation incentives, avoiding litigation, and maintaining patent quality. Clear and narrow claims are essential for valid and enforceable patents[3].
Has this patent been involved in any litigation?
Yes, the patent has been involved in litigation related to infringement, highlighting its significance and the importance of robust claims[5].
Cited Sources
- Form 10-Q for Alkermes PLC - This document provides financial and operational details but does not directly relate to the patent in question.
- US Patent US10143693B2 - This is the patent itself, detailing the dosing regimen and claims.
- Patent Claims and Patent Scope - This paper discusses metrics for measuring patent scope and its implications on patent quality.
- Google Patents: US10143693B2 - This source provides additional details on the patent, including prior art keywords and the legal status.
- Case 3:21-cv-15137-ZNQ-LHG Document 1 - This document relates to litigation involving the patent.
