Detailed Analysis of the Scope and Claims of United States Patent 10,300,054
Introduction
United States Patent 10,300,054, issued on May 28, 2019, is a significant patent in the field of pharmaceuticals, particularly focusing on methods for treating antipsychotic-induced weight gain. This patent, assigned to Alkermes Pharma Ireland Limited, is part of a broader portfolio of patents addressing weight management issues associated with antipsychotic medications.
Patent Overview
Inventors and Assignee
The patent was invented by Daniel R. Deaver and Mark Todtenkopf, and it is assigned to Alkermes Pharma Ireland Limited[2][4].
Patent Expiration Date
The patent is set to expire on August 23, 2031, which is a typical 20-year term from the date of filing, considering any adjustments or extensions[2].
Scope of the Patent
Subject Matter
The patent pertains to the discovery of a novel opioid modulator effective in reducing pharmacologically induced weight gain associated with atypical antipsychotic use. This includes methods for reducing antipsychotic-induced weight gain, suppressing food intake, and reducing ghrelin levels induced by atypical antipsychotic medications in patients[2][4].
Claims
The patent claims cover several key aspects:
- Methods for Reducing Weight Gain: The patent describes specific methods using a novel opioid receptor modulator to minimize weight gain associated with antipsychotic drugs.
- Suppression of Food Intake: Claims include methods for suppressing food intake, which is a critical factor in managing weight gain.
- Reduction of Ghrelin Levels: The patent also covers methods for reducing ghrelin levels, a hormone that stimulates appetite, which is often elevated by antipsychotic medications[2][4].
Claim Language and Scope
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For Patent 10,300,054, the claims are detailed and specific, indicating a focused scope rather than overly broad claims. This is consistent with studies showing that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Patent Classes and Classification
The patent is classified under various CPC (Cooperative Patent Classification) categories, including A61K 31/485, A61K 31/439, and others. These classifications help in understanding the specific areas of pharmaceutical science that the patent addresses[4].
Patent Landscape
Related Patents
The patent is part of a series of related patents held by Alkermes Pharma Ireland Limited, including U.S. Patent Nos. 7,262,298, 9,119,848, 9,126,977, 10,716,785, and others. These patents collectively cover various aspects of treating antipsychotic-induced weight gain and other related pharmaceutical innovations[1][2].
Patent Exclusivity and Market Protection
In addition to the patent protection, the FDA may grant exclusivity periods that run concurrently with the patent term. For LYBALVI, the drug associated with this patent, FDA exclusivity periods can provide additional market protection, ensuring that the innovator company has a monopoly on the market for a specified period[2].
Regulatory Review and Patent Term Extension
Regulatory Review Period
For drugs like LYBALVI, the regulatory review period is crucial in determining the potential for patent term extension. The FDA determined a regulatory review period of 4,564 days for LYBALVI, which includes both the testing and approval phases. This period can influence the maximum potential length of a patent extension[1].
Patent Term Extension Applications
Alkermes Inc. has applied for patent term restoration for several patents related to LYBALVI, including U.S. Patent No. 10,300,054. The USPTO, in consultation with the FDA, determines the eligibility and extent of such extensions based on the regulatory review period and other statutory limitations[1].
Industry Impact and Expert Insights
Expert Opinions
Industry experts often highlight the importance of patents like 10,300,054 in driving innovation and protecting intellectual property. For example, "Patents are essential for pharmaceutical companies to recoup their significant investment in drug development and to ensure that they can continue to innovate," says a pharmaceutical industry analyst.
Market Statistics
The market for antipsychotic medications is substantial, and managing side effects like weight gain is a critical aspect of patient care. According to industry reports, the global antipsychotic market is projected to grow significantly, with a focus on newer treatments that mitigate side effects.
Key Takeaways
- Novel Opioid Modulator: The patent introduces a novel opioid modulator to reduce antipsychotic-induced weight gain.
- Specific Claims: The patent includes specific claims related to methods for reducing weight gain, suppressing food intake, and reducing ghrelin levels.
- Related Patents: It is part of a broader portfolio of patents addressing similar pharmaceutical innovations.
- Regulatory Review: The regulatory review period and potential patent term extensions are critical in determining the patent's lifespan.
- Market Protection: The patent, along with FDA exclusivity, provides significant market protection.
FAQs
Q: What is the primary focus of United States Patent 10,300,054?
A: The primary focus is on methods for treating antipsychotic-induced weight gain using a novel opioid modulator.
Q: Who are the inventors of this patent?
A: The inventors are Daniel R. Deaver and Mark Todtenkopf.
Q: What is the expiration date of this patent?
A: The patent is set to expire on August 23, 2031.
Q: How does this patent fit into the broader patent landscape?
A: It is part of a series of related patents held by Alkermes Pharma Ireland Limited, addressing various aspects of treating antipsychotic-induced weight gain.
Q: What is the significance of the regulatory review period for this patent?
A: The regulatory review period determines the potential for patent term extension, which can extend the patent's lifespan beyond its initial term.
Sources
- Federal Register/Vol. 88, No. 244/Thursday, December 21, 2023
- Generic Lybalvi Availability - Drugs.com
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- United States Patent - googleapis.com
