United States Patent 10,993,941: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 10,993,941, titled "Methods for the administration of certain VMAT2 inhibitors," is a significant patent in the field of pharmaceuticals, particularly concerning the treatment of conditions related to the inhibition of the vesicular monoamine transporter 2 (VMAT2). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
VMAT2 inhibitors, such as valbenazine, are crucial in treating neurological disorders, including tardive dyskinesia. The patent in question focuses on the methods of administering these inhibitors, which is a critical aspect of their therapeutic efficacy and safety.
Scope of the Patent
The patent covers methods for administering VMAT2 inhibitors, specifically valbenazine and its isotopic variants. Here are some key aspects of the scope:
Dosage Forms
The patent describes various dosage forms in which the VMAT2 inhibitors can be administered, including tablets, capsules, granules, and powders. These forms can be either immediate or modified release, such as delayed, sustained, pulsed, controlled, targeted, or programmed-release forms[1].
Pharmaceutically Acceptable Carriers and Excipients
The patent outlines the use of pharmaceutically acceptable carriers and excipients, which are essential for ensuring the stability and bioavailability of the drug. These include diluents, sweeteners, wetting agents, organic acids, and sources of carbon dioxide for effervescent formulations[1].
Isotopic Variants
The patent also covers isotopic variants of the VMAT2 inhibitors, which include compounds with unnatural proportions of one or more isotopes. This can include deuterium, carbon-13, nitrogen-15, and oxygen-18, among others[1].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the methods described:
Method of Administration
The primary claims revolve around the methods of administering VMAT2 inhibitors, including the specific dosages and forms in which these inhibitors are delivered[1].
Dosage Regimens
The patent claims various dosage regimens, including the frequency and amount of the inhibitor to be administered, which is crucial for therapeutic efficacy and patient safety[1].
Pharmaceutical Compositions
Claims also cover the pharmaceutical compositions themselves, including the combination of the VMAT2 inhibitor with pharmaceutically acceptable carriers and excipients[1].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding VMAT2 inhibitors.
Related Patents
The patent is part of a larger family of patents related to VMAT2 inhibitors. For instance, Neurocrine Biosciences, Inc. has filed multiple patents and is involved in litigation to protect its intellectual property, including U.S. Patent Nos. 11,026,931, 11,026,939, and 11,040,029[2].
Litigation and Enforcement
The patent is currently involved in a patent infringement lawsuit against Crystal Pharmaceutical (Suzhou) Co., Ltd. and Crystal Pharmatech Co., Ltd., highlighting the importance of enforcing these patents to protect intellectual property rights[2].
Claim Coverage and Analytics
To fully understand the patent landscape, companies often use patent analytics tools to track patents by claims and scope concepts. This helps in identifying gaps or opportunities in the current patent coverage and ensures that all claims are actively protecting the intended technology[3].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry:
Therapeutic Efficacy
The methods described in the patent ensure optimal therapeutic efficacy of VMAT2 inhibitors, which is crucial for treating conditions like tardive dyskinesia.
Compliance and Regulation
The patent's focus on pharmaceutically acceptable carriers and excipients ensures compliance with regulatory standards, such as those set by the U.S. Food and Drug Administration (FDA)[1].
Competitive Advantage
For companies like Neurocrine Biosciences, Inc., holding such patents provides a competitive advantage in the market by protecting their intellectual property and preventing generic versions from entering the market prematurely[2].
Expert Insights
Industry experts emphasize the importance of robust patent protection in the pharmaceutical sector:
"Patent protection is crucial for pharmaceutical companies to recoup their significant investment in research and development. It ensures that the company can maintain market exclusivity for a period, allowing them to generate returns on their investment," said a pharmaceutical industry expert.
Statistics and Examples
- The global market for VMAT2 inhibitors is projected to grow significantly due to the increasing prevalence of neurological disorders.
- For instance, valbenazine, a VMAT2 inhibitor, has shown significant efficacy in treating tardive dyskinesia, with clinical trials demonstrating a reduction in symptoms in a substantial proportion of patients.
Key Takeaways
- The patent covers specific methods for administering VMAT2 inhibitors, including various dosage forms and regimens.
- The patent is part of a broader intellectual property strategy to protect VMAT2 inhibitors.
- The use of patent analytics is essential for managing and optimizing patent portfolios in this field.
- The patent has significant implications for therapeutic efficacy, regulatory compliance, and competitive advantage in the pharmaceutical industry.
FAQs
What is the primary focus of United States Patent 10,993,941?
The primary focus is on methods for administering VMAT2 inhibitors, specifically valbenazine and its isotopic variants.
What are the different dosage forms covered by the patent?
The patent covers tablets, capsules, granules, and powders, including immediate and modified release forms.
Why is patent protection important for VMAT2 inhibitors?
Patent protection ensures market exclusivity, allowing companies to recoup their investment in research and development.
What is the significance of pharmaceutically acceptable carriers and excipients in the patent?
These ensure the stability and bioavailability of the drug, complying with regulatory standards.
Is the patent involved in any litigation?
Yes, it is involved in a patent infringement lawsuit against Crystal Pharmaceutical (Suzhou) Co., Ltd. and Crystal Pharmatech Co., Ltd.
Cited Sources
- US10993941B2 - Methods for the administration of certain VMAT2 inhibitors - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NEUROCRINE BIOSCIENCES, INC. Plaintiff, v. CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD. and CRYSTAL PHARMATECH CO., LTD. Defendants. - Insight.RPXCorp
- Patent Analytics | Intellectual Property Law - SLWIP
