Detailed Analysis of the Scope and Claims of United States Patent 10,940,141
Introduction
United States Patent 10,940,141, titled "Methods for the administration of certain VMAT2 inhibitors," is a significant patent in the field of neuropharmacology, particularly for the treatment of conditions involving abnormal motor movements. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background on VMAT2 Inhibitors
VMAT2 (vesicular monoamine transporter 2) inhibitors are a class of drugs that regulate the transport of monoamines, such as dopamine, serotonin, and norepinephrine, into synaptic vesicles. Valbenazine, a prominent VMAT2 inhibitor, is used to treat tardive dyskinesia and chorea associated with Huntington's disease[1].
Patent Overview
Publication and Filing Details
The patent 10,940,141 was published on March 9, 2021, and is assigned to Neurocrine Biosciences, Inc. It is part of a series of patents related to the administration and formulation of VMAT2 inhibitors, particularly valbenazine[4].
Scope of the Patent
This patent focuses on methods for administering VMAT2 inhibitors, specifically to subjects with severe renal impairment. The scope includes various dosage forms and administration protocols tailored to ensure effective treatment while minimizing adverse effects in patients with compromised renal function.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core inventions. These claims cover:
- Methods of Administration: Specific methods for administering a VMAT2 inhibitor, such as valbenazine, to patients with severe renal impairment. This includes adjusting dosages based on creatinine clearance levels[4].
- Dosage Forms: Various pharmaceutical compositions, including capsules, tablets, and other formulations designed to optimize the delivery of the VMAT2 inhibitor.
- Therapeutic Regimens: Detailed therapeutic regimens that outline the timing, dosage, and frequency of administration to ensure efficacy and safety.
Dependent Claims
Dependent claims further specify the independent claims by detailing:
- Specific Dosage Adjustments: How to adjust the dosage based on the patient's renal function.
- Monitoring and Adjustment: Procedures for monitoring patients and adjusting the dosage as necessary.
- Combination Therapies: Methods for combining the VMAT2 inhibitor with other medications to enhance therapeutic outcomes.
Patent Landscape
Related Patents
The patent 10,940,141 is part of a larger portfolio of patents held by Neurocrine Biosciences, Inc., related to VMAT2 inhibitors. Other patents in this series include:
- U.S. Patent Nos. 10,065,952, 10,844,058, 10,851,103, 10,851,104, 10,857,137, 10,857,148, 10,874,648, 10,906,902, 10,906,903, 10,912,771, 10,919,892, 10,952,997: These patents cover various aspects of VMAT2 inhibitors, including their synthesis, formulation, and use in treating different conditions[2][5].
Litigation and Infringement
The patent has been involved in litigation related to patent infringement. Neurocrine Biosciences, Inc. has filed complaints against generic drug manufacturers, such as Crystal Pharmaceutical (Suzhou) Co., Ltd., for attempting to market generic versions of valbenazine before the expiration of the patents-in-suit[5].
Expiration Dates
The patent 10,940,141 is estimated to expire on August 10, 2040, which is one of the later expiration dates among the related patents. This extended protection period is crucial for maintaining market exclusivity for Neurocrine Biosciences, Inc.[2].
Impact on Treatment and Innovation
Clinical Significance
The methods described in this patent are clinically significant because they provide tailored treatment protocols for patients with severe renal impairment, a population that often faces challenges with drug metabolism and excretion. This ensures that these patients can safely and effectively receive VMAT2 inhibitors like valbenazine.
Innovation and Research
The patent encourages innovation by providing a framework for further research into the administration and formulation of VMAT2 inhibitors. It also highlights the importance of adjusting treatment regimens based on patient-specific factors, such as renal function, which can lead to better therapeutic outcomes.
Key Takeaways
- Methods of Administration: The patent outlines specific methods for administering VMAT2 inhibitors to patients with severe renal impairment.
- Dosage Forms and Adjustments: It includes various dosage forms and detailed protocols for adjusting dosages based on renal function.
- Patent Landscape: Part of a broader portfolio of patents related to VMAT2 inhibitors, with significant implications for market exclusivity and litigation.
- Clinical Impact: Provides clinically relevant treatment protocols that enhance safety and efficacy for a specific patient population.
- Innovation: Encourages further research and innovation in the field of neuropharmacology.
FAQs
What is the primary focus of United States Patent 10,940,141?
The primary focus of this patent is on methods for administering VMAT2 inhibitors, particularly to patients with severe renal impairment.
Which drug is specifically mentioned in this patent?
The drug specifically mentioned is valbenazine, a VMAT2 inhibitor used to treat conditions like tardive dyskinesia and chorea associated with Huntington's disease.
What are the key claims of this patent?
The key claims include methods of administration, dosage forms, and therapeutic regimens tailored for patients with severe renal impairment.
Is this patent involved in any litigation?
Yes, this patent has been involved in litigation related to patent infringement against generic drug manufacturers.
When is the patent estimated to expire?
The patent is estimated to expire on August 10, 2040.
Sources
- DrugBank: Valbenazine: Uses, Interactions, Mechanism of Action.
- FDA: Approved Drug Products with Therapeutic Equivalence Evaluations.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Methods for the administration of certain VMAT2 inhibitors.
- RPX Corporation: Complaint for Patent Infringement.
