Details for Patent: 10,851,104

Which drugs does patent 10,851,104 protect, and when does it expire?

Patent 10,851,104 protects INGREZZA and INGREZZA SPRINKLE and is included in two NDAs.

This patent has fifty-two patent family members in thirty-two countries.

Summary for Patent: 10,851,104

Title:	Valbenazine salts and polymorphs thereof
Abstract:	Provided herein are salts of (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[- 2,1-a]-isoquinolin-2-yl ester in amorphous and crystalline forms, and processes of preparation, and pharmaceutical compositions thereof. Also provided are methods of their use for treating, preventing, or ameliorating one or more symptoms of neurological disorders and diseases including hyperkinetic movement disorders or diseases.
Inventor(s):	McGee; Kevin (San Diego, CA), Zook; Scott E. (San Diego, CA), Carr; Andrew (Cambridge, GB), Bonnaud; Thierry (Cambridge, GB), Li; Bin-Feng (Suzhou Industrial Park, CN)
Assignee:	Neurocrine Biosciences, Inc. (San Diego, CA)
Application Number:	16/899,654
Patent Claim Types: see list of patent claims	Use; Compound; Process;

United States Patent 10,851,104: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,851,104, hereafter referred to as the '104 patent, is part of a broader patent portfolio related to valbenazine, a medication used for the treatment of tardive dyskinesia. This analysis will delve into the scope, claims, and the surrounding patent landscape to provide a comprehensive understanding.

Background on Valbenazine

Valbenazine, marketed under the brand name INGREZZA by Neurocrine Biosciences, Inc., is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It is specifically designed to treat tardive dyskinesia, a condition characterized by involuntary, repetitive body movements that can be a side effect of long-term use of antipsychotic medications[2][5].

Patent Overview

The '104 patent is one of several patents held by Neurocrine Biosciences, Inc. that protect various aspects of valbenazine, including its salts, polymorphs, and methods of use. Here is a breakdown of the key components:

Patent Number and Classification

• Patent Number: 10,851,104
• Classification: This patent falls under the category of pharmaceutical compositions and methods of treatment, specifically related to VMAT2 inhibitors.

Inventors and Assignees

• Inventors: The inventors listed on the patent are typically researchers and scientists from Neurocrine Biosciences, Inc.
• Assignees: Neurocrine Biosciences, Inc. is the assignee, holding the rights to the patent.

Filing and Grant Dates

• Filing Date: The filing date indicates when the patent application was submitted.
• Grant Date: The grant date marks when the patent was officially approved and granted by the USPTO.

Scope of the Patent

The scope of the '104 patent is defined by its claims, which outline the specific inventions and innovations protected.

Claims

The patent includes multiple claims that cover various aspects of valbenazine:

• Composition Claims: These claims pertain to the chemical composition of valbenazine salts and polymorphs.
• Method Claims: These claims cover the methods of treating or preventing hyperkinetic disorders using valbenazine.
• Use Claims: These claims specify the therapeutic uses of valbenazine, including the treatment of tardive dyskinesia.

Independent and Dependent Claims

• Independent Claims: These are the primary claims that stand alone and define the core inventions.
• Dependent Claims: These claims build upon the independent claims, providing additional specificity and protection.

Patent Landscape

The patent landscape surrounding the '104 patent is complex and involves multiple related patents and legal actions.

Related Patents

Neurocrine Biosciences, Inc. holds a portfolio of patents related to valbenazine, including:

• U.S. Patent Nos. 10,993,941, 11,026,931, 11,026,939, and 11,040,029: These patents also cover various aspects of valbenazine and are often cited together in legal actions[2][5].

Litigation and Infringement Actions

The '104 patent has been involved in several patent infringement lawsuits, particularly against generic drug manufacturers:

• Neurocrine Biosciences, Inc. v. Crystal Pharmaceutical (Suzhou) Co., Ltd. et al.: This lawsuit involves allegations of patent infringement related to Crystal’s Abbreviated New Drug Application (ANDA) for a generic version of valbenazine[2][5].

ANDA Filings and Generic Challenges

Generic manufacturers have filed ANDAs seeking FDA approval to market generic versions of valbenazine before the expiration of Neurocrine’s patents. These filings often include certifications that the generic products do not infringe the patents or that the patents are invalid or unenforceable[2][5].

Metrics for Measuring Patent Scope

The scope of the '104 patent can be evaluated using metrics such as independent claim length and independent claim count, as discussed in patent scope analysis literature:

• Independent Claim Length: Longer independent claims may indicate a narrower scope but greater specificity.
• Independent Claim Count: A higher number of independent claims can suggest a broader scope of protection[3].

Impact on Innovation and Competition

The '104 patent and related patents play a significant role in protecting Neurocrine’s intellectual property and influencing the competitive landscape in the pharmaceutical industry:

• Innovation Incentives: Patents like the '104 patent provide incentives for innovation by protecting the intellectual property of pharmaceutical companies.
• Litigation and Licensing: The presence of these patents can lead to increased litigation and licensing costs, which can affect the entry of generic competitors into the market[3].

Key Takeaways

• Comprehensive Protection: The '104 patent, along with other related patents, provides comprehensive protection for valbenazine, covering its composition, methods of use, and therapeutic applications.
• Litigation Landscape: The patent is part of ongoing litigation involving generic drug manufacturers, highlighting the importance of patent protection in the pharmaceutical industry.
• Innovation and Competition: The patent landscape around valbenazine influences innovation and competition, balancing the need for new treatments with the entry of generic competitors.

FAQs

What is the primary use of valbenazine protected by the '104 patent?

Valbenazine, protected by the '104 patent, is primarily used for the treatment of tardive dyskinesia.

Which company holds the '104 patent?

The '104 patent is held by Neurocrine Biosciences, Inc.

What are the key claims of the '104 patent?

The key claims include composition claims for valbenazine salts and polymorphs, method claims for treating hyperkinetic disorders, and use claims for therapeutic applications.

Is the '104 patent involved in any litigation?

Yes, the '104 patent is involved in several patent infringement lawsuits against generic drug manufacturers.

How does the '104 patent impact the pharmaceutical industry?

The '104 patent and related patents protect Neurocrine’s intellectual property, influencing innovation and competition by delaying the entry of generic competitors into the market.

Sources

1. US10851104B2 - Valbenazine salts and polymorphs thereof - Google Patents
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - Insight.RPXCorp
3. Patent Claims and Patent Scope - SSRN
4. Search for patents - USPTO
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE - Insight.RPXCorp

Drugs Protected by US Patent 10,851,104

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No				Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No				Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No				Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No				Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes				Y		TREATMENT OF TARDIVE DYSKINESIA
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes				Y		A METHOD OF TREATING HUNTINGTON'S CHOREA
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No				Y		TREATMENT OF TARDIVE DYSKINESIA

International Family Members for US Patent 10,851,104

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016343633
Brazil	112018008460
Canada	3002074
Chile	2018001089
China	108473489
China	115304596
China	115322188