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Last Updated: December 23, 2024

Details for Patent: 10,844,058


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Summary for Patent: 10,844,058
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,l-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:16/899,641
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,844,058

Introduction

Understanding the scope and claims of a patent is crucial for navigating the complex landscape of intellectual property, particularly in the context of litigation and innovation. This article will delve into the specifics of United States Patent 10,844,058, examining its claims, the broader patent landscape, and the implications for businesses and innovators.

Background of the Patent

United States Patent 10,844,058 is part of a series of patents held by Neurocrine Biosciences, Inc., a company involved in the development of pharmaceutical products. This patent, along with others, has been central to several patent infringement lawsuits, particularly in the context of generic drug approvals[5].

Patent Claims and Scope

Claim Structure

Patent claims are the heart of any patent, defining the scope of protection granted to the inventor. For U.S. Patent 10,844,058, the claims would typically be categorized into independent and dependent claims. Independent claims stand alone and define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations[3].

Claim Language and Scope

The language used in patent claims is critical for determining their scope. Broader claims can encompass a wider range of embodiments, but they may also face challenges regarding clarity and validity. In contrast, narrower claims are more specific but may offer less protection. The scope of the claims in U.S. Patent 10,844,058 would be analyzed based on metrics such as independent claim length and count, which are indicators of patent scope and quality[3].

Patent Landscape and Related Patents

Context within Neurocrine Biosciences' Portfolio

U.S. Patent 10,844,058 is part of a larger portfolio of patents held by Neurocrine Biosciences, Inc. This portfolio includes multiple patents related to the company's flagship product, INGREZZA® Capsules, which are used for treating certain neurological conditions. The interplay between these patents is crucial, as they collectively define the company's intellectual property position in the market[5].

Litigation and Infringement

The patent has been involved in litigation, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed by generic drug manufacturers. For instance, Crystal Pharmaceutical (Suzhou) Co., Ltd. and Crystal Pharmatech Co., Ltd. have been accused of patent infringement related to their generic versions of valbenazine tosylate capsules, which are equivalent to Neurocrine's INGREZZA® Capsules[5].

Covered Business Method (CBM) Review

While U.S. Patent 10,844,058 is not directly subject to a Covered Business Method (CBM) review, understanding the criteria for CBM reviews can provide insight into the broader patent landscape. CBM reviews are used to challenge patents that are directed to "performing data processing or other operations used in the practice, administration, or management of a financial product or service," except for technological inventions. This distinction is important because it highlights the types of patents that may be subject to additional scrutiny and potential invalidation[1].

Metrics for Measuring Patent Scope

Independent Claim Length and Count

Research has shown that metrics such as independent claim length and count can be useful in measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process. This is relevant for understanding the strategic positioning of U.S. Patent 10,844,058 within Neurocrine's portfolio[3].

Patent Maintenance Payments and Forward Citations

Other metrics, such as patent maintenance payments and forward citations, can also indicate the scope and importance of a patent. Patents that receive more forward citations are generally considered more influential and broader in scope. Similarly, the willingness to pay maintenance fees can reflect the patent's value and the scope of protection it offers[3].

Implications for Businesses and Innovators

Strategic Patent Management

For businesses, understanding the scope and claims of patents like U.S. Patent 10,844,058 is crucial for strategic patent management. This includes navigating potential infringement risks, identifying opportunities for licensing or collaboration, and ensuring that their own innovations do not infringe on existing patents.

Innovation and Litigation

The involvement of U.S. Patent 10,844,058 in litigation highlights the importance of robust patent strategies. Innovators must balance the need to protect their intellectual property with the risk of litigation and the potential for patent challenges. This balance is particularly delicate in highly competitive fields like pharmaceuticals.

Key Takeaways

  • Patent Claims: The claims of U.S. Patent 10,844,058 define its scope and are critical for understanding its protection.
  • Patent Landscape: The patent is part of a broader portfolio related to Neurocrine's pharmaceutical products.
  • Litigation: The patent has been involved in infringement lawsuits related to generic drug approvals.
  • Metrics for Scope: Independent claim length, count, and other metrics can help measure the patent's scope and importance.
  • Strategic Management: Understanding the patent's scope is essential for businesses to manage their intellectual property strategically.

FAQs

Q: What is the significance of U.S. Patent 10,844,058 in the context of Neurocrine Biosciences' portfolio? A: U.S. Patent 10,844,058 is part of Neurocrine Biosciences' portfolio related to their flagship product, INGREZZA® Capsules, and plays a crucial role in protecting their intellectual property in the pharmaceutical market.

Q: How are patent claims structured, and what is their importance? A: Patent claims are structured into independent and dependent claims, with independent claims defining the broadest scope of the invention. These claims are essential for determining the scope of protection granted to the inventor.

Q: What metrics are used to measure patent scope? A: Metrics such as independent claim length, independent claim count, patent maintenance payments, and forward citations are used to measure patent scope and indicate the patent's importance and influence.

Q: What is a Covered Business Method (CBM) review, and how does it relate to U.S. Patent 10,844,058? A: A CBM review is a process to challenge patents directed to performing data processing or other operations used in the practice, administration, or management of a financial product or service. While U.S. Patent 10,844,058 is not subject to CBM review, understanding CBM criteria provides insight into the broader patent landscape.

Q: Why is it important for businesses to understand the scope and claims of patents like U.S. Patent 10,844,058? A: Understanding the scope and claims of patents is crucial for businesses to navigate potential infringement risks, identify licensing opportunities, and ensure their innovations do not infringe on existing patents.

Sources

  1. Healthcare Data Analytics Patent Subject to “CBM” Review at USPTO - Holland & Knight LLP
  2. Patent Claims Research Dataset - USPTO
  3. Patent Claims and Patent Scope - Hoover Institution
  4. Nature-Based Products - USPTO
  5. Complaint for Patent Infringement - Insight.RPXcorp.com

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Drugs Protected by US Patent 10,844,058

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 10,844,058 ⤷  Subscribe Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No 10,844,058 ⤷  Subscribe Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 AB RX Yes No 10,844,058 ⤷  Subscribe Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 AB RX Yes No 10,844,058 ⤷  Subscribe Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes 10,844,058 ⤷  Subscribe Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes 10,844,058 ⤷  Subscribe Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Subscribe
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-001 Apr 30, 2024 RX Yes No 10,844,058 ⤷  Subscribe Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,844,058

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

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