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Last Updated: December 23, 2024

Details for Patent: 10,906,902


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Summary for Patent: 10,906,902
Title:Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Abstract: Provided herein are processes for the preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate), or a solvate, hydrate, or polymorph thereof.
Inventor(s): McGee; Kevin (San Diego, CA), Li; Bin-Feng (Suzhou Industrial Park, CN), Branum; Shawn (San Diego, CA)
Assignee: Neurocrine Biosciences, Inc. (San Diego, CA)
Application Number:16/929,694
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

United States Patent 10,906,902: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,906,902, hereafter referred to as the '902 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent is associated with Neurocrine Biosciences, Inc. and pertains to specific synthetic methods and compounds, particularly those related to valbenazine, a drug used for the treatment of tardive dyskinesia.

Background of the Patent

The '902 patent is part of a broader portfolio of patents held by Neurocrine Biosciences, Inc., which are crucial for the company's intellectual property strategy. These patents protect various aspects of valbenazine, including its synthesis, formulation, and use.

Scope of the Patent

Synthetic Methods

The '902 patent primarily focuses on synthetic methods for preparing specific compounds, notably the (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)[1].

Compound Specificity

The patent details the preparation of this complex compound, which involves several steps and intermediates. The specificity of the compound and its synthesis process is critical, as it ensures the production of a high-quality active pharmaceutical ingredient (API).

Claims of the Patent

Independent Claims

The '902 patent includes several independent claims that define the scope of the invention. These claims typically cover the synthetic methods, the compounds themselves, and any specific conditions or reagents used in the synthesis process[1].

Dependent Claims

Dependent claims further narrow down the scope by specifying particular aspects of the independent claims, such as specific reagents, reaction conditions, or purification methods. These claims provide additional protection by covering various embodiments of the invention.

Patent Landscape

Related Patents

The '902 patent is part of a larger family of patents related to valbenazine. Other patents, such as U.S. Patent Nos. 10,993,941, 11,026,931, 11,026,939, and 11,040,029, also protect various aspects of valbenazine, including its use, formulation, and other synthetic methods[2][5].

Litigation and Enforcement

The '902 patent has been involved in several patent infringement lawsuits. Neurocrine Biosciences, Inc. has filed complaints against various generic drug manufacturers, including Crystal Pharmaceutical (Suzhou) Co., Ltd. and Sandoz Inc., alleging infringement of this and other related patents. These lawsuits highlight the importance of these patents in protecting Neurocrine's intellectual property rights[2][5].

Impact on the Pharmaceutical Industry

Protection of Intellectual Property

The '902 patent, along with other related patents, plays a crucial role in protecting Neurocrine's intellectual property. This protection is essential for maintaining market exclusivity and preventing generic competition until the patents expire.

Innovation and Research

The patent landscape around valbenazine encourages innovation by providing a financial incentive for research and development. Companies are more likely to invest in R&D when they can protect their inventions and recoup their investments through patent protection.

Metrics for Measuring Patent Scope

Independent Claim Length and Count

Research suggests that the scope of a patent can be measured using metrics such as independent claim length and count. Narrower claims, as seen in the '902 patent, are often associated with a higher probability of grant and a shorter examination process[3].

Global Patent System Integration

Global Dossier and Common Citation Document

The '902 patent, like other patents, benefits from global patent system integration tools such as the Global Dossier and the Common Citation Document. These tools facilitate the management and analysis of patent applications across different jurisdictions, enhancing the efficiency of the patent system[4].

Public Access and Search Facilities

USPTO Resources

The United States Patent and Trademark Office (USPTO) provides various resources, including the Public Search Facility and Patent and Trademark Resource Centers (PTRCs), which allow the public to access and search patent information. This transparency is crucial for understanding the patent landscape and ensuring compliance with existing patents[4].

Key Takeaways

  • The '902 patent protects specific synthetic methods for valbenazine-related compounds.
  • It is part of a broader portfolio of patents held by Neurocrine Biosciences, Inc.
  • The patent has been involved in several infringement lawsuits to protect Neurocrine's intellectual property.
  • The scope of the patent is defined by its independent and dependent claims.
  • Metrics such as independent claim length and count can help measure the patent's scope.
  • Global patent system integration tools enhance the management and analysis of patent applications.

FAQs

What is the main subject of the '902 patent?

The '902 patent primarily deals with synthetic methods for preparing specific compounds related to valbenazine.

Why is the '902 patent important for Neurocrine Biosciences, Inc.?

The '902 patent is crucial for protecting Neurocrine's intellectual property rights related to valbenazine, ensuring market exclusivity and preventing generic competition.

How does the '902 patent fit into the broader patent landscape?

The '902 patent is part of a larger family of patents related to valbenazine, including other patents that protect various aspects of the drug's synthesis, formulation, and use.

What are some metrics used to measure the scope of a patent like the '902 patent?

Metrics such as independent claim length and count are used to measure the scope of a patent. Narrower claims are often associated with a higher probability of grant and a shorter examination process.

How can the public access information about the '902 patent?

The public can access information about the '902 patent through the USPTO's Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online databases.

Cited Sources:

  1. US10906902B2 - Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) - Google Patents
  2. 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. Civil Action No. ____ COMPLAINT FOR PATENT INFRINGEMENT - Insight.RPXCorp
  3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
  4. Search for patents - USPTO
  5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE Civil Action No. COMPLAINT FOR PATENT INFRINGEMENT Neurocrine Biosciences, Inc. (“Neurocrine”), by way of Complaint against Defendants Sandoz Inc., Sandoz AG and Sandoz International GmbH (“Sandoz Int’l”) - Insight.RPXCorp

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Drugs Protected by US Patent 10,906,902

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 10,906,902 ⤷  Subscribe Y Y ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 AB RX Yes No 10,906,902 ⤷  Subscribe Y Y ⤷  Subscribe
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes 10,906,902 ⤷  Subscribe Y Y ⤷  Subscribe
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-001 Apr 30, 2024 RX Yes No 10,906,902 ⤷  Subscribe Y Y ⤷  Subscribe
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-002 Apr 30, 2024 RX Yes No 10,906,902 ⤷  Subscribe Y Y ⤷  Subscribe
Neurocrine INGREZZA SPRINKLE valbenazine tosylate CAPSULE;ORAL 218390-003 Apr 30, 2024 RX Yes Yes 10,906,902 ⤷  Subscribe Y Y ⤷  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 10,906,902

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3009169 ⤷  Subscribe
China 108925135 ⤷  Subscribe
Denmark 3394057 ⤷  Subscribe
European Patent Office 3394057 ⤷  Subscribe
Spain 2911351 ⤷  Subscribe
Croatia P20220621 ⤷  Subscribe
Hungary E059065 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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