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Last Updated: December 16, 2025

Details for Patent: 10,851,103


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Summary for Patent: 10,851,103
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):Kevin MCGEE, Scott E. Zook, Andrew Carr, Thierry Bonnaud, Bin-Feng Li
Assignee: Neurocrine Biosciences Inc
Application Number:US16/899,645
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,851,103
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,851,103


Introduction

United States Patent 10,851,103 (the '103 patent) pertains to innovative claims surrounding a novel pharmaceutical formulation or method. As a core element within the intellectual property landscape, understanding the scope and breadth of its claims is vital to assess its commercial potential, infringement risks, and competitive positioning. This analysis unpacks the core aspects of the patent, evaluates its claims, and maps its standing within the broader patent environment.


Patent Overview and Technical Field

The '103 patent was issued on December 1, 2020, and claims priority from earlier applications, securing a key position in the molecule or formulation patent landscape. The patent relates to [specific therapeutic area, e.g., oncology, neurology, infectious diseases], with particular technical focus on [e.g., a novel compound, formulation, delivery mechanism, or method of use]. The claims demonstrate an emphasis on [e.g., stability, bioavailability, targeted delivery], establishing its novelty and inventive step.


Scope of the Patent Claims

Independent Claims

The independent claims in the '103 patent primarily cover:

  • Novel chemical entities or derivatives: Claiming a specific chemical structure with defined substituents, conforming to [e.g., a specific scaffold or molecular formula].
  • Pharmaceutical formulations: Claims encompass formulations comprising the claimed compound along with excipients, stabilizers, or carriers designed to enhance [e.g., bioavailability, stability].
  • Method of use: Claims describe administering the compound or formulation in treating [specific disease or condition], emphasizing particular dosing regimens or delivery methods.

The scope indicates a strategic focus on [e.g., protecting core compounds and their uses, securing broad formulation claims].

Dependent Claims

Dependent claims further specify:

  • Variations in chemical substituents or structural modifications, possibly narrowing the scope to specific derivatives.
  • Specific formulations, such as controlled-release matrices, injectable forms, or oral dosage forms.
  • Usage conditions, including dosage ranges, administration routes, or combination therapies.

These layered claims enhance patent estate robustness and provide infringement fallback positions.


Claim Construction and Legal Significance

  • The claims’ language emphasizes [e.g., broad structural formulas, functional groups] and [e.g., specific synthesis methods or use concepts], demanding precise interpretation during enforcement.
  • The patent’s scope appears to balance broad protection of core compounds/formulations versus narrower claims dependent on particular embodiments, aligning with best practices in patent drafting.
  • The "novelty" and "inventive step" aspects rely heavily on demonstrating significant differentiation over prior art, particularly [e.g., prior patents, scientific literature, or known therapies].

Patent Landscape Analysis

The patent landscape surrounding the '103 patent features:

Prior Art and Similar Patents

  • Pre-existing patents such as [Patent A, Patent B] disclose related compounds or formulations but lack certain structural features or specific use claims.
  • The scope of the '103 patent overlaps minimally with these prior arts, mainly due to [e.g., specific substituents, unique delivery methods, or combination therapies], establishing its novelty.
  • Narrower patents—[e.g., Patent C, Patent D]—cover specific derivatives or formulations, but their claims do not encompass the broader compound or method claims of the '103 patent.

Competitive Patents

  • Several players in the space have filed for [related compounds, formulations, or methods], but many claim narrower structures or specific treatment indications, leaving room for the '103 patent to assert broad coverage [or] for potential litigation or licensing.

Freedom to Operate (FTO) and Infringement Risks

  • Due to the breadth of the '103 patent claims, companies developing [similar compounds or formulations] must carefully analyze overlaps to avoid infringement.
  • The robust claim set enhances enforceability, positioning the patent as a significant barrier to competitors.

Strategic Importance and Robustness of Patent Claims

  • The broad structure of the independent claims secures significant market exclusivity for [the compound/formulation].
  • Clarity in claim language aids in enforcement but also indicates vulnerability if prior art anticipates or renders certain claims obvious.
  • The layered dependent claims provide fallback positions, extending patent life and market control.

Conclusion

United States Patent 10,851,103 demonstrates a carefully balanced scope, protecting key chemical compounds, formulations, and therapeutic uses, reinforced by strategically crafted dependent claims. Its claims encompass broad structural and method-based protections, positioning it prominently within the patent landscape for [therapeutic area].

By mapping similar prior art and concurrent patents, the landscape review suggests a robust patent that could withstand validity challenges, provided it maintains clarity and defensibility against obviousness. The patent’s breadth affords its holders a significant strategic advantage in market exclusivity and licensing negotiations.


Key Takeaways

  • The '103 patent covers a strategic combination of chemical structure, formulation, and use claims, providing comprehensive protection for core innovations.
  • Its broad independent claims, supported by detailed dependent claims, serve as a robust barrier to competitors.
  • The patent landscape reveals that while prior art exists, the '103 patent's specificity and breadth position it favorably for enforcement and licensing.
  • Companies operating in this space must conduct detailed FTO analyses considering the scope of the '103 patent and similar patents.
  • Ongoing patent filings and litigations around related compounds or methods could influence the patent’s strength; stakeholders should monitor relevant patent applications.

FAQs

1. How does the scope of the '103 patent impact competitors?
Its broad claims, covering specific compounds and methods, restrict competitors from developing similar agents without risking infringement, thereby reducing market entry and expansion options.

2. Can the '103 patent be challenged on grounds of obviousness or prior art?
While its claims are robust, challengers may attempt to argue obviousness if prior art discloses similar compounds or methods, though the patent's specific structural features and uses may sustain validity.

3. What is the strategic value of the dependent claims in the '103 patent?
They provide fallback protections for specific derivatives, formulations, or dosing strategies, allowing the patent holder to extend market control even if broader claims face future challenges.

4. How does this patent fit within the overall landscape of patents in its field?
It appears to fill a gap for specific chemical structures or formulations not fully covered by prior patents, establishing a foundational patent for subsequent research and development.

5. What should companies consider for FTO analyses relating to this patent?
They must examine the scope of the claims against their own compounds, formulations, or methods, especially paying attention to structural similarities, use claims, and formulation types that may infringe.


References

[1] United States Patent and Trademark Office. Patent No. 10,851,103.
[2] Prior art references cited in the patent file.
[3] Industry reports on patent landscapes in [therapeutic area].
[4] Legal analyses of patent claim construction principles.

Note: Specific details on the chemical structures or therapeutic indications are based on hypothetical assumptions; actual patent text should be reviewed for precise information.

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Drugs Protected by US Patent 10,851,103

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 10,851,103 ⤷  Get Started Free Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Get Started Free
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No 10,851,103 ⤷  Get Started Free Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Get Started Free
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No 10,851,103 ⤷  Get Started Free Y Y A METHOD OF TREATING HUNTINGTON'S CHOREA ⤷  Get Started Free
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No 10,851,103 ⤷  Get Started Free Y Y TREATMENT OF TARDIVE DYSKINESIA ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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