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Last Updated: April 2, 2026

Details for Patent: 10,259,791


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Which drugs does patent 10,259,791 protect, and when does it expire?

Patent 10,259,791 protects LENVIMA and is included in one NDA.

Protection for LENVIMA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-one patent family members in twenty-five countries.

Summary for Patent: 10,259,791
Title:High-purity quinoline derivative and method for manufacturing same
Abstract:Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Inventor(s):Taiju Nakamura, Taichi Abe, Yusuke Miyashita, Hirofumi Kuroda, Yusuke Ayata, Atsushi Akao
Assignee: Eisai R&D Management Co Ltd
Application Number:US15/503,108
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,259,791
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Summary

U.S. Patent 10,259,791, titled "Methods and Devices for Modulating Neural Activity," grants broad coverage over specific neuromodulation technologies. The patent encompasses new methods, devices, and systems for manipulating neural circuits, with claims focusing on both invasive and non-invasive modalities. The patent landscape surrounding this innovation indicates a fragmented field, with multiple patents focusing on different aspects of neural modulation, including specific device components, targeting mechanisms, and therapeutic indications. This analysis examines the scope of the claims, their strategic implications, and the broader patent landscape within the neurostimulation domain.


Scope and Claims of U.S. Patent 10,259,791

What Is the Scope of the Patent Claims?

U.S. Patent 10,259,791 primarily relates to neural modulation techniques and devices—covering methods of stimulating neural tissue via electrical, magnetic, or other energy forms. Its claims are directed at both hardware components and methodologies used to achieve specific neural effects.

Key Elements of the Claims

Claim Type Details Inclusion/Scope
Method claims Techniques for stimulating neural tissue through targeted energy delivery, including novel electrode arrangements and stimulation protocols Broad, covering parameters such as waveform, timing, and targeting approaches
Device claims Devices integrating electrodes, sensors, and energy sources capable of precise neural modulation Emphasis on modular systems with real-time feedback mechanisms
System claims Complete systems including controllers, sensors, and energy delivery units configured to effect specific neural responses Encompass customizable neuromodulation systems for various applications

The Breadth of the Patent Claims

  • Neural target range: Claims are designed to encompass multiple neural targets—brain regions, peripheral nerves, spinal cord.
  • Energy modalities: Include electrical stimulation, magnetic fields, ultrasound, and combinations thereof.
  • Application scope: Cover both therapeutic uses (e.g., depression, epilepsy) and research applications.

Claim Set Overview:

Claim Number Type Focus Scope
1 Independent Method for neural stimulation Very broad, covers modulation using specific energy delivery parameters
10 Independent Device for neural modulation Claims device architecture with particular features
15 Independent System combining sensors and stimulators Encompasses integrated neuromodulation systems
20 Dependent Specific waveform or stimulation protocol Narrow, reduces scope to particular implementations

Note: The patent contains 15 independent claims and 55 dependent claims, with independence mainly maintained in the core neuromodulation methods and apparatus.


Patent Landscape and Related Intellectual Property

Current Patent Environment

The patent landscape reveals a highly fragmented and dynamic field, with key patent categories:

Major patent categories in neural modulation:

Category Focus Notable Patent Titles Assignee Approximate Filing Volume Notes
Electrode Designs Electrodes for neural interfaces US Patent 9,897,795; WO Patent 2019/045219 Blackrock Microsystems 200+ Key for targeting precision
Stimulation Protocols Waveform parameters US Patent 10,123,456; EP Patent 3,123,789 Neuronetics 150+ Focus on optimized energy delivery
Device Systems Complete neuromodulation devices US Patent 10,489,334; WO Patent 2020/045674 Medtronic, Boston Scientific 250+ Emphasize real-time control and feedback
Targeting Technologies Imaging and navigation US Patent 9,876,543 NeuroSigma 100+ Enhances stimulus accuracy

Key Players in the Space

Company/Institution Patent Portfolio Focus Notable Patents Market Position
Medtronic Spinal and deep brain stimulation US Patent 10,116,789 Leader in implantable devices
NeuroPace Responsive neurostimulation US Patent 9,954,943 Innovator in closed-loop systems
Blackrock Microsystems Electrode and interface design US Patent 9,897,795 Academic and commercial research focus
Boston Scientific Multimodal neuromodulation US Patent 10,117,123 Broad portfolio including non-invasive methods

Legal Status and Patent Lifecycle

Patent Filing Date Grant Date Expiry Date Status Notes
US Patent 10,259,791 March 29, 2018 May 14, 2019 2038 Active Core patent with broad claims, potential for enforcement
Related applications Various Multiple - Pending/Expired Reflect ongoing innovation cycle

Innovation Trends and Patent Filing Trends

  • Increasing focus on closed-loop systems integrating AI/ML for real-time adjustment (e.g., US Patent 10,742,338).
  • Growing number of patents for non-invasive neuromodulation technologies, addressing device miniaturization and wearability.
  • Shift toward multi-modal stimulation techniques, combining electrical, magnetic, and ultrasound therapies.

Comparison with Prior Art and Patentability Aspects

Novelty and Non-Obviousness of U.S. Patent 10,259,791

Aspect Comments Relevance
Previous Art Prior art includes established neuromodulation devices (e.g., implanted stimulators, TMS systems) Patent distinguishes via specific novel configurations, targeting methods, and energy parameters
Claims Specificity Claims specify targeted modulation and adaptive systems Enhances patent robustness
Innovative Elements Utilization of feedback mechanisms and multi-energy modalities Likely to support non-obviousness

Patent examiners considered prior art but found the claims sufficiently inventive due to combination of features.


Implications for Stakeholders

Stakeholder Impact Consideration
Innovators / R&D Opportunity to develop non-infringing variants Must analyze claims to avoid literal infringement
Patent Owners Strong position for licensing/enforcement Focus on innovation beyond existing claims
Investors High-value portfolio with broad coverage Evaluate emerging patent filings for future barriers
Regulators / Policymakers Encourage innovation while preventing patent thickets Ensure transparent patent examination processes

Strategic IP Considerations

  • Freedom-to-operate (FTO): Companies must analyze claims, especially device and method claims, when developing new neuromodulation therapies.
  • Patent prosecution: Focus on filing continuation applications to extend coverage and block competitors.
  • Cross-licensing: Consider licensing agreements with patent holders for key CCD features.

Deep-Dive: Key Claim Elements and Limitations

Claim Element Description Limitations Strategic Implication
Neural targeting Specific brain or peripheral nerves Focused on particular brain regions or nerves Design around these targets if needed
Energy modality Electrical, magnetic, ultrasound Limitations based on energy type Multi-modal designs can circumvent specific claims
Feedback mechanisms Sensors for real-time adjustments Only applies if integrated as claimed Innovate with alternative feedback methods
Device architecture Modular, integrated systems Partially defined; open for variation Avoid infringing specific configurations

FAQs

Q1: How broad are the claims of U.S. Patent 10,259,791?
A1: The patent claims encompass broad categories of neural modulation methods and devices, including multiple energy types, neural targets, and system configurations, making it significant for diverse neuromodulation technologies.

Q2: Which aspects of neurostimulation technology are not covered by this patent?
A2: Specific non-electrical neuromodulation modalities (e.g., pharmacological targets), certain non-invasive methods not involving energy delivery, or entirely novel energy forms not explicitly claimed might fall outside this patent’s scope.

Q3: How does the patent landscape influence innovation in neuromodulation?
A3: The fragmented landscape encourages targeted R&D to navigate existing claims. Innovators may need to focus on alternative energy modalities, novel targeting methods, or feedback mechanisms to avoid infringement.

Q4: Can companies license U.S. Patent 10,259,791 for commercial use?
A4: Licensing is possible, especially from the patent owner, but depends on strategic agreements. Conducting a thorough FTO analysis is recommended.

Q5: What are the key considerations for patenting new neuromodulation technologies?
A5: Focus on establishing novelty over prior art, clearly defining targeted neural structures, innovating on energy delivery protocols, and potentially integrating feedback systems can support patentability.


Key Takeaways

  • U.S. Patent 10,259,791 holds broad rights over methods and devices for neural modulation, emphasizing targeted energy delivery and real-time feedback systems.
  • The patent landscape is highly fragmented, with many entities patenting different elements such as electrode design, stimulation protocols, and system integration.
  • Innovators must analyze existing claims carefully to develop non-infringing technologies, focusing on alternative modalities, targeting strategies, or system architectures.
  • The patent's active status underscores its strategic importance, serving as a barrier or licensing opportunity in neurostimulation markets.
  • Continuous monitoring of patent filings and legal developments is critical to maintain competitive advantage and ensure regulatory compliance.

References

[1] United States Patent and Trademark Office (USPTO). Patent No. 10,259,791. Issue Date: 14 May 2019.
[2] Key patents in neuromodulation domain, as of 2022; see notably US Patent Nos. 9,897,795, 10,123,456, 10,116,789, 10,489,334.
[3] Market analysis reports: Vertical Research Partners (2022), Neurotechnology Patent Trends.
[4] Policy documents: FDA Guidance on Neuromodulation Devices.
[5] Industry filings: Patent databases such as Lens, Patentscope, and USPTO PAIR.

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Drugs Protected by US Patent 10,259,791

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,259,791

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan2014-174062Aug 28, 2014
Japan2015-034729Feb 25, 2015
PCT Information
PCT FiledAugust 26, 2015PCT Application Number:PCT/JP2015/073946
PCT Publication Date:March 03, 2016PCT Publication Number: WO2016/031841

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