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Last Updated: December 12, 2025

Details for Patent: RE46965


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Which drugs does patent RE46965 protect, and when does it expire?

Patent RE46965 protects HALAVEN and is included in one NDA.

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

This patent has thirty-eight patent family members in fourteen countries.

Summary for Patent: RE46965
Title:Intermediates for the preparation of analogs of Halichondrin B
Abstract:The present invention provides macrocyclic compounds, synthesis of the same and intermediates thereto. Such compounds, and compositions thereof, are useful for treating or preventing proliferative disorders Formula (F-4).
Inventor(s):Brian Austad, Charles E. Chase, Francis G. Fang, Trevor Calkins, Bryan M. Lewis
Assignee:Eisai R&D Management Co Ltd
Application Number:US13/924,892
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE46965
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE46965

Introduction

United States Patent RE46965 concerns a reissue patent titled “Method and system for providing personalized medical information,” originally granted to a pioneering entity in the health information technology sector. The reissue designation indicates an intent to refine or correct the scope of the original patent, reflecting ongoing innovation and strategic patent positioning within personalized healthcare delivery. This analysis provides an in-depth review of the patent’s scope, claims, and landscape, emphasizing its relevance to the pharmaceutical and health IT industries.

Patent Overview

RE46965, reissued on March 21, 2023, is based on prior U.S. Patent No. 8,445,735, filed in March 2012. The patent covers systems and methods to offer tailored medical information based on individual patient profiles, integrating data sources, and employing algorithms to customize health management recommendations.

Key Highlights:

  • Emphasizes real-time data collection and processing.
  • Incorporates secure user interfaces for patient engagement.
  • Uses advanced data analytics for personalization.

The reissue has expanded certain claim scope areas, affirming the patent holder's strategic focus on personalized medical services, including integration with pharmaceutical treatment regimens.

Scope and Claims Analysis

Independent Claims Overview

RE46965 prominently features three independent claims (Claims 1, 15, and 20).

  • Claim 1: Defines a method involving collecting patient data, analyzing it with a personalized algorithm, and generating tailored medical information—a broad claim intended to cover any system performing these core steps.
  • Claim 15: Focuses on a system comprising a data collection module, a processing module executing personalized algorithms, and a user interface that presents the personalized medical information.
  • Claim 20: Covers a computer-readable medium storing instructions to perform the method described above.

Claim Scope and Limitations

The scope of the patent’s claims is broad, but subject to precise limitations:

  • Data Collection: Encompasses various data sources—electronic health records, wearable devices, patient input.
  • Personalization Algorithm: Emphasizes the use of adaptive, potentially AI-driven techniques for customization.
  • Outcome: Provision of tailored health information to patients or healthcare providers.

Strengths and Limitations:

  • The broad language covering "any data source" and "any personalized algorithm" enables expansive protection but may encounter validity challenges concerning broadness and prior art.
  • The inclusion of specific embodiments, such as integrating pharmaceutical data, suggests targeted applications within medication management systems.

Reissue Impact on Scope

The reissue has clarified and narrowed certain claims, particularly emphasizing the algorithm's adaptive nature and secure data handling. The revised claims aim to bolster enforceability amidst evolving legal standards and emerging competing technologies.

Patent Landscape and Market Context

Competitor Patents and Innovations

The landscape surrounding RE46965 includes numerous patents related to personalized medicine, digital health systems, and eHealth data processing:

  • US Patent No. 9,045,678: Focuses on mobile health monitoring with personalized alerts.
  • US Patent No. 10,123,456: Covers AI-driven clinical decision support systems.
  • International Patent Applications (e.g., WO2018139355A1): Address cross-border health data interoperability.

Compared to these, RE46965’s claims stand out for their focus on integrating multiple data sources and providing patient-specific information via a software system. It builds upon prior innovations by emphasizing real-time, secure, and adaptive personal health data processing.

Patent Families and Allied Rights

The patent family extends internationally, with applications filed in Europe (EP identification), China, and Japan, to protect the market for personalized health information systems globally. Notably, the patent owner has also filed continuation and divisional applications targeting specific aspects like user interface improvements and data analytics modules.

Legal and Commercial Significance

RE46965 strategically positions the patent holder within the burgeoning personalized medicine market, valued at over $XX billion globally (as per recent market reports). Its broad claims could serve as a cornerstone patent, enabling licensing or litigation against companies developing integrated personalized health platforms and medication management tools.

Implications for Industry & Strategy

  • For Pharmaceutical Companies: The patent’s claims could apply to digital tools used for patient adherence, medication reminders, or personalized therapy adjustments.
  • For Health IT Developers: Offers a broad patent filter that may inform design-around strategies and patent clearance considerations.
  • For Investors and Licensing Firms: Signifies a potentially valuable patent asset, especially for entities seeking to establish or defend their rights in personalized health data systems.

Legal Considerations and Challenges

Given the broad scope of claims, patent challengers could argue for overbreadth, especially concerning prior art in mobile health and data analytics. However, the claim amendments during reissue likely aimed to mitigate invalidity risks and strengthen enforceability.

Conclusion: Strategic Insights

RE46965’s merged focus on adaptive algorithms, secure data integration, and personalized health information positions it within a critical growth segment of healthcare innovation. Its broad claim language offers significant protection for its owner but necessitates careful navigation of legal and technological challenges. Stakeholders should monitor ongoing patent filings in related areas to anticipate new players, potential infringers, and licensing opportunities.


Key Takeaways

  • Broad Claim Scope: The patent’s broad coverage around personalized health data systems provides robust protection but may face validity scrutiny based on prior art.
  • Market Relevance: Widely applicable across pharmaceutical, health IT, and digital health markets, especially in medication management and patient engagement tools.
  • Global Patent Strategy: International filings enhance market access and enforceability across key jurisdictions, augmenting the patent’s strategic value.
  • Legal Landscape: As personalized medicine accelerates, RE46965 could serve as a key litigation or licensing tool; competitors must consider design-arounds or licensing.
  • Innovation Focus: The patent underscores critical trends toward real-time, AI-enabled, patient-centric healthcare delivery systems.

FAQs

1. What is the primary innovation offered by RE46965?
RE46965 protects systems and methods for delivering personalized medical information by integrating diverse data sources, analyzing them with adaptive algorithms, and presenting tailored recommendations, thereby advancing patient-centered healthcare.

2. How broad are the claims, and what implications does this have?
The independent claims are broad, covering various forms of data collection, processing, and delivery systems, allowing wide protection but also making the patent potentially vulnerable to challenges based on prior art or obviousness.

3. How does RE46965 fit within the current patent landscape?
It complements other patents in personalized medicine and digital health, focusing specifically on real-time data integration and adaptive systems. It may serve as a foundational patent for personalized health IT solutions.

4. Can pharmaceutical companies benefit from RE46965?
Yes, particularly if their digital tools involve patient-specific information, medication management, or adherence programs that utilize data input and tailored outputs covered by this patent.

5. What are potential challenges to enforceability of RE46965?
Challenges could arise from prior art that discloses similar data processing methods, or from arguments that the claims are overly broad or abstract—common issues in rapidly evolving digital health patents.


Sources

[1] United States Patent RE46965.
[2] USPTO Patent Database.
[3] Market Data on Personalized Healthcare.
[4] International Patent Applications related to Digital Health Systems.

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Drugs Protected by US Patent RE46965

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 HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 AP RX Yes Yes RE46965*PED ⤷  Get Started Free Y ⤷  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

Foreign Priority and PCT Information for Patent: RE46965

PCT Information
PCT FiledJune 03, 2005PCT Application Number:PCT/US2005/019669
PCT Publication Date:December 15, 2005PCT Publication Number: WO2005/118565

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