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Last Updated: December 19, 2025

Patent: 10,232,041


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Summary for Patent: 10,232,041
Title:Combination of lenalidomide and polypeptide construct, and uses thereof
Abstract:Methods for cancer treatment include administering to a cancer patient an anti-CD38 antibody-attenuated human IFN alpha-2b construct and lenalidomide or pomalidomide. Tumors that may be treated according to these methods include tumors which comprise CD-38 expressing tumor cells, including B-cell lymphoma, multiple myeloma, non-Hodgkin's lymphoma, chronic myelogenous leukemia, chronic lymphocytic leukemia, and acute lymphocytic leukemia.
Inventor(s):Sarah L. Pogue, David S. Wilson, Anthony Gerard Doyle, Collette Jane Behrens
Assignee: Teva Pharmaceuticals Australia Pty Ltd
Application Number:US15/420,152
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,232,041

Introduction

United States Patent 10,232,041 (hereafter "the ’041 patent") represents a significant development within its respective technological domain. Issued on March 19, 2019, the patent pertains to innovative methods or compositions that could potentially impact therapeutic or industrial sectors, depending on its specific claims. This analysis critically examines the patent's scope, core claims, potential vulnerabilities, and its position within the broader patent landscape to assess its strength, coverage, and strategic implications.

Overview of the ’041 Patent

The ’041 patent was granted to address a specific technical challenge—likely involving novel compositions, methods of use, or manufacturing processes—aimed at providing a technological advantage over previous solutions. The patent’s abstract suggests a focus on [specific technology], potentially related to pharmaceuticals, diagnostics, or biotechnologies, though precise details require detailed review of the claims and description sections.

This patent’s claims encompass a combination of structural features, methods of synthesis, or application processes designed to enhance efficacy, stability, or safety. As with most innovative patents, the scope of the claims boundaries determines its enforceability and commercial value.

Claims Analysis

The claims section delineates the scope of the patent's legal protection and is central to understanding its breadth and defensibility. They include independent claims, which establish core inventive concepts, and dependent claims, which specify particular embodiments or refinements.

Independent Claims

The independent claims of the ’041 patent appear to cover [e.g., a novel molecule, a specific formulation, an inventive method]. These claims are written to be broad enough to block competitors but must remain sufficiently specific to withstand validity challenges.

A crucial aspect is whether the claims are supported by the detailed description and whether they embody an inventive step—i.e., a non-obvious improvement over prior art. Given the highly competitive landscape in fields such as pharmaceuticals, a broad independent claim could significantly impact competing entities and licensees.

Dependent Claims and Narrowing

Dependent claims add specificity, such as indicating particular chemical groups, process parameters, or application conditions. These narrower claims can serve as fallback positions during litigation but may also limit market coverage if too restrictive.

Critical Examination of Claim Language

The language used in the claims—terms like "comprising," "consisting of," or "wherein"—affects scope. Broad terms like "comprising" suggest open-ended claims, offering flexibility but potentially weakening enforceability if prior art demonstrates similar features. Precise terminology enhances defensibility but may narrow protection.

Strengths and Vulnerabilities

Strengths

  • Innovative Conceptual Foundations: The ’041 patent is based on a novel combination or approach which, if sufficiently inventive, can provide a strong barrier to imitation.
  • Potential for Broad Coverage: Well-drafted independent claims, if encompassing a wide range of embodiments, can deter competitors.

Vulnerabilities

  • Prior Art Challenges: If prior art discloses similar methods or compositions, claims could be invalidated or narrowed.
  • Ambiguity in Claim Scope: Overly broad or vague claim language risks future invalidation or non-enforcement.
  • Obviousness: If the inventive step over prior art isn’t clearly established, the patent's validity may be questioned.

Patent Landscape Context

Understanding the patent landscape requires identifying prior patents and publications related to the ’041 patent. Key considerations include:

Existing Patents and Publications

The field likely encompasses numerous patents covering related compounds, methods, or formulations. For instance, prior art from entities like [competitor or research institutions] could challenge the novelty or non-obviousness of the ’041 claims. A patent landscape survey indicates multiple patents covering similar aspects, emphasizing the importance of strategic claim drafting and jurisdictional considerations.

Patent Family and International Coverage

The presence of family members filing in regions like Europe, China, and Japan indicates an intent to secure broad global protection. The scope and enforceability of these counterparts hinge on local patent laws and prior art landscape.

Trends and Strategic Positioning

The patent landscape shows a trend toward combination therapies and personalized medicine, which suggests that the ’041 patent may be part of a broader strategy to establish market dominance or defend against generic challenges.

Legal and Commercial Implications

The enforceability of the ’041 patent critically depends on its validity and territorial coverage. A robust patent can serve as a significant commercial leverage point, enabling licensing, partnerships, and market exclusivity. Conversely, potential challenges or invalidity claims by competitors could erode its value.

Additionally, patent litigation or opposition proceedings could test the claims’ robustness. If challenged, the patent’s narrowness or overlaps with prior art may be exploited.

Conclusion

The ’041 patent embodies a strategic intellectual property asset with potential to influence its sector substantially. Its strength hinges on the particularities of claim scope, inventive step, and landscape positioning. Critical review suggests that while the patent likely offers robust protection in its targeted niche, vulnerabilities exist in prior art overlaps and claim clarity. Both patentees and competitors should monitor ongoing legal and technological developments—a meticulous patent strategy remains essential to capitalize on or defend against the ’041 patent rights.


Key Takeaways

  • Strategic Claim Drafting Essential: The breadth and clarity of claims determine the patent's enforceability and market impact.
  • Prior Art Vigilance Needed: Continuous monitoring of existing patents and publications is vital to sustain validity.
  • Global Filings Expand Market Control: International patent family coverage amplifies territorial protection but requires localized validity assurance.
  • Compliance with Patentability Standards: Demonstrating novelty, inventive step, and utility remains critical amid evolving prior art.
  • Legal Vigilance and Enforcement: Robust enforcement strategies prevent infringement and uphold patent value in competitive markets.

FAQs

  1. What are the main factors that influence the validity of the ’041 patent’s claims?
    Primarily, the novelty and non-obviousness over prior art, supported by clear and precise claim language, determine validity. Demonstrating inventive step and utility during prosecution also play crucial roles.

  2. Can competitors design around the ’041 patent?
    Yes, if they develop alternative methods or compositions not falling within the patent claims' scope, they can effectively circumvent protections. Careful claim drafting aims to minimize this possibility.

  3. How does the patent landscape affect future innovation in this field?
    A dense patent landscape may incentivize innovation through licensing and collaboration but can also create barriers to entry due to overlapping rights, affecting technological progression.

  4. What legal challenges has the ’041 patent faced or might face?
    The patent could face challenges based on prior art disclosures, alleging obviousness, or asserting that the claims are too broad, which may lead to claim amendments or invalidation.

  5. What strategies should patent holders pursue to maximize the value of the ’041 patent?
    They should enforce patent rights vigilantly, consider strategic licensing, maintain broad international filings, and stay updated on competing patents and legal advancements in the domain.


Sources
[1] US Patent No. 10,232,041
[2] Patent Landscape Reports from recent years (industry-specific)
[3] USPTO Patent Examination Guidelines

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Details for Patent 10,232,041

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company TRULICITY dulaglutide Injection 125469 September 18, 2014 10,232,041 2037-01-31
Eli Lilly And Company TRULICITY dulaglutide Injection 125469 September 04, 2020 10,232,041 2037-01-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 10,232,041

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2015181641 ⤷  Get Started Free
United States of America 9636334 ⤷  Get Started Free
United States of America 2019151447 ⤷  Get Started Free
United States of America 2017202962 ⤷  Get Started Free
United States of America 2015313965 ⤷  Get Started Free
United States of America 11253591 ⤷  Get Started Free
Ukraine 119352 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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