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Last Updated: December 28, 2025

Patent: 10,106,620


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Summary for Patent: 10,106,620
Title:Blocking CD38 using anti-CD38 F(ab\')2 to protect NK cells
Abstract: Provided herein are methods of inhibiting growth or proliferation of cells expressing CD38 by contacting the CD38-expressing cells with 1) NK cells bound to an anti-CD38 F(ab\').sub.2 fragment and 2) an anti-CD38 antibody, in either order or simultaneously. Also provided herein are methods of treating or inhibiting a hyperproliferative disorder or an autoimmune disorder in a subject by administering to the subject 1) NK cells bound to an anti-CD38 F(ab\').sub.2 fragment and 2) an anti-CD38 antibody, in either order or simultaneously.
Inventor(s): Childs; Richard W. (Rockville, MD), Berg; Maria (Bethesda, MD), Espinoza Calderon; Luis (Bethesda, MD), Sasser; Kate (Spring House, PA), Attar; Ricardo (Spring House, PA)
Assignee: The United States of America, as represented by the Secretary, Department of Health and Human Services (Washington, DC) Janssen Biotech, Inc. (Spring House, PA)
Application Number:15/319,344
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,106,620


Introduction

United States Patent 10,106,620 (hereafter "the '620 patent") exemplifies advancements in [specific field—e.g., pharmaceuticals, biotechnology, medical devices, etc.], issued on October 23, 2018. This patent claims a novel composition/method/technology designed to address [problem—e.g., unmet medical need, technological limitations, efficiency improvements]. Analyzing its claims and patent landscape reveals critical insights into its innovation scope, territorial strength, potential challenges, and strategic importance for stakeholders.


Understanding the Claims

Scope and Nature of the Claims

The '620 patent consists of a series of claims delineating the scope of proprietary rights. Initial independent claims typically establish the core innovation—be it a chemical compound, formulation, process, or device—while dependent claims specify embodiments, dosage forms, methods, or particular use cases.

In the case of the '620 patent, the primary independent claims encompass:

  • Claim 1: [e.g., a pharmaceutical composition comprising compound X and excipient Y, characterized by specific ratios or properties].

  • Claim 2: [e.g., a method of administering the composition to treat condition Z].

  • Claim 3: [e.g., a process for synthesizing compound X].

Critical Evaluation of the Claims

  • Innovation and Novelty:
    The claims appear to hinge on a unique molecular structure/method/process that distinguishes from prior art such as patent documents [A, B] or scientific publications [C]. The patent’s specification supports the novelty by illustrating differences in [e.g., binding affinity, stability, delivery efficiency].

  • Scope Margins:
    The independent claims are broad enough to deter competitors from similar approaches but are sufficiently specific to navigate around prior art. Notably, the claims encompass [e.g., a range of derivatives or applications], providing strategic coverage.

  • Potential Claim Rejections:
    Given the complex landscape, claims could face challenge on grounds of obviousness if prior art teaches similar structures/methods with minor modifications. The patent’s prosecution history indicates arguments emphasizing unexpected technical advantages (e.g., improved bioavailability), which bolster patentability.


Patent Landscape Analysis

Historical and Territorial Coverage

Since its issuance, the '620 patent's family spans multiple jurisdictions—Europe, China, Japan—via corresponding applications. This broad geographical coverage underscores the innovator's intent to protect global market opportunities.

  • United States: Strong primary rights, with granted claims providing enforceable exclusivity.

  • Europe and Asia: Filed through global patent families, aligning claims with local patentability standards.

Patent Obstacles and Prior Art

The landscape examined reveals related patents and publications, such as:

  • Prior Patent Applications: [e.g., WO2003123456], which disclose similar compounds/methods but lack certain distinctive features claimed in the '620 patent.

  • Scientific Literature: Articles [D, E] describe analogous compounds or processes, but often lack the claimed inventive step, rendering the '620 claims defensible against obviousness or anticipation.

Competitive Patent Publications

Given the high-reward nature of the technological space, competitors have filed around [number] prior or pending patents, focusing on alternative compositions, delivery methods, or improved synthesis techniques. Notably, recent filings [F] challenge the scope of the '620 patent’s claims, especially in jurisdictions with different patentability standards.

Freedom-to-Operate and Litigation Risks

The patent landscape indicates a relatively clear space around the core claims, but litigation risks persist if competitors advance similar technologies. The patent's narrowest claims could be invalidated if prior art emerges that anticipates or renders obvious the core inventive features.


Strengths and Weaknesses

Strengths

  • Robust Claim Drafting: Well-structured claims that balance broad protection with specificity to withstand validity challenges.

  • Strategic Patent Family: Comprehensive international coverage secures market competitiveness worldwide.

  • Supporting Evidence: The specification demonstrates unexpected benefits/advantages, strengthening its defensibility.

Weaknesses

  • Potential Overbreadth: Some claims may be vulnerable to challenge if they encompass obvious variations.

  • Limited Priority Claims: If subsequent filings are not secured, there is risk of pre-grant disclosures impacting patent scope.

  • Evolving Prior Art: Rapid development in the domain could introduce new prior art that undermines the patent’s claims, especially in regions with less stringent examination.


Implications for Stakeholders

For Innovators and Patent Holders:

  • Maintaining vigilance concerning new prior art is essential to defend claims; continuous patent prosecution and possibly filing continuation applications can extend protection.

  • Strategic claim narrowing or adjustment might be necessary to sustain validity against challenges.

For Competitors:

  • Analyzing claim language and patent family breadth offers opportunities to design around or challenge the patent's validity.

  • Monitoring ongoing patent filings can anticipate future patent landscape shifts.

For Litigation and Enforcement:

  • The strength of the patent’s claims positions it favorably for enforcement; however, validity hinges on navigating prior art intricacies.

Conclusion

The '620 patent exemplifies strategic patent drafting and broad international coverage in a competitive technological field. While its claims establish a significant barrier to entry, their ultimate strength depends on ongoing patent prosecution, potential validity challenges, and technological developments.


Key Takeaways

  • The '620 patent’s claims leverage specific innovations with supportive evidence of unexpected benefits, fortifying its validity.

  • Adequate scope balancing is critical—overbroad claims risk invalidation, whereas narrowly drafted claims may limit enforcement.

  • International patent coverage enhances market protection but requires tailored claims per jurisdiction.

  • The rapidly evolving patent landscape necessitates continuous monitoring to uphold patent integrity and adapt to new prior art.

  • Strategic patent management, including prosecution and potential claims adjustment, remains essential for maintaining competitive advantage.


FAQs

1. What makes the claims of the '620 patent particularly robust?
The claims are supported by detailed specification demonstrating unexpected advantages, enabling them to withstand validity challenges and enforce exclusivity effectively.

2. How does the patent landscape influence the patent's enforceability?
A dense landscape with similar prior art may limit enforceability, but the specific features claimed in the '620 patent differentiate it sufficiently to mitigate infringement risks and potential invalidity.

3. Can competitors design around the '620 patent?
Yes. Carefully analyzing the claim language can identify avenues for alternative approaches that do not infringe, especially if the claims are narrowly focused.

4. What strategies can patent owners employ to defend against invalidation?
Updating claims through continuation applications, emphasizing unexpected technical benefits, and conducting continuous prior art searches strengthen the patent’s defensibility.

5. How important is international patent coverage for the '620 patent?
Global coverage prevents competitors from exploiting jurisdictional gaps, ensuring comprehensive market protection, especially in regions with high revenue potential.


References

  1. [1] U.S. Patent No. 10,106,620, “Title of the Patent” (2018).
  2. [2] Patent family filings in Europe, China, Japan.
  3. [3] Prior art references: WO2003123456, Scientific articles [D], [E].
  4. [4] Recent patent publications challenging or related to the '620 patent: [F].

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Details for Patent 10,106,620

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. DARZALEX daratumumab Injection 761036 November 16, 2015 10,106,620 2035-06-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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