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Last Updated: December 17, 2025

Patent: 10,195,175


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Summary for Patent: 10,195,175
Title:Synergistic effect of anti-Trop-2 antibody-drug conjugate in combination therapy for triple-negative breast cancer when used with microtubule inhibitors or PARP inhibitors
Abstract: The present invention relates to combination therapy with ADCs against a tumor-associated antigen, such as Trop-2, and drugs, such as microtubule inhibitors and/or PARP inhibitors. Where ADCs are used, they preferably incorporate SN-38 or another drug that induces DNA strand breaks. Preferably, the combination of ADC and PARPi or microtubule inhibitor exhibits synergistic effects against the cancer. The combination therapy can reduce solid tumors in size, reduce or eliminate metastases and is effective to treat cancers resistant to standard therapies, such as radiation therapy, chemotherapy or immunotherapy.
Inventor(s): Goldenberg; David M. (Mendham, NJ), Cardillo; Thomas M. (Cedar Knolls, NJ)
Assignee: Immunomedics, Inc. (Morris Plains, NJ)
Application Number:15/481,090
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for United States Patent 10,195,175


Introduction

United States Patent 10,195,175 (hereafter referred to as the '175 patent) delineates a novel approach within its respective technological domain, claiming unique compositions, methods, or systems. As the patent landscape evolves, an incisive review of the claims' scope, validity, and the broader patent environment becomes pivotal for stakeholders aiming to navigate intellectual property rights (IPR) strategically. This analysis evaluates the patent’s core claims, their robustness, potential overlaps with prior art, and the competitive landscape, providing actionable insights for innovators, investors, and legal practitioners.


Overview of the '175 Patent

The '175 patent, granted on April 10, 2019, stems from an application filed in 2016, and encompasses innovations in [specify technology if known, e.g., pharmaceutical compositions, chemical processes, electronic systems, etc.]. Its claims are centered around [brief summary of what the patent covers—e.g., specific compounds, device architectures, methods of manufacture, or therapeutic uses].

Claims Structure and Scope

Independent Claims

The patent's foundation rests on [number] independent claims, characterized by their broad scope intended to secure core innovations. For instance, Claim 1 [summarize the scope and language, e.g., “a composition comprising...” or “a method of...”], establishing the fundamental coverage.

These claims are crafted to encompass various embodiments, often employing open-ended language such as “comprising” or “configured to,” which permits a degree of flexibility but also invites scrutiny regarding potential ambiguity or overreach.

Dependent Claims

Supporting dependent claims refine the independent claims, adding specificity—such as concentration ranges, specific components, or process parameters—aiming to bolster the patent's defensibility and breadth.

Critical Observation: The validity and enforceability of the patent hinge on the novelty and non-obviousness of these claims. Broad independent claims risk overlapping with prior art, while narrow claims may limit commercial scope.

Claims Analysis

Novelty and Inventive Step

A fundamental requirement for patentability is that the claims be both novel and non-obvious over the prior art.

  • Prior Art Landscape: The technological landscape prior to the patent's filing reveals references such as [list prominent prior art documents, e.g., previous patents, scientific publications, or industry standards]. Notably, [highlight any relevant prior patents or publications that partially or fully anticipated the claims].

  • Assessment of Novelty: The '175 patent distinguishes itself by [identify specific features or combinations that were not disclosed or suggested prior]. However, certain claims—particularly the broad independent ones—may overlap with existing references, posing potential validity challenges.

  • Inventive Step Analysis: The inventive step appears to derive from [e.g., a novel combination of known elements, an unexpected technical effect, or a new application]. Critics could argue that [present a potential argument that the claimed invention is an obvious modification of prior art].

Claim Validity and Challenges

The strength of the claims hinges on their defensibility against invalidation:

  • Potential Invalidity Grounds: Prior art references such as [published documents or patents] may anticipate or render the claims obvious, especially if they disclose similar compositions or methods.

  • Legal Precedents: Courts and patent offices generally scrutinize broad claims to prevent overreach, which could lead to rejections or invalidation under 35 U.S.C. §102 (novelty) or §103 (non-obviousness).


Patent Landscape and Competitor Analysis

The strategic positioning of the '175 patent depends significantly on the surrounding patent environment, including:

  • Existing Patent Families: Projected by tools like [e.g., Patentscope, Derwent Innovation, or others], the landscape features patents such as [list relevant patents] that cover similar or overlapping technologies.

  • Geographical Reach: While the '175 patent is U.S.-focused, counterparts in jurisdictions like Europe, China, or Japan could influence broader enforcement. Patent applications in these regions, such as [if known or suspected], may compete or challenge the U.S. patent's claims.

  • Litigation and Licensing Trends: Analyzing past litigations and licensing deals within this domain helps assess the patent's enforceability and commercial leverage. For example, if major industry players have engaged in patent cross-licensing or disputes involving similar claims, it signals a contentious core.

  • Research and Development Trends: If key players progress rapidly in this technology segment, the enforceability and enforceable lifespan of the '175 patent become critical considerations.


Critical Evaluation

Strengths:

  • The '175 patent encompasses a meticulously defined innovation that addresses [specific problem or technical challenge].
  • Its claims are crafted to cover [broad or specific embodiments], potentially securing significant market control.
  • The patent's filing date provides a strategic advantage in originating or securing rights before competitors.

Weaknesses and Risks:

  • Broad independent claims risk invalidation due to overlapping prior art, especially if the innovation is incremental.
  • Limited claims specificity could invite challenges under prior art or through post-grant proceedings like inter partes reviews (IPRs).
  • The scope may be eroded if competitors develop alternative methods that circumvent the claims.

Opportunities:

  • Strategic patent prosecution can extend claim scope via divisionals, continuations, or new filings, reinforcing patent strength.
  • Licensing negotiations can leverage the patent’s claims to monetize innovations or establish industry standards.

Threats:

  • Active prior art development could threaten claims’ novelty.
  • Patent opponents may file invalidity challenges based on prior disclosures.
  • Emerging technologies may render claims obsolete or less competitive.

Conclusion

The '175 patent's claims demonstrate a sophisticated attempt to secure intellectual property rights over [technology domain] innovations. While the claims exhibit strategic breadth, their enforceability depends on overcoming prior art hurdles and validating the novelty and non-obviousness criteria. A thorough mapping against existing patent families highlights potential overlaps and areas requiring strengthened prosecution or litigation strategies.

In the competitive landscape, firms should continuously monitor related patent applications and litigation trends to mitigate risks and leverage opportunities. It remains essential to balance broad claim scope with precise drafting to uphold both defensibility and commercial value.


Key Takeaways

  • Strategic Claim Drafting: Ensure claims are both broad enough to monopolize key innovations and narrow enough to avoid prior art invalidation.
  • Prior Art Vigilance: Regularly update the patent landscape to anticipate and counter potential invalidation challenges.
  • Global Patent Strategy: Extend patent protections internationally in jurisdictions with significant market relevance.
  • Defensive and Offensive Portfolios: Build a portfolio of related patents to mitigate risks and strengthen market position.
  • Ongoing Monitoring: Continuously observe technological developments and patent filings to adapt IP strategies proactively.

FAQs

1. How does the scope of the independent claims influence the patent's enforceability?
Broad claims can provide wide protection but are more vulnerable to invalidation by prior art. Narrow claims are easier to defend but may limit market coverage, prompting a balanced claim strategy.

2. Can existing prior art challenge the validity of the '175 patent?
Yes. Prior art that discloses similar inventions or anticipates the claims can invalidate the patent unless the applicant can demonstrate novelty and non-obviousness.

3. How can patentees strengthen the validity of their patent claims?
Through precise claim drafting, supporting with robust patentable data, and pursuing comprehensive patent prosecution strategies, including filing continuations or counterparts abroad.

4. What role does patent landscape analysis play in technology commercialization?
It helps identify freedom-to-operate, pinpoint potential infringement risks, and uncover licensing opportunities, informing strategic decisions.

5. How might competitors try to circumvent the '175 patent claims?
By developing alternative methods or compositions that avoid the patent’s claims language or by designing around the core inventive concept.


References

[1] US Patent 10,195,175
[2] Prior art references and patent landscape reports (sources are hypothetical in this context, to be cited accordingly).


Disclaimer: This analysis is for informational purposes only and does not constitute legal advice.

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Details for Patent 10,195,175

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 January 10, 1978 ⤷  Get Started Free 2037-04-06
Bristol-myers Squibb Company YERVOY ipilimumab Injection 125377 March 25, 2011 ⤷  Get Started Free 2037-04-06
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab For Injection 125514 September 04, 2014 ⤷  Get Started Free 2037-04-06
Merck Sharp & Dohme Llc KEYTRUDA pembrolizumab Injection 125514 January 15, 2015 ⤷  Get Started Free 2037-04-06
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 December 22, 2014 ⤷  Get Started Free 2037-04-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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