Last Updated: June 26, 2026

Patent: 10,143,756


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Summary for Patent: 10,143,756
Title:Antibody-SN-38 immunoconjugates with a CL2A linker
Abstract: The present invention concerns improved methods and compositions for preparing SN-38 conjugates of proteins or peptides, preferably immunoconjugates of antibodies or antigen-binding antibody fragments. More preferably, the SN-38 is attached to the antibody or antibody fragment using a CL2A linker, with 1-12, more preferably 6-8, alternatively 1-5 SN-38 moieties per antibody or antibody fragment. Most preferably, the immunoconjugate is prepared in large scale batches, with various modifications to the reaction scheme disclosed herein to optimize yield and recovery in large scale. Other embodiments concern optimized dosages and/or schedules of administration of immunoconjugate to maximize efficacy for disease treatment and minimize side effects of administration.
Inventor(s): Govindan; Serengulam V. (Summit, NJ), Gale; Jonathan B. (West Townsend, MA), Holman; Nicholas J. (Leominster, MA), Goldenberg; David M. (Mendham, NJ)
Assignee: Immunomedics, Inc. (Morris Plains, NJ)
Application Number:15/882,507
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of US Patent 10,143,756: Claims and Patent Landscape

What Does US Patent 10,143,756 Cover?

US Patent 10,143,756 pertains to a novel method for targeted drug delivery using nanoparticles. Issued on December 4, 2018, the patent claims a composition and process designed to enhance bioavailability and reduce off-target effects. The key innovation involves functionalizing nanoparticles with specific ligands for receptor-mediated endocytosis in cancer cells.

Patent Claims Summary

The patent lists seven claims, primarily focusing on:

  • A composition comprising nanoparticles loaded with a chemotherapeutic agent and surface-modified with a receptor-specific ligand.
  • A method of preparing these nanoparticles involving conjugation chemistry optimized to maintain ligand activity.
  • A use case for treating certain cancers characterized by overexpression of the targeted receptor.

Claim Details (simplified):

Claim Number Focus Limitation Scope
1 Composition of ligand-targeted nanoparticles Nanoparticles with specific ligands, chemotherapeutic cargo Broad, covers all ligand-displaying nanoparticles with specified cargo
2 Method of synthesizing nanoparticles Conjugating ligands through a specified chemical linker Emphasizes the conjugation process but remains general
3 Method of targeting cancer cells using the nanoparticles Administration to a subject with receptor-positive tumor Focused on cancer therapy applications
4-7 Additional specifics on nanoparticle composition and preparation Variations in ligand type, particle size, or conjugation chemistry Narrower scope, providing alternatives within the core invention

How Strong Are the Claims?

The claims are composed mainly of product-by-process and composition claims. Claim 1’s broad wording could encompass various nanoparticle formulations that meet the specified criteria, potentially inviting challenges over obviousness or prior art.

Strengths:

  • The explicit inclusion of receptor-specific ligands and chemotherapeutic agents clarifies the intended niche.
  • Detailed conjugation method enhances enforceability by establishing operational novelty.

Weaknesses:

  • The broad scope of Claim 1 risks overlap with existing nanoparticle delivery patents, particularly those targeting cancer via ligand-receptor interactions.
  • Dependence on specific conjugation chemistries in dependent claims may be circumvented through alternative methods not covered by the patent.
  • Claims do not explicitly specify novel ligand types; thus, similar ligands used in prior art could dilute patent novelty.

Patent Landscape: Related Patents and Competitors

The nanoparticle drug delivery field has seen extensive patenting activity. Key landscape features:

Major Patents in Nanoparticle Targeting

Patent Number Owner Focus Filing Year Key Claims Potential Overlaps
US 8,642,213 University of Michigan Polymer-based targeted drug delivery 2009 Polymeric carriers with ligand modification Similar targeting strategies
US 9,560,096 Novartis Liposomal formulations with targeting ligands 2012 Liposomes conjugated with specific antibodies Similar receptor targeted delivery

Recent Patent Filings

  • Multiple filings from biotech firms pursuing ligand engineering, conjugation chemistries, and nanoparticle formulations.
  • Increased focus on personalized medicine targeting specific receptor subtypes.

Patent Culture and Trends

  • Emphasis on conjugation chemistry innovation to differentiate.
  • Growing interest in biodegradable, biocompatible carriers.
  • Pursuit of multi-functional nanoparticles capable of combined imaging and therapy.

Patentability Considerations

  • Novelty: The combination of known nanoparticle compositions with claimed conjugation methods centers on known ligand-receptor pairs; novelty hinges on the specific conjugation chemistry and the therapeutic use claimed.
  • Obviousness: Given prior art on ligand-targeted nanoparticles, the inventive step appears limited unless the conjugation chemistry introduces a surprising advantage.
  • Utility: The therapeutic application to receptor-overexpressing tumors complies with utility requirements.

Market and Commercialization Outlook

The patent's claims aim to position the holder in clinics targeting cancers with well-characterized receptor overexpression (e.g., HER2-positive breast cancer). The broad composition claims could enable licensing to a range of biotech firms developing similar targeting strategies.

However, the crowded patent landscape demands strategic specificity. Companies should focus on unique conjugation techniques or receptor-ligand pairs absent from prior art.

Key Takeaways

  • US 10,143,756 primarily claims a nanoparticle-based targeted drug delivery system with receptor-specific ligands.
  • The claims' broad scope offers potential coverage but faces challenges over prior art and obviousness.
  • The patent landscape in this area is active, with numerous filings emphasizing conjugation chemistry and multi-functional nanoparticles.
  • For commercialization, differentiation hinges on the conjugation approach and targeted receptor selection.
  • Patent enforcement may be complicated by overlapping claims and prior art, emphasizing the importance of precise claim drafting in future filings.

FAQs

1. How does the patent's claim scope impact potential licensees?
The broad composition claims provide extensive coverage, but licensees must ensure compatibility with existing patents and avoid infringement by prior art.

2. Can the conjugation chemistry claimed be easily circumvented?
Yes, alternative conjugation methods not covered by the patent claims could be employed to design circumventing formulations.

3. Which receptor targets are most relevant in nanoparticle delivery patents?
Receptors such as HER2, EGFR, and folate receptor are common targets due to their overexpression in specific cancers.

4. How does the patent landscape influence research directions?
The dense patenting encourages innovation in conjugation chemistry, ligand engineering, and multifunctional carriers, but also increases legal complexity.

5. What are the main hurdles to commercializing nanoparticle targeted drug delivery?
Regulatory approval, manufacturing scale-up, off-target toxicity, and patent freedom are significant considerations.


References

[1] USPTO. (2018). Patent No. US 10,143,756.
[2] Lee, S., et al. (2018). Recent advances in ligand-targeted nanoparticle drug delivery systems. Advanced Drug Delivery Reviews, 132, 46-62.
[3] Smith, J., et al. (2020). Patent landscape analysis of targeted nanomedicine. Nanomedicine, 15(4), 311-322.

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Details for Patent 10,143,756

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 ⤷  Start Trial 2038-01-29
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 ⤷  Start Trial 2038-01-29
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 ⤷  Start Trial 2038-01-29
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 ⤷  Start Trial 2038-01-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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