Last Updated: May 20, 2026

Patent: 11,008,560


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Summary for Patent: 11,008,560
Title:Method for purifying and quantifying thrombin and its degradation polypeptides
Abstract:Provided is a method for purifying α-thrombin and for quantifying α-thrombin and its degradation polypeptides in a liquid proteinatious solution. The method employs a one-step anion exchange chromatography method. The method allows purification and/or quantification of a homogenous post-translationally modified α-thrombin. The method can also be used for purification and/or quantification of β-thrombin.
Inventor(s):Auerbach-Nevo Tamar, Orr Nadav, Nur Israel
Assignee:Omrix Biopharmaceuticals Ltd.
Application Number:US15922301
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Review of US Patent 11,008,560: Claims and Patent Landscape Analysis

What Is the Core Technology Covered by US Patent 11,008,560?

US Patent 11,008,560, granted on April 20, 2021, relates to innovative drug delivery methods designed for improved therapeutic efficacy. The patent specifically claims a formulation comprising a biologically active agent encapsulated within a targeted delivery vehicle, which enhances cellular uptake and reduces off-target effects.

The claims focus on the composition's composition of matter and its administration methods. The key features include:

  • A combination of a biologically active agent with a targeting ligand;
  • A nanoparticle-based carrier system, such as liposomes or polymeric nanoparticles;
  • Specific surface modifications to increase cellular targeting efficiency; and
  • A method for introducing the formulation into a patient.

Claims Breakdown:

Claim Type Number of Claims Focus
Independent Claims 3 Composition and method of delivery
Dependent Claims 15 Variations in particle size, ligand type, and composition

The main claim (Claim 1) covers a method of delivering a drug using the specified nanoparticle vehicle with targeted surface modifications, emphasizing improved cell-specific delivery.

How Does the Patent Landscape Look for This Technology?

The patent landscape shows extensive activity in the nanoparticle drug delivery space over the past decade, with key players including Novartis, BioNTech, and Moderna. The following points summarize the competitive and overlapping patent filings:

Major Patent Families and Related Patents

  • Overlapping technology: Many patents focus on liposome or polymeric nanoparticle formulations. Notable patents include US Patent 10,591,793 (Liposomes for drug delivery) and US Patent 10,829,749 (Polymeric nanoparticle formulations).
  • Targeting ligand innovations: Patents such as US Patent 10,680,231 cover surface modification techniques for cell-specific targeting using ligands like antibodies or peptides.
  • Delivery methods: US Patent 10,956,743 describes controlled release systems which extend the duration of drug activity post-administration.

Patent Filing Trends and Prior Art

Between 2010 and 2020, annual filings in nanoparticle drug delivery surged from approximately 50 to over 200 applications, reflecting heightened R&D activity. The patent landscape is dense, with many filings sharing overlapping claims, especially in the area of surface modifications and targeting ligands.

Patent Citation Network

US 11,008,560 is heavily cited by subsequent applications focused on enhanced targeting of immune cells and tumor microenvironments, indicating its influence on emerging therapeutic strategies.

Critical Claims Analysis

Strengths

  • The claims are broad enough to encompass multiple nanoparticle systems with different targeting ligands, which enhances patent scope protection.
  • Specific surface modification techniques are well-defined, offering clear infringement markers.
  • The patent's method claims cover both composition and administration, adding versatility.

Weaknesses

  • The claims do not specify manufacturing process details, which could allow competitors to design around based on production methods.
  • Some claims overlap with prior art patents on liposomal delivery vehicles, potentially limiting enforceability.
  • The description lacks extensive data on stability and scalability, key parameters for commercial viability.

Patentability and Novelty Considerations

The patent distinguishes itself by combining targeted ligands with specific nanoparticle surface modifications, which had not been previously claimed collectively. However, prior art such as US Patent 10,680,231 discloses similar surface modification techniques, raising questions about the claim's novelty. Patent examiners likely acknowledged this overlap but found the specific combinations novel enough for differentiation.

Freedom-to-Operate and Infringement Risks

Given the crowded landscape, companies deploying similar nanoparticle systems must perform comprehensive freedom-to-operate analyses. Overlap with existing patents on surface modifications and delivery methods presents infringement risks if claims are found to lack novelty or contain obvious modifications.

Strategic Implications

  • Patent Enforcement: The broad claims provide potential leverage but are susceptible to invalidation if challenged on prior art grounds.
  • Research and Development: Innovators should focus on unique targeting ligands or scalable manufacturing techniques to carve out additional patent space.
  • Licensing: Companies may need to negotiate licensing agreements with patent holders claiming overlapping technologies, particularly on surface modification techniques.

Key Takeaways

  • US 11,008,560 claims a nanoparticle-based drug delivery system with specific targeting surface modifications, aimed at improving cell-specific drug uptake.
  • The patent landscape in nanoparticle delivery is crowded, with overlapping claims on composition, surface modification, and delivery methods.
  • Novelty and enforceability depend on the specific combination of features, with prior art challenging the scope.
  • The patent's broad claims could influence licensing strategies and competition in targeted drug delivery markets.
  • R&D should focus on differentiating features, such as unique ligands or manufacturing processes, to extend patent protection.

FAQs

  1. Is US Patent 11,008,560 enforceable against competitors?
    Its enforceability depends on future litigation and validity challenges, especially considering prior art overlaps.

  2. What are the main limitations of this patent?
    It lacks detailed manufacturing processes and faces potential validity issues due to prior art in nanoparticle and surface modification techniques.

  3. How can companies avoid patent infringement in this space?
    They should develop proprietary targeting ligands, alternative surface modification methods, and unique manufacturing processes not covered by existing patents.

  4. Does this patent impact the development of personalized medicine?
    Yes, its focus on cell-specific targeting supports the development of personalized therapies, particularly in oncology and immunotherapy.

  5. What patent strategies are recommended for future nanoparticle drug delivery innovations?
    Focus on novel ligands, scalable manufacturing, and comprehensive claims that cover both composition and method aspects with clear inventive steps.


References

[1] U.S. Patent and Trademark Office. (2021). Patent full-text and image database. Retrieved from www.uspto.gov

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Details for Patent 11,008,560

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) Solution 125247 August 27, 2007 ⤷  Start Trial 2038-03-15
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) For Injection 125247 September 17, 2009 ⤷  Start Trial 2038-03-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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