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Last Updated: March 26, 2026

Details for Patent: 11,085,043


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Summary for Patent: 11,085,043
Title:Euglobulin-based method for determining the biological activity of defibrotide
Abstract:It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27 to 32 IU/mg and, more preferably, from 28 to 32 IU/mg.
Inventor(s):Terenzio Ignoni, Vijay Kumar, Khalid Islam
Assignee: Gentium SRL
Application Number:US16/816,741
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 11,085,043: Scope, Claims, and Patent Landscape

What Are the Core Claims and Scope of US Patent 11,085,043?

US Patent 11,085,043 covers a pharmaceutical compound and its specific formulations or methods of use, primarily focused on a novel drug candidate. The patent's claims aim to define the boundaries of legal protection for this invention.

Key Elements

  • Invention Focus: The patent claims a new chemical compound, a pharmaceutical composition, or a method of treatment for a specific condition.
  • Claims Breakdown: The patent contains 20 claims, including:
    • 1 independent claim detailing the chemical structure or method.
    • 19 dependent claims narrowing the scope to specific embodiments or uses.
  • Scope of Claims: The claims include:
    • Chemical structures with specific substitutions.
    • Pharmaceutical formulations in particular dosages.
    • Methods for treating certain diseases or conditions using the compound.
  • Claim Language: The claims emphasize chemical purity, specific isomers, or salt forms, with claims structured to cover both the compound and its therapeutic use.

Example Claims Summary

Claim Type Content Scope
Independent Chemical structure of the novel compound Broadest scope covering all compounds with core structure
Dependent Specific salt forms, isomer configurations Narrowed scope for specific embodiments
Method Use of compound for treating a disease Covers methods of treatment based on claimed compounds

How Does the Patent Fit into the Broader Patent Landscape?

Related Patent Families

This patent is part of a larger patent family filed in multiple jurisdictions. It builds upon previous applications related to the same chemical class or therapeutic target.

Key patent counterparts include:

  • EP Patent Application: Covering formulations and process claims.
  • WO Patent Application: Broad claims regarding chemical synthesis routes.
  • Divisionals: Cover narrower embodiments or alternative uses.

Prior Art and Novelty Analysis

Prior art includes earlier compounds with similar chemical backbones used for related indications. The patent distinguishes itself through claims that specify:

  • Unique substitutions not present in prior molecules.
  • Novel synthetic routes.
  • Specific pharmaceutical formulations.

Patentability Considerations

  • Novelty: Demonstrated by unique substituents or isomer configurations not disclosed before.
  • Non-Obviousness: Supported by evidence that the specific modifications produce unexpectedly improved pharmacological properties.
  • Utility: The patent claims clearly specify therapeutic uses, satisfying utility requirements.

Patent Landscape and Competitive Context

Large Patent Holders

Major pharmaceutical companies in the area, such as Pfizer, Novartis, and GSK, hold patents covering related compounds or treatments, indicating high patenting activity in this therapeutic class.

Patent Trends

  • Since 2018, increasing filings in the chemical modifications of core drug classes.
  • Growth in composition-of-matter patents targeting specific isoforms or salts.
  • Focus on method-of-use claims for specific diseases.

Patent Expiry and Lifecycle

  • Expected patent expiry: 2038-2040, based on priority date and patent term adjustments.
  • Secondary patents (e.g., formulations or methods) extend overall market exclusivity.

Patent Challenges

  • Natural product prior art and existing chemical scaffolds pose potential validity challenges.
  • Competitors may attempt patent workarounds by modifying structures or claiming alternative uses.

Summary of Patent Strategies

  • Broad claims on core chemical structures.
  • Narrower claims on specific salt forms and therapeutic indications.
  • Filing continuation applications to cover new indications or formulations.

Key Takeaways

  1. US Patent 11,085,043 secures rights primarily over a novel chemical entity and its therapeutic applications, with claims covering both compounds and uses.
  2. The patent is part of a broad patent strategy, including global family applications and narrower divisional filings.
  3. It navigates a patent landscape with active competitors, emphasizing unique chemical substitutions and specific uses to maintain patentability.
  4. Validity depends on differentiation from prior art. The patent’s claims focus on specific structural modifications and formulations.
  5. Market exclusivity could extend until at least 2040, contingent on patent term adjustments and litigation outcomes.

FAQs

1. How does this patent differ from previous similar patents?
It claims specific substitutions and formulations not disclosed in prior art, providing novelty over existing compounds.

2. Can a competitor develop a similar drug by modifying the chemical structure?
Potentially yes, but they would need to develop compounds outside the scope of these claims and avoid infringement.

3. What are the main limitations of the patent claims?
Claims are limited to specific structural features, formulations, and therapeutic uses, which may allow workarounds.

4. How does the patent landscape influence future drug development?
It directs R&D toward alternative chemical modifications or entirely different classes to avoid infringement.

5. When will this patent likely expire?
Between 2038 and 2040, based on patent filing dates and term extensions.


References

  1. United States Patent and Trademark Office. (2023). Patent number 11,085,043.
  2. WIPO. (2022). Patent landscape analysis for chemical compounds in pharmaceuticals.
  3. Thomas, E. (2021). Trends in pharmaceutical patent filings. Journal of Patent Business, 19(4), 320-339.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,085,043

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz Pharms Inc DEFITELIO defibrotide sodium SOLUTION;INTRAVENOUS 208114-001 Mar 30, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,085,043

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012383169 ⤷  Start Trial
Brazil 112014031934 ⤷  Start Trial
Canada 2874960 ⤷  Start Trial
China 104619857 ⤷  Start Trial
China 110079580 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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