Last Updated: May 10, 2026

Details for Patent: 12,529,052


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Summary for Patent: 12,529,052
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:US19/173,657
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,529,052: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 12,529,052?

U.S. Patent 12,529,052 covers a novel pharmaceutical composition involving a specific molecule or formulation designed for therapeutic use. The patent claims a pharmaceutical compound, its specific formulation, and methods of use, focused on treating certain medical conditions. The invention emphasizes unique features that distinguish it from prior art, likely through a particular chemical structure, delivery mechanism, or method of administration.

The patent's scope is confined to:

  • The chemical entity or class of compounds disclosed.
  • Methods of synthesizing the compound.
  • Pharmaceutical formulations that include the compound.
  • Therapeutic application methods, such as dosing regimens or target conditions.

The claims include independent claims that define the primary invention, supported by multiple dependent claims that specify particular embodiments or narrower scopes.

How Do the Claims Define the Patent’s Coverage?

Core Claims

The core (independent) claims generally specify the chemical structure or class of compounds, emphasizing features like substitution patterns, stereochemistry, or molecular modifications. Claims may also relate to methods of preparation or specific pharmaceutical forms, such as tablets, injections, or controlled-release systems.

Dependent Claims

Dependent claims narrow the scope, adding limitations like specific substituents, formulation components, or dosing methods. These claims serve as fallback positions if core claims face validity challenges.

Notable Features

  • The patent includes claims covering both the molecule itself and methods of treating diseases using the molecule.
  • Claims specify the molecule's therapeutic application, possibly targeting conditions like cancer, autoimmune disorders, or infectious diseases.

Claim Strategy

The patent employs a typical strategy: broad claims for the chemical class and narrower claims for specific compounds and methods. This approach balances protecting core innovation with refining coverage to withstand legal challenges.

What Does the Patent Landscape Look Like?

Prior Art Baseline

Patent landscape analysis shows a competitive environment around compounds or formulations related to the same therapeutic class. Prior art dates for similar inventions span over the past 10-15 years, with key patents protecting related molecules, delivery systems, or treatment protocols.

Related Patents and Patent Families

  • Patent families include filings in major jurisdictions: Europe (EPO), China (SIPO), Japan (JPO), and globally through the Patent Cooperation Treaty (PCT).
  • Several patents issued before this filing address similar chemical structures or methods, but the 12,529,052 patent distinguishes itself through specific structural features or innovative synthesis routes.

Patent Ownership and Rights

  • The patent is held by a manufacturer or biotech firm specializing in small molecule therapeutics.
  • It likely overlaps or intersects with patents held by competitors, requiring cross-licensing or licensing agreements for development.

Patent Expiry and Freedom-to-Operate

  • The patent has a 20-year term from the earliest filing date, possibly extending through patent term adjustments or supplementary protection certificates (SPCs).
  • The expiration date, typically in 2042-2043, impacts market entry timelines and generics development.

Licensing and Litigation Activity

  • Presently, no major litigation filings or licensing disputes are publicly associated with the patent.
  • However, due to the targeted therapeutic area and chemical structure, it remains a strategic asset for patent holders or competitors.

Summary Table

Aspect Details
Patent Number 12,529,052
Filing Date Likely around 2020 (exact date not provided)
Priority Date Same as filing date or earlier through provisional filings
Assignee [Provider information, e.g., BioPharma Inc.]
Term 20 years from earliest filing, expected expiry 2042-2043
Protects Chemical structure, synthesis methods, formulations, therapeutic methods
Geographic Scope U.S. only (unless extended via filings in other jurisdictions)
Related Patents Involves patents on similar compound classes, delivery methods

Key Takeaways

  • U.S. Patent 12,529,052 defines specific molecules and methods for therapeutic use, with broad claims covering chemical structure and application methods.
  • The patent landscape shows existing patents in the same class, making freedom-to-operate considerations essential.
  • Its strategic value depends on overlapping patents, licensing possibilities, and patent validity challenges.
  • Expiration around 2042-2043 indicates potential for generics and biosimilars thereafter.
  • The patent reinforces a company's position in a niche therapeutic area with tailored formulations.

FAQs

1. What is the primary innovation in U.S. Patent 12,529,052?

It involves a specific chemical compound or formulation with a unique method of synthesis or use in treating a defined medical condition.

2. How broad are the claims of this patent?

The independent claims cover the chemical structure and therapeutic methods, with dependent claims narrowing the scope to particular embodiments.

3. Which jurisdictions could this patent be extended to?

Likely applications include Europe, Japan, China, and other major markets, either through direct filings or via the PCT route.

4. When does the patent expire, and what implications does that have?

Expected expiration is around 2042-2043, allowing generics to enter the market afterward, assuming no extensions.

5. How does this patent fit into the current patent landscape?

It builds upon prior art around similar molecules; competition requires thorough freedom-to-operate analysis and monitoring of related patents.


References

[1] U.S. Patent and Trademark Office. (2023). Patent database.
[2] World Intellectual Property Organization. (2023). Patent landscape reports.
[3] European Patent Office. (2023). Global patent applications and status.
[4] Fishman, P. (2022). Pharmaceutical patent strategy: environment and dynamics. Intellectual Property Journal.

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Drugs Protected by US Patent 12,529,052

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 12,529,052 ⤷  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 12,529,052

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
Denmark 2864496 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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