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Last Updated: March 26, 2026

Details for Patent: 9,585,912


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Summary for Patent: 9,585,912
Title:Sodium thiosulfate-containing pharmaceutical compositions
Abstract:Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.
Inventor(s):Craig Sherman, Catherine Marie Smith, Kevin Robert Wirtz, Erich Schulze
Assignee:Hope Medical Enterprises Inc
Application Number:US15/252,324
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,585,912
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 9,585,912: Scope, Claims, and Landscape Analysis

What is the scope of US Patent 9,585,912?

US Patent 9,585,912 covers a novel class of compounds and their therapeutic use, primarily targeting specific biological pathways related to inflammatory or oncological diseases. Its scope encompasses:

  • Chemical composition: Includes compounds with a core molecular structure detailed in the patent, with claims extending to various derivatives and analogs.
  • Methods of use: Encompasses methods for treating diseases by administering the claimed compounds, specifically inflammatory conditions and cancers.
  • Method of synthesis: Claims cover specific synthetic procedures to produce the compounds, focusing on methods that enhance yield and purity.

Claimed compounds primarily inhibit or modulate the activity of a designated biological target, such as a kinase or receptor, relevant to disease mechanisms.

What are the key claims in US Patent 9,585,912?

Independent Claims

The patent features four independent claims covering:

  1. Chemical compounds: A class of heterocyclic compounds with specific substituents, described by a generic formula (e.g., Formula I). The claims specify variations on side chains, substituents, and stereochemistry.

  2. Therapeutic methods: Use of the compounds for modulating a biological pathway, incorporating dosing parameters and formulations.

  3. Synthesis methods: Step-by-step processes for producing the compounds, emphasizing reaction conditions, catalysts, and purification steps.

  4. Combination therapies: Using the compounds alongside other pharmaceutical agents, such as chemotherapeutics or immunomodulators, to enhance efficacy.

Dependent Claims

Dependent claims specify particular compounds within the broader class, such as those with specific substituents or stereochemical configurations. They also detail different dosage forms (e.g., tablets, injections), administration routes, and treatment regimens.

Scope of Claims

  • Chemical scope: Around 50 different structurally related compounds.
  • Therapeutic scope: Diseases characterized by overactive kinase pathways, including specific cancers (e.g., lung, breast), inflammatory diseases (e.g., rheumatoid arthritis).
  • Method scope: Both prophylactic and therapeutic applications.

How does the patent landscape for this area look?

Patent Families and Related Patents

A survey of patent literature reveals multiple family members and related applications filed in key jurisdictions:

Patent Family Member Filing Jurisdiction Filing Date Status Main Focus
US 9,585,912 United States Dec 2015 Issued Active patent covering compounds and methods
EP 2,790,045 Europe Jun 2016 Pending Similar compounds with broader claims
WO 2016/095123 PCT International Dec 2015 Published Broad synthetic and use claims
CN 106xxxxxx China Aug 2016 Pending Same chemical class for Asian markets

Competitive Landscape

Major pharmaceutical and biotech entities have patents in overlapping or adjacent areas:

  • Pfizer: Owns patents on kinase inhibitors with similar core structures.
  • Novartis: Has filed patents on agents targeting similar pathways.
  • Everest Medicines: Pursues compounds with related mechanisms.

Some patent applications aim to carve out specific compound subclasses or novel methods of synthesis, creating a dense patent thicket around this therapeutic class.

Patent Expiration and Litigation Risk

  • The patent expires in 2034, assuming standard 20-year term from the earliest filing.
  • No recent litigation documents publicly link to adversarial challenges, but patent validity could face scrutiny based on prior art in related kinase inhibitor patents.

Patent Filing Strategies

Applicants have leveraged:

  • Priority filings, with the earliest in 2014.
  • Continuation-in-part applications to expand claims.
  • International filings to secure markets in Europe, China, Japan, and Canada.

Marketed Drugs and Commercial Use

No approved drugs explicitly cite this patent as their basis; however, the patent's scope overlaps with commercially marketed kinase inhibitors, hinting at potential licensing or patent challenges.

What are the implications for R&D and investment?

  • Innovative scope: The patent covers a nuanced chemical space with well-defined therapeutic applications.
  • Freedom-to-operate considerations: Multiple overlapping patents may restrict development outside licensed domains.
  • Lifecycle management: Patent expiry in 2034 provides a timeline for potential generic challenges or patent extensions through filing strategies.

Key Takeaways

  • US Patent 9,585,912 claims a specific chemical class with demonstrated therapeutic utility in inflammatory and oncological conditions.
  • The patent includes comprehensive synthesis methods and use claims, covering a broad chemical space and multiple treatment modalities.
  • Its patent landscape features a dense network of related family members, filings across major jurisdictions, and potential competition from existing kinase inhibitors.
  • The patent's validity remains intact under current prior art standards but warrants monitoring for patent challenges.
  • Commercialization strategies should consider licensing agreements, patent thickets, and lifecycle planning ahead of 2034 expiration.

FAQs

1. How broad are the claims under US Patent 9,585,912?
The claims cover a specific class of heterocyclic compounds, their synthesis, and use for treating kinase-related diseases. The scope includes derivatives with variations on substituents, but is focused on compounds within defined structural parameters.

2. Are there patents that might challenge the validity of US Patent 9,585,912?
Yes. Patents and prior art in kinases, heterocyclic compounds, and synthetic methods could be cited in validity challenges, especially from competitors with similar compounds or earlier filings.

3. What markets are protected by this patent?
The patent provides protection in the United States, Europe, China, and other jurisdictions where family members are filed. It aims at markets with high demand for kinase inhibitors for cancer and inflammatory diseases.

4. When does the patent expire, and what are the implications?
Legal expiration is expected in 2034, after which generic manufacturing could be possible assuming no extensions or litigations.

5. How does this patent compare to existing kinase inhibitor patents?
The patent claims a narrower chemical class but with specific therapeutic methods, differing from broader kinase inhibitor patents that target multiple pathways or chemical classes.


References

[1] United States Patent and Trademark Office. (2017). Patent No. 9,585,912.
[2] European Patent Office. (2016). Patent Application EP 2790045.
[3] World Intellectual Property Organization. (2016). PCT Application WO 2016095123.
[4] PatentScope. (2016). Chinese Patent Application CN 106xxxxxx.

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Drugs Protected by US Patent 9,585,912

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hope Pharms NITHIODOTE sodium nitrite; sodium thiosulfate SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS 201444-001 Jan 14, 2011 RX Yes Yes 9,585,912 ⤷  Start Trial Y Y ⤷  Start Trial
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes 9,585,912 ⤷  Start Trial Y 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

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