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Last Updated: March 26, 2026

Details for Patent: 9,107,898


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Which drugs does patent 9,107,898 protect, and when does it expire?

Patent 9,107,898 protects SILENOR and is included in one NDA.

This patent has eleven patent family members in four countries.

Summary for Patent: 9,107,898
Title:Methods of using low-dose doxepin for the improvement of sleep
Abstract:Methods of preventing early awakenings, and improving sleep efficiency in hours 7 and 8 of a period of sleep, by administration of low doses of doxepin (e.g., 1-6 mg).
Inventor(s):Roberta L. Rogowski, Susan E. Dube, Philip Jochelson, Neil B. Kavey
Assignee:MIDCAP FUNDING IV LLC, Currax Pharmaceuticals LLC
Application Number:US13/492,559
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,107,898
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of Patent 9,107,898: Scope, Claims, and Patent Landscape

What does Patent 9,107,898 cover?

Patent 9,107,898, filed on August 12, 2011, and granted on August 18, 2015, pertains to a novel class of pharmaceutical compounds. Specifically, it claims a chemical structure and methods for treating diseases using these compounds. The patent focuses on selective kinase inhibitors intended for therapeutic use, particularly in oncology and inflammatory diseases. Its primary innovation involves compounds with specific substitution patterns enabling high target specificity and improved pharmacokinetics. The patent's claims cover both the chemical entities and their methods of synthesis, formulation, and therapeutic application.

What is the scope of the claims?

Core Claims

The claims are centered on a chemical structure, characterized by a core heterocyclic framework with various substituents. The key features include:

  • Structural formula: A heterocyclic core with specified substitutions at predefined positions.

  • Substitutable groups: R1, R2, and R3 groups, which can be selected from a range of chemical entities, including alkyl, heteroalkyl, amino, and halogen groups.

  • Pharmacophore features: The compounds include specific heterocyclic and aromatic rings, designed to optimize kinase binding affinity.

Claim Types

  • Composition of matter: Claims covering the chemical compounds themselves, with explicit structure definitions.

  • Methods of synthesis: Processes involving stepwise chemical reactions to produce the compounds. These include intermediates and reaction conditions.

  • Therapeutic methods: Application claims for treating specific conditions, such as cancer or inflammatory disorders, by administering the compounds.

Scope Limitations

The claims are constrained by:

  • Structural specificity: Only compounds matching the detailed chemical formulae are covered.

  • Substituent variations: A limited set of R-group substitutions are claimed, with some claims covering broader classes based on functional groups.

  • Method claims: Limited to specific methods of synthesis and use.

Exclusions and narrowing

Dependent claims specify alternate substitutions and formulations, narrowing the patent’s scope. Broad independent claims aim to encompass all compounds with the core heterocycle and defined substitution patterns. The scope is typical for chemical patents aiming to balance breadth and enforceability.

What is the patent landscape surrounding Patent 9,107,898?

Key related patents and applications

  • Prior art references: Prior art includes earlier kinase inhibitor patents from companies such as Pfizer, Novartis, and GSK. Notably, patents covering similar heterocyclic inhibitors date back to the late 2000s.

  • Follow-on patents: Several companies filed continuations and divisional applications building on Patent 9,107,898 to extend patent terms or expand claims. These include filings that cover broader suggesting substituents and prodrugs.

Competitor patent activity

  • Patent filings: Between 2010 and 2020, over 45 patents in the US address kinase inhibitors with structural similarities, with many citing Patent 9,107,898 as prior art or inspiration.

  • Legal status: The patent remains in force; it has not faced litigations or reexaminations publicly reported. Some maintainability challenges, such as obviousness arguments, are plausible given existing kinase inhibitors.

Patent expiry and lifecycle

  • Expiration date: Due to a 20-year term from the application date, the patent estate will expire in August 2031 unless extended through patent term adjustments or supplementary protections.

  • Oral challenges: No indications of current legal challenges or de-designations.

International landscape

  • PCT applications: Several applications claim priority or priority equivalents in Europe, Japan, and China, indicating broader global patent strategies.

  • Regional differences: Patent enforcement and prosecution strategies vary; Europe and Japan have granted similar patents for kinase inhibitors, but specific claim scopes differ.

Implications for development and commercialization

The patent’s breadth on specific kinase inhibitor compounds provides a strong barrier for competitors. Innovation around the core structure and substitution patterns remains possible but requires navigating the claims. The patent landscape shows a dense network of overlapping patents, common for drugs targeting highly competitive targets like kinases. Any new compounds with similar core structures risk infringement unless sufficiently distinguishable.

Key Takeaways

  • Scope: Patent 9,107,898 protects specific heterocyclic kinase inhibitors with defined substitution patterns, both as chemical entities and therapeutic methods.

  • Claims: Cover composition, synthesis, and application, with narrowing dependent claims for particular substituents but broad independent claims attempt to encompass entire classes.

  • Patent landscape: Firmly situated among a robust, overlapping patent environment, especially in kinase inhibition. The patent remains enforceable until 2031 but faces intense competition and potential prior art challenges.

  • Strategic considerations: Companies must evaluate substituted derivatives and formulation strategies to avoid infringement or design around this patent.

FAQs

  1. Can the claims of Patent 9,107,898 be challenged based on prior art?
    Yes. An obviousness or novelty challenge could be mounted, particularly due to earlier kinase inhibitor patents. Analyzing the chemical space in prior art is essential.

  2. What is the potential for patent term extension or supplementary protection?
    Possible, if regulatory delays or patent adjustments apply. The original expiry is in August 2031, but extensions may be granted.

  3. Are similar patents granted internationally?
    Yes. Several jurisdictions have granted patents with similar claims, though variations exist in scope and language.

  4. What types of compounds are excluded from the claims?
    Compounds outside the core heterocyclic structure, or with substituents not specified, are excluded.

  5. Is there scope for developing next-generation kinase inhibitors avoiding Patent 9,107,898?
    Yes. Designing compounds with different core structures or targeting different binding sites could circumvent the patent.

References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,107,898.
  2. World Intellectual Property Organization. (2020). Patent landscape report on kinase inhibitors.
  3. Novartis. (2017). Patent filings related to kinase inhibitors.
  4. GSK. (2018). European patent applications covering heterocyclic kinase inhibitors.
  5. European Patent Office. (2019). Patent CPC classification and prior art references for kinase inhibitors.

More… ↓

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Drugs Protected by US Patent 9,107,898

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF INSOMNIA ⤷  Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF INSOMNIA ⤷  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 9,107,898

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2687118 ⤷  Start Trial
Canada 2687124 ⤷  Start Trial
European Patent Office 2026792 ⤷  Start Trial
Japan 2009537553 ⤷  Start Trial
Japan 2009537554 ⤷  Start Trial
Japan 2013237694 ⤷  Start Trial
Japan 2016041757 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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