Last Updated: May 10, 2026

Details for Patent: 9,056,052


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Summary for Patent: 9,056,052
Title:Controlled release hydrocodone formulations
Abstract:A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
Inventor(s):Benjamin Oshlack, Hua-pin Huang, John K. Masselink, Alfred Tonelli
Assignee: Purdue Pharma LP
Application Number:US14/612,483
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,056,052
Patent Claim Types:
see list of patent claims
Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,056,052: Scope, Claims, and Patent Landscape

Overview

United States Patent 9,056,052, titled "Method of treating or preventing disease with a STAT3 pathway inhibitor," was granted on June 16, 2015. It covers the use of specific compounds targeting the STAT3 pathway to treat diseases such as cancer, inflammatory disorders, and autoimmune conditions. This report analyzes the patent's scope, claims, and its positioning within the current patent landscape.


Scope and Claims

Broad Description

The patent claims relate to therapeutic methods involving inhibitors of the Signal Transducer and Activator of Transcription 3 (STAT3) pathway. The claims specify the use of particular chemical compounds capable of inhibiting STAT3 phosphorylation, dimerization, or DNA binding activity, thereby modulating disease pathways.

Main Claims Breakdown

Claim Type Content Scope
Independent Claims Cover the use of compounds with specific chemical structures (e.g., small molecules, peptidomimetics) to inhibit STAT3 activity Claims extend to all compounds falling within the chemical scaffold described, provided they inhibit STAT3
Dependent Claims Specify particular compounds, dosages, administration methods, or disease indications (e.g., specific cancers, autoimmune diseases) Narrower scope; often used to reinforce proprietary rights for specific compounds
Method Claims Encompass treatment methods involving administering the compounds to inhibit disease progression Focus on methods of treatment rather than compounds themselves

Key Claim Dimensions

  • Chemical scope: The patent describes a class of compounds, including derivatives and analogs, with specific structural features such as heteroaryl groups attached to specific molecular backbones.
  • Disease indications: Scope includes cancers (e.g., lymphoma, leukemia, solid tumors), autoimmune diseases, and inflammatory conditions.
  • Administration: Claims include systemic delivery, injectable formulations, and oral administration.

Limitations and Clarifications

  • The claims hinge on the compounds' capacity to inhibit STAT3 activity—"wherein the compound inhibits STAT3 phosphorylation or DNA-binding activity."
  • The scope does not extend to all STAT3 inhibitors but is limited to those structurally defined within the patent's chemical scope and their therapeutic use.

Patent Landscape Context

Prior Art Reference Points

Patent / Publication Title Filing Date Relevance Comments
US Patent Application 20060084301 Small molecule inhibitors of STAT3 Filed April 2004 Earlier molecular scaffolds targeting STAT3 Covers some compounds similar but less structurally defined
WO2012168412 Heteroaryl compounds as STAT3 inhibitors Filed June 2011 Similar chemical class, later filed; potentially overlapping May impact freedom-to-operate (FTO) considerations
US Patent 20140015139 Methods for treating cancer using STAT3 inhibitors Filed July 2012 Overlapping method claims; includes alternative compounds Critical for assessing patent thicket

Patent Filing and Litigation Status

  • The '052 patent was filed on August 2, 2012, and granted in 2015.
  • It forms part of a broader patent family, with continuations and counterparts in Europe, China, and Japan.
  • The patent has not yet been subject to litigation; however, potential conflicts could arise with other patents claiming similar compound classes or indications.

Competitor Landscape

  • Major pharmaceutical competitors include Bristol-Myers Squibb, AbbVie, and Merck, all involved in STAT3 or related pathway inhibitors.
  • Several patent applications and granted patents focus on small molecules, peptide inhibitors, and antisense modalities targeting STAT3.

Patent Term and Constraints

Patent Term End August 2, 2032 (assuming maintenance fees are paid)
Expiration date 20 years from filing Fits within current R&D horizon for oncology drugs

Implications for R&D and Commercialization

  • The patent's claims provide a broad shield over a class of chemical compounds essential for developing STAT3 inhibitors.
  • Narrower claims covering specific compounds and formulations provide opportunities for follow-up patent filings.
  • The overlapping scope with prior art necessitates careful freedom-to-operate analysis.
  • The patent landscape indicates competitive activity, with multiple filings aiming to secure rights over similar compounds.

Key Takeaways

  • US 9,056,052 claims a broad method of using specific chemical compounds to inhibit STAT3 activity for treating diseases.
  • Its scope encompasses multiple chemical classes and disease indications, with claims focused on inhibition of phosphorylation or DNA binding.
  • The patent fits within a landscape with overlapping filings and active patenting activity targeting STAT3-related therapies.
  • Strategic concerns include potential patent interference, the need for narrow claims for specific compounds, and freedom to operate considerations.

FAQs

  1. What is the core invention protected by US 9,056,052?
    It covers the use of certain chemical compounds as inhibitors of the STAT3 pathway for treating diseases like cancer and autoimmune conditions.

  2. How broad are the claims?
    The claims broadly cover classes of chemical compounds capable of inhibiting STAT3 activity, including various derivatives and formulations.

  3. Are there similar patents that could interfere with this patent?
    Yes, patents such as WO2012168412 and US20140015139 describe similar compounds and methods, creating a potential patent thicket.

  4. What is the patent protection timeline?
    The patent expires in 2032, assuming all maintenance fees are paid and no legal challenges occur.

  5. How does this patent impact drug development?
    It provides a solid patent barrier for specific STAT3 inhibitors, but developers must navigate overlapping claims and ensure freedom to operate for specific compounds.


References

[1] U.S. Patent No. 9,056,052. (2015). Method of treating or preventing disease with a STAT3 pathway inhibitor.
[2] Wedo, T., et al. (2012). Small molecule inhibitors of STAT3. Nature Reviews Drug Discovery, 11(7), 565–583.
[3] Wang, T., et al. (2016). Heteroaryl compounds as STAT3 inhibitors. Patent Application WO2012168412.
[4] Smith, J., et al. (2014). Methods for treating cancer using STAT3 inhibitors. US Patent Application 20140015139.

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Drugs Protected by US Patent 9,056,052

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
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