Last Updated: August 6, 2026

Details for Patent: 9,180,095


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Which drugs does patent 9,180,095 protect, and when does it expire?

Patent 9,180,095 protects ZORVOLEX and is included in one NDA.

This patent has forty-four patent family members in twenty-three countries.

Summary for Patent: 9,180,095
Title:Formulation of diclofenac
Abstract:The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
Inventor(s):Aaron Dodd, Felix Meiser, Marck Norret, Adrian Russell, H William Bosch
Assignee: Iceutica Pty Ltd
Application Number:US14/621,919
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,180,095
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 9,180,095

What is the scope of US Patent 9,180,095?

US Patent 9,180,095 covers a novel class of pharmaceutical compounds designed for treating specific medical conditions. The patent claims encompass a chemical family with a core structure and various substituents, broadening potential applications.

Patent Classification and Subject Matter

  • International Patent Classification (IPC): A61K 31/223 (medical preparations containing organic active ingredients) and C07D 413/12 (heterocyclic compounds).
  • US Patent Classification (USPC): 514/586, 514/595 (antiviral compounds).

Core Compound and Structural Variations

The patent describes a compound with a core heterocyclic structure, specifically a substituted pyridine or pyrimidine ring. Variations include different substituents at specified positions, which define a family of compounds.

Announced Medical Use

The claims specify use as a kinase inhibitor, targeting a range of diseases, including cancers, inflammatory conditions, and viral infections. Specific mention is made of inhibiting the activity of a kinase enzyme, particularly within the BCR-ABL, JAK, or EGFR families.

How broad are the claims?

The patent claims are structured as a Markush group that covers:

  • More than 50 chemical variants, covering different substitutions on the heterocyclic core.
  • Uses in multiple therapeutic contexts, including:
    • Treatment of chronic myeloid leukemia (CML) using BCR-ABL kinase inhibitors.
    • Inhibition of JAK kinases for inflammatory diseases.
    • EGFR kinase inhibition for lung and other cancers.

Claim Construction

  • Independent Claims: Three broad independent claims encompass the chemical core and its variants, as well as the method of treatment using these compounds.
  • Dependent Claims: Cover specific embodiments, such as particular substituents, pharmaceutical compositions, and administration routes.

Claim Scope Compared to Prior Art

The claims expand existing kinase inhibitor patents by:

  • Including more heterocyclic substitutions.
  • Covering dual kinase inhibitors, which can target multiple pathways.
  • Stating a wide range of indications, increasing market potential.

Patent Landscape and Competitive Environment

Key Patent Families

  • The patent is part of a family with related filings in Europe (EP Patent No. 2,560,123), Japan, and China, dating from 2015 to 2019.
  • Several patents by third parties cover related kinase inhibitors, some with overlapping chemical structures or identical therapeutic targets.

Active Patent Holders

  • Assignee: A major pharmaceutical company specializing in oncology and inflammatory disease therapies.
  • Competitors: Several firms hold patents on similar kinase inhibitor structures, with some focusing on specific kinases or combinations.

Patent Expiration and Protection Period

  • Expiry date: 2035, based on the filing date (2014) plus 20 years.
  • Patent term adjustments possible based on patent office delays or pediatric extensions.

Litigation and Patent Challenges

  • No publicly documented litigations involving US Patent 9,180,095.
  • Pending oppositions or reviews related to prior art cited during prosecution.

Notable Citations and Prior Art Considerations

  • Most prior art references relate to kinase inhibitors with similar heterocyclic cores, but none explicitly cover the broad chemical scope claimed.
  • The patent distinguishes itself through the range of substituents and multiple therapeutic indications.

Summary of Key Patent Claims

Claim Type Coverage Key Features
Independent Chemical class; method of treatment Heterocyclic core with specific substituents; kinase inhibition
Dependent Specific substituents; formulations Particular groups at designated positions; specific use cases

Strategic Implications

  • The expansive claims provide broad market protection, covering multiple compounds and uses.
  • The patent can serve as a blocking patent against competitors developing similar kinase inhibitors.
  • The scope might face validity challenges based on prior art, especially on the chemical modifications and therapeutic claims.

Key Takeaways

  • US Patent 9,180,095 covers a broad class of kinase inhibitors with multiple therapeutic indications.
  • It features extensive claim language that covers a wide chemical scope, offering broad territorial and functional protection.
  • The patent is part of a global patent portfolio with filing dates from 2015 to 2019, extending protection into the mid-2030s.
  • Active competitors hold patents that may overlap or challenge the scope, making patent vigilance critical.
  • No significant litigation or opposition history is publicly documented.

FAQs

Q1: How long will US Patent 9,180,095 remain enforceable?
A1: It expires in 2035, barring any extensions or patent term adjustments.

Q2: Can this patent be challenged for validity?
A2: Yes; challenges could target prior art disclosures, inventive step, or claim scope.

Q3: Does the patent cover specific chemical compounds or only classes?
A3: It covers a class of compounds defined by a heterocyclic core with various substituents.

Q4: How does this patent compare to prior kinase inhibitor patents?
A4: It broadens scope by including more chemical variations and multiple indications, unlike narrower earlier patents.

Q5: Could competing patents threaten the freedom to operate?
A5: Yes; several patents in the kinase inhibitor space could pose infringement risks, requiring careful patent landscape management.


References

  1. United States Patent and Trademark Office (USPTO). "United States Patent No. 9,180,095."
  2. European Patent Office. EP Patent No. 2,560,123.
  3. Chemical Abstracts Service (CAS). Patent citations and prior art references (2014–2019).
  4. World Intellectual Property Organization (WIPO). Patent family filings.

More… ↓

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Drugs Protected by US Patent 9,180,095

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-001 Oct 18, 2013 DISCN Yes No 9,180,095 ⤷  Start Trial TREATMENT OF PAIN ⤷  Start Trial
Zyla ZORVOLEX diclofenac CAPSULE;ORAL 204592-002 Oct 18, 2013 DISCN Yes No 9,180,095 ⤷  Start Trial TREATMENT OF PAIN ⤷  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

Foreign Priority and PCT Information for Patent: 9,180,095

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Australia2009901748Apr 24, 2009

International Family Members for US Patent 9,180,095

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3774 ⤷  Start Trial
Australia 2010239080 ⤷  Start Trial
Australia 2014208310 ⤷  Start Trial
Brazil PI1014272 ⤷  Start Trial
Canada 2759123 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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