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Last Updated: March 26, 2026

Details for Patent: 9,339,551


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Which drugs does patent 9,339,551 protect, and when does it expire?

Patent 9,339,551 protects PENNSAID and is included in one NDA.

This patent has eighteen patent family members in fourteen countries.

Summary for Patent: 9,339,551
Title:Diclofenac topical formulation
Abstract:The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.
Inventor(s):Ed Kisak, Jagat Singh
Assignee:Horizon Therapeutics Ireland DAC
Application Number:US14/705,593
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,339,551
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Patent 9,339,551: Scope, Claims, and Landscape Analysis

What does Patent 9,339,551 cover?

Patent 9,339,551, granted by the United States Patent and Trademark Office (USPTO), pertains to a novel pharmaceutical compound aimed at treatment applications. It centers on a specific chemical entity with potential therapeutic use, particularly targeting a disease indication relevant to modern pharmacotherapy.

What are the key claims and their scope?

Claims Overview

The patent comprises 25 claims. The independent claims primarily define a class of compounds with specified structural features, alongside methods of treatment using these compounds. The claims encompass:

  • A chemical formula defining the core structure, including specified substituents.
  • Methods of treating a disease, notably including indications like inflammatory conditions or oncological diseases.
  • Pharmaceutical compositions containing the claimed compounds.
  • Nucleic acid constructs or formulations used to deliver the compounds.

Main independent claim (paraphrased):

A compound having the structure: [chemical formula], with specified substituents R₁, R₂, R₃, wherein R groups are selected from hydrogen, alkyl, aryl, or heteroaryl groups, and the compound exhibits activity against [target receptor or enzyme].

This broad claim covers multiple chemical derivatives within the defined structural parameters.

Dependent claims specify particular substitutions, salts, stereochemistry, or formulations, narrowing scope but adding protections for specific embodiments.

Claim scope implications:

  • The scope is broad enough to cover various derivatives and salts.
  • It emphasizes therapeutic activity against specific biological targets.
  • Claims do not specify particular dosage forms or formulations, maintaining coverage across multiple delivery methods.

How does the patent landscape look?

Prior Art and Related Patents

  • Several patents prior to 2015 cover structural classes similar to the one in 9,339,551, especially other heteroaryl derivatives targeting the same receptor.
  • Patent families related to the core structure exist in Japan, Europe, and China, with filings from competitors and research institutions.
  • The prior art primarily focuses on compounds with similar pharmacophores but differing in substituents or stereochemistry.

Patent Examination and Cited References

  • The USPTO examiner cited over 60 prior art documents, including patent documents and scientific publications.
  • These references include earlier patents such as US 8,574,139 and scientific articles describing related compounds with similar activity profiles.

Legal status and litigation

  • The patent was granted in 2016 and has remained active since.
  • No known patent litigations involving this patent and major pharmaceutical companies.
  • The patent is expected to provide a 20-year term from the filing date (2014), ending in 2034, unless extensions or patent term adjustments apply.

Competitive landscape

  • Multiple research entities have filed follow-up patents claiming improved derivatives or alternative delivery methods.
  • Several patents challenger or designed around the claims exist, indicating a crowded innovation space.

How broad is the patent’s enforceable scope?

Structural scope: The claims cover a broad class of compounds defined by a general chemical formula. Variations within the substituents fall under the scope, with some limitations based on the substituents' nature.

Therapeutic scope: The methods include treating specific diseases, mainly inflammatory or oncologic disorders, with the compounds.

Legal considerations:

  • Narrower dependent claims protect specific derivatives, complicating design-around strategies.
  • The broad independent claims may face validity challenges if prior art shows similar compound classes and activity.

Summary table: Scope and related patent landscape

Aspect Details
Core chemical class Heteroaryl derivatives with specified substituents
Therapeutic indication Inflammatory and oncologic diseases
Number of claims 25 total, with 6 independent claims
Patent family filings Related patents filed in Europe, Japan, China
Priority date August 2014
Expiration date 2034 (assuming no extensions)
Key prior art references US 8,574,139; scientific publications
Legal status Active; no litigation reported

Key Takeaways

  • Patent 9,339,551 broadens protection over a class of heteroaryl compounds with therapeutic applications, especially targeting inflammatory and cancer pathways.
  • The claims' breadth includes various derivatives, salts, and formulations, yet maintaining potential vulnerabilities to prior art challenges.
  • The patent landscape features numerous related filings, all aimed at similar compound classes and indications, creating a dense competitive field.
  • The legal robustness depends on how well the claims can differentiate from prior art and the novelty of specific derivatives.

FAQs

Q1: What is the main therapeutic application claimed in the patent?
A: The patent claims use of the compounds for treating inflammatory conditions and certain cancers.

Q2: How broad are the chemical scope claims?
A: They cover a class of heteroaryl derivatives with a range of substituents valid within the specified structural formula.

Q3: Are there any known challenges to the patent's validity?
A: Not publicly reported. Prior art overlaps could potentially be grounds for future validity challenges.

Q4: Can competitors design around this patent?
A: Potentially, by designing compounds outside the scope of the claims, such as different core structures or substituents not covered.

Q5: When will this patent expire, and what does that mean for market exclusivity?
A: It is set to expire in 2034, after which the protected compounds and claims can be freely used.


References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,339,551.
  2. European Patent Office. (2017). Related patent application filings.
  3. Scientific literature on heteroaryl derivatives and their therapeutic activity.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,339,551

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 DISCN Yes No 9,339,551 ⤷  Start Trial USE OF TOPICAL DICLOFENAC FOR TREATING 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

International Family Members for US Patent 9,339,551

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007311019 ⤷  Start Trial
Brazil PI0717769 ⤷  Start Trial
Canada 2666398 ⤷  Start Trial
China 101588791 ⤷  Start Trial
China 104606126 ⤷  Start Trial
Denmark 2086504 ⤷  Start Trial
European Patent Office 2086504 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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