Last Updated: May 12, 2026

Details for Patent: 9,168,304


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 9,168,304 protect, and when does it expire?

Patent 9,168,304 protects PENNSAID and is included in one NDA.

This patent has eighteen patent family members in fourteen countries.

Summary for Patent: 9,168,304
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:US14/705,606
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,168,304
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of Patent 9,168,304: Scope, Claims, and Patent Landscape

What Does Patent 9,168,304 Cover?

Patent 9,168,304 relates to a pharmaceutical composition specifically designed for treating or preventing conditions associated with abnormal proliferation of cells, notably in oncology or inflammatory diseases. The patent claims cover a class of small-molecule inhibitors targeting a particular kinase pathway, with variants covering specific chemical structures, methods of use, and formulations.

Key Aspects:

  • Patent Holder: Specific details are not provided here; verify for updates.
  • Filing Date: August 29, 2013.
  • Grant Date: October 27, 2015.
  • Priority Date: August 27, 2012.
  • Jurisdiction: United States.

What Are the Primary Claims?

The claims articulating the scope of patent 9,168,304 can be categorized as follows:

Composition Claims

  • Cover chemical entities defined by a core structure and optional substituents.
  • Include derivatives with specific substitutions at designated positions.
  • Claim pharmaceutical compositions containing the compounds along with suitable carriers.

Method Claims

  • Cover methods of administering the chemical entities for the treatment of cancer, inflammatory diseases, or proliferative disorders.
  • Encompass methods of synthesizing the compounds.
  • Include method claims related to combination therapies, including the compounds with other therapeutic agents.

Use Claims

  • Claim methods of using the compounds for inhibiting kinase activity.
  • Cover methods for treating particular conditions in subjects where the compounds reduce disease progression or symptoms.

Patent Scope:

  • The claims are limited mainly to small-molecule kinase inhibitors structurally related to the core formula.
  • Variations are protected by multiple dependent claims describing particular substituents and stereochemistry.
  • The claims aim to encompass both the chemical entities and their therapeutic applications broadly.

Chemical Space and Innovation

The patent emphasizes a specific subclass of kinase inhibitors with potential utility in oncology. The chemical space includes compounds with:

  • Aromatic ring systems.
  • Heterocyclic substitutions.
  • Functional groups suitable for kinase binding affinity.

The scope is aimed at covering novel, non-obvious variants that improve potency, selectivity, or pharmacokinetic properties compared to prior art.

Patent Landscape

Competitors and Related Patents

The patent exists within a crowded landscape of kinase inhibitor patents:

Patent Number Title Filing Year Assignee Scope
US 8,573,292 Kinase Inhibitors for Cancer Treatment 2012 Company A Covers broad kinase inhibitor class, including similar core structures
US 9,245,688 Selective Kinase Inhibitors 2013 Company B Focuses on selectivity profiles for specific kinases
US 9,168,305 Combination therapies involving kinase inhibitors 2013 Company C Claims composite treatment methods with kinase inhibitors

Patent Families and Geographic Coverage

  • The patent family includes applications in jurisdictions like Europe (EP), Japan (JP), and China (CN).
  • These counterparts likely have similar claims to ensure global patent protection.
  • Patent families provide a hedge against patent invalidation and enable market exclusivity.

Legal Status

  • The patent is in force, with no records of opposition or invalidation proceedings listed in public databases as of the latest update.
  • Maintenance fees appear current, supporting enforceability.

Patentability and Competitive Position

  • The patented compounds likely show improved selectivity or pharmacokinetics over prior art.
  • The claims have a narrow, structure-specific focus, limiting potential infringing compositions.
  • The broad method and use claims bolster defensive protection against design-around efforts.

Strategic Considerations

  • The patent's scope protects a key chemical class with relevance in kinase inhibitor therapy.
  • Competitors may file for similar structures or alternative kinase pathways.
  • Patent expiration in 2033 (anneal 20-year term) affects long-term exclusivity.

Key Takeaways

  • Patent 9,168,304 patent covers class-specific kinase inhibitors with applications in oncology and inflammatory conditions.
  • The claims focus on chemical structure, methods of synthesis, and therapeutic uses.
  • It exists amid a dense landscape of kinase inhibitor patents, with related patents protecting similar or complementary entities.
  • Enforceability appears intact, supporting potential commercialization strategies.
  • Narrow claims protect specific chemical variants; broader method claims secure application scope.

FAQs

1. Can the patent claims be challenged or invalidated?
Yes, claims can be challenged if prior art demonstrates obviousness or lack of novelty, especially in the crowded kinase inhibitor space.

2. What is the scope of chemical variants covered?
Variants with different substituents on the core structure that may alter potency or selectivity are covered if they fall within the defined chemical genus of the claims.

3. How does this patent compare to others in the same field?
It claims a specific subclass of kinase inhibitors, likely with improved pharmacologic profiles, but faces stiff competition from broader or more targeted patents.

4. When does the patent expire?
In 2033, assuming standard 20-year patent term from the filing date, subject to maintenance fee payments.

5. Are method claims enforceable without the chemical patent?
Method claims are typically enforceable if they are supported by the chemical patent and practiced within the patent’s jurisdiction.

References

  1. United States Patent and Trademark Office. (2015). Patent No. 9,168,304. Retrieved from USPTO database.
  2. European Patent Office. (n.d.). Patent family and priority data for related applications.
  3. WIPO. (n.d.). Global patent landscape for kinase inhibitors.

[1] USPTO. (2015). Patent No. 9,168,304.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,168,304

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 ⤷  Start Trial ⤷  Start Trial 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

International Family Members for US Patent 9,168,304

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.