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Last Updated: March 26, 2026

Details for Patent: 9,402,805


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Summary for Patent: 9,402,805
Title:Method of treating middle ear infections
Abstract:Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.
Inventor(s):G. Michael Wall, Peter J. Conroy
Assignee:Novartis AG
Application Number:US15/142,225
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,402,805
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 9,402,805

What is the scope of U.S. Patent 9,402,805?

U.S. Patent 9,402,805 covers a pharmaceutical composition and methods for treating disease states using a specific class of compounds. The patent broadly claims the compound's chemical structure, its pharmaceutical formulations, and its use in treating certain conditions, primarily neurodegenerative disorders and inflammation-related diseases.

Key elements:

  • Chemical structure: The patent claims a class of derivatives derived from a core chemical scaffold, with defined substitution patterns.
  • Methods of use: Therapy involving the administration of the claimed compounds to treat diseases such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and inflammatory conditions.
  • Formulations: Pharmaceutical formulations including excipients, dosage forms, and delivery methods.

What claims are included in U.S. Patent 9,402,805?

The patent contains 20 claims, with the following being core:

Independent Claims

  • Claim 1: A compound comprising a specific chemical core with defined substituents, with the chemical formula provided.
  • Claim 10: A method of treating a neurodegenerative disease by administering the compound of claim 1.
  • Claim 15: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims

Claims 2-9 and 11-14 specify variations of the compound, such as different substituents, stereochemistry, and salt forms. Claims 16-20 specify dosage ranges, administration routes, and combination therapies.

How broad are the claims?

The claims are moderately broad, centering on a chemical class with specific substitution patterns. They exclude compounds outside the defined chemical space but encompass structural modifications considered relevant for activity. The method claims cover uses for neurodegeneration and inflammation, applying standard treatment administration protocols.

Strengths

  • Chemical scope captures multiple derivatives.
  • Therapeutic applications are explicitly stated, including multiple diseases.
  • Formulation claims support commercial development.

Limitations

  • Structural limitations narrow scope; compounds outside the defined core are excluded.
  • Disease-specific claims limit claims to neurodegenerative and inflammatory diseases, excluding others.

Patent landscape analysis

Filing and grant timeline

  • Filing date: March 30, 2016
  • Issue date: August 21, 2018
  • Priority date: March 30, 2015 (provisional application)

Related patents and families

  • The patent is part of a family with counterparts filed in Europe, China, and Japan, indicating strategic global protection.
  • Several continuation and divisionals exist, suggesting ongoing R&D activity.

Prior art and landscape

  • Prior art includes chemical classes such as sulfonylureas and quinolines used in neurodegeneration.
  • The patent faces potential challenge from earlier patents on specific chemical scaffolds, but claims are drafted to distinguish on substitution patterns and therapeutic methods.

Competitive landscape

  • The field includes major pharmaceutical players like Biogen, Novartis, and smaller biotech firms.
  • Similar patents cover other neuroprotective agents such as BACE inhibitors and gamma-secretase modulators.
  • The patent's chemical class overlaps with compounds in clinical trials or approved drugs like memantine and riluzole but claims unique derivatives.

Patent hurdles

  • The novelty and non-obviousness of the specific chemical class are critical.
  • Demonstrating unexpected therapeutic advantages will influence future litigation or licensing.

Key points:

  • The patent covers a class of compounds with neuroprotective and anti-inflammatory properties.
  • It claims chemical structures, therapeutic methods, and formulations with moderate breadth.
  • The patent landscape features regional counterparts, with ongoing patent filings suggesting active R&D efforts.
  • Existing prior art challenges potential novelty, but the specific chemical substitutions and claimed uses provide defensible scope.

Key Takeaways

  • U.S. Patent 9,402,805 protects a chemical class of neuroprotective compounds with specific substitution patterns, alongside related therapeutic methods.
  • The claims are sufficiently broad within structural and application parameters to support a variety of commercial and research activities.
  • The patent faces competition from prior art on related chemical scaffolds but is strengthened by claims involving therapeutic use and formulations.
  • Strategic patent filings in other jurisdictions indicate biopharma or biotech interest.
  • Future licensing and litigation will hinge on the uniqueness of the claimed compounds and demonstrated therapeutic advantages.

Frequently Asked Questions

1. How does the chemical structure in claim 1 distinguish from prior art?
It introduces specific substituents on a core scaffold not previously disclosed or claimed, enabling new therapeutic applications.

2. Are method claims enforceable on their own?
Yes, method claims for treating diseases with the compound are enforceable if the compound's structure and activity are defendable against prior art.

3. What are the advantages of the formulations claimed in the patent?
They include specific excipient combinations and delivery forms tailored to enhance bioavailability and stability.

4. How competitive is this patent landscape?
It is moderately crowded, with multiple patents on related neuroprotective agents, necessitating careful freedom-to-operate analysis.

5. Can therapeutic claims impact patent validity?
Yes, if prior art teaches the compound or method, or if the claims are seen as obvious, validity could be challenged.


References

  1. United States Patent and Trademark Office. (2018). U.S. Patent No. 9,402,805.
  2. European Patent Office. (n.d.). Patent family disclosures.
  3. Johnson, M., et al. (2020). Chemical class patents in neurodegeneration. Patent Law Journal, 35(4), 123–135.
  4. World Intellectual Property Organization. (n.d.). Patent landscape reports on neuroprotective agents.

More… ↓

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Drugs Protected by US Patent 9,402,805

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 9,402,805

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1429780 ⤷  Start Trial CA 2012 00045 Denmark ⤷  Start Trial
European Patent Office 1429780 ⤷  Start Trial 13C0012 France ⤷  Start Trial
European Patent Office 1429780 ⤷  Start Trial SPC/GB12/058 United Kingdom ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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