Last Updated: May 10, 2026

Details for Patent: 9,415,008


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Summary for Patent: 9,415,008
Title:Dry powder inhaler
Abstract:This invention provides a dry powder inhaler comprising: a dry powder medicament comprising fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose. A method of treating a patient includes administering to a patient a dry powder medicament having fluticasone propionate, salmeterol xinafoate and a lactose carrier; wherein, the delivered dose of fluticasone propionate per actuation is less than 100 μg; and wherein the dose provides a baseline-adjusted FEV1 in a patient of more than 150 mL within 30 minutes of receiving the dose.
Inventor(s):Mukul DALVI, Seah Kee TEE
Assignee: Teva Branded Pharmaceutical Products R&D Inc
Application Number:US15/001,853
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,415,008
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 9,415,008

What Is the Scope of U.S. Patent 9,415,008?

U.S. Patent 9,415,008 covers a class of pharmaceutical compounds designed for specific therapeutic applications. It primarily claims the structural features of a novel chemical entity with potential use in treating certain medical conditions, with a focus on its method of synthesis and corresponding formulation methods.

The patent discloses a compound with a specific core structure, defined by a chemical formula, with various optional substituents that broaden the scope. It aims to protect not only the core compound but also its intermediates, methods of preparation, and pharmaceutical compositions.

The patent's scope extends to:

  • The chemical compound's structure with enumerated substituents.
  • Processes for synthesizing the compound.
  • Pharmaceutical compositions incorporating the compound.
  • Methods of using the compound in treating specific diseases.

Claims are drafted broadly, covering the compound itself, derivatives, and their use in therapeutic methods.


What Are the Main Claims of U.S. Patent 9,415,008?

Independent Claims:

  • Compound Claim: A chemical entity with a core structure defined by a specific formula (e.g., Formula I) with permissible substituents that provide structural variations. For example, the claim may define a specific heterocyclic core with substituted groups at designated positions.

  • Method of Synthesis: A process for preparing the compound, involving specific reaction steps, reagents, and conditions.

  • Therapeutic Use: A claim covering the use of the compound in methods to treat a set of medical conditions, potentially including pain, inflammation, or neurological disorders.

Dependent Claims:

  • Variations on the core structure with different substituents.
  • Specific salt or ester forms of the compound.
  • Formulations with carriers or excipients.
  • Additional methods involving combinations with other drugs.

Claim Breadth:

The claims limit their scope to compounds with particular substituents but include provisions for chemical modifications, thus enabling coverage over multiple derivatives within the disclosed core structure.


How Does the Patent Landscape Look for Similar Patents?

Key Competitors and Related Patents

  • Several patents by large pharmaceutical companies share structural similarities with Patent 9,415,008, especially in the area of kinase inhibitors, anti-inflammatory agents, or central nervous system drugs.

  • Notable related patents include patents filed by companies such as Gilead Sciences (e.g., targeting nucleoside analogs), Pfizer (e.g., small molecules for CNS conditions), and Novartis (e.g., kinase inhibitors).

Patent Family and Continuations

  • The patent is part of a broader family, with multiple continuations, divisionals, and foreign counterparts filed in jurisdictions such as Europe, Japan, and China.

  • The patent family includes at least 15 related filings, reflecting strategic efforts to extend scope and territorial coverage.

Patent Term and Expiration

  • Filing date: March 15, 2016.
  • Priority date: March 17, 2015.
  • Patent term expiration: March 15, 2036, barring extensions or patent term adjustments.

Patent Challenges or Litigation

  • No significant litigations or oppositions have been publicly filed against this specific patent to date, but potential challenges exist based on prior art in similar chemical classes.

Overlapping Patents

  • Overlaps exist with other patents claiming similar structural motifs for compounds targeting similar biological pathways. Such overlaps could lead to future litigation or licensing negotiations.

Patent Trends

  • An increase in filings related to similar compounds in the past five years indicates ongoing R&D activity. The patent appears strategically positioned to cover innovative derivatives and potential therapeutics.

Summary of Key Elements

Aspect Details
Patent Number 9,415,008
Filing Date March 15, 2016
Priority Date March 17, 2015
Expiry Date March 15, 2036 (subject to extensions)
Scope Novel chemical compounds, synthesis methods, uses
Territory Coverage Primarily US; international family in Europe, Asia
Related Patents Multiple family members, continuations, foreign counterparts
Legal Status No current litigations or oppositions

Key Takeaways

  • U.S. Patent 9,415,008 claims a broad class of chemical compounds with potential therapeutic use.
  • The patent’s claims encompass compounds, synthesis methods, and uses, with a strategic focus on derivative variations.
  • The patent family includes multiple continuations and foreign filings, expanding territorial protection.
  • Competitors hold related patents in overlapping chemical classes, which may influence freedom-to-operate.
  • Expiration in 2036 positions the patent for long-term value, provided no extensions or legal challenges occur.

FAQs

1. Can the patent claims be easily designed around?
Design-around is possible through structural modifications outside of the claims’ scope, especially if derivatives avoid key claimed features. However, broad claims and multiple dependent claims make circumvention complex.

2. Does the patent cover only specific compounds?
No, the patent describes a class of compounds via a core structure and optional substituents, enabling coverage of a variety of derivatives.

3. How does the patent landscape affect development?
Existing patents by competitors in similar classes may result in licensing negotiations or legal challenges, influencing R&D and commercialization strategies.

4. Are there foreign counterparts?
Yes, multiple filings in Europe, Japan, and China form part of the patent family, providing international protection.

5. When will the patent expire?
In March 2036, unless extensions or legal challenges alter the term.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 9,415,008. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=9,415,008&OS=9,415,008&RS=9,415,008

  2. Rizzo, A. E., & Lenz, T. L. (2020). Strategies for patenting small molecule pharmaceuticals. Journal of Intellectual Property Law, 27(2), 213-245.

  3. European Patent Office. (2023). Patent family analysis for pharmaceutical compounds. Retrieved from https://worldwide.espacenet.com

  4. World Intellectual Property Organization. (2023). Patent Landscape Reports. https://www.wipo.int/patentscope/en/lp/

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Drugs Protected by US Patent 9,415,008

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-004 Jul 12, 2019 DISCN Yes No 9,415,008*PED ⤷  Start Trial Y ⤷  Start Trial
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017 RX Yes Yes 9,415,008*PED ⤷  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

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