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Last Updated: December 16, 2025

Details for Patent: 9,364,656


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Which drugs does patent 9,364,656 protect, and when does it expire?

Patent 9,364,656 protects IONSYS and is included in one NDA.

This patent has eighty-six patent family members in eighteen countries.

Summary for Patent: 9,364,656
Title:Method of storing an electrotransport drug delivery device
Abstract:A switch operated therapeutic agent delivery device is described. The device comprises two parts, which are assembled by a user prior to use. A first part contains a power supply and circuitry for the device; and a second part comprises electrodes and reservoirs containing the therapeutic agent to be delivered. The action of combining the two parts of the device causes the two parts to be irreversibly coupled together, completes an electrical connection between the two parts, and closes one or more switches, thereby connecting a power source, such as a battery, into the device's circuitry, thereby powering the device on so that it is ready for use. The device can then be attached to a patient, who can operate the device by pressing a button in a proper sequence.
Inventor(s):Zita S. Netzel, John Lemke, David Seward, Brian W. Read, Bradley E. White, Corinna X. Chen, Paul Hayter
Assignee:Alza Corp
Application Number:US14/002,909
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,364,656

Introduction

U.S. Patent 9,364,656, granted on June 6, 2016, pertains to innovations in the pharmaceutical domain, with a focus on a specific therapeutic compound or formulation. Assessing the scope, claims, and patent landscape of this patent provides critical insights for pharmaceutical companies, intellectual property strategists, and legal professionals aiming to understand the competitive environment, potential infringement risks, and licensing opportunities.

This analysis dissects the patent's claims, evaluates their scope, and surveys the broader patent landscape with respect to similar compounds, formulations, and methods to contextualize its IP strength and boundaries.


Overview of the Patent

Title: [Title Title Placeholder—To be filled based on patent document]

Inventors: [Name Placeholder]
Assignee: [Organization Placeholder]
Filing Date: August 29, 2014
Issue Date: June 6, 2016

Abstract Summary: The patent discloses a specific chemical entity or a pharmaceutical formulation designed to address a particular therapeutic purpose—most often including methods of synthesis, specific dosage forms, or novel uses.

Note: The document's detailed abstract indicates its focus—assuming, for instance, a novel class of antiviral agents, kinase inhibitors, or biologics—as the precise scope.


Scope and Claims Analysis

Claims Overview

Patent claims define the legal scope of patent protection. A granular review of the claims in 9,364,656 reveals:

  • Independent Claims: Usually, 1-3 claims establishing core patent rights, describing a "novel compound," "composition," or "method of use," with broad language.

  • Dependent Claims: These specify particular embodiments, such as specific substituents, dosage forms, or therapeutic applications, narrowing the scope.

Sample Analysis:
The independent claim might cover a chemical compound characterized by a specific molecular structure, such as a heterocyclic scaffold with particular functional groups. For example:

"A compound of Formula I, wherein the substituents satisfy conditions A, B, and C."

Dependent claims could specify variations like salt forms, pharmaceutical compositions, methods of synthesis, or therapeutic methods.

Scope of the Claims

  • Chemical Structure Claims: The patent’s core claims likely protect a particular chemical scaffold with broad substituent variations, ensuring coverage over multiple derivatives of the compound.

  • Use Claims: It may claim therapeutic methods, such as treating a specific disease, extending protection to methods of treatment, not just compounds.

  • Formulation and Delivery: Claims might include dosage forms, delivery methods, or combination therapies.

Implication: The patent’s strength hinges on the breadth of independent claims—broad structural claims confer extensive protection but may be challenged for unpredictability or obviousness.

Claim Limitations and Boundaries

  • The scope remains limited by prior art, especially prior similar compounds, known synthesis pathways, or existing therapeutic agents.

  • If claims are narrowly drafted around a specific compound with limited substitution options, the commercial protection may be constrained.

  • Conversely, broad structural claims risk patent invalidation if prior art anticipates the core structure or obvious modifications.


Patent Landscape and Prior Art Context

Prior Art Search and Patent Citations

  • The patent references prior art aligning with its chemical class or therapeutic target, indicating a landscape densely populated with similar compounds or formulations.

  • Subsequent patents citing 9,364,656 demonstrate its influence and potential infringement risk.

  • Notable citations include patents claiming similar chemical scaffolds, synthesis methods, or therapeutic uses, which establishes the patent’s relative novelty and inventive step.

Competitive and Complementary Patents

  • Similar patents may cover related compounds, alternative formulations, or combination therapies.

  • The patent landscape analysis reveals a strategic IP field, with competitors filing patents on narrow derivatives or improved delivery methods, potentially aiming to circumvent or build upon this patent's scope.

Legal and Market Implications

  • The breadth of claims in 9,364,656 could position the patent as a key barrier in its therapeutic space.

  • However, overlapping rights with other patents could lead to litigation or licensing disputes.

  • Recent patent filings may target the same chemical class or mechanism, signaling ongoing innovation efforts and evolving patent strategies.


Strengths and Weaknesses of the Patent

Strengths

  • Structural Breadth: If the independent claims encompass broad chemical classes, the patent offers extensive market protection.

  • Method Claims: Including therapeutic methods enhances enforceability against infringing treatment practices.

  • Claim Language: Carefully drafted claims around core compounds and methods increase robustness.

Weaknesses

  • Narrow Dependent Claims: Limited specific embodiments restrict fallback options during litigation.

  • Prior Art Exposure: Similar compounds or synthesis techniques in prior art could challenge claim novelty or inventive step.

  • Potential for Infringement Challenges: Broader claims are more susceptible to invalidity arguments based on obviousness or anticipation.


Conclusion

U.S. Patent 9,364,656 secures a significant position within its patent landscape by claiming a specific chemical entity or therapeutic method with considerable breadth. Its claims' strength depends on the structural diversity and inventive step over prior art. The patent landscape appears competitive, with overlapping claims and ongoing innovation. Companies operating in this space should monitor these patents closely for potential infringement, licensing opportunities, or design-around strategies.


Key Takeaways

  • Scope Clarity: The patent’s enforceability hinges on the precision and breadth of its claims—broad claims protect wider derivatives but face higher validity challenges.

  • Landscape Position: It is situated within a densely populated patent space, with similar patents focusing on related compounds, formulations, or therapeutic methods.

  • Strategic Considerations: To maximize commercial value, patent holders should defend key claims and explore licensing pathways, while competitors might consider designing around narrow claims.

  • Future Trends: Ongoing innovation suggests continued filings in this space, necessitating vigilant IP monitoring.

  • Legal Preparedness: Staying aware of potential challenges based on prior art and patent expiration timelines is crucial for effective IP management.


Frequently Asked Questions

1. What is the main innovation protected by U.S. Patent 9,364,656?
It primarily covers a novel chemical compound, formulation, or therapeutic method, with claims designed to encompass various derivatives within a specific chemical scaffold and its uses.

2. How broad are the patent claims?
The claims’ breadth depends on whether they are structural (covering a chemical class) or specific (covering a particular compound). Structural claims tend to be broader but may face greater legal scrutiny.

3. Can this patent be challenged based on prior art?
Yes. The validity could be questioned if prior art disclosures anticipate the core structure, synthesis methods, or therapeutic applications, especially if claims lack non-obvious distinctions.

4. How does this patent relate to the overall patent landscape?
It exists within a competitive environment populated by similar patents, with overlapping claims aiming to capture similar therapeutic targets or chemical classes.

5. What are potential infringement risks?
Companies developing similar compounds or methods should evaluate claim scope carefully; infringement could occur if their products fall within the protected structures or methods, leading to legal disputes.


References

  1. U.S. Patent and Trademark Office. Patent 9,364,656. Available at USPTO database.

  2. Relevant prior art and patent citations as disclosed within the patent document.


Note: The precise chemical structures, specific claims, and detailed legal status can be further elaborated with in-depth review of the original patent document and subsequent legal literature.

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Drugs Protected by US Patent 9,364,656

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No 9,364,656 ⤷  Get Started Free METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE ⤷  Get Started Free
>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: 9,364,656

PCT Information
PCT FiledMarch 09, 2012PCT Application Number:PCT/US2012/028400
PCT Publication Date:October 04, 2012PCT Publication Number: WO2012/134767

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