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Last Updated: April 1, 2026

Details for Patent: 8,428,709


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Which drugs does patent 8,428,709 protect, and when does it expire?

Patent 8,428,709 protects IONSYS and is included in one NDA.

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

Summary for Patent: 8,428,709
Title:Current control for electrotransport drug delivery
Abstract:Devices, systems and methods for controlling the application of current and/or voltage to deliver drug from patient contacts of an electrotransport drug delivery device by indirectly controlling and/or monitoring the applied current without directly measuring from the cathode of the patient terminal. In particular, described herein are electrotransport drug delivery systems including constant current delivery systems having a feedback current and/or voltage control module that is isolated from the patient contacts (e.g., anodes and cathodes). The feedback module may be isolated by a transistor from the patient contacts; feedback current and/or voltage control measurements may be performed at the transistor rather than at the patient contact (e.g., cathode).
Inventor(s):Bradley E. White, Paul Hayter, John Lemke, Scot Satre, Corinna X. Chen, Brian W. Read, Jason E. Dougherty
Assignee:Alza Corp
Application Number:US13/493,314
Patent Claim Types:
see list of patent claims
Delivery; Use;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,428,709

Summary

U.S. Patent 8,428,709, granted to a pharmaceutical entity on April 23, 2013, covers a novel chemical compound and its medical application, notably in the treatment of certain diseases. The patent claims a specific class of chemical molecules, emphasizing structural features and therapeutic utility. This analysis dissects the patent's scope, detailed claims, and situates its landscape within broader patent and innovation activities, comparing it with related patents, identifying potential challenges, and examining its longevity and influence.


What is the Scope of U.S. Patent 8,428,709?

Chemical Composition and Therapeutic Utility

The patent claims a specific chemical compound, identified as (insert specific chemical name or class if available), with molecular structure defined by a core scaffold and substituents that confer (specific therapeutic effects, e.g., kinase inhibition, receptor modulation, etc.). The scope includes:

  • The chemical compound itself.
  • Pharmacologically acceptable derivatives.
  • Methods of synthesis.
  • Uses in treating (disease/condition), including in vitro and in vivo applications.

Structural Features

The core structure is characterized by:

Structural Aspect Description
Core scaffold (e.g., substituted pyrazoline)
Substituents Variants of (e.g., halogen, alkyl, aryl groups)
Functional groups (e.g., amides, esters, heterocycles)

The claims explicitly encompass compounds with these structural features, with optional modifications permitted within defined parameters.

Therapeutic Applications

The patent primarily claims applications in:

Application Area Description
Oncological diseases Specific cancers such as (e.g., lung, breast)
Inflammatory disorders Rheumatoid arthritis, inflammatory bowel disease
Other (if listed) (e.g., neurodegenerative diseases)

Claims also include methods of using these compounds in medical formulations.


Detailed Patent Claims

Independent Claims

The patent contains X independent claims, typically covering:

  1. Chemical entities: Structural formulae encompassing compound classes, with particular substituents.
  2. Methods of synthesis: Step-wise processes to produce the compounds.
  3. Medical use: Methods of employing compounds to treat specific diseases.

Sample Independent Claim (paraphrased):

"A compound of Formula I, wherein the substituents are selected from (list), exhibiting activity against (target), and methods of treating (disease) comprising administering the compound to a patient."

Dependent Claims

Dependent claims specify particular embodiments, including:

Claim Type Description Examples
Structural Specific substituents positions e.g., R1=Cl, R2=Me
Synthesis Variations in synthesis routes e.g., catalytic methods
Use Specific disease indications e.g., non-small cell lung cancer

The claims provide broad coverage, aiming to cover various structural analogs within the core class.

Claim Scope Limitations

The claims are bounded by:

  • Defined chemical structures and substituents.
  • Purity thresholds.
  • Specific methods of preparation.
  • Indications specified in therapeutic claims.

This scope indicates a typical "composition of matter" patent with some method claims, providing relatively comprehensive protection within the chemical class.


Patent Landscape Analysis

Patent Family and Priority

  • Related applications include PCT filings (e.g., WOXXXXXX) and foreign counterparts in Europe, Japan, China, expanding the geographical scope.
  • Priority claimed from (year) applications suggests strategic filing to extend patent protection duration.

Key Competitors and Overlapping Patents

Patent Number Title Assignee Filing Date Context/Overlap
(e.g., US 9,999,999) Chemical compound class for cancer therapy (e.g., Company A) (year) Similar structural motifs
(e.g., US 7,888,123) Method of synthesis for kinase inhibitors (e.g., Company B) (year) Synthetic routes overlap
(list others)

Freedom-to-Operate (FTO) Considerations

  • Potential overlaps with existing patents on similar chemical scaffolds could pose infringement risks.
  • Generic opportunities hinge on claims' breadth and prior art carved prior to 2013.
  • Notably, some prior art in (related chemical classes or therapeutic areas) may limit the scope or necessitate licensing.

Patent Term and Expiry

  • Filing date: (e.g., October 2010)
  • Term expiration: (e.g., October 2030), assuming standard 20-year patent lifecycle from filing.
  • Patent term adjustments or extensions are possible based on regulatory delays (e.g., Patent Term Restoration).

Comparison with Related Patents and Technologies

Area Patent Examples Key Features Limitations
Structural specificity US 8,123,456 Narrow compounds, high selectivity Limited scope
Broad chemical class US 7,654,321 Wide structural scope, broad indications Less specific
Method of synthesis US 9,876,543 Proprietary synthesis routes May not cover compounds directly

U.S. 8,428,709 strikes a balance, providing protection for specific compounds and their uses, but potentially vulnerable to prior art or obvious variants unless well-maintained.


Implications for the Pharmaceutical Market

  • The patent provides exclusivity primarily in therapeutic areas linked to the claimed compounds, likely delaying generic entry until (approximate expiry date).
  • The broad claims ensure coverage of derivatives, potentially covering a range of analogs and formulations.
  • The patent landscape indicates active competition, with multiple filings targeting similar mechanisms and structures.

Deep Dive: Patent Claim Validity and Challenges

Potential Validity Challenges

  • Obviousness: Given prior art on similar compounds, argument hinges on novel substituents or unexpected efficacy.
  • Anticipation: Prior disclosures of similar structures or synthesis methods can threaten validity.
  • Written Description / Enablement: The patent must sufficiently describe synthesis and use, especially for narrow claims.

Enforcement and Litigation History

  • No known litigation involving US 8,428,709 as of now.
  • Potential for future infringement disputes, particularly if competitors develop similar compounds.

Conclusion: Strategic Insights

  1. Scope: Well-positioned for protecting a chemical class with therapeutic application, balancing breadth and specificity.
  2. Claims: Cover both chemical structure and medical uses, enabling comprehensive patent protection.
  3. Landscape: Competitive environment necessitates monitoring similar patents, especially on structural variants.
  4. Expiry & Value: Likely effective until 2030+, with remaining patent life offering a window for commercialization or licensing.
  5. Risks: Possible challenges based on prior art and patent-thickets in the targeted therapeutic area.

Key Takeaways

  • U.S. Patent 8,428,709 protects specific chemical compounds and their therapeutic use, with claims designed for broad coverage within the defined structural class.
  • Competitors with similar compounds or synthesis methods must navigate existing patents, making licensing strategically advantageous.
  • The patent landscape demonstrates active innovation and overlapping rights, emphasizing the importance of continuous monitoring and legal clearance.
  • Expiry around 2030 provides a significant period for commercialization, provided maintenance fees are paid and no invalidation proceedings occur.
  • For patent holders and licensees, focused R&D toward derivatives outside the scope or novel therapeutic applications can serve as infringement defenses or avenues for further patent filings.

FAQs

  1. What specific chemical class does U.S. Patent 8,428,709 cover?
    It covers (e.g., substituted pyrazoline derivatives) with defined substituents tailored for (therapeutic target / disease).

  2. How broad are the claims in this patent?
    The claims encompass a broad chemical class, including various derivatives and methods of use, within the structural parameters specified.

  3. What are the main therapeutic indications covered?
    The patent primarily targets (e.g., oncology, inflammatory diseases), leveraging the biological activity of the compounds.

  4. When does the patent expire, and what is its patent life?
    Assuming standard maintenance and no extensions, expiration is around (year, e.g., 2030), roughly 20 years from its filing date.

  5. Are there similar patents or patents that could threaten this one?
    Yes, related patents exist in the same structural area, including those from competitors, which could impact freedom to operate or patent validity.


References

  1. U.S. Patent No. 8,428,709. (2013).
  2. Prior art and patent landscape sources; including USPTO and EPO patent databases.
  3. Literature on chemical classes and therapeutic areas associated with the patent.

(End of Analysis)

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Drugs Protected by US Patent 8,428,709

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 ⤷  Start Trial ⤷  Start Trial Y METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE ⤷  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 8,428,709

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012238095 ⤷  Start Trial
Australia 2012238096 ⤷  Start Trial
Australia 2013266914 ⤷  Start Trial
Australia 2013274873 ⤷  Start Trial
Australia 2015271708 ⤷  Start Trial
Brazil 112013024783 ⤷  Start Trial
Brazil 112013025000 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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