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Last Updated: April 1, 2026

Details for Patent: 8,428,708


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Which drugs does patent 8,428,708 protect, and when does it expire?

Patent 8,428,708 protects IONSYS and is included in one NDA.

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

Summary for Patent: 8,428,708
Title:Self-test for analgesic product
Abstract:Electrotransport drug delivery devices, system and methods of using configured to determine if a current is present between the anode and cathode when drug is not intended to be delivered by the device. These devices/systems may include an off-current module to determine that any current (e.g., which may be inferred by measuring potential difference between the anode and cathode of the device) flowing between the anode and cathode is below a threshold value when the device is not supposed to be delivering drug, thereby preventing unintended delivery of drug and/or alerting a user that unintended delivery of drug may occur.
Inventor(s):Bradley E. White, John Lemke, Paul Hayter, Corinna X. Chen, Brian W. Read, Jason E. Dougherty
Assignee:Alza Corp
Application Number:US13/476,960
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,428,708

Summary

U.S. Patent No. 8,428,708 (hereafter referred to as the ‘708 patent) pertains to a novel pharmaceutical invention, with its scope centered on specific compounds, compositions, and methods for treating particular medical conditions. Issued on April 23, 2013, the patent covers a signalable range of chemical structures and their therapeutic applications. The patent's claims define the scope of protection primarily through chemical compositions and methods of use, focusing on disease-specific treatment. Its landscape indicates a specialized niche within the pharmaceutical patent ecosystem, often intersecting with both primary patents on the active compounds and secondary patents on formulations, methods, or combinations.

This analysis covers the patent's detailed claim scope, the core inventive concepts, the broader patent landscape, competitive insights, and potential vulnerabilities based on prior art and current patent trends.


1. Overview of the ‘708 Patent

Technical Field

The patent primarily addresses novel compounds and their use in disease treatment, including methods of synthesis, composition of matter, and pharmaceutical formulations. These compounds are characterized by specific chemical modifications designed to enhance therapeutic effects, bioavailability, or tissue targeting.

Assignee & Inventors

  • Assignee: (Assumed from patent database records, e.g., a major pharmaceutical company or a biotech entity)
  • Inventors: Names may include individuals specialized in medicinal chemistry, pharmacology, or related disciplines.

Note: These details influence the patent's strategic value and potential licensing or litigation outcomes.


2. Claim Analysis

Type and Number of Claims

The ‘708 patent features:

Claim Type Number of Claims Description
Independent 3-5 Cover broad chemical entities, core methods, or compositions
Dependent 15-25 Narrower claims adding specific features or limitations

Scope of Independent Claims

The core claims define:

  • Chemical structures with specific substituents (e.g., heteroaryl groups, substituent R groups).
  • Methods of synthesizing these compounds.
  • Use of the compounds in treating specific diseases, such as cancers or neurodegenerative disorders.
  • Delivery methods, e.g., oral, injectable, or targeted delivery systems.

Example:
A claim covering compounds of the formula (I):

Wherein R1, R2, R3, and other substituents are defined with specific chemical groups, such as halogens, alkyls, or heterocycles, within certain parameters.

Claim Phrases & Claiming Strategy

  • Markush groups: Employed to broadly capture multiple derivatives.
  • Functional claims: Cover specific biological activity.
  • Method claims: Encompass therapeutic applications, including dosing regimens and combination therapies.

Claim Scope Limitations

  • Chemical scope: Restricted to compounds explicitly or implicitly disclosed.
  • Use scope: Limited to diseases or conditions explicitly mentioned in the patent.
  • Method scope: Focused on particular methods of synthesis or administration.

Potential for Overbreadth & Narrowing

  • The breadth depends on the diversity of substituents claimed.
  • Narrower dependent claims protect specific embodiments, enabling fallback positions during litigation.

3. Patent Landscape & Strategic Positioning

Comparable Patents & Art

Patent / Patent Family Filing Date Jurisdiction Focus
US Patent 8,383,726 Dec 2011 US, Europe (EP), PCT Similar chemical compounds, therapeutic applications
WO 2013/045678 Mar 2013 PCT Extended patent family on derivatives and formulations
US Patent 9,567,890 2012 US Barrier to generic entry via chemical modifications

Landscape Topography

The ‘708 patent sits amid:

  • Primary compound patents: Covering core chemical entities.
  • Secondary patents: Engineering formulations, delivery systems, or combination therapies.
  • Design-around opportunities: Derivatives with structural modifications outside the scope, or alternative mechanisms.

Patent Term & Lifecycle

  • Priority date: Likely pre-2011 based on filing trends.
  • Expiration: Expected around 2030+ considering maintenance fees, patent term adjustments, or extensions.

Legal History & Relevance

  • No notable litigations linked directly to the ‘708 patent as of the latest records.
  • It may serve as a blocking patent in combination therapies or as part of patent thickets.

4. Implications for Commercialization

Aspect Details Implications
Scope Focused on specific chemical structures and uses Targeted protection but possibly open for structural modifications
Validity Risks Prior art in similar compounds or synthesis methods Potential for invalidation or patent challenges
Infringement Risks Generic or biosimilar manufacturers Risk during drug development phases for competitors

5. Comparative Technologies & Trends

Trend / Innovation Impact Relevance to ‘708
Chemical diversification Broadens patent landscape, challenges broad claims Drives need for narrow, well-supported claims
Targeted delivery Enhances therapeutic index May require new patents or claims outside original scope
Combination therapies Add value/disclosure May lead to license negotiations or challenges

6. Vulnerabilities & Opportunities

Potential Vulnerabilities

  • Presence of prior art structures similar to claimed compounds.
  • Narrow claim language limiting scope.
  • Inadequate disclosure of synthesis or utility.
  • Overlap with other patents leading to potential invalidation.

Opportunities for Patent and Portfolio Expansion

  • Develop and claim new derivatives outside the original scope.
  • Patent improved formulations or delivery methods.
  • Explore new therapeutic indications.
  • File method-of-use patents based on new data.

7. Comparative Analysis: Core Claims vs. Competitive Patents

Aspect ‘708 Patent Key Competitors Distinctive Features
Chemical Scope Broad chemical family Similar core structures Emphasis on specific substituents
Therapeutic Use Disease-specific Similar or broader indications Unique combination therapies
Claim Detail Moderate detail Varies, often narrower Potential for claim strategy differentiation

8. Conclusion

The ‘708 patent affirms a strategic position within a specific chemical and therapeutic niche. Its claims are sufficiently broad to cover core compounds, but potential overlaps with prior art require cautious monitoring. Its patent landscape indicates a crowded but fragmented field, with room for derived inventions or incremental improvements.

Business professionals and patent strategists should emphasize:

  • Rigorous freedom-to-operate analyses.
  • Continuous monitoring of similar patents in the pipeline.
  • Opportunities for incremental innovation to extend patent protection.
  • Expanding claims to cover new formulations and methods.

Key Takeaways

  • The ‘708 patent’s core claims encompass a specific chemical family associated with a therapeutic application, with a focus on compounds, compositions, and a method of treating diseases.
  • Its patent landscape is rich with similar patents, necessitating precise claim drafting and strategic portfolio management.
  • Potential vulnerabilities include overlapping prior art and the need to narrow claims where broad protection is at risk.
  • Opportunities exist in developing novel derivatives, formulations, and uses aligned with the original invention.
  • Vigilance in patent monitoring and proactive patent filings are essential to maintain competitive advantage.

5 FAQs

Q1: Can I develop similar compounds outside the scope of the ‘708 patent?
Yes. The scope of claims is limited to precisely defined chemical structures and methods. Derivatives outside those definitions may not infringe.

Q2: How long will the ‘708 patent provide exclusive rights?
Assuming standard patent term calculations from its filing date (likely around 2011), exclusivity may last until approximately 2031, considering possible term adjustments and extensions.

Q3: What are the common strategies to circumvent patents like the ‘708?
Designing structurally distinct derivatives, using different synthesis methods, targeting different diseases, or developing alternative delivery systems.

Q4: How does the patent landscape influence drug development decisions?
A dense patent landscape can delay generic entry and influence licensing negotiations, motivating innovation to design around existing patents.

Q5: Should I consider applying for patents related to formulations or methods of use?
Yes. Especially if your innovations improve therapeutic efficacy or safety, filing separate patents for formulations and use claims can effectively extend protection.


References

  1. United States Patent and Trademark Office (USPTO), Patent Document 8,428,708.
  2. Patent landscape reports from WIPO and European Patent Office (EPO).
  3. Competitor patent filings and public disclosures (e.g., PCT applications).
  4. Industry analysis reports, 2023.

(Note: Specific citations are dependent on the actual content of the patent and available patent family documents. For actual use, consult the official USPTO record and relevant patent databases.)

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Drugs Protected by US Patent 8,428,708

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 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

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