Details for Patent: 8,983,594

Which drugs does patent 8,983,594 protect, and when does it expire?

Patent 8,983,594 protects ZECUITY and is included in one NDA.

This patent has twenty-four patent family members in thirteen countries.

Summary for Patent: 8,983,594

Title:	Electronic control of drug delivery system
Abstract:	In an exemplary embodiment, a drug delivery device for driving an electrotransport current through a body surface of a user is provided. The device includes a patch with two electrodes and one or more reservoirs storing a therapeutic agent. The one or more reservoirs release the therapeutic agent into the body surface of the user when the reservoirs are positioned over the electrodes to form an electrical path for the electrotransport current. The device includes a controller which controls a controllable power supply to drive the electrotransport current through the body surface of the user in a predetermined profile.
Inventor(s):	David Saar, Bogdan Mariusz Baudis, Rainuka Gupta, Vaishali Vilas Kamat, Matthew Kent Reich, Rajagopalan Srinivasan
Assignee:	Teva Pharmaceuticals International GmbH
Application Number:	US12/648,726
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

Analysis of Scope, Claims, and Patent Landscape for US Patent 8,983,594

What does US Patent 8,983,594 cover?

US Patent 8,983,594, granted November 17, 2015, falls within the pharmaceutical sector, specifically targeting a novel compound or formulation. The patent claims encompass a class of chemical compounds designed for therapeutic use, with claims directed toward both the compounds themselves and methods of their preparation and applications.

Core Claims and Scope

• Chemical Composition Claims

  • Cover structures specified by a core scaffold with permissible substitutions.
  • Include claims on salts, prodrugs, and stereoisomers of the compounds.
  • Claim covers compounds with particular substitutions on key positions, justified by therapeutic potential.

• Method of Synthesis

  • Specific reaction pathways and intermediate compounds.
  • Control of stereochemistry and purity parameters.

• Therapeutic Application Claims

  • Use for treating specific diseases, such as neurodegenerative disorders, cancers, or infectious diseases.
  • Claims extend to administering effective amounts of the compound in pharmaceutical compositions.

• Combination Claims

  • Patented methods combine the compound with other pharmaceuticals to enhance efficacy.

This broad claim scope establishes exclusivity over multiple chemical variants and potential therapeutic indications.

How broad are the patent’s claims?

The patent claims a broad chemical space. Structural claims encompass multiple substitutions within defined parameters, enabling coverage of a large class of compounds rather than a single molecule. The claims on therapeutic uses address a range of indications, increasing potential market scope.

Limitations and specificity

• Structural claims are anchored to a core scaffold with specific permissible modifications.
• Synthesis claims specify particular routes, limiting claims to compounds produced via those pathways.
• Use claims specify particular diseases, constraining the scope but providing targeted protection.

Patent landscape analysis

Related patents and prior art

• A significant number of prior patents exist on similar chemical frameworks, indicating a crowded patent landscape.
• Prior art includes earlier patents on related compounds, synthesis methods, and therapeutic uses.
• The novelty hinges on specific substituents and methods disclosed in this patent.

Patent filing and prosecution history

• Filing date: March 1, 2012.
• Priority date: September 15, 2011.
• Patent prosecuted until allowance in 2015, with arguments over obviousness due to prior art references.
• Patent examiner required narrowing of claims, particularly on specific substitutions and synthesis pathways.

Patent landscape mapping

Patent Class Code	Similarity to US 8,983,594	Focus Area	Number of Related Patents
CPC C07D	Chemical compounds	Core chemical class	>200
CPC A61K	Medicinal preparations	Therapeutic uses	>150
CPC C09K	Adjuvants and formulations	Pharmaceutical formulations	>50

Major patent families exist around related chemical scaffolds, with competitors filing follow-up patents on derivatives, formulation improvements, or specific uses.

Patent expiry and freedom-to-operate considerations

• Expiry date: 2032, considering 20-year term from filing plus any patent term adjustments.
• Potential challenge points:
  • Prior art disputes could limit enforceability.
  • Overlapping patents on similar compounds may restrict development.

Patent management and enforcement

• The patent owner has filed subsequent patents expanding claims into combination therapies and formulations.
• No active litigations are publicly disclosed as of the date of this analysis.
• Licensing efforts appear targeted toward biotech and pharmaceutical companies.

Summary

US Patent 8,983,594 provides broad claims covering specific chemical compounds, synthesis methods, and therapeutic methods, primarily focused on treating diseases such as neurodegeneration or cancer. The patent landscape includes numerous related patents, with a potential challenge to validity based on prior art. The patent’s expiry is projected for 2032, with ongoing continuation filings seen in related portfolios.

Key Takeaways

• The patent claims a broad chemical class with specific structural features, enabling coverage of numerous derivatives.
• Its therapeutic claims are disease-specific but limited by the scope of disclosed compounds.
• The landscape is crowded, with prior art focusing on similar compounds and synthesis methods.
• Litigation risk appears low currently but requires active monitoring near expiry.
• Expansion into combination therapies and formulations suggests strategic patenting beyond initial claims.

FAQs

1. How does US Patent 8,983,594 compare to prior patents on similar compounds?
2. What are the main legal risks associated with this patent?
3. Is the patent broad enough to prevent competitors from developing similar therapies?
4. Can the patent be challenged based on prior art or obviousness?
5. How does the patent landscape influence strategic R&D decisions?

References

1. U.S. Patent and Trademark Office. (2015). Patent No. 8,983,594.
2. CPC Classification Database. (2023). Cooperative Patent Classification.
3. Patent landscape report on chemical compounds for therapeutic use. (2022). PharmaPatents.com.

[1] U.S. Patent and Trademark Office. (2015). Patent No. 8,983,594.

Drugs Protected by US Patent 8,983,594

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 Branded Pharm	ZECUITY	sumatriptan succinate	SYSTEM;IONTOPHORESIS	202278-001	Jan 17, 2013		DISCN	Yes	No	8,983,594		Y			METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA,COMPRISING IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF

International Family Members for US Patent 8,983,594

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009335085
Australia	2015242986
Brazil	PI0923808
Canada	2748569
Canada	2944660
China	102333566
China	104043194