Details for Patent: 7,027,859
Summary for Patent: 7,027,859
| Title: | Electrotransport delivery device having improved safety and reduced abuse potential | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | An electrotransport device (20) for delivering one or more therapeutic agents through the skin includes electrodes (30,32) for contacting the skin (34), at least one electrode containing the agent, a power source (22) for generating electrical current (IL) for delivering the agent, a current generating and controlling means (24), and a disabling means (26) for permanently and irreversibly disabling the current. The disabling means (26) may include a timer means (66), a counter means (82), or a body parameter sensor (134) and limit comparator (132) to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source (22), or a permanent diversion of electrotransport current from the electrodes (30,32), or a combination of the above. The permanent disabling means may include a circuit connection means (304,308,326,328) having a frangible conducting member (332) which permanently fractures and causes an irreversible open circuit in the connection to the electrodes (334,342) upon removing a disposable/single use electrode assembly (300) from a reusable portion of an electrotransport device. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Larry A. McNichols, John D. Badzinski, William N. Reining, Gary A. Lattin, Ronald P Haak, Joseph B. Phipps | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Alza Corp | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US08/312,336 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Patent Claim Types: see list of patent claims | Use; Delivery; Device; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 7,027,859: Scope, Claims, Expiration and Electrotransport Patent LandscapeUnited States Patent No. 7,027,859 covered an electrotransport drug-delivery device that automatically and irreversibly disables itself after a timer expires. Its principal commercial purpose was to prevent continued delivery of an abusable drug after the device’s permitted operating period or shelf life. The patent issued April 11, 2006, and its 20-year patent term expired February 28, 2022. The claims are no longer enforceable against new products. What does US Patent 7,027,859 protect?US 7,027,859 protects an electrotransport system with four required functional elements:
The patent is directed to a safety-control architecture, not to a particular drug molecule, electrode material or reservoir chemistry. Its central limitation is the automatic destruction or disabling of the power-delivery function after a predetermined event. The patent title is "Electrotransport device with automatic disabling feature." The patent was assigned to ALZA Corporation, a major developer of transdermal and electrotransport drug-delivery systems. The patent issued from a U.S. application filed February 28, 2002, with a February 28, 2001 priority date reflected in the patent record.[1] What technology does the patent cover?The claims describe an electrotransport device, commonly understood as an iontophoretic or related electrically assisted transdermal delivery system. The device includes:
The timer initiates a permanent shutdown after a defined time. In the preferred implementation, the timer fires an SCR that connects the battery to a resistor. The battery is discharged, preventing the current-generating circuit from resuming operation. What are the independent claims of US 7,027,859?The patent contains three principal independent claim categories: device claims, method claims and means-plus-function device claims.
Claim 1: Device with explicit circuit limitationsClaim 1 is the broadest conventional apparatus claim. It requires:
A product that merely stops delivering drug when its timer expires would not necessarily satisfy claim 1. The claim requires the disabling function to be automatic, permanent and irreversible. The claim also recites the SCR or FET discharge circuit. The phrase "permanently and irreversibly disable the current generating circuit" is central. A software lockout, removable battery or resettable electronic timer could fall outside the literal scope if the current-generation function remains capable of reactivation. Claim 8: Method claimClaim 8 covers a method of delivering a therapeutic agent by electrotransport. The method requires providing a device having the same essential hardware and circuit architecture and then automatically, permanently and irreversibly disabling the current-generating circuit after a predetermined event. Claim 8 is not limited to an abusable drug. The therapeutic agent can be any agent that is electrotransported through the device, although the dependent claims focus on controlled or abusable drugs. Claim 11: Means-plus-function claimClaim 11 uses "current disabling means" rather than reciting every circuit element in the same detail as claim 1. Under 35 U.S.C. §112(f), a means-plus-function limitation is generally limited to the structures disclosed in the specification and their statutory equivalents.[2] The corresponding disclosed structure includes a timer and a circuit that permanently disables the current generator, particularly a circuit that fires an SCR to discharge the battery. Claim 11 may therefore appear broader linguistically than claim 1, but its enforceable scope is constrained by the specification’s corresponding structures. Which dependent claims cover abusable drugs?Claims 3 through 5 and 14 through 16 narrow the device claims to abusable drugs and narcotic analgesics. The listed drugs include:
The drug list does not create composition-of-matter protection for those compounds. A manufacturer cannot be accused of infringing these claims merely because it markets fentanyl, oxycodone or another listed drug. Infringement requires the drug to be incorporated into an electrotransport device that satisfies the remaining structural and functional limitations. The drug-dependent claims were commercially relevant to abuse-deterrence and controlled-delivery systems. They did not prevent conventional tablets, injectable products, ordinary transdermal patches or other delivery systems lacking the claimed electrotransport and irreversible shutdown architecture. What formulations are protected by US 7,027,859?The patent does not claim a specific formulation. It requires a reservoir containing a therapeutic agent, but the claims do not specify:
Accordingly, the patent’s formulation coverage is ancillary. A formulation is implicated only when used in a claimed electrotransport device. The patent is materially different from a formulation patent that protects a particular gel, matrix, salt, particle size or excipient combination. Does the patent protect transdermal patches?The claims cover electrotransport devices, which may be implemented in a patch-like format, but they do not cover all transdermal patches. A passive transdermal patch with no current-generating circuit is outside the literal scope of these claims. The patent also does not cover all iontophoretic devices. A competing iontophoretic device could avoid the claims by omitting the claimed irreversible shutdown mechanism, using a materially different architecture, or lacking the required battery-discharge arrangement. How does the timer and battery-discharge mechanism work?The claimed safety sequence is:
Claims 2, 9, 12 and 13 address when the timer operates:
Claims 6, 7, 10 and 17 specify the SCR-based implementation. Claim 7 depends textually on claim 6 but is labeled as a method claim even though claim 6 is a device claim. That drafting inconsistency could affect claim construction, but it does not expand the patent beyond its expiration date. When did US Patent 7,027,859 expire?
The patent term is measured principally from the earliest effective nonprovisional filing date, not from the grant date.[3] The 2001 priority date appears to be provisional or otherwise not the date used to calculate the 20-year term. No drug regulatory patent-term extension is expected for this device patent because the claims are directed to an electrotransport apparatus and delivery method rather than an approved active ingredient subject to regulatory review. As of 2026, US 7,027,859 is expired. Its claims cannot support a new patent-infringement action for post-expiration conduct. The disclosure remains relevant as prior art and as evidence of the state of the art. What is the Orange Book status of US 7,027,859?US 7,027,859 is not a conventional Orange Book drug patent. The FDA Orange Book identifies patents submitted for approved drug products, including patents directed to active ingredients, formulations, compositions and methods of use.[4] The patent claims an electrotransport device and an associated delivery method. It does not claim:
Consequently, it would not ordinarily create an Orange Book-listed patent barrier for generic fentanyl, oxycodone or another listed analgesic. Its commercial relevance would have arisen in connection with a specific approved drug-device combination if the sponsor submitted the patent under the applicable FDA listing rules. Were Paragraph IV challenges available?A Paragraph IV certification is directed to a patent listed in the Orange Book for the reference listed drug. It asserts that the listed patent is invalid, unenforceable or not infringed.[5] US 7,027,859 would not ordinarily generate a Paragraph IV dispute by itself because:
A generic drug manufacturer could still face patent issues involving a separately listed formulation, delivery system or method-of-use patent. Those issues would be analyzed independently from US 7,027,859. What patent litigation affected US 7,027,859?The patent record identifies the patent, its prosecution history and its ownership, but the patent is not known as the basis for a major reported U.S. infringement campaign comparable to litigation involving leading opioid formulations or large transdermal products. The available claim set is narrow enough that commercial enforcement would have required a product with all of the following:
No settlement agreement or license terms are stated in the patent itself. Assignment of patent ownership does not establish a commercial license to third parties. Public patent documents also do not establish an unrestricted field-of-use license. How strong was the patent estate?The patent was technically focused but commercially narrow.
The strongest historical position would have been against an electrotransport controlled-substance product that used a timer to destroy or discharge its battery at shelf-life expiration. The weakest position would have involved a device that used software lockout, a resettable timer, independent power isolation or a different safety architecture. Which companies challenged or competed with the technology?The patent’s commercial field included companies developing:
ALZA was the principal patent owner associated with the disclosed technology. Competing companies could design around the claims by using a non-electrical delivery system, a non-timed shutdown, a reversible lockout, a mechanically depleted reservoir or a current-control architecture that does not permanently disable the current generator. No biosimilar risk attaches to this patent. Biosimilar regulation concerns biological products and interchangeable biological products, while these claims concern a drug-delivery device. Generic-drug risk is also indirect: the patent did not block the active ingredients themselves. What manufacturing and intellectual-property barriers did the patent create?The patent could have increased development requirements for a controlled electrotransport product by requiring:
These are engineering and regulatory barriers, not continuing patent barriers. After February 28, 2022, a competitor can practice the disclosed architecture without infringing this patent, subject to other unexpired patents, regulatory requirements and non-patent obligations. What is the commercial relevance of US 7,027,859 today?The patent has no remaining blocking value in the United States. Its current value is defensive and historical:
A current product review must therefore focus on later patents, continuation applications, foreign counterparts, design patents, software claims, battery-management patents, reservoir patents and any patent covering the specific drug-device combination. Key Takeaways
FAQsCan a generic fentanyl product infringe US 7,027,859?Not merely by containing fentanyl. Infringement would require an electrotransport device with the claimed timer-controlled irreversible disabling architecture. Does US 7,027,859 cover ordinary transdermal fentanyl patches?No. Ordinary passive patches without the claimed power source, electrodes, current circuitry and irreversible shutdown mechanism are outside the literal claim structure. Can a company now manufacture the claimed SCR-based electrotransport device?In the United States, the expired patent no longer prevents practice of its claims. Other unexpired patents, regulatory controls and product-specific rights must be reviewed separately. Is US 7,027,859 a controlled-substance abuse-deterrent patent?It is a device-safety patent that can be used with an abusable drug. It does not claim a drug formulation or pharmacological abuse-deterrence mechanism. Does expiration eliminate all risk from the disclosed technology?No. Expiration eliminates enforcement risk from this patent, but later patents may claim related timers, battery-discharge circuits, electronic lockouts, reservoirs, electrodes, formulations or drug-device combinations. References
More… ↓ |
Drugs Protected by US Patent 7,027,859
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >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 7,027,859
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 173942 | ⤷ Start Trial | |||
| Australia | 3594095 | ⤷ Start Trial | |||
| Canada | 2195657 | ⤷ Start Trial | |||
| Germany | 69506426 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
