WO2008081465A2

WO2008081465A2 - Interactive smart package - associated device for anti-counterfeit and compliance measures

Info

Publication number: WO2008081465A2
Application number: PCT/IN2007/000235
Authority: WO
Inventors: Praful Ramachandra Naik; Mohan Harakachand Bhandari
Original assignee: Bilcare Limited
Priority date: 2007-01-05
Filing date: 2007-06-08
Publication date: 2008-07-10
Also published as: TW200833317A; WO2008081465A3; TWI422366B

Abstract

System comprising product package with signal generating means and chip along with an associated device (5) that facilitates detection of the presence or absence of product/s in the package. The signal generating means is disposed in the package such that removal of product/s from the package generate signal and / or alter the signal detected by a signal sensing means (3) in the said associated device (5). This synergistic combination of the product package with signal generating means and an associated device (5) facilitates detection of presence / absence of product in the package. Further, the interactive smart package and the associated device (5) ensures user registration and identification, authentication and registration of the package, user interactive capabilities for real time feed back to and /or by the user and/or with an integrated system connecting various user entities to ensure effective and secured user compliance measures.

Description

INTERACTIVE SMART PACKAGE-ASSOCIATED DEVICE FOR ANTI-COUNTERFEIT AND

COMPLIANCE MEASURES

Field of the Invention

The present invention relates to a smart system comprising product package with signal generating means and an associated device that facilitates detection of the presence or absence of product/s in the package.

The interactive smart package and the associated device further ensures user registration and identification, authentication & registration of the package, user interactive capabilities for real time feed back to and /or by the user and/or with an integrated system connecting various user entities to ensure effective and secured user compliance measures.

Background of the invention

Counterfeiting is a growing social menace plaguing markets globally. Tracking the authenticity of packages and the products is of immediate relevance. It is reported that counterfeiting and sale of spurious products continue to grow at 5-7% (US $ 250-350 billion) of world trade. It may be noted that during 1990 - 1995 world trade grew by 47% whereas counterfeits grew by 150% (Briefing on Counterfeiting, AIM® Paper 1999).Consumers must be empowered with easy means of detection of counterfeit packages / products, and further enable and ensure the consumer to achieve the desired product compliance. Present day options available to the consumer are by way of prescriptions, or information provided in the product package. It is common for the user to rely on his memory with regard to the product dosage, usage frequency etc in the absence of any user-interactive system. Some of the desirables of a full proof system are: • Establishing authenticity of the product vis-a-vis information about its manufacturer, date of manufacture, date of expiry, etc;

• Product information and instructions for its effective use,

• Prescription and dosage instructions, its recommended consumption frequency, and relevant precautionary measures as applicable; • Recording product usage history for follow-up and support services

• Real time professional support when required.

Several initiatives by way of security labels on the product or packaging, holographic markers on unit product package, unique colored unit product package, color changing inks, multi color printing etc have already been employed butthere are no systems that ensure full- proof authentication.

Further, it is desirable to make real-time professional help available to the user using systems which automatically capture real-time product usage and user feedback data. For follow and professional support, such real-time user related feedback is of importance to the manufacturers and/or researchers of a product that is under consumer / clinical trials to arrive at better understanding the product features and functions especially in terms of their effectiveness, side effects, claimed efficacy of the medication, etc.

Several efforts have been made in the past to achieve some of the above-mentioned features.

US patent no. 6961285 discloses a drug delivery management system to guide users / patients to take their medication and to assist third parties to collect information with regard to the patient medication intake. The system includes a portable medication monitor used in association with an instrumented medication package to provide intake data acquisition and patient support functions. The system may further be connected to a computer or computer network allowing information distribution between the medication monitor and third parties, such as physicians or pharmacists. This prior art details a monitoring system more specifically for use in medication monitoring, which has medication packaged in a specific blister format and the said blister having capability of monitoring access to medication and relaying it to a separate monitor. The system is not capable of authenticating the packaged medication product nor is it capable of capturing user-feedback on real-time basis with respect to his / her observations, indications and feelings on the consumed product, etc.

US patent no. 5412372 discloses a portable medication dispenser aid which monitors dispensing times including regimen-conforming use of medications provided in standard as- marketed blister packages. A standard blister package and a separate, disposable sensor sheet are loaded onto a compact housing containing supervisory electronics, visual indicators, and an audible alarm. The sensor sheet consists of electrical or optical sensing regions corresponding to each individual compartment of the blister package. An electrically conductive or optical connector in the dispenser housing allows periodic scanning of the sensor sheet circuitry by the control circuitry in the dispenser housing without adding connector components to disposable sensor sheet. When a medication is ejected through the backing layer of the standard blister package, an electrical or optical parameter associated with a corresponding region of the sensor sheet is altered, thereby permitting the control circuitry to monitor the dispensing event. Stored patient compliance data may then be reported remotely through an optical or electrical interface between the dispenser and an external system for review by the pharmacist/physician. The system addresses the issue of reminding the user of when to take a medication from a specific unit dose package containing the medication but is not capable of authenticating the product, capturing user interaction and feedback. The system is specific to a type of package and lacks the desired flexibility for use in diverse types of packages containing different types, forms, sizes and shapes of medication.

US patent nos. 6839304 and 6411567 describe a drug delivery management system for managing delivery of pharmaceutical drugs from a blister package that includes a plurality of cells arranged in a grid. Each of the cells is sealed by a breakable wall and holds a unit-dose of medication. A user gains access to the medication in a given cell by puncturing the breakable wall associated with the given cell. A severable conductor is positioned proximate to each breakable wall. The severable conductor associated with a given cell ruptures upon puncturing of the breakable wall associated with the given cell. A computer chip is electrically connected to the severable conductors. The computer chip senses the puncturing of each cell in the grid by monitoring the rupturing of each of the severable conductors. An RF transmitter is coupled to the computer chip. The RF transmitter sends information corresponding to usage of each of medications stored in the blister package to a remote information transceiver. The system is specific to blister type packages. The key limitation results from the use of non-insulating layer to incorporate the severable conductors. As the non-insulating layer is in direct touch with the medication, it becomes imperative to get the material approved by the regulatory authorities prior to its use. The manufacturing process also gets complicated The system also is limited to and focused on user- compliance but lacks the aspects of capturing the much desired user interaction and feedback. Incorporating remote devices on the package for receiving and transmitting makes the pack unwieldy and unviable for commercial exploitation. The other limitation of this system is that it does not address authentication of the product package through a customized encoding which becomes unique for that specific package.

It may be noted that the drug delivery management systems disclosed above primarily focus on monitoring / tracking delivery / dosing of medication to patients and assisting patients to medical compliance. Further, sensing the presence/ absence of product in the package is not possible in the aforementioned devices. The construction of the packages disclosed in the prior art lack the provision of signal generation that facilitates to sense presence/absence of product in the package easily.

Indian patent application number 171 /mum/2006 overcomes several weaknesses of the prior art and discloses package-companion-user interactive system wherein an array of signal generating means and signal sensing means are provided in the companion device to receive and reflect signals generated by the signal generating means to sense presence/absence of product in the package. In this system it is essential to provide an array of signal generating means in the companion device working in conjunction with signal sensing means. In this device the said plurality of generated signal (by the signal generating means) is reflected to sense the presence / absence of product in the package.

The present invention provides an interactive smart package- associated device that obviates the use of the array of signal generating and corresponding reflecting / sensing means as is disclosed in the Indian patent Application 171/MUM/2006 to detect presence / absence of product in the package and achieve the desirable features.

Further, the present invention also provides an effective solution to anti-counterfeiting on packaged pharmaceutical medicines all various levels in the supply chain and providing compliance assistance to the end user.

Summary of the Invention

The main object of the invention is to provide a smart package- associated device that obviates the use of the array of signal generating and corresponding sensing means to sense the said generated signal/s in the device.

Another object of the invention is to provide versatile product packages that would have inbuilt features that enable the detection of the presence / absence of products in the package via interactive working means with the associated device.

Yet another object of the invention is to provide a smart package capable of generating magnetic fields. Yet another object of the invention is to provide a smart package capable of generating signals based on electrical and/or electromagnetic fields.

Yet another object of the invention is to provide a smart package capable of generating acoustic / sonic signals.

Another object of the invention is to provide an associated device that interacts with the smart package to detect presence / absence of product in the package.

Another object of the invention is to facilitate user interaction with the said associated device and package to provide user compliance, registration and identification, authentication & registration of the package, user interactive capabilities for real time feed back to and/or by the user.

Yet another object of the invention is to provide a smart package capable of generating electrical, electromagnetic, light, laser, video, image etc.

Thus in accordance with the invention the said system comprises of:

An interactive smart package - associated device comprising

a smart package for carrying a product and which package is adapted to communicate with an associated device, the package comprising a plurality of containments adapted to receive a product, each containment being closed or optionally with closure means, the said plurality of containment/s and / or closure/s being non-electrically interconnected; signal generating means adapted to convey to an associated device information relating to one or more of the containments; a chip, the said chip being optional when signal generating means itself is a chip and optionally transmitter and / or receiver means;

the said associated device comprising a housing adapted to communicate with the smart package; signal sensing for detecting a signal from the signal generating means said signal sensing optionally comprising acquiring means configured with data input, storing, output, decoding and processing and communicating means adapted to communicate with an external data record;

wherein

said signal generating means is disposed in the said package such that, on communication with the device, the signal generating means provides information relating to one or more of the containments to the signal sensing means in the said associated device and optionally the information is communicated externally of the said system for the purpose of comparison of the information with the external data record.

DETAILED DESCRIPTION OF THE INVENTION

Features and advantages of this invention will become apparent in the following detailed description and the preferred embodiments with reference to the accompanying drawings.

Figure 1 Schematic of the system and package (sheet 1 ) Figure 2 Schematic of the carding system (sheet 2)

Figure 3 Schematic of the package with carding system and magnetic sheet (Sheet 3) Figure 4 Schematic of the package embodiments (sheet 4)

The system comprising associated device and the package is illustrated in Figure 1, Figure 1a and Figure 1b. The associated device comprises of portion 1 and optional portion 2. The provision 5 is provided to receive / position / place the product package 20. In one of the variants, the said provision 5 in terms of a slot is provided / integrated on the portion 1 itself. In another variant the said provision 5 is provided between portion 1 and portion 2 of the said associated device. The reader device comprises of one or plurality of sensors 3 provided in the portion 1 and / or portion 2 of the said associated device. The said sensors sense signal / detectable signatures generated by the signal generating means / components having individual signatures of the smart package when the product package is inserted / placed in vicinity / positioned / disposed / guided in a particular position in the provision 5. The product package comprises of one or plurality of closures to contain products with means for accessing the said products. One or plurality of the signal generating means / components having individual signatures is provided on the portion, preferably closure of the package such that on communication with the device, the signal generating means provides information relating to one or more of the containments to the signal sensing means in the said associated device. Further, removal of product/s from the package from one or plurality of its containment/s leads to the partial and / or complete removal, detachment, elimination, activation / deactivation of the signal generating means or change in visual property, characteristics / physical change of the package. When the product is present / absent in the package, the signal / detectable signature generated by the signal generating means / components having indMdυai signatures is detected by the said sensor/s 3 to sense / indicate product presence / absence in the package. When the product is removed from the package, the enclosure is also removed / ruptured and / or activated / deactivated and hence the signal generating means.

One of the embodiments of package 20 is shown in the Figure 1 (a) and Figure 1 (b). The package comprises of first lamina /sheet in which one or plurality of enclosed spaces (containment/s) / capsule/s 21 are formed to contain the produces) wherein the said capsule/s up stand from first surface (not shown) of the said first sheet defining one or plurality of corresponding opening/s in a second surface (not shown) of the said first sheet; the means for accessing the product is in the form of second rupturable lamina / sheet (closure) 22 that encloses the said receptacle / capsule wherein portion of the enclosing lamina corresponding / superimposed to the receptacle / capsule portion is ruptured/ removed while removing the product. The said second sheet is secured / bonded / affixed / attached to the unformed portion of the second surface of the first lamina to enclose the said openings and seal the products in the upstanding capsules / receptacle. The first sheet is formed of a first material and the second sheet is formed of a second material that is more easily perforated than the first material wherein first sheet is formed of a pliable material and second sheet material is more easily compromised than the pliable material. When pressure is applied on the receptacle / capsule to remove the product contained in it, the portion of the rupturable closure of the second lamina deforms and breaks to let product out of the receptacle. A circuitry capable of data storage and processing (chip) 24 is affixed / embedded in/on the package. The said circuitry / chip is pre- encoded offline or online during packaging of the said product with information such as manufacturer source, date, batch of manufacture and information regarding the product etc.

Figure 1 (a) shows front view and sectional side view (along section BB) of the package. As seen in the sectional side view, one or plurality of magnets 23 (component having detectable signature as magnetic field) are secured / positioned / affixed to the second sheet / closure 22 opposite openings to corresponding upstanding capsules / receptacle containing product as shown in the figure. The said magnets generate signal in terms of magnetic field of particular strength (measured in Gauss). When the product in the receptacle is taken out, the closure is broken the corresponding magnet gets removed along with the closure resulting in absence of signal (magnetic) in the particular area of the removed product.

Figure 1 (b) shows another variant of the package. It shows front view and side view as seen from direction D. The second sheet / closure 22 is provided with magnetic material in the form of Iayer/s such as magnetic ink (component having detectable signature as magnetic field) having specific strength on areas 25 opposite openings to corresponding upstanding capsules / receptacle as shown in the Figure. The said magnetic inked areas generate signal in terms of magnetic field of particular strength (measured in Gauss). When the product in the receptacle is taken out, the closure is broken resulting in breakage and removal of the inked area resulting in absence of signal (magnetic) in the particular area of the removed product. The said sensor 3 in the associated device senses the magnetic field corresponding to each of the product in the package and sends signal to the processor. When the product is present in the package, the magnetic field will be detected / not detected by the hall sensor depending on the polarization pattern of the magnets. When the product is removed, the sensor will not detect / detect magnetic field as no magnetic field is present. Thus presence/absence of the product in the package is sensed without using array of signal generating means by virtue of unique design of the product package that has capability of generating signal. In one of the variants of this embodiment the rupturable closure area is printed by magnetic ink. In yet other variants of this embodiment the said closure area is partially / completely coated with magnetic ink.

Yet another embodiment of the package is shown in Figure 2 illustrating carding of the package wherein the said package is walletized in the carding. It comprises of laminas 30 and 31 of a generally rigid material. Openings / slots 32 are provided on lamina 30 aligned with the receptacle / upstanding capsule 33 on the first surface of the package so that the said receptacles pass through the said openings when the said lamina (third sheet) 30 is placed on the package from the receptacle side. The lamina 31 is provided with perforated peelable portions / seals 34 that are aligned with the openings in the second surface of the first sheet 35 so that when the product in the package is removed, the perforated portion on the lamina corresponding to that product is also removed. In a variant of this embodiment multipolar pre- magnetized sheet having south and north poles on the same side is used. The material of the sheet 31 is more easily compromised than the generally rigid material. In yet another variant of this embodiment one or plurality of lamina 30 and / or 31 is provided in the said carding. In another embodiment the package is sandwiched between laminas 30 and 31 wherein magnets are positioned between closure of the package and lamina 31 of the carding corresponding to the rupturable closures of the package so that when the product in the package is removed, the said magnet is also removed along with the perforated portion on the lamina 31.

In yet another embodiment as shown in Figure 3 pre-magnetized sheet/s 36 (component having detectable signature as magnetic field) of unipolar planes of south and north poles of which one surface is a north pole and other is south pole with perforations 37, superimposed / corresponding to said rupturable closures 35 of the package is provided between the said lamina 31 and closure of the package along with the sheet 30 such that when the product in the package is removed, the portion of the said magnetic sheet is removed along with the perforated portion on the lamina 31. In yet another variant of this embodiment a non-magnetic sheet is used that is further magnetized.

In another embodiment the said chip 24 is affixed/ embedded in the lamina 30 or 31 of the said carding.

In another embodiment unipolar planes of south and north poles / multi-polar pre-magnetized plastoferrite (component having detectable signature as magnetic field) or any materials capable of getting magnetized is incorporated into the package such that the removal of product/s from the package leads to the removal, detachment or elimination of the plastoferrite or other magnetized materials.

In one of the variants of this embodiment a uni-polar planes of south and north poles / multipolar pre-magnetized plastoferrite or any materials capable of getting magnetized with perforations superimposed to the said rupturable closure of the package is affixed to the closure of the said package such that removal from the product from the receptacle breaks the said magnetized material.

In another embodiment a non-magnetized uni-polar planes of south and north poles / multi-polar plastoferrite or any materials capable of getting magnetized is incorporated into the package such that the removal of product/s from the package leads to the removal, detachment or elimination of the plastoferrite or other magnetized materials. In one of the variants of this embodiment a non-magnetized unipolar / multi polar plastoferrite or any materials capable of getting magnetized with perforations superimposed to the said rupturable closure of the package is affixed to the closure of the said package such that removal of the product from the receptacle breaks the said material.

In another embodiment the said smart package is provided with a proactive signal generating means.

In yet another embodiment the said smart package is provided with passive signal generating means.

In yet another embodiment the smart package is provided with invoked signal generating means.

In another embodiment the smart package is provided with components having individual detectable signatures. In one of the variants of this embodiment the said component is a magnet, magnetic ink, magnetic material or a combination thereof wherein the detectable signature is magnetic field.

In yet another variant of this embodiment the said component is light reflecting surface integral with the closure / second sheet opposite openings to corresponding upstanding containment capsules wherein the substantially detectable signatures comprise reflection of light

In yet another variant of this embodiment the said component is light absorptive surface regions integral with the closure / second sheet opposite openings to corresponding upstanding containment capsules wherein the substantially detectable signatures comprise absorption of light.

In yet another variant of this embodiment the said component is electrical components disposed upon the closure / second sheet opposite openings to corresponding upstanding containment capsules wherein the substantially detectable signatures comprise an electrical characteristic of the respective electrical components. In one of the variants, electrical characteristic includes capacitance. In another embodiment the signal is generated from the smart package resulting from change in the physical, electrical, thermal, optical, visual property / characteristics / signal of the smart package.

In yet another embodiment sensing means is provided to identify / recognize visual signal generated in the form of a customized pattern on the smart package.

In yet another embodiment closure/s 22 and /or containment/s 21 of the product package 20 is affixed / embedded / provided with optic light carrying fiber / conduit corresponding to each product in the said containment /s 21 wherein the sensor/s senses / detects presence/absence of light across the said optic light carrying fiber / conduit to detect presence / absence of the product in the said product package.

In yet another variant of this embodiment with reference to Figure 2, wherein the carding comprises of laminas 30 and 31. Openings / slots 32 are provided on lamina 30 according to the receptacle 33 on the package so that the said receptacles pass through the said openings when the said lamina 30 is placed on the package from the receptacle side. The lamina 31 is provided with perforated peelable portions 34 corresponding / superimposed to the said rupturable closures 35 of the package so that when the product in the package is removed, the perforated portion on the lamina corresponding to that product is also removed wherein the said optic light carrying fiber is affixed / embedded / provide across the said perforated peelable portion so that when the product in the package is removed, the perforated portion on the lamina corresponding to that product is also removed thereby breaking the said optic light carrying fiber / conduit.

In yet another embodiment a customized pattern is printed / affixed / embedded / provided on the closure/s 22 and /or containment/s 21 of the product package 20 corresponding to each product in the said containment wherein the signal generated by the said customized pattern is detected / recognized / sensed by the said signal sensor/s 3 using emission and reception of laser and / or infrared on / from the said customized pattern.

In another variant of this embodiment customized pattern in the form of an image is printed / affixed / embedded / provided on the closure 22 and /or containment/s 21 of the product package 20 corresponding to each product in the said containment wherein the signal generated by the said customized pattern is detected / recognized / sensed by the said signal sensor/s 3 using emission and reception of ambient / white light on / from the said customized pattern.

In another variant of this embodiment customized magnetic pattern is printed / affixed / embedded / provided on the closure 22 and /or containment/s 21 of the product package 20 corresponding to each product in the said containment wherein the electromagnetic signal generated by the said customized pattern is detected / recognized / sensed by the magnetic sensor/s 3 such as pick-up coil wherein the product package 20 is relatively moved / disposed in proximity / positioned in the vicinity of the said magnetic sensor/s.

In another embodiment the closure/s 22 and /or containment/s 21 of the product package 20 is provided with independent spot / layer / zone of electrical conductive material on the corresponding to each product in the containment to generate electrical signal wherein conductivity across each of the said layer is sensed / detected by the sensor/s 3 to detect presence/ absence of the product in the said package.

In another embodiment the closure 22 and /or containment/s 21 of the product package 20 is provided with independent conductive pattern corresponding to each product in the containment to generate electrical signal wherein resistance across each of the said pattern is sensed / detected by the sensor/s 3 to detect presence/ absence of the product in the said package.

In another embodiment the closure 22 and /or containment/s 21 of the product package 20 is provided with a light emitting material (phosphorescence / luminescence) corresponding to each product in the containment to generate signal wherein the sensor/s 3 detect light emitted from the said light emitting material to detect presence/ absence of the product in the said package.

In yet another embodiment the closure 22 and /or containment/s 21 of the product package 20 is provided with a unique DNA marker corresponding to the each product in the containment wherein the sensor /s 3 use ultraviolet light to detect / sense / recognize the said marker to detect presence / absence of product in the said package.

In yet another embodiment the closure 22 and /or containment/s 21 of the product package 20 is provided with nano particulate corresponding to the each product in the containment wherein high frequency visual sensor /s 3 are used to detect / sense / recognize the said particulate to detect presence / absence of product in the said package.

In yet another embodiment the sonic signal generated by the breakage of the closure 22 and /or containment/s 21 is sensed / recognized by the ultrasonic sensor /s 3.

In yet another embodiment the closure 22 and /or containment/s 21 of the product package 20 is provided with memory spot/s corresponding to the each product in the containment.

In yet another embodiment the said closure 22 and / or containment/s 21 of the product package 20 is provided with a characteristic image corresponding to each product which is recorded in the form of digital video signal of either interlaced or progressive scan type by the video camera sensor/s 3 and the presence and absence of the product in the said package 20 is detected based on the presence / absence of the said characteristic individual image sensed by the said video camera sensor/s 3.

In yet another embodiment the said closure 22 and / or containment/s 21 of the product package 20 is provided with a characteristic image corresponding to each product which is scanned by the scanning sensor/s 3 and the presence and absence of the product in the said package 20 is detected based on the presence / absence of the said characteristic individual image sensed by the said sensor/s 3.

Figure 4 illustrates yet another embodiment of the package with the signal generating system. Figure 4(a) shows package comprising product containment / holding cavity 40 in the form of a container and a closure 41. Temporary holding provision 42 for product is provided in the closure 41. When the said container 40 is tilted / shaken / pressed to remove the product from the container 40 for accession, the product from the container 40 comes / rests in the product entrapment provision 42. The signal is generated from this provision. When product occupies the said provision, there is a signal generation or elimination or change which is sensed by the sensor/s 3 of the associated device. The dispensing provision 44 is provided in the closure 41 to dispense the product which is present in the provision 42. The closure is provided with a means that appropriately fits in the associate device. The chip 45 is affixed to the package as shown. It may be provided on the product containment / holding cavity 40. Figure 4(b) shows package comprising product containment / holding cavity 50 formed by flexible material 51 wherein part of the same material is sealed at location 52 to form a pouch. The dispensing system 53 comprises of product entrapment provision 55. The signal is generated from this provision based on presence / absence of the product in this provision. The closure is provided with a means that appropriately fits in the associate device. The product dispensing provision 56 is provided in connection with the passage 57. When the said pouch is tilted to access the product contained in cavity 50, product from the cavity comes to the entrapment provision 55. When product occupies the provision 55, there is a signal generation or elimination or change which is sensed by the sensor/ 3 of the associated device. The chip 58 is affixed to the package as shown. It may be provided on 51.

In yet another embodiment the package comprises of product containment / holding cavity in the form of a container provided with open side to remove product and a means for accessing the product is in the form of closure fitting provision; a removable closure that is fitted on the said container.

In yet another embodiment the package comprises of product containment / holding cavity formed by flexible material wherein part of the same material is sealed to form a pouch and a means for accessing the product comprises of product entrapment and dispensing provision.

Encoder / decoder, connectivity means, real time measuring means, power source, user input means, user interaction means, memory, analog to digital converter, data sampling and organizing means (not shown in figure) are configured with the processing unit in portion 2 of the device as shown in Figure 1. An activation means is provided to activate the signal sensing means according to the location of the receptacles of the product. Further display means is provided on portion 2. When the said package 20 is positioned in provision 5 in such a way that the pre-encoded chip 24 is in the vicinity or in contact of the decoder device(not shown) , the decoding process of the encoded data in the said chip 24 gets initiated in and the decoded data is sent to the processing unit (not shown). The said decoded data is processed for authentication and appropriate message is displayed on the display means. In one of the embodiments the device receives physiological data such as blood pressure, body temperature, ECG etc. from patient's body / other device. In a preferred embodiment of the invention, the associated device contains Hall Sensors to sense the magnetic fields generated by the package when the package is introduced in the device.

In yet another embodiment electromagnetic system is provided on the package / carding to generate electromagnetic field that can be sensed by the sensors in the associated device.

In yet another embodiment package is provided with sonic signal generating means that is sensed by the sensors in the associated device.

In yet another embodiment the package is provided with RFID tag / chip corresponding to each product on the said package.

In yet another embodiment package is provided with a means to generate signals in the form of electrical, temperature, electromagnetic, light, mechanical, pressure, laser, video, measurement of capacitance, image, etc outputs.

In yet another embodiment the said associated device is provided with sensors to sense signals such as electrical, mechanical, pressure, temperature, electromagnetic, light, laser, video, image etc generated by the said signal generating means of the said package.

In yet another embodiment signal generating means of the smart package generates magnetoacoustic signals.

In another embodiment the variation in the capacitance as a result of presence or absence of the product in the said smart package is measured by the said sensor.

In another embodiment the said smart package is provided with microcontroller based RFID to store data.

In yet another embodiment the said smart package is provided with a two-way communication interface to write information to the circuitry and to read information fro the circuitry.

Thus it is evident from the present invention that the synergistic combination of the product package with a provision to generate signal with the associated device with a provision to sense the generated signal by the package results in the technical effect of obviating the use of array of signal generating and corresponding sensing means to sense the said generated signal in the device to detect presence / absence of product in the package.

Further, provision of chip / RFID on the package with the information such as medicine schedule, number of tablets, manufacturing date, batch number, unique identification protocol etc. on the smart package facilitates tracking and authenticating the use of the said smart package along the entire supply chain using appropriate readers at each stage resulting in achieving anti-counterfeit and compliance measures. Further, the synergistic combination of RFID along with customized pattern results in associated device integration with package, end user and relates the product to the user and to the medication plan to the pharmaceutical company; anti-counterfeit capability to each product in the smart package; real time record / data of the product consumption and the difference with respect to the medical plan; restriction / disablement of the chip upon complete consumption of the products in the smart package to avoid misuse of the said chip.

Claims

We Claim:

1. An interactive smart package — associated device comprising

wherein

2. An interactive smart package for use with an associated device wherein the smart package comprises a plurality of containment/s adapted to receive a product, each containment being closed or optionally with closure means wherein the containment/s and/or closure/s are non-electrically-interconnected; chip and optionally transmitter and / or receiver means;

signal generating means provided in or optionally on the containment/s, or in or optionally on the said closure/s such that removal of product/s from the said containment/s generate signal and / or alter the signal detected by the signal sensing means in the said associated device.

3. An interactive smart package - associated device as claimed in claim 1 or claim 2 wherein the package comprises containment/s in the form of one or plurality of enclosed spaces formed in a first lamina to contain the product closed with second rupturable lamina attached to the first lamina to form a closure so as to seal the product in the said enclosed spaces; the said containment/s and / or closure/s being non-electrically interconnected; chip and optionally transmitter and / or receiver means.

4. An interactive smart package - associated device as claimed in any one of claims 1 , 2 and 3 wherein one or a plurality of magnets are disposed on or in the smart package and adapted to provide information relating to the location, portion or zone of one or more of the products in the said enclosed space/s of the containment/s.

5. An interactive smart package - associated device as claimed in any one of claims 1 , 2 and 3 wherein the said containment or closure means is provided with magnetic ink which encodes information relating to the location, portion or zone of one or more of the products in the said enclosed space/s of the containment/s optionally by having specific strength on areas corresponding to the location, portion or zone of the product in the said enclosed space/s of the containment/s.

6. An interactive smart package - associated device as claimed in any one of claims 1 , 2 and 3 wherein the said containment or closure means is printed with magnetic ink having specific strength on areas corresponding to the location / portion / zone of product in the said enclosed space/s of the containment/s.

7. An interactive smart package - associated device as claimed in anyone of claims 1 , 2 and 3 wherein the said containment or closure means is partially / completely coated with magnetic ink having specific strength on areas corresponding to the location / portion / zone of product in the said enclosed space/s of the containment/s.

8. An interactive smart package - associated device as claimed in any one of claims 1 , 2 and 3 wherein the smart package comprises a carded / walletized package system which comprises:

carding comprising

a first lamina provided with openings corresponding to the said formed enclosed spaces of the said package such that the said formed enclosed spaces pass through the said openings;

a second lamina provided with perforated peelable portions provided corresponding to or aligned with the locations of the said rupturable lamina of the package such that when the product in the package is removed, the said perforated portion corresponding to that product is also removed;

the package comprising a plurality of containments in the form of a first package lamina in which one or a plurality of enclosed spaces are formed to contain the produces) closed with a second package rupturable lamina attached to the unformed portion of the first package lamina to seal the produces) in the said enclosed spaces; the said containment/s and / or closure/s being non-electrically interconnected; chip and optionally transmitter and / or receiver means.

wherein

the said package is placed between the first and the second lamina of the said carding;

signal generating means in or optionally on the containment/s, or in or optionally on the said closure/s.

9. An interactive smart package - associated device as claimed in claim 8 wherein a multipolar pre-magnetized sheet provided with perforated peelable portions corresponding / superimposed to the locations of the said rupturable containments) or closure means of the package is sandwiched between the said second lamina of the carding of the said walletized package system and the closure of the package such that that the removal of product/s from the package causes the removal, detachment or elimination of the portion of the multipolar pre-magnetized sheet.

10. An interactive smart package - associated device as claimed in claim 8 wherein an unipolar pre-magnetized sheet provided with perforated peelable portions corresponding / superimposed to the locations of the said rupturable containments) or closure means of the package is sandwiched between the said second lamina of the carding of the walletized package system and the closure of the package such that that the removal of product/s from the package causes the removal, detachment or elimination of the portion of the unipolar pre-magnetized sheet.

11. An interactive smart package - associated device as claimed in claim 8 wherein magnets are positioned corresponding to the product location on the rupturable containment(s) and or closure means of the package and the second lamina of the carding of the walletized package system such that the when the product in the package is removed, the corresponding magnet is also removed along with the perforated peelable portion of the second lamina.

12. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the package comprises a plurality of containments each in the form of a container provided with an open side to remove a product and the closure means in the form of removable closure adapted to fit on the said open side of the container; chip and optionally transmitter and / or receiver means;

signal generating means provided in the said closure means such that removal of the product from the said containment portion results in generation and / or alteration of signal; data chip and optionally transmitter and / or receiver means.

13. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the package comprises of product containment in the form of a flexible material wherein part of the same material is sealed to form a pouch and a closure means in the form of a product entrapment and dispensing provision;

signal generating means provided in the said product entrapment and dispensing provision means such that removal of the product from the said containment portion results in generation of signal and / or alteration of the signal; chip and optionally transmitter and / or receiver means.

14. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the signal generating means of the smart package generates a signal in the form of magnetic f/eld/s.

15. An interactive smart package - associated device as claimed in any one of the preceding claims comprising a multipolar or unipolar sheet capable of being pre- magnetized and which is disposed so as to be disturbed by the removal of a product from the smart package.

16. An interactive smart package - associated device as claimed in any one of the preceding claims wherein a non-magnetized unipolar / multi polar materials capable of getting magnetized with perforations superimposed to the one or more of the containments or closures of the package is affixed to one or more containments or closures of the said package such that removal of the product from the receptacle breaks the said material.

17. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the signal generating means of the package is capable of generating a magnetic field or a change in a magnetic field and the the signal sensing means of the associated device is a Hall sensor to sense the magnetic fields generated or changed by the package when the package is communicates with the device optionally by being introduced, positioned or placed in the said associated device.

18. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the smart package is provided with a proactive signal generating means.

19. An interactive smart package - associated device as claimed in any one of claims 1 to 17 wherein the smart package is provided with invoked signal generating means.

20. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the signal is generated from the smart package resulting from a change in the physical, electrical, thermal, optical, visual property, characteristics or signal of the smart package.

21. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the smart package is provided with customized pattem/s representing information relating to the location, portion or zone of product in the said enclosed space/s of the containment/s to generate a signal and / or alter a signal generated and /or detected by the signal sensing means in the said associated device caused by removal of product/s from the said containment/s.

22. An interactive smart package - associated device as claimed in claim 21 wherein the customized pattem/s is in the form of an image which is printed, affixed, embedded or otherwise provided on the closure and /or containment/s of the smart package corresponding to each product in the said containment.

23. An interactive smart package - associated device as claimed in claim 21 or 22 wherein the pattern comprises a magnetic pattern/s.

24. An interactive smart package - associated device as claimed in claim 21 or claim 22 wherein the signal sensing means comprises a laser and / or an infrared light source that emits and receives laser and / or infrared on / from the said customized pattern of the smart package to detect / recognize / sense the signal from the smart package.

25. An interactive smart package - associated device as claimed in any one of claims 1 to 22 wherein the signal sensing means comprises ambient / white light source that detects, recognizes or senses the signal from the said smart package.

26. An interactive smart package - associated device as claimed in any one of claims 1 to 23 wherein the signal sensing means comprises a magnetic sensor/s such as pick-up coil.

27. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the closure/s and /or containment/s of the smart package is printed, affixed, embedded or otherwise provided with optic light carrying fiber / conduit corresponding to each product in each of the said containment /s.

28. An interactive smart package - associated device as claimed in claim 27 wherein the signal sensing means comprises a sensor/s that senses / detects the presence or absence of light across the optic light carrying fiber / conduit to detect presence or absence of the product in the said smart package.

29. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the closure/s and /or containment/s of the smart package is provided with an independent spot, layer or zone of electrical conductive material on the said closure / containment corresponding to each product in the containment to generate an electrical signal for detection by the device.

30. An interactive smart package - associated device as claimed in any one of claims 1 to 20 or claim 29 wherein the signal sensing means is a conductivity measuring system that measures, senses or detects conductivity across each of the said layer to detect presence/ absence of the product in the said smart package.

31. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the closure/s and /or containment/s of the smart package is provided with an independent conductive pattern corresponding to each product in the containment to generate an electrical signal for detection by the device.

32. An interactive smart package - associated device as claimed in any one of claims 1 to 20 or claim 31 wherein the signal sensing means is a resistance detecting system that measures, senses or detects a resistance across each of the said pattern to detect the presence or absence of the product in the said smart package.

33. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the smart package is provided with a light emitting material (phosphorescence / luminescence) corresponding to each product in the containment to generate optical signal for detection by the device.

34. An interactive smart package - associated device as claimed in any one of claims 1 to 20 and claim 33 wherein the signal sensing means is a light detecting device that detects light emitted from the said light emitting material to detect the presence or absence of the product in the said package.

35. An interactive smart package - associated device as claimed in any one of claims 1 to 20 wherein the closure/s and /or containment/s of the smart package is provided with an RFID tag / chip corresponding to each product in the containment.

36. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the signal generating means of the smart package generates acoustic or sonic signals alone or in combination with other signals .

37. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the signal generating means of the smart package generates signals in the form of electrical, electromagnetic, light, mechanical, pressure, laser, video, measurement of capacitance or image outputs.

38. An interactive smart package - associated device as claimed in any one of claims 1 to 37 wherein the signal generating means of the smart package generates electromagnetic signals.

39. An interactive smart package - associated device as claimed in any one of claims 1 to 37 wherein the signal generating means of the smart package generates magnetoacoustic signals.

40. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the interactive smart package-associated device comprises data management means for storage, recognition, identification and communication of data relating to the product in the package.

41. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the closure/s and /or containment/s of the smart package of the smart package is provided with a marker, optionally a unique DNA marker, corresponding to the each product in the containment.

42. An interactive smart package - associated device as claimed in claim 41 wherein the signal sensing means comprises an ultraviolet light source to detect, sense or recognize a DNA marker so as to detect the presence or absence of product in the said package.

43. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the closure and /or containment/s of the smart package is provided with a nano particulate corresponding to the each product in the containment.

44. An interactive smart package - associated device as claimed in claim 43 wherein the signal sensing means is a high frequency visual sensor /s to detect, sense or recognize the said nano particulate so as to detect the presence or absence of product in the said package.

45. An interactive smart package - associated device as claimed in any one of the preceding claims wherein a sonic signal is generated by the breakage of the closure and

/or containment/s and is sensed, recognized or detected by the signal sensing means of the associated device.

46. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the closure and /or containment/s of the smart package is provided with a memory spot/s corresponding to the each product in the containment.

47. An interactive smart package - associated device as claimed in any one of claims 1 to 46 wherein the said smart package is provided with microcontroller based RFID to store data.

48. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the smart package comprises a customized pattem/s printed, affixed or embedded on the closure/s and / or containment/s corresponding to the location, portion or zone of product in the said enclosed space/s of the containment/s and RFID chip.

49. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the associated device comprises interactive and/or user input means; powered time tracking means; data decoding means, data processing, data storage means; analog to digital converter, data sampling and organizing means so configured to communicate with an external data source so as to one or more of register the product user, authenticate, register product package when housed / located in the said housing and optionally carry out transient data collection or communicate with and /or through a remote or integrated data system optionally for the collection, transmission, collation, archival or dissipation of transient data or information provided by the user or combinations thereof.

50. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the communication means of the said associated device comprises of an analog / digital data converting means to receive and process physiological and / or medical device generated signals.

51. An interactive smart package - associated device as claimed in any one of the preceding claims wherein the communication means of the said associated device comprises an analog / digital data converting means to receive and process data and / or signals generated by external devices used for various monitoring / operational activities.

52. A package comprising: a first sheet having multiple containment capsules (21 ) upstanding from a first surface thereof and dimensioned to receive individual product items and multiple corresponding openings in a second surface of the sheet to the upstanding capsules; a second sheet (22) secured to the second surface of the first sheet so as to provide closures over the multiple openings in the first sheet; and components having individual signatures and being disposed adjacent corresponding closures such that respective signatures are substantially detectable only if their corresponding closures are intact.

53. A package according to claim 52 wherein the respective components include respective discrete magnets respectively secured to the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise respective magnetic fields.

54. A package according to claim 52 wherein the respective components include respective magnetic layers disposed upon the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise respective magnetic fields.

55. A package according to claim 52 or claim 54 wherein the respective components include respective a magnetic layer disposed only upon discrete regions of the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise respective magnetic fields.

56. A package according to claim 52 wherein the respective components include respective light reflecting surface regions integral with the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise reflection of light.

57. A package according to claim 52 wherein the respective components include respective light absorptive surface regions integral with the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise absorption of light.

58. A package according to claim 52 wherein the respective components include respective electrical components disposed upon the second sheet opposite openings to corresponding upstanding containment capsules; and wherein the substantially detectable signatures comprise an electrical characteristic of the respective electrical components.

59. A package according to claim 58 wherein the electrical characteristic includes capacitance.

60. A package according to any one of claims 52 to 59 wherein the first sheet is formed of a first material; and the second sheet is formed of a second material that is more easily perforated than the first material.

61. A package according to any one of claims 52 to 60 wherein the first sheet is formed of a pliable material; and the second sheet is formed of a second material that is more easily compromised than the pliable material.

62. A package according to any one of claims 52 to 61 wherein the second sheet includes perforations formed in regions thereof opposite the multiple corresponding openings in a second surface of the first sheet.

63. A package according to any one of claims 52 to 62 wherein the second sheet includes planar portions formed of a generally rigid material and defines multiple respective perforated regions aligned with the openings in the second surface of the first sheet.

64. A package according to claim 63 wherein the sheet (30) includes planar portions formed of a generally rigid material and defines multiple respective openings sized to receive upstanding capsules of the first surface of the first sheet; and the sheet (31 ) includes one or more seals / peelable portions (34) that overlay the multiple respective openings formed of a material that is more easily compromised than the generally rigid material.

65. A package according to claim 63 to wherein the respective seals (34) are demarcated by perforations that generally conform to respective contours of the respective openings.

66. A package according to any one of claims 52 to 65 further including: a third sheet (30) formed of a generally rigid material that defines multiple respective openings (32) sized to receive corresponding upstanding capsules defined by the first sheet.

67. A package according to any one of claims 52 to 66 comprising: a product holding cavity sized to contain multiple product items; a product dispenser that includes, a first opening to the product holding cavity; a second opening to an external environment; an entrapment region disposed between the first and second openings to contain a product in the course of product passage from the first opening to the second opening; and a third opening between the entrapment region and the external environment.

68. A package according to claim 67 wherein the third opening defines a first passage through the entrapment region.

69. A package according to any one of claims 67 and 68 wherein the product dispenser further includes, a second passage sized to permit passage of a product between the entrapment region and the second opening; and wherein the first passage defined by the third opening is generally transverse to the second passage.

70. A package according to any one of claims 52 to 69 further including: data storage circuitry (24) encoded with information indicative of user identity.

71. A package according to any one of claims 52 to 70 further including: data storage circuitry encoded with information indicative of identity of contained items.

72. A package according to any one of claims 52 to 71 further including: data storage circuitry encoded with information indicative of recommended usage of contained items.

73. A package according to any one of claims 52 to 72 further including: data storage circuitry encoded with information indicative of accession of contained items.

74. A package according to any one of claims 52 to V3 further including: data storage circuitry; and a two-way communication interface to write information to the data storage circuitry and to read information from the data storage circuitry.

75. A smart package as defined in any one of claims 1 to 51.

76. A system to regulate product consumption by an individual consumer comprising: a product package as claimed in any one of claim 52 to 75 that includes an entrapment region to contain a product item; a reader that includes, a signal generator to impart a signal across a free space; a sensor to sense the signal generated by the signal generator across the free space; ■ and a receptor region sized to receive at least a portion of the product package that includes the entrapment region and contoured to align the signal generator and the sensor with the entrapment region to permit the signal generator to impart a signal through a free space in the entrapment region to the sensor in the absence of the product item within the entrapment region.

77. A system as claimed in claim 76, wherein the product package includes, a product holding cavity sized to contain multiple product items; a product dispenser that includes, a first opening to the product holding cavity; a second opening to an external environment; the entrapment region disposed between the first and second openings to temporarily contain a I product in the course of product passage from the first opening to the second opening; and a third opening between the entrapment region and the external environment.

78. A package as claimed in claim 76 or 77, wherein the third opening defines a first passage through the entrapment region.

79. A package as claimed in any one of claims 76 to 78, wherein the product dispenser further includes, a second passage sized to permit passage of a product between the entrapment region and the second opening; and wherein the first passage defined by the third opening is generally transverse to the second passage.

80. A system to regulate product consumption by an individual consumer comprising: a product package that includes; an entrapment region to contain a product; a removable closure that encloses the proάuct within the entrapment region prior to its removal and that allows passage of the product from the entrapment region upon its removal, a component having signatures and being disposed adjacent the closure such that the signatures is substantially detectable only if the closures is intact; a reader that includes, a sensor to sense signature when a product is disposed within the entrapment region; and a receptor region contoured to receive at least a portion of the product package that includes the entrapment region and to align the sensor with the entrapment region to permit sensing of the signature prior to removal of the closure while the product is disposed within the entrapment region.

81. A system as claimed in claim 80 further including: first data storage circuitry secured to the package and encoded with first information; second data storage circuitry secured to the reader and encoded with second information; processing circuitry associated with the reader to process the first information and the second information to authenticate the package; and a communication interface to communicate information between the first data storage circuitry and the second data storage circuitry and the processing circuitry.

82. A system according to claim 80 or claim 81 further including: processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the signal generator; and a communication interface to communicate information externally to the reader that is indicative of the imparting of a signal generated by the signal generator through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region.

83. A system according to any one of claims claim 80 to 82 further including: processing circuitry coupled to receive a sensor signal indicative of detection of the signature; and a communication interface to communicate information externally to the reader that is indicative of whether the signature has been detected.

84. A system to regulate product consumption by an individual consumer comprising: a product package that includes an entrapment region to contain a product; a reader that includes, a signal generator to impart a signal across a free space; a sensor to sense the signal generated by the signal generator across the free space; a receptor region sized to receive at least a portion of the product package that includes the entrapment region and contoured to align the signal generator and the sensor with the entrapment region to permit the signal generator to impart a signal through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region; first data storage circuitry secured to the package and encoded with first information; second data storage circuitry secured to the reader and encoded with second information; processing circuitry associated with the reader to process the first information and the second information to authenticate the package; a first communication interface to communicate information between the first data storage circuitry and the second data storage circuitry and the processing circuitry; processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the signal generator; and a second communication interface to communicate information externally to the reader that is indicative of the imparting of a signal generated by the signal generator through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region.

85. A system to regulate product consumption by an individual consumer comprising: a product package that includes; an entrapment region to contain a product; a removable closure that encloses the product within the entrapment region prior to its removal and that allows passage of the product from the entrapment region upon its removal; a magnetic material associated with the closure; a reader that includes, a sensor to sense a magnetic signal imparted by the magnetic material when the product is disposed within the entrapment region; and a receptor region contoured to receive at least a portion of the product package that includes the entrapment region and to align the sensor with the entrapment region to permit the magnetic material to impart a magnetic signal to the sensor prior to removal of the closure while the product is disposed within the entrapment region; first data storage circuitry secured to the package and encoded with first information; second data storage circuitry secured to the reader and encoded with second information; processing circuitry associated with the reader to process the first information and the second information to authenticate the package; a first communication interface to communicate information between the first data storage circuitry and the second data storage circuitry and the processing circuitry; processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the magnetic material; and a second communication interface to communicate information externally to the reader that is indicative of the imparting of a signal by the magnetic material to the sensor in the absence of the product within the entrapment region.

86. A system as claimed in claim 84 or claim 85 wherein, the first processing circuitry and the second processing circuitry are implemented at least in part, in common hardware.

87. An associated device as defined in any one of claims 1 to 51.

88. A method of providing a real-time health care management system comprising : i) recording in a remote system, healthcare management aspects and / or treatment regime for a patient; ii) providing to the patient a smart package as claimed in claim 52 comprising medication and instructions for administration of the medication according to the recorded healthcare regime; iii) periodically engaging the smart package with an associated device as defined in claim 53 whereby information relating to the medication is communicated from the package to the device and from the device to the remote system; iv) comparing the information communicated to the remote system with the treatment regime to ascertain whether the information relating to the identity of the package and/or the status of the package corresponds with the information relating to the treatment regime and patient recorded in the remote system; v) providing information from the remote system to the device to indicate whether the status of the package and/or identity of the patient corresponds with the information relating to the treatment regime and/or the identity of patient.