WO2014122479A2 - Système, appareil et procédé d'authentification de produits - Google Patents

Système, appareil et procédé d'authentification de produits Download PDF

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Publication number
WO2014122479A2
WO2014122479A2 PCT/GB2014/050377 GB2014050377W WO2014122479A2 WO 2014122479 A2 WO2014122479 A2 WO 2014122479A2 GB 2014050377 W GB2014050377 W GB 2014050377W WO 2014122479 A2 WO2014122479 A2 WO 2014122479A2
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WO
WIPO (PCT)
Prior art keywords
product
container
mark
marking
data relating
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PCT/GB2014/050377
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English (en)
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WO2014122479A3 (fr
Inventor
Kenneth James LEIPER
Original Assignee
Benson Ip Limited
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Publication date
Application filed by Benson Ip Limited filed Critical Benson Ip Limited
Publication of WO2014122479A2 publication Critical patent/WO2014122479A2/fr
Publication of WO2014122479A3 publication Critical patent/WO2014122479A3/fr

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    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/083—Shipping
    • G06Q10/0833—Tracking

Definitions

  • the present invention relates to a product authenticating system as well as to a method of product manufacture and authenticated products.
  • End-user assurance of pharmaceutical products' provenance is of paramount importance to the peace-of-mind, health and safety of the product's user as well as in combatting counterfeiters.
  • drugs dispensed as tablets have possessed low security identifiers such as shape, embossing, coating colour and packaging.
  • These security features have been easily exploited by counterfeiters and no longer provide a guarantee of authenticity for an end-user.
  • Information held on tablets is static and largely non-informative. Indeed, an analogous problem extends to any consumer product that possesses low security features and is easily replicated or imitated, for example cigarettes. The repercussions of counterfeiting extend beyond the potential harm to users, for example to brand protection, manufacturer cash flow and taxation issues.
  • WO 201 1/1 12227 describes a system where a pharmaceutical blister pack is marked with a code which a user can validate by entering it into a web-page. A message is then sent back to confirm the validity of the code.
  • a product authenticating system comprising a product marking means (such as, a printer, engraver or etcher); container marking means (such as, a printer, engraver or etcher) and a remotely accessible database (or, preferably, a server or server comprising a database); wherein the product marking means is adapted to (preferably uniquely) mark a plurality of products and the container marking means is adapted to (preferably uniquely) mark a container for said plurality of products; wherein the remotely accessible database is adapted to store: data relating to the product mark and to the authenticity of the product based on the product mark; and data relating to the container mark and to the markings of the plurality of products contained in the container.
  • Unique authentication of the product is therefore achieved and a relational hierarchy between the product and container is established.
  • the container is used to contain at least one product.
  • the product marking means and the container marking means are arranged to store data in the remotely accessible database.
  • the product and/or container marking may be encryption keys that allow access to data relating to the product mark and to the authenticity of the product based on the product mark and/or data relating to the container mark and to the markings of the plurality of products contained in the container respectively from the remotely accessible database.
  • the data relating to the container mark comprises data relating to the authenticity of the container.
  • the data relating to the product comprises data enabling, preferably unique, visual identification of the product; thereby allowing a user to confirm that the product has been validly packaged in its container.
  • the data enabling visual identification of the product comprises a portion of the product mark.
  • the data enabling visual identification of the product comprises a secondary product mark.
  • the secondary product mark being universally unique or unique amongst the secondary product marks of the products contained within the container for said plurality of products. A failsafe mechanism for parallel authentication is therefore established, indicating that a given product belongs in a given container for example, thereby alerting a user to errors in packaging.
  • the container mark, and/or preferably the product mark comprises a code which corresponds to a unique entry in the remotely accessible database.
  • the remotely accessible database comprises a relational hierarchy of container marks, product marks and data relating to these.
  • data relating to the authenticity of the product based on the product mark is accessible independently of the container mark; this allows, for example, a product to be authenticated even if it is without its container.
  • each product is marked with a universally unique mark.
  • the product container is marked with a universally unique mark.
  • At least one product is marked with a unique mark within a given, preferably uniquely, marked container.
  • a unique product and/or container marks are used.
  • the product and/or container mark comprises at least one of: alphanumeric sequence, two-dimensional graphic and/or three-dimensional relief.
  • said marking provides access to a timestamp, batch number, product code, brand and/or an aesthetic design.
  • the database is accessible via at least one of the Internet, Ethernet, and a telephone network.
  • the authenticity data relating to the product comprises a verification notification sent to a user via a network.
  • the authenticity data relating to the product container comprises authenticity of a container and data relating to the marks on the products contained therein.
  • the data relating to the marks on the products contained therein allows a user to validate that the product correctly belongs in a container. A dependency is thereby established between the container mark and product mark that allows validation of packaging.
  • said container comprises a tub, bottle, box or the containing well and immediate cover strip of a blister pack, preferably with the product being contained therein.
  • the product comprises at least one of: a tablet; pre-filled syringe; a containing well and immediate cover strip of a blister pack; and ampoule, the product being contained in a container.
  • the container marking means is adapted to uniquely mark a secondary container for containing a plurality of containers; wherein the database stores data relating to the secondary container mark and to the markings of the plurality of products and/or containers contained in the secondary container. Thereby authentication at a further level of packaging of the product is provided and also allows for tracking and tracing of the secondary container.
  • the container mark and/or secondary container mark comprises a code which corresponds to a, preferably unique, database entry.
  • the authenticity data relating to the secondary product container comprises authenticity of the secondary container and data relating to the marks on the containers contained therein; preferably, further comprising at least one further container, said further container comprising a unique mark associated with a code which corresponds to a, preferably unique, database entry.
  • the authenticity data relating to the further containers comprises authenticity of the container and data relating to the marks on the containers immediately contained therein.
  • the remotely accessible database is adapted to store data relating to user access to authenticity data relating to a product.
  • the data relating to user access to authenticity data may be shared with medical practitioners, medical establishments, pharmaceutical companies and/or research institutes.
  • the data relating to user access to authenticity data is attributed to anonymous users.
  • the container and/or product marks are tamper-proof, tamper-resistant and/or tamper evidencing mechanisms.
  • a system for monitoring patient compliance with a regimen comprising a remotely accessible database, the remotely accessible database being adapted to store: data relating to a product mark and to the authenticity of the product based on the product mark; and/or data relating to a container mark and to the (preferably unique) markings of the plurality of products contained in the container; and data relating to user access to authenticity data relating to a product and product container.
  • the regimen is a prescribed medication regimen.
  • the data relating to user access to authenticity information relating to a product is logged and associated to the user.
  • user access to authenticity information is logged and associated to an anonymous user.
  • user access to authenticity information is shared with medical practitioners, medical establishments, pharmaceutical companies and/or research institutes. Compliance data may therefore be used to aid with administration of prescriptions for medicines, diagnosis and analysing the efficacy of medication.
  • the logged data relating to user access is used to monitor patient compliance. Patient compliance is thereby able to be recorded for specific unit doses.
  • a counterfeit-protected product or a counterfeit-protected item
  • a counterfeit-protected item comprising: a plurality of uniquely marked products; a marked product container; wherein: the marked product authenticity is derivable from each product marking; and data relating to the identity of each product is derivable from the container marking.
  • the product and/or container marks are universally unique.
  • the product mark comprises a code which corresponds to product authenticity.
  • the container mark comprises a code which corresponds to the product marking and/or authenticity of the container.
  • the data relating to the identity of a product comprises data enabling, preferably unique, visual identification of the product.
  • the data enabling visual identification of the product comprises a portion of the product mark.
  • the data enabling visual identification of the product comprises a secondary product mark.
  • said marking comprises a timestamp, product code, brand and/or an aesthetic design.
  • said markings are associated with authentication data, which are stored on a remote database, comprising at least one of: a timestamp, clinical trial data, active pharmaceutical ingredients, manufacturer, batch number, product code, brand name, or any other authentication information.
  • said markings are an encryption key that allows access to authentication data.
  • said product is contained in said container, which may comprise a bottle or the containing well and immediate cover strip of a blister pack.
  • the container encasing the product is arranged such that a plurality of containers is contained by a secondary container, which is uniquely marked such that the mark is adapted to provide data relating to the markings of the plurality of containers contained therein.
  • product and immediate container markings are co-ordinated such that a user is able to visually validate that a given product uniquely belongs in said container.
  • the product to be marked comprises a pharmaceutical medicine.
  • the product comprises at least one of: a tablet; pre-filled syringe; a package (notably a blister pack) and its content or contents; a containing well and immediate cover strip of a blister pack; and an ampoule; therefore, the term “product” or “item” may herein include inner packaging and its contents, being further contained in a container.
  • the product to be marked comprises a tobacco product, preferably a cigarette.
  • a method of manufacturing a counterfeit-protected product comprising: uniquely marking a plurality of products; marking a container for said plurality of products; wherein the product authenticity is derivable from the product marking and data relating to the product is derivable from the container marking.
  • the method further comprises: marking (preferably uniquely) secondary containers for said container; wherein the products are manufactured, marked and packaged in marked containers and therein packaged in marked (preferably uniquely) secondary containers during continuous production.
  • continuous production relies on maintaining knowledge of product identity, and associated authentication information, for every unique product or unique container throughout the manufacture process.
  • continuous production and product identity is executed by retaining sequence information in a linear-transport system.
  • data associated with the unique marking on the product is input and stored in a database.
  • data associated with the unique marking on the container is input, stored in the database and associated with the database entry for the associated product contained therein.
  • data associated with the unique marking on the secondary container is input, stored in the database and associated with the database entry for the associated container therein.
  • unit operations are performed over time segments in the continuous process of manufacture.
  • a method of manufacturing a counterfeit-protected product wherein the plurality of products is transferred directly from said platen into a plurality of blister packs.
  • a method of manufacturing a counterfeit-protected product wherein a plurality of blister packs is directly transferred into a further container.
  • An additional aspect of the invention provides a process of manufacturing a counterfeit- protected tablet, the method comprising: manufacturing said tablet; marking said tablet with a tablet identifier; and packaging said tablet into a container; wherein the manufacturing process is such that the sequencing of said tablet is retained throughout said process; preferably, the process being continuous.
  • the process takes place on a tablet linear transport system; this allows the identity of the tablet to be retained from manufacture until the tablet is marked.
  • a further aspect of the invention provides a method of monitoring patient compliance with a regimen, the method comprising: receiving a data request at a remotely accessible database for data relating to authenticity of a product based on a product mark; logging said data request; associating said logged request with a user.
  • a method of monitoring patient compliance further comprising: comparing a plurality of logged data requests from a user with a predefined regimen associated with said user.
  • a method of monitoring patient compliance wherein the regimen is a prescribed medication regimen.
  • a method of monitoring patient compliance wherein the logged data is shared, preferably anonymously, with other parties, including medical practitioners, medical institutions and research institutions.
  • a system for authenticating a counterfeit-protected item comprising a plurality of products and a container containing said plurality of products
  • the system comprising: a remotely accessible database adapted to store: data relating to a (preferably unique) product mark on the product and to the authenticity of the product based on the product mark; and data relating to a (preferably unique) container mark on the container, and to the marks of the plurality of products contained in the container; and means for retrieving the data from the database to authenticate the item.
  • the present invention arises from the realisation, pursuant to the present invention, that there is a need to provide absolute assurance of authenticity of the contents of a blister pack.
  • the invention can provide a way for an end-user to authenticate the source of a product securely and also to determine that a package contains authentic products.
  • the invention also provides a computer program and a computer program product for carrying out any of the methods described herein and/or for embodying any of the apparatus features described herein, and a computer readable medium having stored thereon a program for carrying out any of the methods described herein and/or for embodying any of the apparatus features described herein.
  • the invention also provides a signal embodying a computer program for carrying out any of the methods described herein and/or for embodying any of the apparatus features described herein, a method of transmitting such a signal, and a computer product having an operating system which supports a computer program for carrying out any of the methods described herein and/or for embodying any of the apparatus features described herein.
  • Any apparatus feature as described herein may also be provided as a method feature, and vice versa.
  • means plus function features may be expressed alternatively in terms of their corresponding structure, such as a suitably programmed processor and associated memory.
  • any feature in one aspect of the invention may be applied to other aspects of the invention, in any appropriate combination.
  • method aspects may be applied to apparatus aspects, and vice versa.
  • any, some and/or all features in one aspect can be applied to any, some and/or all features in any other aspect, in any appropriate combination.
  • the invention extends to a product authenticating system, a system for monitoring patient compliance, a counterfeit-protected product (or item), a method of manufacture of a counterfeit-protected product (or item), a process of manufacturing a counterfeit-protected tablet and/or a method of monitoring patient compliance with a regimen substantially as described herein and/or substantially as illustrated with reference to the accompanying drawings.
  • Figure 1 shows a flow diagram showing a prior art procedure for validating the authenticity of pharmaceutical packaging
  • Figure 2 shows a product authenticating system comprising: product marking means; container marking means and a remotely accessible database;
  • Figure 3 shows a flow diagram showing the relationship between product and container authentication markings, user authentication, communication to a database and authentication response;
  • Figure 4 shows a flow diagram of an example means of continuous process manufacturing
  • Figure 5 shows a flow diagram of an example process in which a tablet is uniquely marked in an anti-counterfeiting system
  • Figure 6 shows a flow diagram of the authentication procedure between user and database
  • Figure 7 shows an example marking hierarchy as used in the system shown in Figure 6
  • Figures 8 show an exemplary marked tablet
  • Figure 9 shows the tablet of Figure 8 contained in a cavity of a blister pack therein sealed by a cover strip which is further marked;
  • Figure 9a shows a counterfeit-protected product, including a tablet contained in a cavity of a blister pack therein sealed by a cover strip which is marked;
  • Figure 10 shows an exemplary set of tablets as shown in Figure 9;
  • Figure 1 1 is a process flow diagram showing how authentication information, as derived from information on the tablet, is obtained.
  • Figure 12 schematically illustrates the information accessible from a counterfeit-protected product.
  • Figure 1 shows a flow diagram of a prior art process in which a user obtains product authentication information by means of a product container marking.
  • the process is initiated once a user submits the product container marking 1 10.
  • the submission is made via the Internet or telephone network, for example by entering a code into a form on a webpage.
  • the product container marking is thereby transmitted to the database 120 where authenticity information relating to the product is stored.
  • the product container marking corresponds to an entry in the remotely accessible database.
  • the code request is then transmitted for verification within the database 130.
  • the response to that query is transmitted to the verification server 140.
  • the verification server Based upon the query response, the verification server prepares a message for the user 150 via a network 160.
  • Figure 2 shows an overview of an aspect of the disclosed invention - a system for product authentication 200 comprising a product marking means 204, a container marking means 208 and a remotely accessible database or server 212 (for example, a database maintained on a server).
  • the product marking means 204 is adapted to, preferably uniquely, mark a plurality of products, thereby forming marked products 216.
  • the container marking means 208 is adapted to, preferably uniquely, mark a container for a plurality of marked products 216 in association 220 with the product marking means 204 and plurality of marked products 216.
  • the markings on the product are relayed 224 to the remotely accessible database 212 as are the container markings 228, thereby storing data relating to the products' container mark, associated 220 product mark and the authenticity of the product based on the product mark.
  • the marked container 232 for the plurality of marked products 216 is determined to be an authenticated marked container 236 via access 240 to the remotely accessible database 212 to acquire authentication information based on the container mark.
  • a marked product 216 is authenticated 244 by accessing 248 the remote database 212 to acquire the authentication information based on the product mark.
  • the product mark and container mark are related 220, as is the authentication information of the container and product mark.
  • An encryption scheme is therefore provided by the authentication system 200, wherein a key for accessing authentication information in relation to a product and/or container therefor is provided via the product and/or container marks. Providing these marks to an authorised party, such as the remotely accessible database, allows for authentication information to be returned.
  • FIG. 3 shows a flow diagram for a product authenticating system 200, as per Figure 2, comprising a product marking means 204, container marking means 208 and a remotely accessible database 212, wherein the product marking means is adapted to mark uniquely a plurality of unmarked products 300.
  • the product is transferred 304 for marking ensuring that the process retains the product's identity achieved by means of a continuous or pseudo-continuous process (as described with reference to Figure 4).
  • the products are each uniquely marked by a product marking means 204, for example by engraving, etching or printing, including laser etching, dye printer or (electrostatic) deposition techniques such that the sequence of product manufacture can be reconstructed at any point during the continuous process.
  • the markings on the product comprise at least one of: alphanumeric sequence, two-dimensional graphic and three-dimensional relief.
  • Conventional marking means such as stamps are not preferred as it would be impractical to mark uniquely each product with a unique stamp.
  • physical contact with pharmaceuticals introduces the possibility of contamination.
  • affixed markings such as stickers, can be considered, provided these are affixed with considerable security and/or a tamper evident system.
  • Each product mark comprises a code which corresponds to a recorded unique entry 224 in the remotely accessible database 212 as entered via a processor 308.
  • the product's unique marking is relayed 220 to the product container marking means 208.
  • the container mark comprises a code which corresponds to a recorded unique entry 228 in the remotely accessible database and associated with the entries for the contained plurality of markings on each product 220.
  • the associated container and product codes are processed and entered into a database by a processor 308.
  • the product container marking means 208 is adapted to mark uniquely a container for a plurality of manufactured products or at least one manufactured product such that each unique product mark is associated with a unique container marking. Examples of containers include bottles, ampoules, pre-filled syringes, canisters (such as for inhalers), vials, sachets, capsules or a containing well (also referred to as a pocket) and immediate cover strip of a blister pack.
  • the container marking comprises at least one of: alphanumeric sequence, two-dimensional graphic and three- dimensional relief. This allows a product marking to correspond with the marking on the product's container and thereby arrange a nested hierarchy of authentication data. Such a hierarchy is described in more detail with reference to Figures 6-1 1 below.
  • the product is packed into the corresponding container and sealed 312 having transferred the product such that continuous process manufacturing has been satisfied and product information associated with an individual product retained 304.
  • the markings corresponding to the product container are relayed 316 to a system marking secondary containers 320 (if such secondary containers are required).
  • the secondary container mark comprises a code which is processed and entered into a database by the processor 308.
  • the secondary container mark corresponds to a recorded unique entry 324 in the remotely accessible database 212 and associated with the corresponding product container marks and product marks.
  • the secondary container mark is adapted to provide data relating to the markings of the plurality of product containers contained therein. This allows the set of container markings to correspond with the marking on the secondary container, further assembling a hierarchy of authentication data, the hierarchy providing an interrelationship of authentication data between product and container in a nested fashion.
  • the plurality of product containers is transferred 304 into a corresponding secondary container, for example a box for containing blister packs, packed and sealed 328 having retained the sequence information of the products.
  • the marking on the secondary container comprises at least one of: alphanumeric sequence, two-dimensional graphic and three-dimensional relief.
  • the product can undergo further levels of containment and packaging and a process of marking further containers, relating said markings to markings on lower tiers of packaging and storing in a database is possible for any number of packaging levels.
  • a relational hierarchy of packaging and corresponding marks is therefore generated.
  • the product, most likely fully packaged, is delivered 332 to a user 336 via any number of distributors and vendors.
  • the product mark is adapted to provide a user 336 access to authenticity data relating to the product, including a timestamp (for example of the printing time), batch number, product code, location of manufacture of the product, identifying number of the machinery used for manufacture, permutations of manufacture process data, brand, logo and/or an aesthetic design from the remotely accessible database.
  • the container mark is adapted to provide data relating to the markings of the plurality of products (or at least one product) contained therein and the secondary container is adapted to provide data relating to the markings of the plurality of product containers contained therein; this data is provided to the user in the same manner in which the authenticity data is provided, as is described in more detail below.
  • User authentication is achieved by submitting 340 a product marking, via a network 344.
  • the network comprises the Internet, Ethernet or telephone network - mobile (including 3G and 4G networks), or otherwise.
  • the means of submitting the code 340 therefore includes a smartphone application, Email, SMS, MMS or other means of transferring data to a network.
  • the network is in communication 348 with a product marking authentication module 352 configured to access the database 212, thereby permitting the marked product to be authenticated.
  • Authentication comprises validation that the database contains an entry of the product mark. Should the user-submitted product mark be validated 356, as determined by the authentication module 352, the authenticity data relating to the product comprises a positive verification notification 360 sent to the user via the network 344.
  • Further product authentication data is relayed including a manufacture/marking completion timestamp, batch number, product code, brand and/or an aesthetic design.
  • Authentication information from regulatory bodies such as product licence condition, drug class, pregnancy category, CSA schedule, National Drug Code and any other similar relevant information is also related to the product code.
  • Concerned parties such as users, vendors, clinicians and regulators, are able to verify the safety of the product by relating additional product information such as the licence condition of the product, use of an authorised manufacturing operation process (batch or continuous), such as Good Manufacturing Practice compliance, approved manufacturing plant, manufacturing plant GPS location, use of authenticated and approved input materials, approved packaging mitigating degradation of the product, approved labelling to convey expected product degradation and any other specific market requirements.
  • Further authentication information relating the container and product is provided to the user.
  • the user-submitted product mark be deemed invalid 364 as determined by the authentication module 352 the user is informed 368, potentially via relay 372 through the network to authorities, regulators, border controls, pharmacies, clinicians and any other interested parties 376, that the mark is invalid and product is also invalid.
  • An invalid product mark corresponds to any counterfeit, unlicensed, recalled or expired product. This allows a user to be warned if the product is unsafe, harmful or counterfeit and inform the relevant authorities.
  • a user is still able to confirm authenticity should the product be presented on its own or lacking any container.
  • authentication information is able to be derived using a product mark without having first authenticated the product container (via its own mark). This may be the case as governed by the manufacturer or the state in which the product arrives to the customer.
  • a system wherein the product is contained in more than a container and secondary container is equally suitable. Such higher orders of container include bulk product boxes and pallets - commonly encountered by distributors, border controls and vendors - and allow further traceability.
  • This method of authentication at product level such as unit dose level, supersedes the need for forensic identification and authentication. A mechanism for on-dose authentication is thereby provided.
  • the markings on the product and any level of container comprise a code, in turn comprising at least one of: alphanumeric sequence, two-dimensional graphic and three-dimensional relief.
  • a five-to-eight-digit alphanumeric code would suffice in securely coding for a sufficient number of containers and product markings.
  • a (cryptographic) checksum is implemented to confirm validity of the marking code and prevent attempts at fraudulent reproduction of codes. More generally, cryptographic markings are used with encoded authentication information or an encoded relationship to authentication information in the database 212.
  • a record of product usage is generated following submission 340 of a product mark, which can extend to a history of product usage by a user 336, this is particularly useful for clinicians.
  • Such a system is achieved by allowing users to register a device from which a submission is made or create a personal account to relate to the individual 336 and thus the user's product usage. This expands the system to a means of verifying an individual user's history of drug consumption, user compliance and dosage intake. Therefore compliance logging can be achieved alongside authentication. User security is thereby assured on multiple fronts - prevention of counterfeit drug consumption, patient compliance and dosage intake.
  • relating individual markings and registering submission to a user can kerb multiple submissions of markings, either in error or fraudulently.
  • codes relating to authentication marks are single-use; further usage is flagged by the system and the user informed.
  • a natural extension of information logging alongside authentication is a notice of stock levels.
  • An advantage of authentication at unit product, such as unit dose level is that the number of remaining units, including doses, can be known by the database. Therefore, an automatic instruction or notice to re-issue a product or medicine can be supplied when a certain threshold number of remaining products is passed.
  • This information can be provided to the manufacturer to control manufacture and supply dynamically, but also to any other distributors, vendors, pharmacists, medical practitioners, medical institutions, research institutions and dispensaries.
  • the system is particularly appropriate for patients on long-term care.
  • data sharing for example as used by the NHS Data-Sharing Scheme
  • suitable security and anonymity measures be placed on any gathered data.
  • Figure 4 illustrates a method of manufacturing a counterfeit-protected product, comprising the steps of uniquely marking a plurality of products wherein the product authenticity is derivable from the product marking, and data relating to the product is derivable from the product's container marking.
  • the method of manufacture is further characterised, in that products are manufactured, marked and packaged in marked containers and therein packaged in marked secondary containers during continuous production.
  • the method relies on continuous production, which allows knowledge of product identity and associated authentication information for every unique product or container throughout manufacturing, by retaining sequence information of the products or containers using a linear-transport system.
  • a continuous process of manufacture allows otherwise indistinct products, or group of products thereof, to be distinguished by merit of having knowledge regarding product sequence, position or spatial relation with other products throughout the process of manufacture.
  • Manufacture and processing operations are applied as unit operations, which are applied to single distinguishable products rather than en masse to a group or entire batch of products.
  • Such a process is advantageous since it grants the ability to identify individual products by recording unique information (for example, by using applications to assemble a matrix of manufacture information), which comes to characterise the product; unique information such as the completion of operation time slices, e.g. blending, coating, printing, etc.
  • unique information such as the completion of operation time slices, e.g. blending, coating, printing, etc.
  • a more informative log of product authenticity brings greater security measures against counterfeiting, repackaging, generic equivalents and parallel importing.
  • Retaining product sequence information can be done in batch manufacture or continuous mode and the method of production is determined by specific processing or packaging requirements.
  • the methodology can be retrofit to batch applications and will be easily integrated in a continuous process environment.
  • the process integration and intensification is reconfigurable to accept new technologies.
  • the assembly process of manufacturing a counterfeit-protected product is initiated by synthesising a bulk blend 400 of the pharmaceutical drug.
  • the pharmaceutical drug can comprise any medical or clinical drugs, including vaccines, trial drugs, contraceptives, as well as any lifestyle drugs.
  • the contents of the blend are fed 410 to a module which acts to prepare the drug form.
  • Any API auto-sampling means of manufacturing discrete dosage forms is appropriate, such as a tablet press, 3-D printer and capsule manufacture. In the case of tablet manufacture, this takes the form of a tablet press 420 - compressing the raw drug form into discrete dosages of an auto-sampled bulk blend.
  • drug delivery forms, or indeed any products can be assembled using this means to auto-sample a bulk raw ingredient.
  • the tablet press acts as an auto-sampler of the blend, controlling the flow of discrete dosage units across a batch.
  • solid arrows denote the maintaining of the continuous process of manufacture between operations
  • the hashed line 410 represents a non-continuous process when delivering the bulk blend to the press.
  • Continuous unit operations are applied as subsets, occurring within discrete time slices, of the entire continuous process.
  • the press output is fed onto a linear transport system 430, such as a platen-based system, enabling the continuous procession of the tablet cores to ensue.
  • the linear transport system 430 permits knowledge of the manufacture sequence of the tablet cores to be maintained throughout any subsequent operations.
  • Tablet cores are measured at the measurement zone 440 and are statistically assessed for uniformity across the batch.
  • the tablet cores are coated at the coating zone 450.
  • a unique identifier is applied onto the tablet coating in the printing zone 460, at this stage each dosage unit, i.e. a tablet, is identifiable and universally distinguishable.
  • the identity of the tablet is related to its dosage level and process information, thereby extending a link back to the manufacture process and tablet formation, further still, back to the bulk batch and if required to the clinical trial and patient level, all of which is unique information.
  • the tablet can be removed from the continuous process at this point since it is identifiable, however application of subsequent unit operation to specific tablets would be sub-optimal - a process of actively identifying tablets would be necessary. Instead the tablet is maintained as part of the continuous process.
  • the dosage unit now identifiable outside of a continuous process, proceeds to the packaging zones, where it is packaged in a primary container 470, such as the blister pack container.
  • the blister pack and tablet content can be packaged into any number of further containers.
  • the tablet and container is further packaged into a secondary container 480.
  • the process of further packaging containers and contents can be applied any number of times, up to the N th tier of packaging 490 - the most external container.
  • Continuous processing has the advantage of replicating small controllable unit operations, as opposed to scalable batch processing where multiplying the process unit size increases the risk. Continuous processing facilitates upstream (user to manufacturer) and downstream (manufacturer to user) security. Furthermore, the process allows manufacture miniaturisation to be enacted to a greater degree than alternative processes.
  • a linear transport system 430 allows a product to comply with the requirements of continuous production by retaining a consistent sequence of products throughout manufacture where unit operations can be applied to identifiable products. For example, tablets placed in a platen are identifiable by having their position mapped. The printing operation exploits this to mark the product and associate all relevant information with this mark. The product is now universally distinct.
  • the continuous process extends well before and well after printing - from tablet core 420 to packaging 470, 480 and 490. Further necessary manufacture processes, regulatory and quality assurance checks, such as Real-Time Release can also take place through a continuous process.
  • tablet printing as a unit operation in a single batch process consisting of, for example, blending the API, forming tablets and dispelling the plurality of products into a vat, where sequence information is not retained and products are allowed to mix freely, will randomise the printed units after printing making tablet sequencing into e.g. a blister pack, tub or bottle infeasible. This destroys the opportunity to provide extra layers of upstream and downstream security with minimal additional cost, as otherwise facilitated by the continuous process.
  • Figure 5 demonstrates an exemplary flow process for uniquely marking a pharmaceutical tablet 500.
  • the product is manufactured by forming tablet cores, from the bulk blend and tablet press 420, containing uniform amounts of the synthesised and diluted Active Pharmaceutical Ingredients (APIs) and necessary excipients.
  • the tablet cores are moulded, measured and coated to produce a consumable and effective product 51 0 (this step corresponds to the associated steps in Figure 4, 440 and 450). It is desired that the dose dimension and finish is capable of carrying the product mark that allows access to, amongst other information, a dose identifier, therefore the coating process creates a surface able to accept and retain suitably resolved markings made on the coat of the tablet.
  • Tablet coatings are used to fixate marks that allow access to authentication information, whilst also retaining their more conventional use for cosmetic purposes or as part of the API delivery system (e.g. as per enteric coatings).
  • photoactive excipients are added to the coating that, upon interaction with the marking laser's emission, generate chromatic changes, which can depend on the intensity, transferred energy or wavelength of the laser emission or characteristics of the coating. This allows different colour markings to be placed on the tablets. Chromatic identification as a component of product authentication can also extend to the tablet coating colour.
  • the tablet coating which in one example includes sugar coatings, offers a range of anti-counterfeiting options as a medium with significant printing capability e.g.
  • Coating options using electrostatic deposition exploited as a linear system also facilitate printing of marks that allows a user to decrypt the authenticity status of a product and interface this with the product container.
  • the coated tablets are received in tablet-sized pockets formed into a platen 520 ensuring a continuous process via a linear transport system.
  • the tablets are held in place by a partial vacuum.
  • the number of tablet pocket positions to be filled is dictated by the number of product containers, e.g. blister pack cavities, to be filled.
  • product containers e.g. blister pack cavities
  • multiples of 7 tablets per platen are advantageous, typically 280 or 560 tablets, representing 40 or 80 day blister packs respectively.
  • the platen is passed through the tablet marking system and each tablet's obverse face is uniquely marked 530 with a 2D mark and timestamp for the completion of the printing operation.
  • the reverse tablet face is exposed by means of inversion onto a second platen 540.
  • FIG. 6 shows a process flow diagram of the transmission of authentication data from a given marking.
  • the user submits 610 the marking associated with the most exterior container of the product (denoted as the N th tier of container), for example a bulk box for a plurality of secondary containers.
  • the submission is made via network to the authentication module 352 associated with the database 212, as per Figure 3. Should the marking not be authentic 364 authorities, regulators, border controls, pharmacies, dispensaries, clinicians and other relevant parties are notified 378, as well as the user 368.
  • the user is informed, via a network means (such as a telephonic or Internet network), that the container is authentic. Furthermore, the user is also informed of authentication data associated with the container immediately within the N th tier container 620, denoted as the (N-1 ) tier, which comprises, for example, a blister pack box.
  • Authentication data includes a characteristic secondary marking - or interchangeably referred to as an identity marking. Markings allowing access to lower tier authentication data are not provided. The user is therefore able to confirm that the contents of the N th tier container are as expected by inspection 630.
  • Identity markings include any alphanumeric sequence, two- dimensional graphic and/or three-dimensional relief.
  • the initial steps of the process are repeated for the unique authentication marking on the (N- 1 ) tier.
  • a valid input returns confirmation of validity of the (N-1 ) container to the user 650.
  • the user is also informed of secondary markings for identification purposes associated with the container immediately within the (N-1 ) tier container 650- denoted as the (N-2) tier, which comprises, for example, a blister pack well and cover strip.
  • Authentication markings that allow access to lower tier authentication data from the database (other than secondary markings for the purposes of identification by inspection) are not provided. The user is therefore able to confirm that the contents of the (N- 1 ) tier container are as expected by inspection 660.
  • Characteristic markings include any alphanumeric sequence, two-dimensional graphic and/or three-dimensional relief.
  • the mark In the event that a mark becomes compromised such that it appears to have been manipulated or is no longer legible, the mark is considered to be void and the product non- authentic.
  • Product authentication is achieved at product level i.e. the (N-(N-1 )) tier; the marking associated with this tier is submitted for validation 670. Authenticity is queried by the authentication module 352. Should authentication be approved 356 the user is notified 680. Additional authentication data is supplied - in the case of a pharmaceutical tablet this includes API dosage, product code, batch number, expiry date, date to be consumed, brand name, etc. Should authentication return a negative result 364, the authorities are informed 378, as is the user 368. The user is notified that the product is counterfeit, has been recalled, has expired or is notified of any other appropriate eventuality. The user is thereby warned not to consume the product and advised on further action.
  • a further illustration of the applicability of the system, according to Figure 6, is in the case of tobacco products, specifically, cigarettes.
  • Authentication markings on the N th tier container e.g. a carton containing a plurality of (N-1 ) containers, e.g. cigarette packs, are submitted 610 by users to the authentication module 352, to determine if the carton is authentic. Further information offering assurance to the user that the (N-1 ) level - e.g. the cigarette pack - duly belong in said authenticated carton is dispatched in the form of information relating to secondary markings on the (N-1 ) tier. A user confirms the secondary markings by inspection 630. The process can be repeated for individual packs of cigarettes and cigarettes (e.g.
  • the (N-(N-1 )) tier For example, authentication markings on cigarettes, which take any aforementioned form, are printed on the cigarette itself, such as the rolling paper, tipping paper, filter or any securely adjoined label. Since cigarettes are commonly sold individually or in a pack of cigarettes, the anti-counterfeiting mechanism permits authentication of product and containers and traceability to distributors, vendors, manufactures, tobacco growers, etc. The system is of particular importance in regions where plain packaging of cigarettes is required, resulting in fewer security measures against fraudulent imitations and repackaging.
  • Figure 7 shows a tabulation of exemplary product and container tiers that are associated with one-another according to codes derived from the marking on a given tier.
  • Figure 7 extends the concept established in Figure 6 to exemplify the tiers, hierarchical markings and visual secondary authentication markings of the system. Examples of such tiers are provided.
  • Each authentication mark (for example "B") is associated with a secondary mark - an identity mark (for example "a1 " or "a2").
  • the identity mark is received by a user following submission, of an authentication mark.
  • the blister pack comprises a mark deriving authentication data of the blister pack itself.
  • the mark relates to a code in the database system, the code comprises a form denoted by ' ⁇ '.
  • the identity marks (any mark denoted by lower case lettering in Figure 7) comprise at least one of: alphanumeric sequence, two-dimensional graphic and three-dimensional relief, with a form that does not allow access to authentication marks from the database or allow fraudulent derivation of such marks. Within these bounds the identity mark could also be a portion of the authentication code e.g. 'a' is the first 3 digits of TV.
  • An example process is as follows for validating the entire hierarchy of containers:
  • the marking, such as serialisation, of a container does not provide absolute assurance of authenticity, but does provide manufacturing efficiencies. Marking only up to the primary container tier, such as the blister pack, leaves a risk in respect of the blister pack contents; this risk is much higher for high volume containers such as bulk distribution tubs. Unit dose is the least to no-risk option, particularly in high cost, low volume product applications.
  • Figure 8a shows an example of a marked tablet 800 in perspective view.
  • the tablet's nominal obverse face 804 is exposed whilst retained in the platen for marking.
  • a tablet marking 808 is applied on the obverse face 804 of the tablet.
  • the tablet marking 808 relates to a code which grants access to the authentication data entry in the database and/or an identity mark.
  • the reverse face 812 of the tablet 800 is exposed during inversion onto a secondary platen and also marked.
  • Figure 8b shows the obverse face 804 of the marked tablet in Figure 8a.
  • the marking on the tablet 808 comprises an authentication mark 820.
  • the authentication mark further comprises a 2D QR code 816 which relates to an entry in the database.
  • a barcode, dot matrix code or similar 2D graphic code is applicable.
  • a user submits an image of the 2D marking by taking a photo and submitting the image through a website or by email, MMS or on a smartphone application.
  • the tablet authentication mark 820 also possesses a serial code 824 which a user is able to submit to gain access to authentication data.
  • Both the serial code 824 and QR code 816 are classed as an authentication mark 820 which are associated with the code denoted by "A" in Figure 7.
  • the authentication marks 820 such as the serial code or 2D graphic code, allows a user to access authentication information including product batch authentication 828, which relates the individual tablet to a specific batch.
  • the identity marking 832 on the tablet permits a user to confirm that the tablet is packaged in the correct blister pack and is denoted by any of "a1 , a2...an” as shown in Figure 7.
  • the identity marking 832 is validated following user authentication of the tablet container (by submitting the tablet container's authentication marking), thereby allowing a user to authenticate the relationship between product - the tablet - and its container 836.
  • validation of the blister pack returns a number of simple tablet numbers which can be easily verified so that the user has some assurance of the authenticity and that no error in packaging has occurred.
  • the identity marking 832 forms part of the authentication mark 820, or more specifically a portion of the serial code 824, for example illustrated by "XYZ" in Figure 8b. In such an example, a distinct identity mark 832 would not be necessary.
  • each tablet's unique code can be verified individually by submitting the authentication mark, e.g. "A" as per Figure 7.
  • the identity markings 832 may not themselves be unique, but the combination of them in a particular pack may be unique. Further markings may comprise a tablet number, such as for enumerating the sequence of consumption, a code or any other marking from which a user can determine by inspection that the tablet belongs in the container from which it originated. Alternatively, a container possesses a plurality of marks each of which is universally unique. The identity marks are preferably unique in the container containing the product container.
  • the identity marking on the tablet 832 is denoted by one of "a1 , a2...an" as per Figure 7.
  • Figure 8c shows the reverse face 812 of the marked tablet in Figures 8a and 8b.
  • An exemplary further marking on the tablet 840 comprises a timestamp of the printing completion, expiry date of the medicine, API dosage and brand name, aesthetic design or logo. For instance, in the case of paediatric products and medicines, logos and aesthetic designs are often encountered.
  • the further tablet marking 840 could also comprise other relevant data.
  • the further marking 840 relates authentication information to the user regarding the manufacture process 844, such as unit process operation completion time and unit dose information.
  • markings in Figures 8 are exemplary; markings can also be printed on any other facet of the tablet or combination of facets therein. Indeed, the markings can be present on only one face of the tablet or product. Marking a single face of a tablet, avoids the step of having to invert or reposition the tablet in order to facilitate further printing on an alternative face of the tablet; this duly reduces printing and manufacture time.
  • markings from which authentication information, such as batch 828, container 836 and manufacture 844 authentication information, are derivable are also interchangeable; in any case, the combination of this information delivers complete assurance to the user regarding the authenticity of the product and process.
  • Figure 9 illustrates a counterfeit-protected product comprising a uniquely marked product - a tablet 800 - contained in a product container - the cavity 900 of a blister pack 910.
  • the tablet is marked 808 with a unique authentication marking 820.
  • the authentication marking 820 on the authentic tablet corresponds to an entry of authentication data or information stored in the database 212.
  • a cover strip 920 is secured over 930 the blister pack 910.
  • the cover strip securing the tablet possesses an identity marking 960 and a unique authentication marking 940 (alternatively though, this could feature on the exterior or underside of the blister pack 910 itself; interior of the cover strip 920 (when sealed) ; and/or interior of the blister pack cavity 900); this is input into the database as a unique entry along with a record that the markings are to be associated with the authentication marking 820 and identity marking 832 on the tablet contained therein.
  • a relational hierarchy of codes is thereby generated, denoted by the arrow 950, whereby the tablet's identity is derivable from the marking 940 on the blister pack cover strip 920.
  • the authentication marking 940 on the blister pack cover strip must not provide access to a marking on a tablet which allows authentication data to be accessed (e.g. authentication marking "A” as per Figure 7) by a user through the authentication module 352.
  • the authentication marking 940 on the blister pack 920 is represented by "B” and the blister pack identity marking denoted by set "b1 , b2...bn” in Figure 7.
  • An authentication marking on the blister pack 940 that is determined to be authentic allows a user to infer that the product is likely to be authentic (by merit of the fact that a cover strip is tamper evident). However, for near complete assurance of product authenticity, use of the product identity 832 and/or authentication 820 marks is made.
  • Figure 9a illustrates a uniquely marked product that includes a tablet 800 and its inner packaging - a blister pack 91 0 (comprising a containing well 900 and cover strip 920).
  • the tablet 800 is shown, for the purposes of this Figure, through a cutaway in the blister pack.
  • the product is uniquely marked 808 with an authentication mark 820 and identity mark 832; these are placed on the cover strip 920 of the blister pack 910.
  • the authentication 820 and identity 832 marks are associated with higher tier marks on the container for the product (not shown), for example a box for a blister pack, thereby forming a counterfeit-protected item.
  • the product referred to in Figure 9a is a unit good that includes a pharmaceutical compound and its immediate packaging, such as the cover strip and well of a blister pack in which the pharmaceutical compound is contained.
  • the packaging of the pharmaceutical compound is a capsule or the coating that is applied, in which case the blister pack, capsule or coating will be marked and the marking will represent the product mark (e.g. as opposed to the uncoated pharmaceutical compound, which may be impractical to mark).
  • This product is then packaged in an outer container for the products, such as a box.
  • Figure 1 0 shows the arrangement of a plurality of tablets 800 contained in the cavities of a seven-tablet blister pack 1000 wherein each tablet 800 is universally uniquely marked 808 with an authentication marking 820.
  • the blister pack is sealed with a cover strip 920 wherein each tablet has an associated cover strip authentication marking 940.
  • the cover strip is secured 930 onto the blister pack, thereby forming a sealed container for a plurality of products.
  • the container is further packaged 1 010 into a secondary container 1 020, e.g. a box for blister packs or boxes.
  • a single set of product containers is shown in Figure 1 0 however; a plurality of such a set of adjoined containers could be included in said secondary container 1020.
  • the secondary container possesses a unique authentication marking 1030 which is stored in the database 212 and associated with the plurality of unique authentication markings 820 and identity markings 832 on the container and tablets contained within.
  • a hierarchy of authenticity data is achieved through the tiers of packaging down to the product.
  • the authentication marking 1030 on the secondary product container 1 020 permits identification or authentication information relating to the contained blister pack 1000 to be derived.
  • the arrow between authentication marking "C" and identity markings "b” 1040, illustrates the hierarchy of markings and how they are associated with one another, as also shown in Figures 7 and 9.
  • the authentication marking on the secondary container 1030 must not derive any authentication marking on the blister pack and cover strip or tablets, which allow authentication data to be accessed from the database 212.
  • the user is able to submit the secondary container marking 1030. Provided the secondary container marking is valid, the user receives an authenticity validation derived from the secondary container marking database entry indicating that the secondary container is indeed authentic. Further authentication information relating to the product and manufacture process such as batch number and product code can also be supplied.
  • Product validation information for example assuring correct product packaging, is presented to the user, such as the number of blister packs, number of tablets, etc. Additional information relating to the identity markings 960 on the blister pack is also reported to the user, such as a partial form of the authentication marking 1030 on the secondary container or a characteristic feature of the blister pack, thus allowing a user to confirm by inspection that the blister pack is authentic and intended for the given secondary container.
  • the identity markings do not allow access to authentication data from the database.
  • the process is repeated for a given tablet.
  • the user submits the authentication marking on the cover strip 940 associated with the given tablet.
  • the user receives an authenticity validation derived from the container marking database entry indicating that the container is indeed authentic.
  • Additional authenticity data is also is also received, supplying information about the contents of the blister pack cavity.
  • the additional information also comprises an identity marking 832 on the tablet allowing a user to confirm by inspection that the blister pack is authentic and the tablet is intended for the given blister pack.
  • any number of tablets in the blister pack can be uniquely marked, or indeed possess the same marking which is unique among a number of tablets, for example within the entire blister pack.
  • these alternatives offer less scope for patient compliance as well as reduced security and assurance to the user.
  • a counterfeit- detection system based on the frequency or number of non-unique codes submitted to the remotely accessible database 212 could be employed (such that codes that are submitted too frequently or too many times are, on the balance of probabilities, determined to be counterfeit); this kind of system does not provide absolute assurance (but instead a probabilistic risk-assessment) to a user, nor traceability of a unit good.
  • the user is able to confirm authenticity of the product itself by submitting the unique marking on the tablet 820. Provided the tablet marking is valid, the user receives an authenticity validation derived from the unique tablet marking database entry indicating that the tablet is not counterfeit and approved for consumption. Authenticity data is also received, supplying additional information about the tablet such as API content, manufacturing/printing timestamp, batch number, product number, etc.
  • the hierarchy of authentication data helps mitigate manufacturer error in packaging and user error in consuming incorrect medicines. This is particularly helpful for multi-dose blister packs.
  • Authentication markings particularly on containers, can be obscured and only viewed following user interaction with an obstruction. Furthermore, the obstruction is tamper-evident such that access and possible submission by non-users is evident, which could otherwise stand to pollute traceability, dosage logging and compliance data.
  • Means of hiding authentication markings with tamper-evident systems include scratch-off paints or foils, single-use stickers and partially peelable security stickers. Alternatively, tamper proofing against obscuration of makings is applied to prevent the marks from being hidden, for example during repackaging or relabeling; non-stick or glossy surfaces are used in this regard. Attempts to "re-authenticate" units in an uncontrolled manner will be logged and referred to the relevant parties. If a marking is illegible, then, as a failsafe, the submission is deemed invalid.
  • Figure 10 illustrates a counterfeit-protected product whereby the blister pack and the contents of each blister in the secondary container 1020 is associated with data embedded in the secondary container's authentication mark 1030, e.g. a QR code, giving continuous verification of the hierarchal relationship between the secondary container 1020, and its contents (e.g. the blister and/or tablet 800) providing information regarding, for example the manufacturing process and regulatory approval for the product to be marketed in a given jurisdiction.
  • the blister and cover strip and/or its contents become the devices by which the patient verifies the authenticity of the product and dose compliance using, for example, a downloaded app.
  • Figure 1 1 is a process flow diagram showing how authentication information is obtained as derived from information on a tablet and individual product verification and authentication 1 1 10 at unit dose level. This is achieved in real time, without the need for forensic technologies.
  • the tablet 800 acts as a carrier of information 1 120 which permits users to access authentication information, process 1 140 and batch data 1 130 and informs the decision as to whether the product is authentic and valid.
  • Product authentication provides a secure means of confirming the lineage of a unit dose with its regulatory approval conditions back to clinical trials and marketing authorisations by continuous verification against dose- unique process data in combination with batch-specific data while rejected products 1 150, e.g. counterfeits, will be excluded.
  • Mass serialisation at unit dose-level ensures that each unit carries its unique identity across its life to expiry irrespective of its packaging - thereby creating a product carrying a therapeutic dose, means of authenticating said product and dose, product and dose information, manufacture process information and product distribution and use.
  • Figure 12 schematically illustrates the information accessible from a counterfeit-protected product, wherein the product is a unit dose 1210, such as a tablet, with authentication markings.
  • the authentication markings on the unit dose allow a user 1220 to access the unit dose's product information 1230, such as API information.
  • the unit dose's authentication markings further instructs the user as to the unit dose's manufacture process information 1240, such as batch number, manufacture location, etc.
  • the process information 1240 is supported by manufacturing licence information 1250, which can also be related to the authentication markings associated with the unit dose 1210.
  • Further regulatory approval information 1260 can also comprise information a unit dose's authentication markings derive.
  • Any other discovery information 1270 which supports the authenticity and safety of the unit dose 1210, as well as auxiliary functions such as patient compliance, intake logging, such as historical drug consumption and supply levels can also be associated with the unit dose 1210 via discovery information 1270.
  • a record trail of diagnosis, prescription, patient compliance and outcome is thereby established for access by patient and doctor (and other parties, such as medical research institutes).
  • the system therefore allows positive and negative relationships between clinical performance and patient outcomes to be recorded.
  • the aforementioned information accessible with the authentication markings on the unit dose 1210 allows the user 1210 of the unit dose to determine whether the unit dose is authentic and safe for consumption by using the aforementioned information to either accept 1280 a legitimate unit dose or reject an illegitimate unit dose 1290.
  • the above description primarily relates to an anti-counterfeiting system; however the system also acts as an aid to product regulators and during product recall.
  • the system can be extended to other forms of products including, but not exclusive to, tobacco products, electronic components, etc. and in general where authentication of packaging and contents by users can be difficult.
  • marks pertaining to the product level are therefore included securely and in close proximity to the product, and at least within the product's container.
  • a tablet that cannot be directly marked e.g. due to its coating or because of regulatory matters
  • the product mark is applied onto a separate medium to that of the tablet or its coating, such as a portion of paper.
  • the marked portion of paper and tablet are sealed within the containing well of the blister pack using a cover strip.
  • the term container can also refer to a container which acts as a dispenser.
  • a container which acts as a dispenser.
  • a tube for a stack of tablets allowing dispensing of tablets can also be applied.
  • the dispenser itself can act as a device able to log dispensing activity for user compliance and recognise authentication markings such that the dispenser can access and display authentication information.

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Abstract

L'invention concerne un système d'authentification de produit (200) qui comprend un moyen de marquage de produit (204), un moyen de marquage de contenant (208) et une base de données accessible à distance (212); le moyen de marquage de produit (204) étant conçu pour (de préférence uniquement) marquer une pluralité de produits et le moyen de marquage de contenant (208) étant conçu pour (de préférence uniquement) marquer un contenant pour ladite pluralité de produits et la base de données accessible à distance (212) étant conçue pour stocker : des données concernant la marque de produit et l'authenticité du produit sur la base de la marque de produit; et des données concernant la marque de contenant et les marquages de la pluralité de produits contenus dans le contenant. La présente invention concerne également un système pour surveiller l'observance d'un régime par un patient; un produit protégé contre la contrefaçon; un procédé de fabrication d'un produit protégé contre la contrefaçon; un processus de fabrication d'une tablette protégée contre la contrefaçon; et un procédé de surveillance de l'observance d'un régime par un patient.
PCT/GB2014/050377 2013-02-07 2014-02-07 Système, appareil et procédé d'authentification de produits WO2014122479A2 (fr)

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