White Paper Solutions to Combat Counterfeit Medicines Worldwide

DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

White Paper Solutions to combat counterfeit

medicines worldwide February 2009

AlpVision SA Abstract Rue du Clos 12 1800 Vevey Protecting pharmaceutical products against counterfeiting or Switzerland fraudulent importation of donated or discounted medicines is now T: +4121 948 6464 possible using standard packaging and labelling without extra F: +4121 948 6465 production cost. [email protected]

Introduction Protecting pharmaceutical products against counterfeiting or fraudulent importation of donated or discounted drugs will remain a permanent challenge in light of the increase in counterfeiting actions. The increase of the complexity of the supply chain in today’s global economy makes certification of every single supply source a nightmare. This is certainly a key factor in the rapid increase of counterfeiting attacks, including in countries where the supply chains are well established and trustworthy.

DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

How to differentiate authentic products from fakes or illegally imported ones? It is commonly admitted among specialists that packaging or labelling anti-counterfeiting features can be divided into two main categories: • The visible or overt features. • The features which are invisible to the naked eye or covert. Many pharmaceutical companies have added visible security features to their packaging. These include holograms, embossing, special ink and two dimensional bar codes. However, these visible features not only provide minimal security but they also require training for effective authentication. It is interesting to note that various companies offer hologram duplication services via Internet at very low prices. Hopes were placed on RFID technology (Radio Frequency Identification), which consists of the inclusion of a passive antenna in the packaging. But RFID technology was primarily developed for optimisation of the supply chain to achieve just-in-time delivery and not for anti-counterfeiting purposes. It has been revealed as much too costly and not compatible with many substances such as aluminium blisters, to the point that it has been practically abandoned as an affordable and efficient anti-counterfeiting means. If fraudulent business is generated through sales of a mix of genuine and fake medicines in a reprocessed genuine secondary packaging, marking the secondary packaging with visible security features or visible coding is not sufficient protection. More sophisticated techniques can be found in the field of covert security elements. That is features not visible to the naked eye and requiring dedicated detection means. The advantage of a covert element is that counterfeiters must know that there is a security element before they can attack it; on the contrary, if the security feature is visible, the point of attack is evident. The most known covert security solution is invisible ink, such as UV ink (visible under ultra violet light) or IR ink (visible under infrared light). To authenticate these inks, a lamp emitting light in the required wavelength range is sufficient. The drawback of these inks is that they can be bought very easily on the market by anyone. There are other chemical tracers or ink additives providing security against counterfeiting, such as DNA or magnetic tracers which provide higher security as using rare and dedicated detection devices. The problem with such special inks, ink additives or taggant resides in the related logistics and manufacturing procedures, such as press cleaning, temperature and pressure sensitivity, as well as interaction with other chemicals. Although very efficient and effective, their implementation and deployment are quite costly. Authentication on the fly, in the retail space for example, is also difficult. All these techniques based on a security additive can be qualified as “analog or hardware based”, because they require additional security elements or special substances which subsequently have to be managed by the branded product manufacturer in a secured environment, involving a third party security supplier in the packaging or labelling production chain.

Invisible marking printed with regular visible ink In 2005, an article in the Washington Post said some manufacturers of home and office printers delivered printing equipment in such a way that it added invisible marks on each printed page. This was of course introduced without informing the users. The purpose of this hidden marking is to identify the printer used in cases of fraudulent printing. Aside from the political or legal implications, this incident shows that with today’s technologies and equipment it is possible to print invisible information with normal ink and standard printing machines (see Fig. 1). Translated into the packaging and labelling industry and the security printing domain, the incident described above has two important implications: • First, an industrial packaging or labelling printer could produce secured packaging and labels for manufacturers using standard printing machines and standard visible ink.

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DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

• Secondly, a branded product manufacturer can secure its products without informing the printer that the packaging or the labelling contains an invisible security feature. This reduces the number of parties involved in a product security process and creates a distinct advantage, because secrecy and privacy are the two pillars of an efficient security policy.

Fig. 1: Area of invisible dots depending on the size and the colour of the dots as well as the printed background

Depending on the printing process as well as the colours of the printed material and the ink, the dots can vary in size from about 10μm to 80μm for being invisible to the naked eye. It is important to note that the security level is also a function of the dot colour and the dot size. The security level increases as lower contrasts are used and as the dots get smaller. Any printed surface can be protected this way, such as carton for folding boxes or aluminium or polymer for blister foils as well as various printed materials for labels.

Cryptoglyph® invisible marking using standard printing processes A technology now mature and already protecting over a billion items worldwide is marketed by AlpVision, a Swiss supplier of digital security printing solutions, under the name of Cryptoglyph®; it creates a pattern made by apparently random micro dots invisible to the naked eye.

The Cryptoglyph® patented solution combines two elements: • Printing of the invisible micro dots pattern over the entire surface of the label or the primary or secondary packaging, such as the blister foil. As these dots are invisible and spread over the whole surface of the packaging or label, it is impossible to replicate or erase them. • These invisible micro dots contain encrypted information which can only be deciphered with a 128 bit key. If the detection process is performed in a unique and secured place, the key is never endangered. Deciphering the information by a fraudulent party is impossible.

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DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

Fig. 2: Cryptoglyph example printed with 2400 dpi offset printing

These micro dots are integrated in the packaging or in the label design before printing and are invisible to the naked eye. They are very difficult to distinguish, even with a magnifying glass, as the dots’ colour and size are chosen to be camouflaged within the imperfections found in all printed material structures (see Fig. 2). The detection of the presence (genuine) or the absence (fake) of these micro dots on a packaging or on a label is performed by software using specific techniques designed to detect information with low signal-to- noise ratio and built-in redundancies.

The Cryptoglyph® file is simply embedded in the packaging’s or label’s digital image file at the pre-press level, without modification of the design (see Fig. 3). Therefore the introduction of a security element into the existing product’s packaging or labelling is best achieved when packaging or label modification or partial redesign is performed by the brand manufacturer. The colour of the micro dots is selected according to the level of security required and other printing constraints.

Fig 3: Cryptoglyph® pattern inserted into the packaging or the label design at the pre-press stage

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DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

Cryptoglyph® is the only security process in the world that provides invisible security marking with nothing more than regular visible ink and standard printing processes (offset, rotogravure, flexography, laser, inkjet, etc); the Cryptoglyph® can thus be easily integrated into any existing packaging or labelling production line, without alteration of the printing speed and without modification of the production workflow, namely without extra production cost.

Detection of the Cryptoglyph® marking with regular off-the-shelf electronics equipment

Fig 4: authentication performed with a PDA Camera and with a standard office scanner

Although covert security markings usually need specific scanners, the detection of the Cryptoglyph® covert security marking is software based and only requires standard electronic devices such as office scanners or PDA’s (Personal Digital Assistant) equipped with a camera (see Fig. 4). The presence of the invisible marking indicates a genuine product, while its absence uncovers a fake one. Deciphering the information contained in the pattern uncovers market diversion through comparison of the data stored in the invisible pattern with the actual localisation of the item. The authentication is machine readable; it can therefore be performed remotely using a centralised and secured server.

Developing an anti-counterfeiting programme worldwide with the Krypsos open platform

A technology alone cannot provide totally adequate industry-compatible brand protection. It must take into account the realities of large volume production of pharmaceutical goods, which can be in billions spread over hundreds of production centres. A global and customised solution is necessary, integrated into Product Production Management systems existing at any pharmaceutical products manufacturer. The AlpVision Krypsos solution consists of a secured server which stores a data base containing the anti- counterfeiting and other identification marks of every product or SKU. The turnkey AlpVision Krypsos secured server is Internet/Intranet based and requires only a free Internet browser for access to it, but

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DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY under severe access security control processes. The Krypsos – Cryptoglyph® solution has passed the requirements of the FDA 21 CFR Part 11 ERES and FDA Revitalization Act S.1082 for medicines delivered in the USA.

Fig. 5: Krypsos secured authentication server workflow

The same secured server is used to generate the various Cryptoglyph® invisible patterns needed to secure the entire production and to authenticate single products or batches anywhere in the world (see Fig. 5). The Krypsos server provides the entire supply chain with a single point of contact entirely managed by the branded products manufacturer.

“Genuine or fake” online authentication opened to end-consumers is such a demand arises A software approach to anti-counterfeiting measures based on standard printing processes and standard consumer electronic equipment opens new efficient and cost effective ways to protect branded products worldwide. Almost no deployment cost is incurred, providing that standard image capture devices such as office scanners or PDA cameras are available, as well as free use of an Internet browser. As these means are currently used by both professionals at their workplace and anyone at home for entertainment or family communication, AlpVision covert security solutions, created primarily for brand protection controllers, might even be used by end-consumers, if such demand arises.

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DIGITAL IMAGING SOLUTIONS FOR BRAND PROTECTION AND DOCUMENT SECURITY

About the author

Roland Meylan is the co-founder of AlpVision and today serves as Corporate Communications Manager. He holds an MS degree in signal processing and digital communication from the “Swiss Federal Institute of technology of Lausanne (EPFL)”, Switzerland, as well as a postgraduate education in Business Administration from IMD Lausanne International Business School. Meylan started his career at the graphic division of Bobst SA, the leading supplier of equipment for the folding carton packaging and flexible materials industries. Meylan also worked in electronic communication over international data transmission networks, the forerunners of the Internet. Since then, Meylan has contributed to numerous business start-ups in value added mobile telecommunications services as well as in the digital imaging and visual communication domains.

About AlpVision:

AlpVision, headquartered in Switzerland, is a leading supplier of digital security printing solutions developed to combat counterfeiting and secure printed documents. Its clients include companies which count amongst the top 100 enterprises worldwide and which use the AlpVision proprietary Cryptoglyph® technology to protect already over a billion branded products and documents. For solid objects, AlpVision provides a Read-Only technology under the commercial name of Fingerprint™. It is based on microscopic imperfections which are generated by the manufacturing process used to produce an object and which are enough to identify and to trace any object during its entire life.

AlpVision SA Rue du Clos 12 CH-1800 Vevey Switzerland +4121 948 6464 www.alpvision.com

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