Sunday, September 28, 2014

Patents for Humanity 2013 – Identifying counterfeit drugs

Copyright © Françoise Herrmann

It is controversial enough that patented and life-saving drugs are often unavailable for treatment in Third World countries, for reasons ranging from costs and licensing fees [Chneiweiss, 2003] to distribution bottlenecks [Esmail, et al., 2010] and drug development protocols [WHO3, 2014]. But there are other problems plaguing the delivery of drugs to places like Sub-Saharan Africa and South East Asia. One such problem is the Black Market of counterfeit drugs and health-related products [WHO2, 2006; WHO4]. A market estimated (with obvious difficulty) to operate, per year, at various significant amounts, in the billions of dollars, according to different sources (e.g.; 32 billion USD per year in 2011 with a 5-year projected amount of 62 billion USD [Global HealthCare, 2011], or at an estimated 75 billion USD in 2014 according to the WHO [WHO5]). Also a market responsible for the deaths of many thousands of people per year [WHO5].

There are no less than 131 WHO (World Health Organization) Drug Alerts for known falsified or contaminated pharmaceutical products, such as for example:  antimalarial drugs with less than 2% of the active ingredient; emergency contraceptives with no active ingredient; cough syrup with a contaminated active ingredient causing the death of at least 50 people; tainted anti-angina heart medicine also causing deaths, and tainted anti-meningitis medication in 1995 causing 2500 deaths in Nigeria [WHO1].

In response to the dangers and toll of counterfeit drugs, Sproxil, Inc. developed a simple to use, text message and mobile phone-based technology to uncover counterfeit medicine, in direct communication with the pharmaceutical industry or third party data processing centers.

This technology, invented by Gogo Ashifi and Zecha Alden, was awarded the patent US13081882 titled SYSTEMS AND METHODS FOR VERIFYING AUTHENTICITY OF A PRODUCT and was also selected in 2013 as recipient of a USPTO Patent for Humanity Award.
The invention discloses patented tamper-evident packaging with a unique identifier, located within or as part of the tamper-evident packaging. The identifier is additionally sensitive to environmental conditions. This bonus part of the invention means, for example, that if the product is sensitive to heat, then the identifier will also signal exposure to heat, at the level or length of time deemed detrimental to the product, using calibrated and heat-sensitive ink. In other words, environmental conditions are included in the definition of tampering, and there is no intervention required on the part of the end-user to determine whether the product is damaged.
Thus, to determine the authenticity of a product,  the end-user just sends the product code (with a few more visible digits considering heat reactions, whenever this applies) via text-message and receives an instantaneous response to indicate the validity of the product or other information such as “recalled”, “used” “stolen” or “diverted” etc., that may be tagged to the unique code.

Below appears the abstract for US13081882, titled SYSTEMS AND METHODS FOR VERIFYING AUTHENTICITY OF A PRODUCT:
Various aspects of the invention provide systems and method for verifying authenticity of a product. Another aspect of the invention provides a system including: a tamper-evident package; and a unique identifier usable to verify the authenticity of the product, the unique identifier contained within the tamper-evident package. The unique identifier cannot be detected from outside of the tamper-evident package without demonstrating evidence of tampering. Another aspect of the invention provides a system including: a tamper-evident package; and a concealed unique identifier coupled to the tamper-evident package. Another aspect of the invention provides a method of providing a providing a unique identifier. The method includes: providing a tamper-evident package; and placing the unique identifier within the tamper-evident package, wherein the unique identifier cannot be detected from outside of the tamper-evident package. [Abstract US13081882] 

Although this invention was designed to address the problem of counterfeit drugs in the Third World where it is endemic, and the invention was the recipient of a 2013 USPTO Humanitarian Award, the scope of the invention is clearly much broader. Indeed, the invention has broader and disclosed applications to other counterfeit consumer products that are packaged or labeled, such as electronic media, foodstuff, luxury goods, cosmetics..etc.  And this invention also has a broader client (or patient) base than the recognized Third World parties, since the United States is also plagued with counterfeit medicine, albeit at an estimated lesser degree than the Third World [FDA1]. 
Chneiweiss, H. (2003) Sur les rivages de la misère : Épisode 1 : Le marché des médicaments essentiels. M/S – Médecine Sciences,  vol 19(8&9), pp. 892-894.
Esmail, L. C., Phillips, K., Kuek, V., Perez Cosio, A.  and J. C. Kohler  (2010) Framing access to medicines in developing countries: An analysis of media coverage of Canada’s Access to Medicine Regime, BMC International Human Rights, 10(1).
[FDA1] – Counterfeit Medicine
[Global Healthcare] – 2011 The financial pull of counterfeit drugs
[WHO2]  (2006) - Combating counterfeit drugs: A concept paper for effective international cooperation.  
[WHO3] – Ethical considerations for the use of unregistered interventions for Ebola Virus disease
[WHO4] – General information on counterfeit medicine
[WHO5] Growing threat from counterfeit medicines

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