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

Thursday, September 11, 2014

Patents for Humanity – USPTO Awards Program

Copyright © Françoise Herrmann

The USPTO call for submissions to the Patents for Humanity program is extended to October 31, 2014. 

This competitive program, organized by the USPTO (United States Patent and TradeMark Office), is designed to recognize patent owners, assignees and applicants, whether businesses, non-profits or universities, who have contributed a patented invention for humanitarian purposes. In particular, this means an invention that is designed to help underserved populations of the world and/or uses technology to solve major global problems, in five categories: medicine, nutrition, sanitation, household energy and living standards. 

The program's 10 awards and 6 honorable mentions reward the selected winners with public recognition at a USPTO sponsored awards ceremony and acceleration of certain USPTO processes related to a patent application, such as the application process, ex parte reexam, or an ex parte appeal to the Patent Trial and Appeal Board.

The program was piloted in 2012 as part of President Obama’s Global Development Initiative, “encouraging game-changing innovations to solve long-standing development challenges” and the program was renewed in February 2014 (USPTO Press Release, 2014). 

The 2013 Patents for Humanity awards included such recipients as:
  • UC Berkeley (UCB) for ways of producing lower cost and more reliable anti-malarial compounds; 
  • Becton Dickinson (BD) for creating a fast, accurate TB diagnosis machine and placing 300 systems in 22 High Burden Countries, and
  • Sproxil, Inc., for deploying a system to identify counterfeit drugs with an ordinary cell phone in sub-Saharan Africa (Patents for humanity, 2013).
The USPTO screened and accepted list of contending entries for this year’s 2014 Patents for humanity awards is displayed in a public gallery at:

Among the 2014 contending inventions, there are four such viewable applications:
  •  Device to prevent hypothermia in pre-term babies in low resource setting - The device is called the IncuPouch™, the inventor is Prasanga Lokuge, and the entry concerns the humanitarian use of technology described in US 20120234877 A1 titled Infant carrier and US 20080149674 A1 titled Infant Carrier.
  • Cardiopulmonary lightening protection garment – a garment made of conductive fabric that prevents lightening from passing through the body and causing cardiopulmonary arrest. The company is Zoltar Technology, the inventor is Dan Schlager, and technology used for humanitarian purposes is described in US 20130298319 A1 titled Cardiopulmonary lightening protection garment
  • Portable neonatal intensive care unit (NICU) – a unit with reduced electrical power requirements that provides both heat, or cooling, for the infant patient, using water circulating through a heat exchanger. The company is called Designs for the world, LLC, the devices are called the Tokü™ incubators and the technology used for humanitarian purposes is described in US 20100168502 A1 titled Modular neonatal intensive care system.
  • Disaster Emergency Assessment Notification (DEAN) – A mobile app designed to track people in an emergency situation using QR codes. (Blaster Communications Inc.) 

Considering the 45-day extension period for filing entries, there is still time to compete! Here is the link for submitting application forms: 

- Press release: USPTO renews Patents for Humanity Program
- Patents for humanity 2013 Award recipients