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]. 
 
 
 
References
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.
http://www.who.int/medicines/events/FINALBACKPAPER.pdf  
[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: https://p4h.skild.com/skild2/p4h/viewEntryVoting.action

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: 

References
- Press release: USPTO renews Patents for Humanity Program
http://www.uspto.gov/news/pr/2014/14-10.jsp
- Patents for humanity 2013 Award recipients
http://www.uspto.gov/patents/init_events/patents_for_humanity/awards2013.jsp

Monday, August 25, 2014

Interlude

Copyright © Françoise Herrmann
-- Ok, Buddy – you, translator, homotraducens, verbal acrobat, barber, pirate, juggler, builder of bridges and cathedrals, collector of words, detective, invisible author, hybrid being, go-between, textual geologist, scribe without a face, heathen and enemy of God:  Where are your credentials and qualifications?  Z-Mapp, Ebola… you are just the unknown soldier of culture, at best a locksmith and stylistic recycler… (Extrapolated from Delisle, 2007, translations mine).

-- Thanks! As usual you are so tactful in your selection of attributions! How about ventriloquist and chameleon…  or simply informed?
 
Anyhow, truth be told, I borrowed ‘em. And here’s another “hand-me-down” -- verbatum from the distinguished 12-member panel of the WHO Advisory Committee on Ethical Considerations for use of unregistered interventions for Ebola virus disease, a panel which includes the NIH Head of Section on Ethics and Health Policy, among 11 colleagues, doctors and professors each chairing ethics committees of various sorts, in different countries of the world. The concluding and unanimous recommendation of the panel amounting to an unprecedented exception in rules and regulations, motivated by ethical concerns, and in a grave situation, namely:  
“In the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to offer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluated for safety and efficacy in humans as potential treatment or prevention.” [WHO]

 -- So there! Mind you there is much more information to process… about z-Mapp, the patented monoclonal antibody medicine where tobacco plants are used to make recombinant proteins, I am told. And on the social side of this epidemic, the stigma and extreme hardship of the containment measures.


References
Delisle, J. (2007) La traduction en citations. Ottawa, Canada : Presses de l’université d’Ottawa.  
WHO – Ethical considerations for the use of unregistered interventions for Ebola Virus disease
http://apps.who.int/iris/bitstream/10665/130997/1/WHO_HIS_KER_GHE_14.1_eng.pdf?ua=1

Sunday, August 24, 2014

Oh, patents! Z-Mapp

Copyright © Françoise Herrmann

According to the WHO (World Health Organization) Ebola virus disease Updates in West Africa, 
“Between Aug, 19 and Aug. 20, 2014, a total of 142 new cases of Ebola virus disease (laboratory-confirmed, probable and suspected) and 77 deaths were reported from Guinea, Liberia, Nigeria and Sierra Leone” (WHO1 – GAR1). 

As of Aug 20, 2014, according to the same WHO Global Alert and Response (GAR) page, there were 1427 deaths and 2617 cases reported. Ebola virus has a case fatality rate of up to 90%. It is one of the world’s most virulent diseases. The current survival rate in this epidemic is 47%. (WHO2-GAR)

The question that arises almost immediately is whether there is a cure for this deadly disease, and/or for preventing it from spreading any further, both locally in the villages or crowded cities of the infected areas, and internationally across borders and continents -- to Europe and the rest of the world.  Indeed the extraordinary measures of isolation that were taken to bring home for treatment two infected American missionaries,  Dr Kent Brantly and Nancy Writebol, who both survived the disease, serve to further highlight the issue of treatment and access to it.

The usual scenario in connection to patented drugs and access to treatment is one of prohibitive costs, and the monopolies associated with the marketing and production of the drugs. For example, this is the well documented case of antiretroviral drugs for the treatment of Aids (Chneiweiss, 2013).  However, the availability of treatment for Edola virus disease is different in important ways that highlight a different set of ethical issues in the access to patented treatments.

The issue here pertains to a patented drug referred to as Z-Mapp, which is still in the pre-clinical stages of testing. This means that the drug, developed by Mapp Biopharmaceuticals Inc., with the support of the United States government (CDC and DoD), has only been tested in the laboratory, on animals or in test tubes, and has not yet completed the full cycle of clinical testing with humans required for assessing safety and effectiveness of the drug. A process required prior to obtaining authorization to market a drug, and specified in the provisions of US Federal Regulations Title 45, Part 46 on The Protection of human subjects, or equivalent European legislation, such as for example, France’s Code de la Santé Publique, Livre 1er, Titre II pertaining to biomedical research.,  

Who cares?  What other options beyond the miraculous are there for those people infected with the Ebola virus? If the two US missionaries survived the Ebola virus infection to return home to their families, virus free, after treatment with this experimental Z-Mapp drug, then this is already human cllinical testing with grand scale control…Well, that’s the gist of it, minus  roll-out issues. [CDC –Ebola Hemorrhagic Fever]

 Indeed the decision to make this Investigational New  Drug (IND) available under specific conditions within the context of this Ebola outbreak was unanimously approved by the WHO on August 11, 2014 [WHO3- Ethical Committee Report]. So that in a rare, and perhaps ground-breaking instance, communication finally completed in real time, between all the parties involved in the process of developing the drugs and those subjects and patients, for whom the drugs are intended in the first place – our not-so-distant neighbors in a globally connected world --infected with the Ebola virus.

Z-Mapp is patented in US2013149300 titled MONOCLONAL ANTIBODIES WITH ALTERED AFFINITIES FOR HUMAN FCyRI, FCyRIIIa, AND C1q PROTEINS. According to the patent 
specifications, the drug is designed for: 
" the prevention or treatment of human diseases including but not limited to infectious diseases (including Respiratory Syncytial virus, Ebola virus, Influenza virus), cancer (including breast cancer and B cell lymphoma) and inflammatory diseases (including rheumatoid arthritis and Alzheimer's)."
The abstract for Z-Mapp patent US2013149300 is included below as well as an image of this dreadful virus.
Disclosed herein are GNGN and G1/G2 antibodies that recognize and bind various FcRs and C1q. Also disclosed herein are glycan-optiminzed antibodies, predominantly of the GNGN or G1/G2 glycoform, with enhanced Fcgamma receptor binding achieved through CHO, Nicotiana benthamiana and yeast manufacturing systems. Nucleic acids encoding these antibodies, as well as expression vectors and host cells including these nucleic acids are also disclosed herein. Methods and pharmaceutical compositions including the monoclonal antibodies are provided herein for the prevention and/or therapeutic treatment of viral infections, cancers and inflammatory diseases.

References
WHO 1– Global Alert and Response (GAR) – Ebola Virus disease updates – West Africa
WHO 2- Global Alert and Response  (GAR) – Ebola virus disease
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.
WHO 3– Ethical considerations for the use of unregistered interventions for Ebola Virus disease
CDC – Ebola Hemorrhagic Fever
US Federal Regulations –Title 45 – Part 46 on the protection of human subjects
Code de la Santé Publique – Première Partie, Chapt. 1er, Titre II – Recherches biomédicales

Aug. 24, 2014 3:32 am - SFO CA 37.62 … 6.0 on the Richter magnitude scale and no stopping the earth from quaking

Sunday, August 10, 2014

Oh, patents! Cochlear implants

Copyright © Françoise Herrmann

Going back again to the 2014 European patent Awards in Berlin, and the inventors nominated for the lifetime achievement award...
 
Among the three contenders for this award  was an Austrian, husband and wife team: Irwin Hochmair and Ingeborg Hochmair. This team invented an improved cochlear implant, a small computerized device implanted subcutaneously with electrodes extending to the base of the spiral-shaped inner ear called the cochlea. This miniature computerized device, equipped with electrodes, stimulates the auditory nerve with an electric field in response to speech signals, thereby restoring the capacity to hear the full spectrum of speech patterns and thus the capacity to produce them in speech. To date this device has been implanted in more than 200,000 people, affording them the opportunity to hear sounds.
 
The Hochmair cochlear implant device has two parts: a single channel transmitter, including the sound signal processor, which is carried around by the patient and hooked to the outer ear; and a single channel receiver which is implanted subcutaneously, in front of the skull bone, including two electrodes, one active and one grounding  that extend to the base of the cochlea. An electrical field is thus created at the base of the cochlea sufficient for stimulation of the auditory nerve, and energized at a frequency bandwidth that is large enough to accommodate all speech patterns.
 
In contrast to other neural stimulation devices for hearing, such as those inserted in the mastoid bone, operating on the principle of bone conduction, or those inserted inside the cochlea or even inside the auditory nerve, the Hochmair device purports to simplify insertion, without placement of electrodes inside the cochlea.

The abstract for the European patent EP0076096 titled Single Channel Auditory Stimulation is included below with two patent drawings. Fig 1 is a sliced drawing of an ear showing the positions of the implant, and Fig 2 shows the two parts of the device:
 

Chronic auditory stimulation is achieved by establishing an electric field at the base of the cochlea whereby full speech patterns are imparted to a patient. Penetration of the cochlea is not required thereby reducing the risks in installing the implanted electrodes (26. 28). In a preferred embodiment the electrodes are disc shaped with the ground electrode (28) being larger than the active electrode (26). The active electrode is preferably placed in the round window (32) at the base of the cochlea or on the promontory. The ground electrode is placed 2-10 mm from the active electrode to thereby confine the electric field. The interconnections to the electrodes are tissue compatible insulation covered wires (24) thereby minimizing stimulation of cutaneous nerve fibers. Abstract EP0076096

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In an era of wireless devices and communication, there appear more improvements warranted for this type of cochlear implant disclosed with a wired transmitter connection. And most importantly, the competition may be coming from a totally different and decentered perspective on hearing.
 
 Indeed, there are viable socio-cultural options arising from the ever growing visibility and strength of the Deaf community (with a capital “D”). A path taken where people choose to embrace sign language fluency, and the absence of hearing and speech, creating the Deaf way of being, that is, a rich culture of meaning and life (Padden & Humphries, 1988). Indeed, a culture so vibrant that in the year 2005, it is deploring the loss of some of its members to the hearing community via cochlear implants, (Padden & Humphries, 2005; Waltzman, 2005).  
 
By way of illustration, the largest Deaf university of the United States, inspired by the early 19th century Institut des sourds et muets in Paris (France), is Gallaudet University, located in Washington D.C, established by an Act of Congress in 1864, now celebrating 150 years of excellence!

References
Padden, C. & T. Humphries (1988). Deaf in America: Voices from a culture. Cambridge, MA: Harvard University Press..
Padden, C. & T. Humphries (2005). Inside Deaf culture. Cambridge, MA: Harvard University Press.
Waltzman, S. (2005) Inside Deaf culture. Review in The New England Journal of Medicine, July 28, 2005, 353:436.   http://www.nejm.org/doi/full/10.1056/NEJM200507283530431
DOI: 10.1056/NEJM200507283530431
 

 

Saturday, August 9, 2014

Oh, patents! Waterproof makeup remover

Copyright © Françoise Herrmann

 Smudgeproof and waterproof makeup are two very desirable make-up properties. Waterproof so that you can swim and sweat under the tropical sun; dance and sweat at a disco party; or work under the limelight many hours a day if you are an actress or actor, a performer or a model. Smudgeproof so the make-up resists the natural oils of the skin. Thus, there are make-up compositions of all sorts (for lips, eyes and face) that are effectively and pleasantly waterproof, smudgeproof and long lasting. Problem solved and patented.

 However, once the above dysfunctions are resolved in oil-based waterproof formulations, it also becomes very difficult to remove waterproof make-up with conventional non-waterproof make-up remover. Long lasting and waterproof makeup really works, and without a make-up remover designed specifically for removing of it, you will experience serious difficulty removing the make-up… (Barbery-Coulon, 2014)

 In comes L’Oréal, the French cosmetics giant: a recent champion of alternatives to animal testing, with a research agenda committed to the diversity of beauty, including ethnic and age differences in traditional skin or hair types; a commitment to the principles of green chemistry and responsible sourcing of raw materials; a workforce that boasts 70 % women (!), and both fellowship and foundation programs that support women in the sciences.

 An early L’Oréal make-up remover for Waterproof (WP) and Non-Waterproof make-up (NWP) is US5165917 titled Eye make-up remover with two separate phases. The patent discloses a composition that is both effective and pleasant or comfortable for removing WP and NWP eye makeup.  The composition disclosed includes two synergistic phases: an aqueous phase with at least one surfactant, and an oily phase with at least one cosmetic oil. Experimentation results are also presented to highlight both the effectiveness (make-up removal) and cosmetic properties (comfort and appearance) afforded by various formulations, with evidence in support of a 70:30 or 60:40 ratio of the two phases.

 The abstract for US5165917 titled Eye make-up remover with two separate phases is included below with an image of the marketed product, l’Oréal Artiste long lasting and water proof eye make-up remover:

A composition suitable for effective and comfortable removal of both waterproof and non-waterproof eye makeup is disclosed which includes an aqueous phase containing at least one surfactant and an oily phase containing at least one cosmetic oil. The surfactant concentration may be up to 3 wt % of the total weight of the composition. The weight ratio of the aqueous phase and the oily phase may be from 30:70 to 60:40. [US5165917]
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 Reference
Barbery-Coulon, L. (2014).Mascara Waterproof. Le Magazine du Monde. Le Monde, 8-8-2014.
http://www.lemonde.fr/style/article/2014/08/08/le-mascara-waterproof_4467920_1575563.html
L’oréal
Research and innovation in key figures
 Paperclip-listed …

Thursday, August 7, 2014

Oh, patents! The Fischer Plug

Copyright © Françoise Herrmann

Going back a bit to the 2014 European Patent Oscars, held in Berlin on June 17, the 2014 Life Time Achievement award was bestowed upon 94-year old Arthur Fischer, the German inventor of the ubiquitous Fisher Plug, and more than 1,100 additional patented inventions, including the defunct flash cube and Fishertechnik toys!
 
Even if you know nothing about construction or hammering a nail in the wall, you will surely find a discarded Fischer plug in your basement, spot one inserted in your walls, or recognize one that looks just like the picture included here.
 
Disclosed  the United States in 1967, in US3315558 titled Expansion plug, there are about 10 million of these plugs -- called screw anchors, wall plugs or S-plugs – produced each day at the Fisher production plant, in different sizes and for different types of walls,

A Fischer plug is designed to maximize the load bearing capacity of the wall and to expand so as to engage and form a strong bond with the brittle material, such as brick, cement or plaster, on the surface of the anchor hole. When the screw is inserted in the plug, the plug expands to engage with the surface of the bored hole. The tapered tip of the plug was designed for easy insertion of the plug into the drilled hole. The plug is made of plastic, easily manufactured as a single part of any specified length, in contrast to the prevailing prior art, and it was designed for use by both skilled and non-skilled workers.
 

 
In the absence of an abstract, two patent drawings are included for the expansion plug utility patent US3315558.
_____
 
More than half a century after the invention of the Fischer expansion plug, there are many different sorts of Fischer expansion plugs depending on different types of walls. The video below shows the animated expansion of various types of Fischer plugs..
 
 
 
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Hope this flies with the paperclips…