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Innovate4Health

Innovate4Health: Nutriset Uses Patents and Trademarks to Fight Severe Malnutrition Across the Globe

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Nick Churchill

Malnutrition is one of the greatest global health challenges, particularly with regard to children and pregnant women in developing countries. Undernutrition contributes to nearly half of all deaths among children under the age of 5 and has lifelong consequences for physical and cognitive wellbeing.

Nutriset has confronted the global malnutrition problem head-on by developing a range of innovative nutritional products and using its intellectual property to help developing countries reach nutritional autonomy.

Malnutrition is a blanket term that includes both undernutrition and micronutrient deficiency. An estimated 11 percent of the world’s population, or 815 million people, are undernourished. Undernourished people are particularly vulnerable to disease and death, and both undernutrition and deficiencies in micronutrients can prevent proper growth and development. Undernutrition causes children to underperform in school and makes adults less able to work, perpetuating a cycle of poverty. It can also be deadly. Children suffering from severe acute malnutrition, characterized by very low weight and visible muscle wasting, require urgent treatment to survive.

Severely undernourished patients have traditionally been treated with powdered foods which are dissolved in water before consumption. These powdered products carry risks of dosage errors and bacterial contamination, and they are likely to cause diarrhea in undernourished patients. They also tend to have short shelf lives, particularly in tropical climates.

Nutriset was founded in 1986 by Michel Lescanne with the mission of “focusing on research in the field of humanitarian nutrition, developing innovative solutions and acting as an interface between the worlds of humanitarian aid, nutritionists and food industry technologies.” Since then, Nutriset has developed several therapeutic milks, pastes, and tablets. In 1996, Nutriset partnered with Dr. Andre Briend to create Plumpy’Nut®, the first ready-to-use therapeutic food (or, RUTF) for the treatment of severe acute malnutrition.

This new product was field tested in Malawi by Dr. Mark Manary, who discovered that RUTFs were much more effective than traditional treatments. Dr. Manary was able to clear his hospital’s malnutrition ward and use RUTFs to treat his patients at their homes, while increasing the recovery rate from 25% to 95%. Given the product’s success, Dr. Manary recognized the long-term impact RUTFs could have if they were manufactured in the countries that needed them. Together, the doctors simplified the recipe so it could be produced locally.

A woman and child sitting on a bend next to a box. The woman is giving the child something to drink.Plumpy’Nut® has a long, 2-year shelf-life, is formulated to avoid diarrhea-type side effects, and can be eaten right out of the packet, eliminating the risks of dosage errors and contamination associated with mixing a powder with water. Plumpy’Nut®’s long shelf-life, effectiveness, and ease-of-use have led to a rise in community-based treatment of acute malnutrition and have made it possible to treat children in areas that were not reached by traditional methods.

Nutriset has used its patent rights to further increase access to its technologies in developing countries through its PlumpyField® network. Nutriset partners with local entrepreneurs in franchise-like relationships to create sustainable production systems in developing countries. In addition to benefiting from Nutriset’s reputation and manufacturing experience, network partners are given access to Nutriset’s patents and trademarks. The franchise-like system based on granting rights to use its intellectual property allows Nutriset to ensure that all products being locally produced by network members embody the innovations that actually help those suffering from malnutrition. And by supporting the local manufacture of its innovative products, Nutriset enables its partners to provide jobs to local people, source raw materials from local farmers, and customize the products to address the specific nutritional needs of their communities, while decreasing dependency on foreign organizations.

The PlumpyField® network consists of 9 members based in Central America, Africa, Asia, Europe, and the U.S. While the majority of the products are still manufactured in France and the U.S., members in developing countries continue to increase their production capacity, bringing the network’s total capacity to 117,400 metric tons. In 2016, the network’s products were used to treat nearly 8 million children. Thanks to Nutriset’s focus on incentivizing local capacity, that number will surely rise. According to the United Nation’s Food and Agriculture Organization, increasing local production is one of the best ways of ensuring long-term food security. Nutriset’s success in this endeavor would not be possible without its intellectual property rights.

The story of Plumpy’Nut® and PlumpyField® illustrates the power of intellectual property rights to improve and save lives. Not only do IP rights encourage the development of innovative products, they can be used to implement sustainable solutions to some of the world’s most pressing health challenges.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation Patents

Innovate4Health: Treating Neonatal Jaundice in the Developing World with D-Rev’s Brilliance

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthBy Nick Churchill

Severe neonatal jaundice kills over 100,000 newborn babies annually and causes severe brain damage to thousands more. In most cases, the condition can be treated by simply shining a blue light on a baby’s skin. However, each year more than 6 million infants worldwide do not receive adequate treatment. The problem is particularly severe in low-income countries, where many hospitals cannot afford the equipment to treat jaundice.

To address this global health problem, the innovators at D-Rev, a non-profit firm based in San Francisco, designed a high-performance, affordable device called Brilliance to treat severe neonatal jaundice. Brilliance has been praised by users as “effective and user-friendly,” and it was honored as the top innovation in the Health category of the 2016 Tech Awards. Since the introduction of the first Brilliance model in 2012, D-Rev estimates that the device has treated over 250,000 babies and has averted approximately 3,400 infant deaths and disabilities.

Neonatal jaundice occurs when a newborn has elevated levels of bilirubin in the blood. Approximately 18% of babies have severely high levels of bilirubin, which, left untreated, can lead to brain damage, cerebral palsy, hearing loss, and even death. Severe jaundice can be treated with a process called phototherapy, which involves placing the baby under special blue lights. When the light is absorbed by the infant’s skin, it helps break down bilirubin. Treated properly, severe jaundice usually does not cause lasting damage.

Phototherapy has long been recognized as a simple and effective treatment for severe neonatal jaundice; but at around $3,000, traditional phototherapy devices are prohibitively expensive for many hospitals in developing countries. Hospitals that can obtain a traditional unit are often unable to afford the maintenance and repair costs necessary to keep it running. The unreliable electrical systems in many developing countries can cause voltage spikes that damage device components. Commonly used fluorescent lamps require frequent replacement. As a result, phototherapy is unavailable to babies in many developing communities.

D-Rev is a product development company founded in 2007 to provide world-class, affordable healthcare technologies to people living on very low incomes. After learning that severe jaundice continues to cause brain damage in many parts of the world, D-Rev staff members visited hospitals in India and Nigeria to assess the availability of effective phototherapy and found that most of these hospitals did not have phototherapy devices that met standards for care. With the problem identified, D-Rev’s design team got to work.

D-Rev’s advanced devices, for which they are seeking a patent, uses LEDs that last 60x longer than fluorescent lamps, saving hospitals over $240 per year on replacement bulbs. Brilliance is designed to withstand a range of power fluctuations without affecting performance and operates without cooling fans or filters, so there are fewer parts to maintain. The device is height-adjustable and can be integrated with the wide variety of other critical neonatal medical equipment found in hospitals serving low-income communities.

Importantly, D-Rev’s devices are inexpensive to manufacture, which allows D-Rev to sell them for hundreds, instead of thousands, of dollars. The newest model incorporates the technology in their patent application, which ensures light intensity levels remain consistent across the treatment area at any angle of tilt. D-Rev also developed an integrated light meter to help healthcare providers ensure that infants receive appropriate doses of light, something many low income hospitals were previously unable to do. Thus, the innovations developed by D-Rev are improving the technology and reducing cost, making much needed treatments more accessible in the developing world.

After successfully designing an affordable and effective phototherapy device, D-Rev’s next challenge was to find a way to deliver Brilliance to the hospitals that needed it most. D-Rev’s CEO, Krista Donaldson, recognized that the firm would need help to establish a sales and distribution network, noting, “We knew we needed to license in this case.” To achieve its goals, D-Rev needed to find a partner willing to manufacture its products and distribute them to hospitals and clinics in the poorest communities in the world.

D-Rev licensed its technology to Phoenix Medical Systems, a neonatal equipment firm based in India, who agreed to manufacture and distribute Brilliance while capping its price. The licensing agreement was structured so that D-Rev would take a smaller royalty on sales to public and district hospitals, which tend to serve lower-income patients. In this way, D-Rev used its intellectual property rights to align the incentives of Phoenix’s sales team with D-Rev’s goal of reaching those patients who are most in need of affordable phototherapy.

Donaldson has explained why D-Rev’s protection of its intellectual property “is a prerequisite to having the broadest possible impact.” First, intellectual property rights allow D-Rev to ensure that the quality of its products remains consistent. As Donaldson notes, a medical device “cannot fail the user, particularly a user in a vulnerable population.” Second, inconsistency erodes consumer trust, which limits the impact of a product. Third, D-Rev recognizes that designing an effective product does not necessarily solve the targeted problem. By retaining control of its intellectual property, D-Rev can ensure consistent manufacturing of its products, sustainable delivery to users who need it, and continued maintenance and support. Finally, D-Rev protects its intellectual property because the market is “the most economically sustainable and scalable way” of reaching their intended customers.

D-Rev has demonstrated that the value of intellectual property goes beyond incentivizing life-saving innovation like Brilliance. Intellectual property rights empower innovators to increase their impact by partnering with market leaders like Phoenix. As Donaldson concluded: “To succeed, serious partners (for-profit or non-profit) must also make an investment, and none are willing to do that with the threat of knock-offs.”

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.

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Innovate4Health Innovation

CPIP & ITIF Launch “Innovate4Health” Policy Research Initiative

Innovate4HealthIn celebration of World Intellectual Property Day on April 26, 2017, the Center for the Protection of Intellectual Property (CPIP) today joined with the Information Technology and Innovation Foundation (ITIF) to launch “Innovate4Health,” a joint project to promote the critical role that intellectual property rights play in spurring innovative solutions to pressing global health challenges.

People all over the world live better than ever before thanks to innovation. New medicines prevent or alleviate disease. New devices diagnose problems, repair bodies, and overcome physical challenges. Still other inventions keep vaccines and medicines fresh and effective or ensure their authenticity. New business models help innovation to happen and ensure that it reaches those who need it.

Many of these innovations are secured by intellectual property rights, which support the ability of innovators to invent and bring solutions to market. Property rights, particularly intellectual property rights, foster the freedom of many hands and many minds to work on challenging problems. They put decisions in the hands of those closest to problems — innovators with knowledge of potential solutions and caregivers and consumers who understand their own needs best. They fund individual careers and industries dedicated to fixing health problems, as well as the businesses that get these solutions to individuals.

Our Innovate4Health project is providing case studies that describe how IP-driven innovation is tackling some of the world’s toughest health issues, including:

• A cooler that ensures vaccines are safe in areas without power;
• A portable eye examination kit to move care out of the office and into the field;
• Retractable syringes to prevent needlestick injuries;
• A baby warmer that can adapt to volatile electricity conditions;
• Point-of-care testing for malaria that anyone can use;
• A smartphone app that instantly checks the authenticity of pharmaceutical drugs; and
• A new anti-inflammatory drug derived from Brazil’s diverse ecology.

Learn more about Innovate4Health here.

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Innovate4Health Patent Law

Innovate4Health: Global Good’s “Arktek”: A Life-Saving Super-Thermos Vaccine Cooler

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4HealthMore than 1.5 million children die every year from diseases that existing vaccines could prevent. Why aren’t these children vaccinated? One big reason is that vaccines need to be kept cool until they reach patients, but that’s a really hard task in parts of the world where power is unreliable.

A new, patented “super thermos,” the Arktek Passive Vaccine Storage Device, aims to solve this global challenge. The Arktek was developed by Global Good, a collaboration between the Gates Foundation and the innovation lab of Intellectual Ventures.

The Arktek mends gaps in the “cold chain,” the refrigerated vaccine supply chain. Breaks in the cold chain occur because power is unreliable or minimal in many places. Also, many people live in places that cannot be reached by refrigerated transport. These gaps make it impossible to keep the vaccines fresh, and thus render them unusable in less than a week’s time.

In 2008, the Gates Foundation challenged Intellectual Ventures to help fix the cold chain problem. The resulting collaborative effort, spearheaded by Global Good, invented the Arktek Passive Vaccine Storage Device, nicknamed the “super-thermos” and the “keg of life” by Bill Gates.

The Arktek keeps vaccines at a temperature between zero and eight degrees Celsius for 30 to 60 days, depending on outside temperatures and humidity. Testing shows that it retains its cooling capacity even when outdoor temperatures rise to 43 degrees Celsius (110 degrees Fahrenheit). It does not rely on outside sources of electricity or other power. This is a major step forward in vaccine cooling systems, especially in much of the developing world, in which stand-alone cold storage devices struggle to keep vaccines at proper temperatures for a maximum of five days.

The “super-thermos” bears some resemblance to an ordinary coffee thermos. In 2013, the leader of the vaccine cooler development team described it as “a super-insulated, double-walled [bottle] that holds the vaccine and ice in the middle in an inner bottle. A vacuum space separates it from the outer bottle, like a large coffee thermos.” The device combines a double-walled bottle filled with vacuum insulation with multi-layer insulation technology of the type used to protect spacecraft from extreme temperatures. It holds approximately 16 pounds of ice.

Incredibly, a vaccine kept in the Arktek for weeks will be as cold as the moment it was placed inside. No powered refrigeration or additional ice is needed.

Keeping vaccines cold isn’t the only problem that the Arktek solves. Gaps in the cold chain tend to occur in places where travel is rugged and environments are challenging. Also, sophisticated medical facilities are rarely waiting at the end of a gap in the cold chain. Any solution has to be extremely tough and user-friendly.

The Arktek meets these challenges by providing near-indestructible structural integrity and high-usability in the field. To make the device sturdy, user-friendly, and easy to maintain and use, the development team at Global Good sacrificed a bit of longevity in favor of efficiency. The sixth and current prototype is therefore created for maximum efficiency, and can hold routine vaccinations for approximately 200 children or a village with a population of 6,000.

Other features help both local users and remote health officials to monitor the integrity of the vaccines. Sensors measure key information at 15 minute intervals, including the Arktek’s interior temperature, its exterior temperature, and how long it has been opened. It alerts users when temperatures begin to rise too much, and even has an LED light that comes on when a user opens the lid.

The data collected by the Arktek’s sensors is extremely accessible to all concerned. On-site users can download data logs using a simple USB stick. Meanwhile, an antenna sends data via SMS to a local telephone number every day at midnight. It provides remote personnel a summary of the day’s temperatures, location, and statistics recording when the device has been opened and for how long a period. Finally, a GPS sensor allows health officials to track the location of the devices at any given time.

During pilot testing, Global Good found the sensors to be particularly useful. For instance, if a health official was not using the device properly, Global Good was notified, and could contact the official directly and assist with training them appropriately. Armbruster observed that this kind of monitoring could eventually be relegated to local ministries of health to enable them to ensure that “they have a reliable cold chain all the way to the end point.”

Armbruster sees the Arktek as best-suited to modest villages of 5,000 to 15,000 people, in which it will be cost-effective to have a device that can be refreshed once a month by health officials. He says it may be somewhat less-suited to larger villages of 25,000 to 50,000 people, in which a large solar-powered or ice-lined refrigerator is feasible. And it may not be necessary in locales that have a reliable and consistent source of power. The cost per unit for this device currently ranges from $1,200 to $2,400, which makes it relatively affordable to health officials in the developing world.

Currently, the Arktek is in the early adoption stage of development. The WHO has “prequalified” the Arkteks under its Performance, Quality and Safety (PQS) program, which is an important seal of approval for government procurement. Global Good has collaborated with the Clinton Health Access Initiative, PATH, UNICEF, and other United Nations organizations to conduct field trials of the Arktek in Ghana, Senegal, Ethiopia, and Nigeria.

While the Arktek is still being refined for further roll-outs, it has already seen some action where it could do the most good. For example, it has stored vaccines for tuberculosis, polio, influenza, whooping cough, tetanus, hepatitis B and diphtheria. In 2014, Global Good donated 30 Arkteks to help the WHO deliver vaccines during the Ebola outbreak; and in the following year, it donated Arkteks to Nepal to assist with vaccinations after the 2015 earthquake.

Global Good is relying on property rights and commercial distribution to develop and deploy the Arktek. Aspects of the technology have been patented. Meanwhile, Global Good is currently partnering with AUCMA, a leading refrigeration manufacturer, to help commercialize Arktek and produce it at scale at an affordable price.

In 2016, Global Good received a “Patents for Humanity” award for the Arktek from the U.S. Patent and Trademark Office.

The Arktek is a vivid illustration of how patented innovation can tackle global challenges. It’s a clever, pragmatic and practical invention with a global reach and import. It reminds us that secure property rights can generate, develop and disseminate life-saving solutions to seeming intractable problems.

#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at jhartli2@gmu.edu.