Plumpy'nut, a widely distributed ready-to-use therapeutic food (RUTF), has revolutionized the treatment of acute malnutrition, but its 12-year dominance is being challenged by a newcomer.
The patents for Plumpy'nut - a blend of peanuts, sugar, milk powder, oil, vitamins and minerals - are owned by Nutriset, a French family-run business, and the Institute of Research for Development, a French public research institute.
Now an American family-owned company, Tabatchnick Fine Foods, is turning the heat up in the blended food kitchen by applying for a patent for their RUTF in the US - where the Plumpy'nut patent is registered - to treat malnutrition in children and boost women's immune systems.
Tabatchnick hopes to open up the market with his patent challenge and has started manufacturing an RUTF that is being evaluated by the UN Children's Fund (UNICEF), the world's largest buyer of RUTF and Plumpy'nut.
Manufacturers of similar pastes have been wary of challenging Nutriset. "The patents are so broad that if you add one micronutrient into a jar of Nutella [a widely distributed brand of nut pastes] it will fall within the patent," said Stéphane Doyon, leader of the Nutrition Team at Médecins Sans Frontières (MSF), the international medical charity.
The US patent describes Nutriset's RUTF as a "complete food or nutritional supplement" comprising "a mixture of food-grade products, said mixture being coated with at least one lipid-rich substance optionally derived partly from oleaginous seeds".
The mixture could be in the form of "powder, particles or granules", the seeds could be "peanuts, cocoa beans, almonds, coconuts or pistachio nuts, or they can consist of a mixture of various fats of vegetable origin".
|The patents are so broad that if you add one micronutrient into a jar of Nutella [a widely distributed brand of nut pastes] it will fall within the patent|
The protein source in the RUTF could be skimmed milk, powdered yoghurt or whey, and/or at least one product which provides carbohydrates, particularly carbohydrate bulking agents, sucrose, glucose, fructose, skimmed milk, whey, or flour made of maize, wheat, millet, oats, rice, cassava or potato starch", according to the patent documents.
Plumpy'nut was the first RUTF to be developed and is regarded as the industry standard. Several similar pastes have been developed but can only be sold in countries where the Plumpy'nut patents are not registered.
"Because Plumpy'nut is a brand name, it is the most popular," said an aid agency worker. "It is like Coke - people still prefer it, even if you have other similar drinks."
Two is a crowd too
Nutriset has attempted to broaden the scope of its two patents claim industry insiders, who also say the company has been "very vigilant" in ensuring that its patents are respected; manufacturers of peanut-based RUTFs have received legal letters.
"You have to keep reminding people [by sending letters]," said Nutriset spokesman Remi Vallet. "We are not trying to protect any monopoly - there is no monopoly there are other RUTF manufacturers in the market."
In Kenya, where the Plumpy'nut patents are registered, Nutriset has threatened legal action against Compact, an Indian and Norwegian manufacturer, for storing 25 metric tons of its RUTF, eeZeePaste, which it intended to supply to Somalia and the Democratic Republic of Congo.
"Our patent lawyers are studying the letter [from Nutriset] at the moment. I think they are stretching the interpretation of their patents," said Arne Andreassen, managing director of Compact, who pointed out that conflict-torn Somalia does not have adequate storage facilities.
Vallet said Nutriset was flexible where products were for humanitarian interventions. "We are willing to talk to Compact if they can show the supply was meant for Somalia. We allowed Diva [a South African RUTF manufacturer] to supply a UNICEF programme in Kenya, and are now in talks with them to enter into an arrangement with us."
Nutriset patents are registered in the European Union, the US and Canada, as well as in 16 francophone members of the African Intellectual Property Organization and 16 members of the African Regional Intellectual Property Organization in Eastern and Southern Africa.
In countries where Nutriset patents are registered, companies granted a manufacturing license are allowed to make, store, sell or use products similar to Plumpy'nut, but may not use the brand name. A network of Nutriset franchise-holders covers Niger, Ethiopia, Democratic Republic of Congo, Ghana, Tanzania Madagascar, Malawi, Mozambique, Dominican Republic, India and USA.
Nutriset patents are not registered in India, South Africa and Haiti, which have large numbers of malnourished children, and the company said competitors were free to invest in research and development of other RUTF products that would not fall within the scope of its patents.
Ben Tabatchnick, head of the family business, said his product was still in the development phase, but the patent would be "open-source", which would allow other producers to replicate his recipe.
His company "was trying to take the fear out of other producers from producing RUTF and keeping up with demand; no one producer can supply (even with licensed franchises) the world demand for RUTF and RUSF [ready-to-use supplementary foods]", he commented. "By allowing others free access (with proper oversight by UNICEF and MSF), this can and will be accomplished."
MSF's Doyon said patents for humanitarian products should be "filed only on an exceptional basis and ... licensing agreements should be offered to third parties on flexible terms and conditions, so as to ensure the widest possible availability of nutritional products of a humanitarian nature. We have been saying [this] to Nutriset ... [but] their reaction to Compact seems to say that they do not agree."
All the nuts in one jar
According to a study commissioned by UNICEF, Nutriset supplies the bulk of its product from France and the UN agency is the world's largest buyer of Plumpy'nut, which accounts for 89 percent of its RUTF procurement every year.
The cost and difficulty of exporting Plumpy'nut from France could be significant. In 2008 most of UNICEF's emergency supplies to Ethiopia had been air-freighted - 39 percent of the cost - whereas a local supplier in Kenya could have decreased transportation costs by around $80,000 per year and reduced overall supply-chain delay from eight weeks to one week.
[However] "It does not always work out cheaper to buy in the south," than to ship RUTF from Europe said Steve Jarrett, principal advisor in UNICEF's supply division. The study noted that there were "considerable risks in having a vital product like RUTF produced only by one dominant world supplier".
Photo: The Nutrition Articulation Project
|Contribution of sea and air freight to RUTF cost, according to an analysis commissioned by UNICEF|
Nutriset has taken a number of precautions to protect the production process, including security staff, and the ability to rapidly shift staff and equipment to scale up production outside of France, including in the US, noted the study.
But if Nutriset's manufacturing facility were to "go off-line for any reason — be it mechanical failure, worker strike, natural disaster, or a host of other reasons — the ramifications could effectively halt the entire RUTF supply chain for all of Nutriset's customers", the study commented.
A single global producer "limits the extent to which the supply chain includes surge capacity"; in the face of a complex emergency Nutriset would be forced to prioritize orders and reduce its ability to meet needs elsewhere. The study also suggested that multi-sourcing could bring down costs.
Jarrett said UNICEF was in favour of encouraging the production of RUTFs in beneficiary countries because this would help to "advocate its use - it is easier to get a buy-in from countries."