E-DRUG: MSF Patent barriers for ready-to-use-food (RUTF)
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{Although not strictly about essential medicines, this message refers to a therapeutic approach that is being challenged by a patent application. Moderator}
GLOBAL: Making peanut butter gets stickier
11 Nov 2009 11:37:51 GMT
Source: IRIN
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alone.
JOHANNESBURG, 11 November 2009 (IRIN) - 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 Stephane Doyon, leader of the Nutrition Team at
Medecins Sans Frontieres (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 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". 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.
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." jk/he/bp
Kind regards,
Michelle Vilk
Coordination and Communications Assistant
Médecins Sans Frontières
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva, Switzerland
Tel: + 41(0) 22 849 89 02
Fax: + 41 (0) 22 849 84 04
michelle.vilk@geneva.msf.org