No Monopoly on Peanut-Based Products in Malawi

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“RUTF blogger” claims three different companies make peanut-paste products in Malawi and only one of them is franchised by Nutriset. I hope to check this information out when I visit Malawi next year. This information was first posted on my other blog, The Global Health Report. (RUTF is short for ready-to-use-therapeutic food.).

If RUTF blogger is right, this could be another example of prior art.

From RUTF blogger (sorry, no link available):

In Malawi, there are two producers of RUTF essentially using the same formula. One producer has machinery specified by Nuttriset and they are either a franchisee or a licensee. (The terminology is important, but I don’t know what strings are attached to their agreement.) The other producer has developed its own processing equipment, produces the same quality product, and is providing about the same volume of product to Malawi. However, they say they are neither a licensee nor a franchisee, but that they ARE allowed to produce RUTF without any opposition from (or perhaps even with agreement of) Nutriset. They are not using the Plumpy’Nut(R) brand name. A third company is a commercial food processor and has been producing nutritional supplements for years. They have a product sold widely in grocery stores that is very similar (has soy milk instead of dairy milk solids and is lactose free). It has about the same energy value (KCal/100g); same or similar level of vitamin and mineral supplements; same or similar protein, carb, and fat content; also predominantly peanut and sugar-based; also ready-to-eat and no water added… but they definitely have no license from Nutriset. In fact, I’ve been told their product actually pre-dates Plumpy’Nut(R)- I have not been able to validate this. Their product is promoted as a supplement and not as a total food replacing other food. It is not promoted for Severe Acute Malnutrition (SAM) but is positioned as “The most efficient energy and weight accelerator!” See more at their site: http://www.sibusiso.net/. They seem to now be owned by a major Malawi food processer called Rab Processors Ltd. See http://rabmw.com

Was the invention of Plumpy’nut “non-obvious” ??

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I keep meeting people in the intellectual property business who are surprised that Plumpy’nut received a patent in either the U.S. or European Union. Typically, they explain, patents are granted for inventions that are “non-obvious.” On the face of it, however, Plumpy’nut seems like glorified peanut butter. And it’s a rather obvious idea to give peanut butter to malnourished children.

But no one yet is willing to go “on the record” with such a pronouncement. So my search is still on for a recognized patent attorney or other expert who can take a look at Plumpy’nut story.

The other idea several folks have mentioned is finding out which countries do not have a patent on Plumpy’nut. (There’s apparently no such thing as an international patent. Patents are granted on a country-by-country basis.) It would be perfectly legal to make a peanut butter and dried milk concoction using the Plumpy’nut recipe in those countries where the patent does not exist.

The Plumpy’nut Precedent

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Stephanie Weber at the Univeristy of California at Berkeley raises the important issue of precedent. Will we see more patents on humanitarian relief products after Plumpy’nut? Would that be a good/bad/neutral development?

Of particular interest, when does the Plumpy’nut patent expire? I had assumed a standard term of 14 to 20 years. Needs checking.

Herewith Stephanie’s e-mail (published with permission):

I just read your blog posts. Very interesting topic! Coincidentally, a
colleague and I just gave a two hour presentation on Ready-To-Use Therapeutic Foods (Plumpy’Nut) as an approach to treating children with severe acute malnutrition.

After reading your blog, I had a few initial thoughts and questions to share with you.

First – and you might want to triangulate this statement with other people – Plumpy’nut is considered to have revolutionized the way children with severe acute malnutrition (SAM) are treated. Now, instead of spending 30+ days in the hospital or nutritional feeding centers, they can be treated at home by their primary caregiver. Additionally, children are recovering more quickly, and there is no preparation necessary to give them the PN (i.e., no need to add water). PN is cheaper than the traditional mode of treatment and it tastes better.

However, there is still more research that needs to be done to measure the relapse rate of children on Plumpy’nut. For example, are children treated with PN less likely to relapse than children treated with F100?

Second – have you talked with Nutriset? It would be interesting to know why they decided to patent the formula. Also, what is it about the formula that requires patenting? The proportions of ingredients?

I believe the patent is due to expire next year, so an interesting question to consider is what has been the effect of this patent for the past five years? Were more children excluded? Was PN more expensive than it otherwise would have been? To what extent did patenting limit production?

It’s possible that the implications for the future will be more interesting than the findings on cost and access. Even with some restricted access and slightly higher cost for PN, using RUTFs to treat SAM is still way more effective and less expensive than hospitalizing kids
and treating with F100.

Ex Christine: F100 is a milk-based therapeutic food for the treatment of severe malnutrition. Also, it would be good to contact Nutriset but I think a little more background research is in order first. Of course, given this highly interconnected world we live in, Nutriset may post on the blog first?

Patents missing from CBS coverage on Plumpy’nut

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Finally caught up to Anderson Cooper’s report about Plumpy’nut, which aired on Sixty Minutes a little over a week ago. Besides intimating that Doctors Without Borders had invented Plumpy’nut (which it didn’t), the 11-minute CBS report completely neglected to mention that Plumpy’nut is patented. (Thanks to Josh for sending me the link.)

Okay, you say, CBS has produced a feel-good story that doesn’t have to be encyclopedic. But given the fact that Cooper says that there’s not enough Plumpy’nut to go around and ties the shortage to a lack of vision from food aid donors, you would think he might have at least mentioned other challenges, like negotiations over licensing and franchising rights stemming from the patent(s).

It’s a small world, after all

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A nutrition researcher I haven’t seen for over a year tells me about research on peanut-based nutritional supplements in the late 1970s and early 1980s that may (or may not) constitute prior art. While attending my parents’ 50th wedding anniversary in Dallas last weekend, I learn that one of my cousins in France used to work for Nutriset for a year.

The research paper is “Dietary Supplementation of Gambian Nursing Mothers and Lactational Performance” and was published in the Lancet, Oct. 25, 1980, vol. 2, pages 886 to 888. (Will post link to an abtract in Medline soon. Here’s the abstract with a brief description of the peanuts-and-dried-milk-based supplement from Medline.)

The Lancet paper contains a reference to a “supplement that consists of locally prepared groundnut-based biscuits also containing wheat-soy flour, dried skimmed milk, groundnut oil, and sugar, together with a tea drink fortified with 0.6 ml ‘Abidec’ multi-vitamin supplement (Parke-Davis Co. Ltd) per daily portion.”

There are a number of similarities here with Plumpy’nut and some important differences. Similarities include: use of groundnuts (presumably peanuts), dried milk, oil, multi-vitamins. Differences include: use of tea (requiring clean water). Questions to investigate: Is the 1980 Lancet work prior art? Is it significant?

As for my cousin having once worked for Nutriset (my Mom’s family is from Normandy, near where Nutriset is located), that’s quite a coincidence but it doesn’t seem like a conflict to me. In any event, I’m publishing it so that you can reach your own conclusions.

Richard Cash’s experience in Bangladesh

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Dr. Richard Cash, who helped to develop oral rehydration therapy (ORT) for the treatment of severe diarrhea, never even thought about taking a patent out on his product. His experience illuminates the road not travelled for Plumpy’nut, the patented “miracle food” for malnourished children.

I asked Cash after class at Harvard’s School of Public Health earlier this week whether he had ever sought a patent for ORT. He said that as a member of the US Public Health Service (with the NIH) in 1968, he doesn’t think patenting was an option for him or his colleagues. Also, he admitted, it never really crossed his mind. Perhaps if it had, he said with a twinkle in his eye, he might not still be teaching at the School of Public Health.

Did the lack of a patent make it more difficult to get businesses to consider manufacturing and marketing ORT? Yes, at first, he said. Business people he talked to didn’t believe that they could make money through branding the product rather than on the basis of an exclusive monopoly. And yet, “look at aspirin,” Cash pointed out. “There hasn’t been a patent on aspirin for years and yet people still make money selling it.”

ORT, for those who aren’t familiar with it, is a very basic combination of a pinch of salt, a handful of sugar and 500 ml of clean water, that replaces the electrolytes lost during a bout of severe diarrhea. It doesn’t cure diarrhea but it prevents deaths from severe diarrhea, particularly in situations where access to medical care is severely limited. ORT has saved literally millions of lives over the past 40 years.

Cash and others worked with BRAC, the giant non-governmental organization in Bangladesh, to teach women how to stir up their own ORT solutions and treat their children on their own in the 1970s. (Hence the basic recipe of a pinch of salt, a handful of sugar and 500 ml of clean water. How do you get poor women to approximate 500 ml of water when they don’t have measuring cups of their own? You take one measuring cup and fill up each woman’s own pot with 500 ml of water. She then puts a mark on her own cooking pot or pan showing where the fill line is for 500 ml.)

A number of businesses also now sell packets of ORT to NGOs, governments, international travellers and the like. If you’ve ever given Pedialyte (made by Abbott Labs) to treat one of your kids who has been sick all night vomiting or with diarrhea, you can thank Richard Cash and his public health colleagues for figuring out, testing and validating the original formula.

Amazon loses one-click patent review

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A blogger from New Zealand has successfully petitioned the U.S. Patent and Trademark Office to reject several patents protecting “one-click shopping” on Amazon.com. Peter Calveley found enough “prior art” that the USPTO rejected all but five of Amazon’s 26 patents. A sign of things to come?

Read more in Peter Calveley’s own words.

How to suggest potential resources or new lines of inquiry

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Discover your inner Sherlock Holmes and conduct a search, talk to an expert you just met, visit with a librarian, etc. Spend as little as ten minutes or all day, if you want, following your clue.

If you learn something interesting that relates to Nutriset, Plumpy’nut, humanitarian feeding programs or patents, summarize what you have found in a comment to this post.

Other readers are then free to comment on the quality of your information, follow up your clue or add clues of their own. Authors of the best comments will want to become writers in their own right, adding posts of their own.

(For now, the process of becoming a writer–as opposed to a commenter–is pretty informal: just e-mail Christine at cgormanhealth[AT]gmail[DOT]com. Be sure to use your real name, give real contact information and say why you want to publish your own posts on the blog and what you think you can contribute. As the community grows, the process will undoubtedly evolve.)

All posts that suggest new resources or avenues of inquiry should be tagged with the “suggested leads” category.

As noted above, the best part of collaborative reporting–you put as much or as little effort into the project as you want. The experiment is to see if the sum of all these individual intellectual efforts will amount to something valuable–something that will help more malnourished kids get fed or that provides greater insight into the way the humanitarian business gets done.

Is the Neem case at all similar?

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Harvard professor Michael Sandel wonders if the neem story might have some bearing on patenting peanut-based foods for malnourished children. I asked Sandel about Nutriset after a talk he gave this evening at the Nieman Foundation.

At the turn of the 21st century, the European patent office revoked a patent it had granted on a fungicide derived from the neem tree, the source of many traditional agricultural products in India. In essence, the European patent office recognized that farmers had been using the seeds, oils and other parts of the neem tree for years to fight pests, blight and other agricultural problems. So the patent holders–in this case the US Department of Agriculture and W.R. Grace–were not entitled to the patent because they had not in fact created something novel.

Which brings up a few questions: Is there any previous history of using peanut butter mixes to fight starvation or treat malnourishment? If so, would that constitute what patent lawyers call “prior art”? And how many children would die of malnourishment before the challenge could finally be adjudicated? Related to that, how much money would have to be spent on the challenge and wouldn’t that money just be better spent buying the (patented) stuff and giving it to the kids?

U.S. patent on Plumpy’nut

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Here is a 2002 U.S. patent for Nutriset’s Plumpy’nut from the ever-helpful database of the U.S. Patent and Trademark office. Still looking for patent applications in other countries.

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