Tag Archives: licenses

The Plumpy’nut patent: well protected but now also widely available in the developing world

This has been sitting on my desk for a while.  One of the reasons I waited before blogging it was I wanted to see what others in the online community were going to make of the news. 

Many of you will remember the saga of the Plumpy’nut patent.  The web was literally buzzing during 2010 with news about the Plumpy’nut patent.  The high profile articles included the Andrew Rice article in the New York Times, and Jeffrey Sachs in the Huffington Post.  For previous CAS-IP posts on the subject visit: https://casipblog.wordpress.com/?s=plumpy

So the update is this;  in October Nutriset announced that a “Patent Usage Agreement” is now available online for the Plumpy’nut patent.  What does this mean?  Well, providing some basic requirements are met, anyone can download a Patent User Agreement to produce and distribute the product.

 “It allows a company or an organization to manufacture, market and distribute products covered by Nutriset/IRD patents. Eligible entities wishing to do so, can subscribe simply and quickly, in just a few clicks online, a Patents Usage Agreement”

I downloaded a copy of the agreement which can be viewed here. https://casipblog.files.wordpress.com/2010/12/patent-user-agreement-plumpynut.pdf

The requirements for eligibility are pretty basic.  You need to be a legal entity based in one of the developing countries where the patent has been filed (of course where there is no patent filed no licence is required anyway).  There is no compulsory fee to be paid, although IRD do “invite” a 1% of sales turnover be contributed towards research work.

What has the online community said about this announcement?   Not a lot from the searches I did, and from my RSS feeds….  Which is a shame as it certainly seems that Nutriset are trying to honor their commitment to make this product accessible and available – and there was a lot of negative media attention earlier in the year to the contrary. 

From the CAS-IP perspective it’s an interesting turn in the story.  In my first post on this topic I wrote:

“…the argument that underpins this, and many other similar stories [is that] IP relating to a product with a humanitarian nature should somehow be “handled differently””

 And indeed the “Online Patent User Agreement” is handling things differently.  I will be sure to blog any updates on this.

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Plumpy’nut in the New York Times & Huffington Post

The New York Times just published an in-depth story on RUTFs.  Andrew Rice’s story provides a historical perspective and looks at the dramatic impact these products have had on humanitarian assistance.  He also examines the history of the invention, its eventual ownership by Nutriset and the patent dispute.  To read the story visit: “The Peanut Solution

 Here are a few excerpts that relate to our previous posts on the subject, “Plumpynut legal battle and the idea of global responsibility licencing” and “IPRs needn’t be a barrier to development; the plumpy’nut case

 

“American food aid must comply with stringent regulations meant to encourage domestic procurement…  

The patent has since been registered in 38 countries, including much of Africa….

Nutriset’s critics say that…the Plumpy’nut patent is so broad as to encompass just about any kind of nut-based nutritional paste. “There are other people that would like to enter into the business,” Ben Tabatchnick, who runs a New Jersey-based kosher soup company, said. “But everybody is afraid of being sued.””

Then, in response to this posting, an article appeared on the Huffington Post written by Jeffrey Sachs, Jessica Fanzo (a nutritionist at Bioversity International) and Sonia Sachs, entitled “Saying “Nuts” to Hunger”.  This provided some very interesting additions to the debate regarding the type of hunger that Plumpy’nut addresses.  There were also some interesting comments relating to the IP aspects of the case.  Firstly:

 “…it is absurd to think that a patent should legitimately give a monopoly right to use a fortified peanut-paste to fight acute hunger. The ingredients are simple: peanut paste, vegetable oil, powdered milk, powdered sugar, vitamins, and minerals. The nutritional values of peanuts and the other ingredients have been known for ages, and only the worst misuse of patent law would grant a broad monopoly claim to such knowledge”

 Well said! And secondly:

 “…it is a standard solution of global intellectual property law that urgent public health needs supersede patent rights. Poor countries should exercise their full right of “compulsory licensing” and other legal protections to produce or to import urgently needed low-cost nutritional supplementation in the face of famines, just as they do to obtain low-cost AIDS medicines.”

I wanted to look a little deeper into this second point.  Of course, not everyone wants to know the ins and outs of the IP component, but that is what we at CAS-IP enjoy most!!  The global intellectual property law referred to in the article is, presumably, the TRIPS agreement.  I am not a lawyer and therefore I am not familiar with the nuances of TRIPS; however, my understanding is that the “compulsory licensing” of TRIPS (an international agreement) requires definition of an emergency as determined by judiciary (at the national level), adding a level of complexity.  The agreement in fact doesn’t mention “compulsory licensing” outright, rather “other use without authorization of the right holder” (see article 31)

The WTO site goes on to explain:

 “Compulsory licensing is only part of this since “other use” includes use by governments for their own purposes.  Compulsory licensing and government use of a patent without the authorization of its owner can only be done under a number of conditions aimed at protecting the legitimate interests of the patent holder.”

This includes remuneration, incidentally!  So, it is an option, but certainly not an immediate one, and not one without cost!  I haven’t had the time to research the HIV/pharmaceutical examples as cases, but it would be very interesting to know more about these to draw on any lessons learned for agriculture.

 (Thanks to Peter Bloch for his contributions to this post)

IPRs needn’t be a barrier to development; the Plumpy’nut case

Some time back we posted an item on the Plumpy’nut case.  This is a fascinating case for our community; it’s at the intersection of a debate involving patent rights, development economics and the public interest.  It is a real roller-coaster of a case and, if nothing else, serves as a stark warning to those who aren’t paying close attention to their IP strategy.   

As yet, we still don’t have all the pieces of the puzzle, –but we discussed the case during  our recent NPI meeting in Washington and were also given a presentation by the law firm who are representing the NGOs in the Mama Cares v. Nutriset case, (Fulbright & Jaworski).    

Based on the information we have seen and heard some of the issues involved are: 

Patent rights
The plaintiff, Mama Cares[1], says that the claims awarded in the Nutriset patent (US patent 6346284) are overly broad and effectively prevent the manufacture and distribution of any peanut-based RUTF,(ready-to-use therapeutic food). 

A key element in the case, however, rests on a single element in the claim relating to the osmolarity[2]  index.  Mama Cares claims that Plumpy’nut product , as produced by Nutriset licensees, itself does not meet this requirement (and neither does their own self-produced products) and therefore this constitutes a case of “false marking” of the Plumpy’nut product. The Fulbright presentation indicates that Mama Cares is seeking: 

 “Court determination of non-infringement (osmolarity), alternative determination of patent invalidity (inadequate patent disclosure, prior art) and false marking”. 

What is of particular interest is that Mama Cares – before investing in production – is effectively seeking court confirmation that if it does produce its own version of the RUTF it would not be infringing the claims of the Nutriset patent (i.e. there would be no basis for litigation against them for infringement) .  The case schedule is estimated to run into 2013 (including possible appeals scenarios).  

Supply and demand
There are reports that Nutriset’s licensees are not able to meet demand. (There is debate on this, depending on what constitutes demand[3][4])  Back in 2007 Médecins Sans Frontières (MSF) said:   

“If today’s UN recommendation of treating severe acute malnutrition with therapeutic RUF is to be realised, there is a need for 258,000 tons of product. Production capacity in 2007 is estimated to be less than 19,000 tons, with orders placed projected to be for only 8,500 tons. Therefore only 3% of severely malnourished children are likely to have access to treatment this year. This enormous production gap does not even take into consideration the requirements for a potential extension of RUF use for moderately malnourished children or as a supplement to populations of vulnerable children” 

Can local capacity in Africa meet any increases in demand?  This is important because it has been suggested spare processing capacity (and raw materials) in the USA might be available at a reduced rate or “pro bono” to produce enough material to meet demand in developing countries…  For example, the Peanut Association website, communicates their commitment to the development of peanut based RUTF and they have their own “Peanut Butter for the Hungry” initiative.  

One blog (Celsias) quoted Nutriset on this subject: 

 “The problem with U.S. production, says Nutriset, is that funding for humanitarian food and nutritional supplement suppliers requires that almost all the aid money be spent on American-grown surplus crops. This means that third world peanut farmers would get short shrift in a global marketplace, further increasing poverty in those countries at highest risk of childhood malnutrition” 

 The African peanut import/export figures we looked at don’t enable any hard and fast verification of supply of peanuts that could be used in the manufacture.  According FAOSTAT the top African exporters of shelled groundnuts for 2007 are Malawi (10th largest exporter in the world), Gambia (11th), South Africa (14th), Tanzania (17th), Egypt (18th), Mozambique (19th) and Mali (20th) whilst the top 3 African importers of shelled groundnuts for 2007 are South Africa, Gambia and Nigeria. The source of the information was again FAOSTAT

Of course there are other factors to consider when assessing potential supply of product, e.g. disease that can make it difficult to understand what the availability of good raw materials might be.  

 At first glance it would seem that local capacity to provide the key raw material is sizeable.  In fact, interestingly, looking at stats from “World Geography of the Peanut”  in terms of peanut production area (1000ha) the top 5 in 2001 were: India, China, Nigeria, Sudan and Senegal. 

 Capacity building v. trade policy
The Nutriset strategy to license manufacturing to African owned businesses is a desirable goal, as it builds local capacity, encourages the growth of African-owned businesses and supports the idea of “Africans feeding Africa”.  But we do not know enough about the specifics of these licensing agreements to comment further.  An unverified release from Hilina Foods, Nutriset’s Ethiopian licensee, states that: 

“After rigorous audit of the new out lay and set up a…memorandum was signed by both parties in September 2007 to make Hilina Food Processing Center a franchisee of Nutriset Company with a holding of 51% and 49% by Hilina Food Processing Center and Nutriset respectively.” 

We hear repeatedly that US policy can dictate that US companies provide supplies (e.g., RUTF) to fill development grants and humanitarian aid.  A bit of digging around failed to come up with anything concrete to support this position.  Comments in a US Federal Government Accounting Office (GAO) study “recommends” food aid be sourced locally/regionally.  And, a Greenpeace report  published in 2002 during the Bush administration says: 

“While the Bush Administration claims that its offer of food aid to Africa is motivated by altruism, the USAID website is a little more candid. It states: “The principal beneficiary of America’s foreign assistance programs has always been the United States. Close to 80% of the USAID contracts and grants go directly to American firms. Foreign assistance programs have helped create major markets for agricultural goods, created new markets for American industrial exports and meant hundreds of thousands of jobs for Americans.” 

Good v. evil
Ok, so it’s not quite as dramatic as “good v. evil” but there is certainly an element of emotional play here.  From what we can see, a gap certainly exists between the philosophies held by the two sides of the debate -different ways of “doing development”, if you like.  Should development take the form of capacity building along the entire supply chain, so eventually the regions that require the product become the ones that can supply it, –whilst increasing the capacity of the region overall?  Restrictive IPRs are a “normal” part of business models to bring new products to market; however, in cases where a product can provide humanitarian relief, is it permissible to enforce such IPRs if the supply doesn’t meet demand?  Add to this the whispers of protectionism for US peanut farmers and industry and you have a complex mix… 

Overview and opinion
During the NPI week in Washington we spoke to many IP-in-development professionals about this case.  The main questions people had were regarding the licensing strategy of Nutriset.  We have few details on this but it seems this area is where the most room for maneuver exists.  The Plumpy Nut product is one of those rare cases where one could probably use the term “wonder product”, and both the US NGOs and Nutriset claim to share a common mission.  Strategic licensing terms could accommodate the goals of both sides IF everyone could go back to the negotiating table. 

The suggestion that many of the blogs and news items make — that this case is about humanitarian need v. the dictates of the IPR — is, in our opinion, simplistic.  It is too loaded, and in any case who would make such a decision and how would it actually be implemented?  The current patent litigation could take three years to resolve, and circumstances suggest that the matter needs to be settled immediately.  So, while the litigation could continue, surely this is a case where some lateral thinking is in order.  A high visibility public figure (e.g. Bill Clinton) might take on the role of unofficial mediator and approach the French government, (a co-owner of the patent via IRD), to seek an immediate resolution.  Based on its inability to meet demand, Nutriset might agree that, pending resolution of the patent dispute, it would not take any action against infringers, or issue humanitarian use licenses outside of their target areas?  However, Nutriset has already indicated that cheap product from the USA would destroy its African licensee business model.  What should be done next? 

We have said this many times before – IP is just a tool, and a tool can be used or misused.    We don’t believe the answer in this, or similar cases is to criticise the fact that IP protection exists for a product that has humanitarian use applications.  We have to be more creative than that.  IPRs can fulfill humanitarian goals if awarded according to the law (e.g., in the US novel and non-obvious and patentable subject matter) and if licensed thoughtfully. 

A final comment – We think this is a great example of an IP success.  A humanitarian use product has been developed that satisfies a critical need, is supporting the development of African-owned businesses, –but is only reaching a small percentage of those who could benefit.  We hope the baby isn’t thrown out with the bath water whilst trying to increase this success and to produce enough for the need! 

(Post written by Kay Chapman, Peter Bloch                    , Francesca Re                     Manning with input from Karine Malgrand                    , Guat Hong Teh, Victoria Henson-Apollonio, Fayola Phillip and the NPI) 


[1] Visit http://www.rfcexpress.com/lawsuit.asp?id=52936 for lawsuit details Mama Cares Foundation et al v. Nutriset Societe Anonym France et al 

[2] In this context; see presentation from André Briend, one of the inventors, about these qualities of the product  http://www.fantaproject.org/ctc/plumpynut2PPT2.pdf 

[3] “Demand” can be defined in many ways.  See “Copyfight” for some discussion on this http://copyfight.corante.com/archives/2010/04/16/nutriset_responds.php 

[4] Some links to arguments for and against this claim: http://www.celsias.com/article/can-you-patent-life-saving-nutrition/,  http://globalhealthreport.blogspot.com/2008/05/demand-for-plumpynut-outstrips-supply.html, http://aidwatchers.com/2010/04/the-plumpy%E2%80%99nut-dustup/

Learning from the licensing of a papaya variety developed by the public sector in Costa Rica

The National Partners Initiative (NPI) of CAS-IP is publishing five working papers from five Agricultural Research Institutions in developing countries. These case studies aim to share experiences from developing countries in the areas surrounding IP policy-making, policy implementation and use of IPRs by researchers for leveraging more benefits for the stakeholders, people, institutions and countries.

The second case study published comes from Costa Rica. It describes the process that the University of Costa Rica’s Office for Knowledge Management and Transfer (PROINNOVA) undertook to license the seeds of a new papaya variety, named Pococi.  This was developed jointly by the University of Costa Rica (UCR) and the National Institute for Agricultural Technology (INTA, for its acronym in Spanish) from Costa Rica.  The study seeks to better understand the institutional challenges that must be addressed by potential license seeking organizations in Costa Rica to ensure successful transactions.

The project itself was not successful because, after addressing several institutional issues, a license agreement was not concluded.  Failures and/or unsuccessful projects can be a good way of acquiring experience, especially when lessons can be learned.

The full text can be viewed by clicking HERE.

Post written by Karine Malgrand, Facilitator of the National Partners Initiative for CAS-IP

Open Data Commons; new draft attribution licence for data/databases

This item was posted on Peter Suber’s blog a couple of weeks back requesting futher circulation.  It points to draft text for a “Open Data Commons Attribution License (ODC-By)

The draft licence is still open for comments. http://www.opendatacommons.org/licenses/by/

According to the Peter Suber blog the work on this licence is addressing the need for:

“.. an open license for data/databases that provides for attribution but does not impose share-alike requirements. …”

The Open Data Commons website has some FAQs about why data licences are important.  They say:

“…licensing and definitions are important even though they are only a small part of the overall picture. If we get them wrong they will keep on getting in the way of everything else. If we get them right we can stop worrying about them and focus our full energies on other things.”

Nicely put!  Further on they explain:

“…you do need this legal stuff. Whether one likes it or not there are a whole bunch of jurisdictions in the world where there are IP rights in data(bases). Thus if you want your data to be open, even if that means public domain, you need to apply a license (or something very like a license).

For licence text already available visit http://www.opendatacommons.org/licenses/