Tag Archives: licences

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/

Copyright & implied licence

IPKat: Committal for contempt not fit for ‘grey area’ disputes

A case reported on the IPKat today highlights a dispute between a copyright owner and a newspaper publisher. Francesca Re Manning, the CAS-IP consultant who sent this link to me said this could be of interest to the Centres who use photos – even though the legal systems they operate might be different from the English one.

The dispute arose over how far the licence extended (there was no written agreement).  The judge ruled that the publisher had incorrectly assumed to have an ‘implied licence’ to use the owners copyrighted materials in back issues databases which further to the initial use in the publication.

It highlights a need to have an agreement in place when using the copyright of others, even if just to ensure that everyone is reading from the same page!

Pity the lawyers?? Crop scientists say biotechnology seed companies are thwarting research

http://www.nytimes.com/2009/02/20/business/20crop.html?em

This article published last week by the New York Times (see lead link) and reprinted in the International Herald Tribune  describes the frustration of a group of entomologists doing research at land grant universities in the U.S. regarding the contract conditions attached to the use of materials obtained from several major seed companies.  These scientists have sent a letter the U.S. Environmental Protection Agency (EPA) indicating that the have had difficulty in running the experiments needed to test hypotheses, regarding the optimal size(s) of refugia, because of the conditions proscribed by the owners of the materials when they were passed to the scientists for research studies.  Everyone agrees that this research needs to be done.  The scientists wonder, how this can be accomplished –given the contract language.  Now, how will the EPA be able to ask whether their current regulations are sensible?

What does this have to do with intellectual property?  Rights are awarded to patent holders; these rights can then be licensed to others.  Owners of intellectual property rights have great liberty in the conditions associated with licensing the use of materials under patent protection.  In corporations, the text of these licenses is usually under the control of legal departments.  This can bring problems when lawyers see their job as one of reducing risk to as close to zero as possible.  The situation described in this article perhaps provides an example of the difficulty lawyers have when trying to draft an agreement that provides sufficient room for a licensee to use the material in a productive way and yet also provides sufficient risk management for the licensor. 

Here is a very interesting discussion by a patent attorney regarding this situation: http://www.patentdocs.org/2009/02/new-york-times-gets-one-right.html

Additional comments regarding U.S. regulatory agencies involved in approvals of GMOs from:
http://patentbaristas.com/archives/2009/02/20/scientists-say-seed-technology-agreements-stop-research/

The above blog post was written by Victoria Henson-Apollonio

A draft of this post was circulated internally last week and Guat Hong Teh, a lawyer on the CAS-IP team had the following comment to make.

“In my view, putting the right language into licences that would enable both the licensor and licensee to achieve their goals (common or not) is a joint effort. Whilst it is reasonable to have some standardisation of legal language in these documents, both lawyer and scientist need to understand that a case-by-case approach is necessary when new situations emerge. A good piece of legal document requires extensive communication between all parties involved. However, there is sometimes a communication breakdown between the scientist and the lawyer because of the seemingly different roles they play or the goals they would like to see achieved. Although the duty of the lawyer is to ensure that his/her client is afforded the widest protection allowed under the law, this has to take into consideration other needs of the client. I see this to be an increasing challenge for what we do because of the rise in collaborative research, especially public-private partnerships.”

Patents that can be (in effect) public goods

http://money.cnn.com/news/newsfeeds/articles/marketwire/0431732.htm
This article is an update on the Eco-Patent Commons initiative.  Less than a year since its launch this project seems to be gaining momentum.  Two of the most recent pledged patents mentioned in the article relevant to our field are:

“A cutting edge, Xerox technology that significantly reduces the time and cost of removing hazardous waste from water and soil;
A technology developed by DuPont that converts certain non-recyclable plastics into beneficial fertilizer;”

A while back when I first blogged something about the Eco-patent commons, I saw that the commons has the following ‘rule’. 

“Members of the Eco-Patent Commons (known as “pledgers”) sign a nonassert pledge promising not to enforce the donated patents against those who use the patented technology to achieve an environmentally beneficial result (known as “implementers”).”

So, it works in a HUL-kind-of-way in that “implementers” have special licence to use the patent as they are achieving an environmentally beneficial result.  Except that licence is automatic, and the onus is on the rights holder to enforce – the upside to this being small business on the ground can go ahead and use the technologies without having to negotiate licensing terms.  Sounds sensible?!

Prior to making this post I sent the draft to my colleague Guat Hong Teh, the CAS-IP, IP Specialist, to ask what she thought about it.  She wrote:

“I had a quick glance at the website of the WBCSD – fascinating indeed! I think I have a rather different perspective from you in terms of how I see this piece of news. The first thing that came to my mind when I read this was:
How can we (in the public sector/the CGIAR) further encourage PPPs in agriculture/development-related projects through mechanisms such as corporate social responsibility and other models that would work for businesses to engage in our activities in the public sector? In recent years we have seen technology owners to be more active in creating “open’s” or “commons”, licensing innovations broadly for development purposes/for use in developing countries (such as through HULs), and putting forward “non-assert clauses” such as in the particular instance. These are all different creative ways used by IP owners to carve out exceptions to their rights, over and above those granted under the law.  Also, what is interesting about this news is the fact that technologies can sometimes (or even often times?), be applied across different disciplines. Are we in the public sector harnessing these existing innovations for the benefit of the poor engaging in agriculture?”