Immunocompetent

Unless you're a bean breeder, farmer, or epicure, the little yellow beans at left might not look very interesting. But those humble frijoles are the subject of a lengthy patent dispute that may be headed for the US Supreme Court. And it's story has many important parallels with the current debate about H5N1 patents.

We’ll start with the bottom line lessons:

1.    Patents on WHO GISN materials impede WHO’s ability to execute its mission. The most important H5N1 patent issue is not that claims on GISN genes will stop developing countries from being able to use their own viruses (although this is possibile), it is the privatization of a resource given for public health uses, without compensation and with deleterious effects on WHO and, in particular, the GISN’s, ability to serve public health ends.

2.    Other international institutions have protective measures in place and have fought back when public goods they oversee are subjected to patent claim; but WHO has so far sought to downplay theft of its materials, even when WHO’s own Collaborating Centres lay patent claims to H5N1.

3.    Claims on genes per se (as a “composition of matter”) exist and may cause harm but, in fact, it is the broader claims based on WHO GISN materials that are most dangerous, because they encompass not only specific GISN genes; but all things physically and functionally similar.

4.    Acting after an offending patent has issued is too late.  Rescinding offending patents can take years, during which time the claims remain legally enforceable.

5.    Failing to act will only encourage more piracy of WHO GISN materials. In hindsight, WHO’s ongoing failure to protect GISN’s public goods may come to be viewed as the greatest mistake of the current WHO leadership.

The bean you see is either called an enola (by its owner) or a mayocoba (by everyone else).  Like WHO GISN flu strains, the bean's heritage involves being held in the public trust by the International Center for Tropical Agriculture (CIAT), near Cali, Colombia.  CIAT is part of an international network of public sector plant breeding institutions called the CGIAR.

Enter Larry Proctor, US farmer and entrepreneur.  In the 1990s, Larry bought a bag of beans at a market in Mexico.  He liked the yellow color of the well-known mayocoba beans he bought, which were closely related to beans held by CIAT in the public trust. He took the beans home to Colorado and grew more of them, making sure they didn't cross with any local ones. He renamed them enola and called them his own. He then applied for, and received, a United States patent on the beans he grew and all other beans of that yellow color.  

(Nevermind the origin of the beans and that Mexicans and others had grown and eaten such yellow beans for generations. This kind of detail often matters little to the patent authorities, whose idiosyncratic notion of history – called “prior art” - is a very convoluted and self-limiting one.)

In many respects, CIAT’s bean variety work parallels that of WHO CC. For flu, a WHO CC’s mission includes collecting, characterizing, and distributing trains, and producing and distributing vaccine seed strains and diagnostics, for public health purposes. In parallel, when it comes to beans, CIAT’s job includes collecting, characterizing, and distributing beans, and producing and distributing bean breeding lines and varieties, for the public purpose of improved agriculture.

To shorten the long bean story, in 2000, when the CGIAR and CIAT found out about Larry Proctor’s patent, they filed legal opposition to it. And although Proctor has lost ruling after ruling in the legal battle, as of today, he retains exclusive rights to those yellow beans in the United States. In June 2008, he filed his latest appeal, with a US federal appellate court. If he loses there, he can appeal to the US Supreme Court, and until those options are exhausted, Larry is the man who owns the beans.

Initially, WHO’s know-nothing attitude about patent claims on WHO GISN materials invites comparison to CGIAR’s.  While CGIAR is hardly a darling of NGOs when it comes to intellectual property, in the Proctor case (and some others), it did not look the other way and pretend that Proctor’s patent wasn’t threat to its public mission. This contrasts WHO’s modus operandi when it comes to influenza claims, which is to downplay or ignore them. So, unlike WHO, when faced with patent claims over its public trust materials, rather than rolling over and playing dead, CGIAR defended its public mission by fighting back.

Let’s get down to some specific lessons from the Proctor patent for the H5N1 debate:

In reply to concerns about H5N1 patents, WHO, its proxies, and allied apologists (such as WIPO), typically say something like this (my plain English paraphrase):

"Don’t worry about the flu patent applications because many countries don’t allow patents on genes per se and, anyway, they may not apply for many of those patents in developing countries. Besides, many of the claims cover WHO GISN viruses and genes only in a particular form, such as a specific vaccine. The patent claims won’t stop you from doing other things with the viruses, so there isn’t anything to worry about."

The arguments miss the point.  Although it is possible that some patent claims could stop Indonesia, for example, from doing certain things with its viruses, a key problem with the claims is that they appropriate a public resource for private profit, and return nothing to the donor countries – who gave the viruses to WHO expressly for public health purposes.

Another key problem is that the patent claims, even if not on an exact copy of a WHO virus or gene per se, can still be very problematic. In fact, it’s the bigger H5N1 claims than those for a particular sequence that present the greatest problem, just like the Proctor patent:

Like many H5N1 patent applications, Larry Proctor’s bean patent includes claims both on the biological material itself (as a “composition of matter” in patent language) and on anything like it. In the case of H5N1, there are claims on WHO GISN genes as a composition of matter and, frequently, anything genetically or functionally like them. The following two quotes illustrate:

From Proctor:

[I claim:] “Seed from a field bean variety of Phaseolus vulgaris that is completely yellow in color, wherein the yellow color is from about 7.5 Y 8.5/4 to about 7.5 Y 8.5/6 in the Munsell Book of Color.”

To paraphrase in plain English: I claim any bean seed that’s about the same color yellow as the ones that I bought at the market in Mexico.

From a recent US Government H5N1 patent application:

“WHAT IS CLAIMED IS: 1. A nucleic acid molecule comprising a polynucleotide encoding an influenza protein selected from the group consisting of hemagglutinin A (HA), neuraminidase (NA), M2 Protein, and nucleoprotein (NP), wherein said polynucleotide comprises (a) a plasmid taken from Table 1 (or its insert), or (b) an analog of said plasmid or insert having at least 95% identity thereto.”

To paraphrase in as simple language as possible: We claim any DNA or RNA that has a sequence about like any of four genes from several Indonesian and Thai (and some other) flu strains, which we got from WHO GISN.

(Among other things, “Table 1” contains slightly modified sequences of WHO GISN strains. These are called the “insert” in the patent’s language. Therefore on close reading it is apparent that the US government claims these genes a as a composition of matter, as well as anything 95% or more like them.)

So, just as Larry Proctor patented his beans themselves and any bean the same color, in the US government patent application, Uncle Sam is claiming the Indonesian and Thai genes and anything functionally similar.

Another problem comes with the patent apologists mistaken contention that patent applications aren’t relevant to donor countries unless they are filed in the country of origin of the strain. In the case of Proctor, he didn’t file for patent in Mexico (where he got the beans) or in Colombia (where CIAT is located); but the damage was still done.  In fact, Proctor and his attorneys began demanding royalties for every pound of Mexican-grown yellow beans imported into the United States, and suing those companies that didn’t accede to his demands.

Even more important than the ravaging of Mexican bean exporters, arguing that Indonesia shouldn’t be concerned about a patent on its viruses in the US ignores the fact Indonesia did not give the virus to WHO for it to be privatized and used elsewhere with no benefit going to Indonesia. There are also the broader implications for the global system: It was recognized by CGIAR and others that Proctor’s privatization of an international public resource impinged on the value and availability of CIAT’s work by restricting use of genetic materials, and that the patent would encourage more such piracy, undermining CGIAR’s integrity and its ability to serve its public mission.

Much the same undermining process is well underway with H5N1.  Except WHO is determined to turn a blind eye to it, even to the point of ignoring patent claims on WHO GISN materials by its own Collaborating Centres.