Where are the Crops?

Michael Heller, law prof at Columbia, has a nice opinion piece in this month’s Forbes concerning biotech patents. His article, Where are the Cures? is about medical biotech, but the ideas apply to agricultural biotech as well. The problem isn’t patents on finished products, but patents on the building blocks needed to make those products – the kernels, not the cob.
Michael blames the dearth of new drugs on “patent gridlock”. He writes: “Now, more than ever, biomedical invention requires assembling scattered bits of intellectual property. That’s expensive and complex. Simply to determine ownership of intellectual property used in a small lab studying a rare ocular disease, the University of Iowa reportedly had to contact 71 entities. Academic scientists routinely respond to gridlock by becoming patent pirates, just like their students who are illegally downloading music. Secrecy is on the rise, and scientists are increasingly reluctant to share research materials.” Ag biotech researchers have to do the same thing. To develop new crops, a scientist has to either be willing to ignore patent law or work for a corporation with an army of lawyers. With the laws the way they are, it’s no wonder we haven’t seen more innovation in either medicine or crops.
So what do we do? Aside from shifting much more research into the hands of government agencies (which of  course means higher taxes), we have to find a way to encourage companies to innovate while ensuring that they can innovate! Michael’s solution: “With a few tweaks to the patent system, such as changing the formula of determining patent litigation damages, innovators should be able, fairly and efficiently, to assemble multiple patents into valuable new products, including the drugs that might save our lives.” And, the crops that might feed the world.
Image by editorial cartoonist Clay Bennett, found on OpenWetWare‘s page on “Synthetic Society/Ownership, sharing and innovation”.

Solving the IP problem, one rupee at a time

One valid argument against GMOs is that big corporations control the tech and can charge the farmers sky high prices for the seed. For a long time, I’ve been saying that I don’t like the system, but if countries want to protect their farmers then they should pass some legislation. Well, it’s happened!

The Maharashtra government has fixed the price of genetically modified Bt cotton seeds at 750 rupees [about US $17.40] for a 450 gram [about 1 pound] packet, it said on Wednesday.

This is the maximum price that seed companies can charge from farmers in the current sowing season, which will start from [sic.] June.

Other main cotton growing states like Andhra Pradesh in eastern coast and Gujarat in western coast have already imposed similar price restrictions.

Maharashtra, the biggest cultivator of the fibre crop, this year began fixing seed prices ahead of the sowing operations in the upcoming kharif season [autumn harvest], under a new government act.

via CheckBiotech

Patents prevent development of GMOs

Once a transgene is designed and created, getting it into plant cells is surprisingly simple. There are two main ways to transform plants: the gene gun and Agrobacterium tumifaciens. The gene gun literally shoots tiny gold particles coated in DNA into cells. Agrobacterium is a natural soil bacteria that incorporates some of its genes into a plant’s genome so the plant will become a helpful host to the bacteria. For more information on both methods, click on this diagram from ND State Ag Extension.
If the process is so simple, why don’t we see more transgenes, more transformed plant species? BT and RoundUp Ready certainly aren’t the only possibilities!
Regulation isn’t really the issue, as a lot of genetic modifications (such as nutrient enhancement) are safe. Patenting of individual genes could be a problem, but there are many undiscovered genes out there. Patenting of techniques is the biggest issue. I don’t claim to understand the complexities of patent law, but I can report what understand as a young scientist.
“Are university researchers at risk for patent infringement?” in the 1 Nov 2007 issue of Nature Biotechnology describes how innovation in biotechnology has been halted by patents, especially in the case of plant transformation technologies.

Monsanto’s patent on the process of transforming plants through the use of Agrobacterium tumefaciens is claimed so broadly that it could exclude all plant transformation processes that use any engineered bacteria to transfer foreign DNA into plant genomes. The other method, biolistics-mediated transformation, was developed by Cornell University but licensed exclusively to DuPont, which has blocked commercial competitors from accessing the technology.

Any research that includes use of any method covered by currently held patents may not be taken to market or distributed in any way. Researchers can ignore patents and continue their work, but they are technically breaking patent law.

Although the patent statute contains a clearly stated research exemption, the 2002 court decision in Madey v. Duke limits the scope of the research exemption to experiments done “solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry”. Madey was not a company but a disgruntled ex-faculty member, but the case has important implications for universities and their researchers. The court found that the precedent did “not immunize any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications.” Essentially, major research universities often conduct research projects without commercial application, but that research still advances the institution’s educational mission to “increase the status of the institution and lure lucrative research grants, students and faculty.” It is hardly for amusement.

In other words, university researchers can not use any patent-protected technology unless they can prove that their research has no point. They “can be sued for making, using, selling or importing patented technologies, even if they have no intention of commercializing the fruits of the research.”
All of this means that the problems faced by the developers of Golden Rice, the first GMO specifically designed to help the poor, still exist. The following excerpt is from “The IP Handbook of Best Practices” article on biopharming:

An FTO [freedom-to-operate] assessment revealed that Golden Rice was related to over 70 patent applications and issued patents, most notably in the United States and Europe, and that patent applications were owned by over a dozen institutions. Few patents were applied for or issued in developing countries. However, because the material was developed in Europe, it could not be transferred for use in developing countries without proper licenses. There were a few reasons for this, not the least of which was that several material transfer agreements were limited to research use only.

The patent holders did eventually permit Golden Rice to be distributed without licensing fees for humanitarian reasons, but only after a media storm. The final result: Golden Rice still hasn’t been widely distributed, and laypeople the world over don’t trust genetic engineering or the companies involved. The researchers didn’t consider how many patents they might infringe upon, they just wanted to solve a global nutritional problem.
Corporations conduct a FTO analysis before moving forward with research. Can university researchers be expected to do the same? According to The IP Handbook of Best Practices, FTOs can cost $20,000 to $100,000 to conduct. I can’t imagine adding tens of thousands of dollars to already tight grant proposals. No research would ever be funded!
One alternative to patent battles is to develop new techniques that aren’t covered by patents. The non-profit CAMBIA seeks to create open-source alternatives to Agrobacterium. Their work is promising, as reported by BBC News back in 2005 in “Plant biotech goes open-source“, but not mainstream, and still isn’t widely used. Regardless, scientists shouldn’t have to reinvent things before they move forward.
As I’ve shown in this post, patenting prevents GMOs from being created or distributed, unless they have enough market potential for corporations to create them. I’ve always thought that the dearth of intelligently designed genetically engineered organisms was the fault of activists, that public misunderstanding prevented funding of research. Now that I’ve investigated things further, it’s clear that intellectual property law plays a huge part. In fact, the problem of biotechnology lying solely in the hands of corporations is one of the few things that the activists understand.

Genetic enginering for fun and profit

I was very young when I first read Copernick’s Rebellion by Leo Frankowski. It captured my imagination, and is directly responsible for my thoughts on genetic engineering and my desire to become a genetic engineer. The author was ahead of his time, taking the (then fictional) idea of manipulating genomes to fantastic conclusions. The characters turn our dismal world into something beautiful, a utopia that provides food and shelter for everyone.
Of course, some of the organisms in the book are more likely than others, but the idea holds true. So many things could be accomplished with biotechnology, from feeding the world to cleaning up pollution… but regulatory, financial, and social issues are preventing the most interesting and promising work from being done.
The main character in the book took some extreme measures to get his creations to the people who needed them most, but I think we have some better options. One of those is make genetic engineering accessible to more people.
Software has improved by leaps and bounds because so many people have contributed. Big companies like Microsoft and Google don’t have the desire to make every function that people might want to use. However, people who have time and knowledge can create helpful applications and share them, Open Source, for the good of the community. The code can be tweaked by others, shared, and tweaked further, until some highly useful items come about.
How could this idea apply to genetic engineering?
Over 180 genomes have been sequenced to date, according to Craig Venter’s Genome News Network, and we can expect to see more and more. Within these genomes are the genes we need to solve problems, if only there were enough people working on them. There are relatively few hands working on genetic engineering right now, so most of the treasure remains hidden. If more people had access to the genomes, along with basic knowledge of how genes work, they could apply their time and creativity to designing new solutions. A whole new industry could develop, providing the tools people would need to bring their ideas into reality.
I personally would like some cold-tolerant basil and late-flowering cilantro for my herb garden. Various genes for cold-tolerance and flowering are known, but certainly haven’t been applied in this way. One roadblock to long-lasting cilantro in my garden is patenting of genes. I can’t just use a previously described gene without dealing with intellectual property law.
As of 6 December 2007, Nature has opened all papers reporting genome sequences to the public, under a Creative Commons license. This is a step in the right direction, but doesn’t affect the patenting of individual genes. Patents are necessary to drive innovation – they allow the patent holder to recoup the cost of development or discovery.
A modified patent would allow only the patent holder to use the gene for profit, but freely allow non-profit use of the gene. I could design and create my cilantro, as long as I don’t sell it, and give credit to the person who developed the gene. If I do develop something with market potential, I could negotiate with the patent holder, perhaps to pay royalties for the duration of the patent.
Of course, we can’t ignore the negative aspects of the accessibility of technology. There will always be those who use technology to harm others. Harmful organisms certainly pose a special problem because they can replicate. Strict regulation of harmful organisms and genes would certainly be necessary, and not impossible.
This post was inspired by “The Open Organism: Genetic Engineering in the Open Source Era“.