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.