There he goes again, says a group of scientists and activists alarmed by the latest rebel moves of J. Craig Venter.

Since butting heads with the scientific establishment during the sequencing of the human genome–and coming out rich and famous in the process–Venter has had the moxie and smarts to know just when it’s time to blend science with commerce.

This time he’s trying to cash in with a patent for artificial life–specifically, a designer microbe that Venter and his pals at the Venter Institute have been trying to assemble from scratch. In 1999, Venter and Nobel laureate Hamilton Smith used a simple bacterium called Mycoplasma genitalium to roughly figure out the minimal number of genes it would take for an organism to live. Since then they have been trying to synthesize this “minimal genome” inside a cell that could be augmented by additional genes to do things like produce hydrogen or gobble up carbon dioxide.

Three years ago, when I last visited Venter’s institute, located in Rockville, Maryland, he told me he and his colleagues were making great progress on finishing this artificial bug. But so far there has been no announcement of success. “This is not easy to do, to build a living organism from scratch,” he said at the time.

Whatever success or failure the team has had, Venter the businessman quietly filed an application last October that seeks to own the critter his lab wants to create. The U.S. Patent Office published the application (#20070122826) on May 31.

Six days later, I got an e-mail from the ETC Group, based in Ottawa, Canada, decrying the application as an attempt to launch a novel new technology onto society without knowing its full impact. ETC researcher Jim Thomas wrote this to me (and probably hundreds of other science writers):

We believe these monopoly claims signal the start of a high-stakes commercial race to synthesize and privatize synthetic life forms. And Venter’s company is positioning itself to become the “Microbesoft” of synthetic biology. Before these claims go forward, society must consider their far-reaching social, ethical and environmental impacts, and have an informed debate about whether they are socially acceptable or desirable.

ETC, a group of scientists, environmentalists, and other activists, describes itself as a “civil society organization that tracks new biotechnologies and nanotechnologies.” In May the group was joined by 38 organizations that called for the patent office to reject the application on several grounds. These included safety: the group raised an old fear about bioengineered organisms escaping into the environment to wreak havoc. This scenario for M. genitalium is unlikely, however, since this bacterium can only exist in a very specific environment. Other organisms made under the patent might prove more dangerous.

ETC also claims that Venter’s patent should be rejected until there is a thorough discussion about whether or not anyone should own what the application calls a “free living organism that can grow and replicate.” Of course, bioengineered organisms have been patented by biotech companies for years, since a landmark Supreme Court decision in 1980–but should this cover organisms made entirely from scratch? And would Venter’s recipe apply to more-complex organisms, such as animals and even humans?

In its press release, ETC says,

According to synthetic biologist Drew Endy of Massachusetts Institute of Technology (MIT): “There is no technical barrier to synthesizing plants and animals, it will happen as soon as anyone pays for it.” Indeed, in a recent interview (November 2006) Endy predicted that it should be possible to synthesize an entire human genome within a decade.

Well … we’ll see. Perhaps the most serious issue is publishing details of building microbes that terrorists might use to design deadly pathogens.

None of this will matter if Venter can’t actually make his artificial bug. Without a functioning organism, the patent will not be issued. But assuming he will make it, or perhaps already has, ETC does have a point that I have often emphasized: society should debate and discuss radical new technologies like this before allowing entrepreneur-scientists to plunge in.

This sort of discussion occurred in the 1970s when recombinant DNA scared the willies out of some scientists and activists who feared that organisms bioengineered to make drugs might escape into the environment. Mainstream scientists reacted by holding a famous meeting at the Asilomar Conference Center in Northern California, which led to a slowdown in research to explore safety issues and to make sure the new technology would do no harm.

This process for synthetic biology has already begun. Earlier this year, a meeting of synthetic biologists at the University of California, Berkeley, issued a statement that endorses safety measures and a wide public discourse, although critics say it did not go far enough.

The question is, will the man that Time magazine once called the “bad boy of science” heed these calls for caution? He has said that he will be careful. But one thing’s for sure: Craig Venter does what he likes, sometimes with flashes of brilliance, sometimes with all the grace and care of the proverbial bull in the china shop.

June 18, 2007: Addendum to Readers

After publishing this blog, a spokesperson for the Venter Institute e-mailed me to say that Craig Venter speaks often about the societal implications of synthetic biology. In 1998, the Institute of Genomic Research, founded by Venter, issued an ethical report on the topic authored by a team led by bioethicist Arthur Caplan of the University of Pennsylvania. In 2005, the policy group at the Venter Institute, along with MIT and the Center for Strategic and International Studies, were given a grant from the Sloan Foundation to review societal issues and laboratory practices surrounding synthetic genomics. (Check out the press release issued in 2005.) Their final report from this review will be issued in July.

Venter seems determined to forge ahead with his work and with his patent–which is his prerogative as a scientist. It is also the prerogative of critics to continue to challenge Venter and others as they push science to the edge of what society may or may not tolerate at the moment. In between is the great mass of society that will undoubtedly pay scant attention to either side, although the outcome of this discussion may have far-reaching implications–if Venter is able to create a truly synthetic organism.

I plan to closely follow this issue and read the Sloan-funded report next month. Let’s pick up this discussion again then.