[MUSIC] Now to bring us up to today, their comminent DNA advisory committee which, again, originally developed to oversee recombinant DNA technology research. We have seen over the years that these experiments are actually quite low risk. And so the responsibility for reviewing those experiments or providing oversight of those experiments, now belongs to institutional bio safety committees here in the US. But the RAC still exists but it's purview has changed somewhat. So, first it has slightly broader membership than it used to, including not only members with relevant scientific expertise, but also at least four members with much broader expertise, including in the protection of human research subjects. This is particularly important because the main focus of the RAC today is on human gene transfer trials, or gene therapy, which makes up, again, the bulk of the work that they do. But there are two other important policy developments over the last several decades that are important to synthetic biology and I just want to go through those briefly. The first is the Bayh-Dole Act, named after Evan Bayh and Bob Dole, who sponsored it. It was passed in Congress in 1980. It's officially called the University and Small Business Patent Procedures Act, but everyone calls it the Bayh-Dole Act, and it has two key provisions. The first is, in contrast to before the act was passed, when inventions made with federal dollars were property of the federal government, the Bayh-Dole Act stipulated that institutions who were supported by the federal government could own the inventions made with federal funds. But they must make their best efforts to commercialize those inventions. The second key provision is that institutions must share income with the inventors, so with the investigators themselves, the scientists themselves. This was motivated by the fact that a lot of federal dollars were going into university research, for example. And not a lot of products were coming out. And this was in part due to the incentive structure, if you don't get to own your invention, there's not a lot of motivation to patent and develop that idea. So this act was intended to stimulate new ideas, and methods, and help translate this innovative work that the federal government was funding into products and advances that the public and the society at large, could take advantage of. That was really an effort to make universities engine of economic development. And that is certainly happened in the sense that many investigator university researchers now have taken products, developed with federal funds, gotten patents and started companies in order to commercialize those inventions. The second important development that I want to talk about is this court case, Diamond v.Chakrabarty. It was about the patenting of genetically modified organisms, these organisms that we can now make with recombinant DNA technology. Chakrabarty was a genetic engineer working at General Electric. And he had a developed a bacterium that was capable of breaking down crude oil, which he proposed for use in treating oil spills. So you could deploy this organism and sort of have it gobble up all of that crude oil out there on the ocean. Charkabarty, or GE and Charkabarty filed the patent with Charkabarty as the inventor. But the patent was rejected by the patent examiner, because under patent law at the time, it was generally understood that you couldn't patent living things. So it went all the way through the courts, ultimately ended up at the Supreme Court. And a 5-4 ruling the court held that a live, human made micro organism is patentable subject matter. And that the respondent's, that is Chakrabarty's, micro organism constitutes a manufacture or composition of matter within the statute, the patent statutes. So after this case in 1980, it was possible to patent manufactured or genetically modified organisms. So if you pair this with the Bayh-Dole Act, synthetic biology is often running.
