Click here to read the introduction to this four-part interview.
Two events took place in the United States in 1980 that, in retrospect, have dramatically changed the nature and direction of health sciences research. These were the Supreme Court decision in Diamond v. Chakrabarty that allowed the patenting of living things and the passage of the Bayh-Dole Government Patent Policy Act. To begin, could you please give us a broad-brush summary of these policy changes?
Their import is that Diamond v. Chakrabarty removed the ambiguity about whether one could take out a patent on a product of nature. And specifically for our purposes, whether one is able to take out a patent on a living thing. Living things had occasionally been patented in the past. For example, when adrenalin was patented, there were objections that this was actually a discovery rather than an invention. Even Louis Pasteur faced questions when he patented a strain of yeast. Some said, “You didn’t invent this yeast; you just discovered it.”
So now we have a law that stipulates unambiguously that if something is living, that’s not a bar to its being patented. In addition, we have a second law saying that when a university holds a patent, it is legal for the university to license or sell that patent to a corporate entity. Previously, universities were not allowed to do that, the rationale being that these patents arose from research that was subsidized by the government — that is, by you and me. Our tax dollars paid for the development of these molecules, and the feeling was that a private corporation should not be allowed to profit from it. The 1980 Bayh-Dole Act, supplemented by other laws, changed all that, making it feasible and, in fact, making it desirable for the first time, for researchers to take out patents on living things, based on research performed in universities, and to sell and license them to corporations. Bayh-Dole was basically a golden key for corporations who could now profit from patents that they previously were unable to hold.