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The Intertwining of Public and Proprietary in Medical Technology
RICHARD R. NELSON
As I reflect on the papers presented at the fifth workshop in the series Medical Innovation at the Crossroads, and on the discussion, I am struck by how little was said about a topic my instincts tell me is of large and increasing importance: the intertwining of public and proprietary in medical technology, and the actual and potential conflicts associated with that intertwining.
In virtually all of the histories of medical innovation presented at the workshop, both universities and firms were involved at various stages. Both public and private monies contributed to the development of the technology. The findings of the research and the news of the new techniques were published in scientific papers and spread across the community of relevant professionals through talks and discussions at scientific and professional society meetings, and also through informal communication. At the same time, in many cases patents were filed for and granted at particular stages of the process.
There is a myth that is widely held among scholars, as well as among lay persons, that "science" and "technology" define two quite separate as well as different cultures. Science is what academics do, and scientists openly publish and otherwise communicate their findings. Technology is what business firms or profit-oriented private inventors do, and they patent their successes. There is a related myth that the relationship between science and technology is one where technologists draw freely on public science that was created with no notion at all as to its likely uses in the development of technology. The problem with these two myths is that they are largely myths. In fact, the worlds of science and technology are, in many fields, closely intertwined. Much of "science" is done with the express purpose of illuminating various areas of possible "technology" development. People at universities develop new technologies, and people at
firms do publish new science. The intertwining of science and technology is particularly prevalent, it seems to me, in the arena of medical research and innovation.
The advent of modern biotechnology certainly has exacerbated the intertwining problem, but the intertwining has been there for a long time. Consider, for example, the intertwining of science and technology, and universities and industry, in the development of purified insulin. The tradition of American patent law rules out the patenting of "natural substances" or "scientific principles." However, purified natural substances have been patentable, and several of the key patents in biotechnology pretty close to being on "scientific principles." The recent argument and uproar about patenting gene fragments has quieted down for a while, but that issue will not go away. Nor will the debate about whether companies who patent new substances that draw extensively on government-financed public science, such as zidovudine (AZT), should be free to charge any price that they like. A recent issue of Science reported on the uproar that was caused when some university researchers doing sleep research filed for a patent on a particular technique that their colleagues claimed was part of general knowledge among those working at the frontier in that field.
It seems to me that there are two important sets of questions here. The first is: What is public and what in fact is proprietary, and what are the factors that make for the present divide? It is obvious, for example, that the use of patents differs widely across three different fields of medical technology—pharmaceuticals, medical devices, and medical techniques and practices—with patents playing an important role in the first, and hardly any role at all in the last. (This is certainly one of the reasons why the filing noted above for a patent on a technique caused such an uproar.) However, the reasons for these differences are not entirely clear, nor are their consequences in terms of the nature of the research and inventing work done by different parties. The latter issue leads naturally to the second set of questions: What should be kept public and what should be allowed to be proprietary? Patent law and practice is made, and remade, by Congress and the courts. Both Congress and the courts have shown themselves to be relatively responsive to professional opinions. The issue of patenting the human genome is a dramatic instance, but only one of many, where the question of what should be patentable and what should not began to be discussed.
While I will not develop these issues further here, it seems to me that regarding the latter set of questions there are three matters that deserve a lot more attention than they currently have received. One is the increasing tendency of the Patent Office and the courts to allow and uphold patents on what might well be regarded as "scientific findings." A second matter is that neither the Patent Office nor the courts at present have any way of tapping into what professionals in a field already know, unless there is a written and published articulation of knowledge. Third, I think the time is ripe for a reconsideration of the question of private ownership rights to patents that come out of publicly funded research.
