There is another way, however, in addition to march-in, for the government to influence the commercial exploitation of health-related inventions made with federal support. Bayh-Dole has a clever design, but the people who drafted it made their mistakes.
March-in has to do with problems in the private market, where a patent owner has conditional exclusive rights. Let’s return to the government market again, because there the government has complete freedom to use and authorize the use of any subject invention, as provided by the Bayh-Dole-required non-exclusive license.
Let’s frame the government market this way: if the government has a purpose in providing for health care for its citizens, then there is a government market for the provision of government health care services. Vannevar Bush’s Science the Endless Frontier is focused on how the approach to technology innovation used during World War 2 could be adapted for civilian use. President Roosevelt requested, in particular, that Bush address innovation in medicine.
With particular reference to the war of science against disease, what can be done now to organize a program for continuing in the future the work which has been done in medicine and related sciences?
The scientific frontier, argued Bush, would open up new understanding and technology that could then be applied to medicine. Just as the military innovations developed under Bush’s programs did not arise from military priorities and operations, so too the medical innovations that Bush contemplated would not arise from established medicine, but would come from unexpected areas of science. In a nutshell, Bush argued that the established order that defines problems and envisions progress does not do a good job at imagining the full range of what is possible.
Bush argued that science is a “proper concern of government.” The federal government should “open new frontiers” of science:
Moreover, since health, well-being, and security are proper concerns of Government, scientific progress is, and must be, of vital interest to Government.
Bush calls out the pharmaceutical industry for its efforts during the second world war:
These results have been achieved through a great amount of basic research in medicine and the preclinical sciences, and by the dissemination of this new scientific knowledge through the physicians and medical services and public health agencies of the country. In this cooperative endeavour the pharmaceutical industry has played an important role, especially during the war. All of the medical and public health groups share credit for these achievements; they form interdependent members of a team.
Here are all the elements that create the opportunity for Bayh-Dole, and why Bayh-Dole is so utterly wrong while sounding so pleasantly right. First, Bush points to “basic research in medicine and the preclinical sciences. This research produces new scientific knowledge. This new knowledge is then disseminated via physicians and various medical services and agencies, assisted by the pharmaceutical industry:
Discovery of new therapeutic agents and methods usually results from basic studies in medicine and the underlying sciences.
Bush elaborates–what is needed is studies that aren’t directed to a particular medical problem, but rather are focused on establishing the science:
Discoveries pertinent to medical progress have often come from remote and unexpected sources, and it is certain that this will be true in the future.
The contributors to medical progress are likely “remote” from the methods by which professional medical research frames its own account of progress.
It is wholly probable that progress in the treatment of cardiovascular disease, renal disease, cancer, and similar refractory diseases will be made as the result of fundamental discoveries in subjects unrelated to those diseases, and perhaps entirely unexpected by the investigator.
Bush appeals, then, for research that is not specific to any given medical issue but rather advances scientific knowledge. We might pause here and consider confirmation bias. If the object of a study is to, say, cure cancer, then the account of the science may well be skewed toward whether a given result appears useful in curing cancer rather than whether the result is well established as science. What could go wrong? Well, in one review of published results having to do with cancer, Amgen found that it could not replicate 47 of 53 “landmark” studies. There are many versions of what “basic” means in “basic research,” such as lacking immediate commercial purpose or not pursued to meet a programmatic purpose. Bush appears to use “basic” to mean something along the lines of “not serving any agenda of an established order.” Here’s his account of “fronts” in the “war against disease.”
Further progress requires that the entire front of medicine and the underlying sciences of chemistry, physics, anatomy, biochemistry, physiology, pharmacology, bacteriology, pathology, parasitology, etc., be broadly developed.
The pre-condition to medical progress is that a range of sciences be “broadly developed.” That is, discover new knowledge without pressure to choose studies that appear relevant to the immediate needs of medicine. Computer science, for instance, has developed without focusing on the computational requirements of medicine. Once computer science has developed well founded methods, then these methods might be brought to bear on medical issues. But the methods have already been well established–at stake is not their general validity, but whether the methods are appropriate for a given medical purpose.
It’s clear that Bush wanted for the relationship between the “underlying” sciences and medicine something akin to the relationship between physics and military innovations such as radar and atomic bombs. The military did not envision radar. Someone knowing the physics had to bring the idea to the table. The military did not envision an atomic bomb. They lacked the awareness of fission cascades. But the physicists that did understand could imagine how fission might be managed to create a chain reaction explosion. In many ways, basic science could be used to blindside established thinking on what must be done to make progress. This is what Bush proposed for medicine as well.
The discovery phase is a matter of “basic studies.” Discoveries, then, must be developed “to the point at which they become available to medical practitioners.”
The development of such materials and methods to the point at which they become available to medical practitioners requires teamwork involving the medical schools, the science departments of universities, Government and the pharmaceutical industry.
Here we have the Kennedy patent policies “to the point of practical application” and Bayh-Dole’s “practical application.” To develop radar or a digital computer, the physicists, mathematicians, engineers, and “gadgeteers” must work the science, build prototypes, and put the science in a condition to be used. The same thinking applies to medical progress. Here again Bush recites the “interdependent members of a team.” In Bush’s view, “teamwork” is needed among medical schools, science departments, the federal government, and the pharmaceutical industry. At stake, then, is what Bush means by “teamwork.” In the faux Bayh-Dole account of commercialization, teamwork means, roughly, institutional assertion of ownership of discoveries, to be passed as patent monopolies to favorite pharmaceutical companies, to be developed into products that command the highest prices the market will bear. Let’s say it’s an open question whether Vannevar Bush meant this meaning of “teamwork” in Science the Endless Frontier. We might notice that this was not the form of teamwork that led to the development of radar, the digital computer, or the atomic bomb. Industry was involved in these developments, but not as a monopoly dealing partner. While General Electric held patents on vacuum tubes used in the digital computer, it did not obtain a monopoly on the design of the computer itself. John von Neumann saw to that.
If we wish to have a debate, it might center around whether there should be a monopoly on the idea of “teamwork.” That is, should the faux Bayh-Dole idea of commercialization as a trade in patent monopolies be the sole or foremost or dominant or first idea of “teamwork” established by either law or university policy? I would answer–no, absolutely not. A wide range of teamwork is possible for the development of any given discovery, and two similar discoveries might take very different pathways to become useful to medical practitioners. The university’s role is to identify possible teamwork arrangements and be available to implement these arrangements in support of development efforts. The government’s role is not just to fund research but also, potentially, to coordinate research efforts across projects and institutions, and to support development work as well as basic research. After all, Bayh-Dole defines a funding agreement to include “experimental, developmental, or research work.” It is reasonable to expect the federal government, then, to be involved in ways other than the funding of “basic research” at universities. It is also reasonable to expect that any one university should not have an institutional monopoly on development work: development would may be spread out among universities, and shared with companies as well.
I expect, however, a number of university licensing officers would argue–yes, the only teamwork that matters is one in which a university claims ownership of inventions and passes these as monopolies to favorite companies for development. The government’s role is restricted to supplying the research funding that leads to inventions. The university’s role is to take institutional ownership of inventions and put them behind a protective paywall. The pharmaceutical industry’s role is to take an exclusive license and develop the invention into a commercial product, to be made available to physicians. This view of teamwork is now so frequently repeated by university licensing offices, university associations, and certain pundits that one might think it is the only idea of teamwork that ought to be supported. No matter that it wasn’t Bush’s idea of teamwork.
In any event, Bush argues that the federal government has a role to play in the development phase, beyond funding research that leads to a discovery:
Government initiative, support, and coordination can be very effective in this development phase.
Again, let’s pause. Bush argues that discoveries show up in research in basic sciences, where they are validated as good science without having to be rushed into service as advances in medical science as well. As basic science, such discoveries are ill-served by patent monopolies that prevent further development until a controlling institution has struck just the right deal for payment. Bush argues that the patent policy of his proposed National Research Foundation will be to ask for nothing more than a government license. But then Bush also emphasizes that government-funded university basic research depends on the “free play of free intellects,” and whatever patents that might be had on such research would be owned by their inventors, not by universities as a consequence of handling government money on behalf of university faculty. Again, Bush’s idea of teamwork is not that of the faux Bayh-Dole’s commercialization through trade in patent monopolies.
Instead, Bush argues for federal government involvement during development–initiative (to develop), support (for others who develop), and coordination (of work to develop). There is no point to government coordination if the ownership of any given discovery is taken over by university administrators and passed to a single company. There’s nothing to coordinate. May as well argue here that Bush was goofy-wrong about government involvement.
Bush then focuses on two objectives of government support for science that might contribute to medical progress:
Notwithstanding great progress in prolonging the span of life and relief of suffering, much illness remains for which adequate means of prevention and cure are not yet known. While additional physicians, hospitals, and health programs are needed, their full usefulness cannot be attained unless we enlarge our knowledge of the human organism and the nature of disease.
The objectives: prevention and cure. The method: enlarging our knowledge of humans and disease. The government role: expand the broad front of basic sciences to enable a selection of discoveries from potentially remote areas of research to be imported for use in medicine. For these discoveries to be used by physicians, they must be developed to the point of practical application, and for that, team work including the pharmaceutical industry is essential. Again, the aim is to prevent and to cure–that’s where the government ought to spend its time developing discoveries in the basic sciences, just as the government did in developing such discoveries to support its military effort in the second world war.
Bush makes the case for government involvement in science: not just funding “basic research” but also playing an active role in development of discoveries for prevention (such as vaccines) and cures. And just such a thing happened in the 1950s and 1960s. The government not only funded basic research in the sciences but also played a key role in the development of therapies for malaria and leukemia, as the government had with the development of penicillin and vaccines for typhus and yellow fever during World War 2.