War and Publification of Medicine Development, 2

The “war on disease” usage asserts a primary federal government role in directing the research and development of disease-directed therapies. The “war” usage asserts that the “market” for treating disease with new therapies–inventive therapies–is a governmental market, and that patents have no particular meaning in this market. This is especially the case given that the federal government awards patents in the first place. Why should the government give any inventor or company the right to disrupt the government’s efforts to fight anything, including disease?

It is worth here pausing to consider the broad policy implications. If the federal government announces that research concerning public health is within the government’s proper interest, and that the results of such research should be made available to the public, then the private effort to profit from the results of research in this same area–public health–are at odds with the public policy. One might say, contrary to that policy.

Consider water. Say that the federal government were to declare that clean drinking water should be made available to all, and that is a proper and vital interest of government to advance treatments to assay and treat water. The federal government declares war on unsafe water and undertakes to support, develop, and provide such new water technologies. Any advances in science and technology directed at water during this war are publified. If you are going to do research in this area, then you are necessarily part of the war effort or working to exploit and disrupt the war effort.

Some companies perhaps choose to race the government with the idea that if they discover water treatment methods ahead of the government, why, then the government will grant them patents and they should be free to profit from their exclusive positions. If the government wants to take back those patents, that should be a public taking and the patent holders should be compensated. Perhaps if the federal government is too stupid or indifferent that it issues patents with such broad rights in the first place, we deserve to create the conditions favorable to public trolls. But we could easily disable the trolling by modifying federal patent law (35 USC 287, say) to remove remedies for infringement in areas that the federal government has (say, through an act of Congress) declared “war” practices should take precedence. Thus, in our water example, one could be as inventive as one wanted in creating new patentable clean water technologies, but the market for these clean water technologies is still a governmental war market. Any private commercial use must be outside of the war market’s scope.

This is essential the case with the government effort for desalination technologies, which involved The Saline Water Conversion Act, a federal statute providing for government ownership of inventions made in federally supported research under the program. Here’s the general statement of need (from the 1961 expansion of the Act):

Objective: “practical low-cost means for large-scale production of water.” There we see the combination of “reasonable terms” and “benefits available to the public.” If there’s commercialization in there, it is bounded by these two elements of the objective. There follows an extensive listing of the various means by which the Secretary of the Department of the Interior could undertake research, development, construction of test facilities, and the like. Here’s text that joins the effort with the military:

That is, federal agencies are mobilized, with a portion of the activity tied to “defense of the Nation” and developments in that area “be available to . . . strengthen the civil economy of the Nation.” A governmental market and a “civil economy” market. The results of the water research were subject to a requirement of public availability:

That is–everything gets made available to the public that’s acquired under the program–with the exception of background patent rights–that is, rights already present, granted outside of this new federal effort.

This desalination technology effort was remarkably successful in establishing the United States as a leader, at least according to a background paper published by US Office of Technology Assessment:

The technology developed under this program was made freely available throughout the world through workshops and the wide distribution of published reports. Thus, by the late
1960s and early 1970s this R&D program had established the United States in a technological leadership role for desalination throughout the world.

The Harbridge House report (1968) finds that the Department of Interior was nearly 100% successful in bringing inventions under its control to the point of practical application. This claim carries some amount of irony, in that only a few years later Senators Bayh and Dole would claim that federal technology transfer was ineffective and that to restore American technology leadership, new inventions must pass through the exclusive control of private firms.

The Safe Water Conversion law was repealed in 1971, so it was not around for Bayh-Dole to list it as being preempted in the list of statutes at 35 USC 210. However, a similar water-related law–that actually never became law–is in Bayh-Dole’s preemption list. Here’s a graph showing federal expenditures related to desalination:

It’s just a bit more irony that the year Bayh-Dole goes into effect is the year that federal funding ends for this “war” practices effort to develop a publified technology base.

In a sense, then, the list of federal statutes that Bayh-Dole aims to preempt whenever a contractor acquires an invention made with federal support does not represent the height of government ineffectiveness. Just the opposite–this list amounts to the areas of research and development that Congress has determined merited “war” practices methods–that the market for innovation in these areas should be a governmental market–a market led by government, from specification of work to invention to development and construction. In this publified market, companies and universities and scientists and engineers should mobilize for the effort, that the economics of proprietary competition and profit-seeking should be subordinated to a common effort to deliver a public technology, and from that base there might be whatever competition and collaboration that a “civil market” might allow.

The idea of war carries with it a claim on citizens to rally, put aside personal affairs, and work for a common objective with a diligence as if survival–at least as a country–depends on it. Of course, the claim and actual practice often vary, and there are those who take advantage of others’ rallying to enrich themselves, and those who would sell out the country and its rallyers if they got half a chance. The question for federal policy is why the government should go out of its way to subsidize the efforts of those who would take advantage of the government program for their own enrichment or to sell out the country if they could. Or, in the case of Bayh-Dole, pass a law that allows any organization to preempt the war status of any area of technology development simply by taking ownership of a significant research result made in work proposed as appropriate to that war status funding. “If the federal research is sufficiently productive to result in an invention, and a contractor acquires that invention before it is offered to the publified effort, then the contractor can exploit that invention any way it pleases, even blocking access to it by others working in common effort, and blocking access by the public until and unless the contractor finds a way to bigly profit by allowing access.” Why would the federal government adopt such a policy? Why would anyone think such a policy is in the public interest?–other than that they don’t accept the claim that some area of effort really should involve a “war” status–that people need not work together, that outsized profit-seeking is a better motivator of the public good than merely working for the public good because, heck, it is the public good. I’m sure there are ways to argue that profit-seeking is the greatest public good and not merely the producer of the greatest public good–but then we should get rid of all non-profit organizations as useless do-nothings, at least for federal funding.

It’s just that we don’t accept profit-seeking in some areas of our society. We abhor judges and police on the take. We aren’t big on the sale of body parts. We even try to ban ticket scalping. As Michael J. Sandel and The Beatles remind us, there are some things that money can’t buy. Thus, we might ask whether money can buy us new technology or innovation or cure for diseases or new frontiers in science. And even money in some cases might do such a thing, what cases? and how used? Ah, there’s the rub for those that argue that profit-seeking, like an unseen hand, will guide society to its best condition. If there are things that money can’t buy–there are moral limits to markets, as Sandel has it–then there are also limits to the use of money to guide society, or research, or technology, or innovation. That may come as a glum reality to university administrators and federal research policy officials, but there it is.

There is, of course, the possibility that cheating, criminal, unethical, anti-social practices are a great source of discovery, invention, and innovation. Playing by rules–especially rules favored by bureaucrats–doesn’t have the ring of opportunity to it that playing without rules has. If that’s the case, then even the threat of audit might make timid researchers avoid such mal-practices that would be the source of discovery. Such discovery, however, may come at some great injury to community, as we have found with uncontrolled research using humans. How much does one harm community by other such mal-practices of research? Can one organize a war effort with the expectation that everyone one works with is a cheating, lying knave?

At a fundamental level, then, we need to come to terms with whether a “war” effort–government-led, market-constrained, mobilized for cooperation approach provides an effective approach to anything but actual war, which is itself a suspension of lots of ethical requirements. The pharmaceutical industry clearly does not accept the idea of mobilization, as was clear in their boycott of Public Health Service compounds in the early 1960s. They cited “contamination” with their own proprietary compounds and research, but contamination is not the issue if the matter is on war status–the issue is why these companies attempt to hold back what might be beneficial to the overall effort for their own private gain: “we intend to make our own weapons against disease, and induce the government to purchase them at whatever price we choose, even if that means holding out on a common effort, so we can profit more greatly than those that mobilize and join the effort.” The refusal to mobilize then found federal approval in the form of the NIH’s IPA program, by which the NIH’s own patent counsel created a pipeline for patent monopolies that extended from federal funding to pharmaceutical companies.

The problem that has hounded federal research and invention policy for seventy years is the refusal of the pharmaceutical industry to mobilize, to accept that inventions in this area have been declared a matter of a publified market, not a commercial one. That’s what has been debated–and resisted by the pharmaceutical companies. They treat mobilization money as a subsidy for their private efforts. They wish to wage war on disease on their own terms, and expect the government to support their efforts with research subsidies and with patent grants, so they can seek maximal return rather than maximal public benefit. In all this, the companies do not have to be better at discovery or even development–they just have to profit to the satisfaction of their owners. The financial sweet spot for drug development is a product that addresses an acute medical need by creating a lasting dependency. Thus, delaying disease progression is more important, financially, than would be prevention or cure. We might think that as a matter of public interest, prevention and cure would be much more important, overall. The pharmaceutical company response–reasonably–might be along the lines of “You go ahead and work on prevention and cure with your social high-mindedness and in the meantime we will produce products that mitigate symptoms and delay disease.” The implication is that pharmaceutical company leaders don’t believe that a government-led “war” on disease will result in much of anything. Are they right? There’s not a single diabetes drug approved for use in the United States that depends on any invention made in government-funded work. Perhaps there are drugs that depend on inventive stuff developed in government-supported work that was not patented–but really, no cures, no effective prevention. Heck of a war on disease we are having here.

Again, from a profit-seeking perspective, in a war status, the best thing is for the war to continue indefinitely with increasing dependence on the products produced by profit-seekers. At some point, profit-seeking becomes more important than, say, freedom or respect or honesty, and we have to ask whether mal-practice of discovery destroys more than it offers, especially if placed in the hands of profit-seekers. It’s not that non-profit-seekers are necessarily full of virtue–but rather that whether a predominance of virtue might be more ready to come by in the absence of giving free reign to profit-seeking.

Even with the federal government prepared to use war practices to address a public need, companies still have the argument that if they develop a needed inventive technology first, they should have a patent-based two-decade right to extract whatever profit they can. But they also must face the argument that their effort–to profit from monopolies directly in line with what the government has sought as a matter of general public welfare–runs against the public interest. It’s not that companies are not welcome in the effort to identify and develop water treatment technologies, but in the public policy regime that has been established, aiming to do so in order to get patents to block the federal effort, or to extract payment for the use of their technology–is just a nasty form of parasitism. It’s the reverse of the “free-rider” problem. It’s the public troll problem–anticipate what the federal government seeks to do in the public interest, and compete with it to gain proprietary positions to profit from anything the government might do or sponsor. It is just this sort of behavior that the “wage war” usage signals is not acceptable.

It’s not that American drug companies “were there first” conducting research and aiming for proprietary control of results in matters of medical treatment. Physicians and pharmacists were also doing research to find vaccines and blood thinners and anesthesias. The German dye making companies pioneered using the US patent system to gain exclusive control over compounds, taking advantage of their expertise in synthetic chemistry to stake out by patent claims swaths of related compounds in a given area of medical intervention.

The federal government’s decision to move from disease prevention and education to research involving medicinal chemistry, however, moved public policy into a domain–science, the frontiers of that science, and the application of that science–that had been staked out by pharmaceutical companies. These companies have no natural right to the medicinal chemistry domain, and one might argue that when the government declared research involving compounds with potential therapeutic effect to be a matter of public interest, then the pharmaceutical companies necessarily–as a matter of public policy– were delegated to a secondary role and their efforts at proprietary control outside of the government effort–and in competition with it, rather than asking how to support it–became a form of public trolling. But the pharmaceutical companies have never accepted the federal government’s claim on public interest medicine, and have sought to undermine it, circumvent it, compete with it, and turn it into an industry subsidy.

The clash between the drug company interest in maximizing their profit from human suffering and the federal government’s commitment to support research to find new therapies came to a head with the Public Health Service’s revised patent policy in 1962. The immediate issue was “contamination” of rights but the larger issue was that these companies insisted that they must take out exclusive positions against what the federal government had declared the public interest. Their argument was (and is) that without their financial investment, new medicines will not be created, and thus the public will suffer. And they will not invest without wide-scope patent monopolies. Mostly, their argument fails. It is simply not true, as demonstrated by the history of medicines in the United States, the development of medicines by nonprofits, the development of medicines in other countries, paid for by national governments. What is true is that if the US government declines to pay for the development of new medicines, then if pharmaceutical companies dominate the development activity (financially, and with patents, and with regulatory barriers to entry), then in a sense medicines won’t be developed unless pharma gets its patent monopolies.

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