This third form of mixing–intentional–created the problem for the PHS and universities in the area of medicinal chemistry. It was not mixing in the abstract; not mixing in an open university environment, but rather intentional mixing. The drug industry had supported academic work in medicinal chemistry for twenty years. Its deal was that it would provide free screening services for testing classes of compounds for biological activity in exchange for an exclusive option to develop anything that appeared interesting. Since screening services were limited outside of industry, and since there weren’t always funds for screening on top of discovery (though the cost was modest for initial screening), the industry arrangement made some sense. Besides, a class of compounds could be in the thousands, and synthesizing each variant itself was time consuming and generally not so publishable–or supportable by grants that expected “discoveries” not “systematic grinding out of variations 300 to 400 for a class of compounds that may or may not have any therapeutic significance.” A company might do this; academics not so readily.
What’s mystifying, then, is why the advocates for the IPA program, who then went on to draft Bayh-Dole, tried to make the IPA program government-wide, and when that failed, succeeded with Bayh-Dole. The Harbridge House report was clear that in many areas, the government’s patent policy worked fine. In the service departments, such as the Department of Agriculture, all inventions studied made it to commercial product without any exclusive patent position. The Harbridge House report identified six different approaches by industry to patents, ranging from indifference to extreme reliance. No single government policy, the report concluded, would address all of these industry attitudes and respond to the varying government purposes behind the provision of funds for research.
Why then did the Bayh-Dole advocates turn a local problem–how the Public Health Service (and its successor organizations) funded “discovery” research–into a government-wide issue, so that every invention would be claimed to “sit on the shelf” but for university patent brokers creating private patent monopolies in the form of exclusive licenses to favored companies? Why should every invention be called “early stage” when many inventions were, from the moment they were recognized, available for use as tools, as DIY technology? Why should every invention be characterized as requiring “substantial private investment” for there to be any public benefit when this just wasn’t (and isn’t) so? Why should “commercialization” become the dominant theme, rather than “use”? Why should there be such an attack on open innovation that a federal law should all but shut down open innovation in favor of “commercialization” through patent monopolies (even if Bayh-Dole does not openly advocate such a thing, but instead provides the means to enable such a thing and make almost impossible anything else)? Why should all inventions made in public discovery research be characterized as in need of “valley of death” funding between discovery and creating something sufficiently interesting that private investment funds will even take a look? And what is that “gap” funding for, but to make new inventions with their own patent positions that also would be reserved for a favored monopoly partner?
If you see a pattern in the questions, you perhaps begin also to see the nature of the problem that has infected (not informed) the very vocabulary we use to describe the activities that follow on university research. Until we break the habits of that vocabulary, especially among people that have little or no direct experience in the disposition of discovery inventions, we will get nowhere other than digging a deeper, useless hole from which we will eventually have to climb (if we are so lucky). Most university discovery inventions are not early stage, high risk, or sit on shelves through lack of monopoly interest created by patents. Many are tools that are used immediately in research. Others are methods that require little development and may readily be used in industry. Some involve hardware or circuits or materials that have no market and never will, but illustrate a concept and may open up a line of inquiry that many others may follow. Nanotechnology had that property, but university patent brokers gobbled up every bit of patentable right they could and created a two-decade gridlock on carbon nanotubes and the like, from which we may soon, perhaps, emerge.
And those discovery inventions that do require development often gain their commercial positions in that development work. The issue is not whether the first thing out is patented, but whether there is a prospect to develop patent positions in the next things needed to take development toward a particular product. The initial patent, then, does not “protect” the investment in any product, but rather that first patent “precludes” others from exploring possible development work. For every “success” using patents on initial discoveries, one will find 99 or more discoveries that were effectively precluded from early uptake, just when the excitement was highest and the resources available for exploration of variations and extensions and applications.
The university’s commitment to the idea of the “valley of death” funding is an effort to extend its patent monopoly from discovery research to a range of development inventions–variations, extensions, applications, methods of making–and thus creating an enlarged patent “portfolio” to offer to a monopoly partner. That enlarged patent portfolio, while carrying additional “value,” derives the majority of its value from precluding any other use of technology within that extended set of claims (a “thicket of claims,” to use the popular slang). The result of this approach is that everyone in an industry is aligned against the use or success of such a patent portfolio on offer, to the extent that they know they will never have access to that portfolio on terms that are attractive to them (such as non-exclusively, without strings, even if there’s some nominal payment).
COGR ties “mixing” of research funds to the need for a “uniform” patent policy on ownership of inventions. None of this holds up as useful practice for technology transfer. But these arguments are useful in making a local, particular problem in biomedical research funding appear to be a general problem, so that no one can touch the clever work-around to open innovation baked into federal statute without appearing to disrupt all possible benefit arising from federally supported research. That’s the tragedy of Bayh-Dole and what COGR, AUTM, PhRMA and other front groups have worked so hard for forty years to preserve. That’s the golden goose sold by an anonymous writer for The Economist, later walked back in another article a few years later that Bayh-Dole advocates never cite.
University ownership of inventions does not address the “mixing” problem–only makes the problems worse. A single policy on patents does not begin to get at the issues–only makes innovation more difficult across most of a university’s creative research activities. But that’s we have got, and what we have university administrators packing groups such as COGR, AUTM, APLU, and AAU righteously defending. It’s a special interest, a cleverly crafted scheme, and it is suffocating most university innovation practice. Time for it to end. Time to get the rascals out of the general case and deal with the particular issues in public funding for discovery research in the creation of medicines. That’s where the problem emerged, and that’s where it needs to be addressed, without encumbering all other university research with a claim for a “uniform” policy on patents.
This line of development is continued in part 4.