In 2 CFR 215 (Circular A-110), we find definitions of research and development (dd):
Research and development means all research activities, both basic and applied, and all development activities that are supported at universities, colleges, and other non-profit institutions.
This first part seems just to gather in terms–basic and applied, development–and restrict them to federal support at nonprofits. But there’s a subtext–all research is lumped together. Frontier research is no different from a clinical trial, from testing, from mating mice. As such, that’s a bit of policy drama in itself. How far we have fallen from Vannevar Bush’s efforts to distinguish the environment for frontier research from that of other forms of activity. Now it just looks like a boring definition that doesn’t say much at all. Continue reading
Joe Allen has written a new piece warning of the dangers of trying to use Bayh-Dole march-in procedures to control drug prices. And he has a point–the Bayh-Dole march-in procedures were not designed to deal with pricing. In fact, the march-in procedures were designed not to work at all! They are an apparatus with no purpose but to give the appearance of public oversight. They have never been used. They likely never will be.
But Joe Allen makes a few other assertions along the way that are worth examining. I will be brusque.
Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole.
This is not true. Instances: Methotrexate, Cisplatin, MOPP. The policies before Bayh-Dole were not patent destroying. At worst, those policies prevented the creation of private monopolies around inventions that were made in projects dedicated to the public welfare. It takes some balls to argue that the public welfare depends on the formation of massive private monopolies to jack earnings 10x over what they would be with competition.
The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system.
This is nonsense. Continue reading
Universities Help to Make the Problem
Universities created the federal contracting mess for basic research by insisting that the federal government not concentrate contracting authority in a single agency set up specifically for providing grants under the most liberal patent policy short of outright donation of funds. Instead, their advocacy for funding from all directions led to various agencies adopting different requirements suited to their particular purposes and assessment of the “public interest.” There is little doubt that contracting was a mess. The aerospace industry complained about the situation in 1963, for instance. So did big pharma. So did universities.
But the variations with regard to invention administration were not particularly problematic, other than that some federal agencies took a long time to decide whether to allow a private monopoly in any given case. As one commentator put it (in 1964):
Experience has taught that contracting officers are loath to process requests for deviations and when they do the requests mire in administrative procedure, are generally opposed by interested departments and are so time consuming that contract performance may have been completed before the almost inevitable denial is received.
But universities deal with many sponsors of research–companies and foundations, each with its own expectations, requirements, and practices regarding inventions, data, reporting, publication, payment, and termination. Even if all federal contracts were exactly alike, there’s no way that all other sponsors will also agree to use the same form–even if a university sends out its preferred template research agreement. Continue reading
Here’s a diagram that might help discussions of patent rights made with federal funding. A general monopoly A operates without any constraints of law, and in particular without regard for anti-trust law. Thus, such a monopolist may exercise ranging power, including power through the courts to enforce contracts and property rights without limitation for public policy, market power, or scope of claim.
A patent monopoly P, by contrast, is constrained by the Constitution, by the provisions of federal patent law, and by anti-trust law. A patent monopoly concerns only certain subject matter, excludes other subject matter (laws of nature, surgery methods, perpetual motion machines, stuff that’s not new, useful, and non-obvious), and runs for a limited time (presently, 20 years from application date). A patent monopoly is further limited by various matters of public policy–restrictions on tying and price controls, for instance–and by anti-trust concerns having to do with competition and effects on markets.
A patent monopoly on a subject invention S–one made under a federal research contract and owned by a contractor–is more limited still. Bayh-Dole restricts assignment and licensing, and requires extra procedures to go through to secure ownership clear of government claims to title. And the government must have a non-exclusive right to practice the invention. So the government is exempt from any private monopoly practice. But there’s more to a subject invention monopoly. Continue reading
Over at The Hill, James Edwards has an op/ed piece, “Don’t sacrifice patents for politics,” that worries changes to Bayh-Dole march-in procedures. Almost everything about the piece is predicated on the “usual narrative”–which is almost but not entirely false. Let’s have a look.
Before the Bayh-Dole Act, federal research funding was your tax dollars only partially at work. Federal funds went into research — advancing our understanding and producing discoveries — but the government kept the practical application of this new knowledge bottled up.
Before the Bayh-Dole Act, there was the IPA program. It allowed universities and nonprofits to acquire title to inventions made with federal support and was used by the two federal agencies that provided most of the funding to universities–HEW and NSF. It had a 5% commercialization rate. Bayh-Dole’s rate is kept secret, but major universities report commercialization rates of 0.5%. The government did not “bottle up” new knowledge–just the opposite. The government published discoveries and dedicated the rights to the public. The government made research results broadly available for use. Mr. Edwards has it all ass-backwards. Continue reading
The HEW IPA Program
These distinctions become important as the NIH, led by Norman Latker, pushed in 1978 for the adoption of a template IPA agreement on a federal government-wide basis by the Government Services Administration. This effort was rebuffed by the U.S. Senate. Lester Fettig, testifying on behalf of the Office of Management and Budget, noted the distinctions in the FGCAA and commented:
Federal research and development involves both procurement and assistance and it is important to consider the type of transaction when we consider patent policy.
Senator Gaylord Nelson noted that the proposed IPA arrangement had been pushed through without public notice in a process “dominated” by “universities and other insiders.” Sen. Nelson noted that nowhere in the template IPA does it define “public interest” and yet it expects the contractor to make that determination.
Brooke Struck has written an interesting comment on Dan Sarewitz’s article “Saving Science.” Struck argues we should balance internal and external pressures to perform research. Here’s my take on it. The first part I posted to SciSP and is indented.
I’m not persuaded that the military did all the things Sarewitz ascribes to them. I thought that was what Vannevar Bush did at OSRD, which the military could not think to do. The folks who got mobilized by Bush worked on the problems Bush’s folks identified, not on the ones the military most wanted–they already had people working on those things. You can’t always get what you want, and all. Bush proposed a National Research Foundation to fill the same role as OSRD, standing outside professional establishments (but now establishments such as medicine) to mobilize directed research for civilian purposes, working outside the establishment, drawing on the frontiers of science, with institutional-scale resources. When successful, the new work makes obsolete the problems trending in the establishment work. The frontiers of science part was to add to the available tools through discovery and training to do the other part. Instead, we got the National Science Foundation. Superficially close but significantly different.
Apparently it is popular in science policy to think that Vannevar Bush failed to have insights worth pursuing when it comes to science policy. Dan Sarewitz calls him a liar. Venkatesh Narayahnamurti and Toluwalogo Odumosu blame him for a distinction between “basic” and “applied” research, which they then demolish in favor of (I guess) “transdisciplinary” teams. Jeffrey Tasao off-handedly accuses Bush of being the originator of the idea of the goofy “linear model” of innovation. And James Holbrook asserts that Bush was “wrong to argue that the free play of free intellects is necessary to produce societal results.”
Well now. That’s quite a load. No doubt Vannevar Bush made mistakes, but let’s at least make the effort to frame what he did write and what he didn’t before we blame him for our problems. Bush didn’t devise the linear model. He didn’t formalize a dichotomy between basic and applied research. And there’s no evidence he was a liar about all this. There is evidence, however, that he valued technology development, and recognized that some of that technology development thrived when it was aided by new findings of science, and that those new findings of science came about without demands made by institutions.
Bush was asked by President Roosevelt to propose how the use of science during World War 2 might be adapted to civilian work. Roosevelt specifically asks about how things might work in medicine. Bush writes Science the Endless Frontier, drawing on a number of reports and recommendations by committees looking at the various issues. A primary concern is how the federal government becomes involved in research. Bush picks up from a phrase that closes President Roosevelt’s request:
New frontiers of the mind are before us, and if they are pioneered with the same vision, boldness, and drive with which we have waged this war we can create a fuller and more fruitful employment and a fuller and more fruitful life.
That’s the premise for both the study and the metaphor that frames the report. The frontiers of science are in the mind, new ways of thinking about the world that allow us to change our conditions of living. The fundamental challenge is what does it take to do that–to explore “new frontiers of the mind.” And more particularly, how to motivate such exploration through the supply of federal funding? Continue reading