Plotkin moves on to make another good point–that “Big Pharma is the Model.” And it is–but the model is something other than the Cohen-Boyer patents that Plotkin launches into. Plotkin does not appear to recognize that Cohen-Boyer gene-splicing inventions were not made under Bayh-Dole. Or that the patents were licensed non-exclusively to everyone at very low cost. Or that Stanford consulted with industry representatives before filing patent applications. Stanford did not “lock down” the inventions and (as far as I know) did not even bother with requiring universities to take a license. Whatever the pace of genetic medicine based drug approvals, that pace had nothing to do with patents on Cohen-Boyer inventions. Gene splicing and “accurate genetic information” are, other than the common use of “gene,” worlds apart, technologically speaking.
a transition that has many rent-and royalty seeking university technology managers and investors sensing a potentially lucrative new opportunity.
Now this is an area I know well. Most university technology managers couldn’t find lucre in software or digital media if it bit them in their nerveless tails. They are friggin’ clueless. No, the lucre is not what motivates them. What they are concerned with is having their administrative power undermined by research work that is not required to move through their hands. They put a thumb in every innovation pie “as a service.” Yes, they insist on such things.
Furthermore, a number of university administrators are concerned that if people can distribute their digital works and software on their own, then the monopoly model of patenting gets bonked on the head. And finally, they invoke all the conflict of interest and risk management arguments they can–university ownership is a “safe harbor” from accusations that faculty (or any other author or developer) is profiting from the distribution of decidedly non-commercial work, putting the university at risk for product liability, infringement, and all sorts of other badness. In one case, a major research university asserted that distributing software open source was a personal conflict of interest because recipients of the software might ask the software developer to consult for them–and earn money that, so the university administrators argued, should have been paid to the university as a royalty.
What if Bayh-Dole had never been enacted and gene splicing technology had been available for free use by every scientist and researcher when it was first invented, nearly 40 years ago?
Of course, the gene-splicing technology was pretty much available for free use when it was first invented. And that’s with the NIH’s Institutional Patent Agreement program still in effect (terminated in 1978). Even Niels Reimers, who led the Cohen-Boyer licensing effort, said later that patents weren’t necessary for the adoption and use of the inventions. But Stanford’s central control of the patents, combined with non-exclusive licensing, may have served another purpose–that of establishing a de facto industry standard and limiting the incentives for anyone in industry to block the development of gene splicing technology with improvement patents. I don’t know of anyone who has explored this angle–but it would appear a decent hypothesis that Stanford’s non-exclusive licensing program may have created a broader commons than would have no patenting at all.
Thus, as we get to another of Plotkin’s salient points, we can see how it is spot on, but for a bunch of wrong reasons:
Even if the present Big Pharma-University research model really is the very best way imaginable to most rapidly develop important new drugs and bring them to market at affordable prices, which remains very much an open question,
An “open question” is putting it diplomatically . . .
there is no good reason to extend the same Reagan-era privatization scheme to federally funded educational resources.
The extension is not necessary because the privatization is already there in federal grant regulations. The “privatization scheme” was Kennedy, Johnson, and Carter administrations. And it wasn’t a “privatization scheme”–it was a scheme to allow private entities, if they gained ownership of inventions, to preempt public purposes under the color of federal contracts. Despite the baggage, Plotkin’s point hits home:
there is no good reason [for] . . . the scheme to [operate with] federally funded educational resources.
Put this way, Plotkin attacks the claim that the genius of Bayh-Dole is that it makes a “uniform” policy across all federal agencies, all forms of research contracting, for all contractors, in all industries, for all public purposes. Plotkin’s argument is exactly that of the Harbridge House report (1968)–that no single policy on disposition of rights in inventions made in federally supported work could possibly address the disparity of public purposes or the diversity of attitudes toward the use of patents in various industries, or even among companies within any given industry. There is no good reason for such a “uniform” federal policy. There’s only political bluffing and administrative urges.
Plotkin ends with another unwieldy analogy:
No one would have ever dared propose that the contractor who received public funds to build a school should also get the keys to the school along with the right to extract royalty payments from all those who entered.
The problem here is that the “contractor” might be a university, but the person creating the work of authorship is not the university, but rather a faculty member (and often more than one, along with graduate students, professional staff, and various collaborators). The construction analogy doesn’t work–not here with copyright, and not even with patentable inventions. Here’s the Supreme Court, for inventions, working through the analogy to production of a tangible object:
No one would claim that an autoworker who builds a car while working in a factory owns that car. But, as noted, patent law has always been different: We have rejected the idea that mere employment is sufficient to vest title to an employee’s invention in the employer.
For original works of authorship–copyright–employment is also not sufficient. The work prepared has to be within the scope of employment (or commissioned with an agreement in writing that the work will be a work made for hire, and only then if the work is in one of the specified categories). For university faculty, especially, it is difficult to establish that scholarship is within the scope of employment, for what “employment” means in copyright law–including that the employer has the right to control the work produced. For university faculty scholarship, sponsored or not, a university administration not only does not have such a right but makes a point of formal policy of limiting university administrative control. Here’s an example of such policy from Stanford:
Stanford University’s central functions of teaching, learning, research, and scholarship depend upon an atmosphere in which freedom of inquiry, thought, expression, publication, and peaceable assembly are given the fullest protection. Expression of the widest range of viewpoints should be encouraged, free from institutional orthodoxy and from internal or external coercion. Further, the holding of appointments at Stanford University should in no way affect the faculty members’ rights assured by the Constitution of the United States.
Here’s an example from the Rochester Institute of Technology:
All members of the faculty at Rochester Institute of Technology are entitled to full freedom in their teaching, in studies and research, and in the publication of the results of their studies or research.
Here’s the University of California:
The University of California is committed to upholding and preserving principles of academic freedom. These principles reflect the University’s fundamental mission, which is to discover knowledge and to disseminate it to its students and to society at large. The principles of academic freedom protect freedom of inquiry and research, freedom of teaching, and freedom of expression and publication. . .
Members of the faculty are entitled as University employees to the full protections of the Constitution of the United States and of the Constitution of the State of California. These protections are in addition to whatever rights, privileges, and responsibilities attach to the academic freedom of university faculty.
We may note that both the right to patent and the right to copyright are reserved by the Constitution to inventors and authors, respectively–protections, as it were, of the Constitution. Thus, unless a faculty member expressly and voluntarily gives up the freedom of publication, the faculty member’s original works of authorship cannot be works made for hire. This, of course, is not how university administrators bent on owning faculty work view things–they basically treat statements of academic freedom as so much fluff when it comes to intellectual property. As one senior administrator at a major public university quipped to me, “The university owns everything–we just don’t tell the faculty.”
Bayh-Dole, we know, does not require universities to acquire patentable inventions made in work receiving federal support. The same is true for original works of authorship under federal grant regulations. Here’s 2 CFR 200.315:
(a) Title to intangible property (see § 200.59 Intangible property) acquired under a Federal award vests upon acquisition in the non-Federal entity.
If a university (“the non-Federal entity”) acquires intangible property under a grant, then when it does so, title “vests” with the university. Put it this way–when a university uses federal money to acquire a work of authorship, the regulation provides that the university is not purchasing that work on behalf of the federal government, which then loans the work to the university for the purpose of the grant. Rather, the federal government provides that the title to such works vests with the university when the university acquires them, and the federal government gets a license (and imposes other conditions on the intangible property–which also includes patents and patent applications).
Thus, for works prepared by faculty with federal support, such as from the Department of Education, the owners are the authors, not the federal agencies nor the universities that manage federal funds on behalf of the faculty authors. That ownership is not merely a “technical” bit of ownership on the way to having that ownership transferred either to the federal government or to the university–it’s the default of federal patent and copyright laws, the foundation of public policy in its broadest sense–inventors and authors own their works. The problem in all this arises because people insist that public money should change something in this public policy. Authors receiving grants of public funds should owe the public something other than to continue to be authors and have the choices made available to authors by federal copyright law. Federal grant regulations stipulate that this something is (i) a non-exclusive license for federal government use and (ii) a requirement that intangible assets will be used for “its originally-authorized purpose” (2 CFR 200.315(a)) and according to 2 CFR 200.316:
Real property, equipment, and intangible property, that are acquired or improved with a Federal award must be held in trust by the non-Federal entity as trustee for the beneficiaries of the project or program under which the property was acquired or improved.
Original works of authorship that a university acquires or which a university already owns and improves with federal funds must be “held in trust” for the beneficiaries of the federally funded project. The critical step, as it is in Bayh-Dole, is that this property trust requirement does not kick in until a university has ownership of an original work of authorship. Just as in Bayh-Dole, there’s nothing in federal regulations that requires a university to treat all faculty scholarship supported by federal funds as work made for hire or otherwise requires faculty to give up their freedom to publish.
Perhaps, then, the ownership question is a red herring. Consider the three mechanisms that are available to the federal government, including the Department of Education, in funding university faculty. First, the federal regulations for nonprofit grants stipulate that works acquired or developed with federal funds must be used for their originally-authorized purpose. Let’s say that this requirement is broad enough to include faculty authors when they acquire (by authoring) or develop (by importing into the work) their own works with federal funds. Then the Department of Education’s call for proposals, and the specific representations made in funded proposals, should control the disposition of any works acquired or developed. If the Department of Education desires that such works be made broadly available for use, modification, and redistribution in modified form, then all the Department of Education would need to do is to place this requirement in the call for proposals. As for Bayh-Dole, the Department of Education would have to go through the ungainly determination of exceptional circumstances–but that ought to be relatively easy to do.
Second, the federal regulations require the owner of works acquired or improved under a federal grant to a nonprofit to hold such works in trust for the beneficiaries of the funded project. Thus, if a call for proposals identifies beneficiaries to be other education professionals, or in the alternative, a funded proposal does, then the owner of such works must make the works available to those beneficiaries. One does not, in holding such works in trust, withhold the works from the beneficiaries or charge the beneficiaries more than the actual cost of making the works available or prevent the beneficiaries from exploiting the works. One might say, at least for beneficiaries, there’s an implied duty of some form of “open” distribution, even if “open” does not meet the “free as in free beer” standard that some expect–free of copyright claims that would preclude further distribution or modification. It is reasonable, however, that an owner of such a work might require attribution (most open licenses include attribution) and might also require that if a work is modified and redistributed in its modified form, that the original identifiers of the work (such as title) are changed and a clear statement is included that makes note of the changes and makes clear these changes are not those of the original author.
It is worth pointing out that sometimes the value of a scholarly work–even a work intended for use by education professionals–may depend on its validation. If an assessment instrument has been validated to have reliable indicators, then altering that instrument may void the validation and folks will have to start again to establish the reliability of the instrument. Thus, it makes sense in an open environment for the original authors to establish and maintain curatorial control over the work they have authored and distributed–their attribution, their work unchanged by others, their identifiers for the work such as title–even as they permit others to change the work and redistribute the changes, forking the work, as it were.
Third, the federal government receives a broad license in any such work (2 CFR 200.315(b)):
The Federal awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.
Under Bayh-Dole, there’s a similarly broad license (37 CFR 401.14(b)):
With respect to any subject invention in which the Contractor retains title, the Federal government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world.
“Practice” here means “make, use, and sell.” The issue for both of these licenses is the scope of “for Federal purposes” and “for or on behalf of the United States.” It would appear that if a “Federal purpose” was to make sure that a developed work was made available for use and modification and redistribution in modified forms by education professionals, then the Department of Education could do so whenever it so pleased–it would not need to require all works to be made “open” nor would it need to determine that “exceptional circumstances” applied. There is no need to alter the *ownership* of works–just a need for the Department of Education to act on the rights licensed to the federal government in accordance with federal regulations.
Ownership, then, is not the issue. The issue is why federal agencies don’t act on the rights they have in such works, especially if what the federal agencies want is directly in line with their federal purposes. If distribution of a work and its subsequent modification by anyone is of such public importance, then why is not the Department of Education ramping up to make those works available under whatever license it chooses? That’s the question. Anything that the Department of Education can require faculty authors and their universities to do because the doing is a public purpose, the Department of Education can do itself. So why doesn’t it?