[Seven years ago, before I studied the history of Bayh-Dole, I still thought it was a workable framework for the management of inventions made with federal support. It’s amazing how one’s perspective can change with some context. Bayh-Dole was built to give the appearance of offering something special for research-based inventions, a public covenant of sorts, so that patents on these inventions would be managed “in the public interest,” as distinct from “in the interests of the owners of ordinary patents.” It’s just that Bayh-Dole was also built not to operate in this way at all. Although other pathways of management are possible in Bayh-Dole, and may even be mandated as a matter of altered patent law, at its basic Bayh-Dole exists to open a direct pathway by which pharmaceutical companies (and their research proxies, biotech companies) can gain monopoly control over inventions made with federal support.
Perhaps–I don’t think so, but whatever–it is a good thing that pharmaceuticals gain monopoly control over inventions made with federal support at nonprofits. But if so, then why not just declare this control as federal policy? Why make such a big administrative gesture about “public interest” as a matter of special management? Why even bother to have nonprofit organizations insert themselves into the transactions? Why hide this pathway of invention to stripping inventors of their rights to patent to commercial monopoly? If that’s the goal, then go directly at it. Government funding is merely a subsidy for the investors in pharmaceutical companies. That’s a nice deal, but apparently it’s best to keep the deal out of the public eye, and instead champion the virtues of Bayh-Dole in giving university administrators financial “incentives” to participate in these shenanigans.
People fussing about high drug prices can’t see, apparently, the role Bayh-Dole has played. Bayh-Dole is not the only source of high drug prices, of course–but it certainly plays a significant role.
Anyway, here are four issues that ought to be out in the open even if Bayh-Dole is the wonderful law that AUTM folks insist that it is. 7/15/17]
Here are four issues facing university technology transfer that ought to get addressed.
1) Honest reports of activity in the field.
Universities do not report utilization outcomes of the inventions they claim ownership of. Nor do they report their operating cash flows for technology transfer. Nor do they report how they spend their licensing income. Bayh-Dole requires utilization reports but protects these from disclosure. Without clear, honest reports of activity, it is impossible to assess any claims for productivity, effectiveness, or efficiency.
2) Improve the academic study of technology transfer.
The academic literature regarding technology transfer is a shambles. Much of is not really scholarship, though it may have the written trappings of scholarship, what with footnotes and the like. University technology transfer deserves better. Policy makers must demand better. Technology transfer needs some folks willing to get past the posturing, spend time learning the practices, and conducting studies that get at the fundamentals rather than political superficialities. We don’t have that, for the most part, after 30 years. Get a burn barrel. Start over. Get it right.
3) Implement programs responsive to Bayh-Dole.
Bayh-Dole is a smart, powerful, flexible law to make uniform federal agency procurement policy with regard to inventions made in the course of federally supported non-profit research. The university technology transfer community has by and large reduced it to patents for money. Boring, dull, thick. The Act recites a number of goals. The most prominent is to use the patent system to promote the use of federally supported inventions. The use of an invention has to do with practical application—actually working with a new technology to advantage. Universities do little thinking about this. Other goals, such as collaboration with industry, jobs for American workers, support for small companies, and protecting the public from non-use of inventions do not even figure in university reporting, technology transfer methods, and university IP policies. At best, most university IP policies reduce to “we own inventions without accountability and the only issue worth discussing is how much of our licensing income we have to share with the inventors.” Bayh-Dole deserves a broader, thoughtful implementation.
4) Develop IP models supporting consortia and multi-institutional research.
University IP policies and patent practices uniformly assume a single owner of inventions and associated patents. Joint ownership is an exception requiring interinstitutional agreements. Having a joint interest in inventions without joint ownership is uniformly rejected as a viable operating model. Yet in consortia (multiple partners centered around a common institutional leader) or multi-institutional research (multiple institutions sharing a common work plan, with common or multiple sources of funding) the default is necessarily a commons of all those participating, regardless of whether ownership technically is with one institution or another, and regardless of whether an institution wishes to make proprietary products. Until there are models of IP for such situations, and especially for the use of the patent system, there is no way to scale patent administration for broad, mutual, community-based research efforts.