Here is the “Bayh-Dole Coalition” on “What is the Bayh-Dole Act?” I will quote, mark up, and then comment briefly. There is more to write, but here’s enough to show that the Coalition has no grasp of the law, or has a grasp and chooses to misrepresent the law (less likely), or aims to deceive to get at what it wants, in typical political fashion. In the second part, I add eight key elements in Bayh-Dole that the Coalition leaves out, and those elements change everything. Funny they would ignore these things. Funny-sad, not funny-funny.
There are four sections. Let’s get at them.
Empowers universities, small businesses and non-profit institutions to take ownership of inventions made during federally-funded research, so they can license these basic inventions for further applied research and development and broader public use.
Empowers. The Supreme Court in Stanford v Roche said this was not so.
During. No. Just wrong. “Arising from.” Timing does not determine scope.
Federally-funded research. Or development. “Arising” from contractor work under a funding agreement.
So they can license. Nothing in Bayh-Dole requires a contractor to license anything. Small companies, especially. If a contractor does not take ownership, and there’s no patent, then there’s no need for a license–but still may be a need for technology transfer. Consider that–technology transfer without the threat of a patent to suppress use or demand money or cut in speculators.
Basic. Nothing limits inventions within scope to “basic” or “early stage.”
Encourages private-sector investment needed to turn basic government-funded research into tested and approved products, requires these products to be manufactured domestically and ensures royalties for universities to further advance basic research and education.
Encourages. Nothing in Bayh-Dole “encourages” investment. Not in the statement of policy and objectives.
Investment needed. No requirement to report investment. Not a concern of the law.
Basic. No mention of “basic” research, no implication that any or some or most federally supported work is either research or basic research.
Tested and approved products. Projection fantasy. Nothing in the law about “tested” or “approved.” Not even a concern for “products.” The focus is utilization–the practical application–of subject inventions, and the law is indifferent to the means by which utilization is achieved. Standards are as good as products are as good as royalty-free non-exclusive licensing are as good as changed commercial or professional or research practices.
Manufactured domestically. Way over-broad. Domestic manufacture is required only for exclusive licenses to use or to sell in the United States, and the requirement may be waived at the discretion of each federal agency. The NIH set up a web site devoted to processing waivers. The standard in the law is absurdly low–we tried to find a US manufacturer but couldn’t or we didn’t bother to try.
Ensures royalties. Nothing in the law ensures royalties for licensing. A contractor may license royalty-free. Or not license at all–so long as the contractor achieves practical application and otherwise satisfies health and regulatory needs. The law requires nonprofits and their assignees to share royalties with inventors, but that’s another thing entirely. Don’t get confused.
Basic. A second usage of “basic.” Bayh-Dole requires nonprofits to use royalties and income earned with respect to subject inventions for scientific research or education. No restriction to “basic” research. But there is a restriction to scientific research. Not development, not humanities research, not propping up a university’s technology transfer program generally.
Allows the government to require additional licensing of inventions arising from its research if the invention is not being made available for public use or during public health or other national emergencies.
Additional. Only part of it. There may have not been any licensing to start with. And the law provides for the voiding of existing licenses if a federal agency decides that an exclusive license is the thing.
Arising. Got it right here! But can’t be consistent.
Its. But also soon screwed up. The research is not the government’s research–there’s a whole other part of the law ignored here that deals with that. “Inventions arising from federally supported research or development.”
Not being made available. Yes, nonuse is one condition of march-in. But Bayh-Dole’s broader condition is “practical application”–utilized with benefits available to the public on reasonable terms. The essential phrase–perhaps of the whole law–is “on reasonable terms.” Not merely “available for public use.”
During national emergencies. Made up. The law’s concern is failure to reasonably satisfy health or regulatory needs. It does not matter whether there is an “emergency” or not.
Enacted by Congress with strong bipartisan support to ensure basic innovations discovered through federal research are developed into real-life products, including approved therapies that reduce suffering, treat the sick and improve the lives of patients.
Strong bipartisan support. There was a great deal of dissent, but then Senator Long (D), who said the bill was the worst he’d ever seen, cut a deal with Senator Dole (R). Senator Dole then screwed that deal by using an Executive Order rather than legislation to extend parts of Bayh-Dole to big companies.
Basic innovations. No restriction in Bayh-Dole to “basic” anything. “Innovation” is almost entirely skew from “invention” and absent from Bayh-Dole, which is part of federal patent law. Bayh-Dole does not assume any linear movement from basic to development to product.
Through federal research. Missed another chance to use “arising.” Again, not “federal” research, but rather the work performed at small businesses and nonprofits, funded in part by federal agencies. Leaves out “development,” which if included would interfere with the basic to development to product narrative, which the law doesn’t concern itself with.
Developed into real-life products. The concern in the law is utilization of subject inventions, not restricted to products. Even if one does develop a product and offer it on reasonable terms to the public, that does not mean that all obligations with regard to other claims covering stuff not used, developed, or released but controlled by a given patent are satisfied.
Suffering, sick, patients. Distracting melodrama. Norman Latker’s target in drafting Bayh-Dole was the requirement in the Kennedy and Nixon patent policies that federal agencies should take title to inventions made in federal work directed at public health and safety and release these inventions, patented or not, for all to use unless a contractor could show that holding patent rights would better serve the public interest. Bayh-Dole, however, does not concern itself with suffering, or the sick, or patients. Instead, it imposes a range of public protections for all subject inventions, and does not care whether there are products or standards or professional or commercial or research uses of any given subject invention.
Next, we will look at what the Coalition has left out.