NIST wants march-in for Bayh-Dole’s section 203(a)(2) and (3) to be for “national emergencies” only. Section (a)(2) concerns health or safety needs that are not “reasonably satisfied.” Section (a)(3) concerns regulatory requirements that are not “reasonably satisfied.” But the *price* element is in 203(a)(1). Only (a)(1) relies on the definition of practical application–use with benefits available to the public on reasonable terms.
If an invention is not used or the benefits of use are unlikely to be made available to the public on reasonable terms, no practical application has been achieved. If there’s no practical application, then a federal agency has the right under the standard patent rights clause to march in and require licensing of the subject invention. Compulsory licensing is the remedy for a failure to offer the benefits of using an invention to the public on reasonable terms. At least there’s the appearances of an apparatus in Bayh-Dole to protect the public interest. In practice, it’s not that way. In practice, no federal agency has ever “marched-in.” In practice, federal policy is not to protect the public interest with regard to practical application.
An NIH attorney–Norman Latker–drafted Bayh-Dole to reestablish a patent monopoly pipeline from the NIH to pharma. Latker had previously restarted the Institutional Patent Agreement program and drafted the master IPA. The IPA had the same effect as Bayh-Dole–to place federally supported inventions behind patent monopolies to be served out by nonprofits to the pharmaceutical industry. The IPA also had a public interest apparatus–but in practice that apparatus was ignored and nonprofits sought exclusive licenses for the biomedical inventions they claimed to own (and the IPA, unlike Bayh-Dole, provided a legal foundation for nonprofits to assert ownership of inventions made with NIH funding).
One argument for doing so is the monopoly meme. The claim of the monopoly meme is that without a patent monopoly, no one will use or develop a research invention. That’s nonsense, but there are people who love nonsense. Continue reading