In December 2018, the Department of Commerce National Institute of Standards (NIST) published NIST Special Publication 1234, “Return on Investment Initiative for Unleashing American Innovation” as a draft Green Paper. According to the initial release, before the government shutdown, comments were due by January 9, 2019.
The publication was available from: https://doi.org/10.6028/NIST.SP.1234, but is currently offline, due to the federal government shutdown.
[KEI has a copy here: NIST December 2018 Draft Green Paper]
KEI has asked NIST to extend the deadline for comments for those who do not have a copy of the document.
The draft green paper is 135 pages long, with 313 footnotes, and 8 pages of references. On page 7, there is a Summary of Intended Actions which is divided into 5 strategies. Some of the proposals are promising, but others are designed to neuter safeguards in the Bayh-Dole Act, and in particular, to protect companies that sell expensive drugs, vaccines, diagnostic tests and gene- and cell-treatments like CAR T from obligations to ensure products are affordable and accessible.
The initiative was launched after an April 19, 2018 “Unleashing American Innovation Symposium” in Washington, DC,” and followed four public hearings and a request for comments noticed on May 1, 2018 (83 FR 19052). The initial comment period closed July 30, 2018.
What started out as a review of licensing practices by federal labs ended upon with an attack on reasonable pricing obligations for drugs and other inventions.
Among the more appalling recommendations in the draft Green Paper are those that relate to three public interest safeguards in the Bayh-Dole Act, including:
- The federal government’s royalty-free right to inventions it funded, as mandated under 35 USC § 202 and 35 USC § 209;
- March-in rights on federally funded inventions, under 35 USC §203; and
- The obligation to bring federally-funded inventions to practical application, including in particular the requirement that the benefits of the inventions be made “available to the public on reasonable terms.”
The Draft Green Paper also includes analysis that is in some cases factually incorrect, incomplete or out of context, or and often lacks balance, in order to justify the argument that the U.S. government should not use its rights in federally funded inventions to ensure that biomedical products and services are reasonably priced.