Today KEI asked the Department of Commerce National Institute of Standards (NIST) to publish a notice in the Federal Register inviting comments on their Special Publication 1234, Draft Green Paper on Return on Public Investment, with an extended deadline.
The letter sent today is available here in PDF format.
The NIST Draft Green Paper on Return on Public Investment, a 135-pages long technical document published on December 6, 2018, includes proposals designed to narrow and even eliminate important 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, by enacting new regulations to restrict the use of march-in and royalty free rights in patents on federally funded inventions.
When it was originally released the NIST published a call for comments on the draft green paper, but only on their website, with an initial deadline of January 9, 2019 to file comments. During the initial comment period, the report disappeared from the NIST web page, due to the government shut down. Once the NIST web pages were back on line, after the shutdown, NIST simply posted a note on its web page that the comment period would be extended by 7 days, but never communicated to KEI or others who had requested an extension of the comment period.
Important to note that NIST never published a notice about the Green paper through the Federal Register.
KEI did file during the original comment period (copy here), but many groups did not, and had expected to file when a new deadline was announced.